A stunning revelation came back in April, when an Oxford published study pointed to only 3% of the cancer drugs tested between 2000 and 2015 were approved to treat patients, whereas another study released this September posited the reason for this level of failure laying with scientists incorrectly targeting.
As targeting needs to improve, new solutions are being offered in combination with previous therapies to raise survivability rates and offer hope. Now aggressive research is being conducted into how to unleash the full potential of what are known as oncolytic viruses (OVs) against cancer, while applying RNA interference. Several innovative companies are working diligently on oncolytic viruses, including Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), Sorrento Therapeutics, Inc. (NASDAQ:SRNE), and AstraZeneca PLC (NYSE:AZN), while mRNA developers include Sanofi (NASDAQ:SNY) and BioNTech SE (NASDAQ:BNTX).
Pelareorep from Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC) is an OV currently being studied for combinations with some of the world’s top selling anti-cancer drugs—including Keytruda ($7.2B in 2018 sales for Merck), Opdivo ($6.7B in 2018 sales for Bristol-Myers Squibb), Tecentriq ($766M in 2018 sales for Roche) and Bavencio ($75.5M in 2018 sales for Pfizer/Merck).
Already across 13 clinical studies and a broad range of cancers, up to 96% of tumor samples tested positive for replicating pelareorep virus after intravenous delivery. To date, pelareorep is the only oncolytic virus with meaningful clinical data demonstrating intravenous delivery to tumor tissue.
Pelareorep selectively infects tumor cells, leading to the creation of inflamed tumors. The body’s ability to target the inflamed tumors is heightened, leading to the creation of tumor reactive T cells. In turn, pelareorep expands existing T cell clones priming the immune system for checkpoint blockade. To date, the drug has synergized with all checkpoint inhibitor combinations tested.
The OV selectively targets cancer cells, enters them, and fosters inflammation that triggers the body’s natural immune system response that kills the cancer cells (and only the cancer cells). Now when combined with an approved and effective drug, what OVs bring to the table is a potentially significant rise in efficacy and survival rate.
UNLOCKING IMMUNE CHECKPOINT INHIBITORS
As the global oncology drug market is projected to grow at a rate of 7.6% CAGR to hit $176.5 billion by 2025, there’s a growing interest within the big pharma sector to tap into the power of viruses to fight cancer.
Within that market the global immune checkpoint inhibitors segment is projected to reach more than $56.5 billion by 2025, growing at a CAGR of 20.1%—making it the fastest growing segment of immuno-oncology.
Which is why the potential for value-adding combinations for approved drugs with OVs such as pelareorep from Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC) are drawing interest from major partners.
Earlier this year, UK-based AstraZeneca PLC (NYSE:AZN) made a $10 million deal with France’s Transgene—the first entry by AZ into the OV space since it signed a 2015 deal with Omnis Pharmaceuticals. The deal with Transgene will involve the development of five armed OVs. Transgene itself has another deal to develop a separate OV with South Korean mega giant, SillaJen.
Sorrento Therapeutics, Inc. (NASDAQ:SRNE) recently announced the closing of a $25 million registered direct offering. Among the new therapies the company is developing, Sorrento has a clinical stage oncolytic virus known as “Seprehvir”, and another future generation asset called Seprehvec.
French developers Sanofi (NASDAQ:SNY) recently invested over $90 million into German biotech company BioNTech SE (NASDAQ:BNTX). Together they are prepared to start clinical development of the first cancer immunotherapy to come from their original 2015 pact. Sanofi initially paid $60 million upfront for the rights to five discovery-stage immunotherapies. Moving forward Sanofi is set to pay up to $300 million in milestones per asset.
The co-developed asset, the most advanced of the drugs in the Sanofi pact, is made up a mixture of mRNAs that encode for immunomodulatory cytokines. While BioNTech also has a partnership in place with Pfizer, Sanofi also has a potential $805 million deal with Translate Bio to develop other mRNA drugs.
