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OncoSec Appoints Brian Leuthner as Interim Chief Executive Officer
Thu, June 24, 2021, 3:30 PM·6 min read
Avidity partners management, LLC
Takes a 5.5% position in Oncosec
https://d1io3yog0oux5.cloudfront.net/sec/0000919574-21-001347/0000919574-21-001347.pdf
O’Connor just bought 3413 shares @ $7.71 = $99,000
Avinger Initiates Full Commercial Launch of Tigereye(TM) Image-Guided CTO Crossing Catheter
REDWOOD CITY, CA / ACCESSWIRE / January 15, 2021 / Avinger, Inc. (NASDAQ:AVGR), a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of Peripheral Artery Disease (PAD), today announced full commercial launch of its Tigereye™ image-guided chronic total occlusion (CTO) crossing system. With the initiation of full commercial launch, current and prospective accounts throughout the US and Germany are now able to order the Tigereye device.
During the fourth quarter of 2020, Avinger conducted a limited launch at 12 clinical centers in the U.S. and Germany. Approximately 50 CTO cases were successfully performed, showcasing Tigereye's advanced clinical capabilities and excellent product reliability in a variety of lesion types and settings.
"The limited launch program demonstrated Tigereye's strong clinical results and efficiency across a wide range of PAD cases," commented Dr. Jaafer Golzar, an interventional cardiologist and Avinger's Chief Medical Officer. "The enhanced imaging, higher rotational speeds and ability to precisely control the device inside the vessel are truly remarkable advancements in Avinger's family of intravascular OCT-guided catheters. Physicians have been able to consistently, safely and effectively cross complex CTOs, including cases that may have required more invasive procedures such as bypass or amputation, fully demonstrating the unique benefits of Avinger's proprietary image-guided technology."
Jeff Soinski, Avinger's President and CEO, said, "We are excited to progress to full commercial launch of our next-generation Tigereye device. The limited launch program conducted with 14 physician users affirmed our belief that Tigereye represents an important advance for physicians seeking better solutions on behalf of their CTO patients, who often present with the most challenging and complex PAD cases.
"We believe full commercial availability of the Tigereye device will be an important contributor to expanding our revenue growth opportunities in 2021, both in terms of attracting new Avinger user sites and supporting higher utilization per site," Soinski continued. "With three new product families launched in less than three years, Avinger offers physicians a comprehensive suite of the most advanced PAD therapeutic devices available today to provide effective, measurable treatment options with superior patient outcomes."
Tigereye features high definition, real-time intravascular imaging and a user-controlled deflectable tip designed for steerability within the lumen. Tigereye also includes an enhanced distal tip configuration with rotational speeds up to 1000 RPM designed to penetrate challenging lesions. The Tigereye catheter has a working length of 140 cm and 5 French sheath compatibility to enable treatment of lesions in peripheral vessels both above and below the knee. Tigereye is complementary to Avinger's image-guided atherectomy line of catheters, including the Pantheris Next Generation and Pantheris SV devices.
Avinger's proprietary Lumivascular technology allows physicians, for the first time ever, to see from inside the artery during an atherectomy or CTO crossing procedure by using an imaging modality called optical coherence tomography, or OCT, that is displayed on Avinger's Lightbox console. Physicians performing atherectomy or crossing CTOs with other devices must rely solely on X-ray and tactile feedback to guide their interventions while treating complicated arterial disease. With the Lumivascular approach, physicians can more accurately navigate their devices and treat PAD lesions, thanks to the real-time OCT images generated from inside the artery, without exposing healthcare workers and patients to the negative effects of ionizing radiation.
I agree, any idea of future revenue in the next year?
Hey Eros, don't know if you remember me -- still sippin' the coolaid :o/
Didn't you have a avatar of two girls eating a large hotdog?
Dawson James starts OncoSec Medical at buy; PT $10
Stephen KilmerJuly 27, 2020
oncosec
Dawson James Securities launched coverage of OncoSec Medical (NASDAQ:ONCS) with a “buy” rating and $10 price target. The stock closed at $3.19 on July 24.
