USA News Group Commentary
Issued on behalf of Oncolytics Biotech Inc.

VANCOUVER, BC, May 23, 2024 /CNW/ -- USA News Group – Known as one of the deadliest cancers, researchers are working diligently to help increase the chance of survival for pancreatic cancer patients through earlier detection, as according to Johns Hopkins Medicine up to 80% of patients, are diagnosed at later, more difficult-to-treat stages. Now, researchers have identified specific circulating microRNAs (miRNAs) in blood samples that can identify individuals at high risk of developing pancreatic cancer within 5 years. The American Cancer Society projects that approximately 66,440 individuals in the USA, split between 34,530 men and 31,910 women, will be diagnosed with pancreatic cancer in 2024, with, sadly, about 51,750 expected to die from the disease. In the background, biotech developers are intensely focused on pioneering new medical treatments and significantly enhancing the health outcomes for patients, including recent updates from Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Candel Therapeutics, Inc. (NASDAQ: CADL), AstraZeneca PLC (NASDAQ: AZN), Merus N.V. (NASDAQ: MRUS), and Lantern Pharma Inc. (NASDAQ: LTRN).

Pelareorep, an innovative immunotherapeutic agent developed by Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), is making significant strides in the treatment of various cancers, particularly breast and pancreatic cancer. After securing Fast Track Designation from the FDA for its use in pancreatic cancer in late 2022 due to promising clinical results, the company has initiated a preliminary collaboration with the Global Coalition for Adaptive Research (GCAR). This collaboration focuses on setting the stage for evaluating pelareorep as a first-line treatment for metastatic pancreatic ductal adenocarcinoma (PDAC) under GCAR's planned master protocol, which is expected to produce data essential for the drug's registration.

"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 CEO 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."

The research into pelareorep utilizing another chemotherapy backbone, combined with modified FOLFIRINOX (mFOLFIRINOX) +/- Tecentriq® (from Roche), is advancing under Oncolytics' GOBLET study for newly diagnosed pancreatic cancer patients. Following approval from German regulatory and ethics committees, this new cohort has been cleared to begin enrolling patients. Additionally, the Pancreatic Cancer Action Network (PanCAN) supports this segment of the study with a US$5 million Therapeutic Accelerator Award, aimed at speeding up the development of new treatments for pancreatic cancer.

Should the pelareorep/mFOLFIRINOX combination yield favorable results, it could significantly enhance Oncolytics' pancreatic cancer treatment strategies. Oncolytics has already reported promising results from combining pelareorep with Tecentriq, gemcitabine, and nab-paclitaxel. There is optimism within the Oncolytics team that improved response rates from the mFOLFIRINOX combination, compared to historical controls, might pave the way for a registration-enabling study. This development could potentially offer two viable pelareorep-based treatment options for patients with pancreatic cancer. Furthermore, upcoming translational research will focus on exploring pelareorep's mechanism of action, especially its impact on the tumor microenvironment (TME).

Oncolytics will investigate the correlation between tumor responses and the increase of tumor-infiltrating lymphocytes (TILs) in the blood during their evaluation, a phenomenon previously observed in pancreatic cancer studies. The company plans to begin enrolling patients for the mFOLFIRINOX/pelareorep study cohort in the second quarter of 2024.

After announcing positive interim data with notable improvements in estimated median overall survival after experimental treatment, Candel Therapeutics, Inc. (NASDAQ: CADL) received FDA orphan drug designation in pancreatic cancer for its CAN-2409 in combination with valacyclovir and standard-of-care (SOC) chemoradiation followed by resection.

"Obtaining orphan drug designation marks a significant milestone for Candel, as we continue to develop CAN-2409 for pancreatic cancer," said Garrett Nichols, MD, MS, Chief Medical Officer at Candel. "We are excited by this FDA designation, which further supports Candel's efforts in the development of medicines to cure less prevalent yet challenging to treat cancers. The evidence base for CAN-2409 is growing, as we read out clinical trials in patients with difficult-to-treat cancers, such as our recent results in PDAC, and non-small cell lung cancer later in the current quarter."

