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correction: past laboratory usage of electroporation can support an explanation of why there is no need for large patient trials.
Patent 8738125: Devices and methods for delivering molecules to the heart with electric fields
A device and related methodologies to deliver molecules to the cells that comprise any tissues. The invention includes a catheter-based electrode and methods for its use for the delivery of molecules to cardiac tissue, blood vessels, other tissues/organs that can be accessed through a luminal tissue, and luminal tissues. The invention is also a non-catheter based electrode for performing the same functions. In certain embodiments the electrode utilizes a segmented electrode array wherein each electrode is separately addressable by a source of electricity.
An injection and electroporation delivery device according to the invention can be fitted on the tip of a catheter to access and treat tissues that can be accessed using tissues that have a lumen. The heart provides an example of a tissue can be accessed using a catheter with this device on the tip through any number of blood vessels that lead to it. Similarly, kidney, lung, pancreas, liver, gall bladder, urinary bladder, prostate, and stomach can be accessed and treated using the device mounted on the tip of a catheter. The diameter of the device can be tailored to any size that is suitable for accessing the tissue of interest.
In addition, the device can be used to treat the luminal pathway itself. One advantage of the system described herein is that it does not rely on balloon-based systems, as do many of the catheter based electrodes for treating vessels. Moreover, the device can be used in a non-expandable format.
Treatment of the tissue site by localized delivery of the therapeutic agent coupled with focused delivery of the electroporation signal facilitates selective application of the treatment to the target tissue sought to be treated. In this manner surrounding tissue is spared the adverse effects of treatment while the targeted tissue receives enhanced more optimal levels of the agent.
lasmid DNA-based gene transfer is attractive because it eliminates the need for a biological vector. Application of plasmid DNA-based gene transfer has been handicapped by the lack of efficient and/or effective delivery methods. When compared to viral delivery, the advantages of plasmid DNA-based gene transfer include reduced potential for immunogenicity, integration into the genome, and environmental spread. One method that has emerged as a means to facilitate delivery of plasmid DNA is in vivo electroporation or electropermeabilization.
BACKGROUND OF THE INVENTION
Electroporation (“EP”) originated for in vitro transfection (Neumann et al., 1982) and over the past 25 years has become a standard laboratory method. The administration of electric fields at specific pulse conditions increases cell membrane permeability, which allows uptake of molecules through the cell membrane. The initial demonstration of in vivo electroporation was the delivery of chemotherapeutic agents to solid tumors (Okino et al. 1991). In the mid to late 1990's, the effectiveness of this approach for drug delivery was demonstrated in a variety of different tumors in animals and humans (Gotheif et al, 2003). This technique was then tested for enhanced plasmid DNA delivery (Holler et al., 1996; Nishi et al, 1996). In vivo electroporation is theoretically applicable to all tissues tested. A principal issue limiting the use of in vivo electroporation has been the accessibility of the particular tissue for the application of the electric field. The use of in vivo electroporation for plasmid DNA deliver has seen tremendous growth, including the initiation of the first clinical trials.
My conclusion:
As anyone can see, the invention and the use of electroporation has been years in the making and now doctors are ready to apply it to patients. There has been enough research done on the matter which means that what’s really needed is to comply with FDA regulations in order to get approval. Its background in past clinical usage can explain why there is no need for large patient trials.
If that is the way you understand it, then I suggest you reconsider when the dump began and you might realize that it could have finished.
The speed at which the price per share is rising is not fast enough for some to get where they would normally exit and that makes it difficult for them to respect what the company is pursuing. I understand that, and may even agree to some point, since the bottom line are revenues. Sometimes building bridges might take longer due to the distance it needs to connect. But at the end, the longer the bridge the more ground it covers and the more people can use it to benefit from it. The reward can be seen from its view.
On the contrary, the article mentioned that it got upgrade from a strong sell to a hold, which was done in mid August. At the same time, three equities research analysts have rated the stock with a strong buy rating.
It also mentions again that analysts have set a 12 month consensus price objective of $27.33 for the company and are predicting that the company will post ($0.49) earnings per share for the current quarter, according to Zacks. That has not change either, so everything is the same from previous.
Oncosec continues to build on Dr. Heller's work.
The Reidy Center recently finished working on a $1.5 million project initiated in 2008 and funded by the NIH titled “Therapeutic Potential of IL-15 Plasmid Delivery to Tumors Using Electroporation” in which Dr. Heller was the principal investigator for evaluating a potential therapy for cancer. The five-year project, which ended on 2/28/15, will develop an appropriate treatment protocol that can eventually be tested in clinical trials. The study was designed to evaluate B16.F10 melanoma growth or regression in response to electrically mediated IL-15 plasmid delivery, while determining immune responses and evaluating the effect of intratumoral and intramuscular delivery of IL-15 on the growth of metastatic melanomas, including both subcutaneous and lung lesions. Also to evaluate its potential toxicity of electrically mediated IL-15.
