Issued on behalf of Oncolytics Biotech Inc.
VANCOUVER – USA News Group News Commentary – Although death rates for some cancers are declining, the world is facing a sharp increase in cancer cases among people under 50. Globally, new cancer diagnoses have risen by 79%, with the most rapid increases in windpipe and prostate cancers. The highest mortality rates are linked to cancers of the breast, windpipe, lung, bowel, and stomach. According to the United Nations, cancer rates are projected to climb by 77% by 2050. In response, researchers are developing new treatments, with the FDA approving 16 oncology therapies between July and September 2024. Meanwhile, biotech companies continue to make strides, with recent market updates coming from: Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Immuneering Corporation (NASDAQ: IMRX), Zentalis Pharmaceuticals, Inc. (NASDAQ: ZNTL), Instil Bio, Inc. (NASDAQ: TIL), and Zai Lab Limited (NASDAQ: ZLAB).
Analysts at Spherical Insights predict that the global oncology drug market will grow at a compound annual growth rate (CAGR) of 11.5%, reaching $564.50 billion by 2033. Additionally, the Global AI in Oncology Market is expanding rapidly with a projected CAGR of 35%, on track to hit $13.6 billion by 2032.
Oncolytics Biotech® Announces Key Progress and Upcoming Studies for Breast and Pancreatic Cancer Treatments, Prepares for FDA Accelerated Approval Path
Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, recently announced key progress and upcoming studies for its flagship asset pelareorep, an intravenously delivered immunotherapeutic agent in its ongoing trials for breast and pancreatic cancer treatment.
Recent clinical efficacy results from Oncolytics’ BRACELET-1 trial in HR+/HER2- breast cancer pave the way for a clinical study designed to support an accelerated FDA approval. As well, Oncolytics states in the corporate update that key milestones in its gastrointestinal cancer clinical trials are expected in 2025, with potential for new registration-enabling studies.
“We’re excited by the recent BRACELET-1 results, which exceeded our expectations and substantiate the strong efficacy signal previously observed in breast cancer patients treated with pelareorep,” said Wayne Pisano, Interim CEO and Chair of Oncolytics’ Board of Directors. “Having treated well over 100 HR+/HER2- metastatic breast cancer patients in multiple clinical studies, these results provide the basis for a development path leading to an accelerated approval. The BRACELET-1 results, combined with recent feedback from the FDA, give us confidence in our development approach, and we look forward to initiating a clinical trial designed to support the approval of pelareorep as a novel breast cancer therapeutic.”
The strong efficacy results from BRACELET-1 provide the foundation for a large clinical study designed to support an accelerated approval. Early in 2025, Oncolytics plans to submit to the FDA a pelareorep + paclitaxel combination therapy breast cancer trial. The study will enroll approximately 180 patients with HR+/HER2- advanced/metastatic breast cancer who have progressed on antibody-drug conjugates (ADCs) like Enhertu, who are not eligible for ADCs, or who cannot tolerate ADCs, which represents a patient population of approximately 55,000 patients in the US.
The study design has sufficient statistical power to deliver a p-value of < 0.05 with a progression-free survival (PFS) benefit of ≥4.3 months. Notably, the BRACELET-1 study demonstrated a 5.7-month benefit for the pelareorep + paclitaxel arm compared to chemotherapy alone. Enrollment in the registration-enabling study is expected to commence in the first half of 2025.
“With the continuing evolution of breast cancer treatment, we have designed our breast cancer program with the guidance of leading experts in the field,” said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. “Our plan is designed to obtain a regulatory approval with fewer patients, in a shorter time, and requiring less funding than traditional regulatory pathways. Our thorough understanding of pelareorep’s mechanism of action makes us confident that pelareorep-based combination therapy will continue to deliver strong clinical benefits to HR+/HER- breast cancer patients within the current treatment approach.”
