LOS ANGELES, Feb. 21, 2024 — Immix Biopharma, Inc. (Nasdaq: IMMX), a clinical-stage biopharmaceutical company trailblazing cell therapies in autoimmune disease, today announced its 12-month progress update including shareholder letter.
“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) 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 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 Annual Meeting and Exposition (AL Amyloidosis) – Dec 10, 2023 Oral Presentation
- ASH – 65th Annual American Society of Hematology 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 Annual Meeting and Exposition – (Multiple Myeloma) – Dec 11, 2023 Poster Presentation
- ASH – 65th Annual American Society of Hematology 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)
Immix Biopharma Annual Letter to Shareholders
Greetings and best in 2024 to you, colleagues and families from the Immix Biopharma Team. As we reflect on the last 12 months of progress, we wish to connect with you offering an update on Immix Biopharma. We express our deep appreciation for the patience of our shareholders throughout these impactful 12 months.
We are excited to share remarkable progress at Immix Biopharma. Our recent clinical trials for the groundbreaking NXC-201 CAR-T cell therapy have yielded promising results in treating relapsed/refractory AL Amyloidosis (r/r ALA) and relapsed/refractory multiple myeloma (r/r MM), for which NXC-201 has received US FDA Orphan Drug Designation (ODD) in both indications. NXC-201 has demonstrated favorable toxicity, promising clinical results and “Single-Day CRS”, uniquely suited for dosing AL Amyloidosis and expanding into other autoimmune indications. These trials showcased high response rates and promising patient outcomes, solidifying our position as the premier autoimmune CAR-T company, with an unparalleled 73 patients treated to-date. A concise summary of our 2023 clinical results can be found on our “publications” section of our website under “65th American Society of Hematology (ASH) Meeting December 2023.” ASH is the global premier forum for presenting clinical results in blood diseases.
In addition, we plan to continue our success in the U.S., and in new autoimmune indications with high unmet medical need beyond r/r ALA and r/r MM. We recently received U.S. FDA IND (Investigational New Drug) approval in Q4 2023, and are initiating U.S. clinical studies. This achievement underscores our commitment to pioneering transformative therapies that redefine patient care and treatment paradigms. As a recognition of our cell therapy leadership, we were invited by the global investment community to present at the Bank of America Healthcare Trailblazers Conference in October and the JMP Securities Hematology and Oncology Summit in December.
We must credit our team’s tireless efforts for their advancement of our clinical programs, and are grateful to our board of directors, scientific advisory board members, and team members who have supported Immix Biopharma along our journey to bring innovative cell therapies to deliver widely accessible cures. Patients are waiting!
We are grateful for the unwavering support of our investors, collaborators and the tireless effort of our team and look forward to providing ongoing updates during the next 12 months through investor communications, scientific symposia and medical meetings.
Best Regards,
Ilya Rachman, MD, PhD & Gabriel Morris
CEO & CFO, Immix Biopharma
About Immix Biopharma, Inc.
Immix Biopharma, Inc. (ImmixBio) (Nasdaq: IMMX) is a clinical-stage biopharmaceutical company trailblazing cell therapies in autoimmune disease. Our lead cell therapy asset is next generation CAR-T NXC-201 for autoimmune disease, relapsed/refractory AL Amyloidosis, and relapsed/refractory multiple myeloma, currently being evaluated in our ongoing Phase 1b/2a NEXICART-1 (NCT04720313) clinical trial. NXC-201 has the potential to be the world’s first “Single-Day CRS” CAR-T (CRS median onset day 1, median duration 1 day), enabling the potential for a faster return home for patients and supporting ongoing expansion into autoimmune indications. NXC-201 has been awarded Orphan Drug Designation (ODD) by the FDA in both AL Amyloidosis and multiple myeloma. Our second program, a tissue specific therapeutic (TSTx) asset IMX-110, is being evaluated 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. IMX-110 has been awarded Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) by the FDA. Learn more at immixbio.com.
Forward Looking Statements
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.
Contacts
Mike Moyer
LifeSci Advisors
mmoyer@lifesciadvisors.com
Company Contact
irteam@immixbio.com
