Estrogen Receptor Antagonist(Snowdon Ltd.)

USA News Group Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, May 3, 2024 /PRNewswire/ -- 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 O ncolytics 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: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. SOURCE USA News Group

Data published in Molecular Cancer Therapeutics describes the scientific background underlying the design, discovery and optimization of palazestrant (OP-1250)Pre-clinical results demonstrate that palazestrant, as both a CERAN and a SERD, has a highly differentiated mechanism of action as a potential therapy for advanced ER+/HER2- breast cancer SAN FRANCISCO, March 06, 2024 (GLOBE NEWSWIRE) -- Olema Pharmaceuticals, Inc. (“Olema” or “Olema Oncology,” Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers, today announced that Molecular Cancer Therapeutics, an American Association for Cancer Research journal, has selected as a featured article a data publication that describes the distinct properties of palazestrant (OP-1250). The 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”, describes the scientific background underlying the design, discovery and optimization of palazestrant. “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.” As part of the discovery and optimization process, palazestrant was assessed across an extensive series of biochemical, cell culture, and in vivo assays comparing it with other antiestrogens and compounds that are either approved for use by the FDA or are currently in clinical development, including aromatase inhibitors, selective ER modulators (SERMs), traditional SERDs, and proteolysis-targeting chimeras (PROTACs). As a CERAN, palazestrant has a distinct mechanism of action (MOA), and though it actively degrades the ER, the paper shows that degradation alone is not a reliable mechanism to drive the efficacy of an endocrine agent. In mouse xenograft models, palazestrant demonstrated excellent pharmacokinetics, was well tolerated, showed synergy with CDK4/6 inhibitors, and was highly effective at reducing tumor growth in both wild-type and ESR1-mutant ER+ breast cancer. In addition, in an ESR1-mutant intercranial xenograft model, palazestrant inhibited tumor growth and improved survival of animals with CNS metastases, even after stopping drug treatment. The paper can be accessed in the latest print edition of Molecular Cancer Therapeutics or online at https://aacrjournals.org/mct/article/doi/10.1158/1535-7163.MCT-23-0351/731746/Palazestrant-OP-1250-a-Complete-Estrogen-Receptor. About Palazestrant (OP-1250) Palazestrant (OP-1250) is a novel, orally-available small molecule with dual activity as both a complete estrogen receptor (ER) antagonist (CERAN) and selective ER degrader (SERD). It is currently being investigated in patients with recurrent, locally advanced or metastatic ER-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. In clinical studies, palazestrant completely blocks ER-driven transcriptional activity in both wild-type and mutant forms of metastatic ER+ breast cancer and has demonstrated anti-tumor efficacy along with attractive pharmacokinetics and exposure, favorable tolerability, CNS penetration, and combinability with CDK4/6 inhibitors. Palazestrant has been granted U.S. Food and Drug Administration (FDA) Fast Track designation for the treatment of ER+/HER2- metastatic breast cancer that has progressed following one or more lines of endocrine therapy with at least one line given in combination with a CDK4/6 inhibitor. It is currently being evaluated both as a single agent in an ongoing Phase 3 clinical trial, OPERA-01, and in Phase 2 combination studies with CDK4/6 inhibitors (palbociclib and ribociclib) and a PI3Ka inhibitor (alpelisib). For more information, please visit www.opera01study.com. About Olema Oncology Olema Oncology is a clinical-stage biopharmaceutical company committed to transforming the standard of care and improving outcomes for women living with cancer. Olema is advancing a pipeline of novel therapies by leveraging our deep understanding of endocrine-driven cancers, nuclear receptors, and mechanisms of acquired resistance. In addition to our lead product candidate, palazestrant (OP-1250), a proprietary, orally-available complete estrogen receptor (ER) antagonist (CERAN) and a selective ER degrader (SERD), Olema is developing a potent KAT6 inhibitor. Olema is headquartered in San Francisco and has operations in Cambridge, Massachusetts. For more information, please visit us at www.olema.com. Forward Looking Statements Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Words such as “anticipate,” “expect,” “will,” “may,” “goal,” “potential” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These statements include those related to Olema’s preclinical program, including the potential beneficial characteristics of palazestrant (OP-1250), both as a monotherapy and in combination with CDK4/6 inhibitors, palazestrant’s potential to address to address an unmet need in the treatment of women’s cancers, and palazestrant’s ability to transform the treatment paradigm for women with cancer. Because such statements deal with future events and are based on Olema’s current expectations, they are subject to various risks and uncertainties, and actual results, performance or achievements of Olema could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including, without limitation, those discussed in the section titled “Risk Factors” in Olema’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2023, and future filings and reports that Olema makes from time to time with the U.S. Securities and Exchange Commission. Except as required by law, Olema assumes no obligation to update these forward-looking statements, including in the event that actual results differ materially from those anticipated in the forward-looking statements. Contact:Geoffrey Mogilner, Vice President, Investor Relations and Communicationsir@olema.com