Palm Beach, FL – December 21, 2021 – FinancialNewsMedia.com News Commentary – Breast cancer is cancer that develops in the breast tissue. Breast cancer signs include the formation of a lump in the breast and red patches on the skin. Obesity, lack of physical activity, excessive radiation exposure, and alcohol use are all risk factors for breast cancer. Breast cancer is more prevalent in developed countries than it is in developing countries. Post diagnosis, cancer therapy requires different procedures depending upon the form and severity of cancer. The cancer care market is increasing at a substantial pace due to the rise in the occurrence of cancer cases, growing knowledge among people about different stages, and availability of treatment of cancer. Breast cancer treatment relies on different factors, such as breast cancer origin, tumor size, and breast cancer phase, and cancer grade. Operations, radiation therapy, chemotherapy, hormone therapy, targeted therapy, and bone-led therapy are some of the most popular approaches used in the management of breast cancer.  A report from Facts and Factors states that the global breast cancer treatment market was registered at about USD 19.24 Billion in 2019 and is expected to generate revenues worth around USD 34.06 Billion by end of 2026, effectively growing at a CAGR of around 8.5% between 2020 and 2026.  Active biotech and pharma companies in the markets this week include Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC), Intra-Cellular Therapies, Inc. (NASDAQ: ITCI), Galera Therapeutics, Inc. (NASDAQ: GRTX), Lineage Cell Therapeutics, Inc.  (NYSE: LCTX), Gilead Sciences, Inc. (NASDAQ: GILD).

The report added: “The rising number of females diagnosed with breast cancer is a major driver of market development. Aside from this, the demand has grown due to the acceptance of unhealthy lifestyles, an increase in the women geriatric population, exposure to toxic radiation, and increased government initiatives. Since no absolute cure exists, there is room for the industry to develop globally.  The global breast cancer treatment market is driven by America on a regional basis. The demand has grown as a result of changing lifestyles and the increased incidence of breast cancer in the United States. Europe is the market leader in breast cancer. The development of this market in America and Europe is due to technological advancements, increased life expectancy, and increased healthcare spending by people. The market is expected to expand at the fastest rate in the Asia Pacific. “

Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC) BREAKING NEWS:  Oncolytics Biotech^® Promotes Thomas C. Heineman, M.D., Ph.D., to Chief Medical Officer – Oncolytics Biotech^® ) today announced that Thomas (Tom) C. Heineman, M.D., Ph.D., has been promoted to the role of Chief Medical Officer (CMO). Dr. Heineman has over two decades of experience leading clinical development programs and previously served as Oncolytics’ Global Head of Clinical Development and Operations.

“Tom’s clinical expertise, deep understanding of oncology drug development, and impressive track record make him an ideal fit as our CMO,” said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc. “Since joining Oncolytics in August 2020, Tom has provided crucial insights that have enabled the efficient advancement of our lead breast cancer program and facilitated our pipeline’s expansion into additional indications. Looking forward, Tom’s strategic guidance will continue to be an invaluable asset as we move towards a registration study in metastatic breast cancer and advance our broader pipeline.”

Dr. Heineman added, “The opportunity to serve as Oncolytics’ CMO is exciting. Pelareorep’s ability to recruit anti-cancer immune cells into tumors and promote an inflamed microenvironment positions it as a potential immunotherapeutic backbone that can enable the success of a wide range of immuno-oncology agents. We have demonstrated clinical proof-of-concept in several high unmet need indications and are now building on these results in ongoing trials. As CMO, I look forward to leading the clinical development of pelareorep through these and future trials, and to my continued work alongside my highly talented colleagues at Oncolytics.”

Prior to joining Oncolytics, Dr. Heineman was Senior Vice President and Head of Clinical Development at Denovo Biopharma. Prior to his time at Denovo, he served as Vice President and Head of Clinical Development at both Genocea Biosciences and Halozyme Therapeutics. At Halozyme, Dr. Heineman was also Head of Translational Medicine and oversaw clinical trials in indications such as breast and pancreatic cancer. Dr. Heineman’s experience further extends to big pharma and academia, as he previously worked as Senior Director, Global Clinical Research and Development at GlaxoSmithKline and as an Associate Professor at the Saint Louis University School of Medicine.

