Gradalis develops Vigil, a personalized, triple-function cellular immunotherapy that uses bi-shRNA to reduce furin and increase GM-CSF expression to decloak tumor antigens and stimulate tumor-specific T-cell responses. Vigil is manufactured from a patient’s own tumor tissue and has shown safety and signals of clinical benefit across Phase 1, 2A, and 2B studies, including a randomized Phase 2b (VITAL) trial that demonstrated statistically significant improvements in recurrence-free survival and overall survival in certain molecular subgroups. The company reports no Grade 3 or 4 treatment-related adverse events in studies to date and has observed activity across multiple tumor types and in combination or sequence with checkpoint inhibitors. Gradalis’ manufacturing process takes two days and uses tumor tissue shipped to its manufacturing plant in Dallas, Texas, producing vials for intradermal administration every three to four weeks. The company is preparing a pivotal Phase 2 study in platinum-sensitive recurrent ovarian cancer patients with homologous recombination proficient (HRP) tumors and intends to pursue accelerated approval if results are positive. Financially, Gradalis was awarded a $9.9 million Product Development Research grant from the Cancer Prevention and Research Institute of Texas to support the Phase 2 study and external validation of its technology. Gradalis is a Dallas, Texas–based biotechnology company focused on developing, manufacturing and commercializing drugs, vaccines, tools and diagnostics primarily for cancer. The company operates two primary platforms: a personalized autologous vaccine platform (FANG™) and a bifunctional short hairpin RNA platform delivered via a proprietary lipoplex. Led by David Shanahan (president, CEO and co‑founder), Gradalis is advancing FANG™ through clinical development while also progressing clinical and preclinical work on its shRNA platform. The company plans to use new capital to advance FANG™ into late‑stage clinical trials and to expand manufacturing capabilities to support a potential commercial launch. Financially, Gradalis completed a Series B financing totaling $24M; backers were not disclosed in the article.

Total raised

$34M

Funding rounds

2

Latest round

Grant

Latest activity

Nov 2023