ImmPACT Bio Awarded $8 Million CIRM Grant for Phase 1b/2 Development of IMPT-514, a CD19/CD20 Bispecific CAR T-Cell Therapy for Refractory Lupus Nephritis and Systemic Lupus Erythematosus

IMPT-514 is the first-and-only CD19/CD20 CAR T-cell therapy in development for lupus

Designed to reset the immune system, IMPT-514 is a one-time treatment option with potential to replace the need for chronic immune suppression

Initial efficacy and safety data from Phase 1b/2 dose escalation trial expected 2H 2024

LOS ANGELES, Feb. 28, 2024 /PRNewswire/ -- ImmPACT Bio USA, Inc. ("ImmPACT Bio"), a clinical-stage company developing transformative logic-gate-based chimeric antigen receptor (CAR) T-cell therapies for treating cancer and autoimmune diseases, today announced that the Company has been awarded an $8 million grant from the California Institute for Regenerative Medicine (CIRM) to ImmPACT Bio's ongoing Phase 1b/2 study evaluating IMPT-514 for the treatment of refractory lupus nephritis (LN) and systemic lupus erythematosus (SLE). IMPT-514 is a potentially first-in-class CD19/CD20 bispecific CAR T-cell therapy designed for deep and extensive depletion of autoreactive immune cells.

"CAR T-cell therapies have transformed the treatment of blood cancers, but their therapeutic potential in autoimmune diseases is a promising opportunity," said Abla Creasey, Ph.D., vice president of therapeutics development at CIRM. "We are pleased to award ImmPACT Bio this funding to help advance their dual-targeting CAR T-cell therapy approach outside the realm of oncology. Importantly, we believe the ImmPACT Bio approach with IMPT-514 as a one-time treatment holds significant potential to change the treatment paradigm and clinical care of severe, refractory lupus."

Jonathan Benjamin, M.D., Ph.D., chief medical officer of ImmPACT Bio stated, "We are extremely grateful that CIRM has recognized the scientific merit and technical feasibility of our clinical trial evaluating IMPT-514 for the treatment of both LN and SLE. Lupus is a debilitating, multi-organ disease that primarily affects women, often in young adulthood. There is a critical unmet medical need for well-tolerated therapies that offer improved efficacy and durable disease remission. Based on the promising responses and a favorable safety profile observed in the UCLA trial in non-Hodgkin lymphoma, we are encouraged that IMPT-514 has potential to alleviate symptoms and spare patients the need for chronic immune suppression. We expect initial efficacy and safety data from our Phase 1b/2 dose escalation trial in the second half of 2024."

"It is important to understand that due to the heterogeneity of lupus, no two patients are alike. No 'one size fits all' treatment exists for complex individuals like me," said Kathleen A. Arntsen, president and CEO of Lupus and Allied Diseases Association, Inc. "What works in one person may not work in another. Therefore, our physicians need an arsenal of therapies to treat lupus and lupus nephritis."

IMPT-514 is being evaluated in an open label Phase 1b/2 dose escalation clinical trial in participants with active, refractory SLE that have been treated with at least two prior standard-of-care therapies and have a SLE Disease Activity Index score (SLEDAI-2K) > 8. The Phase 1 dose escalation cohort is limited to patients with active, biopsy-proven, proliferative LN. Additional patients with and without active proliferative LN will be enrolled during the Phase 2 portion of the clinical trial.

IMPT-514 has received Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of both active and refractory LN and SLE.

About Systemic Lupus Erythematosus
Systemic lupus erythematosus (SLE), commonly known as lupus, is a chronic, often severe, systemic autoimmune disease. Systemic lupus erythematosus results from an immune attack on healthy tissues and the development of widespread inflammation that results in tissue damage throughout the body. B cells are known to play an early and central role in disease pathogenesis. Lupus afflicts more than 200,000 patients in the U.S. alone, with approximately 50 percent having lupus nephritis, the most severe manifestation of SLE which can result in end-stage renal disease and increased mortality. Despite various therapies used for the treatment of SLE, including approved biologics, there remains a significant unmet need for safe and highly effective therapies for this disease.

About IMPT-514
IMPT-514 is a CD19/CD20-targeting chimeric antigen receptor (CAR) T-cell therapy that utilizes a potent bispecific CAR and a 4-1BB costimulatory domain. It is the same CAR construct as ImmPACT's IMPT-314, which is under development for certain types of non-Hodgkin's lymphoma. IMPT-314 and IMPT-514 are based on work by Yvonne Chen, Ph.D., associate professor, and Sarah Larson, M.D., associate professor of medicine, both of the University of California, Los Angeles. In preclinical studies, IMPT-514 was successfully and efficiently manufactured from heavily immunosuppressed patients with lupus nephritis and systemic lupus erythematosus and showed potent elimination of autologous B cells and a moderate cytokine profile.

About the California Institute for Regenerative Medicine (CIRM)
At CIRM, we never forget that we were created by the people of California to accelerate stem cell treatments to patients with unmet medical needs, and act with a sense of urgency to succeed in that mission. To meet this challenge, our team of highly trained and experienced professionals actively partners with both academia and industry in a hands-on, entrepreneurial environment to fast track the development of today's most promising stem cell technologies. With $5.5 billion in funding and more than 150 active stem cell programs in our portfolio, CIRM is one of the world's largest institutions dedicated to helping people by bringing the future of cellular medicine closer to reality. For more information go to www.cirm.ca.gov.

About Lupus and Allied Diseases Association, Inc.
The Lupus and Allied Diseases Association, Inc. (LADA) was founded in 1978 and is a national patient advocacy organization led by people with lupus dedicated to ensuring that the patient stakeholder is included as an equal participant in the healthcare, regulatory, and public policy arenas and across the research continuum. LADA's goal is to improve access to care and quality of life by fostering collaboration among stakeholders, promoting unity in the community, and wielding the patient and care partner voice as a catalyst to advance innovative advocacy, education, awareness and biomedical research initiatives. For more information, please visit www.ladainc.org.

About ImmPACT Bio
ImmPACT Bio USA, Inc., is a clinical-stage company dedicated to the discovery of transformative chimeric antigen receptor (CAR) T-cell therapies that address key biological challenges in treating cancer and autoimmune diseases. The company's logic-gate-based CAR T-cell platforms, licensed from University of California, Los Angeles (UCLA) Technology Development Group, are specifically designed to deplete B cells, prevent antigen escape, and overcome the immunosuppressive tumor microenvironment. The company's technology is based on the work of pioneering scientists Yvonne Chen, Ph.D., and Antoni Ribas, M.D., Ph.D., both from UCLA. For more information, visit http://www.immpact-bio.com.

SOURCE ImmPACT Bio USA Inc.