CIRM Awards $56 Million to Advance Clinical Research, Including Lupus and Glioblastoma

CIRM Awards $56 Million to Advance Clinical Research, Including Lupus and Glioblastoma

Rare Daily Staff

The California Institute for Regenerative Medicine (CIRM), the world’s largest institution dedicated to regenerative medicine, awarded $56 million to fund various clinical research aimed at treating Parkinson’s disease, autoimmune conditions, and a variety of cancers.

The awards will support seven projects in the agency’s clinical program which provides funding for eligible stem cell and gene therapy-based projects through all stages of clinical trial development.

In addition, CIRM approved awarding $21.3 million to create a network of Shared Resources Laboratories (SRLs) for Stem Cell-Based Modeling, an important component of CIRM’s Infrastructure Program, which is designed to address the challenges that hinder progress in the regenerative medicine field.

Three of the clinical awards approved were for programs focused on the rare cancer glioblastoma and the rare autoimmune disease systemic lupus erythematosus.

CIRM awarded $10.9 million to Hideho Okada at UCSF for a phase 1 study of autologous E-SYNC T cells in adult participants with EGFRvIII+ glioblastoma.

CIRM awarded $8 million to Jonathan Benjamin at ImmPACT-Bio for a phase 1/2 study evaluating a bi-specific CD19/CD20-directed CAR T cell in refractory lupus nephritis and systemic lupus erythematosus.

Through a $7.9 million award to Barbara Hickingbottom of Fate Therapeutics, CIRM and Fate will advance clinical research for FT819, an off-the-shelf induced pluripotent stem cell (iPSC)-derived CD19 CAR T-cell therapy for systemic lupus erythematosus (SLE). SLE is a debilitating autoimmune disease and affects about 200,000 Americans, particularly women of color.

FT819 targets B cells with the aim to reset the immune system and provide drug-free remission for patients with autoimmune diseases.  Fate manufactures FT819 using a clonal master iPSC line as a renewal cell source, providing a uniform cell therapy product that is mass produced and delivered off-the-shelf to patients. As a result, FT819 is designed to bring the curative potential of cell therapy to large numbers of patients with SLE and other autoimmune diseases.

“CD19 CAR T cell therapy has demonstrated tremendous potential for patients with autoimmune diseases,” said Hickingbottom. She said the therapy is the industry’s first CAR T-cell therapy manufactured from a clonal master iPSC line to reach clinical investigation.

Photo: Barbara Hickingbottom of Fate Therapeutics