USA News Group Commentary

Issued on behalf of Oncolytics Biotech Inc.

VANCOUVER, BC , Sept. 24, 2024 /PRNewswire/ -- USA News Group – Optimism is on the rise in fight against cancer, as researchers are making progress across the field of oncology. Helping to spur on the momentum, philanthropists recently gave a historic $150 million for pancreatic cancer research to City of Hope, while Stanfordexperts are calling for more massive federal funding increases to cancer research. According to the latest Cancer Progress Report from the American Association for Cancer Research, the USA has seen a 33% reduction in the overall cancer death rate from 1991 to 2021. Working behind the scenes are several biotech and biopharma companies who've recently made significant developments in the field of oncology, including Oncolytics Biotech Inc.(NASDAQ: ONCY) (TSX: ONC), Nurix Therapeutics, Inc.(NASDAQ: NRIX), Incyte Corporation(NASDAQ: INCY), Regeneron Pharmaceuticals, Inc.(NASDAQ: REGN), and Foghorn Therapeutics Inc.(NASDAQ: FHTX).

Building on the impressive momentum from its BRACELET-1 breast cancer study, Oncolytics Biotech Inc.(NASDAQ: ONCY) (TSX: ONC) continues to advance its flagship therapy, pelareorep, toward a pivotal, registration-enabling study. The recent BRACELET-1 Phase 2 trial results have generated a surge of optimism, with over half of the patients in the pelareorep arm still alive at the study's end—a remarkable achievement that underscores the potential of this innovative cancer therapy.

The median overall survival (OS) for patients treated with pelareorep combined with paclitaxel has not yet been reached, with estimates suggesting a 32-month survival benefit compared to just 18 months for the control arm. This outcome, along with a 64% two-year survival rate for the pelareorep group, highlights the therapy's potential to significantly improve patient outcomes in HR+/HER2- advanced or metastatic breast cancer.

"The fact that the median overall survival was not reached because more than half the patients were still alive at the end of the study is a remarkable achievement for us," said Wayne Pisano, Interim CEO and Chair of Oncolytics' Board of Directors. "It shows just how promising pelareorep treatment can be for extending the lives of breast cancer patients. This is further exemplified by the near doubling of the 2-year survival rate for patients who received pelareorep combination therapy."

These promising results mirror the earlier success of the IND-213 study, which secured FDAFast Track Designation for pelareorep in 2017. Combined, these two trials reinforce the growing belief in pelareorep's ability to make a substantial impact in oncology.

Within the latest update on pelareorep's latest breast cancer study were plenty of reasons to build optimism, corroborating results of its previous randomized IND-213 breast cancer study that led to an FDA Fast Track Designation in 2017.

"Taken together, the BRACELET-1 results provide compelling support for the potential of pelareorep-based combination therapy to benefit patients with advanced or metastatic HR+/HER2- breast cancer," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. "Having recently discussed with the FDA key design elements for our next breast cancer study, in combination with the strong survival data from the BRACELET-1 and IND-213 studies, we are confident in our plan to conduct a registration-enabling study to assess pelareorep-based combination therapy in patients with advanced HR+/HER2- breast cancer."

As Oncolytics pushes forward, the stage is now set for the next chapter in pelareorep's journey—a registration-enabling study that could bring this promising therapy closer to becoming a vital tool in the fight against breast cancer.

Clinical stage biopharma company Nurix Therapeutics, Inc.(NASDAQ: NRIX) is developing targeted protein modulation drugs designed to treat patients with cancer and inflammatory diseases. Recently, Nurix presented at the ADC & Radiopharmaceuticals Pharma & Biotech Partnering Summit in Boston, with a presentation titled Targeted Protein Degraders as Next Generation Antibody Payloads. Back in Q2 2024, Nurix also presented positive clinical data at the European Hematology AssociationCongress (EHA2024) supporting a potential best-in-class profile for NX-5948, its orally bioavailable degrader of Bruton's tyrosine kinase (BTK), for the treatment of  chronic lymphocytic leukemia (CLL).

