Palm Beach, FL – November 9, 2023 – FinancialNewsMedia.com News Commentary – According to the American Cancer Society projections, there were around 9,440 new instances (3,150 in men and 6,290 in women) and about 1,670 fatalities (930 in women and 740 in men) of anal cancer in the U.S. in 2022. For many years, there have been more new cases of anal cancer. An estimated 1 in 500 people get anal cancer in their lifetime, the majority of those who have it are older with an average age in the early 60s. Although anal cancer is becoming more common and is killing more people annually, many patients can still be cured of this disease with the right treatment. A report from Coherent Market Insights projected that the global anal cancer market size is estimated to be valued at US$ 1,242.9 million in 2028 and is expected to exhibit a CAGR of 6.3%.  A separate report from Reports And Data added: “… increased R&D activities, proposed new drug launch in the near future, increased anal cancer diagnostic rate, technological advancement, increased healthcare spending, government support and reimbursement policies, a notable increase in novel and innovative therapy, increased clinical trial for a cancer drug, increased public awareness, increased geriatric population, and increased prevalence of sexually transmitted disease are expected to drive revenue growth of the market over the forecast period.   The incidence of anal cancer has increased over the past several decades, especially among women; (and) is anticipated that the global anal cancer market will expand at a faster rate… the main risk factor for anal cancer is human papillomavirus (HPV) infection; hence, rising HPV (Human Papilloma Virus) risks are anticipated to fuel the expansion of the anal cancer treatment market. According to the Centers for Disease Control (CDC), anal cancer affects 7,334 persons annually, and it is believed that HPV is responsible for 91% of anal cancer cases.”   Active biotech and pharma companies in the markets this week include Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC), Bristol Myers Squibb (NYSE: BMY), Gilead Sciences, Inc. (NASDAQ: GILD), Merck (NYSE: MRK), Pfizer Inc. (NYSE: PFE).

The article continued: “Moreover, increased diagnostic rate of anal cancer is due to increased government-funded cancer screening programs and public and private initiatives for cancer awareness. Additional technological developments, research, and development efforts have led to the creation of a cutting-edge product that focused on a novel approach to treating the disease and the arrival of potent medications in the pipeline. The aging population, lifestyle modifications such as the adoption of an unhealthy diet, consumption of alcohol, and smoking, as well as a rise in partnerships and acquisitions among key competitors, are expected to drive revenue growth of the market during the forecast period.”

Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC):  Oncolytics Announces the Anal Cancer Cohort of the GOBLET Phase 1/2 Study of Pelareorep and Atezolizumab Has Met the Success Criteria for Efficacy – Pelareorep-atezolizumab combination data exceeds historical control trials with a 37.5% objective response rate, including a complete response – Oncolytics Biotech® Inc., a clinical-stage immunotherapeutics company focused on oncology, today announced the presentation of positive, interim results from the Phase 1/2 GOBLET study evaluating the combination of pelareorep and atezolizumab in second-line patients with unresectable squamous cell carcinoma of the anal canal (SCCA) by Dirk Arnold, M.D., Ph.D., Director of Asklepios Tumorzentrum Hamburg, and primary investigator of the GOBLET trial, in an oral presentation at the 2nd International Multidisciplinary Anal Cancer Conference (IMACC) 2023, taking place in Rome, Italy.

“The positive interim data from the anal cancer cohort of the Phase 2 GOBLET study presented today at the IMACC meeting is very exciting for our company and the potential of pelareorep in gastrointestinal cancers. These results met the pre-specified success criteria for the cohort and exceeded the results from historical controls in similar patient populations1-7,” said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics. “I am especially pleased to note that this is the third indication from the GOBLET study in a row to meet its success criteria and the fourth indication combining pelareorep and atezolizumab to present positive data, further validating the potential clinical benefit of this combination and opening the door to another potential registrational pathway for pelareorep. Furthermore, we’ve seen another complete response in an indication where checkpoint inhibitor therapy alone has had limited success historically, which bodes well for the potential of pelareorep to work synergistically with multiple immunotherapies in multiple tumor types.”

Dr. Arnold commented, “Current treatment options for SCCA are poor, with no defined standard of care for patients who have progressed after first-line therapy. Oncolytics is developing a solid compendium of clinical data showing consistent positive results from the combination of pelareorep and the checkpoint inhibitor atezolizumab. We are particularly pleased by the promising data presented today because they show that pelareorep may have the potential to offer the hope of a new, effective treatment option for patients with advanced SCCA.”   CONTINUED… Read these full press releases and more news for ONCY at:  https://www.financialnewsmedia.com/news-oncy/    

Other recent developments in the biotech industry of note for cancer events include:

Bristol Myers Squibb (NYSE: BMY) recently announced the presentation of research across its hematology and cell therapy portfolio and pipeline at the 65^th American Society of Hematology (ASH) Annual Meeting and Exposition, which will take place in San Diego, California from December 9 to 12, 2023. Results from 73 data disclosures across company-sponsored studies will be featured, including 22 oral presentations, showcasing BMS’ commitment to delivering transformative medicines that help more patients living with blood disorders.

