New FDA Designations Accelerate Progress in Pancreatic Cancer Treatments: A Year in Review

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VANCOUVER, BC, Oct. 13, 2023 /PRNewswire/ -- USA News Group  -  Since September 2022, the US Food and Drug Administration (FDA) has seen new treatments for pancreatic cancer that are worthy of further investigation or approval. Known as one of the deadliest cancers on earth, analysis published in The Lancet in April 2023 showed a rising incidence of pancreatic cancer among individuals younger than 55 years, further demonstrating a need for more treatments. Among the treatments in development that caught the eye of the FDA over the past year are those that have come from  Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Pyxis Oncology, Inc. (NASDAQ: PYXS), AstraZeneca PLC (NASDAQ: AZN), Eli Lilly and Company (NYSE: LLY), and Merus N.V. (NASDAQ: MRUS).

A lot of the main efforts in fighting this particular cancer are in line with the work of the Pancreatic Cancer Action Network (PanCAN). They've been asking supporters from every state in the US to get in touch with Congress to boost federal funds for pancreatic cancer research.

PanCAN has been making its own moves, too. They recently chose pelareorep, the leading drug candidate of Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), for their pivotal Phase 3 trial, and things are looking good for it to become a new treatment option, something that is much needed in the pancreatic cancer space. What's exciting about this choice is that it might cut the cost of Phase 3 by around half, compared to usual trials, and could make late-stage development faster. The selection of pelareorep means a new treatment option could become available to patients through a more effective and affordable pathway.

When the news got out about pelareorep being selected, the market responded immediately in favor of ONCY. The company was able to raise another US$15 million to continue the advancement of its pelareorep clinical programs in both pancreatic and metastatic breast cancers, including the significant support of an institutional investor. According to their latest Q2 2023 financial results, on a pro forma basis, including the net proceeds from the public offering, Oncolytics had $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. Matt Coffey, President and CEO of Oncolytics Biotech. "Precision Promise, created by the Pancreatic Cancer Action Network, provides us with the opportunity to reduce the time and costs needed for a potential approval, and we are honored to have been selected for participation in this novel and exclusive trial."

Near the end of 2022, the FDA rewarded pelareorep with a Fast Track Designation (FTD) for treating advanced or metastatic pancreatic cancer.

This news came right after an update on ONCY's GOBLET study. This study is a really important look into how well pelareorep works when it's used with other drugs and treatments. What they've found so far is amazing: 69% of the first group of patients tested had an objective response. Out of the 13 patients checked, one had a complete response - something that doesn't happen often when treating pancreatic cancer. When you think about the usual 25% success rate with regular treatments, this 69% response rate is way above what's typical, nearly three times more successful.

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"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."

Back in May 2023, Pyxis Oncology, Inc. (NASDAQ: PYXS) received Orphan Drug Designation from the FDA for its drug PYX-201 for the treatment of patients with pancreatic cancer. Pyxis expects to present preliminary data from the ongoing phase 1 PYX-201-101 trial of PYX-201 in solid tumors in early 2024. PYX-201 is a novel antibody-drug conjugate designed to target extradomain-B (EDB) of fibronectin, a non-internalizing antigen, that's a key part of the extracellular matrix in tumors.

"We are always looking for potential new treatments for patients who have limited or no options available," said Alexander Spira, MD, director of NEXT Oncology Virginia, co-director of VCS Research Institute, and director of the Thoracic and Phase I Program and clinical assistant professor at Johns Hopkins University. "I am particularly excited about PYX-201 because it was designed to offer several important safety and efficacy improvements compared to traditional ADCs (antibody-drug conjugates), and we look forward to evaluating it in this phase 1 study."

Earlier in September 2022, AstraZeneca PLC (NASDAQ: AZN) received FDA approval in the US for its Imfinzi plus chemotherapy as the first immunotherapy regimen for patients with advanced biliary tract cancer. AstraZeneca's success was part of a greater broad development programme for the treatment of multiple cancers, including GI cancers across several medicines and a variety of tumour types and stages of disease. Within this programme, AZN is committed to improving outcomes in gastric, liver, BTC, oesophageal, pancreatic, and colorectal cancers.

"This approval for Imfinzi and chemotherapy advances our ambition to challenge treatment expectations and transform care for patients with gastrointestinal cancers with high unmet need," said Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca.

During the same month, Eli Lilly and Company (NYSE: LLY) received approval from the FDA for Retevmo® (selpercatinib) for adult patients with locally advanced or metastatic solid tumors with a rearranged during transfection (RET) gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.

"In the LIBRETTO-001 trial, selpercatinib demonstrated clinically meaningful and durable responses across a variety of tumor types in patients with RET-driven cancers, including pancreatic, colon and other cancers in need of new treatment options," said Vivek Subbiah, M.D., associate professor of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center and co-investigator for LIBRETTO-001. "These data and FDA approval of the tumor-agnostic indication underscore the importance of routine, comprehensive genomic testing for patients across a wide variety of tumor types."

In late June 2023, Merus N.V. (NASDAQ: MRUS) received Breakthrough Therapy Designation from the FDA for its common light chain bispecific Biclonics antibody zenocutuzumab as a potential therapeutic option in patients with advanced unresectable or metastatic NRG1 fusion-positive pancreatic cancer after disease progression on previous systemic therapy or who have no satisfactory alternative options available.

The FDA decision came approximately a year after data presented at the 2022 ASCO Annual Meeting showed that at a median follow-up of 6.3 months, zenocutuzumab induced an objective response rate (ORR) of 34% (95% CI, 24%-46%) by investigator assessment and RECIST v1.1 criteria in patients with previously treated advanced NRG1-positive cancers. 

"We believe the compelling clinical data for zenocutuzumab 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 Bill Lundberg, MD, President and CEO of Merus NV.

According to a sister firm of Precedence Research, the global pancreatic cancer market will rise rapidly at a CAGR of 13.7% from 2023 to 2032. By the end of the period cited, the analysts project the market to surpass approximately US$7.4 billion by 2032.

Article Source: https://usanewsgroup.com/2023/10/02/the-most-undervalued-oncolytics-company-on-the-nasdaq/ 

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