Immix Biopharma
Announces FDA Approval of IND Application for CAR-T NXC-201,
Enabling U.S. Patient Dosing
- NEXICART-2 to expand studies of
NXC-201 in relapsed/refractory AL Amyloidosis to U.S. sites based
on IND clearance
- 72 patients previously dosed with
NXC-201 ex-U.S.
- First CAR-T program for light-chain
(AL) Amyloidosis
- Favorable tolerability
enables expansion into autoimmune indications
LOS
ANGELES, Nov. 28, 2023 -- InvestorsHub 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 the
U.S. Food and Drug Administration (FDA) has cleared the
Investigational New Drug (IND) application for BCMA CAR-T NXC-201
(formerly HBI0101). With this clearance, NEXICART-2 (NCT06097832)
is to expand studies of NXC-201 in relapsed/refractory AL
Amyloidosis to the United States. Favorable tolerability enables
potential expansion into autoimmune indications.
"Building
on encouraging NXC-201 clinical data to-date, we are thrilled that
multiple leading U.S. sites are currently planning to enroll
patients in the coming months," said Ilya Rachman, MD PhD, Chief
Executive Officer of Immix Biopharma. "No approved treatment
options currently exist for relapsed/refractory AL Amyloidosis
patients."
72 patients have been
dosed (9 in AL Amyloidosis, 63 in multiple myeloma) with NXC-201
ex-U.S. Relapsed/refractory AL Amyloidosis dose escalation levels
included: 150 x 106
(n=1),
450 x 106
(n=2),
and 800 x 106
(n=6)
CAR+T cells, demonstrating a 100% overall response rate (9/9)
(median 6 lines of prior therapy) (as of the September 20, 2023 AL
Amyloidosis data cutoff). Relapsed/refractory multiple myeloma dose
escalation levels included: 150 x 106
(n=6),
450 x 106
(n=7),
and 800 x 106
(n=50)
CAR+T cells, demonstrating a 95% overall response rate with median
11.9 months of follow-up (as of the July 17, 2023 multiple myeloma
data cutoff). NXC-201 publications, presentations and posters
include the 65th
American Society of
Hematology (ASH) Annual Meeting & Exposition, 27th
Annual American Society for
Gene and Cell Therapy (ASGCT), 20th
International Myeloma
Society (IMS) Annual Meeting, Clinical Cancer Research
(CCR), 49th
Annual Meeting of the
European Society for Blood and Marrow Transplantation (EBMT)
and
Haematologica.
"We credit
our world-class cell-therapy expert team in achieving this IND
clearance in-line with our previously communicated timelines," said
Gabriel Morris, Chief Financial Officer of Immix Biopharma.
"NXC-201's favorable tolerability profile, including overcoming
neurotoxicity, potentially enables expansion beyond AL Amyloidosis
into autoimmune indications."
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 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.
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 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.
About
Nexcella, Inc.
Nexcella, Inc., a subsidiary of Immix
Biopharma, Inc. (Nasdaq:IMMX), is a Los Angeles, California 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 AL amyloidosis and
relapsed/refractory multiple myeloma, has produced 100% and 95%
response rates in each indication, respectively, as of July 17,
2023 across 72 patients. NXC-201 has been awarded Orphan Drug
Designation (ODD) by the FDA in both AL Amyloidosis and multiple
myeloma. We believe NXC-201 has the potential to be the world's
first "Single-Day CRS" CAR-T, enabling faster return home for
patients. Expansion into autoimmune indications is planned:
systemic lupus erythematosus (SLE), myasthenia gravis (MG), and
multiple sclerosis (MS). 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
Forward-Looking
Statements
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release contains "forward-looking statements." Forward-looking
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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
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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
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historical fact nor guarantees of assurance of future performance.
We caution you, therefore, against relying on any of these
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actual results to differ materially from those in the
forward-looking statements include, without limitation, our ability
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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
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Contacts:
Mike
Moyer
LifeSci Advisors mmoyer@lifesciadvisors.com
Company
Contact
irteam@immixbio.com
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