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Furbush copied and pasted:
"I spoke at length with Punit this week, and I'm going to post parts of the conversation as I have time, it was over an hour, so it will take me some time. Punit feels that the big issues facing stock price right now is that few people are really able to follow what they are doing, having NeoPulse and not pursuing it, doing MCC and T-Cell Lymphoma and not pursuing them, so people dont see what they are doing and understand where the company is going. Why decisions are made etc. 2 trials that are important, Phase2B and TNBC, both will most likely lead to a Registration trial for combination with Keytruda for melanoma, and a combination of IL-12 and a new drug for Phase 1B in TNBC. They have limited resources and are really trying to focus all their attention into these 2 and only these 2"
"Heat Pre-clinical data should be available later this year (I guess late April), Plexxikon the trial is done, but they have not decided if they are proceeding further. We may not see that data. Phase 2B Interim data later this year (I expect at the electroporation conference in Aug/Sept), from the sound of it, they are progressing at a very respectable enrollment pace. He didn't say exactly, but I'd guess 3-4 a month. They are using their Perkins machine that they developed in the screening process. The big key here is that OncoSec is the ONLY company that is doing a trial with patients screened to not respond to Keytruda. So, If they get to the market, and provide a screening that shows who will not respond, there will only be one product that is FDA approved. If they aren't screened then the Dr.s may just use the shotgun approach of some other combination, now it is for the insurance to dictate which is lowest priced/ best bang for the buck. Big point is they will be the only FDA approved treatment for non responders of PD1."
"I think both Heat and Plexxikon will end up in partnerships. The Heat one won't happen till late this year as ONCS will have to pay for part of the trial and they are conserving cash. Plexxikon is the one I am not as confident about, but at least they could pay for the trial if they choose to, from my conversation I don't think Punit knows if that is going to go anywhere either. The first conversation he said "no one would get bonuses" the 2nd time they were "seriously considering" not giving bonuses, so we'll see where that goes. Dr. Pierce is 100% not going to be leaving the company, and is fully engaged in the process. Dr. Adil Daud is still heavily involved in their daily activities."
"I'm putting together a timeline of events that I now believe will happen. I'll post it here once I've got it ordered in what I believe to be an accurate manner. I don't know how many warrants are out there right now, but I know 2 lots of them will expire shortly. Punit has no interest in diluting this year, or at least at this share price. I just listened to him again, and he was rather clear about that. Don't expect it to happen unless the stock price goes up significantly. Both major shareholders (and I don't have there names in front of me) still own all the shares they have bought and are very comfortable with where ONCS is at.
People don't fully understand that ImmunoPulse is not IL-12 delivery, they have the ability to dose any DNA plasmid that they want. They can deliver dozens of plasmids at one time, so this can be a delivery system for other companies that develop DNA plasmids. Punit sounded very confident that they would be successful, which might just be him being a CEO."
"Poor communication: T-Cell Lymphoma trial was shutdown, they never finished enrollment, even though they had responses they shut it down as it wasn't something they wanted to pursue (he gave me a more detailed answer, but that is the gist). This was not PR'd, but no big deal IMO. May pursue it as a monotherapy in the future (so it had good response rates), but they need a better electroporation device to treat efficiently, and limited resources it is better to focus on Melanoma."
"Humorous post
So Punit is speaking and says "So I think your question is why are we undervalued as a company....see I'm making you ask the hard questions", only I hadn't asked any questions. On a serious note, I do have more respect for Punit after this. He relayed some personal stories to me, which I may share later, that show me this guy is dedicated and very personally invested in seeing ONCS be successful."
Indirectly Titan, OncoSec already is...and with a nice phase 2B head start!
Good afternoon lasers, not too much concerned about the shorters and definitely not a daytrader. I don't even care if this goes down to a penny I believe in the science so much. But pretty soon people should be worried about being on the sidelines in preparation for ASCO... I really think that's going to be huge regarding combination trial update.
OncoSec to Present at Prominent Investment Conferences in February
PR Newswire
SAN DIEGO, Feb. 3, 2016
SAN DIEGO, Feb. 3, 2016 /PRNewswire/ -- OncoSec Medical Incorporated ("OncoSec") (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, announced today that members of its leadership team will be making presentations at several high-profile events in February, including:
The 18th Annual BIO CEO & Investor Conference
Source Capital Group's 2016 Disruptive Growth & Healthcare Conference
Biocom's Global Life Science Partnering Conference
4th Annual Sachs Cancer Bio Partnering & Investment Forum
The 18th Annual BIO CEO & Investor Conference
Punit Dhillon, President and CEO, will present a corporate overview at The 18th Annual BIO CEO & Investor Conference on February 8 at 11:00 AM ET at The Waldorf Astoria in New York City. To view to the live webcast, please access the following link at the time of the presentation: http://www.veracast.com/webcasts/bio/ceoinvestor2016/76113125724.cfm. An archived version of the webcast will be available for 90 days on OncoSec's website: http://www.oncosec.com.
In its eighteenth year, The BIO CEO & Investor Conference is the largest investor conference focused on established and emerging publicly traded and select private biotech companies. Companies are able to present their company story to an audience of target investors and meet one-on-one with new and current investors, analysts, investment bankers, and other potential corporate partners. The conference also provides a platform to network with peers, investors, and potential partners attending the conference. For more information, please visit: https://www.bio.org/events/conferences/bio-ceo-investor-conference.
Source Capital Group's 2016 Disruptive Growth & Healthcare Conference
Mr. Dhillon will present a corporate overview at Source Capital Group's 2016 Disruptive Growth & Healthcare Conference on February 10 at 12:30 PM ET at Convene in New York City.
The 2016 Disruptive Growth & Healthcare Conference will feature presentations from life science companies focusing on solutions to unmet medical needs and growth companies with disruptive technologies and business models. Attendees will include over 400 institutional investors, accredited investors, family offices, analysts, registered investment advisors, wealth managers, Source representatives, and their clients. The panels will cover a variety of topics, including regenerative medicine, immunotherapy, diagnostics, disruptive innovations, and business models. For more information, please visit: www.sourcecapitalconference.com.
Biocom's Global Life Science Partnering Conference
Mr. Dhillon will present a corporate overview at Biocom's Global Life Science Partnering Conference taking place February 24-25 at The Lodge at Torrey Pines in La Jolla, CA.
Biocom's 6th Annual Global Life Science Partnering Conference is an exclusive global partnering and networking forum that brings together senior executives, bankers, venture capitalists, and business development professionals from leading pharmaceutical and biotech companies. The conference will include panel discussions on relevant topics with senior industry leaders, start-up company presentations, one-on-one meetings, and numerous networking opportunities. For more information, please visit: https://www.biocom.org.
4th Annual Sachs Cancer Bio Partnering & Investment Forum
Robert H. Pierce, MD, Chief Scientific Officer, will present a corporate overview at the 4th Annual Sachs Cancer Bio Partnering & Investment Forum on February 24 at 2:40 PM ET at the New York Academy of Sciences in New York City.
The 4th Annual Sachs Cancer Bio Partnering & Investment Forum is designed to bring together thought leaders from cancer research institutes, patient advocacy groups, pharmaceutical, and biotech to facilitate partnering and funding/investment. The conference will attract approximately 250 delegates and 30 company presentations by listed and private biotechnology companies seeking licensing and investment opportunities. The event provides a platform for one-on-one meetings and dedicated meeting facilities to make the event more productive. For more information, please visit: http://www.sachsforum.com/.
2016 ASCO Annual Meeting, June 3-7, Chicago IL
This is the conference I am hoping to here from Merck and/or Oncosec or both about any data they've obtained from UCSF regarding combo trial.
Abstract Submission Key Dates
November 13
Abstract Submitter Launches
February 2 by 11:59 PM (EST)
Abstract Submission Deadline
March 15
Late-Breaking Data Submission Deadline
March 16-17
Scientific Program Committee Meets to Select Abstracts
Late March
First Authors Notified of Abstract Selection Decision
Attendee Demographics
ASCO Registration Numbers
Total—37,000
Professionals—30,400
Exhibitors—4,890
Spouse, Guest, Media—1,750
Domestic Attendees—50%
International Attendees—50%
Top 10 Countries
United States—15,298
Germany—1,448
Japan—1,324
France—1,178
United Kingdom—996
Canada—925
China—845
Brazil—762
Switzerland—569
Italy—538
Primary Professional Role
Attendees were allowed to choose only one answer.
Responded— 24,588 (81%)
No Response—5,812 (19%)
Total—30,400
Primary Professional Role
Percentage of Attendees who Responded
Physician
52%
Other
20%
Researcher
10%
Marketing Representative
5%
Pharmacist
3%
Business Administrator
2%
Sales Representative
2%
Student
1%
Biostatistician/Epidemiologist
1%
Office Manager
1%
Nurse
1%
Financial Service Representative
1%
Board Certification or International Equivalent
Some attendees chose more than one response therefore the total number of responses is greater than the total number of attendees who responded.
Responded—19,656 (65%)
No Response—10,744 (35%)
Totals—30,400 (100%)
Board Certification or International Equivalent
Percentage of Attendees who Responded
Medical Oncology
38%
Not Applicable
27%
Internal Medicine
23%
Hematology
15%
Other
6%
Oncology Pharmacy
5%
Laboratory Research
5%
Pharmacology (Clinical)
4%
Surgery (including Surgical Oncology and Surgical Specialties)
3%
Biostatistics/Epidemiology
3%
Allied Health (e.g. Psychology, Physical Therapy, Social Work, etc.)
3%
Radiation Oncology
3%
Pediatics (including Pediatric Oncology and Pediatric Specialties)
2%
Gynecologic Oncology
2%
Oncology Nursing
2%
Gastroenterology
2%
Urology/Urologic Oncology
2%
Pathology
2%
Health Care Administration
1%
Neurology
1%
Hospice and Palliative Medicine
1%
Dermatology
1%
Primary Interest
Some attendees chose more than one response therefore the total number of responses is greater than the total number of attendees who responded.
Responded— 19,298 (63%)
No Response—11,102 (36.52%)
Totals—30,400
Primary Interest
Percentage of Attendees who Responded
Breast Cancer
24%
Clinical Trials
23%
Lung Cancer
20%
Developmental Therapeutics
13%
Gastrointestinal (Colorectal Cancer)
13%
Tumor Biology
11%
Lymphoma and Plasma Cell Disorders
10%
Leukemia, Myelodysplasia, and Transplantation
9%
Cancer Prevention, Genetics, and Epidemiology
9%
Gastrointestinal (Noncolorectal Cancer)
9%
Melanoma/Skin Cancers
7%
Genitourinary Cancer
7%
Head and Neck Cancer
5%
Gynecologic Oncology
5%
Health Services Research and Quality of Care
5%
Patient and Survivor Care
4%
Professional Development
4%
Sarcoma/Bone and Soft Tissue Cancers
3%
Care Delivery and Practice Management
3%
Central Nervous System Tumors
3%
Pathology
3%
Pediatric Cancer
2%
Practice Management and Information Technology
2%
Other
2%
Ethics
2%
Geriatric Oncology
1%
They might be waiting until the market carnage is all over. Not to mention they like to release valuable data at scientific conferences at just a press release.
Guti had a response over on yahoo to someone questioning institutional investors...
"Institutional strategy is to wait for March not because of a report, but more so for the science moving along.
An example of this will probably be an update on the TNBC study to be given at The 16th Multidisciplinary Management of Cancers: A Case-based Approach.
Tumor Board Cases will be presented by faculty, with discussion by a panel of surgical, radiation and medical oncologists from Stanford, UCSF, UC Davis and the practice community. On Friday, March 18, dr. Melinda Telli will present at the Breast Tumor Cases panel and on Sunday, March 20, dr. Adil Daud will present at the Cutaneous Malignancies Tumor Board Cases panel."
Also, this is at infantile stage of development. Mice show survivability but they have a long way to go with experimentation and clinical trials to demonstrate how long survival is, And what kind of response efficacy and durability of response will be in the future.
Good morning TJ, if I'm not mistaken this is not a device by Merck, it is a local injection at the tumor site with IL-12 rather than a systemic application, Since that process has high toxicity.
They are really just talking about another drug combination. I think it's also important to point out they don't get a systemic effect this way, It just assists the IL-2 and IL-7 to work systemically--I think.
Not if you don't sell!!!
Hey there Holycowitsteriffic (did I get that right?) my friend...
I don't have private communication here so I just copied and pasted some notes prior to Christmas of what we have to look forward to I believe in the first half of 2016 which in football terms I believe is that Oncosec is entering in the red zone and has to score a touchdown here, a field goal will not win the game for them. They have to demonstrate that they can significantly increase the micro environment with tumor infiltrating lymphocytes or at least for me, the game is over. Some of the smaller trials with Heat Biologics and Plexxikon will provide enough potential forward punch and build the energy for the data that will be released at ASCO. Guti added that I should also include the importanceof the mouse trial as well but I don't think that's going to be a big deal -- or should I say a PPS mover.
