Pelareorep

Equity Insider News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, May 23, 2025 /PRNewswire/ -- Equity Insider News Commentary – With early onset cancer rates on the rise and funding being cut to NIH, the future for cancer patients is increasingly being shaped not by public institutions, but by the breakthroughs emerging from the private sector. For investors watching the next wave of oncology breakthroughs, companies like Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Akoya Biosciences, Inc. (NASDAQ: AKYA), Quanterix Corporation (NASDAQ: QTRX), TScan Therapeutics, Inc. (NASDAQ: TCRX), and Arcellx, Inc. (NASDAQ: ACLX) are increasingly standing out. Continue Reading New Data and Deal Flow Signal a Turning Point for Precision-Driven Cancer Biotechs Pelareorep Facts (PRNewsfoto/Equity Insider) Cancer treatment markets are on track for massive expansion over the next decade. Immunotherapy, in particular, is expected to reach an annual market size of US$1.2 trillion by 2033, driven by a compound annual growth rate of 18%, according to analysts at Precedence Research. Meanwhile, global oncology spending overall is projected by Vision Research Reports to surpass US$900 billion, climbing at an estimated 11% per year. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) is gaining new visibility ahead of its upcoming presentation at the 2025 ASCO Annual Meeting, where the company will unveil new clinical trial data on pelareorep's immunological activity in pancreatic cancer. The data, drawn from the GOBLET study, highlights how pelareorep appears to convert immunologically "cold" tumors into "hot," inflamed environments—potentially making them more vulnerable to immune attack. Specifically, new analyses show pelareorep induces a pro-inflammatory tumor microenvironment (TME) and activates both innate and adaptive immunity. This is a rare achievement in pancreatic ductal adenocarcinoma (PDAC), a cancer type widely considered resistant to immune-based therapies. "For the first time, we're able to map the cascade of immune responses stimulated by pelareorep," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer for Oncolytics. "It starts with the expansion of anti-reovirus T cells, followed by the upregulation of chemokines that mediate the expansion of pre-existing TIL (tumor-infiltrating lymphocyte) clones in the blood." According to Heineman, these immune cells don't just expand in the bloodstream—they're believed to return to the tumor itself and help shrink it. "These T cells can now return to the tumor and attack it, resulting in a reduction in tumor size," Heineman added. "Pelareorep-mediated upregulation of chemokines also makes the tumor microenvironment immunologically active and able to actively recruit cancer-specific T cells to the tumor. These findings deepen our understanding of pelareorep's ability to convert immunologically cold tumors into immunologically active ones that may benefit from pelareorep-based combination therapy." The abstract, titled "Role of pelareorep in activating anti-tumor immunity in PDAC," (Abstract #2562) will be presented as a poster during the Developmental Therapeutics – Immunotherapy session on June 2, 2025. A copy will be made available on the Media page of Oncolytics' website following the session. This new mechanistic insight builds on prior efficacy data from GOBLET Cohort 1, where pelareorep—combined with nab-paclitaxel, gemcitabine, and the checkpoint inhibitor atezolizumab—produced a 62% overall response rate, 85% disease control rate, and 45% 12-month survival rate in first-line metastatic PDAC patients. For context, GOBLET is a multi-cohort, phase 1/2 study evaluating pelareorep in combination with various immunotherapy and chemotherapy regimens across gastrointestinal cancers. Conducted in partnership with AIO-Studien-gGmbH in Germany, the trial uses an adaptive design: cohorts meeting efficacy thresholds may expand enrollment. In pancreatic cancer, this trial is a proving ground for pelareorep's use in first-line and newly diagnosed settings—potentially setting up future pivotal decisions. Progress continues elsewhere in the GOBLET study as well. In Cohort 5, newly diagnosed metastatic PDAC patients received pelareorep with modified FOLFIRINOX, with or without atezolizumab. After completing the safety run-in in six evaluable patients, the study has been cleared to proceed by both Germany's Paul-Ehrlich-Institut and an independent data safety monitoring board. This arm is backed by a US$5 million PanCAN grant, with further data expected in 2026. Favorable data from this cohort could expand pelareorep's potential addressable market in this indication. Meanwhile, in anal cancer, Cohort 4 has already reported signs of durable response. Of 12 evaluable patients treated with pelareorep and atezolizumab, four achieved partial responses, and one reached a complete response lasting more than 15 months—results that surpass historical benchmarks for checkpoint inhibitors alone. The cohort is now being expanded to validate these findings and assess registrational potential. In breast cancer, the recently completed randomized phase 2 BRACELET-1 trial in HR+/HER2- metastatic disease showed patients receiving pelareorep plus paclitaxel nearly doubled their progression-free survival compared to paclitaxel alone. These outcomes are supportive of those seen in a prior randomized phase 2 study and