Immix Biopharma Announces Major Comprehensive Cancer Center as Lead Site for NXC-201 AL Amyloidosis Clinical Trial
Immix Biopharma, Inc. selects Memorial Sloan Kettering Cancer Center as lead clinical site for NXC-201 clinical trial in AL Amyloidosis. NXC-201 CAR-T therapy offers hope for relapsed/refractory patients.
The partnership between Immix Biopharma and Memorial Sloan Kettering Cancer Center to conduct a multi-site clinical trial for NXC-201 in AL Amyloidosis patients is a significant step for the company. The collaboration with such a prestigious institution not only lends credibility to Immix's research but also potentially accelerates the development process of NXC-201. This is particularly relevant as AL Amyloidosis is a rare disease with limited treatment options and advancements in this area could lead to substantial market opportunities.
From a medical research perspective, the development of CAR-T therapies like NXC-201 is groundbreaking. CAR-T therapies, which involve modifying a patient's T-cells to attack cancer cells, have shown promise in treating certain types of cancer. If NXC-201 proves to be effective for AL Amyloidosis, it could pave the way for new treatment protocols and offer hope to patients with this challenging condition. However, the complexity and cost of CAR-T therapies could pose challenges in widespread adoption and reimbursement scenarios.
Investors closely monitor clinical trial advancements, especially in biopharmaceuticals focusing on novel therapies. Immix Biopharma's announcement regarding the clinical trial for NXC-201 could potentially impact the company's stock valuation. Positive trial outcomes often lead to increased investor confidence and can drive up stock prices, while negative results can have the opposite effect.
Moreover, the association with a reputable clinical site like Memorial Sloan Kettering can attract additional investment and partnership opportunities. However, investors should be mindful of the inherent risks in biopharmaceutical investing, particularly in clinical-stage companies. The costs associated with conducting multi-site trials are substantial and the path to FDA approval is rigorous and uncertain. It's essential to consider the long-term investment horizon and the company's pipeline diversification when evaluating Immix's financial health and growth potential.
The strategic decision to involve Memorial Sloan Kettering Cancer Center as the lead site for the clinical trial underscores the importance of collaborative efforts in advancing medical treatments. For stakeholders within the healthcare industry, this move signifies a robust validation of Immix Biopharma's research direction and its potential impact on the market for AL Amyloidosis treatments.
Given that AL Amyloidosis is a rare condition, the market size is relatively small, but the lack of effective treatments creates a high unmet medical need. If NXC-201 demonstrates efficacy and safety, it could command a premium price and enjoy orphan drug status, which offers benefits like market exclusivity. The long-term implications for the healthcare industry include not only the direct benefits for patients but also the potential for Immix to leverage its CAR-T platform to target other autoimmune diseases, potentially expanding its market reach.
03/20/2024 - 09:46 AM
LOS ANGELES, CA, March 20, 2024 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (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 Memorial Sloan Kettering Cancer Center as lead clinical site for its NXC-201 relapsed/refractory AL Amyloidosis multi-site clinical trial.
“We are looking forward to this important multi-site clinical trial with NXC-201 CAR-T for patients with AL Amyloidosis,” said Heather Landau, MD, Memorial Sloan Kettering Cancer Center Amyloidosis Program Director. “NXC-201 represents a novel direction in the treatment landscape for relapsed or refractory AL Amyloidosis patients.”
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 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 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 27, 2023 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.
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Company Contact
What is the lead clinical site selected by Immix Biopharma, Inc. for the NXC-201 clinical trial in AL Amyloidosis?
Memorial Sloan Kettering Cancer Center has been chosen as the lead clinical site for the NXC-201 clinical trial in AL Amyloidosis.
What is the focus of the NXC-201 clinical trial conducted by Immix Biopharma, Inc.?
The NXC-201 clinical trial by Immix Biopharma, Inc. is centered around treating relapsed/refractory AL Amyloidosis patients with CAR-T therapy.
Who is Heather Landau and what role does she play in the NXC-201 clinical trial?
Heather Landau is the Memorial Sloan Kettering Cancer Center Amyloidosis Program Director and expressed excitement for the NXC-201 clinical trial, highlighting its potential in treating AL Amyloidosis patients.