OncoSec has developed a plasmid-based vector that is delivered using a novel local system of administration: electroporation. The company’s lead product is a plasmid that encodes for the production of interleukin-12 (IL-12) for the treatment of Stage III/IV melanoma.
“We ultimately expect to see expansion into the broader melanoma market, as well as other indications such as squamous cell carcinoma head and neck cancer and triple negative breast cancer,” writes analyst Jason Kolbert.
Mr. Kolbert said OncoSec’s TAVO, which is plasmid-based IL-12, is administered locally via OncoSec’s electroporation gene delivery system. TAVO induces the local expression of IL-12, turning “cold” tumors “hot” and enabling checkpoint therapies such as Keytruda to be effective, he added.
In a Phase 2 trial on immunologically quiescent melanoma, patients were treated with intratumoral TAVO plus Keytruda. In the study of 22 patients, nine, or 41%, were observed to have best overall objective response rate (ORR), with 36% displaying complete responses to treatment of their target lesions, Mr. Kolbert said.
A Phase 2 trial in Stage III/IV metastatic melanoma showed patients were treated intratumorally with TAVO. In the study of 28 patients, 36% were observed to have an ORR, with 18% displaying a complete response to treatment of their target lesions, he added.
Bet they dropped corvax-12 IND
I thought began with the announcement of OncoSec's Tavo granted ATMP certification in Europe for application in melanoma
Read more at:
thefly.com/landingPageNews.php?id=3093160
Fox hopes that by the end of May, the FDA will grant approval for the vaccine’s Investigational New Drug (IND) application.
Say Tj, if I remember correctly, you've had Big Pharma experience and wondered if you could help me understand what "Fox" meant when He said:
Ya know Twiz, after all this time, it's hard to be enthusiastic about ONCS. However, I always thought that if they can reach soft tissue cancers, ONCS would have tough time of it--and they have. But I have to admit, I got a bit of a spark at this device actually reaching human trials.
I have thought bone, lung, pancreatic, and liver represent a potential, new future well over treating melanoma.
OncoSec Presents Pre-Clinical Data from Its Visceral Lesion Applicator (VLA) and APOLLO Feasibility Study Demonstrating TAVO™ Can Be Safely Delivered and Electroporated in Liver at the Online Society of Interventional Radiology Annual Meeting
https://www.prnewswire.com/news-releases/oncosec-presents-pre-clinical-data-from-its-visceral-lesion-applicator-vla-and-apollo-feasibility-study-demonstrating-tavo-can-be-safely-delivered-and-electroporated-in-liver-at-the-online-society-of-interventional-radiology-an-301044318.html
SAN DIEGO and PENNINGTON, N.J., April 21, 2020 /PRNewswire/ -- OncoSec Medical Incorporated ("OncoSec") (Nasdaq: ONCS), a company developing late-stage intratumoral cancer immunotherapies, today announced pre-clinical data from a feasibility study of its visceral lesion applicator (VLA) electroporation device and APOLLO generator which were presented online at the Annual Meeting of the Society of Interventional Radiology (SIR). The feasibility study demonstrated the capability of a rigid, trocar-like VLA applicator to safely deliver and electroporate DNA-based immunotherapy directly into target organs in a large animal model using a CT-guided approach and OncoSec's new, lower voltage APOLLO generator.
In a study titled, "Can an Intratumoral DNA-Encoded Immunotherapeutic Device Platform Currently Used in the Management of Cutaneous Lesions Be Scaled in Size to Function in the Treatment of Visceral Tumors Through Image-Guided Techniques?", investigators built upon data presented at the Annual Meeting of the Society of Interventional Oncology (SIO) demonstrating the VLA's ability to reach deep visceral organs using laparoscopic/ultrasound and bronchoscope/steerable catheter methods in live large animal models.
