VANCOUVER, British Columbia, Jan. 12, 2026 (GLOBE NEWSWIRE) -- Equity-Insider.com News Commentary – The biotechnology sector is entering a high-stakes survival sprint as major pharmaceutical giants confront a looming $170 billion patent cliff[1]. This massive pressure is forcing a strategic capital rotation toward late-stage, registration-ready oncology platforms that can be delivered with biologic-like manufacturing efficiency. With blockbuster drugs losing exclusivity through 2030, the precision oncology market is projected to reach $225.65 billion by 2032[2] as buyers aggressively target scalable technologies. This industry-wide shift into proprietary precision platforms fuels the 2026 investment case for Oncolytics Biotech Inc. (NASDAQ: ONCY), Allogene Therapeutics (NASDAQ: ALLO), Coherus Oncology (NASDAQ: CHRS), Pyxis Oncology (NASDAQ: PYXS), and Enliven Therapeutics (NASDAQ: ELVN).
Accelerated approval pathways for rare oncology indications are creating immediate commercial opportunities for de-risked assets showing deep response rates in heavily pretreated populations. The convergence of precision medicine's expansion to $537.17 billion by 2035[3] with M&A urgency has positioned 2026 as a defining inflection point. Companies demonstrating both platform scalability and long-term intellectual property protection through therapeutic innovation now command premium valuations in a sector prioritizing speed-to-market over traditional phase-by-phase development timelines.
Oncolytics Biotech Inc. (NASDAQ: ONCY) is advancing pelareorep, an investigational immunotherapy, toward potential accelerated approval in anal cancer after reporting third-line data that nearly tripled historical response rates in a setting with no FDA-approved treatment options.
The company announced updated clinical data from GOBLET Cohort 4 showing pelareorep combined with atezolizumab achieved a 29% objective response rate in patients with third-line metastatic squamous cell anal carcinoma (SCAC). These responses included two complete responses among 14 evaluable patients. Notably, the median duration of response was approximately 17 months (67 weeks). Historical third-line SCAC studies typically show objective response rates of approximately 10% or less, and when responses do occur, duration of response is generally limited.
The third-line results build on equally compelling second-line data, where pelareorep achieved a 30% response rate, more than doubling the 13.8% benchmark for the only FDA-approved immunotherapy in this setting. The median duration of response reached 15.5 months compared to 9.5 months for standard care, with two durable complete responses.
This depth and durability of responses in heavily pretreated patients address a critical unmet need. There are currently no FDA-approved therapies for patients with third-line anal cancer, making pelareorep's activity particularly significant for a patient population with virtually no options outside of chemotherapy.
Based on these results and after initial encouraging feedback from the FDA, Oncolytics plans to advance pelareorep into a registration-directed clinical study in second-line and later SCAC. Oncolytics is planning a Type C meeting with the FDA in Q1 2026 to discuss and receive guidance on this development plan.
If the objective response rate and duration of response observed in GOBLET Cohort 4 are reproduced in the planned registration study, Oncolytics believes the resulting dataset would be sufficient to support accelerated approval in this indication, consistent with regulatory precedent in rare cancers with no available therapies.
“As we continue to analyze the Goblet data, we are finding important trends that are helping to shape our clinical development strategy,” said Jared Kelly, Chief Executive Officer of Oncolytics. “When you isolate to anal cancer patients with two prior lines of treatment and see a strong signal like this, it points the arrow in a direct line to a registration study in an indication where there are no FDA-approved therapies. We already had good data here, but looking closer, it becomes clearer that we can make an immediate impact on patients’ lives who have no options.”
The company's broader gastrointestinal oncology strategy received validation through expansion of its Scientific Advisory Board with three globally recognized experts from Memorial Sloan Kettering Cancer Center and MD Anderson Cancer Center. Oncolytics has also secured FDA alignment on its Phase 3 study design for pelareorep in first-line metastatic pancreatic cancer, positioning it to launch the only immunotherapy registration trial currently planned for this disease.
Leading the charge is CEO Jared Kelly and Chief Business Officer Andrew Aromando, who were both crucial contributors to Ambrx Biopharma's $2 billion acquisition by Johnson & Johnson.
CONTINUED… Read this and more news for Oncolytics Biotech at: https://equity-insider.com/2025/03/18/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/
In other recent industry developments and happenings in the market include:
Allogene Therapeutics (NASDAQ: ALLO) positioned 2026 as a program-defining year for scalable, real-world allogeneic CAR T with a first-half catalyst stack anticipated to validate scalable, off-the-shelf CAR T in oncology and autoimmune disease. An interim futility analysis of MRD clearance from the pivotal Phase 2 ALPHA3 trial with cemacabtagene ansegedleucel in first-line consolidation large B-cell lymphoma is planned for early Q2 2026, while initial proof-of-concept for ALLO-329 leveraging the Dagger technology to reduce or eliminate lymphodepletion in autoimmune diseases is slated by end of first half 2026.