9-DIGIT INTEREST IN FIGHTING CANCER
Interest in BioNTech was on full display earlier this summer when it raised a whopping $325 million to develop individualized cancer vaccines. BioNTech is set to use the money to fuel the clinical development of the company’s individualized mRNA-based immunotherapy for treating melanoma, which completed a phase I trial in 2017.
Whether that level of interest translates to groups like Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC) and pelareorep is yet to be seen. However, with partnerships in place with Pfizer Inc. (NYSE:PFE), Roche Holding AG(OTC:RHHBY), Bristol-Myers Squibb (NYSE:BMY), and Merck & Co. (NYSE:MRK) for combinations with major drugs already approved on the market, there’s plenty of potential for a mega-deal based on positive study results in the future.
Oncolytics Biotech is currently studying pelareorep’s potential with Merck’s Keytruda in targeting metastatic pancreatic cancer, through a partnership with Merck and Northwestern Medicine’s Feinberg School of Medicine. The phase 2 study incorporates up to 30 patients.
With Keck Medicine of USC, Oncolytics is involved with another study involving Keytruda combination efficacy for multiple myeloma. The phase 2 study involves 22 patients, and will incorporate existing safety data in combination with Keytruda.
Oncolytics is also targeting multiple myeloma through a potential combination with Opdivo from Bristol-Myers Squibb and Emory University, in a phase 1 study. The study involves 40 to 50 patients, and so far at the top dose, there has been a 100% response rate.
“Having worked with pelareorep in multiple myeloma and understanding its ability to act as a potentiator of checkpoint blockade, I’m very excited to work with the Oncolytics team on this study,” said Dr. Craig Hofmeister, Associate Professor, Department of Hematology and Medical Oncology Emory University School of Medicine. “Pelareorep has proven its ability to create an inflamed phenotype and its potential for upregulation of PD-1 on tumor-infiltrating lymphocytes. My hope is this study leads not only to an effective combination dosing schedule but provides quantitative data describing the expression of PD-1, along with correlative studies that reveal the roles of both immune-mediated and direct cytotoxic myeloma cell killing.”
ANTI-CANCER ASSETS MOVING FORWARD
To date, Oncolytics Biotech’s pelareorep has been involved with 1,100 patients treated, of which over 900 were administered intravenously—So far, no maximum tolerated dose (MTD) has been reached.
Oncolytics Biotech has established a commercial scale manufacturing agreement with SAFC (part of Merck Millipore Sigma). The final formulation was produced at 100 liter-scale under cGMP—which is more than 50,000 standard doses per production run. When stored frozen, the liquid formulation is stable for at least five years (with stability testing ongoing).
Oncolytics has 398 patents issued worldwide, including 48 US and 21 Canadian, with over 21 more pending applications worldwide. The reovirus issued patent claims cover compositions of matter comprising reovirus (through 2028 and extendable to 2033), and all pharmaceutical uses of it.
Sorrento Therapeutics, Inc. (NASDAQ:SRNE) is implementing a multifaceted approach to fighting cancer. Among its key assets, the company has its fully human antibodies G-MAB library, clinical stage immuno-cellular therapies CAR-T, intracellular targeting antibodies iTAbs, antibody-drug conjugates ADC, and clinical stage oncolytic virus Seprehvir.
AstraZeneca PLC (NYSE:AZN) doubled down on oncolytic viruses when it invested $10 million into a deal with France’s Transgene. This was a follow-up on a previous 2015 deal with Omnis Pharmaceuticals. With Transgene, AstraZeneca is set to develop five armed OVs.
Moving forward, many eyes will be on the partnership between BioNTech SE (NASDAQ:BNTX) and Sanofi (NASDAQ:SNY). Sanofi invested over $90 million into BioNTech to start clinical development of the first cancer immunotherapy to come from their original 2015 pact. Sanofi is set to pay up to $300 million in milestones per asset.
Read more about Oncolytics Biotech here: https://usanewsgroup.com/2019/10/06/what-if-you-could-teach-your-body-to-fight-cancer/
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