Biotechs Race for New Treatments as Breast Cancer Therapeutics Market Could Reach $15 Billion by 2028

PALM BEACH, Fla., Dec. 8, 2022 /PRNewswire/ -- FinancialNewsMedia.com News Commentary - According to a report from Global Market Insights the Breast Cancer Therapeutics Market size, which exceeded USD 25.5 billion in 2021, is estimated to register around 8% CAGR between 2022 and 2028. The growing incidence of breast cancer is amongst the major factors stimulating the overall market growth. According to the International Agency for Research on Cancer (WHO), in 2020, the incidence of breast cancer was 2,261,419, accounting for approximately 11.7% of the total cancer cases globally. Further, the disease accounted for 684,996 mortalities in 2020. Thus, the high incidence and mortality rate associated with breast cancer is expected to render significant impact, driving the market expansion.  The report said: "Breast cancer therapeutics can be defined as the treatment or management of breast cancer using therapeutic approach & drugs such as the targeted therapy, chemotherapy, hormonal therapy, and other therapeutics. These therapeutics abduct the growth and multiplication of cancerous cells by disrupting certain proteins or DNA.  The rising incidence of breast cancer and increased mortality rate among breast cancer patients with acquired COVID-19 infection are expected to uplift the market size. Further, the reducing COVID-19 cases and initiatives taken by the authorities to facilitate the treatment of breast cancer patients would further benefit the market statistics. As a result, the market witnessed slow growth owing to delayed breast cancer diagnosis and treatment, although the industry is expected to follow the growth trajectory in the coming years."  Active biotech and pharma companies in the markets this week include Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC), Gilead Sciences, Inc. (NASDAQ: GILD), Bristol Myers Squibb (NYSE: BMY), Prometheus Biosciences, Inc. (NASDAQ: RXDX), TransCode Therapeutics, Inc. (NASDAQ: RNAZ).

Global Market Insights continued: "Developments in treatment for metastatic hormone receptor-positive breast cancer have promoted the use of targeted therapies. Majority of the treatment guidelines, including the National Comprehensive Cancer Network suggests the use of targeted therapeutic options with artificial intelligence or selective ER modulators rather than chemotherapy. Thus, the heightened use and increased preference for targeted therapy is expected to drive the demand for breast cancer therapeutics.  The U.S. breast cancer therapeutics market is anticipated to surpass USD 15.8 billion by 2028. This dominant market share is attributable to several factors such as the high incidence of breast cancer, steadily rising disease burden, and presence of major market players among others. According to the Breast Cancer Organizations statistics, as of January 2022, breast cancer affects more than 3.8 million American women. The statistics indicate that in the year 2022, around 30% of newly diagnosed cancers among women are estimated to be breast cancer cases."

Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC) BREAKING NEWS:  Oncolytics Biotech's^® Chinese Development Partner Adlai Nortye Presents Interim Clinical Data Further Demonstrating the Anti-Cancer Activity of Pelareorep-Paclitaxel Combination Therapy in HR+/HER2- Metastatic Breast Cancer at the San Antonio Breast Cancer Symposium - Oncolytics Biotech^® Chinese partner Adlai Nortye today announced interim results from a multicenter, single-arm bridging clinical trial to evaluate the safety, tolerability, and preliminary efficacy of pelareorep-paclitaxel combination therapy in Chinese patients with advanced/metastatic HR+/HER2- breast cancer. The data were featured in a poster presented yesterday at the San Antonio Breast Cancer Symposium (SABCS), which is being held at the Henry B. González Convention Center in San Antonio, Texas through December 10, 2022.

Fifteen patients were treated in the trial as of the data cut-off date (September 26, 2022), with fourteen having had at least one post-baseline tumor assessment (i.e., evaluable for efficacy). All patients enrolled into the trial were previously treated with at least one endocrine therapy and no more than one line of chemotherapy for recurrent/metastatic disease. Data and conclusions presented in the poster are summarized below.

• Disease control, partial response (PR) or stable disease (SD), was achieved in thirteen of fourteen evaluable patients (93%), with twelve (86%) showing tumor shrinkage from baseline.
• Seven of fourteen evaluable patients achieved a PR (50%). Three of these patients achieved a confirmed PR (20%), while two patients are awaiting potential confirmatory scans.
• One patient achieving a PR at week 8 has maintained the PR through week 48 and remains on study.
• Evolving median progression-free survival (PFS) for trial participants as of the data cut-off date was 9.1 months (95% confidence interval: 3.8 - NA).
• The studied combination has been well tolerated, with no dose-limiting toxicities or serious adverse events (SAEs) reported to date.

"These impressive results have us well-positioned to leverage Oncolytics' prior positive data and join pelareorep's global development program," said Lars Birgerson, M.D., Ph.D., Adlai Nortye President and Chief Medical Officer. "With no SAEs reported, the data suggests the favorable safety and potent anti-cancer activity displayed by the studied combination in North American HR+/HER2- breast cancer patients extends to the Chinese population. There are also promising signs of pelareorep-paclitaxel combination therapy driving durable clinical benefit, with one patient notably still on study for nearly a year while maintaining a PR. We look forward to further characterizing the efficacy and durability of the studied combination as data from the trial mature and to continuing our collaboration with Oncolytics."

