LOS ANGELES — Immix Biopharma, Inc. (Nasdaq:IMMX), a clinical-stage biopharmaceutical company advancing personalized therapies for oncology and immunology, today announced that it will host a virtual KOL event to discuss its BCMA-Targeted CAR-T cell therapy candidate NXC-201, in development for relapsed/refractory AL amyloidosis (R/R ALA) and relapsed/refractory multiple myeloma (R/R MM) with planned expansion into autoimmune indications, on November 29, 2023 at 4:15 pm ET.
The event will feature Heather Landau, MD (Director of Amyloidosis Program, Memorial Sloan-Kettering Cancer Center), Vaishali Sanchorawala, MD (Professor, Boston University School of Medicine), and Susan Bal, MD (Assistant Professor, University of Alabama at Birmingham) who will discuss the current treatment paradigm for patients with relapsed/refractory AL Amyloidosis and the NEXICART-1 study of NXC-201 as a potential chimeric antigen receptor T (CAR-T) treatment option.
NXC-201 is a BCMA-targeted investigational CAR-T cell therapy. NXC-201 has been dosed in more than 70 patients to date and has demonstrated promising Phase 1/2a data in ALA, with a 100% overall response rate (9/9) in heavily pre-treated relapsed/refractory AL amyloidosis patients, as well as a 95% overall response rate, with a median of 11.9 months of follow-up, in patients with R/R MM (36/38 heavily pre-treated patients).
On November 21, 2023, IMMX announced receipt of IND clearance to expand NXC-201 dosing into the U.S. NXC-201 has been selected for an oral presentation and a poster presentation at the American Society for Hematology 65th Annual Meeting on December 10, and December 11, 2023.
NXC-201 has been awarded Orphan Drug Designation (ODD) by the FDA in both AL Amyloidosis and multiple myeloma.
A live question and answer session will follow the formal presentations.
About Heather Landau, MD
Heather Landau, MD, is the Director of Amyloidosis Program and a Bone Marrow Transplant Specialist & Cellular Therapist at Memorial Sloan-Kettering Cancer Center in New York, with extensive experience designing clinical trials in hematology and oncology, novel treatment approaches for AL amyloidosis and multiple myeloma, and thought leadership.
Dr. Landau has authored more than 100 peer-reviewed publications. Dr. Landau received her medical degree from SUNY Upstate Medical University, completed her Internal Medicine residency at University of Colorado and her Hematology & Oncology fellowship at Memorial Sloan Kettering Cancer Center. Dr. Landau is board certified in Internal Medicine, Medical Oncology, and Hematology.
About Vaishali Sanchorawala, MD
Vaishali Sanchorawala, MD is the Director of the Amyloidosis Center at Chobanian and Avedisian School of Medicine and Skinner Professor of Amyloidosis Research in the Department of Medicine at Boston University.
Dr. Sanchorawala is a widely published researcher, recognized international clinical expert and key opinion leader whose work has defined the field in AL amyloidosis and resulted in the evolution of the standard of care for these patients. Dr. Sanchorawala is leading several clinical trials for the treatment of AL amyloidosis, including two conducted through the Southwest Oncology Group (SWOG0115 and SWOG1702). Under her leadership, these trials completed accrual in a timely fashion, resulting in publications in peer-reviewed journals.
Dr Sanchorawala a member of the Executive Steering Committee of Amyloidosis Research Consortium which is developing pathways to education, patient voice, development of treatment and access to novel therapies. She has participated in meetings with the FDA for enhancing the amyloidosis drug development pathway and providing guidance for more efficient and successful programs. Dr Sanchorawala also serves on the advisory board of number of leading pharmaceutical partners for drugs in AL amyloidosis.
Dr Sanchorawala is dedicated to cultivating the next generation of physician-scientists in the area of clinical research in AL amyloidosis. She regularly participates in patient information seminars and support group meetings.
Dr Sanchorawala serves as the Associate Editor of Amyloid: The Journal of Protein Folding Disorders. She was the secretary of the International Society of Amyloidosis for the term 2020-2022. She completed her medical training at Boston University Medical Center and Rutgers Health and is board certified in Internal Medicine and Hematology.
