Palm Beach, FL – March 5, 2024 – FN Media Group News Commentary – Pancreatic cancer is one of the leading causes of cancer death globally. The increasing incidence of this cancer across the U.S. and other parts of the world is one of the factors driving the need for the drugs used in the treatment. Moreover, the prevalence is significantly higher in the geriatric population compared to other types of cancers. Thus, an increase in the geriatric population is one factor driving the pancreatic cancer treatment market growth. The incidence is significantly higher in the geriatric population above 65 years of age compared to other types of cancers.  A report from Fortune Business Insights said that: “the pancreatic cancer treatment market size is projected to grow to USD 6.85 billion by 2029, exhibiting a CAGR of 15.7% during 2022-2029. North America dominated the global market with a share of 46.97% in 2022. The increase in the number of patients suffering from the condition has increased the demand for the drugs used in treatment. These are some factors driving the growth during the forecast period.  Companies engaged in manufacturing cancer drugs have increased their focus on R&D activities to develop new drugs for pancreatic cancer treatment. Additionally, the companies operating in the market have received approval from several regulatory bodies, such as the U.S. Food and Drug Administration (FDA), the Medicines and Healthcare Products Regulatory Agency (MHRA) (U.K.), among others, thereby propelling the growth of the market. Moreover, new testing technologies are being adopted by hospitals and diagnostic centers to diagnose cancer. The increase in the diagnosis rates is driving the demand for drugs, thereby providing opportunities for the players.”   Active biotech and pharma companies in the markets this week include Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC), Ocean Biomedical, Inc. (NASDAQ: OCEA), LAVA Therapeutics N.V. (NASDAQ: LVTX), Merck & Co., Inc. (NYSE: MRK), AbbVie Inc. (NYSE: ABBV).

Fortune Business Insights continued: “Shifting the focus of key players in extensive R&D activities to develop new drugs and an increase in funding for cancer research led to the development of new drugs for treatment. Additionally, several pharmaceutical companies are involved in clinical trials to develop new drugs and explore the potential of the molecule to treat the disease.  Thus, with the increased funding for R&D activities, companies are focused on developing new drugs, thereby contributing to the overall rise in demand for drugs for pancreatic type of cancer treatment. Thus, increasing aging population and rising government initiatives to create awareness for the diagnosis of the condition are some factors propelling the market growth.”

Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC) Files Amendment to Initiate New Pancreatic Cancer GOBLET Cohort Supported by PanCAN – US$5M grant supports study of pelareorep in combination with modified FOLFIRINOX +/- atezolizumab – Oncolytics Biotech® Inc., a clinical-stage immunotherapeutics company focused on oncology, today announced it has submitted an amendment to GOBLET to initiate a new Phase 1/2 cohort evaluating pelareorep in combination with modified FOLFIRINOX (mFOLFIRINOX) with and without atezolizumab (Tecentriq®) in patients with newly diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC). This amendment will be reviewed by the Paul Ehrlich Institute (PEI; Germany’s regulatory body) for approval before patient enrollment can begin. The cohort, the fifth of the GOBLET gastrointestinal cancer study, is being supported by the US$5 million Therapeutic Accelerator Award from the Pancreatic Cancer Action Network (PanCAN), an innovative program established to accelerate the development of new treatments for pancreatic cancer.

“We are enthusiastic to have the support of PanCAN to expand the evaluation of pelareorep in pancreatic cancer and explore mFOLFIRINOX as another combination that could improve outcomes for patients. Notably, this patient population is newly diagnosed patients who are receiving first-line treatment. Chemotherapies, including either mFOLFIRINOX or gemcitabine and nab-paclitaxel, are the backbone treatment regimens of pancreatic cancer therapy. Evaluating pelareorep in combination with these widely used regimens is an important step in our broad clinical development program,” said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics. “Last fall, we reported a 62% objective response rate for the GOBLET PDAC cohort studying pelareorep in combination with the checkpoint inhibitor atezolizumab in addition to gemcitabine and nab-paclitaxel (link to the PR, link to the poster). This response is about three times that of historical controls and forms the basis of the registrational program, expected to begin this year. Therefore, we are enthusiastic about this new mFOLFIRINOX pancreatic cancer cohort and look forward to enrolling the first patient as soon as possible.”

Dirk Arnold, M.D., Ph.D., Director of Asklepios Tumorzentrum Hamburg, and primary investigator of the GOBLET trial, commented, “One of the reasons for pancreatic cancer’s poor survival rate is that it effectively evades the immune system and can induce an immunosuppressive tumor microenvironment (TME). Pelareorep is an attractive combination partner because of its ability to address both issues by activating the innate and adaptive immune systems while driving the remodeling of the tumor microenvironment. Positive results from the Phase 2 study evaluating pelareorep combined with atezolizumab and chemotherapy reported last fall support the potential use of these agents together. I am hopeful that the combination of pelareorep and mFOLFIRINOX (with or without atezolizumab) will yield positive response data and advance the development of new treatment options for patients with pancreatic cancer.”

