EDITOR’S NOTE* Be sure to carefully review the updated pipeline chart of Oncolytics’ clinical studies with pelareorep, below.
Within the fiercely competitive oncology treatment market, one of the biggest stories has been the increase in interest in a new treatment that is becoming one of the fastest growing segments in all of biotech—and that is projected to grow at an explosive CAGR of 34.5%. 
This segment is Chimeric antigen receptor T-cell therapy—more commonly known as CAR T-Cell Therapy.
Pharma giants have swarmed into the space and have spent billions on acquisitions of CAR-T assets.
Novartis was the first to get FDA approval for its CAR-T leukemia treatments, and also acquired CAR-T developers Endocyte for $2.1 billion  and complementary gene therapy biotech company AveXis for $8.7 billion. 
Gilead Sciences paid nearly $12 billion to acquire Kite Pharma and its lead CAR-T candidate in order to position itself as a leader in this type of cell therapy. 
Celgene acquired CAR-T development pioneers Juno Therapeutics for ~$9 billion. 
These deals indicate big pharma’s desire to improve on CAR-T cell therapy’s established clinical potential.
As its use becomes more widespread, the global CAR-T therapy market is expected to balloon from $734 million in 2019 to $3.15 billion in 2025 and $6.1 billion in 2030. 
These exciting CAR T-Cell therapy developments are also quickly becoming popular with patients, as the therapy uses a patient’s own immune system to fight cancer, with incredible results.
Dubbed a breakthrough treatment for patients with certain types of blood cancers, such as lymphoma and leukemia, after other treatments have failed, CAR T-Cell Therapy is quickly becoming one of the hottest stories in oncology.
Now we’ve identified a company that has entered the CAR-T sector and has already garnered a solid reputation (with multiple big pharma research partners) in developing agents to help immune checkpoint inhibitors reach their full therapeutic potential. Immune checkpoint inhibitors are another explosive market that’s globally expected to reach +$56.5 billion by 2025, growing at CAGR of 20.1%. 
Over its timeline to date, Oncolytics Biotech Inc. (NASDAQ:ONCY)(TSX:ONC) has established itself as a successful development stage biotech company through its proprietary immuno-oncology virus (called pelareorep) that’s currently being studied in combination with Opdivo® from Bristol-Myers Squibb Company, Roche’s Tecentriq, Pfizer’s & Merck KGaA’s Bavencio, and with Keytruda® from Merck & Co., Inc.
Now with their latest announcement involving research conducted at The Mayo Clinic, Oncolytics is adding combination therapy with CAR T cells to their lineup, in what they believe to be a perfect one-two punch combo in the battle against cancer.
Watch this short explainer video, then continue reading below:
WHY IS CAR-T SUCH A BIG DEAL?
Once considered a niche field of oncology, the concept of CAR T-cell therapy has been in the works for approximately two decades.
It has only been in the last five years, however, that the promise of this therapy has started to show, beginning with the FDA’s historic first approval of Novartis’ Kymriah in 2017.
Since then, the acquisitions and further research started to truly take off—and for good reason…
Here are some highlights of recent CAR T-Cell Therapy developments:
- Remarkable efficacy in treating certain bloodborne tumors and for recurrent and malignant CD30-positive peripheral T-cell lymphomas
- As effective as first-line treatment for high-risk B-cell lymphoma
- Extremely high response rates in treating:
WHAT IS ONCY’S ADVANTAGE IN THE CAR-T SPACE?
When Oncolytics Biotech Inc.(NASDAQ:ONCY)(TSX:ONC) sought out the perfect combination for its flagship pelareorep’s immunotherapy capabilities, it became more and more obvious that the company was destined to enter the CAR-T therapy field.
It’s the perfect complement.
Pelareorep is a naturally derived, non-genetically engineered oncolytic virus that can be delivered intravenously and that preferentially infects cancer cells. This means that pelareorep attacks and kills cancer cells while leaving healthy cells intact. As the virus kills cancer cells, it alerts the body to the presence of these cells and activates the immune system against the tumor. Despite being a virus, pelareorep is not known to cause any disease has been shown to be safe in over one thousand patients.
CAR T cells, meanwhile, are created by drawing blood from a patient’s own body, separating the T-cells (which help produce an immune response and kill infected cells ), and genetically engineering them to produce receptors (chimeric antigen receptors, or CARs) on their surfaces.
The CARs allow the T-cells to recognize specific proteins (called antigens) on tumor cells, attach to them, and kill the tumor cells. This means that when CAR T cells are injected back into the patient, they help the body mount a targeted immune response against the patient’s tumor.
It is thought that pelareorep will enhance the effect of CAR T-cell therapy because the virus alerts the immune system to the presence of cancer cells, which can be good at hiding from the immune system. Treating them with pelareorep exposes them, and signals CAR T-cells to mount an assault on the cancer.
In a way, the body’s T-cells (especially engineered CAR T cells) are like a domestic police force going door to door, looking for suspicious activity—whereas pelareorep acts as an informant that snitches on the cancer’s whereabouts.
