Researchers at the University of Cincinnati Cancer Center have found a potential new combination therapy for breast cancer that would integrate the body’s immune system with targeted treatment for a protein that advances cancer. The UC study came on the heels of other announcements involving combination therapies, in particular with established chemotherapy drug paclitaxel, produced by Bristol-Myers Squibb (NYSE:BMY). Recent combination studies with paclitaxel have come from developers such as Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), Athenex, Inc. (NASDAQ:ATNX), Merck KGaA (FRA:MRK) (OTC:MKKGY), Merck & Co., Inc. (NYSE:MRK) and Pfizer Inc. (NYSE:PFE).
Paclitaxel’s importance is understood around the world. Even the World Health Organization has it published on its Model List of Essential Medicines. However, the drug’s efficacy may be greatly improved through its combination with other platforms.
Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC) recently announced that the first patient was dosed in the company’s Phase 2 study of a combination therapy to treat HR+/HER2- metastatic breast cancer (mBC). The therapy involves a combination of the company’s proprietary pelareorep in combination with paclitaxel alone, and with paclitaxel and Bavencio from Merck KGaA (FRA:MRK) (OTC:MKKGY)— which operates its biopharmaceutical business in the US and Canada as EMD Serono—and Pfizer Inc. (NYSE:PFE).
The study, known as BRACELET-1 is being conducted under a co-development agreement between all three companies.
This latest randomized BRACELET-1 study was designed to support the results of a prior successful Phase 2 trial that showed a near doubling of overall survival with pelareorep treatment.
Oncolytics Biotech’s pelareorep success came from its ability to induce a robust anti-tumor immune response in an identical patient population (patients with HR+/HER2- mBC). The ability of pelareorep-induced immune responses to enhance anti- PD-L1 therapy will also be evaluated through the inclusion of the paclitaxel-pelareorep-avelumab combination therapy cohort.
Athenex, Inc. (NASDAQ:ATNX) has also worked to improve upon Taxol—the brand name given to paclitaxel by Bristol-Myers Squibb (NYSE:BMY).
In an effort to improve deliverability, Athenex is working to highlight the superiority of an oral paclitaxel called Abraxane over the intravenous version. Athenex claims that its oral version of paclitaxel produced less neuropathy (a paclitaxel side effect) than the IV version.
Last summer, Athenex released its pivotal Phase III study of combining oral paclitaxel with encequidar, showing the combo met the primary efficacy endpoint with statistically significant improvement over IV paclitaxel.
In May, Merck & Co., Inc. (NYSE:MRK) reported good results with the PD-1 inhibitor Keytruda, when given alongside chemotherapy. This treatment reportedly reduced the risk of disease progression or death by 35% compared to chemo alone, in its phase 3 KEYNOTE-355 trial, showing the drug was effective in previously untreated TNBC patients with high levels of the biomarker PD-1.
THE ONGOING FIGHT AGAINST BREAST CANCER
Roughly 90% of all breast cancer is estimated to be diagnosed at an early stage. Of that population, approximately 70% of all breast cancers are HR+, HER2-, the most common subtype of the disease.
The American Cancer Society has focused a lot of attention on researchers learning more about changes in cells that cause cancer, and the potential use of targeted therapies.
Biotechnology company Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC) is developing pelareorep, which is an intravenously delivered immuno-oncolytic virus.
The proprietary compound induces selective tumor lysis (where the tumor cells break down and die) and promotes an inflamed tumor phenotype. This in turn transforms “cold” tumors “hot” , through innate and adaptive immune responses to treat a variety of cancers.
Pelareorep has been in development for combinations with several of the world’s other top selling anti-cancer drugs, including Bavencio from Merck KGaA (FRA:MRK) (OTC:MKKGY) and Pfizer (NYSE:PFE).
Bavencio recently snagged the first-in-class designation for treating bladder cancer earlier this year. However, Pfizer has been pickier with its studies for breast cancer, including it swiftly pulling the plug on several Bavencio studies earlier this year.
That didn’t happen with Oncolytics Biotech’s pelareorep.
Having now dosed the first patient in the BRACELET-1 study, new data is on the way. The study aims to validate T cell clonality as a biomarker of pelareorep response, and to enable advancement into a Phase 3 registrational study.
By combining with the checkpoint inhibitor therapy avelumab, Oncolytics Biotech is aiming to improve outcomes in metastatic breast cancer.
The immune-oncolytic virus platform is also being studied in combination with multiple other top selling cancer drugs, including Keytruda (also from Merck KGaA), Tecentriq from Roche, and Opdivo from Bristol-Myers Squibb (NYSE:BMY).
With Tecentriq, pelareorep is being tested in combination with atezeolizumb, in the company’s clinical program with the SOLTI WOO study in breast cancer. In late March, Oncolytics Biotech reported positive preliminary data from early findings in its AWARE-1 trial.
According to preliminary findings announced back in 2019, the first three patients demonstrated immunohistochemically positive viral replication in the tumor mass following intravenous administration of pelareorep in combination with atezolizumab.
Of the three patients, two showed greater than 50% of the tumor cells infected. The drug was found to generate inflammation and T cell recruitment at the tumor site.
The BRACELET-1(BReast cAnCEr with the Oncolytic Reovirus PeLareorEp in CombinaTion with anti- PD-L1 and Paclitaxel) study is an open-label, phase 2, randomized study in patients with HR+/HER2-, endocrine-refractory metastatic breast cancer being conducted under a co-development agreement between Oncolytics, Merck, and Pfizer. PrECOG LLC, a leading cancer research network, is managing the study.
The study will take place at 20 trial sites and enroll 45 patients randomized into three cohorts. A three patient safety run-in will be conducted with patients receiving pelareorep, paclitaxel, and avelumab prior to randomization.
The primary endpoint of the study is overall response rate. Exploratory endpoints include peripheral and tumor T cell clonality, inflammatory markers, and safety and tolerability assessments.
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