Back in 2012 I started accumulating stock and I'm up to 15k of genuine OncoSec shares. I was at 13,831 shares but was able to up my purchases by selling high and buying low again and accumulating more at lower prices. I wish I knew the dates of completion, press release dates, major scientific conferences that they will be releasing interim data at – – but I would be prepared for something big by the first week of June for the ASCO conference -- and I would watch for a prioritized publication of their material at the conference either by Oncosec or by Merck or both (collaboration, partnership, buyout are alwys a possibility, to include licensing agreement, at any point following a significant presentation of successful data by any of these smaller trials, melanoma with Merck not withstanding) To add spice to this I also think there will be a lead up of interim news from the following potentials:
The OncoSec Team is busting their ass' to break the “DaVinci Code” of the immune system and here's a little of what we have to look forward to as this unfolds in the coming New Year!
The christening of the NEW "go-anywhere" catheterized electroporation device which will allow OncoSec to reach tumors inside the body at soft tissue sites like bladder, lung, liver, pancreas, etc., possibly with new platform featuring IL-15
PerkinElmer’s new imaging-based staining methods to quantitatively evaluate CD8+ T cell density in tumor biopsy research--this work has the potential to identify responders from non-responders. Dr. Tumeh’s work, combined with PerkinElmer’s technology, may lead to the development of a critical diagnostic tool for identifying non-responders to anti-PD-1 monotherapy
Efficacy data of Heat’s proprietary DNA constructs with OncoSec’s clinical stage electroporation platform compatibility to be applicable across multiple cancer indications for both surface and sub-epidermal (soft tissue) tumors
Data Evaluating the potential of intratumoral treatment with pIL-12 delivered via electroporation to promote a pro-inflammatory molecular and histological signature in patients with triple negative breast cancer, Does it increase TILs, or turn non-responders to responders.
Data demonstrating whether or not blocking CSF-1R with Plexxikon’s selective CSF-1R inhibitor will lead to synergistic effects with Immunopulse in the syngeneic B16.F10 melanoma mouse model
and what we will all be waiting for--Data to be delivered in Chicago at ASCO June 3-7; Interium Data assessing the anti-tumor efficacy (defined as the best overall response rate using RECIST v1.1) and safety of the combination of plasmid interleukin-12 electroporation and pembrolizumab in patients with low tumor-infiltrating lymphocyte (TIL) melanoma.
-Waitforit
Immunotherapy Inside the Cell: Three Companies on Their Way to the 'Holy Grail' of Cancer Treatment SRNE, INO, ONCS
Source: Tracy Salcedo of The Life Sciences Report (1/6/16)
Targeting diseases from inside the cell could be medicine's version of the dawn of the Internet. Or, as newsletter writer Chen Lin describes it, advances from companies like Sorrento Therapeutics Inc. to introduce autologous immunotherapy intracellularly "opens a whole dimension." Dorman Followwill of Frost & Sullivan suggests this new approach could shift the focus from "therapy" to "cure," with rewards for the companies leading the way. In this article, The Life Sciences Report explores the possibilities of these new technologies—and the prospects for companies like Sorrento, Inovio Pharmaceuticals Inc. and OncoSec Medical Inc.—with Lin, Followwill and Ram Selvaraju of Rodman and Renshaw.
Immunotherapy is relatively new in the biotech space, but has already seen commercial success. Marketed immunotherapeutics include inhibitors such as Humira (adalimumab; AbbVie Inc. [ABBV:NYSE]), for autoimmune diseases such as rheumatoid arthritis, plaque psoriasis and ulcerative colitis, and Erbitux (cetuximab; Eli Lilly and Co. [LLY:NYSE]), for head-and-neck and metastatic colon cancer. Other big players in the immunotherapy field include Bristol-Myers Squibb Co. (BMY:NYSE) and Genentech/ Roche Holding AG (RHHBY:OTCQX), developer of blockbusters Avastin (bevacizumab; 2014 sales of ~$8.6 billion [$8.6B]) and Rituxan (rituximab; 2014 sales of ~$6.9B).
These approved therapies home in on targets that are either in the microenvironment surrounding the cell or on the cell membrane, and have shown great efficacy in the treatment of a variety of diseases. But researchers and sector analysts consider the interior of the cell the ultimate target—or, as Frost & Sullivan analyst Dorman Followwill dubs it, the "Holy Grail" of cancer treatment.
"Inovio Pharmaceuticals Inc. generated very positive and encouraging clinical data from a Phase 2b trial of VGX-3100."—Ram Selvaraju
Think of a cancer cell as a castle surrounded by a moat. You can lay siege outside the walls, attack the walls themselves, or breach the walls and take out the command center. The first two modes of attack can be successful, but a comeback could be staged if defenses are rebuilt from inside. By taking out the core, everything crumbles. Better yet, nothing is left to stage a comeback with. Cancer cured.
To find out more about the promise of intracellular immunotherapies, both for patients and investors, The Life Sciences Report spoke with Followwill, Rodman & Renshaw analyst Ragharum "Ram" Selvaraju, Chen Lin, publisher of the popular investment newsletter What Is Chen Buying, What Is Chen Selling?, Dr. J. Joseph Kim, CEO of Inovio Pharmaceuticals Inc. (INO:NASDAQ), and Henry Ji, president and CEO of Sorrento Therapeutics Inc. (SRNE:NASDAQ), which recently launched a new collaboration focused on delivering therapeutics intracellularly.
"If everything plays out through the clinical trials process, that will position Sorrento Therapeutics Inc. as one of the greatest biotechs in history."—Dorman Followwill
Ji draws parallels between immunotherapeutic targets and real estate. But instead of "location, location, location," it's all about "target, target, target."
"Scientists have been looking for ways to build inside the cell for the last 30 years. This is the biggest frontier," Ji explained. His company's new joint venture with City of Hope National Medical Center, a respected research and treatment hospital in Southern California, is called LA Cell Inc. The venture is focused on "the development of groundbreaking cell-penetrating antibody therapies" that provide access to the disease-causing proteins located inside the cell.
Engineering Intracellular Immunotherapies
Selvaraju and Followwill provided nuanced explanations of how an intracellular approach could work against cancer and other diseases. By triggering autologous immunotherapy within the cellular structure itself, the oncoproteins in the cell are exposed to cytotoxic drugs and the body's own immunological weaponry.
"Cancer cells tend not to be red-flagged by the immune system, but autologous (generated within the patient's body) immunotherapy would unmask the cells so that the immune system could then attack," Followwill explained. "The Holy Grail in oncology therapeutics is to find a way to trigger the body's own immune responses against cancer cells wherever they happen to be presenting."
"Inovio Pharmaceuticals Inc. has an interesting technology; the therapy has a two-sided aspect to it." —Dorman Followwill
Targeted immunotherapeutic monoclonal antibodies already on the market "are known to be quite effective in the treatment of cancer," Selvaraju said. These drugs now act on targets outside the cell. The problem? They lose effectiveness over time. "There is wide-ranging evidence that resistance can develop against these antibodies," Selvaraju said.
But if antibodies can be delivered intracellularly, Followwill and Selvaraju believe they'd be better able to kill cancer cells. “If they can trigger the autologous immunotherapy within the cell structure itself, then I think we've taken a major leap forward," Followwill said.
Several companies are looking at ways to penetrate the cell membrane and expose the ideal targets within. Sorrento and LA Cell, for example, are developing monoclonal antibodies against the same targets that have been effectively addressed by Herceptin (traztuzumab; Roche) and Rituxan, "the idea being that these new, next-generation, engineered antibodies will hit the targets both on the cell and intracellularly. This is important because in vitro data and some testing in animal models indicate that these new, next-generation drugs retain cell-killing, or cytotoxic, effectiveness," Selvaraju said.
"For a therapy from Sorrento Therapeutics Inc. I would look for a 505(b)(2) pathway." —Chen Lin
Two other companies, Inovio Pharmaceuticals and OncoSec Medical Inc. (ONCS:NASDAQ), are developing therapies that breach the cell membrane using electrical pulses, opening the door for delivery of their therapeutics.
Selvaraju believes the potential for retained efficacy through immunotherapy "creates a very, very broad array of future product development opportunities."
"If you can target and treat inside the cell, that opens a whole dimension," Lin agreed. "If this is as successful as we hope, it will be like the dawn of the Internet age, but for medicine. We can use intracellular immunotherapeutic technology, potentially, to kill many, many diseases and save millions and millions of people."
Companies in the Field
Followwill, Selvaraju, and Lin are all following the technology being developed by Sorrento Therapeutics' LA Cell Inc. joint venture.
"We, as a firm, have been watching Sorrento since its inception, because we've been looking at the monoclonal antibody field for a long time," Followwill said. The fact that Sorrento has compiled an extensive monoclonal antibody (mAb) library and patent protection—Ji said his company's goal is to possess "the #1 antibody library in the world"—means it has the ability and freedom to generate novel therapeutics for a wealth of targets.
"Intracellular immunotherapy is the 'Holy Grail' of cancer treatment."—Dorman Followwill
Sorrento's chemical approach to intracellular immunotherapy does have competition. Both Inovio (~$454 million [$454M) market cap) and OncoSec (~$39M market cap) are hoping to develop technologies that penetrate the cell membrane. These two companies, in Selvaraju's view, "are very closely related." The management teams "share bloodlines," and their technology platforms both employ electrical means to gain access to insides of cells.
But they differ in significant ways, the analyst explains. Inovio is developing "a suite of DNA vaccines" that, when delivered to patients, "effectively induce immune cell activation by getting tumor cell antigens to be expressed at higher levels, effectively creating an endogenous immune response within the patient." Electroporation is employed to breach the cell membrane and insert the vaccine.
Followwill finds Inovio's use of electroporation and vaccines intriguing. "It's a very interesting technology," he said. "Is it a technology that could trigger autologous immunotherapy? I would say possibly. I like the fact that it's not only immune therapy but also a vaccine. The therapy has a two-sided aspect to it."
"We should see Sorrento Therapeutics Inc.'s first investigational new drug (IND) application filed in 2016; there is enough evidence for investors to at least be intrigued."—Ram Selvaraju
Inovio generated some "very positive and encouraging clinical data from a Phase 2b trial of VGX-3100, which is its lead drug candidate for the treatment of cervical cancer" in late 2014, Selvaraju said. The company is also active in HIV and hepatitis infections.
OncoSec is trying to increase the expression of interleukin-12 (IL-12), "a well-known pro-inflammatory cytokine found in and around the tumor itself." Selvaraju said. "If you boost IL-12, it basically acts as a chemo-attractant for the immune cells. It's like a dog's scent and a fox—the IL-12 is the fox drawing the dog to a specific site of the tumor, the dog in this context being the immune cells."
The ImmunoPulse IL-12 technology has already demonstrated activity in Merkel cell carcinoma in one Phase 2 study. And in metastatic melanoma, Selvaraju said, "the activity appears to be quite intriguing because the company saw a number of complete responses. I believe there were four complete responses, and a number of partial responses, as well as some stable disease."
What OncoSec and Inovio are developing is very different from what Sorrento and LA Cell are doing, Selvaraju added. "Sorrento is applying an extrinsic factor—the engineered monoclonal antibodies—and OncoSec and Inovio are trying to induce an intrinsic immune response against the tumor."
The Investment Proposition
All these companies, given their early-stage status and disruptive technologies, are primed for partnerships with larger biotechs or big pharma.
Lin, being "very focused on the investment perspective," is a proponent of this thesis. "Because this target is so big and has the potential to cure so many different diseases, as it becomes a new center of the industry, I expect that major pharma will get involved, either through collaborations or licensing technologies," he said.
Followwill agreed. "I think the big milestone for any one of these companies is when it signs a big collaboration or a big deal with one of the Top 10 pharma companies. That's your ultimate market validation."
Sorrento's management, Selvaraju noted, "has been very clear it views the company as an idea generator, as a relentless innovator." He sees Sorrento as "emblematic of all three companies in that they are going to wind up seeking and potentially establishing significant strategic partnerships geared toward the commercialization of their individual specific therapeutic entities."
"If we can trigger autologous immunotherapy, then we can start to use a different word in the same sentence with cancer. We can start using the word cure."—Dorman Followwill
Striking a collaboration—for instance, if Sorrento can hook up with Celgene Corp. (CELG:NASDAQ)—"is something that investors should watch for very closely," Selvaraju added. "Obviously, the faster these companies can get collaboration agreements in place—the faster these companies can validate their technology platforms by entering into these kinds of strategic agreements—the better the stocks are going to perform."