Dr. Heineman has co-authored over 60 peer-reviewed publications and is board certified in Internal Medicine and Infectious Diseases. He completed his fellowship in Infectious Diseases at the National Institutes of Health and his internship and residency at the University of Maryland. Dr. Heineman earned his M.D. and Ph.D. in Virology at the University of Chicago.  CONTINUED… Read this full press release and more news for ONCY at:  https://www.financialnewsmedia.com/news-oncy/    

Other recent developments in the biotech industry of note include:

Intra-Cellular Therapies, Inc. (NASDAQ: ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, recently announced that the U.S. Food and Drug Administration (FDA) approved CAPLYTA for the treatment of depressive episodes associated with bipolar I or II disorder in adults, as monotherapy and as adjunctive therapy with lithium or valproate.

“CAPLYTA is the only medication approved by the FDA to treat depressive disorders associated with bipolar I or bipolar II as both monotherapy and adjunctive therapy with lithium or valproate. CAPLYTA has shown a consistent favorable profile on weight, cardiometabolic parameters and extrapyramidal symptoms (movement disturbances). We are positioned to launch immediately and are excited to offer CAPLYTA to the millions of patients living with bipolar depression,” said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies. “We thank the patients, healthcare professionals and our Intra-Cellular team for all their contributions that led to this approval.”

Lineage Cell Therapeutics, Inc.  (NYSE American: LCTX) recently announced that Lineage and its subsidiary, Cell Cure Neurosciences Ltd., have entered into an exclusive worldwide collaboration and license agreement with Roche and Genetech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), for the development and commercialization of a retinal pigment epithelium (RPE) cell therapy for the treatment of ocular disorders, including advanced dry age-related macular degeneration (dry AMD) with geographic atrophy (GA).

Genentech will assume responsibility for further clinical development and commercialization of Lineage’s OpRegen program, which currently is being evaluated in a Phase 1/2a open-label, dose escalation clinical safety and efficacy study in patients with advanced dry AMD with GA. Under the terms of the collaboration agreement, Lineage will complete activities related to the ongoing clinical study, for which enrollment is complete, and perform certain manufacturing activities. Genentech will pay Lineage a $50 million upfront payment and Lineage is eligible to receive up to $620 million in additional development, approval and sales milestone payments, in addition to tiered double- digit royalties.

Gilead Sciences, Inc. (NASDAQ: GILD) recently announced new data from the Phase 3 ASCENT study evaluating Trodelvy^® (sacituzumab govitecan-hziy) in relapsed or refractory metastatic triple-negative breast cancer (TNBC) who received two or more prior systemic therapies, at least one of them for metastatic disease. In this subgroup analysis of Black patients, Trodelvy improved progression-free survival (PFS), with a 56% reduction in the risk of disease worsening or death (HR: 0.44; 95% CI: 0.24-0.80; P=0.008) and a median PFS of 5.4 months (n=28) versus 2.2 months with chemotherapy (n=34).

Trodelvy also extended median overall survival to 13.8 months versus 8.5 months with physician’s choice of chemotherapy (HR: 0.64; 95% CI: 0.34-1.19; P=0.159). The results were presented at the 2021 San Antonio Breast Cancer Symposium (SABCS) (Poster #P5-16-07).

Galera Therapeutics, Inc. (NASDAQ: GRTX) closed up over 28% on Monday on heavy trading volume of over 112 Million Shares and was up slightly in aftermarket trading.  Galera Therapeutics recently announced that corrected results from its Phase 3 ROMAN trial of avasopasem for the treatment of RT-induced severe oral mucositis (SOM) in patients with locally advanced head and neck cancer (HNC) achieved statistical significance on the primary endpoint of reduction in the incidence of SOM. Avasopasem has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the reduction of SOM induced by RT.

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