“This study is designed to evaluate whether pelareorep can enhance outcomes in patients receiving mFOLFIRINOX, one of the most commonly used metastatic pancreatic cancer treatments. Combining pelareorep with mFOLFIRINOX represents an expansion of our existing pancreatic cancer program and maximizes the potential of pelareorep-based combination therapies to benefit pancreatic cancer patients,” commented Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. “The mFOLFIRINOX cohort utilizes a screened selection design within a Simon two-stage approach that will also allow evaluation of the contribution of atezolizumab to the pelareorep/mFOLFIRINOX combination. In addition, this study is designed to provide valuable translational assessments, such as the expansion of tumor-infiltrating lymphocytes (TILs) in the blood, which has been associated with tumor responses. We look forward to building on PanCAN’s strong relationships with the pancreatic cancer community and furthering our collaboration with AIO-Studien-gGmbH (AIO) on the GOBLET study.”  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:

Ocean Biomedical, Inc. (NASDAQ: OCEA), a biopharma company which endeavors to accelerate the development of compelling discoveries from top research scientists, recently congratulated its joint venture partner, Virion Therapeutics, LLC, a clinical-stage biotechnology company developing T cell-based immunotherapies, for the acceptance of their abstract highlighting the first-ever human data from its novel checkpoint modifier immunotherapy for HBV functional cure, for late breaker oral presentation at the upcoming 33rd Annual Meeting of APASL (The Asian Pacific Association for the Study of the Liver), taking place in Kyoto, Japan from March 27-31, 2024.

The late breaker presentation will highlight the safety data observed, to date, in the ongoing Phase 1B clinical trial of VRON-0200. “This accepted abstract highlights Virion’s commitment to finding a functional cure for chronically HBV-infected patients – and the first-ever human data for a genetically encoded checkpoint modifier T cell vaccine of any kind. VRON-0200 is uniquely developed to stimulate a patient’s own immune response to the virus. Additionally, its mechanism of action and intramuscular administration were designed to limit safety issues for this novel therapy,” said Dr. Sue Currie, COO of Virion, and one of the study authors. “We look forward to sharing these late breaking clinical HBV data at APASL, one of the leading meetings on the treatment of liver diseases in the world.”

LAVA Therapeutics N.V. (NASDAQ: LVTX), recently announced that it has entered into a clinical trial collaboration and supply agreement with Merck & Co., Inc. (NYSE: MRK), Rahway, NJ, USA to evaluate its anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in combination with LAVA-1207, a Gammabody® designed to target the prostate-specific membrane antigen (PSMA) to trigger the potent and preferential killing of PSMA-positive tumor cells, in patients with therapy refractory metastatic castration-resistant prostate cancer (mCRPC).

Under the terms of the agreement, Merck & Co., Inc., Rahway, NJ, USA will provide pembrolizumab for the dose escalation and expansion phases of LAVA’s ongoing Phase 1/2a study of LAVA-1207 (NCT05369000), with the combination arm expected to be initiated in the first half of 2024. Enrollment and dose escalation will also continue in the LAVA-1207 monotherapy and interleukin-2 arms of the study.

“We are excited to work with Merck & Co., Inc., Rahway, NJ, USA as we continue to unlock the therapeutic potential of LAVA-1207 and explore its potential capabilities in combination with KEYTRUDA®,” said Stephen Hurly, President and Chief Executive Officer, LAVA. “To date, LAVA-1207 has demonstrated a favorable safety profile and shown preliminary signs of anti-tumor activity. Prostate cancer has presented challenges for immune checkpoint therapies in the past – we are hopeful the combination of our products may deliver important clinical outcomes.”

AbbVie Inc. (NYSE: ABBV) and OSE Immunotherapeutics SA, a clinical-stage immunotherapy company, recently announced a strategic partnership to develop OSE-230, a monoclonal antibody designed to resolve chronic and severe inflammation, currently in the pre-clinical development stage.

OSE-230 is a first-in-class monoclonal antibody designed to activate ChemR23, a G-Protein Coupled Receptor (GPCR) target. Activation of ChemR23 may offer a novel mechanism for the resolution of chronic inflammation, modulating functions of both macrophages and neutrophils.

“This collaboration underscores our commitment to expanding our immunology portfolio with the ultimate goal of improving the standard of care for patients living with inflammatory diseases globally,” said Jonathon Sedgwick, Ph.D., senior vice president and global head of discovery research, AbbVie. “By leveraging our expertise in immunology drug development, we look forward to advancing OSE-230, which offers a novel mechanism-of-action to treat chronic inflammation.”

“We are very pleased to collaborate with AbbVie, a global leader in the development and commercialization of innovative medicines, to drive our OSE-230 program forward,” said Nicolas Poirier, chief executive officer, OSE Immunotherapeutics. “This partnership represents a major milestone in our company’s progress and recognizes the value of our innovative R&D capabilities. I would like to thank all our employees who helped us reach this milestone through dedication and hard work.”

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