FN Media Group Presents USA News Group News Commentary
Vancouver, BC – October 23, 2023 – USA News Group – Despite being a relatively rare form of cancer, pancreatic cancer remains one of the deadliest in the oncology field, the third leading cause of cancer death in the USA. Still not fully understood, pancreatic cancer’s 5-year survival rate is currently only 12%. New analysis of data from the National Program of Cancer Registries database, covering around 65% of the US population, suggests that the incidence of pancreatic cancer among individuals younger than 55 years is increasing more rapidly than in those 55 years or older, and also more quickly in women than in men. As more and more cases of young people are showing up, calls from the leading pancreatic cancer organization PanCAN to increase funding for research are getting louder. Thankfully, within the biotech sector, there have been plenty of developments giving hope in the fight against pancreatic cancer, including those from Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), Eli Lilly and Company, Roche Holding AG (OTCQX:RHHBY), BioNTech SE (NASDAQ:BNTX), and even 23andMe Holding Co (NASDAQ:ME).
One of the more promising developments in treatment is pelareorep, the flagship drug candidate of Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), which was given a Fast Track Designation (FTD) for treating advanced or metastatic pancreatic cancer by the FDA in late 2022. The FDA’s decision came almost immediately 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).
“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.
In the months that followed, pelareorep’s progress caught the attention of PanCAN, which selected the ONCY drug to be included in its Precision Promise study as part of a pivotal Phase 3 trial. Further aiding the cause, PanCAN recognized the drug developer’s efforts by rewarding them with its second annual PanCAN Therapeutic Accelerator Award, which comes with a US$5 million grant to further develop leading-edge treatments.
“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.”
Now, with the $5M grant in hand, Oncolytics Biotech can continue the next stage of its research focused on pelareorep, including pursuing a new combination with modified FOLFIRINOX chemotherapy with or without an immune checkpoint inhibitor. Previous to the award, ONCY successfully raised another US$15 million to continue advancing its clinical programs in both pancreatic and metastatic breast cancers, with significant support from an institutional investor.
“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. Coffey. “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.”
According to their Q2 2023 financial results, Oncolytics is equipped with an excellent cash runway position. 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.
Last fall, Eli Lilly and Company received FDA approval for its Retevmo® (selpercatinib), the first and only RET inhibitor for adults with advanced or metastatic solid tumors with a RET gene fusion, regardless of type.
“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.”
As well, Lilly is seeking first-line KRAS treatment with its AACR data release from earlier this year. The KRAS G12 mutation is a specific alteration in the DNA of the KRAS gene. It happens at the 12th spot and switches out one building block, known as glycine, for another one, often either aspartic acid or valine. This change is frequently seen in different kinds of cancer like lung, colorectal, and pancreatic.
Perhaps the next form of treatment that’s getting increased attention is cancer vaccines, especially the collaboration between Roche Holding AG (OTC:RHHBY) and BioNTech SE (NASDAQ:BNTX). Their efforts are built upon a concoction of several powerful drugs that target the immune system towards cancers with mRNA vaccine technology.
Initially, there was little hope it would work in “cold” cancers with few mutations, such as pancreatic cancer, but that didn’t deter the Roche/BioNTech efforts. In a limited continuing study that combines a custom BioNTech vaccine and modified FOLFIRINOX with Roche’s Tecentriq, 8 out of 16 pancreatic cancer patients developed an immune reaction. Moreover, no relapses were observed in any of the patients after a year and a half, based on information released in Nature in May 2023.
Citing the severity of the disease, the News & Views editorial segment of Nature commented: “These data are exceedingly promising, and will provide the framework for a planned further clinical trial.”
Also in the realm of DNA are new efforts coming from genetics testing company 23andMe Holding Com (NASDAQ:ME). Recently 23andMe received FDA clearance to report an additional 41 genetic variants in the BRCA1 and BRCA2 genes that increase risk for breast, ovarian, prostate and pancreatic cancer, aiding their clients by potentially delivering an early warning that could lead to earlier diagnoses.
“We continue to be the first and only company with FDA clearance to provide genetic information on cancer risk directly to consumers, without a prescription,” said Anne Wojcicki, CEO and Co-Founder of 23andMe. “We are proud to continue pioneering a path for greater access to health information by becoming the first company to receive PCCP clearance from the FDA under this novel approach, which will enable us to increase the pace at which we improve and expand our BRCA report.”
The BRCA1 and BRCA2 variants may also be associated with an increased risk for prostate cancer, pancreatic cancer, and potentially other cancers. It’s believed that with early detection, the survival rate of pancreatic cancer can increase 6-fold.
As new developments for treatment and diagnosis become available, hopefully pancreatic patients and their families can be more optimistic for the future. For the first time since 2017, the survival rate has gone up two years in a row.
“We are heartened by another increase in five-year survival,” said PanCAN President and CEO Julie Fleshman, JD, MBA. “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.”
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