Candel's CAN-2409 is the company's most advanced cancer treatment candidate. It uses a specially engineered virus to deliver a specific gene directly into a patient's tumor. This gene triggers a powerful immune response against the cancer. The treatment involves taking a drug called valacyclovir, which the introduced gene converts into a substance that kills cancer cells. This process not only targets the tumor but also helps the immune system recognize and attack the cancer across the body.

The FDA was also recently active in giving accelerated approval for the expanded use of Daiichi Sankyo and AstraZeneca PLC's (NASDAQ: AZN) drug Enhertu for treatment across multiple HER2-expressing solid tumors. HER2 is a protein that stimulates the quick growth of cancer cells, and according to AstraZeneca is present in solid form in multiple cancers, including pancreatic cancer.

"As the first antibody drug conjugate to be granted a tumor agnostic indication, ENHERTU is truly delivering on its potential across metastatic HER2 targetable tumors," said Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca. "This approval also elevates the importance of testing for biomarkers, including HER2, across a broad range of tumors to ensure these patients with advanced cancer who have few options know whether a targeted medicine might be right for them."

On a path to being potentially the first targeted therapy for NRG1+ cancer, Merus N.V. (NASDAQ: MRUS) recently announced the FDA accepted a Biologics License Application (BLA) for priority review for the company's bispecific antibody zenocutuzumab (Zeno) in patients with neuregulin 1 fusion (NRG1+) pancreatic (PDAC) cancer), as well as NRG1+ non-small cell lung cancer (NSCLC).

"FDA acceptance of our first BLA represents an important achievement for Merus and an important potential treatment opportunity for patients with NRG1+ cancer, a disease with poor prognosis and high unmet need," said Dr. Andrew Joe, Chief Medical Officer at Merus. "Zenocutuzumab has the potential to be the first and only targeted therapy for patients with NRG1+ lung and pancreatic cancer, and may offer a substantial improvement over currently available therapies."

The FDA has already awarded Breakthrough Therapy Designation (BTD) to Zeno for two indications: first, for treating patients with advanced unresectable or metastatic NRG1+ pancreatic cancer who have progressed following prior systemic therapy or who lack satisfactory alternative treatment options, and second, for the treatment of patients with advanced unresectable or metastatic NRG1+ non-small cell lung cancer (NSCLC), following progression with prior systemic therapy.

In an effort to optimize development of the first-in-class drug candidate XCE853, Lantern Pharma Inc. (NASDAQ: LTRN) has launched a strategic AI collaboration with Oregon Therapeutics. Through the collaboration, Lantern will leverage its proprietary RADR AI platform to uncover biomarkers and efficacy-associated signatures of XCE853 across solid tumors that can aid in precision development. Oregon Therapeutics is developing XCE853 in various cancer indications, including drug-resistant pancreatic and ovarian cancer, certain hematological cancers, and several pediatric cancers, including CNS cancers.

"To date, our first-in-class metabolic inhibitor, XCE853, has exhibited robust preclinical efficacy in both in vitro and in vivo models across multiple cancer types," said Marc-Henry PITTY, MD, CEO of Oregon Therapeutics. "Lantern's RADR® AI platform will leverage the in vitro and in vivo data to potentially advance XCE853 development in a highly targeted manner and will help inform disease indications and biomarker signatures that can aid in the design of future clinical trials and in the pursuit of combination therapies with other approved cancer drugs."

Oregon Therapeutics has previously performed preclinical studies indicating that in addition to ovarian and pancreatic cancer, XCE853 may also be particularly active in renal, prostate, lung, breast, and head and neck cancers, and leukemia based on preclinical cell-line studies.

Article Source: https://usanewsgroup.com/2023/10/02/the-most-undervalued-oncolytics-company-on-the-nasdaq/ 

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