Issued on behalf of Oncolytics Biotech Inc.
VANCOUVER – USA News Group – The surge in global cancer cases is raising serious concerns among experts. A recent study published in Monday in Cancer, a leading journal of the American Cancer Society, predicts a staggering 84% increase in cancer cases and a 93% rise in cancer deaths among men worldwide by 2050. In response, the Biden Administration is ramping up its “Cancer Moonshot” initiative, recently awarding $150 million in research funding to advance groundbreaking techniques in precision cancer surgery. At the research level, several players are making significant progress in oncology, with recent developments coming from Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Amgen Inc. (NASDAQ: AMGN), Abbvie Inc. (NYSE: ABBV), BeiGene, Ltd. (NASDAQ: BGNE), and Exelixis, Inc. (NASDAQ: EXEL).
Bolstered by favorable results in its BRACELET-1 breast cancer study, Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) is advancing toward a potentially game-changing registration-enabling study for its flagship therapy, pelareorep. The recently completed Phase 2 BRACELET-1 trial has provided evidence of pelareorep’s potential to improve outcomes for patients with HR+/HER2- advanced or metastatic breast cancer.
In a highly promising finding, the median overall survival (OS) for patients treated with pelareorep combined with chemotherapy has not yet been reached, indicating that more than half the patients in this arm were still alive at the study’s conclusion. These results reflect a significant improvement over the control group, where median OS was just 18.2 months. Pelareorep also delivered a near doubling of two-year survival rates, with 64% of patients in the pelareorep arm surviving beyond two years compared to 33% in the chemotherapy-only group.
“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.”
Additionally, pelareorep nearly doubled progression-free survival (PFS) to 12.1 months, compared to 6.4 months in the control arm, reinforcing its potential as a transformative therapy in the treatment of advanced breast cancer.
These findings build on the success of the IND-213 trial, which secured FDA Fast Track Designation for pelareorep in 2017, further solidifying its status as a promising player in the oncology landscape. With the FDA already supporting the next steps, Oncolytics is preparing for its registration-enabling study, which could be a major milestone on the road to offering patients a breakthrough treatment in their fight against breast cancer.
“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.”
Recently at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain, Amgen Inc. (NASDAQ: AMGN) presented multiple early-stage clinical trials, showcasing data from Amgen-sponsored and investigator-sponsored studies for colorectal, lung, prostate and gastric cancers using molecularly targeted modalities. Key presentations included: first findings from the Phase 1b study of LUMAKRAS® plus Vectibix® in combination with FOLFIRI in first-line patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC); Phase 1 dose escalation and initial dose expansion data from AMG 193 selected for a presidential symposium session; and First-in-human study of xaluritamig in men with metastatic castration-resistant prostate cancer (mCRPC).
“The breadth of these data reflects our strategy to advance diverse modalities for difficult-to-treat cancers,” said Jay Bradner, M.D., Executive Vice President, Research and Development, and Chief Scientific Officer of Amgen. “These ESMO results underscore our leadership in oncology, contributing significant advancements with both investigational and established therapies. Guided by a deep understanding of cancer biology and leveraging incisive therapeutics, we can target dominant drivers of disease with unprecedented precision.”
A dispute over allege theft of cancer therapy secrets has led Abbvie Inc. (NYSE: ABBV) to sue rival BeiGene, Ltd. (NASDAQ: BGNE). Abbvie’s lawsuit focuses on the companies’ development of a “BTK degrader” cancer therapy, which targets and destroys a molecule present in B cell growth. Key to the allegations is AbbVie’s assertion it had invested millions of dollars and “years of research” into developing a compound that might treat certain types of blood and bone marrow cancers that are associated with the growth of B cells, which produce antibodies that fight infection.
Beigene denied AbbVie’s allegations, stating the company will “vigorously defend our intellectual property rights against this lawsuit.”
BeiGene also recently received approval from the Israeli Ministry of Health for TEVIMBRA® for the treatment of oesophageal squamous cell carcinoma (OSCC) after prior chemotherapy.
“In Israel, the incidence of cancer continues to rise, with solid tumors representing a substantial health burden and where access to these inhibitors remains limited for the patients,” said Itzik Mizrahi, Country General Manager of BeiGene Israel. “The recent approval of Tevimbra by the Israeli Ministry of Health provides a new, innovative treatment for patients with esophageal squamous cell carcinoma (ESCC), offering renewed hope and potentially improved outcomes for those affected by these challenging malignancies. We are pleased to have received approval in Israel, which represents a significant step forward in our mission to bring innovative treatments to cancer patients around the world.”
AbbVie also recently showcased advancement of its solid tumor pipeline at ESMO 2024, with new data in tumor types with high unmet needs, including data from the primary analysis of the Phase 2 PICCOLO trial evaluating investigational mirvetuximab soravtansine monotherapy in heavily pre-treated patients with FRα positive, platinum-sensitive ovarian cancer (PSOC) showed that the trial met its primary endpoint with an objective response rate (ORR) of 51.9% (95% CI 40.4, 63.3), including 6 complete and 35 partial responses.
“There is an urgent patient-driven unmet need to identify novel, effective and tolerable therapies for patients with platinum-sensitive ovarian cancer, including the PARPi pre-treated setting where diminished response to subsequent platinum-based chemotherapy has been reported,” said Angeles Alvarez Secord, M.D., M.H.Sc., from the Duke Cancer Institute. “The response rate seen with mirvetuximab soravtansine in PICCOLO highlights the potential of mirvetuximab soravtansine for platinum-sensitive ovarian cancer patients.”
Exelixis, Inc. (NASDAQ: EXEL) also presented at ESMO 2024 showcasing final results from its Phase 3 pivotal CABINET study evaluation cabozantinib in advanced neuroendocrine tumors, which were also published in the esteemed New England Journal of Medicine.
“The phase 3 CABINET study, which was conducted through the National Cancer Institute’s National Clinical Trials Network, reflects real-world clinical practice in that it enrolled a wide and heterogeneous range of patients regardless of primary tumor site, grade, somatostatin receptor expression and functional status,” said Jennifer Chan, M.D., M.P.H., study chair for the CABINET trial, Clinical Director of the Gastrointestinal Cancer Center and Director of the Program in Carcinoid and Neuroendocrine Tumors at Dana-Farber Cancer Institute. “I’m encouraged by these final results showing that cabozantinib provided a clinically meaningful treatment benefit for patients with previously treated advanced neuroendocrine tumors, including across all major clinical subgroups. The findings suggest that cabozantinib has the potential to become a new standard of care for these patients greatly in need of new treatment options.”
Article Source: https://usanewsgroup.com/2023/10/02/the-most-undervalued-oncolytics-company-on-the-nasdaq/
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