In the study presented online at the Annual Meeting of the SIR, OncoSec demonstrated the ability to guide and deploy the VLA under a different guidance method and electroporate with the APOLLO generator. Using CT-guidance, investigators were able to reach high value targets including liver, lung, bone, and pancreas in a live large animal model. Additionally, TAVO was safely delivered and electroporated directly into the liver. Importantly, data also showed that it had no significant effects on hemodynamics, as indicated by consistent heart rate and arterial blood pressure. Animals were survived for at least 24 hours and no adverse events were observed.
"The potential opportunities that this technology represents are very promising. Interventional radiologists are eager to find treatment solutions that extend beyond standard of care. The possibility of delivering potent immunotherapy directly to visceral tumors in radiology suites could shift the paradigm of how we treat certain tumors, particularly in the liver, lung and bone," said Dr. Daniel Simon, Board Certified Interventional Radiologist at Vascular Management Associates of New Jersey and Maryland Cardiology Associates, and scientific advisor to OncoSec, who performed these large animal studies presented at SIR.
OncoSec has developed a short mechanism of action video that illustrates the way the VLA system is designed to target and treat tumors in humans. The video can be accessed on the Company's website via https://oncosec.com/vla/.
In the previous feasibility study originally reported at SIO, large live healthy animal subjects were placed under general anesthesia while investigators safely and successfully accessed and deployed the VLA in the lungs with a flexible, catheter-based applicator using a bronchoscope and a steerable catheter, and liver using ultrasound-guided laparoscopy with a rigid-trocar-based applicator. Following deployment of the VLA, electroporation was performed in the liver using the company's proprietary APOLLO generator. No adverse effects were recorded during or after electroporation. Additionally, initial data from the APOLLO generator's built-in feedback system embedded within the platform detected and recorded trends in impedance values between different tissue types, as well as between the presence and absence of DNA. The APOLLO generator was also able to indicate when the applicator tip was not effectively placed within the tissue. These data highlight the safety mechanisms as well as the future possibility of differentiating between healthy tissue and a local tumor. Data from both SIR and SIO can be accessed via the two respective posters at https://oncosec.com/vla/.
"This study of our VLA device demonstrates the feasibility of reaching critical tissue targets, delivering a drug -- in this case our lead product, TAVO, and electroporating in a large-animal model," said John Rodriguez, Vice President, Product Engineering at OncoSec. "We are very encouraged by these data, as they support our belief that electroporation combined with delivering drug intratumorally may be possible in tumors located within internal organs. These results allow us to move forward with a preclinical safety study in the near term, followed by the potential filing of an Investigational New Drug application and initiation of a phase 1 human clinical trial using the VLA platform in combination with TAVO."
TJ, what's a fact sheet in this context?
IL-12 is mentioned as an injection but not with oncosec's electroporation. IL-12 is not owned by ONCS and has been in use for at least 3 decades.
Clinical Cancer Research highlights OncoSec's Merkel Cell Carcinoma Clinical Study on the Cover of its February Issue
PR NewswireFebruary 4, 2020, 7:30 AM CST
SAN DIEGO and PENNINGTON, N.J., Feb. 4, 2020 /PRNewswire/ -- OncoSec Medical Incorporated ("OncoSec") (Nasdaq: ONCS), a company developing late-stage intratumoral cancer immunotherapies, today announced the publication of data showing that TAVO™ (plasmid-based interleukin-12) treatment, administered through OncoSec's electroporation gene delivery system, resulted in regression of injected and non-injected Merkel cell carcinoma (MCC) tumors. The study, a pilot with fifteen patients, is featured on the cover of the February issue of Clinical Cancer Research (print edition available here).
The study showed that all patients successfully received at least one treatment cycle of TAVO via electroporation, OncoSec's lead product candidate, without significant systemic toxicity and with only transient, mild grade adverse events. Sustained intratumoral expression of IL-12 protein was observed, along with increased tumor-specific CD8+ T cell infiltration, as well as systemic immunologic and clinical responses. In the first cohort (A, n=3), two of three patients were recurrence-free at 44+ and 75+ months, respectively, and one of these patients experienced pathologic complete remission. In the second cohort (B, n=12), overall response rate was 25 percent, with two patients experiencing durable clinical benefit (16 and 55+ months, respectively).