NX-5948 demonstrated an objective response rate (ORR) of 69.2% in heavily pretreated chronic lymphocytic leukemia (CLL) patients, including in patients with Bruton's tyrosine kinase (BTK) inhibitor resistance mutations and patients with central nervous system (CNS) i

"The data presented at EHA2024, reaffirm the best-in-class potential of our protein degradation platform to address the limitations of current inhibitors against challenging targets such as Bruton's tyrosine kinase," said Arthur T. Sands, M.D., Ph.D., President and CEO of Nurix. "We enter the second half of 2024 well positioned to develop our lead clinical program, NX-5948, into pivotal clinical trials in CLL in 2025 and to continue to advance our wholly owned pipeline of clinical assets, preclinical programs and strategic collaboration programs with Gilead, Sanofi and Pfizer."

Recently at the ESMO 2024 Congress, Incyte Corporation(NASDAQ: INCY) gave a mini-oral presentation sharing promising results for its CDK2 inhibitor INCB123667 showing promising evidence of clinical activity in patients with advanced solid tumors, notably ovarian cancer. Of the 37 evaluable participants with platinum-resistant ovarian cancer, nine participants (24.3%) experienced an overall response (OR; 2 complete responses [CR] and 7 partial responses [PRs]). The highest OR rate of 31.3% (5 responders, including 2 CRs) was found in the 50mg BID cohort (16 evaluable participants). Additionally, a disease control rate (DCR) of 75.7% (28/37) was achieved in patients with ovarian cancer.

"The early-stage clinical activity of INCB123667 represents an exciting and promising breakthrough for patients with ovarian cancer," said Pablo Cagnoni M.D., President, Head of Research and Development, Incyte. "We believe this novel CDK2 inhibitor has the potential to be a foundational treatment for platinum-resistant ovarian cancer, offering a new and differentiated treatment for patients who currently have limited treatment options. We look forward to advancing the development of INCB123667 for the treatment of patients with ovarian cancer both as a single agent and in combination."

At both the ESMO 2024 Congress and IASLC 2024 World Conference on Lung Cancer (WCLC), Regeneron Pharmaceuticals, Inc.(NASDAQ: REGN) presented progress across its differentiated oncology portfolio and pipeline. Regeneronfirst shared five-year survival data on Libtayo (PD-1 inhibitor) first-line monotherapy in advanced non-small cell lung cancer (NSCLC) at IASLC 2024, then shared longer-term results with investigational fianlimab (LAG-3 inhibitor) plus Libtayo from initial trial in advanced melanoma showing high clinical activity, including deepening responses, per a blinded independent central review.

"The breadth of our presentations at ESMO and WCLC underscore our progress in advancing treatment approaches for cancer that have the potential to be among the best in their class," said Israel Lowy, MD, PhD, Clinical Development Unit Head, Oncology, at Regeneron. "At WCLC, five-year outcomes for Libtayo monotherapy in advanced NSCLC reinforce its position as the anti-PD-1 backbone of our oncology portfolio. At ESMO, the latest two-year data for our LAG-3 inhibitor fianlimab combined with Libtayo show persistent and high clinical activity in advanced melanoma patients. As our portfolio and pipeline mature, the insights from these data are helping us advance our differentiated and novel combination approaches – all with the goal of transforming care for those living with cancer."

Within its Q2 2024 financial and corporate update, Foghorn Therapeutics Inc.(NASDAQ: FHTX) stated it expects topline Phase 1 dose escalation data for its FHD-286 in combination with decitabine in relapsed and/or refractory AML patients to come in Q4 2024, and dosing of its first patient in a Phase 1 trial for FHD-909, a potential first-in-class SMARCA2 selective inhibitor for a primary target population in SMARCA4 mutated NSCLC to come in H2 2024.

"We anticipate topline data from our Phase 1 combination trial with FHD-286 in patients with relapsed and/or refractory AML in the fourth quarter of 2024," said Adrian Gottschalk, President and CEO of Foghorn. "We believe FHD-286 has the potential to be a first-in-class, mutation-agnostic differentiation therapeutic. Additionally, the IND for FHD-909 cleared in May and we anticipate FHD-909 to be the first SMARCA2 selective inhibitor to enter the clinic. Dosing of the first patient in our Phase 1 trial, with primary target population in SMARCA4 mutated NSCLC, is planned for the second half of the year. We are also on track to initiate IND-enabling studies in the fourth quarter of 2024 for our Selective CBP degrader program targeting tumors harboring EP300 mutations including bladder, gastric and endometrial cancers."

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

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