Gradalis

Gradalis, Inc. is a late-stage clinical biotechnology firm focused on developing and commercializing personalized immunotherapies for cancer. Founded in 2003 by David Shanahan and Dr. John Nemunaitis, the company operates from Carrollton, Texas. Shanahan, who serves as Chairman, was inspired to start the company by his grandmother's battle with cancer and previously led the Mary Crowley Cancer Research Centers. Dr. Nemunaitis, the Chief Scientific Officer, is a board-certified oncologist with over three decades of experience in cancer therapy research and has held academic positions at several cancer research centers. The company's business model centers on the development and eventual commercialization of its proprietary therapeutic platforms. Gradalis has secured significant funding, including a Series B round of $24 million in 2013 and a total of over $100 million from investors like WP Global Partners and the Cancer Prevention and Research Institute of Texas (CPRIT).

The company's lead product candidate is Vigil® (gemogenovatucel-T), a personalized cellular immunotherapy. Vigil is created using a patient's own tumor tissue, which is genetically modified to enhance the immune system's ability to recognize and attack cancer cells. This is achieved through a proprietary bi-shRNA therapy platform that performs three key functions: it blocks the production of immunosuppressive proteins (TGF beta types 1 and 2), stimulates the immune system by producing GM-CSF, and exposes the immune system to the full range of the patient's specific tumor antigens. The manufacturing process involves taking a small piece of a patient's tumor, modifying its genetics, and preparing it for intradermal injection over a period of up to six months. This approach makes Vigil a highly personalized treatment applicable to the patient's unique cancer profile.

Gradalis is primarily targeting the oncology market, with a specific focus on ovarian cancer. An estimated 23,000 women are diagnosed with ovarian cancer annually in the U.S., with around 13,000 succumbing to the disease. In a Phase 2b clinical trial (VITAL), Vigil demonstrated a positive trend in recurrence-free survival for the overall patient population and a significant improvement in both recurrence-free and overall survival for a subgroup of ovarian cancer patients with the BRCA wild-type (BRCA-wt) profile. Based on these results, the FDA has granted Vigil the Regenerative Medicine Advanced Therapy (RMAT) designation. The company is now preparing for a pivotal Phase 3 registration trial for this patient subgroup, funded in part by a grant from CPRIT, with the goal of seeking accelerated regulatory approval. Beyond ovarian cancer, Phase 1 trials have indicated positive activity in 19 different tumor types, suggesting a broad potential market for the Vigil platform.

Keywords: personalized immunotherapy, cellular therapy, cancer vaccines, ovarian cancer treatment, bi-shRNA platform, oncology therapeutics, clinical-stage biotechnology, Vigil, gemogenovatucel-T, TGF beta inhibitor, GM-CSF stimulation, autologous tumor cell therapy, BRCA-wt, regenerative medicine advanced therapy, cancer research, John Nemunaitis, David Shanahan, solid tumors, clinical trials, immuno-oncology, gene therapy for cancer, neoantigens, tumor microenvironment, furin inhibitor, personalized medicine