Issued on behalf of Oncolytics Biotech Inc.
VANCOUVER – USA News Group – With the recent wrapping up of the World Cancer Congress 2024 in Geneva, Switzerland, and the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain, there is plenty of optimism in the oncology sector with plenty of new developments in the fight against cancer to celebrate. For the market, the potential is in place, with analysts projecting the Cancer Immunotherapy Market expected to grow at a CAGR of 13.8% through 2032 to hit US$674 billion. There’s plenty to celebrate recently in oncology, with cancer deaths falling by 33% in the last 30 years. Several players are meeting milestones and creating optimism, with recent developments coming from Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Nuvalent, Inc. (NASDAQ: NUVL), Castle Biosciences, Inc. (NASDAQ: CSTL), Corcept Therapeutics Incorporated (NASDAQ: CORT), and Illumina, Inc. (NASDAQ: ILMN).
Backed by remarkable results from its BRACELET-1 breast cancer study, Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) is moving forward with renewed confidence toward a registration-enabling study for its flagship immunotherapy, pelareorep. The recently completed Phase 2 BRACELET-1 trial has brought strong optimism, particularly for patients with HR+/HER2- advanced or metastatic breast cancer.
The final data from BRACELET-1 not only reinforced the positive findings from Oncolytics’ earlier IND-213 trial, which earned pelareorep an FDA Fast Track Designation, but also delivered even more encouraging results. Most notably, the median overall survival (OS) for patients receiving pelareorep in combination with chemotherapy was not reached, meaning more than half the patients were still alive at the end of the study. This promising outcome points to the potential long-term survival benefits of pelareorep.
“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.”
Additional data showed that patients receiving pelareorep alongside chemotherapy had a 5.7-month progression-free survival (PFS) advantage over chemotherapy alone, and a two-year survival rate of 64%, compared to just 33% for patients on chemotherapy alone. This near-doubling of survival rates underscores the potential for pelareorep to make a meaningful impact in the treatment of 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.”
With such promising results, Oncolytics is now well-positioned to move forward with its registration-enabling study, bringing pelareorep one step closer to potentially transforming the way advanced breast cancer is treated.
At the upcoming European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain, Nuvalent, Inc. (NASDAQ: NUVL) is set to present clinical data for its parallel lead programs for ROS1 and ALK-positive non-small cell lung cancer (NSCLC). Nuvalent will be presenting data from: the Phase 2 portion of its ARROS-1 trial of zidesamtinib for TKI-naïve and TKI pre-treated patients with advanced ROS1-positive NSCLC and other solid tumors; the Phase 2 portion of the ALKOVE-1 trial of NVL-655 for TKI-naïve and TKI pre-treated patients with advanced ALK-positive NSCLC and other solid tumors; and the ALKAZAR Phase 3 randomized, controlled trial of NVL-655 for TKI-naïve patients with advanced ALK-positive NSCLC.
“With the announcement of our planned ALKAZAR randomized, controlled Phase 3 study, we are thrilled to also establish a potential registration path for TKI-naïve patients with advanced ALK-positive NSCLC,” said Darlene Noci, A.L.M., Chief Development Officer at Nuvalent. “We are grateful for the strong investigator enthusiasm for our programs, exemplified by the accelerated Phase 2 enrollment in our ARROS-1 and ALKOVE-1 trials. We now anticipate reporting pivotal datasets from both Phase 2 trials in 2025. Through our multi-pronged strategies, our goal is to bring potential best-in-class therapies that can move up the treatment paradigm to patients as efficiently as possible. We look forward to initiating the ALKAZAR study in the first half of 2025.”’
When it comes to detecting cancer ahead of time, Castle Biosciences, Inc. (NASDAQ: CSTL) recently announced the publication of a new study in the World Journal of Surgical Oncology that further demonstrated that its DecisionDx-Melanoma test can precisely predict sentinel lymph node (SLN) positivity risk to help guide risk-aligned SLNB decisions, potentially reducing the number of unnecessary procedures and increasing the SLNB positivity yield if the procedure is performed. The study showed that using the DecisionDx-Melanoma test to guide sentinel lymph node biopsy (SLNB) surgery decisions could have significantly reduced the number of unnecessary SLNBs by 33% for patients with T1-T2 melanoma tumors.
“Our DecisionDx-Melanoma test has significant clinical utility in helping to rule-out and rule-in SLNB procedures, as this study showed,” said Derek Maetzold, President and CEO of Castle Biosciences. “And as demonstrated by data we shared earlier this year from our ongoing prospective, multicenter DECIDE study, patients with low-risk DecisionDx-Melanoma results whose providers use the test to help guide decisions to avoid SLNB surgery still experience good outcomes.”
Another test that’s gaining momentum is Illumina, Inc.’s (NASDAQ: ILMN) TruSight Oncology Comprehensive cancer biomarker test, which recently became the first US FDA-approved, distributable comprehensive genomic profiling IVD kit with pan-cancer companion diagnostic claims. Illumina’s 500+ gene biomarker test advances access to localized precision oncology for patients.
“FDA approval for TruSight Oncology Comprehensive with accompanying companion diagnostics marks an awaited milestone for our oncology customers and community,” said Everett Cunningham, Chief Commercial Officer of Illumina. “We are committed to partnering with industry leaders like Bayer and Lilly to advance cancer diagnostics and help broaden access to precision oncology for more patients.”
Within its Q2 2024 financial report and corporate updates, Corcept Therapeutics Incorporated (NASDAQ: CORT) highlighted progress in its oncology programs involving its selective glucocorticoid receptor modulater, relacorilant. In particular Corcept highlighted its pivotal Phase 3 ROSELLA trial of relacorilant plus nab-paclitaxel in 381 patients with platinum-resistant ovarian cancer; its open-label, Phase 1b trial of relacorilant plus pembrolizumab in 14 patients with advanced adrenal cancer with cortisol excess; and its randomized, placebo-controlled, Phase 2 trial of relacorilant plus enzalutamide in patients with prostate cancer in collaboration with the University of Chicago.
“Relacorilant has the potential to become the standard of care for patients with platinum-resistant ovarian cancer,” said Dr. Bill Guyer, PharmD, and Chief Development Officer of Corecpt. “If our pivotal ROSELLA trial replicates the positive results from our large, controlled, Phase 2 study, it will constitute a major medical advance. We expect progression-free survival data, ROSELLA’s primary endpoint, by the end of this year.”
Article Source: https://usanewsgroup.com/2023/10/02/the-most-undervalued-oncolytics-company-on-the-nasdaq/
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