Immix Biopharma, Inc. (Nasdaq: IMMX) (“ImmixBio”, “Company”,
“We” or “Us”), a biopharmaceutical company pioneering
Tissue-Specific Therapeutics (TSTx)TM targeting oncology and
immuno-dysregulated diseases, today announced positive early
interim clinical trial data: 100% Tumor Shrinkage at 2-months in
advanced metastatic colorectal cancer demonstrated by IMX-110 +
BeiGene / Novartis anti-PD-1 antibody tislelizumab combination in
the first cohort of patients (two out of two first evaluable
patients) who received the lowest IMX-110 dose in its ongoing dose
escalation 1b/2a clinical trial of IMX-110 + anti-PD-1 antibody
tislelizumab (IMMINENT-01), as of the April 14, 2023 data cutoff
date.
“We are excited to see 100% tumor shrinkage in the very first
cohort at the lowest dose of IMX-110 in combination with anti-PD-1
antibody tislelizumab in our ongoing IMMINENT-01 dose escalation
trial, especially in patients with advanced colorectal cancer, who
have limited treatment options,” said Ilya Rachman, MD PhD, CEO of
ImmixBio. “These initial results potentially validate the
scientific rationale for the promise of IMX-110 to unlock our
immune system’s ability to fight cancer.”
Dosing of the first cohort of three advanced metastatic
colorectal cancer patients is complete, as of April 14, 2023, for
the ongoing Phase 1b portion of the IMMINENT-01 Phase 1b/2a
clinical trial investigating IMX-110 in combination with BeiGene /
Novartis anti-PD-1 antibody tislelizumab in advanced solid tumors,
including colorectal cancer. No dose limiting toxicities have been
observed in the first cohort, which means that the trial can now
enroll the next cohort of three patients at a higher dose of
IMX-110 in combination with anti-PD-1 antibody tislelizumab. Tumor
shrinkage was observed in the first two out of two (2/2) evaluable
patients (100%) at 2-months. To put this early interim clinical
data in perspective, anti-PD-1 antibody pembrolizumab alone
(marketed as KEYTRUDA® by Merck) produced tumor shrinkage in 3 of
19 patients (16%) with an evaluable postbaseline tumor assessment
in a Phase 1b study of pembrolizumab in patients with advanced or
metastatic colorectal cancer according to O’Neil, et al., 2017.
This study was not a head-to-head evaluation with IMX-110 and
differences exist between trial designs, subject characteristics,
and caution should be exercised when evaluating clinical data
across studies.
The PD-1/PD-L1 antibody market size is approximately $49.5
billion in 2023 and expected to reach $123.3 billion by 2033
according to Future Market Insights.
The colorectal cancer market is estimated to reach approximately
$31.2 billion by 2025 from the estimated $26.3 billion in 2019
according to IndustryARC.
About
IMMINENT-01IMMINENT-01 is a
first-of-its-kind, ongoing phase 1b/2a clinical trial combining
tissue specific therapeutic IMX-110 with BeiGene / Novartis’
anti-PD-1 antibody tislelizumab, in patients with advanced solid
tumors. The novel approach combining TSTx IMX-110 with anti-PD-1
antibody tislelizumab is designed to expand the population of
cancer patients experiencing extended remissions from
immunotherapies by converting immunologically “cold” tumors
“hot”.
In Phase 1b of IMMINENT-01, cohorts of 3 patients will receive
escalating doses of IMX-110 until the maximum tolerated dose is
reached and the recommended phase 2 dose is determined.
Phase 2a will then begin, treating patients in certain solid
tumor indications selected based on Phase 1b clinical data
collected in a variety of tumor types. 30 patients are expected to
be enrolled in IMMINENT-01.
The primary endpoints of IMMINENT-01 are to identify the maximum
tolerated dose and recommended Phase 2 dose of IMX-110 + anti-PD-1
antibody tislelizumab, and to evaluate safety. The secondary
endpoints of IMMINENT-01 are to evaluate the pharmacokinetics and
preliminary efficacy of IMX-110 + anti-PD-1 antibody
tislelizumab.
As of the data cutoff of April 14 2023, the first cohort dosing
at the lowest dose of IMX-110 + anti-PD-1 antibody tislelizumab has
reached full enrollment.
Immix Biopharma is currently enrolling the next higher dose
cohort of IMX-110 + anti-PD-1 antibody tislelizumab in advanced
solid tumors.
About Colorectal Cancer
According to American Cancer Society, there were roughly 153,020
new cases of colorectal cancer in the United States in 2023.
Globally, there are roughly 1,930,000 new cases of colorectal
cancer each year, of which 519,500 are in Europe, 148,500 are in
Japan, 20,500 are in Australia and New Zealand, and 555,000 are in
China. The five-year survival rate in the United States for
advanced metastatic CRC is 15.6% according to NIH SEER.
About Immix Biopharma,
Inc.Immix Biopharma, Inc. (ImmixBioTM) (Nasdaq: IMMX) is a
clinical-stage biopharmaceutical company pioneering a novel class
of CAR-T cell therapies and Tissue-Specific Therapeutics (TSTx)TM
targeting oncology and immuno-dysregulated diseases. Our lead CAR-T
cell therapy, NXC-201 for multiple myeloma and AL amyloidosis, has
produced 92% and 100% response rates in each indication,
respectively, as of February 9, 2023. Our lead TSTx is IMX-110,
currently in Phase 1b/2a clinical trials as a monotherapy and in
its IMMINENT-01 combination clinical trial with BeiGene/Novartis’
anti-PD-1 antibody, tisleilizumab, for which patient dosing began
in February 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.
In combination with BeiGene / Novartis’s anti-PD-1 antibody
tislelizumab in the ongoing IMMINENT-01 trial, IMX-110 produced
100% tumor shrinkage in relapsed/refractory colorectal cancer in
the very first dose escalation cohort as of the April 14, 2023 data
cutoff date. Learn more at www.immixbio.com.
Forward Looking StatementsThis 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.
Investor ContactSuzanne MessereStern Investor
RelationsSuzanne.Messere@sternir.com
Company Contactirteam@immixbio.com
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