Vancouver, BC – February 18, 2025 – USA News Group News Commentary – Despite optimism coming from the launch of Project Stargate (a $500 billion investment in AI data centers), there is still cause for alarm regarding soaring cancer rates around the world, especially among young people. Lifestyle factors are gaining more attention, as the World Health Organization (WHO) recently announced it believes that alcohol products should come with cancer warning labels. Thankfully, progress is still being made, with new blood tests being announced that can detect deadly pancreatic cancers before they spread. Several biotech companies have been reaching milestones already in 2025, with recent developments coming from Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Allogene Therapeutics, Inc. (NASDAQ: ALLO), Verrica Pharmaceuticals Inc. (NASDAQ: VRCA), OS Therapies Incorporated (NYSE-American: OSTX), and ImmunityBio, Inc. (NASDAQ: IBRX).
The article continued: The Center for Innovation and Translation of Point of Care Technologies for Equitable Cancer Care (CITEC) has recently launched a global initiative aimed at advancing cancer detection technologies. As the demand for innovative oncology solutions grows, the global cancer therapy market is expected to experience significant expansion, with DelveInsight Business Research projecting a 9.12% compound annual growth rate (CAGR)—bringing its estimated market value to $285.96 billion by 2030.
Oncolytics Biotech® Strengthens Its Pipeline in 2025 with Key Pancreatic and Anal Cancer Advances in Addition to Metastatic Breast Cancer
Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage company focused on immunotherapy for cancer, continues to make good progress in 2025 with key regulatory and clinical advancements, reinforcing pelareorep’s potential in hard-to-treat cancers. Oncolytics was pleased to highlight two significant developments for its immunotherapy, pelareorep: the safety and regulatory clearance to advance enrollment in its pancreatic cancer study and the recent presentation of new efficacy and safety data at the 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in late January.
“We’re hitting critical milestones that validate our progress and set the stage for what we believe will be an exciting year,” said Wayne Pisano, Interim CEO and Chair of Oncolytics’ Board of Directors. “With positive feedback from regulators in place, we’re advancing our pancreatic cancer study toward full enrollment, and our ASCO GI presentations highlighted pelareorep’s strong safety and efficacy results in two hard-to-treat cancers. We remain focused on bringing new treatment options to patients while creating value for shareholders as we move forward in 2025.”
Germany’s Paul-Ehrlich-Institute (PEI) has granted Oncolytics Biotech approval to proceed with full enrollment in its pancreatic cancer trial (GOBLET Cohort 5) following a successful safety review. This milestone allows the study to advance as planned, with 30 patients set to participate in Stage 1 across two treatment arms evaluating pelareorep in combination with modified FOLFIRINOX, with or without atezolizumab. With the safety run-in complete, Oncolytics will continue gathering safety data, with an initial efficacy readout expected later this year. This progress reinforces pelareorep’s potential in one of the most aggressive and challenging-to-treat cancers, bringing the company one step closer to expanding its clinical impact in gastrointestinal oncology.
At ASCO GI 2025, Oncolytics Biotech presented new clinical data reinforcing pelareorep’s potential in two difficult-to-treat cancers: anal and pancreatic cancer. In anal cancer, patients receiving pelareorep + atezolizumab continue to show stronger-than-expected responses, outperforming results seen in published studies using checkpoint inhibitors alone. In pancreatic cancer, pelareorep has previously demonstrated a strong efficacy signal in combination with gemcitabine, nab-paclitaxel, and atezolizumab. The latest findings confirm a favorable safety profile when using pelareorep with a different chemotherapy regimen (modified FOLFIRINOX), with and without atezolizumab, potentially broadening its clinical applications. These results further de-risk pelareorep’s development and could support the advancement into larger, registration-enabling trials, bringing the therapy closer to addressing major unmet needs in gastrointestinal oncology.
As Oncolytics moves into a pivotal year, multiple high-impact milestones are set to shape the company’s progress. Upcoming data readouts from ongoing gastrointestinal cancer trials will provide further insights, including translational results that help characterize pelareorep’s mechanism of action. Additionally, regulatory interactions throughout the year could play a crucial role in accelerating future trials, bringing pelareorep closer to potential registration-enabling studies in both breast and gastrointestinal cancers. These milestones position Oncolytics for continued momentum as it advances its clinical pipeline toward broader patient impact.