Coincidently, in January 13, 2015, Oncosec received allowance for claims covering the method of treating cancerous tumors with plasmid-encoded IL-15 and electroporation therapy on tumors. I would presume that the research by Dr. Heller was positive which is why Oncosec went ahead with applying for the patent before any results are released. In addition, recent studies concluded in 2014 have shown that the combination of Cetuximab with IL-15 may be considered an attractive therapeutic approach to enhance the clinical efficacy of Cetuximab in TNBC. The rights to Cetuximab, also known as Erbitux in the market, were recently transferred to Lilly from BMS after a battle for ImClone, the company that design the drug, which ended up costing $6.1 billion.
Similarities between Merck, Pfizer, Immune Design and Oncosec leans more towards combinations and the future of immunotherapy.
On June 11, 2013, OncoSec signed a Sponsored Research Agreement with Old Dominion University and the Frank Reidy Research Center for Bioelectrics. Under the agreement, OncoSec and the University would collaborate on nonclinical research focused on developing new technology related to electroporation and delivery of different agents into solid tumors by electroporation.
The first research experiment under this SRA was to evaluate the effects of ImmunoPulse in combination with Anti-CTLA4, Anti-PD1 and Anti-PDL-1 in a melanoma mouse model. The study began that same month and data from these experiments are still pending. The idea is to figure out how ImmunoPulse can be combined with other therapies to either improve the effectiveness or broaden its use into other indications.
On May 7, 2015, Dr. Pierce showed at the 11th Annual PEGS how new cases from the melanoma trial and Phase II Merkel cell carcinoma trial, showed intratumoral electroporation of DNA-based IL-12 driving a CD8+ TIL response. This provided additional evidence that OncoSec's immunotherapies can play an important role in cancer treatment. Dr. Pierce said that results will be release after they are further analyzed.
At the same time, Pfizer and Merck have agreed to collaborate on the development of the Anti-PD-L1 inhibitor MSB0010718C as a potential treatment for multiple types of cancer. There is already a mid-stage trial of anti-PD-L1 in patients with MCC on its way. By the time that study is completed, Oncosec will be more advanced on their combination trial with Keytruda (anti PD-1), if not completed, and will be able to show that ImmunoPulse IL-12 can make a difference when combined.
Meanwhile, Immune Design has partnered with the subsidiaries of Merck to assess the safety and efficacy of its oncology investigative agents, G100 and LV305, with Merck's Keytruda for non-Hodgkin's lymphoma and melanoma. The Phase I trials will evaluate the safety and efficacy of both investigative agents separately combined with an anti-PD-1 therapy. G100 is an agent designed to generate a robust anti-tumor immune response when administered directly to the tumor micro-environment. It is a synthetic toll-like receptor 4 agonist which enhances T-cell responses.
On a recent study of MCC, Dr. Bhatia designed a trial to evaluate ID-G100 in patients with the cancer. The trial will provide insights into the ability of ID-G100 to stimulate an immune response in patients with Merkel cell carcinoma. Immune Design is a clinical stage bio company with a recent IPO trading at $16 in charge of the trial. It can be compared to Oncosec in their finances as well as who they are collaborating with. The investigator-sponsored trial is being conducted at the Fred Hutchinson Cancer Research Center, where Oncosec has a clinical research division and is working along with Dr. Paul Nghiem and DR. Shailender Bhatia, who have done an exploratory analysis of samples from Oncosec’s data collected from patients in the Phase II study in Merkel cell carcinoma trial which will have final clinical results later this month.
"We were impressed by the results of the Phase I study in malignant melanoma patients and strongly believe that OMS ElectroImmunotherapy will be especially effective in an immunogenic cancer such as Merkel cell carcinoma," commented Dr. Shailender Bhatia, principal investigator at the University of Washington.
Immune Design CEO, Dr Carlos Paya has said: "There is great potential to expand the potential of immunotherapy through combination approaches that will stimulate and enhance the immune system in order to mount the strongest response against cancer." A second clinical study in melanoma will assess safety and response to the combination of LV305 and Keytruda in patients who have not yet responded to treatment with Keytruda alone after three months of treatment. Immune Design has designed G100 and LV305 investigational agents to work in vivo and activate the immune system through the induction or expansion of anti-tumor CD8 T cells.
G100 is a potent toll-like receptor-4 (TLR4) agonist being developed to generate a robust anti-tumour immune response when administered directly to the tumour micro-environment.In contrast, LV305 is being developed to activate the immune system through the in vivo generation of cytotoxic T cells (CTLs), initially against a specific tumour-associated antigen, NY-ESO-1.
Prospective Shareholders
In a June 16 article by MissionIR, it states that “The vast market potential of OncoSec's therapeutic delivery system makes the company an intriguing investment opportunity moving forward. As of April 30, the company reported $25.4 million in cash and cash equivalents, which it expects will adequately fund operations for the next year. Additionally, the company's uplisting to the NASDAQ Capital Market, which it completed in May, should provide a platform for increased visibility when the need for additional funding arises. With financial flexibility in place, OncoSec is in a strong position to make continued progress toward the eventual commercialization of its groundbreaking therapeutic pipeline in the coming months.”
