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FinancialNewsMedia.com 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. The 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. The increase in the number of patients suffering from the condition has increased the demand for the drugs used in treatment. A report from Fortune Business Insights said that this factor will be driving the growth for the next several years. The report projected that the global pancreatic cancer treatment market size was valued at USD 2.48 billion in 2022 and will grow to USD 6.85 billion by 2029, exhibiting a CAGR of 15.7% during the forecast period. The report continued: “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. (ONCY – ONC.TSX), Sotera Health Company (NASDAQ: SHC), Centessa Pharmaceuticals plc (NASDAQ: CNTA), Bristol Myers Squibb (NYSE: BMY), Gilead Company (NASDAQ: GILD).

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. It concluded: “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 through 2029.”

Oncolytics Biotech^® Inc. (ONCY - ONC) BREAKING NEWS: Oncolytics Biotech’s® Pelareorep Selected for Inclusion in Precision PromiseSM Pivotal Phase 3 Platform Trial –

• Adaptive clinical trial designed to accelerate registration pathways for pancreatic cancer therapies and expected to reduce cost of a Phase 3 study for pelareorep by ~50% compared to a traditional trial
• If successful, new clinical study expected to support approval of pelareorep in combination with a checkpoint inhibitor, gemcitabine, and nab-paclitaxel in first-line metastatic pancreatic cancer
• Data presented at SITC 2022 showed a near tripling of overall response rate for pelareorep + gemcitabine + nab-paclitaxel + a PD-L1 inhibitor compared to historical control trials

Oncolytics Biotech^® (trading on the NASDAQ under the Symbol ONCY and the TSX exchange under ONC) today announced pelareorep has been selected for inclusion as a new investigational treatment in Precision PromiseSM, an innovative adaptive Phase 3 clinical trial. The Precision Promise study is designed to evaluate pelareorep in combination with a checkpoint inhibitor and the chemotherapeutic agents gemcitabine and nab-paclitaxel. If successful, the clinical study is expected to support approval of the studied combination as a treatment for first-line metastatic pancreatic ductal adenocarcinoma (PDAC).

Precision Promise has a primary endpoint of overall survival and can include multiple investigational treatments as well as control arms evaluating: (1) gemcitabine plus nab-paclitaxel or (2) mFOLFIRINOX. Each investigational therapy is subject to pre-specified interim analyses prior to proceeding to the registrational portion of the trial. This design, which was developed with guidance from the U.S. Food and Drug Administration, minimizes the number of participants needed to generate licensure-enabling data, thereby accelerating late-stage development by up to two years and reducing costs compared to non-platform trials.

“We are delighted at being selected by the Precision Promise panel of experts,” said Dr. Matt Coffey, President, and Chief Executive Officer of Oncolytics Biotech. “Our next step is to engage with stakeholders to finalize the protocol for Precision Promise’s pelareorep-containing investigational treatment so that we can enter into this study. We are thrilled to have the opportunity to leverage Precision Promise, which we expect will allow us to reduce the time and costs needed to reach a potential approval.”

Julie Fleshman, JD, MBA, President and CEO of PanCAN commented, “With a five-year survival rate of 12%, pancreatic cancer patients cannot afford to wait for new treatment options. This urgent unmet need was the driving inspiration behind the Precision Promise platform trial, which was designed specifically to identify, accelerate, and de-risk the development of promising pancreatic cancer treatments. We are thrilled to be bringing pelareorep into Precision Promise as a new investigational therapy to study against the current standard of care.”

