LOS ANGELES, Nov. 22, 2023 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (Nasdaq:IMMX) (“ImmixBio”, “Company”, “We” or “Us”), 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. To register for the event, click here.
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.
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.
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. Learn more at www.immixbio.com.
This press release contains “forward-looking statements.” Forward-looking statements reflect our current view about future events. When used in this press release, the words “anticipate,” “believe,” “estimate,” “expect,” “future,” “intend,” “plan,” or the negative of these terms and similar expressions, as they relate to us or our management, identify forward-looking statements. Such statements, include, but are not limited to, statements contained in this press release relating to our business strategy, our future operating results, continuing development of our product candidates, including development timelines, timing of FDA submissions and expected endpoints, long-term visions and strategies, evaluations and judgements and beliefs regarding potential efficacy and safety of our product candidates, future clinical development of our product candidates, including any implication that results or observations in initial data, data observed to date, or earlier clinical trials will be representative of results or observations in later data or clinical trials, the expected timing of such results and the potential market size and benefits for our product candidates. Forward-looking statements are based on our current expectations and assumptions regarding our business, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Our actual results may differ materially from those contemplated by the forward-looking statements. They are neither statements of historical fact nor guarantees of assurance of future performance. We caution you, therefore, against relying on any of these forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, without limitation, our ability to raise capital to fund continuing operations; our ability to protect our intellectual property rights; the impact of any infringement actions or other litigation brought against us; competition from other providers and products; our ability to develop and commercialize products and services; changes in government regulation; our ability to complete capital raising transactions; that our product candidates may not realize the anticipated responses discussed in this release or that their development may suffer delays that materially and adversely affects future commercial viability; that the market for our product candidates may not grow at the rates anticipated or at all; and other factors relating to our industry, our operations and results of operations. Actual results may differ significantly from those anticipated, believed, estimated, expected, intended or planned, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Immix Biopharma’s Annual Report on Form 10-K for the year ended December 31, 2022, and other periodic reports subsequently filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and we specifically disclaim any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We cannot guarantee future results, levels of activity, performance or achievements.