"Achieving the cover study in Clinical Cancer Research is an important milestone, as it further validates the use of TAVO via electroporation as a meaningful immunotherapeutic agent in this cancer setting," stated Christopher G. Twitty, Ph.D., Chief Scientific Officer of OncoSec. "We believe this study reinforces the broad potential to treat multiple types of cancer using TAVO with our proprietary electroporation gene delivery system. We look forward to building on these studies and further investigating TAVO for the immunotherapy of cancer."
About OncoSec Medical Incorporated
OncoSec is a clinical-stage biotechnology company focused on developing cytokine-based intratumoral immunotherapies to stimulate the body's immune system to target and attack cancer. OncoSec has built a deep and diverse clinical pipeline utilizing its primary technology, TAVO™ (tavokinogene telseplasmid) as a potential treatment for multiple cancer indications either as a monotherapy or in combination with leading checkpoint inhibitors; with the latter potentially enabling OncoSec to address a great unmet medical need in oncology: anti-PD-1 non- responders. In addition to TAVO™, OncoSec is identifying and developing new DNA-encoded therapeutic candidates and tumor indications for use with its new Visceral Lesion Applicator (VLA), to target deep visceral lesions, such as liver, lung or pancreatic lesions. For more information, please visit www.oncosec.com.
TAVO™ is a registered trademark of OncoSec Medical Incorporated.
Pharma Updates: Oncosec Grows, CytoSorbents Takes on Coronavirus
By
U.S. 1 Princetoninfo.com
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February 26, 2020 151
Oncosec Partners With Two Companies, Gets $30 Million
Oncosec, a Pennington-based biotech company that is developing immunotherapy for skin and breast cancer (U.S. 1, May 22, 2019), has formed a strategic partnership with two companies and received $30 million in funding. The cash infusion will help Oncosec carry on clinical trials of its product candidate, TAVO, which, is an immunotherapy agent injected directly into tumors using a device that the company has developed.
Oncosec, with just 15 employees in its Main Street headquarters, has partnered with Boston-based biopharmaceutical company Sirtex to market TAVO if and when it wins FDA approval. Oncosec CEO Daniel J. O’Connor said Sirtex’s success in marketing its own product, tiny porcelain spheres that help deliver drugs to tumors, indicates that it could be successful in marketing Oncosec’s product, part of which is a medical device. Oncosec will pay a royalty “in the low single digits” to Sirtex for marketing.
The second company, China Grand Pharma (also a minority shareholder in Sirtex) obtained a license to market TAVO in the Asian market outside Japan.
O’Connor said the investors paid Oncosec $2.50 a share, a premium over its stock price. The transaction resulted in CGP owning 45 percent of Oncosec stock, and Sirtex another 8 percent. Oncosec’s shareholders approved the deal. “At the moment, biotech companies, when they raise capital, are giving discounts to the stock price and giving warrants as sweeteners to the deal,” O’Connor said. “We avoided all of that.”
CGP will conduct the clinical trials necessary to bring the drug to market in China, and Oncosec will collect up to a 20 percent royalty. Oncosec will also obtain access to the clinical data generated by CGP’s studies. “Clinical data is expensive, and getting it in any market is very helpful,” O’Connor said. “We will be able to use it in the U.S. and Europe and Japan and other markets.” O’Connor says the Chinese market is “impenetrable” for U.S. companies without working with a local partner.
O’Connor said Oncosec was doing well on other fronts. Many executives in biotech business in general are feeling nervous about the results of the upcoming presidential election. BioNJ, a pharmaceutical trade group, has been lobbying against legislation to control drug prices. O’Connor said he is less concerned about that issue because TAVO would be cost-effective to manufacture. “We have the opportunity to have that reflected in pricing,” he said.
In addition to its study on TAVO, in which the drug is being administered in combination with Merck’s Keytruda immunotherapy agent, Oncosec is testing its candidate’s safety and effectiveness against a particularly treatment-resistant form of breast cancer called triple-negative breast cancer.