Another promising aspect of the immunotherapy proposition, as it pertains to Sorrento particularly, is potentially quicker access to the market, according to Lin. "For a therapy from Sorrento, I would look for [a] 505(b)(2) pathway," he said.
Management should always factor into investment decisions. Sorrento's management and ethic has been integral to its success, and is part of what makes it an attractive investment, in Followwill's view. Reflecting on a 2013 visit to the company's headquarters in San Diego, he noted Sorrento had a "full pipeline of oncology candidates. It was really impressive to me. And it had achieved that with a mere 18 employees." That kind of "frugal innovation," which is badly needed by big pharma, sets the company up for continued success, he said.
"This is what pharma 2.0 needs to look like—guys that are churning out phenomenal pipelines of new, innovative products with relatively small human capital but genuine innovation, genuine creativity," he said.
Leadership is also key, Followwill continued. In Sorrento's CEO, Ji, for example, "you have both scientific brilliance and commercial acumen. He's really built a company that I think investors should watch more than any other in the space right now. . .Frankly, if everything plays out through the clinical trials process, that will position the company as one of the greatest biotechs in history."
In terms of milestones, "in the case of Sorrento and LA Cell, this is very early-stage work," Selvaraju said. "Nothing has been progressed into the clinic. I would anticipate that we should see the first investigational new drug (IND) application filed [in 2016], and potentially the first clinical development milestones reached a year after that." But, he added, "There is enough evidence for investors to at least be intrigued."
Inovio SynCon
Courtesy of Inovio Pharmaceuticals
For OncoSec and Inovio, there are some nearer-term milestones. "From our perspective," Selvaraju said, "OncoSec is potentially earlier stage than Inovio, but the ImmunoPulse IL-12 technology-based agent for metastatic melanoma has generated Phase 2 results. This agent could generate additional results from the Phase 2 study within the coming months."
Selvaraju said Inovio's DNA technology could potentially generate pivotal data within the next 12–18 months. "If that's the case, then Inovio would be in a very good position to potentially advance to the formal regulatory filing of its first DNA vaccine," he said.
Additionally, Inovio plans to move "into the domain of what it calls DNA monoclonal antibodies," Selvaraju said. "Essentially, it plans to introduce the DNA and coding of a monoclonal antibody into the patient, and trigger the body of the patient to make the antibody. In effect, the technology primes the patient into his/her own bioreactor." The company is using that approach primarily on highly resistant bacterial infections. Selvaraju expects Inovio could provide proof-of-concept data for that technology by the end of 2016.
Dr. J. Joseph Kim, CEO of Inovio, said, "Inovio’s SynCon DNA-based immunotherapies enhance the body’s existing mechanisms to tackle cancers and infectious diseases, and we can uniquely target any of the specific diseases in these categories. Successful commercialization represents market potential of many tens of billions of dollars. This is not just the glint of an eye. Our Phase 2 data showing best-in-class killer T-cell generation in the body, correlated to efficacy, was recently published in The Lancet. Inovio will launch a Phase 3 study of this lead product this year for HPV-related cervical dysplasia. We see the potential for the first product approvals over the next few years."
All three experts noted that investors considering adding intracellular immunotherapy companies to their portfolios should be prepared for the long haul. Selvaraju expects that immunotherapies will start in the marketplace as "the final option—the last line of defense—because they're the newest agents." However, if drugs delivered intracellularly "provoke complete responses and have high objective response rates clinically, then there's no reason why they couldn't potentially gradually be elevated up the food chain."
The Promise of Intracellular Immunotherapies
In the end, all the experts agree that the promise of intracellular immunotherapies and the companies developing them is not just about investment opportunity.
"There's an overarching human good here," Followwill said. "If we can finally truly trigger autologous immunotherapy, then we can start to use a different word in the same sentence with cancer. We can start using the word cure, as opposed to therapy, regimen, stage, and all the typical language of oncology. If we can truly get the Holy Grail of autologous immunotherapy triggered, then we can take a quantum leap forward in the field."
A founding member of Frost & Sullivan's global Growth Consulting enterprise, Dorman Followwill has more than 30 years of experience, both in the field of management consulting and as a manager in the nonprofit sector. He began his career as a management consultant with Marakon Associates in San Francisco. He has worked for Frost & Sullivan for more than 16 years, in both the U.S. and in Europe, having overseen the global Growth Consulting enterprise in its infancy, as well as managing the most profitable business unit in the 54-year history of the firm. Followwill currently serves as a partner on the Partner Leadership Team overseeing the European practice as a whole, as well as managing the Healthcare practice in Europe, Israel and Africa. He has managed a wide variety of consulting engagements with Frost & Sullivan, including acquisition analyses and emerging market analyses for GE Healthcare, long-term strategic planning projects for a division of Merck, quarterly product tracking to the brand level over more than 11 years for Bayer, market size and epidemiology analysis for GlaxoSmithKline, multiple product analyses for Philips Medical, as well as a host of other projects for clients such as 3M, Medtronic, Johnson & Johnson, Siemens Medical Systems, IBM, Hewlett Packard, Roche Diagnostics, Hitachi and many others. He has executed coaching workshops focused on mega trends-driven innovation over the past five years with Daiichi Sankyo, Roche Diagnostics, Merck Millipore, Honeywell, Endress + Hauser, Shell, GE Healthcare and Hitachi. Followwill had a bachelor's degree in management of organizations from Stanford University.
Chen Lin writes the popular stock newsletter What Is Chen Buying? What Is Chen Selling?, published and distributed by Taylor Hard Money Advisors, Inc. While a doctoral candidate in aeronautical engineering at Princeton, Chen found his investment strategies were so profitable that he put his Ph.D. on the back burner. He employs a value-oriented approach and often demonstrates excellent market timing due to his exceptional technical analysis.
Raghuram "Ram" Selvaraju's professional career started at the Geneva-based biotech firm Serono in 2000, where he discovered the first novel protein candidate developed entirely within the company. He subsequently became the youngest recipient of the company's Inventorship Award for Exceptional Innovation and Creativity. Selvaraju started in the securities industry with Rodman & Renshaw as a biotechnology equity research analyst. He was the top-ranked (#1) biotech analyst in The Wall Street Journal's "Best on the Street" survey (2006) and went on to become head of healthcare equity research at Hapoalim Securities, the New York-based broker/dealer subsidiary of Bank Hapoalim B. M., Israel's largest financial services group. While at Hapoalim, Selvaraju was regularly featured in The Wall Street Journal, Barron's, BioWorld Today, and Reuters/AP. He was also a regular guest on the Bloomberg TV program "Taking Stock," appeared with Bloomberg TV's on-air correspondents Betty Liu and Gigi Stone and was a guest on CNBC's "Street Signs with Herb Greenberg."
From SEC FORM 8-K re: Dr. Le
OncoSec is paying half a million per year in combined salaries to Dr.'s Pierce and Le.
On September 16, 2014, the Company appointed Dr. Mai Hope Le as Chief Medical Officer of the Company. Dr. Le has replaced Dr. Pierce in such position.
Prior to joing the Company, Dr. Le, 38, was Medical Director at Calithera Biosciences, Inc. from July 2013 to September 2014, where she formulated and launched the early clinical development plans for a novel small molecule inhibitor of glutaminase for a variety of solid and hematological tumor indications. From June 2008 to April 2013, she was medical director or associate medical director at Plexxikon Inc., Onyx Pharmaceuticals, Inc., and Proteolix, Inc. At Proteolix and, later, Onyx Pharmaceuticals, her work contributed to the accelerated approval of carfilzomib (Kyprolis™), a second generation proteosome inhibitor, for the treatment of relapsed/refractory multiple myeloma. Prior to entering medical school, Dr. Le managed clinical trials for PAREXEL Inc. in Waltham, Massachusetts. Dr. Le received her medical degree at the University of Rochester School of Medicine and Dentistry and completed her residency in Clinical Pathology/Laboratory Medicine at the University of California at San Francisco. She received her Bachelor of Arts in Biology from Cornell University. Dr. Le is licensed to practice in California.
Dr. Robert Pierce, our Chief Scientific Officer, and Dr. Mai Hope Le, our Chief Medicial Officer, are married to each other and they will both report to the Company’s Chief Executive Officer. There have been no related transactions, and none are contemplated, between Dr. Le or any of her immediate family members and the Company that would require disclosure pursuant to Item 404(a) of Regulation S-K promulgated by the Securities and Exchange Commission.
Executive Employment Agreement with Chief Medical Officer
In connection with Dr. Le’s appointment, effective as of September 16, 2014, the Company entered into an executive employment agreement (the “Employment Agreement”) with Dr. Le. The principal terms of the Employment Agreement are as follows:
The Employment Agreement provides for the following, among other things: (a) a base annual salary of $260,000; (b) a relocation bonus of $54,000; (c) eligibility to receive an annual bonus at the discretion of the Board of Directors; (d) as an inducement material to entering into employment with the Company, a stock option award granted under the Company’s Amended and Restated 2011 Stock Incentive Plan to purchase up to 1.7 million shares of the Company’s common stock at an exercise price of $0.52 per share, the closing price of the Company’s common stock on the date of grant of the award, and to vest as follows: 25% of the shares underlying the award shall vest on September 16, 2014 and the remaining 75% of the shares underlying the award shall vest in equal installments on each monthly anniversary of September 16, 2014; and (e) if Dr. Le is terminated other than for cause, by death or by disability, or if she terminates her employment with the Company for good cause, then Dr. Le will be entitled to receive (i) prior to such time as she shall have provided services to the Company for twelve (12) months, severance payments by the Company of an amount aggregate equal to nine (9) months of her then-current base annual salary plus accrued bonus (if applicable), less applicable statutory deductions and withholdings, or (ii) following such time as she shall have provided services to the Company for twelve (12) months, severance payments by the Company of an aggregate amount equal to twelve (12) months of her then-current base annual salary plus accrued bonus (if applicable), less applicable statutory deductions and withholdings, with any such severence payments to be paid as salary continuation (and not as a lump sum) over the applicable period and in accordance with the Company’s standard payroll practices.
Business Wire
FDA Approves Expanded Indication for Merck’s KEYTRUDA® (pembrolizumab) for the Treatment of Patients with Advanced Melanoma
KEYTRUDA is Now the First and Only Anti-PD-1 Therapy to Achieve Superior Overall Survival Compared to Ipilimumab
December 18, 2015 04:05 PM Eastern Standard Time
KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 (programmed death receptor-1) therapy, to include the first-line treatment of patients with unresectable or metastatic melanoma. This approval marks the second FDA-approved indication in advanced melanoma for KEYTRUDA, which is now the first anti-PD-1 therapy approved for previously untreated advanced melanoma patients regardless of BRAF status. The FDA-approved dose of KEYTRUDA is 2 mg/kg every three weeks.
“As recently as five years ago, there were few treatment options for patients suffering from advanced melanoma”
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In a Phase 3 trial, KEYNOTE-006, patients with unresectable or metastatic melanoma who were treated with KEYTRUDA experienced superior overall survival (OS) compared to those treated with ipilimumab. In this study supporting the first-line approval, patients given KEYTRUDA 10 mg/kg every two weeks demonstrated a 37 percent reduction in the risk of death and those given KEYTRUDA 10 mg/kg every three weeks demonstrated a 31 percent reduction in the risk of death, both compared to ipilimumab (hazard ratio: 0.63 [95% CI: 0.47, 0.83; p<0.001] and hazard ratio: 0.69 [95% CI: 0.52, 0.90; p=0.004], respectively).
Immune-mediated adverse reactions occurred with KEYTRUDA including pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis. Based on the severity of the adverse reaction, KEYTRUDA should be withheld or discontinued and corticosteroids administered. For more information regarding immune-mediated adverse reactions, see "Selected Important Safety Information" below.
“As recently as five years ago, there were few treatment options for patients suffering from advanced melanoma,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. “Today’s news is another exciting milestone for KEYTRUDA and for patients with this disease. Data supporting the approval emerged from a large and diverse patient population, including patients with very advanced disease and patients whose tumors carried BRAF mutations, thus demonstrating both the breadth of our clinical development program for KEYTRUDA, and the potential of KEYTRUDA to extend the lives of those afflicted with this grievous malignancy.”
KEYTRUDA (pembrolizumab) is a humanized monoclonal antibody that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.
“This growing body of evidence in patients with advanced melanoma supports the expanded indication for KEYTRUDA,” said Dr. Omid Hamid, Director of the Melanoma Center at The Angeles Clinic and Research Institute, and a principal investigator for the KEYTRUDA melanoma clinical program. “This approval highlights the importance of KEYTRUDA for advanced melanoma, where we are in need of additional treatment options.”
