Issued on behalf of Oncolytics Biotech Inc.
VANCOUVER – USA News Group – Pancreatic cancer is among the deadliest cancers, prompting researchers to focus on early detection to improve survival rates. Johns Hopkins Medicine reports that up to 80% of patients are diagnosed at advanced stages, making treatment much more challenging. A recent study in the journal Cell Genomics reveals that key protein biomarkers for early detection have been identified. According to analysts at Research Nester, the pancreatic cancer market is slated to expand by ~18% CAGR between 2024-2035, reaching US$36 billion by 2036. Biotech developers are actively working on innovative treatments to significantly enhance patient health outcomes, with recent developments coming from Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Halozyme Therapeutics, Inc. (NASDAQ: HALO), Candel Therapeutics, Inc. (NASDAQ: CADL), Merus N.V. (NASDAQ: MRUS), and Roche Holding AG (OTCQX: RHHBY).
Recently, at this year’s American Society of Clinical Oncology (ASCO) Annual Meeting, Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) presented two abstracts related to their novel immunotherapy, pelareorep.
Among these was a trial-in-progress abstract for cohort 5 of the GOBLET study, which will explore the effectiveness of combining pelareorep with 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 supported by a US$5 million Therapeutic Accelerator Award grant from the Pancreatic Cancer Action Network (PanCAN). Oncolytics Biotech expects enrollment for this cohort to start this quarter.
“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 describe a study evaluating new treatments for patients with newly diagnosed metastatic PDAC using a Simon two-stage design. In the first stage, 15 patients per treatment arm are randomly assigned to receive either pelareorep with mFOLFIRINOX, or pelareorep with mFOLFIRINOX and atezolizumab. The main goals are to measure the response rate and safety of the treatments. Additional goals include assessing progression-free survival, overall survival, and biomarkers. If the first stage meets its success criteria, one or both groups may advance to Stage 2, with 17 more patients per treatment arm. Blood and tumor samples will be collected for further analysis throughout the study.
Earlier in May, Oncolytics (supported by Roche) secured regulatory clearance to begin enrolling patients in this new cohort, which is expected to occur this month.
Roche is also continuing to develop its personalized neoantigen vaccine, autogene cevumeran, with partners BioNTech. In the first-in-human trial, investigators administered the personalized messenger RNA-based vaccine plus Roche's Tecentriq (atezolizumab) and chemotherapy in 16 pancreatic cancer patients after surgical resection.
Working to improve the way cancer drugs are delivered, Halozyme Therapeutics, Inc. (NASDAQ: HALO) recently announced that the FDA updated its Prescription Drug User Fee Act goal date for the subcutaneous formulation of Bristol Myers Squibb’s Opdivo (nivolumab) co-formulated with Halozyme’s proprietary asset ENHANZE®. The newly updated goal date is December 29, 2024, moved up from the previous date of February 28, 2025.
Should the FDA approve this new ENHANZE-formulated version of Opdivo, it would make the drug the first and only subcutaneously administered PD-1 inhibitor. Opdivo, an immunotherapy treatment that utilizes the body's own immune system to combat cancer, generated over $9 billion in revenue last year and is currently administered intravenously.
This pending decision is for treatment across all previously approved adult, solid tumor Opdivo indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib.
Earlier this year, a pilot study suggested that for people with borderline resectable pancreatic cancer, administrating nivolumab (aka Opdivo) in combination with chemotherapy before surgery is safe and may improve long-term outcomes.
Further targeting borderline resectable pancreatic cancer, Candel Therapeutics, Inc. (NASDAQ: CADL) recently reported “very encouraging results” in updated survival data from its phase 2 clinical trial of CAN-2409. Within the results, patients reached an estimated median overall survival of 28.8 months after experimental treatment with CAN-2409 versus only 12.5 months in the control group in borderline resectable PDAC. At 24 months, the survival rate was 71.4% in CAN-2409 treated patients compared to only 16.7% in the control group after 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."
Back in May, the FDA granted priority review to Merus N.V.’s (NASDAQ: MRUS) zenocutuzumab (MCLA-128) (‘Zeno’) for use in the treatment of patients with neuregulin 1 fusion (NRG1)-positive non-small cell lung cancer (NSCLC) and pancreatic cancer. The FDA already granted Breakthrough Therapy Designation (BTD) to Zeno for the treatment of patients with advanced unresectable or metastatic NRG1+ pancreatic cancer following progression with prior systemic therapy or who have no satisfactory alternative treatment options, back in June of 2023.
“FDA acceptance of our first [biologics license application (BLA)] represents an important achievement for Merus and an important potential treatment opportunity for patients with NRG1-positive cancer, a disease with poor prognosis and high unmet need,” said Andrew Joe, MD, chief medical officer at Merus NV. “Zenocutuzumab has the potential to be the first and only targeted therapy for patients with NRG1-positive lung and pancreatic cancer, and may offer a substantial improvement over currently available therapies.”
Article Source: https://usanewsgroup.com/2023/10/02/the-most-undervalued-oncolytics-company-on-the-nasdaq/
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