USA News Group – A new study is bringing hope in the fight against one of the deadliest cancers, revealing a blood test that can detect early-stage pancreatic cancer with 97% accuracy. This breakthrough is crucial, as Johns Hopkins Medicine reports that up to 10% of patients diagnosed early can become disease-free after treatment. The American Cancer Society estimates that around 66,440 people (34,530 men and 31,910 women) in the USA will be diagnosed with pancreatic cancer this year, with approximately 51,750 expected to succumb to the disease. Behind the scenes, biotech drug developers are working diligently to advance new treatments and improve patient outcomes, including recent updates from Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Roche Holding AG (OTCQX: RHHBY), Merus N.V. (NASDAQ: MRUS), MacroGenics, Inc. (NASDAQ: MGNX), and Immuneering Corporation (NASDAQ: IMRX).
One innovative immunotherapeutic agent, pelareorep, developed by Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), is advancing as a potential treatment for multiple cancers, particularly breast and pancreatic cancer. After receiving Fast Track Designation from the FDA for pancreatic cancer in late 2022 due to encouraging clinical results, Oncolytics has embarked on a preliminary collaboration with the Global Coalition for Adaptive Research (GCAR). This partnership is set to begin planning the evaluation of pelareorep for first-line metastatic pancreatic ductal adenocarcinoma (PDAC) within GCAR’s anticipated master protocol, which is expected to generate registration-enabling data.
“We are thrilled to collaborate with GCAR and are honored that pelareorep has been selected as the first therapeutic for evaluation in GCAR’s planned adaptive trial in pancreatic cancer patients,” said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics. “We believe this opportunity presents a strategic and efficient pathway forward for the development of pelareorep to address an urgent need for pancreatic cancer patients. GCAR’s anticipated trial design seeks to cut registrational study time and reduce trial costs, speeding up the journey to potentially deliver effective cancer treatment sooner.”
Oncolytics is progressing with its lead asset, having recently secured regulatory clearance to evaluate pelareorep in combination with modified FOLFIRINOX (mFOLFIRINOX) +/- Tecentriq® from Roche Holding AG (OTCQX: RHHBY) in newly diagnosed pancreatic cancer patients in a new cohort of its ongoing GOBLET study. This approval follows clearance from German regulatory and ethics bodies. The new cohort is supported by a US$5 million Therapeutic Accelerator Award from the Pancreatic Cancer Action Network (PanCAN), an innovative program designed to expedite the development of new treatments for pancreatic cancer.
Positive outcomes from the pelareorep/mFOLFIRINOX combination could significantly boost Oncolytics' efforts in combating pancreatic cancer. Previously, Oncolytics has shared encouraging data results from the combination of pelareorep with Tecentriq, gemcitabine and nab-paclitaxel. The team at Oncolytics is optimistic that if the mFOLFIRINOX combination shows improved response rates compared to historical control trials, it could advance to a registration-enabling study. This would provide two potential pelareorep-based treatment options for pancreatic cancer patients. Additionally, planned translational research for this cohort will delve deeper into understanding pelareorep’s mechanism of action, particularly its effects on the tumor microenvironment (TME).
In this evaluation, Oncolytics will also explore how tumor responses correlate with the expansion of tumor-infiltrating lymphocytes (TILs) in the blood, an effect seen in prior pancreatic cancer studies. The company intends to commence patient enrollment for the mFOLFIRINOX/pelareorep study cohort in Q2 2024.
Roche recently had an investigator-led trial of Tecentriq terminated back in March, while another clinical supply agreement was reached in May to evaluate another Tecentriq combination. Roche is also moving forward with partners BioNTech for a jointly-developed pancreatic cancer vaccine that demonstrated lasting responses in an early trial. In Phase II trials, the mRNA vaccine is administered along with Roche’s Tecentriq and chemo against pancreatic cancer.
Now Roche is also working through an agreement with PathAI, a global leader in artificial intelligence AI-powered technology for pathology. Under the terms of the deal, PathAI will work exclusively with Roche Tissue Diagnostics (RTD) to develop AI-enabled digital pathology algorithms in the companion diagnostics space.
"This collaboration with Roche is a testament to our shared commitment to advancing the field of digital pathology and AI-enabled diagnostics for both drug development and clinical care," said Dr. Andy Beck, CEO and Co-Founder of PathAI. "High medical value diagnostic products with seamless integration into the laboratory workflow will accelerate the transition to digital pathology as the standard to aid clinicians in diagnosis and biomarker characterisation."
Recently the FDA granted priority review to a biologics license application (BLA) from Merus N.V. (NASDAQ: MRUS), seeking the approval of zenocutuzumab (MCLA-128) (“Zeno”) for use in the treatment of patients with pancreatic cancer (and NSCLC). The FDA has already granted Breakthrough Therapy Designation (BTD) to Zeno for the treatment of patients with advanced unresectable or metastatic NRG1 fusion-positive pancreatic cancer following progression with prior systemic therapy or who have no satisfactory alternative treatment options.
“FDA acceptance of our first 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.”
MacroGenics, Inc. (NASDAQ: MGNX) recently delivered an update on its corporate progress, which included preclinical data for its MGC028 at the recent AACR Annual Meeting, after the antibody-drug conjugate (ADC) demonstrated specific antitumor activity in in vivo models representing pancreatic cancer (among other cancers).
“In preclinical studies, MGC028 demonstrated specific antitumor activity in in-vivo models representing gastric, lung, pancreatic, colorectal, small cell carcinoma, the head and neck, and cholangiocarcinoma,” said Scott Koenig, President and CEO of MacroGenics during a recent earnings call. “In addition, in a nonhuman primate study, MGC028 was well tolerated at high dose levels with mild reversible side effects and no ocular toxicity, which is offered a concern with tubulin-inhibitor-based ADCs. These promising preclinical results support the continued investigation of MGC028 as a therapeutic option for treating ADAM9 solid tumors.”
Back in February, Immuneering Corporation (NASDAQ: IMRX) was granted Fast Track Status for its IMM-1-104 for pancreatic cancer. IMM-1-104 is designed to provide universal-RAS activity through deep cyclic inhibition of the MAPK pathway with once-daily oral dosing.
“We welcome FDA’s decision to grant Fast Track designation for IMM-1-104,” said Ben Zeskind, Ph.D., Co-founder and CEO of Immuneeringin a statement. “Our Phase 1/2a study is designed to evaluate IMM-1-104 in pancreatic cancer, as well as a number of other tumor types associated with the RAS pathway. We look forward to a data-rich 2024 as we plan to provide multiple readouts from our study this year.”
Article Source: https://usanewsgroup.com/2023/10/02/the-most-undervalued-oncolytics-company-on-the-nasdaq/
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