Data Supporting First-Line Indication in Advanced Melanoma and KEYTRUDA Full Approval
The approval was based on data from a multicenter, controlled, Phase 3 study, KEYNOTE-006, which evaluated KEYTRUDA compared to ipilimumab in 834 patients with unresectable or metastatic melanoma with progression of disease; no prior therapy with ipilimumab; and prior therapy with at most one other systemic treatment. Patients were randomized (1:1:1) to receive KEYTRUDA at a dose of 10 mg/kg every two (n=279) or three weeks (n=277) until disease progression or unacceptable toxicity, or ipilimumab, the standard of care at the time of the study, at a dose of 3 mg/kg every three weeks for four doses unless discontinued earlier for disease progression or unacceptable toxicity (n=278). The primary efficacy outcome measures were OS and progression-free survival (PFS) (as assessed by Blinded Independent Central Review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1). Secondary efficacy outcome measures were overall response rate (ORR) and response duration. KEYTRUDA 10 mg/kg every two or three weeks showed superior OS compared to ipilimumab (hazard ratio: 0.63 [95% CI: 0.47, 0.83; p<0.001] and hazard ratio: 0.69 [95% CI: 0.52, 0.90; p=0.004], respectively). Median PFS was 5.5 months (95% CI: 3.4, 6.9), 4.1 months (95% CI: 2.9, 6.9), and 2.8 months (95% CI: 2.8, 2.9) with KEYTRUDA 10 mg/kg every two weeks, KEYTRUDA 10 mg/kg every three weeks and ipilimumab, respectively. For PFS, both schedules for KEYTRUDA 10 mg/kg every two or three weeks resulted in superior outcomes compared to ipilimumab (hazard ratio: 0.58 [95% CI: 0.46, 0.72; p<0.001] and hazard ratio: 0.58 [95% CI: 0.47, 0.72; p<0.001], respectively). KEYTRUDA every two or three weeks demonstrated a 42 percent reduction in the risk of disease progression or death as compared to ipilimumab. The ORR was 34 percent (95% CI: 28, 40) with KEYTRUDA 10 mg/kg every two weeks and 33 percent (95% CI: 27, 39) with KEYTRUDA (pembrolizumab) 10 mg/kg every three weeks, as compared with 12 percent (95% CI: 8, 16) with ipilimumab. KEYTRUDA 10 mg/kg every two weeks and three weeks achieved partial response rates of 29 percent and 27 percent, respectively, and complete response rates of 5 percent and 6 percent, respectively; there was a 10 percent partial response rate and 1 percent complete response rate for ipilimumab. Among the 94 patients randomized to KEYTRUDA 10 mg/kg every two weeks with an objective response, response durations ranged from 1.4+ to 8.2 months. Among the 91 patients randomized to KEYTRUDA 10 mg/kg every three weeks with an objective response, response durations ranged from 1.4+ to 8.1+ months.
Eighty percent of patients had PD-L1 positive melanoma, 18 percent had PD-L1 negative melanoma, and 2 percent had unknown PD-L1 status (positive: greater than or equal to 1 percent of tumor cells using an Investigational Use Only assay). BRAF mutations were reported in 36 percent of patients, of which 46 percent were previously treated with a BRAF-inhibitor. Patients with BRAF V600E mutated melanoma were not required to have received prior BRAF inhibitor therapy.
The most commonly reported adverse reactions were fatigue (28% with KEYTRUDA vs. 28% with ipilimumab), diarrhea (26% with KEYTRUDA), rash (24% with KEYTRUDA vs. 23% with ipilimumab), and nausea (21% with KEYTRUDA). Corresponding incidence rates are listed for ipilimumab only for those adverse reactions that occurred at the same or lower rate than with KEYTRUDA.
Severe and life-threatening infusion-related reactions have been reported in 3 (0.1%) of 2,117 patients. Monitor patients for signs and symptoms of infusion related reactions including rigors, chills, wheezing, pruritus, flushing, rash, hypotension, hypoxemia, and fever. For Grade 3 or 4 reactions, stop infusion and permanently discontinue KEYTRUDA.
Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. If used during pregnancy, or if the patient becomes pregnant during treatment, apprise the patient of the potential hazard to a fetus. Advise females of reproductive potential to use highly effective contraception during treatment and for four months after the last dose of KEYTRUDA.
FDA Approves Labeling Update in Advanced Melanoma: Supporting Data from KEYNOTE-002
Additionally, the FDA approved an update to the product labeling for KEYTRUDA for the treatment of patients with ipilimumab-refractory advanced melanoma. This update is based on results from the randomized Phase 2 trial, KEYNOTE-002, which demonstrated KEYTRUDA was superior to investigator’s choice chemotherapy.
KEYNOTE-002 is a multicenter, randomized controlled study of KEYTRUDA (pembrolizumab) 2 mg/kg every three weeks or 10 mg/kg every three weeks compared to investigator‘s choice chemotherapy (dacarbazine, temozolomide, carboplatin plus paclitaxel, paclitaxel, or carboplatin) in 540 patients with unresectable or metastatic melanoma with progression of disease; refractory to two or more doses of ipilimumab and, if BRAF V600 mutation positive, a BRAF or MEK inhibitor; and disease progression within 24 weeks following the last dose of ipilimumab. Patients on chemotherapy who experienced progression of disease were offered KEYTRUDA. Median PFS was 2.9 months (95% CI: 2.8, 3.8), 2.9 months (95% CI: 2.8, 4.7), and 2.7 months (95% CI: 2.5, 2.8) with KEYTRUDA 2 mg/kg every three weeks (n=180), KEYTRUDA 10 mg/kg every three weeks (n=181) and chemotherapy (n=179), respectively. Doses of KEYTRUDA 2 mg/kg or 10 mg/kg every three weeks were superior compared to chemotherapy for the PFS primary endpoint (hazard ratio: 0.57 [95% CI: 0.45, 0.73; p<0.001] and hazard ratio: 0.50 [95% CI: 0.39, 0.64; p<0.001], respectively). KEYTRUDA 2 mg/kg every three weeks demonstrated a 43 percent reduction in the risk of disease progression or death compared to chemotherapy. There was no statistically significant difference between KEYTRUDA and chemotherapy in the interim OS analysis. The ORR was 21 percent (95% CI: 15, 28) with KEYTRUDA 2 mg/kg every three weeks and 25 percent (95% CI: 19, 32) with KEYTRUDA 10 mg/kg every three weeks, as compared with 4 percent (95% CI: 2, 9) with chemotherapy. KEYTRUDA 2 mg/kg and 10 mg/kg every three weeks achieved partial response rates of 19 percent and 23 percent, respectively, and complete response rates of 2 percent and 3 percent, respectively; there was a 4 percent partial response rate and no complete responses for chemotherapy. Among the 38 patients randomized to KEYTRUDA 2 mg/kg with an objective response, response durations ranged from 1.3+ to 11.5+ months. Among the 46 patients randomized to KEYTRUDA 10 mg/kg with an objective response, response durations ranged from 1.1+ to 11.1+ months.
The most commonly reported adverse reactions were fatigue (43% with KEYTRUDA), pruritus (28% with KEYTRUDA vs. 8% with chemotherapy), rash (24% with KEYTRUDA vs. 8% with chemotherapy), constipation (22% with KEYTRUDA vs. 20% with chemotherapy), nausea (22% with KEYTRUDA), diarrhea (20% with KEYTRUDA vs. 20% with chemotherapy), and decreased appetite (20% with KEYTRUDA). Corresponding incidence rates are listed for chemotherapy only for those adverse reactions that occurred at the same or lower rate than with KEYTRUDA.
KEYTRUDA was initially approved in 2014 under the FDA’s accelerated approval process for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. At the time of the initial approval, an improvement in survival or disease-related symptoms was not established. In accordance with the accelerated approval process, full approval was contingent upon verification and description of clinical benefit, which has now been demonstrated in KEYNOTE-002 and KEYNOTE-006.
Selected Important Safety Information for KEYTRUDA (pembrolizumab)
Immune-mediated pneumonitis, including fatal cases, occurred in patients receiving KEYTRUDA. Pneumonitis occurred in 32 (2%) of 1,567 patients with melanoma, including Grade 1 (0.8%), 2 (0.8%), and 3 (0.4%) pneumonitis. Pneumonitis occurred in 19 (3.5%) of 550 patients with non-small cell lung cancer (NSCLC), including Grade 2 (1.1%), 3 (1.3%), 4 (0.4%), or 5 (0.2%) pneumonitis. Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.
Immune-mediated colitis occurred in 31 (2%) of 1,567 patients with melanoma, including Grade 2 (0.5%), 3 (1.1%), and 4 (0.1%) colitis. Immune-mediated colitis occurred in 4 (0.7%) of 550 patients with NSCLC, including Grade 2 (0.2%) or 3 (0.4%) colitis. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.
Immune-mediated hepatitis occurred in 16 (1%) of 1,567 patients with melanoma, including Grade 2 (0.1%), 3 (0.7%), and 4 (0.1%) hepatitis. Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.
Hypophysitis occurred in 13 (0.8%) of 1,567 patients with melanoma, including Grade 2 (0.3%), 3 (0.3%), and 4 (0.1%) hypophysitis. Hypophysitis occurred in 1 (0.2%) of 550 patients with NSCLC, which was Grade 3 in severity. Monitor patients for signs and symptoms of hypophysitis (including hypopituitarism and adrenal insufficiency). Administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2; withhold or discontinue for Grade 3 or 4 hypophysitis.
Hyperthyroidism occurred in 51 (3.3%) of 1,567 patients with melanoma, including Grade 2 (0.6%) and 3 (0.1%) hyperthyroidism. Hypothyroidism occurred in 127 (8.1%) of 1,567 patients with melanoma, including Grade 3 (0.1%) hypothyroidism. Hyperthyroidism occurred in 10 (1.8%) of 550 patients with NSCLC, including Grade 2 (0.7%) or 3 (0.3%) hyperthyroidism. Hypothyroidism occurred in 38 (6.9%) of 550 patients with NSCLC, including Grade 2 (5.5%) or 3 (0.2%) hypothyroidism. Thyroid disorders can occur at any time during treatment. Monitor patients for changes in thyroid function (at the start of treatment, periodically during treatment, and as indicated based on clinical evaluation) and for clinical signs and symptoms of thyroid disorders. Administer replacement hormones for hypothyroidism and manage hyperthyroidism with thionamides and beta-blockers as appropriate. Withhold or discontinue KEYTRUDA (pembrolizumab) for Grade 3 or 4 hyperthyroidism.
Type 1 diabetes mellitus, including diabetic ketoacidosis, occurred in 3 (0.1%) of 2,117 patients. Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Administer insulin for type 1 diabetes, and withhold KEYTRUDA and administer anti-hyperglycemics in patients with severe hyperglycemia.
Immune-mediated nephritis occurred in 7 (0.4%) of 1,567 patients with melanoma, including Grade 2 (0.2%), 3 (0.2%) and Grade 4 (0.1%) nephritis. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 nephritis.
Other clinically important immune-mediated adverse reactions can occur. For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered. Resume KEYTRUDA when the immune-mediated adverse reaction remains at Grade 1 or less following corticosteroid taper. Permanently discontinue KEYTRUDA for any Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.
The following clinically significant, immune-mediated adverse reactions occurred in less than 1% (unless otherwise indicated) of 1567 patients with melanoma: arthritis (1.6%), exfoliative dermatitis, bullous pemphigoid, uveitis, myositis, Guillain-Barré syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic anemia, and partial seizures arising in a patient with inflammatory foci in brain parenchyma. The following clinically significant, immune-mediated adverse reactions occurred in less than 1% of 550 patients with NSCLC: rash, vasculitis, hemolytic anemia, serum sickness, and myasthenia gravis.
Severe and life-threatening infusion-related reactions have been reported in 3 (0.1%) of 2,117 patients. Monitor patients for signs and symptoms of infusion related reactions including rigors, chills, wheezing, pruritus, flushing, rash, hypotension, hypoxemia, and fever. For Grade 3 or 4 reactions, stop infusion and permanently discontinue KEYTRUDA.
Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. If used during pregnancy, or if the patient becomes pregnant during treatment, apprise the patient of the potential hazard to a fetus. Advise females of reproductive potential to use highly effective contraception during treatment and for 4 months after the last dose of KEYTRUDA (pembrolizumab).
