As October rolled in to welcome the 35th annual Breast Cancer Awareness Month, hope remains alive as new drugs continue to develop from the biotech sector. These include the smaller cap developers such as Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC) and Infinity Pharmaceuticals, Inc. (NASDAQ:INFI), who are working with majors such as Pfizer Inc. (NYSE:PFE), Merck & Co. (NYSE:MRK), and Roche Holding AG (OTC:RHHBY) with their already-approved drugs to improve lives and chances for survival.
While October accrues valuable awareness through high-profile marketing campaigns with large amounts of visibility such as the NFL, or on the roads with major trucking companies, it’s on the front lines where the true battle is being waged.
Take for example, development-stage biotech company Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC) that’s developing an immuno-oncology virus for the treatment of cancer, both solid and in malignancy. Once entered into the bloodstream, the virus specifically targets and enters cancer cells, where it replicates itself and triggers an attack response from the body’s immune system.
Dubbed ‘pelareorep’ Oncolytics Biotech is partnering its proprietary drug with already approved cancer drugs, such as Bavencio from Pfizer Inc. (NYSE:PFE) and Merck & Co. (NYSE:MRK), and Tecentriq from Roche Holding AG (OTC:RHHBY).
Also being tested in combination with Tecentriq is IPI-549 from Infinity Pharmaceuticals, Inc. (NASDAQ:INFI), in two studies initiated in September: the first being solely in combination with Tecentriq, and another with Tecentriq and Abraxane in front-line triple negative breast cancer.
Preliminary results have been promising, and are worth a look at again during this October’s Breast Cancer Awareness Month.
EYES ON THE PRIZE
Beyond the benefit of saving lives, and improving quality of life, drug developers are clearly incentivized by the economics of the problem. Last year the global breast cancer therapeutics market was valued at US$17.87 billion—but projected growth at CAGR of 10.2% has led analysts to predict the market to reach US$38.57 billion by the end of 2026.
It’s worth looking at today’s approved drugs, and their current sales to figure out where the market is heading.
While sales of Bavencio more than tripled between 2017-18 from US$23 million to $75.5 million, Tecentriq had a successful 2018 with $766 million in sales.
However, it’s also worth keeping some attention on Merck’s Keytruda, which in July saw a hopeful study to bring the drug back on path as a potential treatment for breast cancer. Sales of Keytruda in 2018 were over $7.2 billion worldwide.
The effectiveness of each of these treatments may soon be greatly enhanced with the introduction of combinations currently in development—especially pelareorep from Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), which is being looked at for combination viability with all three drugs mentioned above.
BIOTECH TEAMWORK
Both Pfizer and Merck KGaA are working with Oncolytics through co-development agreement 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.
As per the terms of the agreement, Oncolytics and Pfizer are set to share costs associated with the phase 2 clinical trial, an open label study that will enroll 45 patients into three cohorts with 15 patients per cohort: paclitaxel alone, paclitaxel in combination with pelareorep and paclitaxel in combination with both pelareorep and avelumab.
Oncolytics is also working solo with Merck, by combining pelareorep with Merck’s anti-PD-1, pembrolizumab (Keytruda), in two Investigator Sponsored Trials (IST’s). The goal is to expand the use of checkpoint inhibitors as anti-cancer agents by promoting an inflamed phenotype in the tumor or turning cold tumors hot.
The first study is in second line pancreatic cancer will enroll approximately 40 patients with advanced pancreatic cancer. The second study is in multiple myeloma and will continue to build on Oncolytics’ I-O program by combining proteasome inhibitors and pelareorep to demonstrate an increase of PD-L1 expression on multiple myeloma cells and recruitment of T-cells to the bone marrow.
Roche has signed on with Oncolytics for a Master Clinical Supply Agreement, which will supply atezolizumab (Tecentriq) for use in a clinical development program. The supply agreement enables Oncolytics to further investigate pelareorep’s impact on cancer treatments in combination with atezolizumab and has already been incorporated into their clinical program with the SOLTI WOO study in breast cancer.
ENCOURAGING PROGRESS TO DATE
With an immediate focus on checkpoint inhibitors, Oncolytics’ primary objective is to obtain regulatory approval for pelareorep as quickly as possible.
Pelareorep comes with very compelling metastatic breast cancer survival data, as well as synergies with checkpoint approved inhibitors and positive clinical biomarker data.
The company’s second objective is to expand pelareorep into commercially valuable new treatment areas including other immunotherapy agents in collaboration with pharmaceutical partners.
Oncolytics has established a successful partnership with Adlai Nortye in China, Hong Kong, Macau, Singapore, South Korea and Taiwan. As per the relationship, there are already in place upfront and milestone payments of up to $86.6 million, with $65 million tied to potential development expansion.
FROM AWARENESS TO ACTION
As most media coverage during the month of October pertains to pink ribbon campaigns, there is plenty to be encouraged about in the field of drug development.
Much like Oncolytics, Infinity Pharmaceuticals, Inc. (NASDAQ:INFI) is also pairing its drug IPI-549 in combination with major drugs such as Opdivo and Tecentriq. The company is evaluating an Opdivo combination in a phase 1/1b study (MARIO-1) in about 200 patients with advanced solid tumors. Pairing with Tecentriq and Abraxane, the company is also evaluating IPI-549 having initiated a phase II, MARIO-3 study in collaboration with Roche Holding AG (OTC:RHHBY) in front-line triple negative breast cancer (TNBC).
Less than a week before Breast Cancer Awareness month began, Pfizer Inc. (NYSE:PFE) announced new evidence from four studies supporting the effectives of their IBRANCE (palbociclib) combination therapy in everyday clinical practice. The results also provided additional insights on IBRANCE’s use in certain patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (MBC).
With pairings like the above mentioned Oncolytics pelareorep potential, Merck & Co. (NYSE:MRK) still has high hopes for new studies for its Keytruda. Data from a recent study of Keytruda and chemotherapy in triple negative breast cancer gave promising results, including
increased response from 51.2% with neoadjuvant chemotherapy to 64.8% with the neoadjuvant combination with the pre-surgery patients.
For more information see the article at USA News Group: https://usanewsgroup.com/2019/10/06/what-if-you-could-teach-your-body-to-fight-cancer/
USA News Group
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