Palm Beach, FL – January 27, 2022 – FinancialNewsMedia.com News Commentary – According to International Agency for Research on Cancer (IARC) published by the World Health Organization (WHO) in 2018, breast cancer ranks as the fifth leading cause of deaths in women; accounting for 627,000 deaths every year. Moreover, as per estimates of the American Cancer Society, in U.S., 266,120 new cases were expected to be diagnosed in women by 2018. Furthermore, aging is considered as one of the greatest risk factors. According to Cancer Treatment Centers of America, women above 60 years of age are more likely to be diagnosed and only about 10% to 15% of cases occur in women younger than 45 years of age. High prevalence of the disease coupled with patent expiry are some of the major factors influencing investment in research and development of new products. The R&D spending from companies like Johnson & Johnson Services, Inc.; Merck & Co., Inc.; Celgene Corporation; Pfizer, Inc.; GlaxoSmithKline plc; Sanofi; and AbbVie, Inc. has increased exponentially. A report from Grand View Research projected that the global breast cancer drugs market size was valued at USD 16.98 billion in 2017 and is expected to register at a CAGR of 10.7% through 2025, over the forecast period. Rising prevalence of the disease along with emerging novel therapies are some of the major factors likely to drive the market. Early detection of breast cancer is a key to effective management of the disease. Active biotech and pharma companies in the markets this week include Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), Sierra Oncology, Inc. (NASDAQ: SRRA), Vaccinex, Inc. (NASDAQ: VCNX), Bristol Myers Squibb (NYSE: BMY), Merck (NYSE: MRK).
Grand View Research said: “Early detection can lead to desired outcomes including increased survival rate, number of treatment options, and improved quality of life. According to an article 2018 Research Fast Facts published by Susan G. Komen, early detection and regular screening with mammography can lower the death rate by 30%. HER2 inhibitors is identified as the most lucrative segment of the breast cancer drugs market. Growing incidence of HER2 positive breast cancer is the major factor attributed to the growth of this segment. According to an article published by F. Hoffman La Roche Ltd in 2013, it was estimated that approximately one in five women diagnosed with breast tumor would have HER2 positive cancer. Moreover, rapidly growing demand from emerging markets such as Asia Pacific and Latin America, is expected to further drive the growth during the forecast period.”
Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) BREAKING NEWS: Oncolytics Biotech® Partner Adlai Nortye Advances to the Second Dose Escalation Cohort of the Chinese Bridging Trial Evaluating Pelareorep-Paclitaxel Combination Treatment in Breast Cancer – Oncolytics Biotech® ) today announced that its partner Adlai Nortye has advanced to the second of three dose escalation cohorts in the bridging clinical trial evaluating the safety, tolerability, and preliminary efficacy of pelareorep-paclitaxel combination therapy in Chinese patients with advanced or metastatic breast cancer. Dosing in the trial’s first dose escalation cohort is complete and no safety issues have been reported. The second dose escalation cohort is the equivalent dose that was administered in the IND-213 study, which reported a near doubling of survival in HR+/HER2- metastatic breast cancer patients.
“Initiation of the bridging trial’s second dose escalation cohort is an important advancement that reflects the positive safety findings observed in the trial to date,” said Andrew de Guttadauro, President of Oncolytics Biotech U.S. and Global Head of Business Development. “Completion of the bridging trial will allow future Chinese regulatory submissions that will include previously reported clinical data demonstrating pelareorep’s potential to substantially benefit metastatic breast cancer patients. This may accelerate pelareorep’s development in rapidly growing pharmaceutical markets such as China, which is the second largest in the world after the United States. Looking ahead, we will continue to collaborate closely with Adlai Nortye to advance pelareorep towards registration in these jurisdictions and maximize its potential therapeutic impact.”