In Trial 6, KEYTRUDA was discontinued due to adverse reactions in 9% of 555 patients with advanced melanoma; adverse reactions leading to discontinuation in more than one patient were colitis (1.4%), autoimmune hepatitis (0.7%), allergic reaction (0.4%), polyneuropathy (0.4%), and cardiac failure (0.4%). Adverse reactions leading to interruption of KEYTRUDA occurred in 21% of patients; the most common (≥1%) was diarrhea (2.5%). The most common adverse reactions were fatigue (28% with KEYTRUDA vs. 28% with ipilimumab), diarrhea (26% with KEYTRUDA), rash (24% with KEYTRUDA vs. 23% with ipilimumab), and nausea (21% with KEYTRUDA). Corresponding incidence rates are listed for ipilimumab only for those adverse reactions that occurred at the same or lower rate than with KEYTRUDA.
In Trial 2, KEYTRUDA was discontinued due to adverse reactions in 12% of 357 patients with advanced melanoma; the most common (≥1%) were general physical health deterioration (1%), asthenia (1%), dyspnea (1%), pneumonitis (1%), and generalized edema (1%). Adverse reactions leading to interruption of KEYTRUDA occurred in 14% of patients; the most common (≥1%) were dyspnea (1%), diarrhea (1%), and maculo-papular rash (1%). The most common adverse reactions were fatigue (43% with KEYTRUDA), pruritus (28% with KEYTRUDA vs. 8% with chemotherapy), rash (24% with KEYTRUDA vs. 8% with chemotherapy), constipation (22% with KEYTRUDA vs. 20% with chemotherapy), nausea (22% with KEYTRUDA), diarrhea (20% with KEYTRUDA vs. 20% with chemotherapy), and decreased appetite (20% with KEYTRUDA). Corresponding incidence rates are listed for chemotherapy only for those adverse reactions that occurred at the same or lower rate than with KEYTRUDA.
KEYTRUDA was discontinued due to adverse reactions in 14% of 550 patients with NSCLC. Serious adverse reactions occurred in 38% of patients. The most frequent serious adverse reactions reported in 2% or more of patients were pleural effusion, pneumonia, dyspnea, pulmonary embolism, and pneumonitis. The most common adverse reactions (reported in at least 20% of patients) were fatigue (44%), decreased appetite (25%), cough (29%), and dyspnea (23%).
No formal pharmacokinetic drug interaction studies have been conducted with KEYTRUDA.
It is not known whether KEYTRUDA is excreted in human milk. Because many drugs are excreted in human milk, instruct women to discontinue nursing during treatment with KEYTRUDA and for 4 months after the final dose.
Safety and effectiveness of KEYTRUDA have not been established in pediatric patients.
Merck’s Commitment to Patients
Merck provides multiple programs to help ensure patients who are prescribed KEYTRUDA have access to our anti-PD-1 therapy. The Merck Access Program provides reimbursement support for eligible patients receiving KEYTRUDA, including help with out-of-pocket costs and co-pay assistance. Merck also offers financial assistance for eligible patients who are uninsured through our patient assistance program. More information is available by calling 1-855-257-3932 or visiting www.merckaccessprogram-keytruda.com.
Merck also offers a 24/7 Patient Support program called KEY+YOU. The KEY+YOU program is staffed by compassionate nurses offering patients phone calls, email check-ins, wellness support, and referrals to community/peer groups as part of a comprehensive plan of support. A patient may enroll in the program by dialing 1-85-KEYTRUDA or visiting www.Keytruda.com.
About KEYTRUDA® (pembrolizumab) Injection 100 mg
KEYTRUDA is indicated in the United States at a dose of 2 mg/kg administered as an intravenous infusion over 30 minutes every three weeks for the treatment of patients with unresectable or metastatic melanoma.
KEYTRUDA is also indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDA-approved test with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA. The NSCLC indication is approved under accelerated approval based on tumor response rate and durability of response. An improvement in survival or disease-related symptoms has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Our Focus on Cancer
Our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At Merck Oncology, helping people fight cancer is our passion and supporting accessibility to our cancer medicines is our commitment. Our focus is on pursuing research in immuno-oncology and we are accelerating every step in the journey – from lab to clinic – to potentially bring new hope to people with cancer. For more information about our oncology clinical trials, visit www.merck.com/clinicaltrials.
About Merck
Today's Merck is a global health care leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook, YouTube and LinkedIn.
Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2014 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).
Please see Prescribing Information for KEYTRUDA (pembrolizumab) at http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf and the Medication Guide for KEYTRUDA at http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_mg.pdf
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My thoughts to my fellow longs here as we look to the New Year.
I wish you all a Very Merry Christmas and Happy New Year!
We have a lot to look forward to in 2016 which is a make or break moment in the treatment of cancer for OncoSec in combo study with Merck – may the results of the synergistic effects of these two treatments far exceed expectations for the thousands of those who are hoping this Christmas, that they will live to see at least one more! My hopes and prayers go out to them all, while I am reminded not to take the life I have today for granted and live it to my fullest.
For those of you who are excited more about the science than the trading, I would like to offer a few words of encouragement. The following quotes are not my own:
“Patience is not simply the ability to wait-- it's how we behave while we are waiting.”
“Never cut a tree down in the wintertime. Never make a negative decision in the low time. Never make your most important decisions when you are in your worst moods. Wait. Be patient. The storm will pass. The spring will come.”
And lastly, from one of my favorite people of all time: “Things may come to those who wait, but only the things left by those who hustle” --Abraham Lincoln
Don't be fooled by the foolish here, The OncoSec Team is busting their ass' to break the “DaVinci Code” of the immune system and here's a little of what we have to look forward to as this unfolds in the coming New Year!
The christening of the NEW "go-anywhere" catheterized electroporation device which will allow OncoSec to reach tumors inside the body at soft tissue sites like bladder, lung, liver, pancreas, etc., possibly with new platform featuring IL-15
PerkinElmer’s new imaging-based staining methods to quantitatively evaluate CD8+ T cell density in tumor biopsy research--this work has the potential to identify responders from non-responders. Dr. Tumeh’s work, combined with PerkinElmer’s technology, may lead to the development of a critical diagnostic tool for identifying non-responders to anti-PD-1 monotherapy
Efficacy data of Heat’s proprietary DNA constructs with OncoSec’s clinical stage electroporation platform compatibility to be applicable across multiple cancer indications for both surface and sub-epidermal (soft tissue) tumors
Data Evaluating the potential of intratumoral treatment with pIL-12 delivered via electroporation to promote a pro-inflammatory molecular and histological signature in patients with triple negative breast cancer, Does it increase TILs, or turn non-responders to responders.
Data demonstrating whether or not blocking CSF-1R with Plexxikon’s selective CSF-1R inhibitor will lead to synergistic effects with Immunopulse in the syngeneic B16.F10 melanoma mouse model
And What We Are All Waiting For--Data to be delivered in Chicago at ASCO June 3-7; Interium Data assessing the anti-tumor efficacy (defined as the best overall response rate using RECIST v1.1) and safety of the combination of plasmid interleukin-12 electroporation and pembrolizumab in patients with low tumor-infiltrating lymphocyte (TIL) melanoma
I raise a glass, “To better times ahead for Patients, Patents, and Prosperity to all of us here in this bless nation in 2016!”
Sincerely,
Waitforit
“He is the radiance of the glory of God and the exact imprint of his nature, and he upholds the universe by the word of his power. After making purification for sins, he sat down at the right hand of the Majesty on high” --Hebrews 1:3
OncoSec Opens New Headquarters and Research Facility in San Diego
December 17, 2015
SAN DIEGO, Dec. 17, 2015 /PRNewswire/ -- OncoSec Medical Incorporated ("OncoSec") (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, today announced the Company consolidated its three previous offices into one new headquarters and research facility, developed by Alexandria Real Estate Equities, Inc., in Sorrento Mesa, San Diego. As a result of the Company's growth over the past year, OncoSec moved into a new office that houses over 50 employees and all of the Company's discovery research, clinical, and administrative activities under one roof.
"This is an exciting time for OncoSec as we join the Sorrento Mesa community and find a home in San Diego, a city that is on the cutting edge of the life science and biotech industries," said Punit Dhillon, President and CEO of OncoSec. "This move allows for greater efficiencies and interactions among our dedicated teams. Our new facility enhances our development capabilities and provides OncoSec with a base of operations that matches the magnitude of our ambitions."
"We are proud of the robust biotech industry and its incredible impact in California. It's encouraging to see another biotech company join and further strengthen the San Diego area, bringing jobs and economic vitality to the region," said Panorea Avdis, Director of the California Governor's Office of Business and Economic Development. "Not only are biotechs like OncoSec enhancing California's economy, they also play a greater role in advancing innovative technologies to provide better care and treatment for patients everywhere."
"OncoSec's stunning new headquarters was a result of a truly collaborative effort between the Company and Alexandria. We are thrilled to welcome them to our innovative tenant community," said Daniel Ryan, Executive Vice President, Regional Market Director (San Diego) and Strategic Operations of Alexandria Real Estate Equities, Inc. "The new facility provides OncoSec with a sustainable and environmentally friendly space that accommodates growth and enhances their R&D operations. We look forward to continuing to serve OncoSec's facility needs and support its efforts developing targeted cancer therapies."
The new facility, located at 5820 Nancy Ridge Drive, was built with environmental and green features in mind to reduce the Company's carbon footprint. The 34,000 square foot building features recycled materials, drought-tolerant vegetation, and a recycled water irrigation system, which will lower the water consumption impact and create an environment prepared to thrive in Southern California's current drought conditions.
OncoSec's research facility also integrates approximately 15,000 square feet of laboratory space with state-of-the-art equipment required for Discovery Research activities. The design approach incorporates laboratory benches, specialized rooms, and equipment strategically positioned to maximize workflow, provide sufficient ambulatory space, and minimize potential disruption to research.
There is no abstract release listed on ASCO site
AHHHHH! Every once and while a fresh breeze...thanks ahab.
Amen Twiz!
"Merkel cell carcinoma responds to immunotherapy"
By: CAROLINE HELWICK, Dermatology News Digital Network
October 9, 2015
AT THE EUROPEAN CANCER CONGRESS 2015
Vitals
Key clinical point: Merkel cell carcinoma may respond well to immunotherapeutic approaches.
Major finding: Patients had robust and durable responses to the PD-1 inhibitor pembrolizumab and to intratumoral IL-12 injections.
Data source: Single-arm open label studies; pembrolizumab study included 24 patients. IL-2 study included 15 patients.
Disclosures: Dr. Nghiem reported no conflicts of interest. In the IL-12 study, some investigators have financial relationships with OncoSec Medical, which manufactures the study drug. Dr. Bhatia had no relevant disclosures.
VIENNA – High response rates to pembrolizumab and to intratumoral delivery of plasmid interleukin-12 (IL-12) were observed among patients with advanced Merkel cell carcinoma (MCC), based on studies presented at the 2015 European Cancer Congress.
There is strong rationale for immunotherapy in MCC. For one thing, the Merkel cell polyomavirus, which is expressed in 80% of tumors, serves as a powerful antigen for stimulating an immune response. Secondly, MCC tumors often express the ligand for the programmed death protein (PD-1), creating an opportunity for PD-1 pathway blockade with PD-1 inhibitors such as pembrolizumab, according to the investigators.
Responses in 10 of 14 given pembrolizumab
Dr. Paul Nghiem of the University of Washington in Seattle, led an open-label, single-arm, multicenter phase II trial of pembrolizumab, which is approved for metastatic melanoma and which could become the first systemic therapy for unresectable or metastatic MCC (Abstract 22LBA).
Dr. Paul Nghiem
In the study, which opened in January 2015, there are 24 evaluable patients treated with pembrolizumab 2 mg/kg every 3 weeks for up to 2 years. Fourteen had at least one posttreatment scan; 10 of these 14 patients (71%) have responded, 2 had complete responses. One patient had stable disease and three progressed.
“Responses were rapid, and appear more durable than we see with chemotherapy,” Dr. Nghiem said.
The drug was generally well tolerated, with an adverse event profile similar to what has been seen in melanoma. One patient experienced grade 4 myocarditis after one dose and one developed grade 4 transaminase elevation after two doses. Both improved after discontinuing pembrolizumab and starting corticosteroids.
“Strikingly, despite receiving only one or two doses, both patients had profound and ongoing responses to pembrolizumab,” Dr. Nghiem observed.
Many subjects had “profound shrinkage of tumor that has not rebounded,” he noted. “Pembrolizumab looks to be very favorable in terms of durability of response. With chemotherapy, at 90 days half of our patients have gone off treatment.”
The researchers are considering expanding the study population, and may include a chemotherapy-relapsed cohort. They are also analyzing biomarkers, and hope to evaluate response according to virus-positive versus virus-negative status.
Dr. Caroline Robert of the Institut Gustave Roussy in Villejuif, France, commented on the findings, first noting the difficulty of treating patients for whom there are no approved therapies. Median overall survival is less than 10 months, she said, and clinicians have lacked clinical trials to enroll patients.