O’Connor expects the deal will result in further expansion of Oncosec’s New Jersey presence. (The company also has a lab in San Diego, where it was founded.) Even if the company outgrows its office space, O’Connor anticipates staying in New Jersey, thanks in part to the state’s Net Operating Loss program, which Oncosec has taken advantage of. TNOL is an economic development program that allows research and development companies to raise cash by “selling” their losses to other companies, which can claim them for tax purposes. O’Connor said Oncosec has made $800 to $900,000 from TNOL, raising capital without having to sell stock.
“New Jersey is the only state in the U.S. that offers that program,” he said. “It’s a really tangible incentive.”
The headquarters of Oncosec is a non-traditional one for a pharmaceutical company. Oncosec occupies a 19th-century building that was a fire house and a town hall at different points in its history. O’Connor says that if they outgrow the space, they will likely seek another “atypical business environment.” He said it is cost-effective compared with a sterile and isolated corporate office park.
Keeping overhead low is critical for a company like Oncosec that needs to use all its resources on gathering clinical data in an effort to get its product to market. The board table was bought from a Crate & Barrel outlet store for $90. “We’re always looking for ways to be efficient,” O’Connor says.
OncoSec, 24 North Main Street, Pennington 08534. Daniel O’Connor, CEO. www.oncosec.com.
OncoSec Releases
Video Highlighting
Why CGP/Sirtex
Strategic Transaction
Will Create Significant
Shareholder Value
https://advancingoncosec.com/
2 million new cases world wide of breast cancer of which 10-20% are diagnosed as TNBC. If you split the difference to 15%, that's 300,000 new TNBC cases per year, if treated at an OncoSec price tag of just $20k per patient, that's a potential market of $6 billion. That might help with OncoSec's PPS.
Good Morning Pazzo, would you please post the link to where you got this?
I saw this yesterday from jckrdu at biotech inv.:
"One other thing I'll mention is that I did have a conversation with DOC (Dan O'Connor) several months ago. When I asked him about Merck's interest in ONCS, DOC basically said that Merck likes the data, but would only move forward to pull the trigger on a bigger deal (monetary partnership or buyout) if they "had to". When I asked follow-up questions, the response was … that's just the way Merck does their business development... they don't make major moves unless they feel someone else is interested, and their hand is forced.
IMO, this deal with CGP is DOC's way of forcing Merck to make a decision. I'm going to hold until we see how the story ends. I think it ends higher than $4.50 with multiple parties appearing to be interested (Alpha, CGP and Merck) and the institutional investors still holding."
I'm assuming this patent is directly related to the followning:
Patent claim #'s 10, 11, 12 and 18;
10. The method of claim 1, wherein the treatment-refractory cutaneous or subcutaneous cancerous tumor is a treatment-refractory, cutaneous or subcutaneous, breast cancer tumor or a treatment-refractory, cutaneous or subcutaneous, triple-negative breast cancer tumor.
11. The method of claim 1, wherein the cancerous tumor is melanoma.
12. A method of treating a subject having a treatment-refractory, cutaneous or subcutaneous, cancerous tumor comprising: a) administering a first treatment at a first time (T1), wherein the first treatment comprises injecting the cancerous tumor with a first effective dose of at least one plasmid encoding at least one immunostimulatory cytokine and administering a first electroporation therapy to the cancerous tumor, wherein the first electroporation therapy further comprises administration of at least one voltage pulse having a duration of about 100 microseconds to about 1 millisecond; b) administering a second treatment at a second time (T2) after T1, wherein the second treatment comprises injecting the cancerous tumor with a second effective dose of at least one plasmid encoding at least one immunostimulatory cytokine and administering a second electroporation therapy to the cancerous tumor, wherein the second electroporation therapy further comprises administration of at least one voltage pulse having a duration of about 100 microseconds to about 1 millisecond; c) administering a third treatment at a third time (T3) after T2, wherein the third treatment comprises injecting the cancerous tumor with a third effective dose of at least one plasmid encoding at least one immunostimulatory cytokine and administering a third electroporation therapy to the cancerous tumor, wherein the third electroporation therapy further comprises administration of at least one voltage pulse having a duration of about 100 microseconds to about 1 millisecond; and d) administering a fourth treatment at a fourth time (T4) after T3, wherein the fourth treatment comprises administering an effective dose of an immune checkpoint inhibitor to the subject.
