Seven notable oncolytic virus firms worth exploring

Seven notable oncolytic virus firms worth exploring

Leading Companies Advance Oncolytic Virus Therapies in Cancer Treatment

The field of oncolytic virus therapies in immuno-oncology is rapidly expanding, with several biotech and pharmaceutical companies at the forefront of this promising approach to cancer treatment.

Akamis Bio, formerly known as PsiOxus Therapeutics, is an oncology company with a mission to use its Tumor-Specific Immuno-Gene Therapy (T-SIGn) platform to treat solid tumors. The company's portfolio consists of therapies that target both primary and metastatic epithelial-derived solid tumor tissue, turning solid tumor cells into "drug factories" while leaving healthy tissue unaltered. Akamis Bio recently secured a $30 million financing to fund development activities for its clinical-stage programs, NG-350A and NG-641.

Calidi Biotherapeutics is a clinical-stage biotech focused on proprietary genetically engineered oncolytic viruses. Their lead candidate, CLD-401, targets metastatic cancers. Calidi Biotherapeutics aims to revolutionize the effective delivery and potentiation of oncolytic viruses for targeted therapy against difficult-to-treat cancers. The company plans to commence a phase 1b/2 clinical trial for NNV1, their oncolytic adenovirus-based therapy for the treatment of patients with glioblastoma, in collaboration with Northwestern University during the first half of 2024.

CG Oncology is focused on developing and commercializing a potential bladder-sparing therapeutic for patients afflicted with bladder cancer. Their primary product candidate, cretostimogene grenadenorepvec, is an engineered oncolytic immunotherapy designed to preferentially replicate in retinoblastoma gene pathway-defective cells present in the majority of urothelial carcinomas and trigger an anti-tumor immune response. In November 2023, the U.S. Food and Drug Administration (FDA) granted Fast Track Designation and Breakthrough Therapy Designation for cretostimogene in BCG-unresponsive NMIBC with carcinoma in situ with or without Ta or T1 (papillary) tumors. CG Oncology announced the closing of an upsized $437 million initial public offering (IPO) in January 2024.

Other notable companies in this field include Amgen, Merck, Oncorus, Replimune, SillaJen, TILT Biotherapeutics, Transgene, and ViraTherapeutics. These firms are leading significant clinical and preclinical development programs leveraging genetically engineered viruses to selectively infect and kill cancer cells while stimulating anti-tumor immunity.

The global oncolytic virus therapies market is expected to reach $609.7 million in 2028, registering a compound annual growth rate (CAGR) of 26.2% during the forecast period. The primary factors driving the growth of the market are a rise in the prevalence of cancer, an increase in the number of clinical trials, and investment in research and development for cancer therapies.

IconOVir Bio announced the first patient was dosed in a phase 1 clinical trial of IOV-1042 in patients with relapsed or refractory solid tumors in July 2023. TILT Biotherapeutics' lead candidate, TILT-123, is in phase 1 clinical trials in combination with tumor infiltrating lymphocytes (TIL) therapy in Europe, with promising initial efficacy responses observed in some patients.

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. Genelux received FDA Fast Track Designation for Olvi-Vec in platinum-resistant/refractory ovarian cancer in November 2023.

As the market for oncolytic virus therapy continues to grow, these companies and others will continue to push the boundaries of cancer treatment, combining direct tumor lysis with immune activation to create durable cancer treatment responses. Several have major clinical milestones anticipated in the next 1-3 years.

1. Akamis Bio, with its Tumor-Specific Immuno-Gene Therapy platform, targets both primary and metastatic epithelial-derived solid tumor tissue, leveraging science to turn solid tumor cells into "drug factories" without affecting healthy tissue.
2. Calidi Biotherapeutics is aiming to revolutionize oncolytic virus therapies, focusing on proprietary genetically engineered viruses and aiming to commence a phase 1b/2 clinical trial for NNV1 in the first half of 2024.
3. CG Oncology's primary product candidate, cretostimogene grenadenorepvec, has received Fast Track Designation and Breakthrough Therapy Designation from the FDA for BCG-unresponsive NMIBC, indicating a potential bladder-sparing therapeutic for bladder cancer patients.
4. The global oncolytic virus therapies market is projected to reach $609.7 million by 2028, driven by factors such as a rise in the prevalence of medical-conditions like cancer, an increase in the number of clinical trials, and investment in research and development for health-and-wellness solutions like cancer therapies.
5. Companies such as IconOVir Bio, TILT Biotherapeutics, KaliVir Immunotherapeutics, and Genelux are making significant strides in the field, conducting clinical trials for their immunotherapy and gene therapy treatments for various types of cancer, anticipating major clinical milestones in the next 1-3 years.

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