“MCC patients represent a high medical need,” she said. Although the results with pembrolizumab are early, “they are very promising.”
Intratumoral plasmid IL-12
Dr. Shailender Bhatia of the University of Washington in Seattle, described a different immunotherapeutic approach in an MCC population (Abstract 504).
IL-12, which regulates adaptive type-1 immunity, has demonstrated antitumor efficacy in MCC but is associated with severe toxicities when administered systemically. Local IL-12 delivery to the tumor microenvironment “may provide adequate cytokine concentration in the vicinity of tumor antigens, and therefore improve efficacy while sparing systemic toxicity,” he said.
Intratumoral IL-12 plasmid DNA (pIL-12) injection with electroporation (which uses pulsed electricity to open pores in cell membranes) has shown antitumor activity in melanoma, and might also work in MCC, Dr. Bhatia and his colleagues hypothesized. The concept is one of promoting tumor inflammation and thereby a systemic antitumor immune response. This would be reflected, and measured, by increased IL-12 protein expression in the tumor microenvironment, which became this study’s primary endpoint.
“To the best of our knowledge, this study represents the first prospective clinical trial of immunotherapy in advanced MCC,” Dr. Bhatia noted.
Beginning in January 2012, the study enrolled 15 patients with MCC and superficial injectable tumors. Patients received injections of pIL-12 on days 1, 5, and 8; 2 weeks later, on day 22, their lesions were biopsied. The 3-person cohort with localized MCC (stage IIIb) then underwent definitive surgery and/or radiation therapy starting in week 4, while the 12 with distant metastatic disease (stage IV) could receive additional treatment cycles (maximum of 4) at least 6 weeks apart.
The treatment was well tolerated, with most adverse events – primarily pain and local inflammatory reaction – being mild and transient. No patients discontinued because of toxicity.
The primary endpoint, sustained local expression of IL-12 protein on day 22, was observed in 79% of patients. In paired biopsy samples, comparing baseline to day 22 levels, IL-12 protein expression increased by almost 2-fold to more than 3,000-fold.
In addition, enrichment of Merkel cell polyomavirus-specific CD8-positive T cells were found in the tumor infiltrating lymphocytes (TILs) of treated and distant tumors in some patients.
“Additionally, the pIL-12/electroporation treatment led to objective clinical responses in metastatic MCC,” Dr. Bhatia reported.
Among the three patients with locally advanced disease, one had a pathologic complete response and remains free of recurrence more than 6 months later. Another patient has been recurrence free for more than 3 years. The third patient was recurrence free for 9 months before developing progressive disease.
Among the 12 patients with metastatic disease, 3 responded to treatment and 1 achieved stable disease, while 8 (52%) progressed.
The injections led to regression not only of treated lesions, but also of clearly distinct noninjected MCC tumors. The proportion of treated lesions with major (more than 30%) regression was 44%. Among 10 patients with at least one distant lesion, 30% of noninjected distant lesions regressed.
“We believe this approach warrants further exploration in MCC, perhaps in combination with emerging systemic therapies, such as anti-PD-1/PD-L1 agents,” Dr. Bhatia said. Dr. Nghiem and Dr. Bhatia had no relevant disclosures. In the IL-12 study, some investigators have financial relationships with OncoSec Medical, which manufactures the study drug.
Hey RB, still here with my 13,831 in OncoSec--that is my confidence in, as salgovernale would say, "electrocutation platform". Everything hinges on Combo P2b results: as I've quoted before, "“True valuation is never reflected until we get an exit opportunity,” Dhillon said. “Everything in-between is just noise.”
Check the link to ONCS Bottom Triangle pattern out and read the supportive material if you like: compliments of recognia.
Estimated Intermediate Target Price Range: $9.80 - $10.60
http://lnk.recognia.com/3nQ
Bottom Triangles and Bottom Wedges are considered to be bullish signals that mark a possible reversal of the current downtrend.
Bottom Triangles and Bottom Wedges make up a group of patterns which have the same general shape as Symmetrical Triangles, Wedges, Ascending Triangles and Descending Triangles. The difference is that these particular formations are reversal and not continuation patterns. These patterns have two converging trendlines. The pattern will display two highs touching the upper trendline and two lows touching the lower trendline. Contrary to Triangle formations, Wedges are characterized by their boundary trendlines both moving in the same direction.
This pattern is confirmed when the price breaks upward out of the Bottom Triangle or Bottom Wedge formation to close above the upper trendline
Volume is an important factor to consider. Typically, volume follows a reliable pattern: volume should diminish as the price swings back and forth between an increasingly narrow range of highs and lows. However, when the breakout occurs, there should be a noticeable increase in volume. If this volume picture is not clear, investors should be cautious about decisions based on the particular Triangle or Wedge pattern.
Important Characteristics
Following are important characteristics for this pattern.
Occurrence of a Breakout
Technical analysts pay close attention to how long the pattern takes to develop to its apex. The general rule is that prices should break out - clearly penetrate the upper trendline - somewhere between three-quarters and two-thirds of the horizontal width of the formation. The break out, in other words, should occur well before the pattern reaches the apex of the Triangle or Wedge. The closer the breakout occurs to the apex the less reliable the formation.
Duration of the Triangle or Wedge
This pattern is a relatively short-term. While long-term Bottom Triangles and Bottom Wedges do form, the most reliable patterns take between one and three months to form.
Volume
Investors should see volume decreasing as the pattern progresses toward the apex of the triangular or wedge shaped pattern. At breakout, however, there should be a noticeable increase in volume.
Trading Considerations
Duration of the Pattern
Consider the duration of the pattern and its relationship to your trading time horizons. The duration of the pattern is considered to be an indicator of the duration of the influence of this pattern. The longer the pattern the longer it will take for the price to reach its target. The shorter the pattern the sooner the price move. If you are considering a short-term trading opportunity, look for a pattern with a short duration. If you are considering a longer-term trading opportunity, look for a pattern with a longer duration.
Target Price
The target price provides an important indication about the potential price move that this pattern indicates. Consider whether the target price for this pattern is sufficient to provide adequate returns after your costs (such as commissions) have been taken into account. A good rule of thumb is that the target price must indicate a potential return of greater than 5% before a pattern should be considered useful. However you must consider the current price and the volume of shares you intend to trade. Also, check that the target price has not already been achieved.
Inbound Trend
The inbound trend is an important characteristic of the pattern. A shallow inbound trend may indicate a period of consolidation before the price move indicated by the pattern begins. Look for an inbound trend that is longer than the duration of the pattern. A good rule of thumb is that the inbound trend should be at least two times the duration of the pattern.
Criteria that Support
Support and Resistance
Look for a region of support or resistance around the target price. A region of price consolidation or a strong Support and Resistance Line at or around the target price is a strong indicator that the price will move to that point.
Moving Average
Watch for the 200 day moving average to flatten. When prices cross above the 200 day moving average (usually about two-thirds to three-quarters of the way through the pattern), the pattern is considered more reliable.
Volume
A strong volume spike on the day of the pattern confirmation is a strong indicator in support of the potential for this pattern. The volume spike should be significantly above the average of the volume for the duration of the pattern. In addition, the volume during the duration of the pattern should be declining on average.
Criteria that Refute
No Volume Spike on Breakout
The lack of a volume spike on the day of the pattern confirmation is an indication that this pattern may not be reliable. In addition, if the volume has remained constant, or was increasing, over the duration of the pattern, then this pattern should be considered less reliable.
Short Inbound Trend
An inbound trend that is significantly shorter than the pattern duration is an indication that this pattern should be considered less reliable.
Underlying Behavior
This pattern is a result of converging trendlines of support and resistance which give this pattern its distinctive shape. This occurs because the trading action gets tighter and tighter until the market breaks out with great force. Buyers and sellers find themselves in a period where they are not sure where the market is headed. Their uncertainty is marked by their actions of buying and selling sooner, making the range of the price movements increasingly tight. As the range between the peaks and troughs marking the progression of price narrows, the trendlines meet at the "apex".
The narrowing of the trading action and the decreasing volume of trade reflect the indecision in the market. Finally consensus or decision in the market is reached and this is reflected as the price breaks out upward to close above the triangular or wedge shaped boundary. A spike in volume on this breakout date reflects stronger consensus that the financial instrument should move in that direction.
I think you guys are confused, that world conference took place last week September 6 through the 10th. Or am I missing some reason why you're bringing it up now?
Titan, Technically speaking, we broke and have been above a 15 month downtrend resistance line as of Sept. 5th. and I'll definitely interested if there will be a run-up in PPS leading up to MCC re-release.
Actually I think it hinges on the synergy outcome of the UCSF melanoma combo trial, THEN I think Merck will be considering all possible avenues of Lease, Partner or Buyout with OncoSec.
Don't think so Titan, cuz they have already mentioned that they wouldn't pursue further clinical development as a monotherapy. I do think we will here of it's relative success as a monotherapy, but Pierce had the trials stopped because he knew of Keytruda's effectiveness and that it would be better to offer the added benefits of non-responder to responder, systemic effects, and the PD-1 punch AND the treatment outcomes of the combination will be greater than the sum of it's parts.
I'll be interested to see Dr. Meininger's insider buying
Tom, look again. They have all been moves of Promotion with greater and greater responsibility with large, prestigious Bi Pharma's UNTIL little Ol' OncoSec Medical. I would think this guy makes moves that take him upward with greater payoff!
From Meininger's Linkedin Profile:
Summary
Ph.D. with more than twenty years of experience in basic and applied scientific research. Diverse industry experience in biotech and pharmaceutical start-up, midsize, and industry-leading companies. Fifteen years industry experience with twelve years as group or department manager. Extensive background in small molecule and biopharmaceutical drug discovery and development, preclinical study design, and preclinical and clinical data analysis. Proven track record in developing novel and in leveraging existing intellectual property. Current role focused on scouting and evaluation of therapeutic leads. Large network of scientific and business contacts.
Experience
Executive Director, Business Development & Licensing
Merck
February 2014 – Present (1 year 8 months)Palo Alto, California
Member of Bay Area BD&L group. Responsibilities include in- and out-licensing of therapeutic assets, initiating and maintaining collaborations with external partners and advising the Merck Research Venture Fund team on selected investment opportunities.
Executive Director, Molecular Discovery
Merck
July 2012 – February 2014 (1 year 8 months)Palo Alto, California
Head of Department of Protein Sciences. Responsible for lead generation and early characterization efforts at Merck supporting indications addressed by Merck's Disease Area franchises. Member of Biologics Review and Licensing Committee and Ambrx Joint Steering Committee.
Senior Director, Biologics Discovery
Merck
April 2011 – July 2012 (1 year 4 months)
Head of Department responsible for all large molecule lead discovery and early characterization efforts at Merck. Projects pursued span the full spectrum of indications addressed by Merck's seven Disease Area Franchises.
Vice President, Biotherapeutics
Boehringer Ingelheim
August 2010 – January 2011 (6 months)
Head of Biberach NBE Unit. Departmental focus on discovery, design and early development of New Biological Entities. Indications span those across Cardiometabolic, Respiratory, and CNS therapeutic areas.
Principal Scientist
Amgen, Inc.
March 2007 – June 2010 (3 years 4 months)
Protein Biochemistry group leader supervising ten direct and skip-level reports. Group focus on homology modeling/construct design, purification and characterization of mammalian, insect and microbial cell culture-derived antibodies, antigens, enzymes and other research proteins in support of multiple Amgen oncology and inflammation therapeutic area projects. Core project team member on multiple Oncology & Inflammation TA research strategy teams. Seattle site co-leader on early stage biotherapeutic molecule assessment & engineering effort. Advisor to Amgen External R&D Affairs Group and consultant to Amgen Ventures.
- Progressed two Amgen antibody-drug conjugate leads to clinical development.
- Amgen team leader on antibody-drug conjugate internal technology development project. Set terms and authored contract covering in-licensing from academic lab of novel cytotoxic ADC warheads with initial compound delivery anticipated in Q3-Q4 of 2009. Designed and supervised internal site-specific conjugation project. Presented cost of good manufactured and cost of goods sold comparative analyses to senior Amgen management.
- Seattle site team leader on biochemical characterization and optimization efforts supporting novel bi-specific and half-life extension biotherapeutic alternate scaffolds. The modules comprising these alternate modalities are derived via phage library panning, humanized and normal mouse hybridomas, and through rational design strategies.
- Core team member on Amgen molecule assessment effort. Supervisory responsibility for initial analysis on commercial potential of antibody therapeutics targeting oncological and inflammatory indications.
Senior Scientist
Amgen, Inc.