“At this year’s ASH meeting, we look forward to highlighting our continued commitment to unlocking the full promise of cell therapy and our differentiated research platforms, demonstrating the clinical and real-world value of our medicines through our scientific innovation,” said Samit Hirawat, M.D., executive vice president, chief medical officer, Global Drug Development, Bristol Myers Squibb. “New data from our diverse portfolio, spanning multiple platforms and combinations, reinforce our pursuit of the next wave of hematology advances across a spectrum of blood diseases with the highest unmet needs.”

Gilead Sciences, Inc. (NASDAQ: GILD) and Arcus Biosciences, Inc. (RCUS) recently announced that domvanalimab plus zimberelimab and chemotherapy showed encouraging overall response rate (ORR) and six-month progression-free survival (PFS) rate results in a preliminary analysis from Arm A1 of the EDGE-Gastric study. This ongoing Phase 2, multi-arm, global study is evaluating the safety and efficacy of various combinations of the Fc-silent anti-TIGIT antibody domvanalimab plus the anti-PD-1 antibody zimberelimab and chemotherapy in patients with locally advanced unresectable or metastatic gastric, gastroesophageal junction or esophageal adenocarcinoma. These results will be presented tomorrow during the American Society of Clinical Oncology (ASCO) Monthly Plenary Series, a virtual forum for presentation and discussion of the latest cancer research.

“The preliminary data from the EDGE-Gastric study underscore the potential role of dual anti-TIGIT and anti-PD-1-containing regimen in the treatment of gastroesophageal cancer where front-line chemotherapy with anti-PD-1 blockade is currently the standard,” said Yelena Y. Janjigian, M.D., Chief Attending Physician of the Gastrointestinal Medical Oncology Service, Memorial Sloan Kettering Cancer Center, and a principal investigator for the EDGE-Gastric study. “These early data are encouraging and indicate the potential for the anti-TIGIT, domvanalimab-based therapy to improve upon anti-PD-1 and chemotherapy in this setting, with a similar safety profile to anti-PD-1 and chemotherapy.”

Merck (NYSE: MRK) recently announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with gemcitabine and cisplatin, for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC). The approval was based on results from the Phase 3 KEYNOTE-966 trial, in which KEYTRUDA plus chemotherapy demonstrated a statistically significant improvement in the study’s primary endpoint of overall survival (OS), reducing the risk of death by 17% (HR=0.83 [95% CI, 0.72-0.95]; one-sided p=0.0034) compared to chemotherapy alone at the trial’s pre-specified final analysis for OS. Median OS was 12.7 months (95% CI, 11.5-13.6) for KEYTRUDA plus chemotherapy versus 10.9 months (95% CI, 9.9-11.6) for chemotherapy alone. This approval marks the sixth indication for KEYTRUDA in gastrointestinal cancers.

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue and can affect more than one body system simultaneously. Immune-mediated adverse reactions can occur at any time during or after treatment with KEYTRUDA, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, dermatologic reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions. Early identification and management of immune-mediated adverse reactions are essential to ensure safe use of KEYTRUDA. Based on the severity of the adverse reaction, KEYTRUDA should be withheld or permanently discontinued and corticosteroids administered if appropriate. KEYTRUDA can also cause severe or life-threatening infusion-related reactions. Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. For more information, see “Selected Important Safety Information” below.

Pfizer Inc. (NYSE: PFE) recently announced that it will present its latest data showcasing advances in the treatment of hemophilia, sickle cell disease, and blood cancers at the 65^th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego from December 9-12. These data from 39 presentations represent continued innovation and advancement in hemophilia including pivotal findings for Pfizer’s novel anti-tissue factor pathway inhibitor (anti-TFPI) candidate marstacimab and the latest findings on a next-generation investigational treatment for sickle cell disease (SCD) in GBT021601 (GBT601). Pfizer will also present the latest research in blood cancer, including for ELREXFIO (elranatamab-bcmm), a BCMA-directed bispecific antibody recently approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

“Pfizer has been advancing science in hematology for more than 30 years, starting with the introduction of recombinant factor replacement therapy, which became the standard of care for people living with hemophilia. This year at ASH we will deliver five oral presentations including the latest clinical findings from our hemophilia programs and exciting data from the GBT601 program in sickle cell disease, representing progress in our unrelenting efforts to address the broad spectrum of patient needs,” said Sonal Bhatia, M.D., Chief Medical Officer, Rare Disease, Pfizer. “The findings reflect the company’s scientific capabilities and use of translational science to potentially offer improved treatment options to help people living with these rare diseases.”

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