Biotech Innovations Surge as Global Cancer Diagnosis Rates Continue to Climb

14 May 2024


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

USA News Group – In the fight against cancer, a political stumbling block was recently put in place by the US Congress after it voted against the renewal of funding for President Biden's "Cancer Moon Shot" designed to advance cancer research towards a cure. The need for solutions is mounting, as health authorities, on behalf of the United Nations, are predicting global cancer cases to rise around 77% by 2050, with richer countries expected to have the greatest absolute increase in cancer. As analysts from Custom Market Insights forecast the global cancer immunotherapy market to soar to US$314.4 billion by 2032, expanding at a 7.2% CAGR, the biotech sector continues to advance cancer treatment and diagnostics, with recent updates coming from Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Candel Therapeutics, Inc. (NASDAQ: CADL), AstraZeneca PLC (NASDAQ: AZN), Halozyme Therapeutics, Inc. (NASDAQ: HALO), and Janux Therapeutics, Inc. (NASDAQ: JANX).

In the case of pelareorep, an intravenously delivered immunotherapy agent developed by Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), the case is getting stronger for it to one day become a treatment for multiple cancers, including most prominently pancreatic cancer. Near the end of 2022, the FDA granted pelareorep a Fast Track Designation for the treatment of pancreatic ductal adenocarcinoma (PDAC) after it demonstrated some optimistic results. Now Oncolytics is continuing to move its flagship asset forward, having recently received regulatory clearance to evaluate pelareorep in combination with modified FOLFIRONOX +/- Tecentriq® (from Roche) in pancreatic cancer in a new cohort for its ongoing GOBLET study, following German regulatory and ethics approvals.

The new cohort is also being supported by a US$5 million Therapeutic Accelerator Award from the Pancreatic Cancer Action Network (PanCAN)—an innovative program established to accelerate the development of new treatments for pancreatic cancer.

"Oncolytics is pleased to announce receipt of regulatory clearance to initiate the mFOLFIRINOX cohort in patients with newly diagnosed metastatic PDAC," said Dr. Matt Coffey, President and CEO of Oncolytics. "We believe that working with PanCAN will help to further enrich Oncolytics' clinical relationships with the pancreatic cancer community. We are also grateful for PanCAN's Therapeutic Accelerator Award, which is enabling the evaluation of this combination therapy."

Positive results from a combination with mFOLFIRINOX could greatly enhance pelareorep's potential in addressing pancreatic cancer. So far, Oncolytics has already reported data for pelareorep in combination with gemcitabine and nab-paclitaxel. According to the Oncolytics team, if the mFOLFIRINOX combination shows a compelling efficacy signal, this therapeutic approach could also be advanced to a registration-enabling study, providing two opportunities for pelareorep-based treatment to benefit pancreatic cancer patients. In addition, translational research studies planned for this cohort will help to further elucidate pelareorep's mechanism of action, including its ability to shape the tumor microenvironment (TME).

"Oncolytics has taken a very strategic approach to the development of pelareorep in pancreatic cancer by focusing its clinical studies on combinations with the most widely used treatment regimens," said Dirk Arnold, M.D., Ph.D., Director of Asklepios Tumorzentrum Hamburg and primary investigator of the GOBLET trial. "My experience to date with the GOBLET study, including the positive metastatic PDAC and encouraging anal cancer data reported last year, makes me enthusiastic to initiate enrollment in the mFOLFIRINOX cohort."

Notably, Oncolytics plans to evaluate the correlation between tumor responses and the expansion of tumor-infiltrating lymphocytes (TILs) in the blood, an effect that was observed in earlier pancreatic cancer studies. According to the company, they will be initiating enrollment into the mFOLFIRINOX/pelareorep study cohort in Q2 2024.

In the case of Candel Therapeutics, Inc. (NASDAQ: CADL), another potential treatment for pancreatic cancer was given a nod by the FDA in the form of an Orphan Drug Designation given to Candel's most advanced multimodal biological candidate, CAN-2409. The news of the designation came weeks after Candel reported updated overall survival data from its ongoing randomized phase 2 clinical trial of CAN-2409 plus valacyclovir (prodrug), together with standard of care (SoC) chemoradiation, followed by resection for borderline resectable PDAC.