About Susan Bal, MD
Susan Bal, MD is an Assistant Professor in the Division of Hematology and Medical Oncology at the University of Alabama at Birmingham (Birmingham, AL). She is also an Associate Scientist at the O’Neal Comprehensive Cancer Center. Prior to moving to Birmingham, she completed an advanced fellowship in Stem Cell Transplant and Immunotherapy at Memorial Sloan Kettering Cancer Center (New York, NY) as well as her Hematology and Medical Oncology fellowship at the University of Cincinnati (Cincinnati, OH). Her clinical and research interests include plasma cell dyscrasia as well as transplant and cellular therapies. Dr. Bal is board certified in Internal Medicine and Hematology.
About NXC-201
NXC-201 (formerly HBI0101) is a BCMA-targeted investigational chimeric antigen receptor T (CAR-T) cell therapy that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed/refractory AL amyloidosis, relapsed/refractory multiple myeloma, and potentially expanding into autoimmune indications: systemic lupus erythematosus (SLE), myasthenia gravis (MG), and multiple sclerosis (MS).
NXC-201 has been awarded Orphan Drug Designation (ODD) by the FDA in both AL Amyloidosis and multiple myeloma.
About NEXICART-1
NEXICART-1 (NCT04720313) is an ongoing Phase 1b/2a, open-label study evaluating the safety and efficacy of NXC-201 (formerly HBI0101), in adults with relapsed/refractory multiple myeloma and relapsed/refractory AL amyloidosis.
The primary objective of the Phase 1b portion of the study is to characterize the safety and confirm the recommended Phase 2 dose (RP2D) and Phase 2 dose of NXC-201. The Phase 1b portion has been successful in determining the recommended Phase 2 dose (RP2D) of 800 million CAR+T cells. The expected primary endpoint for the Phase 2 portion in relapsed/refractory multiple myeloma is overall response rate and duration of response. ImmixBio plans to submit data to the FDA in relapsed/refractory multiple myeloma once 100 patients are treated with NXC-201. The expected primary endpoint for NXC-201 in relapsed/refractory AL Amyloidosis is overall response rate. ImmixBio plans to submit data to the FDA in relapsed/refractory AL amyloidosis once 30-40 patients are treated with NXC-201.
About AL Amyloidosis
AL amyloidosis is a rare systemic disorder caused by an abnormality of plasma cells in the bone marrow. Misfolded amyloid proteins produced by these cells cause a buildup of misfolded immunoglobulin proteins in and around tissues, nerves, and organs, gradually affecting their function. This can cause progressive and widespread organ damage and high mortality rates.
AL amyloidosis affects roughly 30,000 – 45,000 patients in the U.S. and Europe, and it is estimated that there are approximately 3,000 – 4,000 new cases annually in the U.S. The estimated annual global incidence of AL Amyloidosis is ~15,000 patients. The Amyloidosis market was $3.6 billion in 2017, expected to reach $6 billion in 2025, according to Grand View Research.
About Immix Biopharma, Inc.
Immix Biopharma, Inc. (ImmixBio) (Nasdaq: IMMX) is a clinical-stage biopharmaceutical company pioneering personalized therapies for oncology and immunology with more than 100 patients treated to-date. Our lead cell therapy asset is CAR-T NXC-201 for relapsed/refractory AL Amyloidosis and relapsed/refractory multiple myeloma, for which we have observed overall response rates of 100% and 95%, respectively, in the ongoing Phase 1b/2a NEXICART-1 (NCT04720313) clinical trial (July 17, 2023). NXC-201 has the potential to be the world’s first “Single-Day CRS” CAR-T, enabling a faster return home for patients. Expansion into autoimmune indications is planned: systemic lupus erythematosus (SLE), myasthenia gravis (MG), and multiple sclerosis (MS). NXC-201 has been awarded Orphan Drug Designation (ODD) by the FDA in both AL Amyloidosis and multiple myeloma. Our lead tissue specific therapeutic (TSTx) asset IMX-110, currently in Phase 1b/2a clinical trials as a monotherapy and IMMINENT-01 combination clinical trial with BeiGene’s anti-PD-1 antibody tislelizumab in relapsed/refractory solid tumors, holds Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) by the FDA.
Contacts
Mike Moyer
LifeSci Advisors
[email protected]