Great article: 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.
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Oncolytics Biotech Inc ONCY:NASDAQ
'Guided-Missile' Cancer Drugs are the Biotech Sector's First Major Story of the 2020s
PR Newswire
8:45 AM ET
USA News Group - With a new decade still less than a month underway, it appears the 2020s should see some major breakthroughs in the fight against cancer. A recent analysis from Reuters uncovered that a record 89 therapies are underway in human trials that feature the pairing of treatments with antibodies with toxic agents to fight cancer--affectionately dubbed "guided-missile" cancer drugs.
Cancer treatments are being targeted for drastic improvements by several biotech developers large and small, including Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), Roche Holding AG (OTC:RHHBY), Seattle Genetics, Inc. (NASDAQ:SGEN), ImmunoMedics, Inc. (NASDAQ:IMMU), and AstraZeneca PLC (NYSE:AZN).
More technically known as antibody-drug conjugates (or ADCs), treatments are engineered to zero in on tumors and then attack with up to 10,000 times the potency of standard chemotherapy, while minimizing damage to healthy tissue.
MAXIMIZING CANCER-FIGHTING POTENCY
One of the best examples of this method is pelareorep--an immuno-oncolytic virus (OV)--from Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC).
Pelareorep is 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). To date, the drug has synergized with all checkpoint inhibitor combinations tested.
It's potential developments such as pelareorep that could be the embodiment of what makes a "guided-missile" cancer drug hit its target.
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.
The potential for these new treatments is quite large, as the global oncology drug market is projected to grow at a rate of 7.6% CAGR to hit $176.5 billion by 2025 with the therapeutic cancer vaccine market alone projected to surpass $15 billion by 2025.
ARE RISING APPROVALS A SIGN OF THINGS TO COME?
The rise of these types of treatments over the last two decades has been arguably slow--But that could be changing very soon.
Only five ADCs won approval between 2000 and 2018. But in 2019, US regulators approved three ADCs--the most ever in a single year.
The key turning point has been results from studies on last-ditch treatments showing they helped patients whose survival outlook was bleak.
Kadcyla from Roche Holding AG (OTC:RHHBY), approved in 2013 for breast cancer, so far is the only one to have surpassed $1 billion in annual sales. This came after data last year showed it boosted disease-free survival for some patients compared with the standard treatment, the company's other drug, Herceptin.
Most recently, bladder cancer drug Padcev from Seattle Genetics, Inc. (NASDAQ:SGEN) received expedited approval in December. This was based on evidence that 44% of patients who had failed immunotherapy showed improvement, including in some cases showing no evidence of cancer when they were assessed after treatment.
Also approved in December was breast cancer drug Enhertu from AstraZeneca PLC (NYSE:AZN), following positive results showing the drug helped patients who had failed numerous treatments survive a median of more than 16 months before their disease worsened.
Earlier in the summer, was lymphoma drug Polivy from Roche Holding AG getting approval after producing complete response rates, with no signs of disease, in 40% of patients when combined with two other therapies.
Now on deck could be ImmunoMedics, Inc. (NASDAQ:IMMU), whose market cap has gained more than 60% to approximately $4.3 billion over the last six months. In late December, the US Food and Drug Administration (FDA) decided to review ImmunoMedics' ADC that targets triple-negative breast cancer, specifically which is hard to treat and has poor prognosis.
ASSISTED TARGETING FOR THE 'GUIDED MISSILES'
Helping these new treatments succeed, will be complimentary biotech developments, such as pelareorep from Oncolytics Biotech Inc. (ONCY-ONC).
Most recently, ROTH Capital Partners sponsored a Key Opinion Leader call discussing recent data presented at the 61st American Society of Hematology Annual Meeting and Exposition.
During the call, which featured two of Oncolytics' multiple myeloma clinical investigators, Dr. Craig Hofmeister M.D. and Dr. Flavia Pichiorri Ph.D., the speakers highlighted that carfilzomib promotes reovirus infection, that pelareorep upregulates PD-L1, and that delivery of additional data from ongoing pelareorep studies in multiple myeloma is planned for presentation at ASCO in June 2020.
"I think that carfilzomib promotes pelareorep infection by suppressing the innate antiviral response and our data suggest that it does not get in the way of T-cell activation," said Dr. Hofmeister. "Pelareorep infection, not proteasome inhibition, can upregulate PD-L1 expression on myeloma cells and the adaptive immune system can then assist in clearing infected tumor cells. The combination in fact enhances the body's immune attack on infected myeloma cells."
The call also discussed the competitive landscape for refractory multiple myeloma and the paucity of available therapies to treat these patients.
"Reovirus is the only strategy I see in the market that is completely different and may be able to activate the immune system of these patients," said Dr. Pichiorri. "It would be a salvage therapy for now, but so many patients need a salvage therapy after being refractory to other therapies."
PROGRESSION OF THE MOVEMENT
Pelareorep to date has been involved with 1,100 patients treated, over 900 of which were administered intravenously--So far, no maximum tolerated dose (MTD) has been reached.
Oncolytics Biotech Inc. (ONCY-ONC) has accumulated 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.
Getting ahead of a breakout, Oncolytics Biotech Inc. (ONCY-ONC) has already established a commercial scale manufacturing agreement with SAFC (part of Merck Millipore Sigma), with a final formulation produced at 100 liter-scale under cGMP--which is more than 50,000 standard doses per production run.
While it helped pioneer ADCs Kadcyla and Polivy, Roche Holding AG appears to be backing off of the ADC bandwagon for now.
"We have shifted our technology priorities," Roche CEO Severin Schwan told Reuters. "Maybe others will be luckier, but we failed to master the complexity."
This is where groups like AstraZeneca PLC are looking to pick up the ball. Already the Enhertu developer has struck a $7 billion deal with Japan's Daiichi Sankyo ( receiving $1.35 billion up-front)--and potentially more to come if it challenges Roche's drugs' dominance in breast cancer.
With 89 therapies underway with human trials, the era of the guided-missile cancer drug could be officially upon us in 2020
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