FN Media Group Presents USA News Group Commentary
Los Angeles, CA – January 17, 2020 – USA News Group – In the war against cancer, it appears that all hands are on deck, with contributions coming from across the biotech sector. As the 2020s begin, new approvals and promising data are encouraging the market to pay more attention to the developers of new treatments, including Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), GlaxoSmithKline plc (NYSE:GSK), Aethlon Medical, Inc. (NASDAQ:AEMD), Clovis Oncology, Inc. (NASDAQ:CLVS), and Merck & Co., Inc. (NYSE:MRK).
Market researchers see big things to come from investment into the oncological war, with recent forecasts such as: the cancer gene therapy market surpassing $3.2 billion by 2026; the global breast cancer drug market offering a $40 billion opportunity; the noninvasive cancer diagnostics market hitting $195 billion by 2025; and the immunotherapy market estimated to reach $115 billion by 2023.
Key to the current optimism for drugs and therapies that are being developed, either from scratch or as enhancements.
PELAREOREP’S 1-2 COMBO PUNCH AGAINST CANCER
One thriving example an important enhancement therapy is pelareorep from Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC)—an immuno-oncolytic virus (OV) being combined 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).
Recently Reuters published an analysis that revealed a record 89 therapies are currently undergoing human trials involving the pairing of treatments with antibodies with toxic agents to fight cancer—which Reuters calls “guided-missile” cancer drugs.
Like a guided missile, pelareorep selectively infects tumor cells, leading to the creation of inflamed tumors. These then engage the body’s immune system to create of tumor reactive T cells.
This process is designed to enhance the likes of the market’s best oncology drugs out there, as listed above. It does this by expanding existing T cell clones priming the immune system for checkpoint blockade. To date, the drug has synergized with all checkpoint inhibitor combinations tested.
So far, based on the final advice from the FDA following their EOP2 meeting, the company’s been granted Special Protocol Assessment (SPA). It’s been recommended that identification of biomarker should be done before Phase III. Confirmation of a single phase 3 study is required for approval.
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.
To date, it’s been used to treat 1,100 patients, over 900 of which were administered intravenously—So far, no maximum tolerated dose (MTD) has been reached.
Worldwide, Oncolytics Biotech Inc. (ONCY-ONC) has accumulated 398 patents issued, including 48 US and 21 Canadian, and more than 21 additional applications pending.
The reovirus issued patent claims cover compositions of matter comprising reovirus (through 2028 and extendable to 2033), and all pharmaceutical uses of it.
GUIDED MISSILE PARTNERSHIPS
Pharma giants, such as GlaxoSmithKline plc (NYSE:GSK), and Merck & Co., Inc. (NYSE:MRK) are throwing a lot of weight into these guided missile approaches—and there could be a lot more to come.
Between 2000 and 2018, US regulators only approved five antibody-drug conjugates (ADCs). In 2019, those same regulators approved three more, making it the largest one-year total ever. The tide is changing.
GlaxoSmithKline is currently testing its belantamab mafodotin against multiple myeloma. Most recently, the treatment’s pivotal DREAMM-2 trial supported the drug’s use for heavily-treated multiple myeloma.
Oncolytics Biotech Inc. (ONCY-ONC) has also recently highlighted pelareorep’s unique ability to activate the immune system in late stage myeloma, with multiple myeloma data expected at ASCO 2020.
On top of the success of its top-selling Keytruda (which is being studied in combination with pelareorep), Merck has also added to the optimism for ADCs. The drug giant is ramping up its facilities in hopes that drugmakers will farm out complex ADC production. Merck expects the overall ADC market to grow by more than 20% in coming years.
Clovis Oncology, Inc. (NASDAQ:CLVS) saw its stock soar after the FDA accepted its supplemental new drug application (sNDA) for its prostate cancer treatment Rubraca. The regulator granted priority review status for the drug, as recently presented data suggested Rubraca may play a meaningful role in the treatment of patients with BRCA1/2-mutant recurrent, metastatic castrate-resistant prostate cancer.
From a technological standpoint, Aethlon Medical, Inc. (NASDAQ:AEMD) and its Hemopurifier is still riding high from its own FDA approval of its Investigational Device Exemption (IDE) application back in October. The clinical-stage immunotherapeutic device removes exosomes and life-threatening viruses from the human circulatory system, which in turn can be used for the treatment of individuals with advanced or metastatic cancer.
For more information on the latest Biotech trends, please visit: https://usanewsgroup.com/2019/10/06/what-if-you-could-teach-your-body-to-fight-cancer/
USA News Group
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