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On May 4, 2022, Oncolytics Biotech announced favorable results from its AWARE-1 study on pelareorep for HR+/HER2- breast cancer. The treatment demonstrated a 100% favorable Risk of Recurrence Score (ROR-S) in evaluable patients, up from 55% at baseline. Increases in tumor cell death markers and T cell activation were also noted. The study's findings support pelareorep's potential to enhance clinical outcomes by transforming tumors into less aggressive types. Future clinical trials, including BRACELET-1, aim to further evaluate its effectiveness.
Oncolytics Biotech announced positive long-term results from the ReoGlio phase 1b trial, demonstrating pelareorep's potential in treating glioblastoma multiforme (GBM). A higher dose led to a median overall survival (mOS) of 50% at 24 months, with one patient alive at 42 months. The trial confirmed the treatment's favorable safety profile, supporting further studies. These findings suggest pelareorep may extend survival benefits beyond breast cancer to other challenging cancers. The results will be presented at the AACR Annual Meeting.
Oncolytics Biotech announced that its partner Adlai Nortye has begun dosing in a clinical trial in China, assessing the safety and efficacy of pelareorep-paclitaxel for advanced breast cancer. This bridging trial aims to enable data inclusion from North American studies in future regulatory submissions. Notably, previous trials indicated a significant survival benefit for patients using pelareorep in combination with paclitaxel. The ongoing collaboration aims to advance pelareorep towards registration in global markets, leveraging China's rapidly growing pharmaceutical landscape.
Oncolytics Biotech reported significant progress in its clinical trials and financial health for Q2 2021. The AWARE-1 trial achieved its primary endpoint, showing that pelareorep synergizes with checkpoint inhibitors, enhancing survival metrics in breast cancer. Additionally, proof-of-concept data in metastatic pancreatic cancer indicates broad applicability across tumor types. The company maintains a strong financial position with $50.8 million in cash, supporting ongoing trials and strategic partnerships.
Oncolytics Biotech (NASDAQ: ONCY) will hold a conference call on August 6, 2021, at 8:00 a.m. ET to discuss the second quarter financial results and corporate updates. The call will be accessible via a toll-free number and will also be available through a webcast for three months. The biotechnology company is focused on developing pelareorep, an immunotherapeutic agent that induces anti-cancer immune responses. This agent is currently in clinical trials for various cancers, including a registration study in metastatic breast cancer.
Oncolytics Biotech (NASDAQ: ONCY) announced a promising clinical proof-of-concept for its pelareorep-checkpoint inhibitor combination therapy in pancreatic cancer. The phase 2 trial, featuring pembrolizumab (KEYTRUDA), showed a 42% disease control rate among patients who had progressed after first-line treatment. The results will be presented at the ASCO Annual Meeting in June 2021. Key findings highlight enhanced T cell activation and well-tolerated treatment. Oncolytics plans to further develop this therapy in collaboration with Roche through the GOBLET study.
Oncolytics Biotech Inc. (NASDAQ: ONCY) announced the appointment of Dr. Richard Vile to its Scientific Advisory Board. Dr. Vile, a Professor at Mayo Clinic, specializes in oncolytic viruses and immunotherapy. His expertise is expected to enhance Oncolytics' strategic direction as the company advances its lead candidate, pelareorep, which targets immunosuppressive tumor environments and shows promise in treating breast cancer. Positive clinical data supports pelareorep's potential advantages in regulatory approval and efficacy against challenging cancers.
Oncolytics Biotech has initiated the IRENE study, a phase 2 trial examining the combination of pelareorep and Incyte's anti-PD-1 checkpoint inhibitor, retifanlimab, in treating unresectable locally advanced or metastatic triple-negative breast cancer (TNBC). The first patient has been dosed as part of this multi-center study, co-sponsored with Rutgers Cancer Institute and The Ohio State University. The trial aims to assess safety, efficacy, PD-L1 expression changes, and T cell clonality. This innovative approach addresses the urgent need for effective treatments in the aggressive TNBC subtype.