OncoSec Announces Collaboration For TAVO™ In Australia With Emerge Health--TAVO to Become Revenue Generating Potentially As Early As Year-End 2019
Collaboration uses Australia's Special Access Scheme (SAS) Allowing Patients Prescription Access To TAVO at Commercial Rates Prior To Regulatory Approval
SAN DIEGO and PENNINGTON, N.J., May 29, 2019 /PRNewswire/ -- OncoSec Medical Incorporated (OncoSec) (NASDAQ: ONCS), a company developing intratumoral cancer immunotherapies, and Emerge Health Pty (Emerge), the leading Australian company providing full registration, reimbursement, sales, marketing and distribution services of therapeutic products in Australia and New Zealand, have entered into a collaboration agreement commercializing OncoSec's proprietary TAVO (enhanced IL-12 DNA-plasmid) and making it available under Australia's Special Access Scheme (SAS) in 2019. As a specialized Australian pharmaceutical company focused on the marketing and sales of high quality medicines to the hospital sector, Emerge has previously made numerous other products successfully available under Australia's SAS.
This collaboration will allow OncoSec to begin generating revenue, potentially as early as the fourth quarter of 2019. The ability to begin this process in Australia with TAVO sets OncoSec apart from other clinical-stage companies developing therapies for the treatment of refractory metastatic melanoma. TAVO will be the only drug available under the SAS program for melanoma patients who have failed checkpoint inhibitor or targeted therapy.
The SAS was introduced by Australia's Therapeutics Goods Administrations (TGA) in recognition that there are circumstances where patients need access to therapeutic products that are not on the Australian Register of Therapeutic Goods (ARTG). Australia's SAS allows physicians to prescribe and treat patients with drugs not yet approved in Australia provided those patients have a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment. 1
In 2019, it is estimated that 15,229 new cases of melanoma skin cancer will be diagnosed in Australia (8,899 males and 6,330 females) and that it will become the ninth most common cause of death from cancer in 2019. TAVO, to be used for melanoma patients who have failed either checkpoint inhibitors or targeted therapy, could treat up to 1,000 Australian patients.
I wonder since the patent is for all trial indications--if that may help extend Australia's SAS program to Triple-negative breast cancer and Head and Neck cancer on top of their present approval for melanoma.
I like Jckrdu's (Biotech Investor Board) timeline for potential upcoming events:
“Dr. Wayne Marasco is a world-renowned antibody engineering expert who works on infectious diseases and cancer immunotherapies. Dr. Marasco’s laboratory has developed one of the largest human antibody phage display libraries ever made (with tens of billions of members).
For cancer, as well as HIV/AIDS and other infectious diseases, one possible treatment involves the use of human monoclonal antibodies (Mabs) – which are proteins that are produced to bind to only one substance. For cancer treatments, Mabs bind only to cancer cells and produce immunological responses against the cancer cells. There is great promise with Mabs because their tumor-fighting effects would be less harmful to normal cells than that of traditional cancer treatments.
In an effort to greatly expand the use of Mabs in the treatment of cancer, Dr. Marasco and NFCR founded the NFCR Center for Therapeutic Antibody Engineering. He collaborates with accomplished global cancer investigators in a joint effort to uncover new Mabs using his laboratory’s human antibody library.
Dr. Marasco has had great success developing Mabs that attach to an important protein – carbonic anhydrase IX (CAIX) – that is highly expressed in renal cell carcinoma, the most common type of kidney cancer. Once attached, the CAIX antibody can halt abnormal cancer growth.
