Seven prominent oncolytic virus firms worth investigating
In the realm of cancer treatment, oncolytic virus (OV) therapies have been making significant strides, thanks to enhanced viral engineering, improved delivery methods, and innovative combination treatments. These advancements are moving the field toward more effective and personalized cancer immunotherapy.
Recent key developments include:
- Genetic Engineering and Synthetic Biology: New viral constructs, built on herpes simplex virus (HSV), adenovirus, vaccinia virus, and reovirus platforms, are engineered to express immune-stimulatory transgenes like GM-CSF, interleukins, and checkpoint blockade peptides. This makes OVs not only cytolytic but also capable of converting the tumor microenvironment into an immune-active site.
- Combination Therapies: OVs are increasingly combined with immune checkpoint inhibitors (such as anti-PD-1/PD-L1 antibodies), CAR-T cell therapies, and radiotherapy to address resistance and elicit stronger systemic anti-tumor immune responses. For example, RP1 (vusolimogene oderparepvec), an HSV-1 based OV, showed promising response rates when combined with nivolumab in patients with advanced melanoma, including those resistant to prior PD-1 therapies.
- Delivery Enhancements: Strategies like viral capsid modifications, nanoparticle shielding, cellular carriers, and engineering OVs to express matrix-degrading enzymes (e.g., hyaluronidase) improve viral circulation, tumor penetration, and immune infiltration.
- Biomarkers and Monitoring: The development of liquid biopsy and imaging biomarkers allows dynamic monitoring of viral persistence, immune cell infiltration, and therapeutic responses to optimize treatment.
- Clinical Progress: Several OVs have attained regulatory approval or are in advanced clinical trials, exemplified by T-VEC (FDA-approved for advanced melanoma), Oncorine, and Reolysin. Emerging OVs with enhanced immunomodulatory profiles—such as CARG-2020 targeting IL-12, IL-17, and PD-L1 pathways—are entering clinical testing. Adoptive cellular therapies like TILs (tumor-infiltrating lymphocytes) are also evolving with engineered variants that express immune-stimulating proteins, showing promising early-phase trial results.
In the realm of cancer-specific advancements, several companies are making headway:
- Calidi Biotherapeutics has completed a phase 1 clinical trial for its lead candidate, NeuroNova 1 (NNV1), in patients with newly diagnosed high-grade gliomas. The trial established NNV1's safety and signs of efficacy.
- CG Oncology is focusing on developing and commercializing a potential bladder-sparing therapeutic for patients afflicted with bladder cancer. Their primary product candidate, cretostimogene grenadenorepvec, is designed to preferentially replicate in retinoblastoma gene pathway-defective cells present in the majority of urothelial carcinomas and trigger an anti-tumor immune response.
- KaliVir Immunotherapeutics announced FDA clearance of an Investigational New Drug application to initiate a phase 1 trial for ASP1012 in patients with locally advanced or metastatic solid tumors.
- IconOVir Bio announced the first patient had been dosed in a phase 1 clinical trial of IOV-1042 in patients with relapsed or refractory solid tumors in July 2023.
- TILT Biotherapeutics is conducting phase 1 clinical trials in combination with tumor infiltrating lymphocytes (TIL) therapy in Europe for its lead candidate, TILT-123.
- Genelux received FDA Fast Track Designation for Olvi-Vec in platinum-resistant/refractory ovarian cancer in November 2023.
- Akamis Bio's T-SIGn therapeutics have the potential to be used either as a monotherapy or in combination with other immuno-oncology agents, such as CAR-T cell therapy. Their mission is to deliver novel immunotherapeutic proteins, biomolecules, and transgene combinations to treat solid tumors using its Tumor-Specific Immuno-Gene Therapy (T-SIGn) platform. They announced a $30 million financing in January 2023 to fund development activities for its clinical-stage programs, NG-350A and NG-641.
In summary, recent progress in oncolytic virus therapies emphasizes improved viral design, combination regimens with checkpoint inhibitors, sophisticated delivery methods, and biomarker-driven patient management, with promising clinical outcomes especially in melanoma and other refractory cancers. The global oncolytic virus therapies market size is expected to reach $609.7 million in 2028, registering a compound annual growth rate (CAGR) of 26.2% during the forecast period. The future of oncolytic virus therapies looks promising, with numerous clinical trials underway and more advancements on the horizon.
- The advancements in oncolytic virus (OV) therapies, such as cell therapy and gene therapy, are contributing to the field of biotech, with recent key developments focusing on genetic engineering, immunotherapy, and clinical trials for various medical conditions including cancer.
- Companies like Calidi Biotherapeutics, CG Oncology, KaliVir Immunotherapeutics, IconOVir Bio, TILT Biotherapeutics, Genelux, and Akamis Bio are making significant strides in the development and commercialization of OVs for cancer treatment, with several of their candidates in clinical trials or having received regulatory approval.
- These OV therapies are increasingly being combined with other treatments, like immunotherapy, CAR-T cell therapies, and radiotherapy, to address resistance and elicit stronger systemic anti-tumor immune responses, as demonstrated by RP1 in patients with advanced melanoma.
- The future of oncolytic virus therapies appears promising, as the global market size is projected to reach $609.7 million by 2028, driven by a compound annual growth rate of 26.2%, underscoring the importance of science and health-and-wellness in cancer research and treatment.