MissionIR’s core value is to understand that “more and more companies are beginning to realize the benefits and value of outsourcing their investor relations and strategic communication functions to a team of dedicated professionals. In recent years, the competition for investment capital has escalated to new heights and continues to grow. Securing the capital required for growth now requires greater creativity, discipline, understanding of legal and accounting issues, and increasingly more important, a strong online presence with continual interaction.“
Oncosec will have such platform to help gain visibility at the upcoming event held on September 8-10 in NYC with the Rodman & Renshaw Annual Global Investment Conference, which coincidently MissionIR also has that same event with its client International Stem Cell Corp presenting. The same date of that event, Oncosec will be sponsoring the 1st World Congress on Electroporation, in which Dr. Adil Daud is invited to give the lecture, “Clinical trials with plasmid IL-12 electroporation in melanoma and Merkel cell cancer.” Such event can be a preview of what might be expected on the read out of final data for the Merkel cell cancer study, which will be released at the end of the month. Following the conference, and in addition, Oncosec will be presenting at the 15th Annual BEF meeting in Basel on September 29-30. The Biotech Forum is Europe’s leading congress for both partnering and investment.
The price might make it seem that the company is on a still, but it is only moving forward. Some shareholders might not be very happy because of its pace, but there is no need to run on an uphill.
statistically data by this September will be the Phase 2 MCC results and it will be significant because it shows reaffirmation as to why go with the anti PD-1 combinational trial.
IL-12 conditioning improves retrovirally mediated transduction efficiency of CD8(+) T cells.
Abstract published on The National Center for Biotechnology Information, July 17
The ability to genetically modify T cells is a critical component to many immunotherapeutic strategies and research studies. However, the success of these approaches is often limited by transduction efficiency. As retroviral vectors require cell division for integration, transduction efficiency is dependent on the appropriate activation and culture conditions for T cells. Naive CD8(+) T cells, which are quiescent, must be first activated to induce cell division to allow genetic modification. To optimize this process, we activated mouse T cells with a panel of different cytokines, including interleukin-2 (IL-2), IL-4, IL-6, IL-7, IL-12, IL-15 and IL-23, known to act on T cells. After activation, cytokines were removed, and activated T cells were retrovirally transduced. We found that IL-12 preconditioning of mouse T cells greatly enhanced transduction efficiency, while preserving function and expansion potential. We also observed a similar transduction-enhancing effect of IL-12 preconditioning on human T cells. These findings provide a simple method to improve the transduction efficiencies of CD8(+) T cells.
If that’s the case, then it is only logical to assume that the price will go significantly up. The institutions that purchased shares at a supposed discount would not be very happy if there is an offering within two months at a lower price. Maybe it is a good time to buy.
Interview with the Co-Founder, Director, President & CEO: OncoSec Medical Incorporated by The Wall Street Transcript.8/14/15
TWST: You talked about it being a hybrid technology. What regulatory pathway would you go through in the United States?
Mr. Dhillon: You are still following the BLA pathway through the biologics group. That is the primary mode of action. The delivery is secondary; it’s what we’ve chosen as the path to deliver the DNA into the tumor. The unique thing about our platform is that, with these DNA-based molecules, you can encode them for almost anything, and we have selected a specific molecule, the pro-inflammatory cytokine interleukin-12.
Here are some NDA and BLA Similarities
- IND regulations, Fast Track designation, Special Protocol Assessment
- Financial Disclosure, CTD format
- Labeling and Advertising
- Pediatric study requirements and waivers
- Accelerated Approval
- Orphan Exclusivity
Differences unique to NDAs
- Patent Exclusivity
- Pediatric Exclusivity
- NDA Field Copies
- Regulations more detailed (NDA content and filing criteria)
Differences unique to BLAs
- Product and facility must meet product standards prior to license issuance
- Review includes Application review, facility inspection, method validation and compliance
- Cooperative manufacturing arrangements permitted (divided, shared, contract)
- FDA official release of each product lot (at discretion of FDA)
- Container and packaging requirements
BLAs are used by center for biologics and NDAs are used by center for drugs. The BLA requires close scrutiny of the manufacturing process and facilities, because of the greater variability of biological products.
Although there is no regulatory mechanism in the US to approve a generic version of a product that is marketed under BLA, it is possible that a generic version of a biotech product that has been approved under an NDA could be approved.
Because it is a cytokine that the electroporation device is working with, they will need to file for a BLA with the Center for Drug Evaluation and Research (CDER).
Low, I know the difference as shown in previous post, just glad you noticed my misstatement. What's important is that we are on the same page now.
