USA News Group – According to a “highly troubling” new study, the rising number of cancer cases in young people is being attributed to “accelerated aging.” Further alarm is being spread by the United Nations, whose health authorities are predicting global cancer cases to rise around 77% by 2050, with richer countries expected to have the greatest absolute increase in cancer, with an additional 4.8 million new cases predicted in 2050. With the global cancer immunotherapy market projected by analysts at Custom Market Insights to reach US$314.4 billion by 2032, growing at a 7.2% CAGR, the biotech sector continues to make significant developments in cancer treatment and diagnostics, with recent updates coming from Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Celcuity Inc. (NASDAQ: CELC), Olema Pharmaceuticals, Inc. (NASDAQ: OLMA), Bio-Rad Laboratories, Inc. (NYSE: BIO), and AstraZeneca PLC (NASDAQ: AZN).
Since receiving Fast Track Designation from the FDA in late 2022 for its leading cancer treatment, pelareorep, in the treatment of pancreatic cancer, Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) has maintained strong progress. The company recently announced that it has requested a Type C meeting with the FDA to discuss an upcoming registration-enabling trial of pelareorep for treating HR+/HER2- metastatic breast cancer (mBC) patients.
“A key focus for Oncolytics in 2024 is defining the regulatory path for pelareorep in breast cancer treatment,” said Matt Coffey, President and CEO of Oncolytics. “We are optimistic that pelareorep, in combination with paclitaxel, could significantly enhance clinical outcomes for patients with HR+/HER2- metastatic breast cancer. Our position is strengthened by encouraging data from two randomized studies (BRACELET-1 and IND-213) and the AWARE-1 study, paving the way for the next phase of pelareorep's development and registration.”
Dr. Coffey has noted that ongoing collaborations with clinical collaborators have been key to preparing a comprehensive and convincing briefing document. Oncolytics Biotech requested to meet with the FDA in Q2 2024 to finalize the registrational trial design and objectives for using pelareorep to treat metastatic breast cancer. This meeting is essential for moving this promising treatment closer to patient use. With forthcoming survival data from its BRACELET-1 study and productive discussions with the FDA, Oncolytics is hopeful that 2024 will mark a significant milestone for the company and its stakeholders.
“The data from the randomized BRACELET-1 trial showcased compelling results for the pelareorep/paclitaxel combination therapy in HR+/HER2- metastatic breast cancer patients, with a nearly tripled confirmed response rate, a 50% improvement in median progression-free survival, and a hazard ratio of 0.29 compared to the paclitaxel alone control,” said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. “Importantly, these data support the statistically significant near doubling of median overall survival in another randomized phase 2 study, IND-213, which also evaluated pelareorep and paclitaxel in HR+/HER2- metastatic breast cancer patients.”
Another company that’s developing targeted therapies for multiple cancer indications is Celcuity Inc. (NASDAQ: CELC). Within its latest Q4/FY 2023 financial results and corporate update, Celcuity spoke of how it had dosed its first patient in a Phase 1b/2 trial evaluating gedatolisib in combination with darolutamide for the treatment of metastatic castration-resistant prostate cancer.
“We are excited to begin enrolling patients in our 201 trial and advancing towards our ultimate goal of providing a transformative therapeutic option for patients with prostate cancer,” said Igor Gorbatchevsky, M.D., Chief Medical Officer of Celcuity. “A significant unmet need remains for patients with metastatic castration-resistant prostate cancer who have become resistant to a next generation androgen receptor inhibitor.”
Late last year, Celcuity also presented preclinical data on the therapeutic effects of gedatolisib in breast cancer models at the 2023 San Antonio Breast Cancer Symposium. As its flagship asset, Celcuity’s gedatolisib is a potent, reversible dual inhibitor that selectively targets all Class I PI3K isoforms and mTOR.
In the process of becoming an impressive comeback story, Olema Pharmaceuticals, Inc. (NASDAQ: OLMA) has moved from making job cuts in 2023 to moving forward with pivotal drug studies in 2024. Recently in March, Olema announced the publication of data highlighting its proprietary treatment palazestrant’s (OP-1250) ability to inhibit wild-type and mutant ER+ breast cancer both as monotherapy and in combination with CDK4/6 inhibitors through a paper titled “Palazestrant (OP-1250), a Complete Estrogen Receptor Antagonist, Inhibits Wild-type and Mutant ER-positive Breast Cancer Models as Monotherapy and in Combination.”
“The research described in this paper reviews the deliberate design and processes used in discovering and optimizing palazestrant as a molecule purpose-built to address a crucial unmet need in the treatment of women’s cancers, and we are delighted that Molecular Cancer Therapeutics has featured our work,” said David C. Myles, Ph.D., Olema’s Chief Discovery and Non-Clinical Development Officer. “What’s even more exciting is to see how faithfully the pre-clinical research predicted the behavior of palazestrant now that it is in late-stage clinical development. We saw the potential then, as told in the paper, and we believe that every day brings us closer to having a real impact transforming the treatment paradigm for women with cancer.”
Helping to potentially detect breast cancer more easily, Bio-Rad Laboratories, Inc. (NYSE: BIO) recently launched its first ultrasensitive multiplexed digital PCR assay for breast cancer mutation detection in clinical research. The newly launched ddPLEX ESR1 Mutation Detection Kit assay expands Bio-Rad’s Droplet Digital PCR (ddPCR™) offering for the oncology market, where highly sensitive and multiplexed mutation detection assays aid translational research, therapy selection, and disease monitoring.
“With the ddPLEX ESR1 Mutation Detection Kit, our customers can achieve new levels of sensitivity and multiplexing without compromising throughput,” said Stephen Kulisch, Vice President of Marketing for Bio-Rad's Digital Biology Group. “This launch reflects our ongoing menu expansion in oncology and our commitment to providing oncology researchers with technologies that enable everything from biomarker discovery to clinical trials that support improvements in patient monitoring.”
Shortly after the launch, Bio-Rad partnered with Alleghany Health Network (AHN) to advance clinical evidence for monitoring solid tumor cancers using the ddPCR technology. The collaboration will use ddPCR technology for molecular residual disease (MRD) monitoring of patients across a range of solid tumor types.
Even more promising breast cancer data has come out recently from AstraZeneca PLC (NASDAQ: AZN) and partners Daiichi Sankyo for their jointly developed antibody drug conjugate Enhertu (trastuzumab deruxtecan), from their phase 3 breast cancer trial. Results from the DESTINY-Breast06 trial demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to standard-of-care chemotherapy in the primary trial population of patients with HR-positive, HER2-low metastatic breast cancer following one or more lines of endocrine therapy.
"DESTINY-Breast06 shows that ENHERTU could become a new standard of care for patients with HER2-low and HER2-ultralow metastatic breast cancer following one or more lines of endocrine therapy,” said Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca. “These data underscore the potential for treatment with ENHERTU across the spectrum of HR-positive breast cancer, further redefining the treatment of metastatic breast cancer."
Article Source: https://usanewsgroup.com/2023/10/02/the-most-undervalued-oncolytics-company-on-the-nasdaq/
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