Immix Biopharma Inc.'s (IMMX:NASDAQ) updated results from its ongoing NEXICART-1 Phase 1b/2 trial evaluating NXC-201 show continued potency in relapsed/refractory multiple myeloma, reported ROTH MKM analyst Dr. Jonathan Aschoff in an October 2 research note. NXC-201 is Immix's autologous, BCMA gene-targeted, chimeric antigen receptor (CAR) T-cell therapy.
"Given the continued favorable data, we expect Immix to file its U.S investigational new drug [application] in Q4/23 and to file a biologics license application after treating a total of 100 relapsed or refractory multiple myeloma patients," Aschoff wrote.
309% Return Implied
Upon this news, ROTH reiterated its US$14 per share target price on the California-based developer of personalized oncologic and immunologic therapies. The biopharma is trading now at about US$3.42 per share, noted Aschoff.
From the current price, the return to target represents a substantial 309% gain.
Immix remains a Buy.
About the Data Set
Immix presented the updated NXC-20 results in a poster session at the International Myeloma Society's annual meeting. These findings are for 63 relapsed/refractory multiple myeloma patients. They encompass new data on 13 new patients and continued follow-up results on 50 previously enrolled patients.
These new data are from a July 17, 2023, cutoff date. At that time, the median time of follow-up was 11.9 months. Overall, follow-ups were done between 0.6 and 19 months.
Of the 63 patients, most (50 patients) were administered 800 CAR T-cells. Seven patients got 450 million CAR T-cells, and six patients received 150 million.
Efficacy Results
Of the 63 treated patients, 38 had not received any prior BCMA-targeted therapy. Of the 38, all but two patients, or 95% of patients, showed an overall response rate (ORR) and a 12.9-month median progression-free survival (PFS).
Of the group of 50, including patients who had and did not have previous BCMA-targeted treatment, the ORR was 90% (45 patients), complete response (CR) was 58% (28 patients), the very good partial response rate was 20% (10 patients) and the partial response rate was 12% (6 patients).
When patient data were analyzed by number of cells received, they showed that among the 50 participants who got 800 million CAR T-cells, the median PFS was 10.6 months and the ORR was 90%. Of the six patients who got 150 million CAR T-cells, 50% had an ORR. Among the seven patients who received 450 million CAR T-cells, the ORR was 86%.
The updated NXC-201 ORR results compare favorably to the 72% ORR from competitor Bristol Myers Squibb's pivotal 100-patient trial of Abecma in relapsed/refractory multiple myeloma, Axchoff wrote, "and the therapy appears to work almost as well in patients exposed to prior BCMA-targeted therapy."
Safety Profile
In terms of safety during the trial, with respect to the 50 patients who received the highest dose of NXL-201, the most common side effects were grade three to four hematological toxicities. Specifically, 100% of patients experienced lymphopenia, 98% neutropenia, 62% anemia, and 54% thrombocytopenia.
Of the 50, 48 patients experienced cytokine release syndrome (CRS), grade 1 to 2 in 41, or 82%, and grade 3 in seven, or 14%. Tocilizumab was used in 40 of the patients who developed CRS, whereas corticosteroids were used in eight.
"For the first time, Immix observed ICANS, or immune effector cell-associated neurotoxicity syndrome, with NXC-201, with two cases observed (one each of grades 1 and 2), and two patients developed CAR T-associated hemophagocytic lymphohistiocytosis syndrome," Aschoff reported.
There were no irreversible organ toxicities or treatment-related deaths.
The duration of adverse effects previously was shown to be one to two days.
Tolerability is an Advantage
This safety profile of NXC-201 is critical, Aschoff pointed out, because CAR-T treatment generally is associated with significant potential adverse effects. This limits the number of U.S. medical centers that can provide it. NXC-201, however, seems to be an exception.
As such, Immix's cell treatment could "become the first outpatient CAR-T procedure, thereby potentially reducing hospitalization costs [by] up to 80%," Aschoff wrote.
The analyst added that "as long as the risk/reward profile of NXC-201 continues to be highly promising in the clinic, we believe that NXC-201 may offer a tolerable enough CAR-T therapy to be offered by at least some of the overwhelming majority of advanced medical centers that currently cannot handle the adverse event profile of approved CAR-T therapies, especially if NXC-201 therapy can be completed in three rather than the current roughly 14 days."
Additional Company Updates
In other news, Immix recently finished manufacturing its second engineering batch of NXC-201 at its U.S.-based CAR-T plant, according to Aschoff. The U.S. Food and Drug Administration (FDA) likely will require a third.
Also, the FDA granted Immix orphan drug status for NXC-201 when used for multiple myeloma or amyloid light chain amyloidosis.
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Disclosures for Roth MKM, Immix Biopharma Inc., October 2, 2023
Regulation Analyst Certification ("Reg AC"): The research analyst primarily responsible for the content of this report certifies the following under Reg AC: I hereby certify that all views expressed in this report accurately reflect my personal views about the subject company or companies and its or their securities. I also certify that no part of my compensation was, is or will be, directly or indirectly, related to the specific recommendations or views expressed in this report.
Disclosures: Shares of Immix Biopharma, Inc. may be subject to the Securities and Exchange Commission's Penny Stock Rules, which may set forth sales practice requirements for certain low-priced securities
ROTH Capital Partners, LLC expects to receive or intends to seek compensation for investment banking or other business relationships with the covered companies mentioned in this report in the next three months. The material, information and facts discussed in this report other than the information regarding ROTH Capital Partners, LLC and its affiliates, are from sources believed to be reliable, but are in no way guaranteed to be complete or accurate. This report should not be used as a complete analysis of the company, industry or security discussed in the report. Additional information is available upon request. This is not, however, an offer or solicitation of the securities discussed. Any opinions or estimates in this report are subject to change without notice. An investment in the stock may involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Additionally, an investment in the stock may involve a high degree of risk and may not be suitable for all investors. No part of this report may be reproduced in any form without the express written permission of ROTH. Copyright 2023. Member: FINRA/SIPC