"We recently reported data from the phase 2 randomized clinical trial of CAN-2409 in borderline resectable pancreatic cancer, showing that CAN-2409, when added to standard of care, more than doubled the median overall survival obtained with standard of care alone," said Paul Peter Tak, MD, PhD, FMedSci, President and CEO of Candel. "We are pleased that the FDA has now granted Candel with both Orphan Drug and Fast Track Designation to this program, as we seek to reshape the treatment paradigm in pancreatic cancer."

Pharma giant AstraZeneca PLC (NASDAQ: AZN) recently saw its revenue spike in Q1 2024, bolstered by sales of its cancer medicines, according to Bloomberg. Over the last few weeks, AstraZeneca has been making more progress across the oncology scene, including the release of topline findings from its Phase III DESTINY-Breast06 study, showing significant progression-free survival benefits in certain patients with metastatic breast cancer with its antibody-drug conjugate Enerhertu with partners Daiichi Sankyo.

As well, AstraZeneca also reported results for its CALQUENCE combination regimen, which demonstrated a statistically significant and clinically meaningful improvement in progression-free survival improvement in 1st-line mantle cell lymphoma from its ECHO Phase III trial.

"These impactful results in mantle cell lymphoma show that bringing CALQUENCE to the first-line setting significantly delays disease progression and, for the first time, shows potential to extend survival," said Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca. "The improvement in progression-free survival together with the differentiated safety profile of CALQUENCE are both important as we strive to transform outcomes earlier in the course of disease treatment."

In combination with its Enhanze drug-delivery technology, Halozyme Therapeutics, Inc. (NASDAQ: HALO) was recently linked to the acceptance of an approval-seeking FDA application involving a subcutaneous formulation of Bristol-Myers Squibb's blockbuster cancer drug Opdivo. As per the announcement, the application covers Opdivo co-formulated with Halozyme's Enhanze drug-delivery technology across all previously approved adult, solid-tumor Opdivo indications as monotherapy maintenance following completion of Opdivo plus Yervoy combination therapy or in combination with chemotherapy or cabozantinib.

Back in January, Halozyme also saw its other co-collaborator, Roche, receive European Commission approval of Tecentriq® SC with Enhanze, representing the EU's first subcutaneous PD-(L)1 cancer immunotherapy for multiple cancer types.

"As the first subcutaneous PD-(L)1 cancer immunotherapy in Europe, Tecentriq SC can provide a new treatment option that can enhance the treatment experience for patients and caregivers while freeing up resources in constrained healthcare systems," said Dr. Helen Torley, President and CEO of Halozyme.

Back in February, Janux Therapeutics, Inc. (NASDAQ: JANX) announced encouraging safety and efficacy data in ongoing dose escalation trials for PSMAxCD3-TRACTr JANX007 in metastatic castration-resistant prostate cancer (mCRPC) and EGFRxCD3-TRACTr JANX008 in late-stage solid tumors.

"The clinical data provide compelling proof-of-concept for the TRACTr platform in a setting where many other approaches have failed due to material safety issues or lack of efficacy," said David Campbell, Ph.D., President and CEO, Janux Therapeutics. "Our TRACTr platform provides an entry point to multiple, large solid tumor indications that are intractable with conventional TCE approaches. We look forward to continuing to advance these clinical trials and expanding to additional TCE targets, as we look to fulfill our mission to meaningfully address the unmet medical needs for cancer patients, especially those with late-stage disease."

The market's immediate reaction was quite positive upon these results, but by mid-April Janux began working with an adviser after drawing interest in a potential takeover. According to BloombergJanux is likely to draw interest from bigger drugmakers who are looking to acquire new medicines to replenish their portfolios or expand into cancer treatments. Janux develops tumor-activated immunotherapies to treat cancer, and has already seen its shares quadruple this year.



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