The bridging clinical trial is designed to satisfy Chinese regulatory requirements and thereby accelerate pelareorep’s development in territories that include China, Hong Kong, and Macau. Results from the trial are expected to allow Adlai Nortye to include data from Oncolytics’ randomized North American metastatic breast cancer trials in future submissions to regulators in China and its territories.
The first of Oncolytics’ randomized North American trials, IND-213, showed a statistically significant near doubling of overall survival in patients treated with pelareorep and paclitaxel compared to those treated with paclitaxel alone. Oncolytics’ second randomized North American trial, BRACELET-1, is ongoing and evaluates pelareorep-paclitaxel combination therapy both with and without a checkpoint inhibitor. Oncolytics expects to complete enrollment in BRACELET-1 later this quarter and to report top-line data from the trial in Q4. Oncolytics believes completion of BRACELET-1 represents the last major clinical step on pelareorep’s path to a registrational study in metastatic breast cancer in the United States. 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:
Sierra Oncology, Inc. (NASDAQ: SRRA), a late-stage biopharmaceutical company dedicated to delivering targeted therapies for rare cancers, recently announced positive topline data from the pivotal Phase 3 MOMENTUM study—a global, randomized, double-blind clinical trial evaluating momelotinib (MMB) in myelofibrosis patients who are symptomatic and anemic and previously treated with an approved JAK inhibitor. The trial met all of its primary and key secondary endpoints.
“These data are extremely exciting and everything we had hoped to see from the trial,” said Stephen Dilly, MBBS, PhD, President and Chief Executive Officer of Sierra Oncology. “To achieve statistically significant and clinically important efficacy across all prespecified primary and key secondary endpoints while maintaining platelet counts in such a difficult to treat patient population is remarkable, and a confirmation of the anemia response we identified in the comprehensive review of our previous Phase 3 studies.”
Vaccinex, Inc. (NASDAQ: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating cancer and neurodegenerative disease through the inhibition of semaphorin 4D (SEMA4D), recently reported positive interim response data in the Phase Ib segment of the KEYNOTE-B84 study of Vaccinex’s pepinemab in combination with Merck’s (known as MSD outside of the United States and Canada) anti-PD-1 therapy KEYTRUDA (pembrolizumab) in patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC).
Among the three patients enrolled in the Phase1b safety segment of the study, two patients have been observed to experience a complete response (CR), as per RECIST v.1.1. Biomarker analysis revealed that tumors in both responders expressed low levels of PD-L1 biomarker (CPS<20), a subset of HNSCC patients who have historically low response rates to anti-PD-1/L1 antibodies administered as single agents.
Bristol Myers Squibb (NYSE: BMY) recently announced that Orencia® (abatacept) was approved by the U.S. Food and Drug Administration (FDA) for the prophylaxis, or prevention, of acute graft versus host disease (aGvHD), in combination with a calcineurin inhibitor (CNI) and methotrexate (MTX), in adults and pediatric patients 2 years of age and older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated donor (URD).
“Orencia is the first FDA-approved therapy to prevent acute graft versus host disease following hematopoietic stem cell transplant, a potentially life-threatening complication that can pose a comparatively higher risk to racial and ethnic minority populations in the U.S. due to difficulty finding appropriately matched donors, said Tina Deignan, senior vice president, U.S. Immunology, Bristol Myers Squibb. “With this fourth indication for Orencia, Bristol Myers Squibb draws on its legacy and expertise in both immunology and hematology to deliver an important treatment option for patients in a disease with high unmet need.
Merck (NYSE: MRK), known as MSD outside the United States and Canada, recently announced the final results from the Phase 3 KEYNOTE-394 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, plus best supportive care (BSC) in patients in Asia with advanced hepatocellular carcinoma (HCC) previously treated with sorafenib. KEYNOTE-394 is the first trial with an anti-PD-1/L1 as a second-line monotherapy treatment to show an improvement in overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) compared to placebo plus BSC for these patients. These data add to the body of evidence relating to the use of KEYTRUDA as a monotherapy in second-line HCC post sorafenib.
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