I meant the Scientific Advisory Board, which provides input to the company’s R&D and clinical strategies, including OncoSec’s multiple planned Phase II clinical trials for the treatment of melanoma, Merkel cell carcinoma and cutaneous T-cell lymphoma. Basically he chose to follow ImmunoPulse along with Dr. Daud, for the same reason Dr. Pierce joined as well. OncoSec’s is its own identity and slowly but shortly others are realizing that IL-12 can safely be used to help strengthen the immune system in the fight against tumors. They are taking the fight directly into the tumor, something Inovio can not do.
I never said the deal validates Oncosec, but it gives a value that can be used as a starting bid once ImmunoPulse gets validated. Just to make things more clearly, Oncosec received NeoPulse from Inovio, which is what got discarded according to you. Electroporation of IL-12 was given by Dr. Heller to Oncosec with a total different patent for the electroporation device, which is why he is now on the board of directors. Just ask yourself why he didn’t give it to Inovio in the first place. By the way, thanks to that, Punit now has his own patent of electroporation device and Dr. Heller continues to work closely with Oncosec and the SBIR grant in Virginia. So expect more exciting things to come.
Mr. Low, I can see why you would say that Oncosec acquired discarded technology, since in 2004, Genetronics Biomedical received fast track for their electroporation therapy (MedPulser) to deliver bleomycin to tumour cells for the treatment of Head and Neck cancer. As you probably know, it did not go too far and Genetronics, the year after, adquired Inovio and changed its name. Oncosec in 2011 was created and purchased SECTA, the electroporation delivery system for bleomycin, which Oncosec named as NeoPulse. However, everything changed for Oncosec, when a few months after, Dr.Richard Heller, who was one step ahead in the use of IL-12, granted Oncosec the license of his patent device for treating malignant tumors with a high field strength electroporation of plasmids encoding of IL-12, which marked the beginning of ImmunoPulse. “OncoSec is the ideal choice to further develop this technology that I and my colleagues pioneered while working at the University of South Florida, and I am pleased they have secured this license,” said Richard Heller, author of the patented technology which he began in 2005. This new license from USFRF complements OncoSec's seminal patents that were acquired from Inovio, but in particular it protects the methods involved in the ImmunoPulse treatment, specifically for the use of DNA IL-12.
As you can see, what Oncosec received from Inovio is totally different to what it is being pursued by the company at present time. However, they both are utilizing IL-12 as a unique approach that specifically activates tumor specific cytotoxic T-cells. So they do have something in common other than electroporation.
In 2006, Inovio presented interim results of a Phase I open-label study, where plasmid DNA encoding a cytokine, interleukin-12 (IL-12), was delivered directly to tumors in patients with malignant melanoma through electroporation using the MedPulser(R) DNA Electroporation System, in which Inovio's technology enabled the entry and significant uptake of the plasmid DNA into the tumor cells, ultimately leading to cytokine production. In a prior pre-clinical study conducted by Dr. Richard Heller and his team at USFRF, they found that the electroporation of IL-12 plasmid resulted in an 80 percent complete regression of a very aggressive melanoma in a mouse model and that this response correlated with IL-12 expression in the tumor. Considering the past observation from Dr. Heller, together with the data given by Inovio, which showed significant levels of interleukin-12 protein in the treated tumor mass together with infiltration of immune cells, it was indicative of clinical responses that should be achievable in future clinical studies.
"We are encouraged that this first set of clinical data from what we believe is the first human study of plasmid DNA delivered using electroporation is exhibiting safety and tolerability of the MedPulser(R) DNA Electroporation System. This is a significant milestone and we are very pleased with the progress of our collaboration with the H. Lee Moffitt Cancer Center, which is focused on developing new treatments for melanoma, one of the deadliest and hardest to treat forms of cancer," stated Avtar Dhillon, CEO of Inovio at the time. "These results should further encourage other developers of DNA vaccines and gene-based treatments of protein-deficiency diseases to consider Inovio's proprietary DNA electroporation technology as an alternative to viral and other delivery methods."
That is exactly what Inovio did with INO-3112, and the reason why the AstraZeneca deal validates Inovio’s technology of generating cancer-specific killer T cells in vivo through the incorporation of IL-12. If it wasn't for the Interleukin 12, such deal would not have taken place, which opens a big door for OncoSec.
how convenient, post 31077 deleted, but you kept 31080, which by the way I was being sarcastic. However, post 31082 is the one that matters, which clearly shows that Punit decided to cut chords with Ms. Vallejo as it is positioning the company for bigger things, and he needs someone with experience to compensate his lack of. She was hired within, with no prior experience as CFO, when the position was created only two years ago. She is practically a certified public accountant.
On the other hand, Mr. Slansky who has many years of experience as CFO, brings more than 25 years of senior management experience, some of it in a nuclear medical device company. He was involved in a profitable merger from a public company into a private one. He has shown a high success rate in raising capital, as well as growing business partnerships between R&D, sales, finance, and operations support. In addition, he has been instrumental in investing in technology and implementing process improvements, which is exactly what Oncosec needs at the moment. He has a bachelor's degree in economics and science from the University of Pennsylvania's Wharton School of Business and a master's degree in business administration in finance and accounting from the University of Arizona.
