Oncolytics Biotech and Bio-Path Holdings have recently announced significant progress in their respective cancer therapy development programs, offering new hope for patients with difficult-to-treat malignancies.
Oncolytics Biotech Presents Promising Pelareorep Data at ASCO GI Symposium
Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) presented compelling new efficacy and safety data for pelareorep, an intravenously delivered immunotherapeutic agent, at the 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium. The data highlighted pelareorep's potential in treating both relapsed anal cancer and metastatic pancreatic cancer.
In a cohort of the GOBLET study evaluating pelareorep combined with the checkpoint inhibitor atezolizumab in patients with second-line or later unresectable squamous cell carcinoma of the anal canal (SCCA), the treatment combination met the pre-defined efficacy success criteria for Stage 1 of its Simon two-stage design. Updated results from this cohort showed that four of twelve evaluable patients achieved a partial response, resulting in an objective response rate of 33%. Notably, one patient experienced a prolonged complete response that persisted for over 15 months. These findings are significant given that historical response rates to checkpoint inhibitor monotherapy are generally low, ranging from 10-24%.
Furthermore, safety data from a safety run-in for first-line metastatic pancreatic ductal adenocarcinoma (PDAC) patients treated with pelareorep + modified FOLFIRINOX +/- atezolizumab was also presented. The safety data have been reviewed by the Data Safety Monitoring Board (DSMB) and Paul Ehrlich Institute (PEI), Germany's medical regulatory body, and they have recommended patient enrollment continue without modification.
"The posters that will be presented at the symposium later this week continue to show pelareorep's compelling potential in gastrointestinal cancers," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer for Oncolytics Biotech. "In relapsed anal cancer, the efficacy signal that was initially reported continues to outperform historical control trials with the inclusion of additional patients. Importantly, the complete response we observed previously continued beyond the 12 months initially reported. Together, these results point to a clinically meaningful synergy between pelareorep and checkpoint inhibitors like atezolizumab."
Bio-Path Holdings Reports Positive Updates on AML and Solid Tumor Trials
Bio-Path Holdings, Inc. (NASDAQ:BPTH) has announced encouraging updates from its clinical trials evaluating BP1002 for refractory/relapsed acute myeloid leukemia (AML) and BP1001-A for advanced solid tumors. The company reported a meaningful patient response in the Phase 1/1b clinical trial of BP1002, with one patient in the third cohort experiencing stable disease and a significant reduction in blast count after just one treatment cycle. Based on these results, the trial has progressed to the fourth, higher dose cohort of 90 mg/m2.
"We were excited to learn that one patient in the third cohort had a meaningful response to just one treatment cycle, experiencing stable disease and a significant reduction in blast count, which we believe offers promise for venetoclax-resistant AML patients with limited treatment options," said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings.
In the Phase 1/1b clinical trial of BP1001-A in solid tumor patients, the first patient treated with the second, higher dose (90 mg/m2) experienced tumor reduction and continued stable disease through a tenth treatment cycle. This elderly female patient with gynecologic cancer had previously been treated with multiple lines of chemotherapy and surgeries, and is now showing positive clinical results with BP1001-A treatment without the typical onerous side effects seen with standard chemotherapies.
Furthermore, Bio-Path reported continued patient progress from the Phase 2 triple combination study of prexigebersen, venetoclax, and decitabine in AML patients. Two elderly patients remain in complete remission after two years of treatment, underscoring the potential for prexigebersen to treat fragile AML patients for extended periods.
These updates from Oncolytics Biotech and Bio-Path Holdings highlight the ongoing advancements in cancer therapy development and offer potential new treatment options for patients with gastrointestinal cancers, AML, and solid tumors.
