developments in oncolytic virus treatment for cancer throughout 2025: a summary
In the realm of cancer treatment, oncolytic virus therapies have been making strides, with notable progress in regulatory approvals and innovative clinical developments.
The latest advancement came in the form of Teserpaturev (Delytact), an oncolytic virus therapy for malignant glioma, which received sakigake designation from the Japanese PMDA. This fast-track status accelerates review and approval for promising treatments, reflecting growing global recognition and regulatory support for oncolytic virus therapies as viable cancer treatments.
The broader oncology field also saw a surge in innovative cancer drug approvals, with China playing a major role. Between 2021 and 2025, China approved 15 first-in-class drugs in oncology, indicating robust innovation and faster regulatory timelines that may impact oncolytic virus therapy development.
Research in 2021 continued to focus on viro-immunotherapy platforms targeting aggressive cancers, such as inflammatory breast cancer, and understanding molecular mechanisms to make oncolytic viruses more effective.
One of the standout developments was Theriva's viral candidate VCN-01, which was granted Orphan Drug designation from the EMA and both Orphan Drug and Fast Track designations from the FDA for the treatment of pancreatic cancer.
CG Oncology's engineered oncolytic virus immunotherapy, cretostimogene grenadenorepvec, showed promising results in patients with bladder cancer, achieving a 42.3% complete response rate. Candel Therapeutics is working with the FDA to seek approval for its viral therapy, CAN-2409, which demonstrated statistically significant improvement in disease-free survival in patients with prostate cancer.
Genelux revealed promising preliminary phase 1b/2 results of its oncolytic virus therapy Olvi-Vec for small-cell lung cancer. Tilt's lead asset TILT-123, engineered and armed with two signaling proteins called cytokines, is currently in a phase 2 trial in ovarian cancer.
However, not all developments were successful. Replimmune's skin cancer candidate RP1 was rejected by the FDA based on claims that the phase 3 trial was faulty.
In the area of acquisitions, UroGen Pharma bought IconOVir Bio's ICVB-1042, an engineered oncolytic adenovirus to treat bladder cancer, for $4 million. Tilt Biotherapeutics closed a $25 million series B financing round in May, fueling its candidate TILT-123's phase 2 trial in ovarian cancer.
Despite these advancements, ovarian cancer remains generally highly resistant to immunotherapy, with immune checkpoint inhibitors reaping disappointing outcomes in studies. However, the ongoing research and clinical trials offer hope for future breakthroughs.
These developments collectively signal a maturing landscape for oncolytic virus therapies, with increasing clinical relevance and regulatory momentum during this period. As research continues and clinical trials progress, we can expect to see more advancements in this promising field of cancer treatment.
- In the ongoing journey of cancer treatment, immunotherapy, specifically oncolytic virus therapies, continue to show significant progress in clinical trials, with biotech and biopharma companies actively investing in their development.
- The global medical-conditions sector has witnessed a spike in innovative cancer drug approvals, such as China's approval of 15 first-in-class drugs in oncology between 2021 and 2025, indicative of an accelerated pace in regulatory approvals for pioneering treatments.
- Science has been focusing on viro-immunotherapy platforms for aggressive cancers like inflammatory breast cancer, aiming to improve the effectiveness of oncolytic viruses and broaden the spectrum of cance treatments and therapies-and-treatments available under health-and-wellness.
- Despite setbacks, such as Replimmune's RP1 being rejected by the FDA, ongoing research and clinical trials in the field of oncolytic virus therapies offer hope for future breakthroughs, collectively signaling a maturing landscape in the fight against cancer.