strengthen the case for a pivotal trial. Key opinion leaders continue backing pelareorep's approach. In a recent panel hosted by H.C. Wainwright, Profs. Martine Piccart and Alexander Eggermont emphasized how pelareorep may help "turn cold tumors hot"—a key requirement for making immunotherapies effective in traditionally resistant cancers. While still in the clinical development stage, pelareorep has demonstrated compatibility with multiple chemotherapies and checkpoint inhibitors, suggesting it could function as a plug-in immune booster across diverse treatment regimens. Its intravenous delivery, systemic impact, and favorable safety profile further support its adaptability in combination trials. "Pelareorep continues to build clinical momentum, delivering encouraging results in challenging cancer types and has the potential to extend and improve the lives of patients," said Wayne Pisano, Chair of Oncolytics' Board of Directors and Interim CEO. "This versatility and broad potential applicability are achieved via intravenous administration and the ability to combine with chemotherapies and checkpoint inhibitors while maintaining a favorable safety profile." As it stands, Oncolytics may be entering a stretch where scientific validation, clinical optionality, and capital flexibility are all converging. The company ended Q1 2025 with $15.3 million in cash and a US$20 million equity facility from Alumni Capital, giving it financing control without restrictive terms or dilutive warrants. With fresh data coming out of ASCO and multiple arms of GOBLET advancing, pelareorep's immune-activating potential appears to be gaining traction across an expanding range of solid tumor indications. Infographic - CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: Akoya Biosciences, Inc. (NASDAQ: AKYA) recently reported Q1 2025 revenue of $16.6 million, with a 12% year-over-year increase in installed instruments and a 44.7% rise in total publications. Gross margin improved to 59.3%, and operating losses narrowed 38% compared to the same quarter last year. The company highlighted major cancer collaborations in the U.S. and Singapore, along with a new ADC breast cancer assay unveiled at AACR. This comes just two weeks after Akoya and Quanterix Corporation (NASDAQ: QTRX) announced amended terms to their merger agreement, reducing share issuance by over 9 million while preserving a $20 million cash component. The merger brings together two complementary platforms—spatial phenotyping and ultra-sensitive biomarker detection—aimed at accelerating next-generation precision diagnostics across oncology and immunology. "We remain excited to combine with Quanterix and believe this partnership offers compelling value for Akoya shareholders," said Brian McKelligon, CEO of Akoya Biosciences. "We look forward to closing the transaction and leveraging our collective scale to drive synergies across our organizations and customers, expediting our path to profitability." Akoya shareholders are now set to receive $0.38 per share in cash and 0.1461 shares of Quanterix common stock. "The strategic merits of the transaction remain strong even as the market has been focused on academic funding and tariff concerns," said Masoud Toloue, PhD, CEO of Quanterix. "The combined company will provide a significant value creation opportunity for shareholders." The transaction is expected to close in Q2 2025, positioning the combined company as a scaled leader in spatial biology and ultra-sensitive biomarker detection. TScan Therapeutics, Inc. (NASDAQ: TCRX) posted Q1 2025 revenue of $2.2 million, driven by collaboration activity with Amgen, and ended the quarter with $251.7 million in cash and marketable securities. "This is an exciting year for TScan as we advance our mission of bringing life-changing T-cell therapies to patients with both heme and solid tumor malignancies," said Gavin MacBeath, Ph.D., CEO of TScan Therapeutics. "We look forward to dosing our first patient with multiplex therapy soon, and to sharing safety and efficacy data later this year." Net loss for the quarter was $34.1 million, with R&D spending up due to manufacturing scale-up and preclinical work. The company is actively enrolling patients in two ongoing Phase 1 studies: ALLOHA in heme malignancies and PLEXI-T in solid tumors. Key milestones this year include a planned IND submission, a registrational trial initiation, and clinical data readouts from both trials. Arcellx, Inc. (NASDAQ: ACLX) recently reported new data from its Phase 2 iMMagine-1 study showing a 97% overall response rate and 68% complete/stringent complete response rate in heavily pretreated multiple myeloma patients. No delayed neurotoxicities or immune-mediated enterocolitis have been observed to date, with safety and durability metrics continuing to impress at 12.6 months median follow-up. "These clinical data from our registrational study continue to support our belief that anito-cel has the potential to address the needs of myeloma patients and the physicians who serve them," said Rami Elghandour, CEO of Arcellx. "There is no cure for multiple myeloma. We believe there remains an unmet medical need for CAR-T therapies that are efficacious, safe, and accessible." The data will be presented in an oral session at EHA2025, ahead of a planned commercial launch in 2026 with partner Kite, a Gilead company. 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