Biotechs Zeroing In on Developing Breakthrough Therapeutics for Metastatic Breast Cancer

FinancialNewsMedia.com News Commentary

PALM BEACH, Fla., June 5, 2023 /PRNewswire/ --   - The COVID-19 pandemic has had a limited impact on the global breast cancer therapeutics market and reports see substantial growth now that it has receded. The status of breast cancer as one of the most commonly occurring cancers in the world is expected to be a key driving factor for the global market. As more and more patients are diagnosed with breast cancer across the globe, the need for accurate and efficient treatment outcomes for the patient remains unparalleled. Furthermore, the strong trend of continuous R&D amongst key market players engaged in breast cancer therapeutics would lead to the launch of breakthrough therapeutics in the coming years. This trend of introducing new and advanced therapies such as targeted therapies and immunotherapies is expected to strongly surge the growth of the global market in developed as well as emerging regions during the forecast period. A report from Fortune Business Insights projected that the global breast cancer therapeutics market size is projected to reach USD 55.27 billion by 2027, exhibiting a CAGR of 13.1% during the forecast period.  The report said: "One of the most prevalent trends in the global market is the ongoing R&D initiatives for the development and the marketing of efficient drugs for breast cancer treatment. As the number of patients suffering from breast cancer continues to increase across the globe, the importance and the critical need for the development of advanced therapeutics for better outcomes remains unparalleled.  Such trends are expected to significantly boost the global breast cancer therapeutics market growth in the forecast period as the development of new therapeutics is expected to lead to new product launches. This is further set to result in greater sales of breast cancer drugs and the inclusion of new patients in the treatment process, as more types of breast cancers are anticipated to be treated through these new drugs."  Active biotech and pharma companies in the markets this week include Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC), Gilead Sciences, Inc. (NASDAQ: GILD), Rain Oncology Inc. (NASDAQ: RAIN), CNS Pharmaceuticals, Inc. (NASDAQ: CNSP), Bristol Myers Squibb (NYSE: BMY).

Fortune Business Insights continued: "One of the foremost drivers influencing the growth of the global market is the increased prevalence of breast cancer across the world, which is expected to result in a large patient population demanding accurate and efficient treatment options. Breast cancer is one of the most prevalent forms of cancer worldwide and improved diagnostics are further expected to result in a greater number of patients being diagnosed.  Furthermore, the increasing demand for preventive care and early treatment has led many individuals to undergo cancer screening tests, which would also strongly drive the number of patients demanding treatment in the forecast period. Besides, the increasing patient awareness due to such alarming statistics is anticipated to further drive the market growth. Hence, the rising prevalence of breast cancer is projected to boost market growth in the forecast period.  North America is projected to be the key market in the forecast period (2027). This growth is attributable to the presence of prominent companies in the region, which, in turn, would lead to the launch of new therapeutics in the region. Other reasons include the strong prevalence of breast cancer, the increasing number of breast cancer therapeutics R&D clinical trials, and the increased awareness and adoption of advanced therapeutics."

Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC) BREAKING NEWS:  Oncolytics Biotech® Announces Updated Randomized Phase 2 Data from BRACELET-1 Metastatic Breast Cancer Trial that Show Pelareorep Driving Robust Increases in Progression-Free Survival and Confirmed Overall Response Rate –

• Pelareorep-paclitaxel combination reduced risk of disease progression by 71% (hazard ratio of 0.29) compared to paclitaxel monotherapy
• 37.5% confirmed overall response rate with pelareorep-paclitaxel vs. 13.3% with paclitaxel monotherapy
• 12-month progression-free survival rate of 32.8% for pelareorep-paclitaxel compared to 0% for paclitaxel monotherapy and 0% for pelareorep-paclitaxel-avelumab
• Oncolytics' HR+/HER2- breast cancer program now phase 3-ready and advancing to a registrational study of pelareorep-paclitaxel combination

Oncolytics Biotech^® today announced updated results from BRACELET-1, a randomized phase 2 trial in HR+/HER2- metastatic breast cancer, which include data featured in an oral presentation at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, as well as additional new data and analyses. 

BRACELET-1 enrolled 48 patients, including 45 that were randomized and well-balanced across three cohorts evaluating: (1) paclitaxel monotherapy; (2) paclitaxel in combination with pelareorep; and (3) paclitaxel plus pelareorep in combination with the anti-PD-L1 checkpoint inhibitor, avelumab (Bavencio®). A three-patient safety run-in was also conducted with patients receiving pelareorep, paclitaxel, and avelumab prior to randomization. All participants enrolled in the trial had previously progressed on at least one hormone-based therapy with a CDK 4/6 inhibitor. No patients in BRACELET-1 received chemotherapy for metastatic disease prior to enrolling in the trial. 