“We’re seeing clinical validation across multiple studies,” added Pisano. “With encouraging regulatory interactions in hand and data readouts ahead, 2025 is shaping up to be an exciting year for Oncolytics and our investors. As we have shown in GOBLET, BRACELET-1, and numerous previous studies, pelareorep has a favorable safety profile and efficacy signals across multiple indications with a high unmet need. We are excited about the potential for moving to a registration-enabling study in breast cancer and advancing our clinical program in gastrointestinal cancers.”
CONTINUED… Read this and more news for Oncolytics Biotech at: https://usanewsgroup.com/2023/10/02/the-most-undervalued-oncolytics-company-on-the-nasdaq/
In other recent industry developments and happenings in the market include:
Allogene Therapeutics, Inc. (NASDAQ: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, recently announced the publication of data from its Phase 1 ALPHA and ALPHA2 clinical studies of cemacabtagene ansegedleucel (cema-cel; formerly ALLO-501/A) in relapsed/refractory (R/R) large B-cell lymphoma (LBCL) as a Rapid Communication in the Journal of Clinical Oncology.
The ALPHA/ALPHA2 Phase 1 trials evaluated cema-cel (ALLO-501) in 87 heavily pretreated patients with relapsed/refractory (R/R) non-Hodgkin lymphoma (NHL), including 33 CAR T-naive patients with R/R large B-cell lymphoma (LBCL) who received the final manufacturing process for pivotal studies. The treatment showed a 67% overall response rate (ORR) and 58% complete response rate (CRR), with strong durability (median DOR: 23.1 months, OS: not reached), a manageable safety profile, and a median treatment initiation time of just two days, significantly faster than autologous CAR T therapies. With a minimum two-year follow-up, this represents the largest dataset and longest follow-up for LBCL patients treated with an allogeneic CAR T therapy to date.
“With multiple patients in ongoing complete remissions beyond four years, the lingering question of whether an allogeneic CAR T could deliver durable responses has now been answered,” said Zachary Roberts, M.D., Ph.D., Executive Vice President, Research and Development and Chief Medical Officer of Allogene. “Furthermore, these results provide potent evidence supporting the use of CAR T in patients with low disease burden and the unique opportunity for the ALPHA3 trial to achieve something novel in this disease – predict and intervene before relapse. Opportunities to redefine the standard of care in oncology are rare, but if successful, ALPHA3 has the potential to achieve precisely that.”
Verrica Pharmaceuticals Inc. (NASDAQ: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, recently presented three posters at the 2025 Winter Clinical Dermatology Conference, featuring clinical data from Part 2 of the Phase 2 study (the “Study”) of Verrica’s novel oncolytic peptide, VP-315, for the treatment of basal cell carcinoma (“BCC”).
“We believe these results will support the use of VP-315 as a potential first line therapy for use in both primary and neoadjuvant settings, and that VP-315 could provide the millions of basal cell carcinoma patients diagnosed in the United States each year with a non-surgical alternative to painful, invasive surgical treatments,” said Dr. Jayson Rieger, PhD, MBA, President and CEO of Verrica. “We believe that VP-315 could represent a multi-billion-dollar commercial opportunity for Verrica. We look forward to our discussions with the FDA about designing a development path forward for VP-315 in 2025.”
OS Therapies Incorporated (NYSE-American: OSTX), a clinical-stage biotechnology company advancing immunotherapies and targeted drug conjugates for cancer treatment, recently announced that it has entered into agreements for the commercial manufacture of OST-HER2.
OS Therapies is currently organizing additional data in relation to the recently completed treatment phase of its Phase 2b trial of OST-HER2 in the prevention of recurrence of lung metastatic osteosarcoma in preparation for a Type B or Type C meeting with the US Food & Drug Administration (FDA). Following the FDA meeting, OS Therapies anticipates that it will be submitting a Biologics Licensing Authorization (BLA) application to the FDA for accelerated or conditional approval consideration.
ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunity therapy company, recently announced the Medicines and Healthcare products Regulatory Agency (MHRA) has validated and accepted the marketing authorization application for ANKTIVA. The MHRA will now begin assessing the marketing authorization application (MAA) for ANKTIVA® (nogapendekin alfa inbakicept-pmln) in combination with bacillus Calmette-Guérin (BCG) for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. MHRA regulates medicines, medical devices and blood components for transfusion in the UK.
“MHRA’s acceptance of our marketing authorization application for the UK comes less than three weeks after the European Medicines Agency accepted for review our MAA for the 30 countries covering the European Union, and just 10 months after FDA approval in the United States,” said Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. “We are determined to reach as many patients as possible with ANKTIVA and BCG and are encouraged by the momentum of our efforts.”
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