Nexcella, Inc., a subsidiary of Immix Biopharma,
Inc. (“Nexcella”, “Company”, “We” or “Us”), a
biopharmaceutical company pioneering cell therapies targeting
oncology and other diseases, today announced it has completed
a Pre-Investigational New Drug (“Pre-IND”) meeting with the FDA.
The subject of the Pre-IND meeting was planned NXC-201 US
manufacturing and US clinical trials in AL amyloidosis and multiple
myeloma.
“Completion of our planned Pre-IND meeting with
FDA is an important milestone towards opening U.S. clinical
trial sites for NXC-201,” said Ilya Rachman, MD, PhD, Chief
Executive Officer of Immix Biopharma. Gabriel Morris, Chief
Financial Officer of Immix Biopharma, added, “We appreciate the
FDA’s guidance and believe that with regulatory clarity in hand,
our next step is to proceed with submitting a US IND application to
the FDA for NXC-201.”
A pre-IND meeting provides an opportunity for
communication between a drug development company and the FDA to
discuss an investigational new drug (IND) proposed filing and plan
to obtain the agency’s guidance for the initial clinical studies of
a novel drug candidate. The FDA reviewed the pre-IND package
submitted by Nexcella including clinical data, manufacturing plan
and the phase 1b/2 study protocol synopsis for NXC-201, provided
guidance and recommendations, as well as addressed Nexcella’s
questions on the development plan of NXC-201 in adults with
relapsed/refractory multiple myeloma and relapsed/refractory AL
amyloidosis.
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
multiple myeloma and relapsed/refractory AL amyloidosis.
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 was to characterize the safety and confirm the
recommended Phase 2 dose (RP2D) and Phase 2 dose of NXC-201. The
Phase 2 portion of the study will evaluate the efficacy and safety
of NXC-201 in relapsed/refractory Multiple Myeloma according to the
International Myeloma Working Group (IMWG) Uniform Response
Criteria and in relapsed/refractory AL Amyloidosis according to
consensus recommendations.
The Phase 1b portion of the ongoing Phase 1b/2a
clinical trial has been successful in determining the recommended
Phase 2 dose (RP2D) of 800 million CAR+T cells. Nexcella plans to
submit an IND application to the FDA for a Phase 1b/2 of NXC-201 in
relapsed/refractory multiple myeloma and relapsed/refractory AL
amyloidosis in order to expand the ongoing clinical trial to the
U.S. The expected primary endpoint for the Phase 2 portion of the
ongoing Phase 1b/2a clinical trial of NXC-201 in
relapsed/refractory multiple myeloma is overall response rate and
duration of response. Nexcella 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.
Nexcella plans to submit data to the FDA in relapsed/refractory AL
amyloidosis once 30-40 patients are treated with NXC-201.
About Nexcella, Inc.
Nexcella, Inc. is a Los Angeles, CA based
clinical-stage biopharmaceutical company engaged in the discovery
and development of novel cell therapies for oncology and other
indications. Our lead candidate, next generation BCMA-targeted
CAR-T NXC-201 for relapsed/refractory multiple myeloma and
relapsed/refractory AL amyloidosis has produced 92% and 100%
response rates in each indication, respectively, as of February 9,
2023 across 58 patients. We believe NXC-201 has potential to be the
world’s first outpatient CAR-T. Our N-GENIUS platform allows us to
discover, develop, and manufacture cutting-edge cell therapies for
patients in need. To learn more about Nexcella, Inc. visit us at
www.nexcella.com.
About Immix Biopharma, Inc.
Immix Biopharma, Inc. (ImmixBio) (Nasdaq: IMMX) is
a clinical-stage biopharmaceutical company pioneering a novel class
of CAR-T cell therapies and Tissue-Specific Therapeutics (TSTx)
targeting oncology and immuno-dysregulated diseases with >75
patients treated to-date. Our lead cell therapy asset is NXC-201 in
relapsed/refractory multiple myeloma and relapsed/refractory AL
Amyloidosis, which we believe could be the world’s first
out-patient CAR-T. Our lead 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,
holds Orphan Drug Designation (ODD) and Rare Pediatric Disease
Designation (RPDD) by the FDA. ImmixBio subsidiary
Nexcella, Inc develops CAR-T NXC-201 for multiple myeloma and AL
amyloidosis, with 92% and 100% response rates in each indication,
respectively, as of February 9, 2023, currently being trialed in
NEXICART-1. Learn more at www.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 and liquidity and capital
resources outlook. 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; 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 filed with the Securities and Exchange Commission.
Any forward-looking statements contained in this press release
speak only as of the date hereof, and Immix Biopharma, Inc.
specifically disclaims 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.
ContactsStern Investor RelationsAlex
LoboManaging DirectorAlex.lobo@sternir.com
Company
Contactirteam@immixbio.com
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