Updated data from BRACELET-1 showed a median progression-free survival (mPFS) of 9.5 months in the paclitaxel plus pelareorep cohort vs. 6.3 months in the paclitaxel monotherapy cohort for a hazard ratio of 0.29 as of a March 3, 2023 cut-off date. Confirmed overall response rate (ORR) in these cohorts was 37.5% and 13.3%, respectively. As previously reported, ORR at week-16 (the trial's primary endpoint) in the pelareorep plus paclitaxel and paclitaxel monotherapy cohorts was 31.3% and 20%, respectively. Overall survival data from the trial continue to mature. 

"BRACELET-1's positive results complement prior phase 2 data showing a statistically significant increase in overall survival when pelareorep was combined with paclitaxel by demonstrating similar robust improvements in PFS and ORR in less heavily pre-treated patients," said Dr. Matt Coffey, President and Chief Executive Officer. "Given this exciting finding, our next step is to discuss our data with the FDA to investigate incorporating dual PFS and OS endpoints into our breast cancer program's registrational study. Including a PFS endpoint could substantially reduce the time to a pivotal readout from the registrational trial, thereby accelerating pelareorep's path to potential approval as we work to address the urgent needs of HR+/HER2- breast cancer patients."  CONTINUED… Read this full press release and more news for ONCY at:  https://www.financialnewsmedia.com/news-oncy/  

Other recent breast cancer developments in the biotech industry of note include:

Gilead Sciences, Inc. (NASDAQ: GILD) and Kite, a Gilead Company, will present 17 abstracts from its industry-leading cell therapy portfolio and growing blood cancer pipeline at the upcoming 2023 European Hematology Association (EHA) Annual Congress being held in Frankfurt, Germany, June 8-11, and virtually June 14-15.

Real-World Evidence and Multi-Year Follow-Up of Pivotal Studies Reinforce Confidence in CAR T - Four real-world evidence presentations include Yescarta^® (axicabtagene ciloleucel) vein-to-vein time in large B-cell lymphoma (LBCL) and early outcomes in follicular lymphoma (FL). Presentations for Tecartus^® (brexucabtagene autoleucel) include outcomes in relapsed/refractory (R/R) mantle cell lymphoma (MCL) and long-term results from the Phase 3 ZUMA-3 trial in R/R B-cell acute lymphoblastic leukemia (ALL). Additional data to be presented include trials-in-progress on the use of Yescarta in FL versus standard of care (ZUMA-22), as a first-line treatment in high-risk LBCL (ZUMA-23) and in the outpatient setting (ZUMA-24).

Rain Oncology Inc. (NASDAQ: RAIN), a clinical stage company developing precision oncology therapeutics recently announced an update to its clinical strategy for milademetan, its small molecule inhibitor of the MDM2-p53 complex, to optimize Company resources. The Company is focused on reducing its cash burn with the expectation to extend cash runway to year-end 2026.

"We are working diligently, as additional information continues to come in, to analyze and understand the outcomes in the Phase 3 MANTRA study in DD LPS," said Avanish Vellanki, co-founder and chief executive officer of Rain. "It is imperative we understand those outcomes before allocating further capital to the milademetan program, with corporate expenses to be greatly reduced to maximize optionality for Rain. In the near-term, Rain plans to suspend enrollment in our Phase 2 MANTRA-2 basket trial and terminate plans to initiate the planned Phase 1/2 MANTRA-4 combination trial."

CNS Pharmaceuticals, Inc. (NASDAQ: CNSP), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, recently  announced that its ongoing potentially pivotal study evaluating Berubicin for the treatment of recurrent glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer, has enrolled 134 patients, representing more than 50% of the total planned enrollment for the study.

"The achievement of this milestone in any study is no small feat. The dedication of our team and the proficiency of their operational execution continues to be shown by reaching over 50% of the total planned enrollment in our study. This is an important step that brings us closer to providing a potential treatment option to patients with GBM and addressing this disease, which remains a significant unmet need. We are focused on continuing this momentum towards the interim analysis for the study, which remains on target for the third quarter of this year," commented John Climaco, CEO of CNS Pharmaceuticals.

Bristol Myers Squibb (NYSE: BMY) recently announced the acceptance of two late-breaker abstracts for Breyanzi (lisocabtagene maraleucel) studies TRANSCEND FL and TRANSCEND NHL 001 for patients with relapsed or refractory follicular lymphoma (FL) and patients with relapsed or refractory mantle cell lymphoma (MCL), respectively, for presentation at the 2023 International Conference on Malignant Lymphoma (ICML). These results follow the topline announcement shared on May 1 of this year.

"We are dedicated to bringing new and innovative treatment options to patients living with lymphoma and leukemia and believe that Breyanzi provides transformative potential for patients with heavily pre-treated relapsed or refractory follicular lymphoma or mantle cell lymphoma," said Anne Kerber, senior vice president, head of Cell Therapy Development, Bristol Myers Squibb. "TRANSCEND FL is the largest clinical trial to date evaluating CAR T cell therapy in patients with relapsed or refractory indolent non-Hodgkin lymphoma, including follicular lymphoma. We look forward to sharing positive data from both this and the TRANSCEND NHL 001 study in relapsed or refractory mantle cell lymphoma this year at ICML."

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