Immix Biopharma Reports 89% Complete Response in NXC-201 AL Amyloidosis Study

Key Points

• NXC-201 showed strong clinical activity: 40 of 45 relapsed/refractory AL amyloidosis patients achieved a complete response, while all 45 normalized toxic light chains. Immix also reported 100% cardiac and 92% renal response rates among evaluable patients.
• The therapy demonstrated a favorable safety profile, with median cytokine release syndrome lasting one day and no reported high-grade CRS, neurotoxicity or enterocolitis. The company is targeting a biologics license application next year and plans a randomized frontline trial in 2027.
• Immix is preparing for a targeted commercial launch focused initially on 60 to 70 CAR T-experienced treatment centers, supported by roughly 35 to 45 account managers. A recent capital raise extends its cash runway into the first quarter of 2029, assuming no revenue.

Immix Biopharma NASDAQ: IMMX reported updated clinical data for NXC-201, its investigational CAR T-cell therapy for relapsed or refractory light-chain (AL) amyloidosis, and outlined plans for a biologics license application, a frontline study and a targeted commercial launch strategy.

AL amyloidosis is a disease in which plasma cells produce toxic light-chain fragments that can damage organs including the heart, kidneys, liver and nerves. Chief Executive Officer Ilya Rachman said the company views the condition as an underserved patient population, noting that there are no FDA-approved treatments in the relapsed/refractory setting.

Updated NXC-201 Results

President and Chief Financial Officer Gabriel Morris said 44 of 45 treated patients had normalized toxic light chains. The company reported that 40 of 45 patients, or 89%, had achieved a complete response as of the update. Immix said it believes the complete-response rate could rise to 44 of 45 patients, or 98%, as four patients who are minimal residual disease, or MRD, negative convert to complete response with additional follow-up.

For the 25 newly reported patients, Morris said all were either in complete response or MRD negative. Rachman said the new group had baseline characteristics similar to the initial 20 patients.

Management said all previously reported patients who reached MRD-negative status subsequently converted to complete response. Morris said the four currently MRD-negative patients who have not yet converted had less than six months of follow-up. Rachman said the median time to complete response was about two months after MRD negativity, although conversion could take as long as 320 days.

The company also reported organ responses in evaluable patients, including a 100% cardiac response rate and a 92% renal response rate. Rachman said cardiac responses were observed at 26 days following dosing and renal responses followed at 59 days. Immix described a 95% overall downstream organ-response rate.

Safety and Regulatory Plans

Rachman said the median duration of cytokine release syndrome, or CRS, was one day across the treated population. He said the company had observed no high-grade CRS, neurotoxicity or enterocolitis. The company emphasized the potentially important role of a short CRS duration for patients who may have both cardiac and kidney impairment.

Immix said NXC-201 has received both Breakthrough Therapy and Regenerative Medicine Advanced Therapy, or RMAT, designations. The company plans to lock its database after follow-up from enrollment completed in March 2026 and is targeting a planned BLA next year.

Management said it remains in ongoing communication with the FDA and intends to advance the program as quickly as possible. However, Morris said the company believes obtaining roughly one year of follow-up before submission makes sense in order to assess whether the complete-response rate has reached a steady state.

Immix also plans to initiate a randomized frontline trial in 2027 comparing NXC-201 with daratumumab plus CyBorD, the current frontline standard of care. Rachman said the planned study would enroll about 260 patients with one-to-one randomization and would mirror the design of the ANDROMEDA study that supported daratumumab’s approval in AL amyloidosis. Morris said the study design includes an opportunity for an interim analysis based on complete response.

Commercial Strategy

Chief Commercial Officer Michael Grabow said Immix has completed market research with hematologist-oncologists treating relapsed/refractory AL amyloidosis. According to Grabow, the research indicated a significant unmet need and strong stated likelihood among surveyed physicians to prescribe NXC-201 based on data released at ASH 2025.

The company estimates that about 2,800 hematologist-oncologists account for 90% of AL amyloidosis claims. Grabow said many of these physicians are connected to FACT-accredited institutions with experience administering CAR T therapies.

• Immix initially expects to onboard approximately 60 to 70 treatment centers.
• The company anticipates a commercial field team of roughly 35 to 45 CAR T account managers.
• Management said it intends to use a lean, targeted launch model centered on treatment centers already familiar with CAR T administration.

Grabow said the company has not set a price for NXC-201 and will do so only if the therapy is approved. He said Immix is evaluating pricing from the perspectives of physicians, payers, treatment centers and patients, while using existing CAR T products as reference points. He added that the company believes NXC-201’s efficacy and safety profile could support premium pricing, though no specific price was provided.

Morris said a recently completed capital raise extends the company’s cash runway from mid-2028 into the first quarter of 2029, assuming no revenue.

About Immix Biopharma (NASDAQ:IMMX)

Immix Biopharma, Inc is a clinical-stage biopharmaceutical company focused on developing cell therapies for cancer and autoimmune diseases. The company's research centers on treatments designed to use a patient's immune system to identify and attack disease-related cells.

Its lead product candidate is NXC-201, an investigational autologous CAR T-cell therapy targeting B-cell maturation antigen (BCMA), a protein found on malignant plasma cells. NXC-201 is being evaluated in clinical studies involving patients with relapsed or refractory AL amyloidosis and multiple myeloma, including the company's NEXICART-1 study.

Immix Biopharma was founded in 2012 and is based in Los Angeles, California.

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