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Oncolytics Biotech Inc. (symbol: ONCY) is a pioneering biotechnology company dedicated to the development of oncolytic viruses as innovative cancer therapeutics. Their flagship product, pelareorep, is a unique immunotherapeutic agent designed to harness the power of the human reovirus to enhance the body's immune response against cancer. Pelareorep has shown promising potential in making tumors more responsive to a variety of oncology treatments by promoting an inflamed tumor phenotype.
The company's robust clinical development pipeline includes multiple human trials targeting some of the most prevalent cancers, such as breast, gastrointestinal, and pancreatic cancers. Notably, Oncolytics is conducting a Phase III trial for head and neck cancers and has several ongoing trials in advanced stages, including the GOBLET study, which explores the efficacy of pelareorep in combination with different chemotherapy regimens.
In breast cancer, Oncolytics is advancing towards registration-enabling studies for HR+/HER2- metastatic breast cancer, supported by compelling data from the BRACELET-1 and IND-213 randomized studies. The company is also making significant strides in pancreatic cancer research, recently receiving a US$5 million grant from the Pancreatic Cancer Action Network (PanCAN) for a new Phase 1/2 cohort in the GOBLET study, assessing pelareorep in combination with modified FOLFIRINOX and atezolizumab (Tecentriq®).
Financially, Oncolytics is well-positioned with a strong balance sheet and ongoing support from strategic partnerships and grants. The company’s collaborations with leading research institutions and oncology networks enhance its clinical programs and accelerate the development of pelareorep as a versatile cancer therapy. Oncolytics continues to innovate and push the boundaries of cancer treatment, aiming to bring new hope to patients worldwide.
Oncolytics Biotech (NASDAQ: ONCY) released a letter to shareholders reviewing 2021 achievements and outlining goals for 2022, particularly in developing pelareorep for metastatic breast cancer. The company highlighted a near doubling of overall survival in HR+/HER2- breast cancer patients and progress in clinical trials. Key objectives include confirming pelareorep's mechanisms, assessing synergy with immune checkpoint inhibitors, and identifying biomarkers for patient selection. Upcoming milestones include full enrollment in BRACELET-1 and top-line data release expected in Q4 2022.
Oncolytics Biotech Inc. (NASDAQ: ONCY) announced the promotion of Dr. Thomas C. Heineman to Chief Medical Officer. Dr. Heineman brings over two decades of clinical development experience, having previously served as Global Head of Clinical Development at Oncolytics. His role will focus on the advancement of the company's lead program for metastatic breast cancer and the ongoing development of pelareorep, an immunotherapeutic agent. This compound aims to induce immune responses against cancer and is currently being evaluated in combination with other therapies.
Oncolytics Biotech has announced promising preclinical results showing that the combination of pelareorep and azacitidine significantly reduces tumor burden in acute myeloid leukemia (AML) cells. Data presented at the 2021 American Society of Hematology Annual Meeting indicates a p<0.01 reduction in tumor burden and a p<0.001 enhancement of anti-leukemic activity compared to individual treatments. The combination also upregulated genes driving immune responses, highlighting pelareorep's potential across various blood cancers. The company aims to expand research into leukemia and other malignancies.
Oncolytics Biotech presented a positive interim safety update from the investigator-sponsored Phase 2 IRENE trial at the 2021 San Antonio Breast Cancer Symposium. This trial evaluates the combination of pelareorep and Incyte's retifanlimab for treating metastatic triple-negative breast cancer (TNBC). No safety concerns were reported among the five enrolled patients. The study aims to assess both safety and efficacy, focusing on PD-L1 expression changes, which might identify patients likely to respond to therapy. The trial continues at key cancer institutes.
Oncolytics Biotech will present updates on the Phase 2 IRENE trial for treating metastatic triple-negative breast cancer (TNBC) at the 2021 San Antonio Breast Cancer Symposium from December 7-10, 2021. The study evaluates the combination of pelareorep and Incyte's anti-PD-1 inhibitor, retifanlimab, on 25 patients. This open-label trial focuses on safety and response rates, with secondary endpoints including progression-free survival and overall survival. The IRENE trial is crucial in advancing pelareorep as a potential treatment option in oncology.
Oncolytics Biotech reported significant advancements in its pelareorep development programs, particularly in breast and gastrointestinal cancers. The AWARE-1 study suggested blood T cell changes could predict therapy response, enhancing future patient selection. The company also initiated the GOBLET trial in collaboration with Roche, targeting unmet needs in gastrointestinal cancers. Financially, Oncolytics holds approximately $48 million in cash, with a net loss of $4.9 million for Q3 2021, showing improvement from $6.7 million the previous year.
Oncolytics Biotech (NASDAQ: ONCY) has initiated the phase 1/2 GOBLET trial, dosing the first patient to evaluate the safety and efficacy of the combination of pelareorep and Roche's atezolizumab in gastrointestinal cancers, including metastatic pancreatic, colorectal, and anal cancers. The trial, managed by AIO in Germany, aims to improve patient responses to immune checkpoint inhibitors, addressing the high unmet need in gastrointestinal cancer treatments. The GOBLET study follows promising earlier results, which suggest significant clinical benefits in related conditions.
Oncolytics Biotech Inc. (NASDAQ: ONCY) will host a conference call on November 5, 2021, at 8:00 a.m. ET, to discuss third-quarter financial results and corporate updates. Investors can dial in North America at (888) 664-6383 or internationally at (416) 764-8650. The event will be webcast and archived on the company's Investor Relations page. Oncolytics is focused on developing pelareorep, an immunotherapeutic agent aimed at inducing immune responses against various cancers. The company is conducting clinical trials in combination with existing oncology treatments.
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 announced promising preclinical data highlighting the synergistic effects of pelareorep combined with radiotherapy. Presented at The International Conference on Immunotherapy Radiotherapy Combinations in Paris, the study demonstrated a significant increase in anti-cancer CD8+ T cells and improved survival rates in murine models. The pelareorep-radiotherapy combination outperformed single-agent therapies, indicating its potential for broader application across multiple cancer types. These findings advocate for further research into pelareorep as an effective cancer treatment.
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