This targeted approach is different than traditional chemotherapies, which affect all fast-growing cells in the body. This is why chemotherapies can cause serious side effects across a range of organ systems, such as hair follicles and the lining of the stomach.
Where the Oncolytics Biotech Inc. (NASDAQ:ONCY)(TSX:ONC) entry point becomes even more exciting is the potential to one day replicate CAR T- cell therapy’s efficacy in liquid cancers (blood cancers such as leukemia and lymphoma) in solid tumors.
So far, solid tumors have been more difficult to treat with CAR T-cells because they present several barriers to their function, including restricted tumor access and insufficient trafficking in tumors (in other words: it is hard for CAR T cells to fully penetrate solid tumors, among other difficulties).
A CLOSER LOOK AT PELAREOREP
In addition to its suspected synergy with CAR T-cell therapy, pelareorep can potentially be combined with a number of checkpoint inhibitors, which are a class of compounds that block the proteins that keep the body’s immune system from naturally seeing a tumour.
When combined with these compounds, pelareorep can cause more inflammation in the cancer cells, which, as noted above, alerts the body’s immune system to the presence of those cells and allows it to fight off tumours faster and more effectively.
Pelareorep has also been combined with more traditional chemotherapies and has been shown to increase the overall survival of women with hormone-receptor positive, metastatic breast cancer who are treated with paclitaxel. This is a promising improvement for patients.
Oncolytics Biotech Inc. (NASDAQ:ONCY)(TSX:ONC) is focusing on combining pelareorep with a range of the biggest names in the immunotherapy sector across multiple cancer indications —including in studies with Bavencio®, Keytruda®, Opdivo® and Tecentriq®.
Oncolytics’ primary objective is to obtain regulatory approval for pelareorep as quickly as possible.
The company’s second objective is to expand pelareorep into commercially valuable new treatment areas including other immunotherapy agents in collaboration with pharmaceutical partners. The company is in the process of opening a study that will use Tecentriq® in combination with pelareorep to treat a variety of gastrointestinal cancers, as part of their partnership with Roche (see below for further details).
Oncolytics has established a successful partnership with Adlai Nortye in China, Hong Kong, Macau, Singapore, South Korea and Taiwan. As per the relationship, there is an upfront and milestone payments of up to $86.6 million, with $65 million tied to potential development expansion.
Perhaps most notable are the 5 ongoing studies Oncolytics is performing with Pfizer, Merck KGaA, Merck, Bristol-Myers Squibb, Incyte, and Roche. These involve checkpoint inhibitors, targeting metastatic breast cancer, early-stage breast cancer, multiple myeloma and pancreatic cancer.
Pfizer Bavencio® Co-Development
Oncolytics entered into a co-development agreement with Pfizer and Merck KGaA to develop pelareorep in combination with paclitaxel and Bavencio®, a human anti-PD-L1 antibody, for the treatment of hormone-receptor positive, metastatic breast cancer.
Sales of Bavencio® more than tripled
from ~US$23 million in 2017, to ~US$75.5 million in 2018.
Oncolytics and Pfizer are sharing costs associated with the phase 2 clinical trial, a randomized, open label study that will enroll 48 patients into three cohorts: paclitaxel alone (15), paclitaxel in combination with pelareorep (15), and paclitaxel in combination with both pelareorep and avelumab (18).
Roche Tecentriq® Collaboration
Oncolytics entered into a Master Clinical Supply Agreement with Roche to supply atezolizumab (Tecentriq®) at no cost for use in the company’s clinical development program. The supply agreement enables Oncolytics to further investigate pelareorep’s impact on various cancer types, in combination with atezolizumab, and has already been incorporated into the company’s clinical program with the SOLTI AWARE-1study in breast cancer and a study called GOBLET, which is a multiple indication phase 2 biomarker, safety and efficacy study in advanced or metastatic gastrointestinal tumors. Data from these studies will increase Oncolytics’ experience with the entire checkpoint inhibitor class.
Sales of Tecentriq® totaled $3 billion in 2020 
Merck Keytruda® Combination
Oncolytics is investigating pelareorep in combination with Merck’s anti-PD-1, pembrolizumab (Keytruda®), in an Investigator Sponsored Trial (NU 18I01). The study in second line pancreatic cancer enrolled 13 patients and final survival data is pending.
Sales of Keytruda® were $14.4 billion in 2020 
Bristol-Myers Squibb Opdivo® Combination
Oncolytics is combining pelareorep and nivolumab (Opdivo®) from Bristol-Myers Squibb with a proteasome inhibitor for patients with relapsed/refractory multiple myeloma. The study expands on Oncolytics’ strategy of investigating the importance of systemic pelareorep administration followed by checkpoint blockade.
Sales of Opdivo® were $7 billion in 2020 
Oncolytics Biotech Inc. (NASDAQ:ONCY)(TSX:ONC) has also analysed blood and tissue samples from some of its clinical trials, and has identified a biomarker which may allow the company to predict which patients are most likely to respond to treatment with pelareorep, and possibly to confirm that response in as few as 3 weeks.