April 2005 – March 2007 (2 years)
Protein Purification group member supervising two direct reports while working full-time at the bench. Responsibility for purification and characterization of mammalian cell culture-derived antibodies, antigens, enzymes and other research proteins in support of multiple Amgen therapeutic area projects. Core team member on key ESA research project with responsibility for providing quarterly project status updates to Amgen executive management.
- Derived strategy enabling production of novel, long-acting, phage library-derived erythropoiesis stimulating agents (ESAs) designed to interdict anemia of cancer at ten-fold lower cost of goods manufactured in comparison to conventional production strategies.
- AWA team leader on key metabolic disease research project. Derived and championed novel rational design strategy leading to discovery of activity-enhanced, lipid profile-modifying enzyme drug lead with authorship on related patent application.
- Introduced modern molecular modeling techniques to the department in support of recombinant protein expression construct design.
Scientist
Tularik, Inc.
May 2003 – March 2005 (1 year 11 months)
Protein expression and purification sub-group leader supervising two to three direct reports. Design and assistance in production of oncology drug-target and other protein expression vectors. Supervision and assistance in production of protein from baculovirus-infected insect cells, yeast, and E. coli for co-crystallization with small-molecule drug leads, HTS, and target validation studies.
- Designed expression construct leveraged to produce first known X-ray structure of high-value oncology target.
- Derived conditions producing high-resolution co-crystal structures of 11?-HSD1 in complex with multiple inhibitor lead series.
- Directed and applied novel strategy enabling efficient Se-Met labeling of recombinant protein in insect cell/baculovirus expression system.
Senior Scientist
Gryphon Therapeutics
September 2002 – May 2003 (9 months)
(Gryphon was a start-up engaged in chemical synthesis of protein therapeutics including epo and others. Its $100mm deal with Amgen terminated shortly after my departure).
Supervision of two direct reports in synthesis and chemical ligation of peptides and polymers into novel, long-acting protein therapeutics homologues. Optimization of synthesis of organic intermediates; chromatography- and mass spectroscopy-based characterization of reaction intermediates and final products. Molecular modeling of biotherapeutic drug leads.
Senior Scientist
Triad Therapeutics, Inc.
September 1999 – September 2002 (3 years 1 month)
Supervision of two direct reports in gene cloning and expression, purification and characterization of oncology, inflammation and infectious disease drug-target protein. Contribution to development of NMR-based methods and applications. Supervision of and participation in the co-crystallization of protein-ligand complexes and subsequent structural determination.
- Established and built-out a fully functional protein production facility as founding employee.
- Contributed to development of patented aryl amide series of p38 inhibitors out-licensed to Novartis and currently in phase II clinical trials.
Post-Doctoral Research Associate
Genentech, Inc.
January 1997 – September 1999 (2 years 9 months)
NMR-based characterization of the variable domain of the Herceptin? antibody. Expression and characterization of receptor fragments for NMR-based screening of small molecule solid and liquid tumor inhibitors.
- Key contributions to multiple proprietary Ab fragment expression and isotopic labeling methods, many of which remain in practice at Genentech.
- Multiple contributions to ongoing development efforts in support of Herceptin® and Avastin®.
Wow, now that's a powerful addition to the OncoSec Team!
When Pierce talks, you should listen: Determining Why Not All Patients Respond to PD-1 Inhibitors
A Conversation With Robert H. Pierce, MD
By Jo Cavallo
March 10, 2015, Volume 6, Issue 4
Robert H. Pierce, MD---
One of the biggest hurdles facing immunotherapy today is identifying the patients who respond and then finding means to convert nonresponders into responders.
—Robert H. Pierce, MD
Recent research1 conducted by Robert H. Pierce, MD, and his colleagues investigating why PD-1 (programmed cell death protein 1) inhibitors result in remarkably durable clinical remissions in some patients with melanoma, whereas others reap a short-term benefit or no benefit at all is showing that response is likely dependent on the presence of PD-L1 and tumor-infiltrating lymphocytes in the patient’s tumor. Termed “adaptive immune resistance,” this compensatory upregulation of PD-L1—the ligand that “turns off” antigen-specific CD8-positive T cells by activating the PD-1 receptor—may be the potential biomarker researchers have been looking for to accurately predict response to anti–PD-1 therapy.
Dr. Pierce, Chief Scientific Officer at OncoSec Medical, a biopharmaceutical company developing DNA-based intratumoral cancer immunotherapies, is planning on using the information gained from this research to investigate whether combining anti–PD-1 drugs, such as pembrolizumab (Keytruda), with therapies that can drive immunogenicity and increase tumor-infiltrating lymphocytes will lead to enhanced responses not just in melanoma patients, but in patients with other cancer types as well.
In January 2015, OncoSec Medical announced that it is launching a pilot study to assess the effectiveness of its investigational intratumoral immunotherapy ImmunoPulse IL-12 (interleukin 12) to increase tumor-infiltrating lymphocytes in patients with triple-negative breast cancer.
In a wide-ranging interview with The ASCO Post, Dr. Pierce talked about progress being made in immunotherapy; the use of genomic sequencing in the design of clinical trials; and how personalized medicine will increase the cost of cancer care.
Phenomenal Future for Immunotherapy
What role will immunotherapy play over the next decade? Will it be an effective treatment that can be utilized in many different cancers?
Yes, absolutely. I think that is the picture that is clearly emerging. How immunotherapy moves forward will be interesting to observe, because certainly PD-1 inhibitors are proving to be relatively nontoxic and highly effective in at least a significant subpopulation of patients in many different tumor types. However, one of the biggest hurdles facing immunotherapy today is identifying the patients who respond and then finding means to convert nonresponders into responders.
Right now, there is a debate about how to sequence therapy for the greatest effectiveness. For instance, in the future, an oncologist who has a melanoma patient with a BRAF mutation and a great burden of disease may want to treat him first with a BRAF inhibitor to debulk the cancer and then with a PD-1 inhibitor.
Conversely, there may be other circumstances in which you might want to invert that treatment sequence, so I see a future with a lot of choices for potential combinations that are coming down the pike. There is a phenomenal future for immunotherapy both in terms of combining multiple immunotherapies together and also putting immunotherapies together with targeted agents and chemotherapies.
Over time, given its relatively benign safety profile, we will likely see PD-1 therapeutics being given in earlier lines of treatment to those patients whose tumors are characterized by a “responsive phenotype.”
Next-Generation Sequencing and Drug Development
Advances in genomic sequencing are turning every cancer into essentially a rare disease. How will this change the way pharmaceutical companies develop and test drugs for individual patients?
Next-generation DNA and RNA sequencing technologies are allowing us to carve out smaller and smaller buckets of cancer types. I’m a pathologist by training, and we tend to think of tumor types by virtue of their cell of origin and where the malignant cells arise in the body. What we are seeing with immunotherapies is that the tumor histotype does not seem to matter as much as the immunophenotype. Right now, there are many ways one can imagine that next-generation sequencing can guide drug development.
In immunotherapy, the mutational load in a patient’s tumor may prove to be a critical determinant in response to immune-based therapies—as those mutated peptides are what the immune system recognizes in the tumor as “foreign.” I think we will see a day in the not too distant future where we can determine from next-generation sequencing data that a patient’s tumor has sufficient mutational load to drive an immune response but not enough expression of antigen-processing and presentation machinery and positive co-stimulatory molecules to convert those “virtual” antigens into a bona fide antitumor T- cell response.
In such a patient, perhaps an upfront combination with a proimmunogenic stimulus like intratumoral IL-12 will be considered. Given the power of these evolving technologies, we could speculate all day on the possibilities.
Future Design of Clinical Trials
How will pharmaceutical companies design clinical studies in the future? Will they be modeled more on the “basket” trial approach, in which patients with different cancers but the same specific genetic alteration or mutation are enrolled into a trial investigating a molecularly targeted therapy?
I think there are times when the basket trial approach is appropriate and times when it is not. In particular, response assessments are often very different, according to the tumor type, and then you end up having what amounts to a bunch of different clinical trials bundled together; so in the end, this approach may not add efficiency.
Also, there may be logistic issues stemming from the fact that patients with different tumor types may be seen by different sets of doctors and even different institutions. Despite those limitations, we often look to see whether there is the possibility for a given therapeutic strategy to take advantage of the unifying biology with a basket approach. However, I haven’t been involved in one yet.
Appropriate Use of Biomarkers
Doesn’t the basket-trial approach have the potential to eliminate a lot of waste in the development of new drugs, because the results would signal early on which targeted agents might be most effective for specific mutations?
Yes, that is absolutely true, and I think that model will be very valuable in the future, particularly for drugs targeting oncogenic “driver” mutations. Patient selection in immunotherapy may not prove to be as straightforward. Whether one is testing an immunotherapy or a mutant kinase, the power of the trial lies in how good your patient-selection biomarker is. A truly selective biomarker, such as in detection of mutant BRAF, can enable investigators to see the efficacy of the drug in a smaller and less expensive study.
However, as has often been the case, in the initial development of anti–PD-1 monoclonal antibodies, we knew that we had an effective therapeutic before we had the confidence that we had a good biomarker. And, given that some patients who score “negative” for the various assays still respond to PD-1 blockade, there is some controversy about how to use these biomarkers for patient selection in practice.
I think we simply need to be clear that every assay has a false-negative rate and a false-positive rate and that we must differentiate the use of a biomarker as a drug development tool for enriching the responder population in a clinical trial from that of using a biomarker in clinical practice to determine patient access to—or reimbursement for—a potentially efficacious therapy.
With the appropriate use of response-enriching biomarkers in clinical trials, we hope to accelerate drug approval and get these therapies to patients as soon as possible.
Cost of Drug Development
How will the success of immunotherapy and the development of patient selection biomarkers impact the cost of cancer care?
As we develop effective therapies and those therapies prove to be even more effective in combination and these successes result in even more lines of therapy, it is difficult not to imagine the cost of care going up. So, success is driving some of these costs, but, clearly, this is a good problem to have.
The rising cost of care is a fact that, as a society, we have to wrap our heads around. Although as a “techno-optimist” I like to think that some low-cost, super-effective technology is waiting around the corner, this may be a dangerous fantasy if it keeps us from dealing with the current economic realities.
Effective personalized medicine involves the search for validation and ultimately commercialization of biomarker test kits to classify patients into subpopulations, and this, too, is adding to the cost of drug development. This added dimension of care is something we often do not talk about, but the potential need for codeveloping a companion diagnostic, depending, of course, on the clinical scenario, can present a major economic challenge for smaller companies endeavoring to develop oncology drugs.
The development of adoptive T-cell transfer and chimeric antigen receptor T-cell therapy, which are cost-intensive at the point of care, has been fueling considerable discussion on the rising cost problem. And although these therapies appear to show great promise, many of us have questions about their scalability, commercialization, and, ultimately, how to factor them into the finite cost-of-care universe, which is our reality.
Exploring Biologic Combinations
What major advances in cancer care do you see happening over the next decade? Will there be more cures and conversions of cancer into a chronic disease?
I think the next decade will be characterized by both new cures for some cancers and the conversion of others into controlled chronic states, which are still associated with improved quality of life for patients. In terms of therapeutics, I think the next 10 years will be about exploring biologic combinations—combinations of immunotherapies, combinations of immunotherapy with so-called immunogenic chemotherapy, and combinations of immunotherapy with targeted molecules.
The next stage will be about employing these combinations and harnessing multiple physiologic and cytotoxic mechanisms to attack tumors. Immunotherapy is exciting because of the impressive durability of responses and the characteristic long tail on the overall survival curves. We are all focused on raising the percentage of patients who experience those long-duration responses and significantly increased survival rates.
I recently attended a meeting in which there was fairly sober speculation that combination immunotherapies in melanoma would, in the near future, push that overall survival “tail” north of 50%. Part of this push will be the development of new therapies that enhance immunogenicity, increase tumor-infiltrating lymphocytes, and convert PD-1 nonresponders into responders.
In triple-negative breast cancer, the presence of CD8 tumor-infiltrating lymphocytes not only correlates with response to PD-1/PD-L1 therapeutics, but to response to certain chemotherapeutic regimens as well. In breast cancer, as well as other solid tumor types, I think we are going to find that maximally effective therapy involves a rational combination of immunogenic chemotherapies with immunotherapy, which is really exciting.
One of the emerging areas that I predict will become “hot” is the development of intratumoral cancer immunotherapies, in which we “take the fight to the tumor,” deploying immunostimulatory molecules directly into the tumor to combat the local immunosuppressive microenvironment to drive a systemic antitumor response. I think we are beginning to see this approach as a real opportunity in the treatment of solid tumors such as triple-negative breast cancer. ¦
Disclosure: Dr. Pierce is Chief Scientific Officer at OncoSec Medical, a biopharmaceutical company.
