CaroGen

CaroGen Corporation is a clinical-stage biopharmaceutical firm established in 2012, specializing in the development of immunotherapies for cancer and infectious diseases. The company was co-founded by Dr. Bijan Almassian, who serves as President and CEO, and Dr. Valerian Nakaar, the Chief Scientific Officer. Dr. Almassian is a seasoned pharmaceutical executive with extensive experience in leading R&D operations at various life science companies. Dr. Nakaar, a vaccine expert, identified the core technology while seeking a potent vaccine delivery platform. Their collaboration was strengthened by the inclusion of academic co-founders Dr. John Rose, the inventor of the platform, and Dr. Michael Robek, a recognized expert in the hepatitis B virus.

The company's operations are centered around its proprietary AVIDIO (Artificial Virus for Infectious Diseases and Immuno-Oncology) platform, a versatile virus-like vesicle (VLV) technology exclusively licensed from Yale University. This self-amplifying RNA-based technology acts as an artificial virus, designed to deliver a high payload of antigens or immune modulators to elicit a robust and broad immune response. A key feature of the AVIDIO platform is its ability to overcome the delivery challenges often associated with mRNA therapies without requiring external formulation agents.

CaroGen's business model focuses on maintaining a lean core management team while collaborating with academic institutions to advance its product pipeline. The firm generates revenue through a combination of government grants, private investments, and potential future licensing agreements. To date, CaroGen has secured significant non-dilutive funding, including over $16 million in grants from the National Institutes of Health (NIH) and the Department of Defense (DoD), which has substantially de-risked its lead program.

The company's lead product candidate is CARG-201, a therapeutic vaccine for patients with chronic hepatitis B virus (HBV) infection, a condition affecting over 300 million people globally with no available cure. CARG-201, currently in IND-enabling preclinical development, is designed to deliver two key HBV antigens to stimulate the immune system and has shown significant reduction of HBV markers in animal models. The DoD has recommended up to $6.2 million in funding to advance CARG-201 through Phase I clinical trials. Another prominent candidate is CARG-2020, an oncolytic immunotherapy for solid tumors, including ovarian, melanoma, and breast cancer. CARG-2020 delivers multiple immune modulators that work synergistically, demonstrating the ability to eradicate large tumors and prevent recurrence in preclinical models.

Keywords: immunotherapies, vaccine platform, virus-like vesicle, VLV, AVIDIO platform, self-amplifying RNA, chronic hepatitis B, HBV vaccine, CARG-201, oncolytic virus, cancer immunotherapy, CARG-2020, Yale University spin-off, Bijan Almassian, Valerian Nakaar, John Rose, Michael Robek, infectious diseases, solid tumors, clinical-stage biopharmaceutical