Data from the bridging trial are expected to accelerate Adlai Nortye's development of pelareorep in China by allowing future regulatory submissions to include data from Oncolytics' North American metastatic breast cancer trials, IND-213 and BRACELET-1. IND-213 is a previously completed randomized phase 2 trial that showed a statistically significant near doubling of median overall survival when HR+/HER2- metastatic breast cancer patients were treated with paclitaxel plus pelareorep vs. paclitaxel alone. BRACELET-1 is an ongoing randomized phase 2 trial in HR+/HER2- metastatic breast cancer patients with cohorts evaluating: (1) paclitaxel monotherapy; (2) paclitaxel plus pelareorep; and (3) paclitaxel plus pelareorep in combination with the anti-PD-L1 inhibitor avelumab. Oncolytics expects to report overall response rate, PFS, and evolving overall survival data from BRACELET-1 at a major medical meeting in the first half of 2023.   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:

Gilead Sciences, Inc. (NASDAQ: GILD) recently announced new data from a post-hoc analysis from the Phase 3 TROPiCS-02 study evaluating Trodelvy^®(sacituzumab govitecan-hziy; SG) versus comparator chemotherapy (physicians' choice of chemotherapy, TPC) in patients with HR+/HER2- metastatic breast cancer who progressed on endocrine-based therapies and at least two chemotherapies. In the analysis, Trodelvy improved progression-free survival (PFS), overall survival (OS) and objective response rate (ORR) compared with TPC across Trop-2 expression levels. Details of the late-breaking abstract will be presented today at the 2022 San Antonio Breast Cancer Symposium (SABCS, Abstract #GS1-11).

"Sacituzumab govitecan improved both progression-free survival and overall survival in pre-treated HR+/HER2- metastatic breast cancer in the Phase 3 TROPiCS-02 study compared to standard chemotherapy options. This post-hoc analysis demonstrates that the level of Trop-2 expression on an individual's tumor did not impact sacituzumab govitecan efficacy," said Dr. Hope Rugo, Professor of Medicine and Director, Breast Oncology and Clinical Trials Education at the University of California San Francisco Comprehensive Cancer Center, U.S. "These data can give us confidence in the potential benefit of sacituzumab govitecan for patients with endocrine-resistant metastatic breast cancer who have progressed on available chemotherapies, across Trop-2 expression levels."

Prometheus Biosciences, Inc. (NASDAQ: RXDX), a clinical-stage biotechnology company pioneering a precision medicine approach for the discovery, development, and commercialization of novel therapeutic and companion diagnostic products for the treatment of immune-mediated diseases, recently reported results from its ARTEMIS-UC Phase 2 and APOLLO-CD Phase 2a studies of PRA023 demonstrating strong efficacy and favorable safety results in both studies. Based on the totality of the data in these two studies, Prometheus intends to advance PRA023 into Phase 3 studies for ulcerative colitis (UC) and Crohn's disease (CD) in 2023.

TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology company committed to more effectively treating cancer using RNA therapeutics, recently announced that it has submitted an exploratory Investigational New Drug (eIND) application to the U.S. Food and Drug Administration (FDA) for a planned First-in-Human Phase 0 clinical trial. The planned clinical trial is to evaluate TransCode's lead therapeutic candidate, TTX-MC138, in cancer patients with advanced solid tumors. TTX-MC138 is designed to inhibit the pro-metastatic RNA, microRNA-10b, described as the master regulator of metastasis in a number of advanced solid tumors. TransCode believes that TTX-MC138 could be used as a treatment for many of these cancers.

"We are very excited to take this next step in the development of TTX-MC138 which we hope will bring us closer to introducing this first of its kind treatment for metastatic disease," said TransCode's Chief Executive Officer and co-founder, Michael Dudley. "We are hopeful that the study conducted under the eIND will demonstrate successful delivery of our lead therapeutic candidate to metastatic lesions in patients with advanced solid tumors. The delivery of oligonucleotide therapeutics to sites other than the liver has remained a significant challenge for decades. Overcoming this challenge would represent an unprecedented step in unlocking therapeutic access to a variety of well documented genetic targets involved in a range of cancers and beyond."

Bristol Myers Squibb (NYSE: BMY) recently announced the presentation of research across its hematology portfolio at the 64^th American Society of Hematology (ASH) Annual Meeting and Exposition, which will take place in New Orleans, Louisiana, and virtually, from December 10 to 13, 2022. Data from more than 100 company-sponsored studies will be featured, including 34 oral presentations, highlighting the range of modalities, targets and research platforms the company is advancing and showcasing our commitment to scientific progress across hematologic diseases.

"Our presence at ASH underscores the transformational potential of our diverse pipeline, poised to deliver the next wave of advances in hematology," said Samit Hirawat, M.D., executive vice president, chief medical officer, Global Drug Development, Bristol Myers Squibb. "These exciting data, spanning a variety of modalities and targets, demonstrate significant progress toward our goals of improving long-term outcomes across patient populations and finding solutions in important areas of remaining need."

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