Most recently, his team at the NFCR Center developed a combination immunotherapy treatment that holds promise for treating metastatic kidney cancer more effectively. The immunotherapy they have engineered includes not only the CAIX antibody that detects and binds to CAIX growth-promoting proteins on cancerous kidney cells, but also unblocks T cells to enable more rigorous attacks against cancer. Moreover, this double treatment approach could be adapted to treat advanced colon, breast, brain and other difficult-to-treat solid cancers using different antibodies.
Bio
Wayne Marasco, M.D., Ph.D., studied at the University of Connecticut’s School of Medicine, where he received his Ph.D. in 1980. He conducted his postdoctoral training at the University of Michigan Medical School, where he also earned a M.D. in 1986. He received his sub-specialty training in infectious diseases at Harvard Medical School, where he is currently a professor, and he joined the Dana-Farber Cancer Institute in 1989. In 1992, he also joined the Division of Infectious Diseases at Brigham and Women’s Hospital.
In 1980 and 1981, Dr. Marasco won the Biomedical Research Council Award and the National Research Service Award from the University of Connecticut School of Medicine, and the University of Michigan awarded him the United States Public Health Service Award in 1981, the Dean’s Award for Research Excellence in 1986 and the Lung Immunopathology Training Grant Award in 1987 and 1988.
In 2003, Dr. Marasco became the Director of the NFCR Center for Therapeutic Antibody Engineering to expand the use of human monoclonal antibodies in the treatment of cancer. In 2009, U.S. News & World Report listed Dr. Marasco as a “Medical Pioneer” and a top scientist in his field. In the same year, Dr. Marasco was selected as a Distinguished Speaker by the Walter Reed Army Institute of Research.
Areas of Focus
Antibody Engineering
Immunotherapy
Personalized Treatments
Cancer Types
Blood cancers
Breast cancer
Brain cancer
Colorectal cancer
Kidney cancer
Years of NFCR Funding
1994 – Present”
“Jacob Plieth. Senior Reporter. Jacob has 21 years' experience of writing about healthcare, and joined Vantage in 2012 from Edison Investment Research, where he spent five years as an equity research analyst.”
So divide my total shares by 10...oh man! or adding 70 million outstanding shares?
2019-03-31 13F ONCS / OncoSec Medical Incorporated 0.56 503,324 280
Investor Intrinsic Edge Capital Management LLC
Portfolio Value $ 590,686,000
Current Positions 109
Opened Positions 5
Closed Positions 58
Intrinsic Edge Capital Management is based out of Chicago. Intrinsic Edge Capital Management is a large advisory firm with 12 clients and discretionary assets under management (AUM) of $1,388,487,950 (Form ADV from 2019-04-22). Their last reported 13F filing for Q1 2019 included $590,686,000 in managed 13F securities and a top 10 holdings concentration of 32.23%. Intrinsic Edge Capital Management's largest holding is Eldorado Resorts Inc with shares held of 712,450. Whalewisdom has at least 10 13F filings
Since 2012 at 52 years old, now knocking on the door of 60--I've been supporting the effort to fight cancer through ONCS. I've gone through the dating stage of electroporation with Bleomycin (Chemo injection), then committing to ONCS with the treatment of melanoma cancer tumors with IL-12, which then blossomed into demonstrating systemic effect.
Since then, I have watched the maturing of the technology by fine-tuning the electropulse settings, upgrading IL-12 to TAVO, and then discovering it's new role of reaching non-responders (turning cold tumors to hot) to serve the dreadnought of Keytruda in immunotherapy.
Then to watch this yet to be seen, a new proprietary technology can treat tumors that were previously inaccessible. It is a technology that can be used with other immunotherapeutic drugs such as checkpoint inhibitors. In particular, this technology is a non-toxic physical method, that has the advantage that it can be applied to a wide range of cell types since it can destroy the molecule. I measures for tumor hardness, quantity of T-cells (for best dosage), real-time measure of gene absorption by the tumor to be st determine pulse frequency and duration. And be deployed throughout internal organs of the body.
