The Fight Against Pancreatic Cancer: Biotech Firms Develop New Solutions for Rising Gen X Cases

USA News Group – After looking at public health records for 3.8 million patients with invasive spreading cancer, researchers recently discovered that Generation X may be experiencing larger per-capita increases in the incidence of leading cancers, including the very deadly pancreatic cancer, compared to previous generations. The startling revelations come from a study conducted by experts at the National Cancer Institute’s Division of Epidemiology and Genetics and was published in JAMA Network Open. Compared with baby boomers, Gen X women had projected increases in pancreatic, thyroid, kidney, rectal, uterine, colon, and ovarian cancers, as well as non-Hodgkin’s lymphoma and leukemia. Among those, pancreatic cancer is generally considered the deadliest, with its very low five-year survival rate, typically late diagnosis, and aggressive nature. In order to significantly enhance patient health outcomes, several biotech developers are actively working on innovative solutions, including recent developments coming from Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Verastem, Inc. (NASDAQ: VSTM), Candel Therapeutics, Inc. (NASDAQ: CADL), FibroGen, Inc. (NASDAQ: FGEN), and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN).

Presented recently at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) presented two abstracts related to their novel immunotherapy, pelareorep, an intravenously delivered immunotherapeutic agent.

One of the abstracts presented was a trial-in-progress for cohort 5 of the GOBLET study. This cohort will examine the effectiveness of combining pelareorep and modified FOLFIRINOX (mFOLFIRINOX) with and without atezolizumab —made by Roche Holding AG (OTCQX: RHHBY)— in newly diagnosed patients with metastatic pancreatic ductal adenocarcinoma (PDAC). The cohort is funded by a US$5 million Therapeutic Accelerator Award grant from the Pancreatic Cancer Action Network (PanCAN). Oncolytics Biotech expects to begin enrollment for this cohort this quarter, having received regulatory clearance to begin the enrollment process in May.

“The first abstract outlines the design of a new GOBLET PDAC cohort that could significantly expand the potential of the company’s pancreatic cancer program,” said Dr. Matt Coffey, President and CEO of Oncolytics. “The chemotherapy regimens of mFOLFIRINOX and gemcitabine/nab-paclitaxel are the two most common standards of care in metastatic pancreatic cancer. We previously reported that the combination of pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab yielded tumor response rates nearly triple historical results. Should the combination of pelareorep and mFOLFIRINOX produce a similarly positive outcome, an even broader range of metastatic PDAC patients may benefit from pelareorep-based therapy.”

The GOBLET cohort 5 abstract and poster outline a study evaluating new treatments for patients with newly diagnosed metastatic PDAC using a Simon two-stage design. This design helps determine if a treatment is promising enough to continue testing. In the first stage, 15 patients in each treatment arm will be randomly assigned to receive either pelareorep with mFOLFIRINOX or pelareorep with mFOLFIRINOX and atezolizumab. The main goals are to measure how well the treatments work and their safety. Additionally, the study will look at progression-free survival (how long patients live without the cancer getting worse), overall survival (how long patients live overall), and biomarkers (indicators of how the body responds to the treatment). If the first stage is successful, one or both groups may proceed to Stage 2, which will include 17 more patients per treatment arm. Blood and tumor samples will be collected for further analysis throughout the study.

Also presented at ASCO’s meeting were positive initial interim safety and efficacy results from Verastem, Inc. (NASDAQ: VSTM) in an ongoing Phase 1/2 trial evaluating its avutometinib plus defactinib in combination with gemcitabine and Nab-paclitaxel for first-line treatment in patients with metastatic pancreatic cancer. Like Oncolytics' pelareorep, Verastem's avutometinib received funding from PanCAN through its Therapeutic Accelerator Award.

"Verastem was the inaugural recipient of the PanCAN Therapeutic Accelerator Award, which has been an important part of PanCAN’s approach to advancing innovative treatments for pancreatic cancer," said Anna Berkenblit, M.D., MMSc, Chief Scientific and Medical Officer at PanCAN. "There is a critical need for new treatment options in this disease, and we hope that the results from this study lead to improved outcomes for patients with pancreatic cancer."

As of May 14, 2024, Verastem reported that patients receiving the combination therapy achieved a confirmed overall response rate (ORR) of 83%, with 5 out of 6 patients responding positively. The release of these results led to a positive market reaction, boosting Verastem's shares in pre-market trading in the process. Notably, there was one case of dose-limiting toxicity (febrile neutropenia) in the dose level 1 cohort. However, this dose level was cleared after enrolling additional patients in three other cohorts of the study.

"The initial interim results from the RAMP 205 trial evaluating avutometinib and defactinib in combination with standard of care first-line chemotherapy are encouraging and demonstrate the importance of targeting the RAS/MAPK pathway, as more than 90% of pancreatic tumors have a KRAS mutation," said John Hayslip, M.D., Chief Medical Officer of Verastem Oncology. “We continue to progress the study evaluating other dose and schedule regimens to determine the recommended Phase 2 dose in the trial."

In another recent update, Candel Therapeutics, Inc. (NASDAQ: CADL) reported “very encouraging results” from its phase 2 clinical trial of CAN-2409, which targets borderline resectable pancreatic cancer. The data showed that patients treated with CAN-2409 had an estimated median overall survival of 28.8 months, compared to just 12.5 months for the control group. Furthermore, at 24 months, the survival rate was 71.4% for those treated with CAN-2409, whereas the control group had a survival rate of only 16.7% following chemoradiation.

"Given the frequent recurrence and short survival with SoC chemotherapy for non-metastatic PDAC, effective new treatment options are urgently needed," said Garrett Nichols, MD, MS, Chief Medical Officer of Candel. "We are very encouraged by the improved survival associated with CAN-2409, which has been shown to be durable after prolonged follow-up based on the updated data in this randomized clinical trial. CAN-2409 was generally well tolerated without significant additional local or systemic toxicity when added to SoC chemoradiation."

Because pancreatic cancer is considered a solid tumor, news of a joint effort between FibroGen, Inc. (NASDAQ: FGEN) and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announcing a supply agreement to evaluate FG-3165 as a monotherapy and in combination with LIBTAYO in patients with select solid tumors is relevant. Under the clinical study collaboration and supply agreement, Regeneron will provide drug supply to FibroGen, who will be the sponsor of each Phase 1 monotherapy and combination trial. Each company retains all rights to their respective compounds, including as a monotherapy or as combination therapies.

“We are very excited to collaborate with Regeneron Pharmaceuticals to evaluate two separate novel combination approaches to treat patients with select solid tumors,” said Deyaa Adib, M.D., Chief Medical Officer of FibroGen. “We believe that the mechanisms of action for both FG-3165 (anti-Gal9) and FG-3175 (anti-CCR8) have the potential to be synergistic with cemiplimab, providing the possibility for an improvement in clinical outcomes for patients. We look forward to building a collaborative relationship with Regeneron, who is a leader in oncology therapeutic products development and commercialization.”

In their Q1 2024 financial results, FibroGen announced several upcoming milestones. The company expects to release topline data from the PanCAN Precision Promise Phase 2/3 study of pamrevlumab in metastatic pancreatic cancer by mid-2024. Additionally, they anticipate delivering topline data from the LAPIS Phase 3 study of pamrevlumab in locally advanced unresectable pancreatic cancer (LAPC) in Q3 2024.

“Looking ahead, we expect to report topline data from our two late-stage clinical trials of pamrevlumab in pancreatic cancer in the coming months,” said Thane Wettig, CEO of FibroGen.

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