Nexcella, Inc., a subsidiary of Immix Biopharma, Inc. (“Nexcella”,
“Company”, “We” or “Us”), today announced the commencement of CAR-T
NXC-201 Engineering Batches at its U.S. Manufacturing Site. These
U.S. engineering batches will support the planned U.S. expansion of
the Company’s ongoing Phase 1b/2a NEXICART-1 (NCT04720313) study of
its novel BCMA-targeted chimeric antigen receptor T (car-T) cell
therapy NXC-201. This manufacturing milestone represents a
crucial next step in transferring the Company’s existing CAR-T GMP
manufacturing process to the United States following the selection
of a U.S. GMP manufacturer in February 2023.
“We are working tirelessly to bring NXC-201 to U.S. patients,”
said Ilya Rachman, M.D. PhD Chief Executive Officer of Immix
Biopharma. “NXC-201 is the first CAR-T being developed in AL
Amyloidosis, and in Multiple Myeloma, patients face significant
obstacles when seeking BCMA-targeted CAR-T treatments like NXC-201.
We look forward to continuing to advance NXC-201 as we work to
improve treatment outcomes for patients in the U.S. suffering from
AL amyloidosis and multiple myeloma.”
“Today, 95% of U.S. medical centers are unable to offer CAR-T
cell therapy,” said Gabriel Morris, Chief Financial Officer of
Immix Biopharma. “NXC-201 has already been trialed in over 50
patients, demonstrating a 1-2 day median short side-effect
duration, which offers potential to become the first out-patient
CAR-T, potentially reducing hospitalization costs up to 80% and
enabling dosing in 95% of U.S. medical centers today unable to
offer CAR-T cell therapy.”
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 or refractory multiple myeloma
and AL amyloidosis across 58 patients.
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 or refractory multiple myeloma
and 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 with
endpoints of overall survival, progression-free survival and
response rates according to International Myeloma Working Group
(IMWG) Uniform Response Criteria.
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. Over the coming months, Nexcella
plans to submit an IND application to the FDA for a Phase 1b/2 of
NXC-201 in relapsed/refractory multiple myeloma and 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 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
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 plasma cells cause buildup 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 – 40,000 patients in total
throughout the U.S. and Europe, and it is estimated that there are
approximately 3,000 – 4,000 new cases of AL amyloidosis annually in
the U.S. The 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 Multiple Myeloma
Multiple myeloma (“MM”) is an incurable blood cancer of plasma
cells that starts in the bone marrow and is characterized by an
excessive proliferation of these cells. Despite initial remission,
unfortunately, most patients are likely to relapse. There are
35,730 patients in the United States diagnosed with MM each year.
Prognosis for patients who do not respond to or relapse after
treatment with standard therapies, including protease inhibitors
and immunomodulatory agents remains poor.
The $13.9 billion Multiple Myeloma market in 2017 is expected to
reach $28.7 billion in 2027 according to Wilcock, et al. Nature
Reviews
About Nexcella, Inc.
Nexcella, Inc., a subsidiary of Immix Biopharma, Inc
(Nasdaq:IMMX), 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
multiple myeloma and 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 Tissue-Specific Therapeutics (TSTx) targeting oncology and
immuno-dysregulated diseases. Our lead asset is IMX-110, currently
in Phase 1b/2a clinical trials as a monotherapy and in its
IMMINENT-01 combination clinical trial with BeiGene’s anti-PD-1,
tisleilizumab, for which patient dosing begin in Feb 2023. IMX-110
holds orphan drug designation (ODD) by the FDA for soft tissue
sarcoma, and has received Rare Pediatric Disease Designation (RPDD)
by the FDA the treatment of rhabdomyosarcoma, a life-threatening
form of cancer in children. RPDD qualifies ImmixBio to receive fast
track review and a priority review voucher (PRV) at the time of
marketing approval of IMX-110. Additionally, ImmixBio subsidiary
Nexcella, Inc, developing 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. 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.
Contacts:Stern Investor RelationsSuzanne
MessereManaging DirectorSuzanne.Messere@sternir.com
Company Contact:irteam@immixbio.com
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