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Vancouver, BC – September 26, 2023 – USA News Group – The seriousness of pancreatic cancer continues to grow, with increasing alarm since The Lancet published an analysis back in April 2023, showing a rising incidence of pancreatic cancer among individuals younger than 55 years. Another study published in JAMA Network Open showed that early-onset cancer in people younger than 50 rose over the last decade, with gastrointestinal cancers seeing the fastest increase. This has led to increased calls from pancreatic cancer organizations such as Pancreatic Cancer Action Network (PanCAN) for more action in the space, including advocating that the US Congress invest more in cancer research funding now. Among the ongoing efforts that are drawing more attention in the pancreatic cancer space have been the developments coming from Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), Merus N.V. (NASDAQ:MRUS), Guardant Health, Inc. (NASDAQ:GH), Medtronic plc (NYSE:MDT), and even NVIDIA Corporation (NASDAQ:NVDA).
PanCAN recently followed up their selection of pelareorep—the leading drug candidate of Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC)—for their pivotal Phase 3 trial, by rewarding the drug’s developer with its second annual PanCAN Therapeutic Accelerator Award. The award comes with a US$5 million grant to further develop leading-edge treatments.
For Oncolytics Biotech, the grant will enable the company to continue the next stage of its research focused on a clinical trial with pelareorep, this time in combination with modified FOLFIRINOX chemotherapy with or without an immune checkpoint inhibitor.
“This generous grant will enable early and late-stage patients with pancreatic cancer to potentially benefit from another commonly employed chemotherapy backbone, as FOLFIRINOX and gemcitabine + nab-paclitaxel are the most frequently used chemotherapy standards of care in both the first and second-line setting,” said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. “By teaming up with PanCAN, we believe we may be able to expedite development and provide pancreatic cancer patients with a bespoke immunotherapeutic treatment option.”
Prior to the award, ONCY successfully raised another US$15 million to continue the advancement of its pelareorep clinical programs in both pancreatic and metastatic breast cancers, with the significant support from an institutional investor. With the injection of another US$5 million from the PanCAN grant, Oncolytics is in an excellent cash runway position. According to their Q2 2023 financial results, on a pro forma basis, including the net proceeds from the public offering, Oncolytics had CAD$42.7 million on June 30, 2023, which should last them into the second half of 2024.
“Our core programs in pancreatic and breast cancer are both progressing rapidly towards registrational studies on the back of the impressive clinical data showing the potential of pelareorep as a backbone immunotherapy,” said Dr. Coffey. Pelareorep delivered the company a big win near the end of 2022, when the FDA rewarded it with a Fast Track Designation (FTD) for treating advanced or metastatic pancreatic cancer. This came right after an update on ONCY’s GOBLET study, which delivered amazing results, including a 69% objective response rate (ORR) in the first group of patients tested and one even having a rare complete response (CR).
“With a five-year survival rate of 12%, pancreatic cancer patients cannot afford to wait for new treatment options,” said Julie Fleshman, JD, MBA, President and CEO of PanCAN. “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.”
Another pancreatic cancer therapy that received a boost from the FDA was Merus N.V. (NASDAQ:MRUS), which, back in early July 2023, received a Breakthrough Therapy Designation for its drug Zeno (zenocutuzumab) for the treatment of patients with advanced, unresectable or metastatic NRG1 fusion pancreatic cancer that has gotten worse with a prior systemic therapy and has no other satisfactory treatment options.
“We believe the compelling clinical data for Zeno in NRG1-positive cancer, and Breakthrough Therapy Designation, provide the opportunity to further engage with the FDA to expedite the review of a potential (Biologics License Application) submission,” said Dr. Bill Lundberg, President and CEO of Merus.
Based on information provided during the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, it was found that 34% of patients who underwent treatment with Zeno witnessed a positive response. This response indicated a reduction in tumor size or complete disappearance, with an average response duration of 9.1 months. This data compilation involved 79 patients who were diagnosed with various solid cancers, all of whom had an NRG1 fusion.
At the 2023 ASCO GI Annual Meeting there was a demonstration by Guardant Health, Inc. (NASDAQ:GH) of its blood tests for patients with gastrointestinal cancers. Spanning over 10 poster presentations, Guardant shared important updates of its Guardant360® and Guardant Reveal blood tests, as well as the GuardantINFORM real-world evidence dataset to identify critical biomarkers and acquired co-mutations, track associated treatment patterns and clinical outcomes, and predict disease recurrence from minimal residual disease (MRD) detection.
The Guardant360 CDx test was the first blood test to be approved by the FDA for comprehensive genomic profiling for all solid tumors, and it is now FDA-approved as a companion diagnostic test for four targeted therapies in NSCLC and one in advanced breast cancer.
While Guardant’s blood tests are making progress, endoscopic ultrasound (EUS) is still considered one of the most useful imaging studies for diagnosing pancreatic cancer, and the technology behind endoscopies is also rapidly progressing.
Back in March, Medtronic plc (NYSE:MDT) announced a plan with Cosmo Pharmaceuticals NV and NVIDIA Corporation (NASDAQ:NVDA) to integrate Nvidia’s artificial intelligence technologies into Medtronic’s GI Genius intelligent endoscopy module—the first FDA-cleared, AI-assisted colonoscopy tool to help physicians detect polyps that can lead to colorectal cancer.
“The possibility for GI Genius to host multiple real-time AI applications is a game-changer for physicians performing gastrointestinal procedures,” said Giovanni Di Napoli, president of the Gastrointestinal business at Medtronic. “With the launch of our AI Access platform, we are now able to support developers everywhere and accelerate the creation of real-time AI applications. This technology may allow us to offer clinicians expanded access to these tools, potentially improving patient outcomes. We believe that the AI Access platform may be a critical tool for advancing medical AI innovation and improving patient care in the years to come.”
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