The change of CFO, for whatever reasons other than to save money, is a step up to what Oncosec is setting itself to accomplish.
Low, if that was the case and she left, why would Oncosec give Ms. Vallejo more than a year’s severance pay (which includes 30 days pay in LIEU of notice under her employment agreement) as stated on the 8-K.
Ms. Vallejo signed a release in "favor" of the Company, which Oncosec agreed to accelerate the vesting of stock options held by her as of the date of her termination, and extend the exercise period for one year post-termination for all of her vested stock options.
This decision by Oncosec is more than what was agreed to under the Amendment to Employment Agreement made between Oncosec and Veronica Vallejo as of August 2, 2013:
1.1 Section 4.3.5.1(a) of the Agreement is hereby deleted and replaced in its entirety with the following:
“a severance payment in an amount equal to twelve (12) months of the Employee’s annual Salary at the time of Termination pursuant to subsection 2.1 of this Agreement, less applicable statutory deductions and withholdings, to be paid in accordance with the Company’s standard payroll practices in equal cash installments beginning on the first payroll date following the date that the Severance Release (as defined in Section 4.3.6) becomes effective in accordance with its terms (the “Release Effective Date”) and ending on the twelve (12) month anniversary of the Employee’s termination date”.
Yes, I see what you mean, but at the same time there is also a pole formed during the 28-29 of May followed by a very slanted pennant, all due to the difference of the exchange which occurred after a very long drop. A significant shift can be formed so it could go either way.
Depending from what time frame you are looking at it, the bear pennant might have already occurred in December 2014, after the SMA crossed the EMA and eventually the middle Bollinger Band crossed both the EMA and the SMA bands by taking control. Looking at daily graphs, after the news of ONCS moving to Nasdaq was released on May 28, for the first time since October24 the EMA finally crossed both of the two other bands and took the lead, but it only lasted a week after the SMA crossed it on Tuesday. It seems now that the SMA is forming a gap away from the EMA and that the middle Bollinger Band wants to take control again and maybe create a drop, only by looking at how the week ended. However, confirmation is needed, especially with today’s low of 6.55 which was held by the resistance from the EMA band which was holding at 6.51. This can act as a support, and if you are right about the drop, it would help create only a small and temporary one, or it might just continue its reverse trajectory. We will know on Monday.
actually it is incorrect, it was probably filed the same way he would for a derivative security.
It was filed correctly, but since the order was filled in two parts1,400 at $ 6.749 and 1,100 at $ 6.725, the form shows the total amount of securities for the reported transaction. The crazy thing is that he could not even buy 2500 shares in one transaction, and a few days ago it would have been easily done. Everyone is patiently awaiting news while some are patiently waiting for a discount. Some should learn to follow by example.
No problem Ryansk, Punit did mention that they were not planning on continuing the MCC project at this time, but would rather focus on the non-responders and combination with anti PD-1,however, in need of confirmation for recent findings, the study which was half way needed to be finish. From a 2014 announcement of strategic update, the study in Merkel cell carcinoma was expected to complete enrollment in the first quarter and report additional data from the trial in mid 2014. The delay was temporarily, until the conclusion of the melanoma study which gave Oncosec a base for their hypothesis, along with more resources to move forward. Now it seems they need to finish it for comparing results and help conclude anti-tumor TIL responsiveness, since it is a short study with a secondary outcome that measures immunologic effects of IL-12 injection and electroporation with a time frame of 2-4 weeks after the first injection.
The primary outcome will be exciting to see results for, since patients who experience at least 2-fold increase in the expression of IL-12 protein will be counted as having a successful outcome. Patients who do not experience a 2-fold or greater increase in IL-12 protein levels in the injected tumor tissue will be classified as a failure for analysis purpose. It will be something for future studies if results are good, but for now they will focus on what can produce the most revenue in a shorter time frame.
This answers your question...
OncoSec's collaborators at the University of Washington, Paul Nghiem, MD, PhD, and Shailender Bhatia, MD, are conducting an exploratory analysis of samples collected from patients in the Phase II single-agent study in Merkel cell carcinoma, which completed enrollment in January of this year. Final clinical results from the Phase II Merkel cell carcinoma study are expected later this year.
"While we continue to analyze the tumor samples from these trials, the preliminary findings are exciting and point to ImmunoPulse™ IL-12 doing what it's supposed to do: enhance immunogenicity and drive an anti-tumor TIL response," said Dr. Pierce. "Combined with the preclinical data on IL-12 electroporation and our gene expression data from melanoma samples, I am increasingly confident that intratumoral expression of IL-12 is pushing the immune system in the right direction."
