Biotech Innovators Making Strides Towards Meeting Increased Demand for Breast Cancer Treatments

Biotech Innovators Making Strides Towards Meeting Increased Demand for Breast Cancer Treatments

VANCOUVER – USA News Group – Last year in 2021, an estimated 281,550 new cases of invasive breast cancer were expected to be diagnosed in American women, according to the American Cancer Society. A new report on the Global Breast Cancer Drug Market from is projecting CAGR growth of 8.6% between 2021 and 2026 to hit US$27.04 billion. Meanwhile Global Markets Insights Inc. has projected that the breast cancer therapeutics market is expected to hit $42.6 billion by 2028. Innovators in the biotech sector continue to work diligently towards developing new breast cancer treatments, including Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), Pfizer, Inc. (NYSE:PFE), AstraZeneca PLC (NASDAQ:AZN), Gilead Sciences, Inc. (NASDAQ:GILD), and Puma Biotechnology, Inc. (NASDAQ:PBYI).

On track for top-line data in Q4 2022 is the Randomized phase 2 HR+/HER2- metastatic breast cancer trial (BRACELET-1) for the flagship product pelareorep, from Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC)—which recently released operational highlights for Q4 2021 and FY 2021.

"We begin 2022 with a strong foundational dataset and potential value-inflection points expected across our pipeline throughout the year," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc. "Chief among these potential inflection points is the expected fourth quarter top-line data announcement for BRACELET-1, our randomized phase 2 trial in HR+/HER2- metastatic breast cancer. This trial builds upon prior clinical data demonstrating pelareorep's ability to deliver statistically significant survival benefits and synergize with checkpoint inhibition in breast cancer. Importantly, its completion represents the last major clinical step on our path to a registrational study."

Ahead of its key milestones that the company expects to achieve through this year and into 2023, Oncolytics Biotech also reported a strong financial position with approximately C$41.3 million (~US$32 million), giving plenty of cash runway along the way.

At the core of Oncolytics’ developments is pelareorep, a safe and well-tolerated intravenously delivered immunotherapeutic agent that activates the innate and adaptive immune systems and weakens tumor defense mechanisms. It’s designed to improve the ability of the immune system to fight cancer, making tumors more susceptible to a broad range of oncology treatments.

Along with BRACELET-1Oncolytics Biotech also gave updates to its two other ongoing breast cancer trials, AWARE-1 and IRENE studies—both of which have also delivered promising results in the last year.

Pfizer, Inc. (NYSE:PFE) produces both paclitaxel (Taxol) and avelumab (Bavencio) with partners Merck KGaA and Merck Serono respectively—both of which are being studied through BRACELET-1 in combination with pelareorep.

“BRACELET-1 is… designed to expand upon our prior positive Phase II results in this indication by generating critical data requested by the FDA and our global pharma collaborators,” said Dr. Coffey in his company’s most recent earnings call.  “I will say now that the trial remains on track for full enrollment in late Q1, early Q2 with top line data in Q4, assuming no or limited impact from COVID-19.”

Shares of AstraZeneca PLC (NASDAQ:AZN) rose upon the release of positive results for its breast cancer treatment, Enhertu—developed with partners Daiich Sankyo.

"Today’s historic news from DESTINY-Breast04 could reshape how breast cancer is classified and treated,” said Susan Galbraith, AstraZeneca Executive VP of Oncology R&D. “A HER2-directed therapy has never-before shown a benefit in patients with HER2-low metastatic breast cancer. These results for ENHERTU are a huge step forward and could potentially expand our ability to target the full spectrum of HER2 expression, validating the need to change the way we categorize and treat breast cancer."

The latest Enhertu results open up a new treatment option for roughly 55% of patients whose breast cancer isn’t tied to high levels of a specific protein.

ENHERTU (5.4mg/kg) is approved in more than 40 countries for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens based on the results from the DESTINY-Breast01 trial.

Gilead Sciences, Inc. (NASDAQ:GILD) recently revealed new results from its TROPiCS-02 study for its drug Trodelvy, which outperformed chemotherapy at staving off disease progression or death in heavily pretreated patients with HR-positive, HER2-negative metastatic breast cancer.

“Trodelvy demonstrated consistent activity in this difficult-to-treat patient population,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “We are evaluating the data and will explore potential pathways with regulatory authorities to bring Trodelvy to this group of patients.”

In the overall HR-positive, HER-negative breast cancer population, Trodelvy could potentially reach $2.2 billion in peak worldwide sales if it shows good efficacy and safety profiles, according to RBC Capital Markets analyst Brian Abrahams.

Puma Biotechnology, Inc. (NASDAQ:PBYI) recently updated the market on its operations, including the state of its fight against breast cancers, including the presentation of data from the SUMMIT trial at the 2021 San Antonio Breast Cancer Symposium, and the ongoing commitment to provide neratinib (NERLYNX®) to patients with HER2+ breast cancer.

Earlier in the year, Puma announced that the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines) for the treatment of breast cancer were updated for 2022 to include two important changes involving neratinib.

“These updates help to increase the awareness of neratinib within the guidelines and should further support neratinib as an appropriate option to reduce the risk of recurrence for patients battling HER2-positive breast cancer,” said Alan H. Auerbach, CEO and President of Puma.

First, neratinib (NERLYNX®)  was added to the body of the guidelines for the treatment of adjuvant HER2-positive Breast Cancer (BINV-L) under the heading Useful in Certain Circumstances, with a recommendation for considering extended adjuvant neratinib for patients with HR-positive, HER2-positive disease with a perceived high risk of recurrence.

Next, the NCCN included dose escalation as an approach to improve the tolerability of neratinib in the treatment of adjuvant HER2-positive Breast Cancer (BINV-L).

“Oncologists should be aware of an important recent update to the NCCN guidelines that now include adjuvant neratinib to be used in certain circumstances, i.e., high-risk HR+, HER2+ early-stage breast cancer patients,” said Dr. Joyce O’Shaughnessy, M.D., Baylor University Medical Center, Texas Oncology, US Oncology, Dallas Texas. “These high-risk patients need access to every available treatment option proven to decrease their risk of recurrence, and the new NCCN guidelines update supports neratinib in this context.”

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