On February 21, 2024 Immix Biopharma, Inc. (Nasdaq: IMMX), a clinical-stage biopharmaceutical company trailblazing cell therapies in autoimmune disease, reported its 12-month progress update including shareholder letter (Press release, Immix Biopharma, FEB 21, 2024, View Source [SID1234640326]).
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"The past 12 months have seen landmark achievements for Immix Biopharma, cementing our position as a leading cell therapy company in autoimmune disease. We successfully received U.S. FDA investigational new drug clearance for NXC-201. NXC-201 is the only CAR-T in AL Amyloidosis and is expanding into additional autoimmune indications, a $25 billion combined annual market segment, where limited treatments are available today. At the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December 2023, we presented clinical data from additional NXC-201 patients enrolled in our ongoing NEXICART-1 clinical trial, totaling 73 NXC-201 patients dosed to-date, demonstrating 100% and 95% overall response rates in relapsed/refractory AL Amyloidosis patients and relapsed/refractory multiple myeloma patients, respectively. We received U.S. FDA Orphan Drug Designation in both AL Amyloidosis and multiple myeloma, as well as EU Orphan Drug Designation for AL Amyloidosis. NXC-201 is the first and only ‘Single-Day CRS’ CAR-T, a critical advancement for autoimmune diseases like AL Amyloidosis," said Ilya Rachman, MD PhD CEO Immix Biopharma. Gabriel Morris, CFO Immix Biopharma, added, "In the next 12 months, we plan to continue our approximately quarterly clinical data updates, presenting at premier academic forums, finalize the selection of our next autoimmune indication, and to dose U.S. patients with NXC-201. We are in an exciting position as the premier autoimmune CAR-T company with a robust clinical dataset. Top-tier U.S. clinical sites are currently being activated for NXC-201 dosing."
In the last 12 months, Immix Biopharma achieved:
Clinical
Dosed additional NXC-201 patients: totaling 10 relapsed/refractory AL Amyloidosis patients and 63 relapsed/refractory multiple myeloma patients, presented at the 65th annual ASH (Free ASH Whitepaper) conference in San Diego, CA
Regulatory
Received U.S. Food and Drug Administration (FDA) clearance of Investigational New Drug (IND) for NXC-201 treatment of U.S. patients
Received FDA Orphan Drug Designation (ODD) for the treatment of AL Amyloidosis
Received FDA Orphan Drug Designation (ODD) for the treatment of multiple myeloma
Received EU Orphan Drug Designation (ODD) for the treatment of AL Amyloidosis
Expanded Scientific Advisory Board Membership
Heather Landau, MD – Memorial Sloan Kettering Amyloidosis Program Director
Michaela Liedtke, MD – Stanford Medicine Cancer Center Hematology Program Lead and Co-Director Stanford Amyloid Center
Suzanne Lentzsch, MD – Director of the Multiple Myeloma and Amyloidosis Program at the College of Physicians and Surgeons of Columbia University and at New York Presbyterian Hospital
Marko Radic, PhD – Autoimmune CAR-T Pioneer and Associate Professor at the University of Tennessee Health Science Center
Vaishali Sanchorawala, MD – Skinner Professor of Amyloidosis Research in the Department of Medicine at Boston University Chobanian & Avedisian School of Medicine, and Director of the Amyloidosis Center at Boston Medical Center (BMC) and Boston University
Expanded Team
Dr. Gerhard Bauer, head of cell therapy manufacturing, with more than two decades of experience in design, manufacturing, and operation of GMP cell therapy manufacturing facilities and numerous investigational new drug (IND) applications to FDA
David Marks, MBBS, PhD, chief medical officer, cell therapy, who was appointed by regulators as a clinical expert in 2 CAR-T regulatory approvals: KYMRIAH and TECARTUS
Henry A. McKinnell, former Pfizer CEO; Mary Sue Coleman, former Johnson & Johnson Director; Jeffrey Cooper, former BioMarin CFO; Edward Borkowski, former Mylan CFO, who along with existing director Helen Adams have participated in close to $20 billion in U.S. pharmaceutical mergers & acquisitions
Additional team members across business development, regulatory, clinical and research & development staff
NXC-201 AL Amyloidosis Publications and Presentations
ASH – 65th Annual American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (AL Amyloidosis) – Dec 10, 2023 Oral Presentation
ASH – 65th Annual American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition – (AL Amyloidosis) – 2023 Abstract
IMS – International Myeloma Society – 20th Annual Meeting – Oral Presentation (AL Amyloidosis) – Sep 27-30, 2023 Oral Presentation
ASGCT – American Society of Gene & Cell Therapy – 29th Annual Meeting – May 19, 2023 Oral Presentation (Late-Breaking)
ASGCT – American Society of Gene & Cell Therapy – 29th Annual Meeting – May 19, 2023 Late-Breaking Abstract
NXC-201 Multiple Myeloma Publications and Presentations
ASH – 65th Annual American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition – (Multiple Myeloma) – Dec 11, 2023 Poster Presentation
ASH – 65th Annual American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition – (Multiple Myeloma) – 2023 Abstract
IMS – International Myeloma Society – 20th Annual Meeting – (Multiple Myeloma) – Sep 27-30, 2023 Poster Presentation
European Society for Blood and Marrow Transplantation 49th Annual Meeting – 58 Patient Clinical Data Poster Presentation – Apr 23-26, 2023 Poster Presentation
5th European CAR T-cell Meeting – 42 Patient Clinical Data Poster Presentation – Feb 9-11, 2023 Poster Presentation
Publication: Asherie N, Kfir-Erenfeld S, Avni B, Assayag M, Dubnikov T, Zalcman N, Lebel E, Zimran E, Shaulov A, Pick M, Cohen Y, Avivi I, Cohen C, Gatt ME, Grisariu S, Stepensky P. Development and manufacture of novel locally produced anti-BCMA CAR T cells for the treatment of relapsed/refractory multiple myeloma: results from a phase I clinical trial. Haematologica. 2023 Jul 1;108(7):1827-1839. doi: 10.3324/haematol.2022.281628. PMID: 36200421; PMCID: PMC10316256.
Editorial Publication: Sjöstrand M, Sadelain M. Driving CARs to new places: locally produced BCMA CAR T cells to treat multiple myeloma. Haematologica. 2023 Jul 1;108(7):1721-1723. doi: 10.3324/haematol.2022.282053. PMID: 36794501; PMCID: PMC10316265.
The above publications and presentations are available on the "publications" section of the ImmixBio website.
Investor Events
Presented at the Bank of America Healthcare Trailblazers Conference
Presented at the JMP Securities Hematology and Oncology Summit
Hosted a Key Opinion Leader (KOL) event discussing NXC-201 for the treatment of relapsed/refractory AL Amyloidosis (November 29 2023)