Date for delivery of final data Phase 2 Merkel Cell Cancer trial, something to look forward to
The estimated primary outcome completion date is June 2015, for the phase 2 trial in which ImmunoPulse has been used for treating patients with Merkel cell cancer, with the hypothesis that placing the gene for interleukin-12 into Merkel cells may help the body build an effective defense to kill tumor cells. On Friday, July 24th, at the World Cutaneous Malignancies Congress, in a session: Clinical Presentations of Cutaneous Malignancies, Dr. Shailender Bhatia will be presenting an abstract on Merkel cell tumor. The deadline for submitting an abstract is May 18, 2015, which means Oncosec might already have clinical information of its results and is not disclosing, but continues moving forward. Expect excellent results on the primary outcome based on early clinical feedback.
Merkel cell carcinoma (MCC) is an aggressive, polyomavirus-associated cancer with very limited therapeutic options for metastatic disease. Cytotoxic chemotherapy is associated with high response rates, but responses are seldom durable and toxicity is considerable, which is something that concerns Dr. Bhatia and has being researching for years before beginning his collaboration with Oncosec. In 2013, he completed a study on the use of palliative single-fraction radiotherapy (SFRT) in MCC patients in which results were associated with an excellent in field control rate and durable responses with minimal toxicity. According to the study, SFRT may represent a convenient and appealing alternative to systemic chemotherapy for palliation, for which most patients with oligometastatic MCC are eligible. Oligometastasis describes patients who have only a few metastatic spots that are typically confined to one organ. SFRT may also synergize with emerging systemic immune stimulants by lowering tumor burden and enhancing presentation of viral/tumor antigens. Dr. Bhatia's past research might have enlightened his interest into electroporation.
Thank you David, I think that information package was created to be used at the presentations that OncoSec was planning for the following months, and it was done in September, right after they had a job opening for a web design position, which was eventually removed. I would assume once the company informs the scientific community as well as large investors on the latest trial results, they will update the website with lots of new information. I can see some changes already made to its design.
I believe they recently hired someone to work on that and there is already some change made. Here is a link for the most recent information package created September 2014. I would imagine that is the next focal point once final results are released.
http://oncosec.com/oncs-investor-package-09-2014/
Twiz, what is significant to me is the source of the story, coming from Randy Osborne who has been a writer and editor in biotech for 15 years, mostly at BioWorld Today which delivers actionable intelligence on developmental science around the world. It is owned by Thomson Reuters, which is the world’s leading source of information for businesses and professionals. That is coverage that many professionals will read and gives OncoSec a lot of credibility to new investors and the results are not even there yet, since everything that was written we already knew. Thanks.
IL-12 TO RESCUE IN CANCER?
Body electric: Oncosec sings praise of booster bid for immunotherapy
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By Randy Osborne
Staff Writer
Monday, December 1, 2014
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The approval this fall of Merck & Co. Inc.'s lauded Keytruda (pembrolizumab) for melanoma – well ahead of its Oct. 28 PDUFA date – opened the door for the promising class of programmed cell death-1 (PD-1) inhibitors, and represented another stride in the steady march of immunotherapy in cancer.
Whitehouse Station, N.J.-based Merck was the first to file a biologics license application for a drug targeting PD-1, ahead of closest competitor nivolumab, from Bristol-Myers Squibb Co. (BMS), of New York, though BMS' drug was the first to win approval in Japan, where it is branded Opdivo and partnered with Osaka, Japan-based Ono Pharmaceutical Co. Ltd. (See BioWorld Today, May 7, 2014, July 9, 2014, and Sept. 5, 2014.)
Some estimates peg sales of cancer immunotherapies as high as $30 billion by 2025, and more than half of cancer therapies are expected to have immunotherapy as their backbone within the next decade.
Keytruda was cleared for use in patients with advanced or unresectable melanoma who are no longer responding to other drugs. But as much as 70 percent of patients do not respond to the drug, and finding a way to change this – for Keytruda and other immunotherapies – could mean big money.
Enter Oncosec Medical Inc., of San Diego, with its drug/device electroporation approach, Immunopulse pIL-12, by way of which DNA interleukin-12 (IL-12) – a plasmid DNA construct with "instructions" to produce the IL-12 protein – is delivered into the electroporated cells. The gene then triggers each cell to produce and secrete the IL-12 protein, which goes after cancer cells as part of natural immune response.
"Even though melanoma is a very tractable tumor type," said Punit Dhillon, CEO of Oncosec, tumor-infiltrating lymphocytes (TILs) are in short supply with the disease, and the "low-TIL environment" keeps PD-1 drugs such as Keytruda from working in more patients. "What we can do with Immunopulse, specifically because we're using IL-12, is bring the immune cells to that environment," he told BioWorld Today.