Pelareorep is currently being manufactured at commercial scale and its final formulation is under a commercial supply agreement with the life science business of Merck KGaA, who will manufacture all the necessary product for clinical testing, as well as the commercial product upon the receipt of regulatory approval.
MANAGEMENT TEAM BEHIND ONCOLYTICS BIOTECH
Co-Founder, Director, President & CEO – Matt Coffey, PhD, MBA
Dr. Coffey completed his doctorate degree in oncology at the University of Calgary with a focus on the oncolytic capabilities of the reovirus. The results from his research have been published in various respected scientific journals, including Science, Human Gene Therapy, and The EMBO Journal.
Head of Clinical Development and Operations – Thomas Heineman, MD, PhD
Dr. Heineman completed his medical degree and doctorate in Virology at the University of Chicago. His drug development experience spans more than 25 years including 15 years in the biopharmaceutical industry. He has held senior roles at GSK, were he led the clinical development of Shingrix, and at several biotechnology companies where his focus has been oncology and immuno-oncology. Dr. Heineman has led clinical programs in multiple oncology indications including breast cancer, pancreatic cancer, B-cell lymphoma, glioblastoma and colorectal cancer.
Global Head of Business Development – Andrew de Guttadauro
de Guttadauro is +25-year biopharmaceutical commercialization and business development veteran, who’s held executive and senior-level positions at leading pharmaceutical and biotechnology companies, including as VP of Corporate Development at Vical supporting the execution of distribution agreements for Allovectin®, and a variety of positions at Amgen where he contributed to the success of Enbrel®, Aranesp®, and Epogen® before joining MedImmune to lead marketing efforts for the FluMist® inhaled influenza vaccine. He also served as Director of Strategy at Biogen Idec.
VP of Product Development – Allison Hagerman, Peng, PMP
Hagerman is a biotech-focused professional engineer who joined the team in 2010. She’s served multiple roles within the company, including Vice President of Product Development, and Director, Manufacturing and Engineering, as well as Project Manager. She has led the process performance qualification for pelareorep drug substance.
Chair of the Board – Wayne Pisano, MBA
Pisano was recognized as Pharma Executive of the Year by the World Vaccine Congress in 2010. He served as the President and CEO of VaxInnate, and has been a Board Member of Immunovaccine since 2011. He is the former president and CEO of Sanofi Pasteur, one of the largest vaccine companies in the world. He’s credited with driving SanofiPasteur’s leadership within the worldwide influenza market and capturing 50% of global sales.
The remaining leadership roles, Board of Directors, and Scientific Advisory Board consist of highly qualified members, with senior level experience with such companies and institutions as: Ernst & Young LLP, Nabisco, Hospital for Sick Children, Aptose Biosciences, Achillion Pharmaceuticals, National Cancer Institute-Frederick Cancer Research and Development Center, GPC Biotech, Harvard Medical School, Princeton University, Massachusetts General Hospital, EMD Serono, Breast International Group (BIG), SOLTI – Breast Cancer Research Group, Amgen & BMS IO Network and more.
Oncolytics Biotech Inc. (NASDAQ:ONCY)(TSX:ONC) is creating potent combination of a viable drug that stimulates a type of immune response that can synergize with agents called Checkpoint Inhibitors, with the exciting new breakthrough of CAR T-Cell therapy. Together, these two segments targeting a potential $56.5 billion market (with CAGR of +20%) and a potential $6.1 billion market (with a CAGR of 34.5%) respectively.
- Oncolytics Biotech is developing a pair of treatments in two of the fastest growing segments in oncology, with a CAR-T market projected to be worth $6.1 billion by 2030 and an immunotherapy market projected to be worth $56.5 billion by 2025.
- Working towards a combination with their flagship drug pelareorep with two immune checkpoint inhibitor giants expected to be worth a combined $17 billion by 2024.
- 5 ongoing combination studies with major pharmaceutical companies including Pfizer, Merck, Merck KGaA, Bristol-Myers Squibb, Incyte and Roche.
- Product has already demonstrated it can double the survivability rate of women with hormone-receptor positive, metastatic breast cancer.
- Manufacturing agreement in place with Merck KGaA.
- Potential combination with popular and successful drugs already on the market, such as with Bavencio®, Keytruda®, Opdivo® and Tecentriq®, which together in 2020 combined for roughly $24.5 billion in sales.
- First in class, safe and well-tolerated, intravenously delivered immune-oncolytic virus (IOV) that selectively infects cancer cell, causing innate and adaptive immune responses.
- Identified a biomarker that can determine whether a patient is viable for treatment within 3 weeks.
- Successful partnership with Adlai Nortye in China, Hong Kong, Macau, Singapore, South Korea and Taiwan, with upfront and milestone payments of up to $86.6 million, with $65 million tied to potential development expansion.
- Experienced leadership spanning oncology research, drug development, and other medical fields.
Lastly, for an extremely in-depth overview on what CAR T is and how it works, please watch this video located here: https://www.youtube.com/watch?v=gmjLSeAXAmw
USA News Group
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