Reference
1. Tumeh PC, Harview CL, Yearley JH, et al: PD-1 blockade induces responses by inhibiting adaptive immune resistance. Nature 515:568-571, 2014
Non-Responder Percentage and the Limited Drug Treatments Potential
Some info for your DD
Yervoy (ipilimumab), Keytruda (pembrolizumab), and Bristol Myers-Squibb's
Opdivo (nivolumab) Zelboraf (vemurafenib), Tafinlar (dabrafenib), and Mekinist (trametinib). These drugs target common genetic mutations, such as the BRAF V600 mutation, found in a subset of melanoma patients.
Despite the recent FDA approvals of these drugs, some patients with advanced metastatic melanoma still have a significant risk of mortality. A substantial unmet need remains for new successful therapies in patients with this disease.
Triple Negative Breast (TNBC)~ 70 – 82% Pembrolizumab (Keytruda,by Merck), PD-L1 inhibitor, MPDL3280A,
Renal Cell Carcinoma (RCC)~ 71% tyrosine kinase inhibitors VEGF-TKI, rapamycin (mTOR) inhibitor, immunotherapy in the form of cytokines was the mainstay of treatment for metastatic RCC. However, responses were seen in only a minority of highly selected patients with substantial treatment-related toxicities
Lung Carcinoma (NSCLC)~ 79 – 83% Nivolumab (Opdivo by Bristol Myers-Squibb ), Pembrolizumab (Keytruda by Merck)
Pembrolizumab (Keytruda,by Merck), Atezolizumab (Roche/Genentech)
Bladder~ 84% Atezolizumab (Roche/Genentech), nivolumab (Opdivo, Bristol-Myers Squibb), and pembrolizumab (Keytruda, Merck).
Gastric ~ 69% Opdivo (nivolumab, Bristol-Myers Squibb/Ono Pharmaceuticals), Keytruda --there are no known late-stage trials of Opdivo in Western gastric cancer patients, but it can be assumed that trials may be initiated in the near future. As in melanoma, Opdivo may ultimately have a first-to-market advantage over Keytruda in gastric cancer in Japan, but Keytruda may have a leg up in the Western markets for this indication. Other targeted therapies are planning Phase II trials, including Stivarga® (regorafenib, Bayer, NCT01913639) and AMG 337 (Amgen, NCT02016534). Eli Lilly has also announced plans for another Phase III trial for Cyramza (RAINFALL, NCT02314117), which will compare capecitabine plus cisplatin with or without Cyramza in 616 newly diagnosed gastric or gastroesophageal junction cancer patients.
As with other tumors, the competitive landscape for gastric could dramatically change within the next several years given the data presented. These data are certainly at an early stage, but the high response rates and preliminary OS data justify the excitement associated with the PD-1 inhibitors and add gastric cancer to the growing list of tumors in which immuno-oncology may play a significant role.
References:
1.Muro et al., Abstract 3, ASCO GI 2015.
2.Muro et al, Abstract LBA15, ESMO 2014.
3.Fuchs et al., Lancet. 2014 Jan 4;383(9911):31-9.
4.Wilke et al., Lancet Oncol. 2014 Oct;15(11):1224-35.
Exactly Titan, that's been my perspective for a long time on OncoSec's potential. When you think about the number of cancer patients across the number of different cancer indications, NOW whether these solid tumors are on the skin, or occurring internally on soft tissue allowing for the treatment of rumors on Lung, Bladder, Pancreatic and others above and beyond their present trials!?!?! WOW... Just think of the purchase value of a company that could unlock 70 to 80% of unreachable patients to your drugs to those various indications whether they be internally or externally derived tumors – – don't even think of just a $1 billion buyout deal. A company like that globally at least for the next 5 to 10 years giving a big Pharma the edge will be of credible value!!!
OncoSec Presents Advancements in Intratumoral Gene Electro-Transfer Devices for Immuno-Oncology
DOWNLOAD AS PDF
SEPTEMBER 09, 2015
Advancing 'smart' electroporation technology for minimally invasive immunotherapy; Expanding electroporation IP portfolio with additional license from the University of South Florida
SAN DIEGO, Sept. 9, 2015 /PRNewswire/ -- OncoSec Medical Incorporated ("OncoSec") (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, today presented recent advancements in the field of electroporation (EP) and the future of catheter-based devices to perform minimally invasive intratumoral immunotherapy treatment at the First World Congress on Electroporation and Pulsed Electric Fields in Biology, Medicine and Food & Environmental Technologies in Portoroz, Slovenia.
In a keynote presentation entitled: "Advances in Clinical Electroporation: Tissue Sensing, Feedback Control, and Catheter Technology," Robert H. Pierce, MD, Chief Scientific Officer, discussed OncoSec's advances in intratumoral gene electro-transfer, using 'smart' tissue-sensing technology and the development of catheter-based electrodes, enabling treatment of deep and visceral tumors.
"We are excited to be presenting our engineering advances at the First World Congress," said Dr. Pierce. "The development of minimally-invasive electroporation devices capable of high-efficiency delivery of immunotherapeutic genes into tumors located anywhere in the body is critical to establishing intratumoral EP-mediated gene therapy as a standard therapeutic modality in immuno-oncology."
OncoSec's New Catheter Electrode Technology
OncoSec's new catheter-based electrodes are designed to be compatible with standard medical instrumentation, allowing access to deep and visceral tumors, where they are capable of anchoring to and treating the tumor using OncoSec's proprietary technology. These all-in-one devices have the ability to inject a DNA-based agent, while deploying electrodes to perform electroporation in a single procedure. Moreover, these devices have an adjustable needle and electrode penetration depth allowing clinicians to treat tumors of varying dimensions to perform minimally invasive intratumoral immunotherapy.
Development of Tissue Sensing and Feedback Control
OncoSec is developing 'smart' electroporation technology capable of tissue sensing and real-time feedback control of electroporation pulse trains in order to attain optimal gene transfer and minimal electroporation-mediated tissue damage. Dr. Pierce added: "Taken together, these engineering advances can enable access and high-efficiency gene delivery to tumors throughout the body. This is key as we move forward in developing OncoSec's pipeline of novel intratumoral therapies."
"Our partnership with Rev.1 Engineering and internal bioengineering expertise have allowed OncoSec to enhance our ImmunoPulse™ platform and position the Company as a leader in gene electro-transfer technologies in cancer immunotherapy," said Punit Dhillon, President and CEO of OncoSec. "We are also strengthening our intellectual property portfolio in the area of gene and drug delivery via electroporation to reach visceral tumors and enhance the uptake of therapeutic agents."
Licensing of University of South Florida Catheter Electrode Patent
OncoSec secured an exclusive license for a specific patented technology from the University of South Florida Research Foundation (USFRF). The patent provides a device and related methods to deliver molecules to cells that comprise any tissue. The patent includes a catheter-based electrode and methods to deliver molecules to cardiac tissue, blood vessels, other tissues/organs that can be accessed through a luminal tissue and luminal tissues. The device also functions as a non-catheter based electrode for performing the same functions. Financial terms of this agreement were not disclosed.
For more information about OncoSec and its technologies, please visit: www.oncosec.com.
About OncoSec Medical Incorporated
OncoSec is a biopharmaceutical company developing DNA-based intratumoral immunotherapies with an investigational technology, ImmunoPulse™, for the treatment of cancer. ImmunoPulse™ is designed to enhance the local delivery and uptake of DNA-based immune-targeting agents, such as IL-12. In Phase I and II clinical trials, ImmunoPulse™ IL-12 has demonstrated a favorable safety profile and evidence of anti-tumor activity in the treatment of various skin cancers as well as the potential to initiate a systemic immune response. OncoSec's lead program, ImmunoPulse™ IL-12, is currently in Phase II development for several indications, including metastatic melanoma, squamous cell carcinoma of the head and neck (HNSCC), and triple-negative breast cancer (TNBC). In addition to ImmunoPulse™ IL-12, the company is also identifying and developing new immune-targeting agents for use with the ImmunoPulse™ platform. For more information, please visit www.oncosec.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as "anticipate," "intend," "estimate," "can," "expect," "future," "may," "should," "will," and similar references to future periods.
Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on management's current preliminary expectations and are subject to risks and uncertainties, which may cause our results to differ materially and adversely from the statements contained herein. Potential risks and uncertainties that could cause actual results to differ from those predicted include, among others, the following: uncertainties inherent in pre-clinical studies and clinical trials, such as the ability to enroll patients in clinical trials and the risk of adverse events; unexpected new data, safety and technical issues; our ability to raise additional funding necessary to fund continued operations; and the other factors discussed in OncoSec's filings with the Securities and Exchange Commission.
Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. OncoSec disclaims any obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.
If You Like Inovio Pharmaceuticals, You'll Love This Company (ONCS, INO) Inovio Pharmaceuticals Inc. (NASDAQ:INO) and OncoSec Medical Inc. (NASDAQ:ONCS) are working on the same biotechnology for the same reason, though each has a different endzone in mind.
By James E. Brumley
The term electroporation isn't exactly a term commonly thrown around at the dinner table or around the water cooler. In fact, it's such a rare thing, the average person has likely never even heard of it. It's an idea that's caught the attention of a couple of publicly-traded companies, though, and a handful of academic researchers. The two companies in question are Inovio Pharmaceuticals Inc. (NASDAQ:INO) and OncoSec Medical Inc. (NASDAQ:ONCS), and though they have their similarities, for investors, they're different enough to merit distinguishing.
But first, what's electroporation? In layman's terms, it's the application of an electrical current to living cells to widen their porous openings, which in turn lets certain medicines into them where they may have more - or even some - effect.
It is in many regards the next evolution of medical science.
The advent of DNA-based therapies is only as meaningful to the degree an engineered virus or genetic code can enter into a cancerous cell and rewrite its code to either program it to die, or two "wire" it so a body's immune system can kill it. Many of these medicines simply wash around a cancerous cell without ever actually penetrating it, renderings them pointless. By opening up a diseased cell and letting particular treatments into the cell in question, however, allows a medicine to work to its fullest extent.
Based on that science, a company called Inovio Pharmaceuticals has combined the process of electroporation with its SynCon(r) DNA plasmid technology.
The concept is simple enough - take the genetic code for a vital element of the immune system or immune response and create a significant production of it inside the body. Its products aim to create disease-specific cytokines that put an immune system in a higher gear with more potent weapons.
Inovio Pharmaceuticals presently has fifteen trials underway, most of which are in phase 1 trials. It's an impressive number to be sure, but also an expensive one just due to the sheer number of tests the company must manage. And, regardless of how many of the fifteen drugs make it to the market, most of them are still well away from an approval in terms of time.
That's in contrast to OncoSec Medical, which is focusing primarily on melanoma. Two of its four clinical trials underway now are taking aim at the dreaded skin cancer, another is aimed and head and neck cancer, and the fourth is seeking to treat so-called triple-negative breast cancer.
These are the perhaps the biggest underserved markets on the cancer front, largely because they've been the most difficult to treat; many companies don't even bother trying to top the current standard of care.
The reason and result of the super-tight focus OncoSec brings to the table is making sure it allocates time and resources where it has the best shot at making a meaningful dent. To that end, it's focusing on one narrow but important sliver of the cancer immunology market.... DNA-based interleukin-12 (IL-12), a naturally occurring protein with immune-stimulating functions. The treatment is designed to produce a controlled, localized expression of IL-12 in the tumor microenvironment, which in turn, enables the immune system to target and attack tumors throughout the body.
And so far, its melanoma results have been very encouraging. In phase 2 trials, the combination of ImmunoPulse and IL-12 created a response in 48% of melanoma patients, and drove a complete response in 14% of patients.
Those are compelling results for a disease that's often simply ceded to a "let's just do the best we can probably do" kind of mentality from the medical community using the current standard of care to treat melanoma patients.
In other words, for investors, the "less is more" philosophy means ONCS a better focused, smaller, more nimble way to play the budding field of electroporation.
Do you have any idea of how that sounds in light their pursuit of providing a cure for dying people from a very deadly cancer? And where there is no other alternate form of treatment that is been able to find A way of penetrating this horrible killer? Really?
At the BEGINNING of a conference!?!
Right, PR always comes out on a FRIDAY!?!
“True valuation is never reflected until we get an exit opportunity,” Dhillon said. “Everything in-between is just noise.” That holds true for Zack's, Wainwright and all the other analysts--when you think about it, they've been wrong for the last 4 years about ONCS. Unless your a trader and want more predictability in the ups and downs, then the only thing that matters are the data readouts. Until then we are going to be subject to the market forces of fear/greed and pumping and dumping.
No Titan, they published their upgrade from strong sell to a hold a while back, and they're simply reiterating the latest analyst Price targets.