Palm Beach, FL – June 28, 2022 – FinancialNewsMedia.com News Commentary – Pancreatic cancer therapeutics and diagnostics involve medical procedures used to diagnose pancreatic cancer and subsequent treatment. Factors such as the increasing prevalence and incidence of pancreatic cancer and advancements in molecular biology, development of drugs, and diagnostic technology play a major part in market growth. With the increase in R&D initiatives, favorable reimbursement scenarios, and the launch of novel products, the market is expected to grow significantly during the forecast period. A report from Mordor Intelligence projected that the global pancreatic cancer therapeutics and diagnostics market, which was estimated to be USD 3,689.61 million in 2021 is expected to reach USD 5,656.58 million by 2027, registering a CAGR of 7.43% from 2022 to 2027.  The report said: “Pancreatic cancer occurs when there is an uncontrollable growth of cells in the pancreas. Pancreatic cancer is categorized as exocrine and endocrine, based on the cells affected by cancer. Exocrine cells in the pancreas create pancreatic enzymes. When cancer manifests in these cells, it is referred to as exocrine pancreatic cancer. Endocrine cells are a small cluster of cells and are also called islets of Langerhans. These cells create hormones, such as insulin and glucagon, releasing them into the blood flow. Cancer in these cells is called endocrine pancreatic cancer.”  Active biotech and pharma companies in the markets this week include Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC), Epizyme (NASDAQ: EPZM), Axsome Therapeutics, Inc. (NASDAQ: AXSM), Precision BioSciences, Inc. (NASDAQ: DTIL), NeuroSense Therapeutics Ltd. (NASDAQ: NRSN).

Mordor Intelligence continued: “The Chemotherapy Segment is expected to witness a major share in the Studied Market through 2027. Chemotherapy is one of the main cancer treatments that kill pancreatic cancer cells by preventing them from growing and dividing. These drugs are systemic treatments; the drugs travel through the bloodstream and damage cancer cells throughout the body. Unfortunately, chemotherapy can damage some healthy cells and cause major side effects. Chemotherapy may shrink and/or prevent the growth of pancreatic tumors.  North America dominated the overall market and is expected to retain its dominance. The United States is expected to retain its significant market share due to the rising incidence of pancreatic cancers, supportive reimbursement policies, and high healthcare spending. The USFDA is taking steps to enhance the growth of the pancreatic cancer therapeutics and diagnostic market by approving drugs in the clinical phase, thereby accelerating clinical developments. Companies and research organizations are investing in R&D. Thus, the market is expanding quickly… These clinical trials’ positive outcomes will result in a new treatment, positively influencing the regional market growth. Thus, owing to the factors mentioned above, the studied market is anticipated to register significant growth over the forecast period in the region (2027).”

Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC) BREAKING NEWS:  Oncolytics Biotech^® Achieves Success Criteria for Efficacy in the Pancreatic Cancer Cohort of GOBLET – Oncolytics Biotech^® today announced that the pancreatic cancer cohort of the multi-indication phase 1/2 GOBLET study has met the efficacy expansion criteria for Stage 1 of the trial. The data from the phase 1b portion of this cohort, which are featured in an abstract accepted for a poster presentation at the European Society for Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer 2022, show a strong efficacy signal as evidenced by all patients achieving a partial response (n = 3). An independent safety review noted no toxicity concerns in these patients. The trial’s metastatic colorectal and advanced anal cancer cohorts are proceeding as planned.

The GOBLET study’s pancreatic cancer cohort is evaluating the safety and efficacy of pelareorep in combination with Roche’s anti-PD-L1 checkpoint inhibitor atezolizumab and the chemotherapeutic agents gemcitabine and nab-paclitaxel. Per the study’s Simon two-stage design, any cohort meeting a pre-specified efficacy threshold in Stage 1 (defined as achieving a minimum number of objective radiologic responses by week 16) may be expanded to enroll additional patients in an optional Stage 2 study expansion. In addition to evaluating the safety and efficacy of pelareorep-atezolizumab combinations, the study seeks to assess the potential of CEACAM6 and T cell clonality to serve as predictive biomarkers that may increase the probability of success in subsequent trials by informing patient selection. The study is being conducted at 14 clinical sites in Germany and is being managed by AIO, a leading academic cooperative medical oncology group.

“With Stage 1’s pre-specified efficacy threshold met after just the first three patients, the GOBLET trial’s pancreatic cancer cohort is clearly exceeding expectations,” said Dirk Arnold M.D., Ph.D., Director of Asklepios Tumorzentrum Hamburg, and primary investigator of the GOBLET trial. “Novel therapeutic approaches are urgently needed in pancreatic cancer, as standard-of-care chemotherapy has a limited response rate, and less than 2% of patients are eligible for treatment with checkpoint inhibitors. Prior data in pancreatic cancer patients demonstrated pelareorep’s ability to remodel the tumor microenvironment to be less immunosuppressive. These latest results indicate that pelareorep’s immunotherapeutic effects may enhance the efficacy of checkpoint inhibitors in pancreatic cancer and increase tumor response rates. This promising finding suggests that pelareorep has the potential to dramatically improve the current therapeutic approach in an indication that is amongst the most difficult to treat.”

Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc., commented, “Though early, these data provide a strong and exciting signal of efficacy for the studied combination. Looking forward, we will continue to follow this cohort closely to see if its initial positive results are substantiated as additional patients are evaluated and the data mature. If this impressive signal persists, it may enable us to pursue regulatory paths in pancreatic cancer that include subsequent trials designed to facilitate an expedited approval. We intend to engage regulators to gain insights on pelareorep’s optimal path forward in pancreatic cancer later this year and believe this program has the potential to provide a significant source of value that will complement our core efforts in breast cancer.”  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:

Ipsen  and Epizyme (NASDAQ: EPZM) recently announced that they have entered into a definitive merger agreement under which Ipsen will acquire Epizyme. The transaction was unanimously approved by both Ipsen and Epizyme Boards of Directors and is anticipated to close by the end of the third quarter of 2022, subject to the satisfaction of all closing conditions. Epizyme is a fully integrated, commercial-stage biopharmaceutical company developing and delivering transformative therapies against novel epigenetic targets for cancer patients.

The primary focus of the acquisition is on the lead medicine, Tazverik^® (tazemetostat), a first-in-class, chemotherapy-free EZH2inhibitor, which was granted Accelerated Approval by the U.S. Food and Drug Administration (FDA) in 2020. It is currently indicated for adults with relapsed or refractory follicular lymphoma (FL) whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies, and for adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options, as well as for adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. Tazverik is currently in the Phase III stage of a registrational confirmatory study (SYMPHONY-1) in combination with rituximab and lenalidomide (R²) in patients with relapsed/refractory FL who have received at least one prior therapy. Initial results from the Phase III randomized portion of this study are planned to read out in 2026.

Axsome Therapeutics, Inc. (NASDAQ: AXSM) recently announced the results of the SUPPORT (Studying the Impact of Patient Treatment Experiences on Patient Hope for Future Major Depressive Disorder Pharmacotherapies) survey of 385 patients with depression, demonstrating persistence of high levels of depressive symptoms despite treatment, substantial interference with work and daily life, low levels of patient hope, and high levels of patient dissatisfaction with current treatments.

The SUPPORT survey assessed treatment experiences and expectations in patients taking antidepressants for major depressive disorder (MDD). The web-based survey was developed in collaboration with the Depression and Bipolar Support Alliance (DBSA) and the DBSA Peer Council; Roger McIntyre, MD, Professor of Psychiatry and Pharmacology, University of Toronto, Canada and Chair of the DBSA Scientific Advisory Board; and Greg Mattingly, MD, Associate Clinical Professor of Psychiatry at Washington University and President of the Midwest Research Group. The SUPPORT results were presented on June 1, 2022 at the American Society of Clinical Psychopharmacology (ASCP) 2022 Annual Meeting, held in Scottsdale, Arizona and virtually.

Precision BioSciences, Inc. (NASDAQ: DTIL), a clinical stage gene editing company developing ARCUS-based ex vivo allogeneic CAR T and in vivo gene editing therapies, recently announced it has entered into an exclusive worldwide in vivo gene editing research and development collaboration and license agreement with Novartis Pharma AG (the “Agreement”). As part of the Agreement, Precision will develop a custom ARCUS nuclease that will be designed to insert, in vivo, a therapeutic transgene at a “safe harbor” location in the genome as a potential one-time transformative treatment option for diseases including certain hemoglobinopathies such as sickle cell disease and beta thalassemia.

Under the terms of the Agreement, Precision will develop an ARCUS nuclease and conduct in vitro characterization, with Novartis then assuming responsibility for all subsequent research, development, manufacturing and commercialization activities. Novartis will receive an exclusive license to the custom ARCUS nuclease developed by Precision for Novartis to further develop as a potential in vivo treatment option for sickle cell disease and beta thalassemia. Precision will receive an upfront payment of $75 million and is eligible to receive up to an aggregate amount of approximately $1.4 billion in additional payments for future milestones. Precision is also eligible to receive certain research funding and, should Novartis successfully commercialize a therapy from the collaboration, tiered royalties ranging from the mid-single digits to low-double digits on product sales.

NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) recently announced results from Stage III of its biomarker study conducted in collaboration with Massachusetts General Hospital (MGH) to evaluate PrimeC, NeuroSense’s lead combination drug candidate for the treatment of amyotrophic lateral sclerosis (ALS). PrimeC is currently being evaluated in NeuroSense’s Phase IIb PARADIGM study following the successful conclusion of its Phase IIa study which met its primary endpoints.

The purpose of the initial ALS biomarker study (Stage I) was to characterize the baseline phenomena observed in people living with ALS. The study identified novel ALS biomarkers that are indicative of PrimeC’s mechanism of action (MOA), via an analysis comparing blood samples obtained from healthy people and from people living with ALS. TDP-43 accumulation and neuroinflammation via prostagladin2 were amongst the disease-modifying targets characterized, along with miRNA dysregulation, iron accumulation, lysosomal dysfunction, and impaired autophagy.

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