- Scheduling U.S. site initiation visits April and May 2024
- On track to dose relapsed/refractory AL Amyloidosis patients with CAR-T NXC-201 at New York City lead site and other leading U.S. sites mid-2024
- No change in patient enrollment timing
LOS ANGELES, April 18, 2024 (GLOBE NEWSWIRE) -- Nexcella, an Immix Biopharma, Inc. subsidiary (Nasdaq: IMMX) (“ImmixBio”, “Company”, “We” or “Us” or “IMMX”), a clinical-stage biopharmaceutical company trailblazing cell therapies in AL Amyloidosis and other autoimmune diseases, today announced that it is on track to dose NXC-201 patients in the U.S. with no change in patient enrollment timing.
“We are on track to dose relapsed/refractory AL Amyloidosis NXC-201 patients at our New York City lead site and other leading U.S. sites in mid-2024. U.S. site clinical trial agreements have been signed, and site initiation visits are being scheduled,” said Ilya Rachman, MD PhD CEO of Immix Biopharma and Executive Chairman of Nexcella. “Building on our existing NXC-201 clinical dataset, our U.S. relapsed/refractory AL Amyloidosis clinical trial design is focused on patients with adequate cardiac function who are most likely to experience the greatest clinical benefit from NXC-201. We are committed to providing additional treatment alternatives for relapsed/refractory AL Amyloidosis patients, where there are no FDA approved drugs today.”
About NEXICART-2
NEXICART-2 (NCT06097832) is an open-label, single-arm, multi-site Phase 1b dose expansion clinical trial in relapsed/refractory AL Amyloidosis for CAR-T NXC-201 in the United States. NEXICART-2 is expected to enroll 40 patients with adequate cardiac function over a period of approximately 18 months from first patient dosing. The objectives are the safety and efficacy of NXC-201. The expected primary endpoints are complete response rate and overall response rate according to consensus recommendations (Palladini et al. 2012).
About NXC-201
We believe NXC-201 (formerly HBI0101) is the only “Single-Day CRS” BCMA-targeted CAR-T cell therapy that is uniquely suited to target AL Amyloidosis and other autoimmune diseases. It is being studied in a comprehensive clinical development program for the treatment of patients with relapsed/refractory AL amyloidosis, and expanding into other autoimmune indications. These trials build on a robust NXC-201 clinical dataset initiated in February 2021. NXC-201 has been awarded Orphan Drug Designation (ODD) by the FDA in both AL Amyloidosis and multiple myeloma, and awarded EU ODD by the EMA in AL Amyloidosis.
About Immix Biopharma, Inc.
Immix Biopharma, Inc. (ImmixBio) (Nasdaq: IMMX) is a clinical-stage biopharmaceutical company trailblazing cell therapies in AL Amyloidosis and other autoimmune diseases. Our lead cell therapy is FDA IND cleared next generation CAR-T NXC-201, currently being evaluated in our ongoing Phase 1b/2 NEXICART-1 (NCT04720313) clinical trial, initiated in February 2021. 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, and ODD by the European Commission (EMA) in AL Amyloidosis. Learn more at www.immixbio.com and www.BeProactiveInAL.com.
Forward Looking Statements
This press release contains forward-looking statements regarding Immix Biopharma, Inc., including the potential benefits of our initial product candidates, CAR-T NXC-201 and IMX-110. Forward-looking statements include, but are not limited to, our plans, objectives, expectations and intentions and other statements that contain words such as “expects,” “contemplates,” “anticipates,” “plans,” “intends,” “believes”, “estimates”, “potential” and variations of such words or similar expressions that convey the uncertainty of future events or outcomes, or that do not relate to historical matters. Those forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially. Among those factors are: (i) the risk that the further data from the ongoing Phase 1b/2a clinical trials for CAR-T NXC-201 and IMX-110 will not be favorably consistent with the initial data initial data readouts, (ii) the risk that the Company may not be able to advance to registration-enabling studies for the CAR-T NXC-201 and IMX-110 product candidates, (iii) success in early phases of pre-clinical and clinicals trials do not ensure later clinical trials will be successful; (iv) no drug product developed by the Company has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (v) the risk that the Company may not be able to obtain additional working capital with which to continue the clinical trials for CAR-T NXC-201 or IMX-110, or advance to the initiation of registration-enabling studies, for such product candidates as and when needed and (vii) those other risks disclosed in the section “Risk Factors” included in the Company’s Annual Report on Form 10-K filed with the SEC on March 29, 2024 and other periodic reports subsequently filed with the Securities and Exchange Commission. Immix Biopharma cautions readers not to place undue reliance on any forward-looking statements. Immix Biopharma does not undertake, and specifically disclaims, any obligation to update or revise such statements to reflect new circumstances or unanticipated events as they occur, except as required by law.
Contacts
Mike Moyer
LifeSci Advisors
mmoyer@lifesciadvisors.com
Company Contact
irteam@immixbio.com
irteam@nexcella.com