Dr. Thomas Heineman, Chief Medical Officer of Oncolytics Biotech, commented, “Prior trials in pancreatic cancer show pelareorep-based combinations outperforming historical controls on key metrics such as one and two-year survival and objective response rate. In addition, mechanistic data from these studies highlight how pelareorep’s immunologic mechanism of action allows it to synergize with chemotherapy and checkpoint inhibition in this indication. I look forward to working with the Precision Promise team of investigators to seek to confirm the therapeutic value of pelareorep in a randomized setting so that we can potentially provide pancreatic cancer patients with a new treatment option.” CONTINUED…Read this full press release and more news for ONCY at: https://www.financialnewsmedia.com/news-oncy/

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

Sotera Health Company (NASDAQ: SHC) recently announced that the opt-in process for the January 2023 settlements of ethylene oxide claims against Sterigenics in the Circuit Court of Cook County, Illinois is complete and Sterigenics has elected to proceed with the settlements.

879 of the 882 claimants eligible to participate in the settlement program have opted in. The settling claimants and Sterigenics will now request that the Circuit Court enter an order confirming that these are good-faith settlements under the Illinois Contribution Among Joint Tortfeasors Act. The settlement funds will be released from escrow for disbursement to the settling claimants ten days after the Court enters the anticipated good-faith determination and their claims against Sterigenics will subsequently be dismissed with prejudice. The lawsuits of the three claimants who opted out of the settlement will proceed to pretrial discovery pursuant to a schedule to be set by the Circuit Court.

Centessa Pharmaceuticals plc (NASDAQ: CNTA), a clinical-stage pharmaceutical company that aims to discover and develop medicines that are transformational for patients, recently announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to SerpinPC, an investigational novel inhibitor of activated protein C (APC) being developed for the treatment of hemophilia B, with or without inhibitors.

"We are pleased with the FDA’s decision to grant Fast Track designation for SerpinPC as we continue to advance the PRESent registrational studies for SerpinPC in hemophilia B,” said Saurabh Saha MD PhD, Chief Executive Officer of Centessa. “This designation is important recognition of SerpinPC’s novel mechanism of action and underscores the critical need for new treatment options for persons with hemophilia B. We believe SerpinPC has the potential to be a first-in-class subcutaneously administered therapy with a differentiated safety profile for persons with hemophilia B, subject to review and approval.”

Bristol Myers Squibb (NYSE: BMY) announced the first disclosure of primary analysis results from two pivotal studies, TRANSCEND FL, an open-label, global, multicenter, Phase 2, single-arm study evaluating Breyanzi (lisocabtagene maraleucel; liso-cel) in patients with relapsed or refractory follicular lymphoma (FL) and the relapsed or refractory mantle cell lymphoma (MCL) cohort of TRANSCEND NHL 001, an open-label, multicenter, Phase 1, single-arm, seamless-design study evaluating Breyanzi. These data were presented in late-breaking oral presentations at the 2023 International Conference on Malignant Lymphoma (ICML) on Saturday, June 17.

"With Breyanzi, we’re dedicated to delivering a CAR T cell therapy with a differentiated profile to transform outcomes for some of the most difficult-to-treat lymphomas," said Anne Kerber, senior vice president, head of Cell Therapy Development, Bristol Myers Squibb. "Based on results from TRANSCEND FL and TRANSCEND NHL 001, Breyanzi continues to demonstrate the ability to elicit significant deep and durable responses alongside a manageable safety profile, potentially addressing areas of high unmet need and reinforcing our commitment to advancing innovative solutions for the broadest array of hematologic malignancies of any CD19-directed CAR T cell therapy."

Kite Pharma, Inc., a Gilead Company (NASDAQ: GILD) announced that the Marketing Authorization in Japan for Yescarta® (axicabtagene ciloleucel), a chimeric antigen receptor (CAR) T-cell therapy, has been transferred from Daiichi Sankyo Co., Ltd. to Gilead Sciences K.K., the Japan subsidiary of Gilead Sciences, Inc.

This follows the announcement made by Daiichi Sankyo and Kite Pharma, Inc. in December 2022 about changes to their initial 2017 partnership whereby Daiichi Sankyo obtained the Marketing Authorization for Yescarta®. With this completion of the Marketing Authorization transfer, the sales and promotion activities of Yescarta® in Japan now will be managed by the Kite Cell Therapy Business Unit of Gilead Sciences K.K.

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