"We believe 2026 is a program-defining year for allogeneic CAR T and Allogene with value-defining readouts and clinical maturity unmatched in the allogeneic field," said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. "With multiple first-half clinical milestones, we aim to demonstrate that CAR T can be delivered at biologic-like scale in real-world settings."
The Company's off-the-shelf platform is designed to deliver rapid on-demand availability, consistent product performance, simplified administration compatible with outpatient use, manufacturing scalability of approximately 30,000-60,000+ doses annually, and efficient cost-of-goods profile. Allogene's cash runway extends into the second half of 2027.
Coherus Oncology (NASDAQ: CHRS) announced the publication in Molecular Cancer Therapeutics describing the high selectivity, picomolar binding affinity and significant effector-mediated killing of CCR8+ cells of its investigational anti-CCR8 monoclonal antibody tagmokitug. The findings show that tagmokitug demonstrated no off-target binding and selectively eliminates CCR8+ T regulatory cells and not other T cells, supporting its potential as an anticancer treatment with CCR8 target present with high prevalence and density in many solid tumors.
"This publication presents the robust pharmacology of tagmokitug in preclinical and clinical studies, and with a selectivity profile and potent binding and killing of CCR8+ T regulatory cells and not other immune cells," said Theresa LaVallee, PhD, Chief Scientific and Development Officer at Coherus. "The data show a high abundance of CCR8 target expression in a broad range of solid tumors suggesting the promise of the tagmokitug program."
The publication provides important scientific evidence supporting the ongoing advancement of tagmokitug in clinical studies evaluating its antitumor activity across multiple solid tumor settings in combination with toripalimab, a checkpoint inhibitor, and chemotherapy. Key highlights include robust characteristics with picomolar binding affinity, exquisite selectivity for CCR8 with no off-target binding, and proof of mechanism established with translational data.
Pyxis Oncology (NASDAQ: PYXS) announced positive preliminary Phase 1 data for micvotabart pelidotin (MICVO) monotherapy in second-line or later recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) with 46% confirmed objective response rate and 92% disease control rate observed at 5.4 mg/kg, while 71% confirmed ORR and 100% DCR was observed with MICVO in combination with KEYTRUDA in 1L/2L+ R/M HNSCC at 3.6 mg/kg and 4.4 mg/kg.
"The preliminary data for MICVO as monotherapy and in combination with pembrolizumab add to the growing body of evidence supporting MICVO's therapeutic potential and highlight its agility as a novel potential treatment option across the recurrent/metastatic head and neck squamous cell carcinoma landscape," said Lara S. Sullivan, M.D., President, Chief Executive Officer and Chief Medical Officer of Pyxis Oncology. "The emerging response rates and disease control observed across these studies are highly encouraging, and the lack of early disease progression supports confidence in the durability profile as we advance MICVO in clinical development."
Updated data from the ongoing Phase 1 monotherapy study in 2L+ R/M HNSCC expected in mid-2026 includes additional patients and initial durability data. Pyxis Oncology completed the sale of royalty rights for another drug candidate for $11 million to support MICVO development.
Enliven Therapeutics (NASDAQ: ELVN) reported positive initial Phase 1b data for ELVN-001 in chronic myeloid leukemia (CML) with a cumulative major molecular response (MMR) rate of 69% by 24 weeks, with 53% of patients achieving MMR by 24 weeks in ongoing randomized Phase 1b cohorts. ELVN-001 continues to demonstrate a favorable safety and tolerability profile across all dose levels evaluated, consistent with previously reported data, with enrollment of 60 heavily pretreated patients as of December 22, 2025.
"We are excited about these initial Phase 1b data, the progress we made throughout 2025 and the year ahead," said Helen Collins, M.D., Chief Medical Officer of Enliven. "Our data continue to demonstrate that ELVN-001 has the potential to be the best-in-class active-site TKI for the treatment of CML and an important treatment option across all lines of therapy. We are preparing for upcoming regulatory interactions with the FDA to align on dose selection and support initiation of the Phase 3 trial in the second half of 2026."
Despite the heavily pretreated patient population where 67% received prior asciminib and 32% received prior ponatinib, robust clinical activity was observed at doses from 60 mg to 120 mg QD. Mid-year presentation of additional Phase 1 data is expected in 2026.
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SOURCES CITED:
- https://www.cnbc.com/2026/01/07/big-pharma-race-to-snap-up-biotech-assets-as-170-billion-patent-cliff-looms.html
- https://www.newstrail.com/precision-oncology-market-scope/
- https://www.precedenceresearch.com/precision-medicine-market