Oncolytics anticipates several key milestones in 2025. In the first half of the year, the company plans to initiate a registrational study of pelareorep combined with paclitaxel in HR+/HER2- breast cancer. Also expected in H1 2025 are safety run-in data from cohort 5 of the GOBLET study, which is investigating pelareorep and modified FOLFIRINOX (mFOLFIRINOX), with or without atezolizumab, in newly diagnosed pancreatic cancer, as well as updated efficacy data from cohort 4 of the GOBLET study focused on pelareorep and atezolizumab in second-line or later anal cancer. Once the master protocol has been finalized with the Global Coalition for Adaptive Research (GCAR) for the pelareorep combination therapy, Oncolytics intends to approach the FDA before the end of the year. In the second half of 2025, Oncolytics expects initial efficacy results from cohort 5 of the GOBLET study in pancreatic cancer patients.
CONTINUED… Read this and more news for Oncolytics Biotech at: https://usanewsgroup.com/2023/10/02/the-most-undervalued-oncolytics-company-on-the-nasdaq/
In other industry developments and happenings in the market this week include:
Immuneering Corporation (NASDAQ: IMRX), a clinical-stage oncology company seeking to develop and commercialize universal-RAS/RAF medicines for broad populations of cancer patients, recently announced positive initial response data from the first five patients treated with its Deep Cyclic Inhibitor, IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel in first-line pancreatic cancer as part of its ongoing Phase 2a clinical trial.
“While the initial ORR of 40% and Disease Control Rate of 80% are very encouraging – and both more than would be expected for gemcitabine/nab-paclitaxel alone- we are still in the early stages of this trial, with more scans for all five of these initial patients and for additional patients planned to come,” said Ben Zeskind, Ph.D., Co-Founder and CEO of Immuneering. “If the early trends with IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel continue, we will have an exciting direction for potential future development of IMM-1-104, which could greatly improve the prognosis for a drastically underserved patient population.”
Zentalis Pharmaceuticals, Inc. (NASDAQ: ZNTL), a clinical-stage biopharmaceutical company discovering and developing clinically differentiated small molecule therapeutics targeting fundamental biological pathways of cancers, recently announced the FDA had lifted the partial clinical hold on studies of its novel, selective, and orally bioavailable WEE1 inhibitor, azenosertib. As per the FDA’s shift, Zentalis is cleared to resume enrollment in all ongoing azenosertib clinical studies with no changes in the clinical development plan. Zentalis will be working with clinical trial investigators to resume study activities across the azenosertib development program as quickly as possible.
“We are grateful to the FDA for their collaboration and review of our complete response package, which included a comprehensive safety assessment of the azenosertib program,” said Kimberly Blackwell, M.D., CEO of Zentalis. “We are extremely pleased with the successful resolution of the partial clinical hold. Our confidence in the therapeutic index of azenosertib has been unwavering, and we continue to believe in the potential for this treatment to address unmet medical needs faced by people living with gynecologic malignancies.”
Instil Bio, Inc. (NASDAQ: TIL), a clinical-stage biopharmaceutical company focused on developing a pipeline of novel therapies for the treatment of multiple solid tumor cancers, recently announced a global registrational strategy for the PD-L1xVEGF bispecific antibody SYN-2510/IMM2510 in combination with chemotherapy in front-line non-small cell lung cancer (NSCLC) and in front-line triple-negative breast cancer (TNBC). The announcement was made with Instil’s partners ImmuneOnco which is accelerating the development of the combination in front-line NSCLC in China, while Instil is prioritizing development of the combination in NSCLC and TNBC in the United States.
“SYN-2510 may have the opportunity to meaningfully improve on the current standard of care in NSCLC and TNBC,” said Bronson Crouch, CEO of Instil. “Our expectation for the initial US study of SYN-2510 is that it would lay a foundation for the efficient enrollment of potential global Phase 3 studies.”
Zai Lab Limited (NASDAQ: ZLAB), an innovative, research-based, commercial-stage biopharmaceutical company based in China and the USA, recently presented a poster session at the European Society for Medical Oncology (ESMO) Congress 2024, presenting preliminary results from the ongoing dose-escalation clinical trial that will highlight the potential of ZL-1218 to reduce regulatory T cells and modulate T-cell function in the tumor microenvironment (TME) of advanced solid tumors.
“The ability to overcome the complexities of the tumor microenvironment are critical to improving patient outcomes in cancer immunotherapy,” said Rafael G. Amado, M.D., President, Head of Global Research and Development, Zai Lab. “The reduction of suppressive tumor-associated regulatory T cells by ZL-1218 offers promise to re-stimulate the immune attack on advanced solid tumors.”
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