According to the American Cancer Society in its Cancer Facts & Figures 2023 report, the five-year survival rate for pancreatic cancer increased by 1% from the previous year to 12%. The increase has generated more optimism from the Pancreatic Cancer Action Network (PanCAN), whose President and CEO Julie Fleshman, JD, MBA, stated, “It’s an important milestone that shows we’re headed in the right direction – and this means so much to all those affected by pancreatic cancer.” Several biotech developers have been making strides against the deadly disease, including a new mRNA vaccine in the works from BioNTech SE (NASDAQ:BNTX), as well as promising drug-combo therapies from Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), Seagen Inc. (NASDAQ:SGEN), and better diagnostics from Myriad Genetics, Inc. (NASDAQ:MYGN) and Illumina, Inc. (NASDAQ:ILMN).
Coming off of a late-2022 Fast Track Designation (FTD) from the FDA for the treatment of advanced/metastatic pancreatic cancer with its flagship asset, pelareorep, biotechnology company Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC) has now been selected to be part of the Precision PromiseSM Phase 3 platform trial by PanCAN.
“With a five-year survival rate of 12%, pancreatic cancer patients cannot afford to wait for new treatment options,” said Fleshman. “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.”
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).
“We are delighted at being selected by the Precision Promise panel of experts,” said Dr. Matt Coffey, President and CEO 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.”
Pelareorep is a first-in-class intravenously delivered immunotherapeutic agent for the treatment of solid tumors and hematological malignancies, which demonstrated an objective response rate (ORR) of 69% in advanced/metastatic pancreatic cancer patients, including a complete response last year through its reported interim clinical data before receiving its FTD from the FDA.
“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,” said Dr. Thomas Heineman, Chief Medical Officer of Oncolytics Biotech. “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.”
For reference, pelareorep’s ORR of 69% was recognized as delivering nearly triple the average ORR of ~25% reported in historical control trials evaluating gemcitabine in combination with nab-paclitaxel in pancreatic cancer. However, it was the complete response that was pleasantly unexpected.
Ahead of its potential $43-billion acquisition by Pfizer, SEA-CD40 developer Seagen Inc. (NASDAQ:SGEN) saw its own combo of the drug with gemcitabine, nab-paclitaxel and pembrolizumab demonstrate efficacy in patients with metastatic pancreatic ductal adenocarcinoma (PDAC).
The SEA-CD40 combo showed a total confirmed ORR of 44%, with comparable response rates observed at both evaluated dose levels of SEA-CD40.
“Patients with pancreas cancer need more and better treatments,” lead study author Andrew L. Coveler, MD, of Fred Hutchinson Cancer Center and the University of Washington School of Medicine, both in Seattle, said to OncLive®. “The combination of SEA-CD40, pembrolizumab, gemcitabine, and nab-paclitaxel compared favorably with historical controls, demonstrating that immunotherapy may one day be a treatment for patients with pancreas cancer.”
Earlier this year, Myriad Genetics, Inc. (NASDAQ:MYGN) and Illumina, Inc. (NASDAQ:ILMN) expanded their strategic partnership aimed at broadening access to oncology homologous recombination deficiency (HRD) testing for oncology, making it available in the USA. Through an agreement that aligns Myriad’s MyChoice CDx HRD technology with Illumina’s pan-cancer test, TSO 500 HRD research test. The resulting product is available to order now and ready to ship in the US.
“Research continues to reveal the growing relevance of HRD status across multiple cancers,” said Kevin Keegan, vice president and general manager, Oncology Business Unit, at Illumina. “Now with this test, we are empowering labs in the US to unlock the most comprehensive tumor analysis from a single sample.”
TSO 500 HRD is a single, comprehensive pan-cancer test to identify key genetic variants and homologous recombination deficiency critical for understanding cancer development and progression. HRD status is an important biomarker in tumors that harbor high levels of DNA damage, such as those present in ovarian, breast, prostate, and pancreatic cancers. Illumina and Myriad are offering distributable kits and centralized laboratory service, respectively.
Built to be patient-specific, a new tailored neoantigen pancreatic cancer vaccine from BioNTech SE (NASDAQ:BNTX) through a study conducted at Memorial Sloan Kettering Cancer Center (MSKCC) demonstrated an immune response in 50% of patients and prevented relapse. The personalized mRNA vaccine is designed to help immune cells recognize specific neoantigens on patients’ pancreatic cancer cells.
“It’s exciting to see that a personalized vaccine could enlist the immune system to fight pancreatic cancer—which urgently needs better treatments,” said research team lead Dr. Vinod Balachandran from MSKCC. “It’s also motivating as we may be able to use such personalized vaccines to treat other deadly cancers.”
Customized vaccines were successfully created for 18 of the 19 study participants. The process, from surgery to delivery of the first dose of the vaccine, took an average of about nine weeks.
All patients received an immune checkpoint inhibitor called atezolizumab before vaccination. Atezolizumab prevents cancer cells from suppressing the immune system. The vaccine was then given in nine doses over several months.