When you consider how quickly ONCS has adapted from chemo to gene therapy, then needing to adapt from being a sole treatment to the need of combination with Keytruda treatment, then adapting to only surface application to melanoma, the adapting surface electroporation to subcutaneous (internal tumor treatment), adapting device to administer multi-gene cocktail into multiple tumor types while simultaneously having real-time measuring tumor hardness, absorbtion by the tumor cells, and t-cell amounts.
This has been watching science history in the making, despite Punit dillion, his dad Avatar, Changing out of science staff, board members, and CEO to DOC--the science of ONCS has persevered.
I have at times stood at edge of flip-flopping, only to keep a grip on the science and it's potential which has required tremendous amounts of PATIENCE, PATIENCE, PATIENCE and more PATIENCE!
I know there are many different positions of different amounts of shares, over different time frames, but we are all dependent on the Science, which if it performs well before any other technological leaps of immunotherapy--Then I am still seeing ONCS postioned to be a near-term technological leap of it own.
And TRADING.JEFF, I really want to thank you for your constant presence on this board from the beginning. Your leadership, oversight, and integrity has meant more to me than you'll every know! You stand on Point everyday and spare, expose, support, educate, soothe and have been a true MENSCH (I am not Jewish), which means "stand-up guy", a person with the qualities one would hope for in a friend or trusted colleague.
Blessing to the Longs here and to the Science of OncoSec.
From Bioposter at biotech Inv. board:
ThinkEquity Conference (DOC speaking):
Thinks Keytruda is one of the most important drugs developed in his lifetime
Says checkpt therapies started at Imclone, where DOC worked at for a while
Yes, there are hundreds of combo trials currently underway with MRK’s Keytruda, but how many have done a second trial w/ MRK? ONCS is doing that.
At first he said, “most” of the other trials are not on definitive checkpt failures. Then he corrects himself and says, “all” of the other trials…
When DOC came to ONCS, the K695 n=48. He said that wasn’t enough for AA, so they increased to n=80. Now, Merck has approval rights on ONCS’ Keynote trial protocol. So ONCS went to MRK about increasing n=80. MRK said, “No, we think you should go to n=100.” MRK said that’s the number you want to go with to make a strong, tight case to the FDA. “So, that’s what we did. We went to 100 patients.”
They’ve now treated 40 patients and have data on 20.
AA: “This time next year, or close to it.”
He says he thinks stock is tremendously undervalued.
DOC: “Hopefully, with our study, we’ll see anywhere between 17% to 20% to 25%...probably a pretty good range of what we’re likely to see.”
TNBC: K890: this study is not designed for AA. MRK wanted to do another study with ONCS here. This trial is “enrolling very quickly.” DOC said that, as of three weeks ago, the TNBC trial is about halfway enrolled. Will release data “most likely at the end of the year...we could do something earlier. We’ll see.”
I hope Dr. Dalesandro brings some of that $6.5 billion dollar buyout deal mojo from the sale of ImClone to Eli Lilly, to Oncosec.
Wow ahab, you sure dated yourself with that one (big smiles)
Note to self: "introduce the new VLA...in early 2020"
OncoSec's Head of Clinical Development and Operations not too long ago
akhsv777, i liked moderator ACTCFAN'S response over on biotech investor:
"The data is what matters to me. I don’t draw many conclusions about the data from a $20m atm. It feels more about leverage at the negotiating table a year from now - so as not to bargain from a desperate cash position when the trial is near completion.
EDIT:
Looking at the last Corp presentation:
- most significant trial milestones about 9 -18 months out
- cash runway of 12+ months
I think it’s always better to have the second much further out than the first."
Multi-gene patent published late Dec 20, 2018:
patentscope.wipo.int/search/en/detail.jsf?docId=WO2018229696
Personally, I think you're onto something Chick ;)
Yep Chick, that's the bottom line isn't it!
Oh, by the way Ahab--Yes ;)
they've been wrong for the last 7 years
Seeking Alpha makes a point that small cap Biotech happens to be on the move today across the board, 10 to 15% for many.