Oncosec this month entered a collaboration with the University of California, San Francisco (UCSF), to evaluate the safety, tolerability and efficacy of the combination of Keytruda and Immunopulse in melanoma. Enrollment is expected to begin in the first quarter of next year. Also this month, the firm kicked off a preclinical collaboration with Plexxikon Inc., part of Daiichi Sankyo Co. Ltd., of Tokyo, to test the combination of Plexxikon's selective colony-stimulating factor-1 receptor (CSF1R) inhibitor with Immunopulse pIL-12. Recent interim data from Oncosec's phase II study in melanoma showed that local delivery of IL-12 by electroporation increases the production of cytokines like IFN-?, resulting in increased expression of genes related to the processes required for cytotoxic CD8-positive T cells to recognize and kill cancer cells, the company noted.
"There are a lot of different choices out there for delivery – such as viruses, lipids or other biologic means," Dhillon said, but electroporation has the benefit of being "very clean, with no side effects or lingering issues left over." Oncosec, he said, is "the only company doing it intratumorally and the first company delivering gene therapy using in vivo electroporation," though other firms are advancing in somewhat similar areas. Dhillon cited as an example Inovio Pharmaceuticals Inc., of Plymouth Meeting, Pa., which delivers into muscle. "We believe it's important to bring the fight to the tumor and have the specific antigen response in the tumor micro-environment," he said.
Dhillon was the vice president of finance and operations at Inovio. "We were the pioneers in the electroporation space," he said, adding that the intellectual property "was divided up into different tissue types, basically. We didn't have the bandwidth to focus on intratumoral delivery." Spinout Oncosec has "advanced significantly, looking at a whole range of other immune targets and electroporation parameters," he said. (See BioWorld Today, Aug. 12, 2011.)
The firm has several phase II trials enrolling already, with OMS-I100 in metastatic melanoma being conducted in collaboration with UCSF. The open-label, multicenter, phase II trial will enroll about 25 patients with advanced-stage, cutaneous, in-transit malignant melanoma. Trials are under way at three centers across the U.S. Previous data from a phase I study demonstrated that using Immunopulse in melanoma patients is safe and well tolerated, with objective responses (as defined by RECIST criteria) observed in 53 percent of patients.
OMS-I110 targets the rare but deadly Merkel cell carcinoma, with a mortality rate of 40 percent. Because 80 percent of cases are caused by an associated viral infection (Merkel cell polyomavirus), researchers believe an efficient and targeted immunotherapy could be the best hope. Oncosec's safety and efficacy trial is being conducted with the University of Washington. The open-label, multicenter experiment will enroll about 15 patients at two U.S. centers.
In cutaneous T-cell lymphoma, Oncosec has OMS-I120. The phase II study in early and late-stage patients, like the melanoma trials, is being conducted with UCSF. The open-label trial will enroll about 27 patients at a single center.
"Melanoma represents a low-hanging opportunity for us" given the "awesome" data in phase I and phase II trials, Dhillon said. "The monotherapy results speak for themselves. It's pretty unbelievable to see the response in untreated lesions."
yes, it will be out Monday morning. This is the link, but if you can't get it, let me know I will paste it.
http://www.bioworld.com/content/body-electric-oncosec-sings-praise-booster-bid-immunotherapy-0?ref=latest_news&news_type=In
Exposure is building for OncoSec and it has come on its own, due to its results.
When a former Merck research labs executive director speaks, the scientific community listens. A graduate of Yale College and the Brown University School of Medicine, Dr. Pierce has put his career on the line for OncoSec, and people are beginning to pay attention. The same writer of the piece “Merck’s Melanoma Label Perplexes, Disappoints” with an interview of Dr. Pierce was written on September 17, 2014, for a blog that teaches about the latest news and developments in Life Sciences, just wrote an article for BioWorld Online. It is the news service of record for the biotechnology industry and is updated every business morning, owned by Thomson Reuters. Randy Osborne, who has been a writer and editor in biotech for 15 years mostly at BioWorld, just wrote “Body electric: Oncosec sings praise of booster bid for immunotherapy”, which will be on the December 1 Monday morning update. In it he discusses the approval of Merck’s Keytruda for melanoma ahead of its Oct. 28 PDUFA date, and how it has opened the door for the promising class of programmed cell death-1 (PD-1) inhibitors while representing another step towards immunotherapy in cancer. He estimates the sale of cancer immunotherapies to be as high as $30 billion by 2025, and expects for more than half of cancer therapies to have immunotherapy as their backbone within the next decade. Keytruda is to be only used in patients with advanced melanoma who are no longer responding to other drugs. But as much as 70 percent of patients do not respond to the drug, and finding a way to change this could mean big money.
This time he interviews Punit, "Even though melanoma is a very tractable tumor type," said Punit Dhillon, CEO of Oncosec, tumor-infiltrating lymphocytes (TILs) are in short supply with the disease, and the "low-TIL environment" keeps PD-1 drugs such as Keytruda from working in more patients. "What we can do with Immunopulse, specifically because we're using IL-12, is bring the immune cells to that environment," he told BioWorld Today.
"There are a lot of different choices out there for delivery – such as viruses, lipids or other biologic means," Dhillon said, but electroporation has the benefit of being "very clean, with no side effects or lingering issues left over." Oncosec, he said, is "the only company doing it intratumorally and the first company delivering gene therapy using in vivo electroporation," though other firms are advancing in somewhat similar areas. Dhillon cited as an example Inovio Pharmaceuticals Inc., of Plymouth Meeting, Pa., which delivers into muscle. "We believe it's important to bring the fight to the tumor and have the specific antigen response in the tumor micro-environment," he said.
And ends the article with "Melanoma represents a low-hanging opportunity for us" given the "awesome" data in phase I and phase II trials, Dhillon said. "The monotherapy results speak for themselves. It's pretty unbelievable to see the response in untreated lesions." Conclusion, people will start listening.
Welcome to the new OncoSec Investor Information Page
Here you'll find the updated scientific research in an information package designed to attract new investors.
http://oncosec.com/oncs-investor-package-09-2014/
you are right, it is good stuff the fact that PCMR Journal has included the abstract. I was just mentioning why there was no press release about it. I also noticed that all of the speakers listed on the SMR Congress agenda are representing an institution of research and not a company.
http://www.melanomacongress.com/docs/2014_SMR_Agenda.pdf
Oncosec was not presenting at the Society for Melanoma Research 2014 International Congress, according to 2014 SMR Congress Agenda. However, Adil Daud was presenting a symposiums called “charting our evolving understanding of the melanoma treatment landscapes”, representing the faculty via Satellite, on Saturday morning.
The abstract “Delivery of plasmid encoding IL-12 by electrotransfer for effective immunotherapy” is to be included on the scientific journal Pigment Cell & Melanoma Research Volume 27, Issue #6, November 2014, and it was first published online 10/23/2014. Pigment Cell & Melanoma Research publishes manuscripts on all aspects of pigment cells including development, cell and molecular biology, genetics, diseases of pigment cells including melanoma. Papers that are purely descriptive or make only minor advances to the knowledge of pigment cells or melanoma in particular are not suitable for this journal.
It will close over the neckline’s resistance .55, eventually creating a fast rise reaching .80 by December. The chart pattern that will show this has a name which signifies temple and good fortune. That’s exactly how I hope this company will be defined in the future.
It shows last updated 12/17/2012, right after they announced positive interim results from the Phase IV trial of investigating the use of NeoPulse in Europe. They decided to focus their resources for immunotherapy as it opens a greater market while they continued building company value and await for NeoPulse partnering.
they have not forgotten about NeoPulse, but will continue with partnership. Oncosec has been registered with EvaluatePharma for partnering opportunities to reach a global audience of business development and licensing professionals at the world's leading pharmaceuticals companies. http://www.evaluategroup.com/Universal/View.aspx?type=Search&query=oncosec
Product: NeoPulse Program, PhaseIII
Opportunity Comment: OncoSec Medical is seeking partnering opportunities as it begins to approach the FDA & other regulatory bodies with product registration plans. Seeking partner in developing locations such as Eastern Europe & Asia.
Good question, since it would be a major step, but a better question, which you yourself can find the answer, should be how much time does it take to get a scientific paper reviewed by peers. And when you find out the answer, keep in mind that Dr. Pierce is just about to complete his first year with Oncosec, and while you are at it, find out the reason for him leaving Merk in the first place, and if he has already achieved his purpose.
If they had nothing to say, they would not be setting themselves up for such important forums.
They have already registered for the 22nd International Molecular Medicine Tri-Conference which is the industry's preeminent event on molecular medicine, focusing on drug discovery, genomics, diagnostics and information technology. On Tuesday Feb.17, on a forum titled Translational to Clinical R&D “Strategies and Technologies to Reduce Attrition and Improve Clinical Outcomes” OncoSec will present in the morning alongside a group of companies that stand with great value, GlaxoSmithKline, Genentech and Merck. Robert Pierce will speak of data titled Translational Approaches for the Development of Intratumoral Immunotherapies. In it he will discuss Intratumoral therapies are capable of reversing local immunosuppressive mechanisms and driving systemic anti-tumor immune responses. Given the safety and potential systemic efficacy of this approach, Intratumoral therapies will likely play a growing role in future combination immunotherapy regimens. The pros and cons of current syngeneic mouse models will be addressed with particular emphasis on unique aspects of intratumoral therapies. A month before that OncoSec will be at 2:30 pm, Tuesday January 13, Biotech Showcase 2015, where Punit will be attracting new investors and building a stronger case for partnership. In the mean time they will start the month of November broaden the horizons in Europe with the BIO-Europe 2014 presenting at 11:30, Tuesday, November 4. This is just getting started, since they are planning for a long future, and at this point in time, it is easy to see where it is heading. OncoSec just received the equivalent of acceptance to Harvard with a scholarship, as they plan to improve on their product with a SBIR program through NIH. And they will graduate.
OncoSec will give a presentation on Immunotherapy at 11:30, Tuesday, November 4 at the BIO-Europe 2014