Open-label Phase 1b Dose Escalation/Dose Expansion study exploring the safety and efficacy of NXC-201 in patients with relapsed or refractory light chain amyloidosis (AL).

Start Date05 Jun 2024

Sponsor / Collaborator

Nexcella, Inc.

[+1]

NCT04720313 / RecruitingPhase 1IIT

A Phase 1 Dose Escalation and Safety Study of NXC-201 (Formerly HBI0101) CART in BCMA-Expressing Multiple Myeloma Patients

It is a phase one study with dose escalation and safety CART in BCMA- Expressing Multiple Myeloma and AL amyloidosis Patients

Start Date01 Jan 2021

Sponsor / Collaborator

Hadassah University Hospital

[+1]

100 Clinical Results associated with NXC-201

100 Translational Medicine associated with NXC-201

100 Patents (Medical) associated with NXC-201

Literatures (Medical) associated with NXC-201

13 Aug 2024·Blood Advances

Clinical evaluation and determinants of response to HBI0101 (BCMA CART) therapy in relapsed/refractory multiple myeloma

Article

Author: Kenett, Ron S ; Zelmanovich, Veronica ; Shehadeh, Alaa ; Lebel, Eyal ; Kfir-Erenfeld, Shlomit ; Stepensky, Polina ; Grisariu, Sigal ; Elias, Shlomo ; Roziner, Ilan ; Gatt, Moshe E ; Ishtay, Aseel ; Pick, Marjorie ; Alexander-Shani, Rivka ; Asherie, Nathalie ; Assayag, Miri ; Zimran, Eran ; Avni, Batia ; Cohen, Yael ; Cohen, Cyrille J ; Bessig, Nomi ; Dubnikov Sharon, Tatyana ; Vainstein, Vladimir ; Avivi, Irit

AbstractHBI0101 is an academic chimeric antigen receptor T-cell (CART)–targeted to B-cell maturation antigen (BCMA) for the treatment of relapsed and refractory multiple myeloma (R/RMM) and light chain amyloidosis. Herein, we present the phase 1b/2 results of 50 heavily pretreated patients with R/RMM dosed with 800 × 106 CART cells. Inclusion criteria were relatively permissive (i.e., performance status and baseline organ function) and consequently, approximately half of the enrolled patients would have been ineligible for pivotal clinical trials. The median time elapsed from patient enrollment until CART delivery was 25 days (range, 14-65). HBI0101-related toxicities included grade 1 to 3 cytokine release syndrome, grade 3 to 4 hematologic toxicities, and grade 1 to 2 immune effector cell–associated neurotoxicity syndrome. Responses were achieved in 90% of the patients, 56% achieved stringent and complete response, and 70% reached a minimal residual disease negativity. Within a median follow-up of 12.3 months, the median progression-free survival (PFS) was 11.0 months (95% confidence interval [CI], 6.2-14.6), and the overall survival was not reached (95% CI, 13.3 to not reached). Multivariable analysis on patient/disease and CART-related characteristics revealed that high-risk cytogenetic, extramedullary disease, and increased number of effector-memory T cells in CART products were independently associated with inferior PFS. In conclusion, comprehensive analyses of the parameters affecting the response to CART therapy are essential for improving patients’ outcome. This trial was registered at www.ClinicalTrials.gov as #NCT04720313.

Haematologica

Development and manufacture of novel locally produced anti-BCMA CAR T cells for the treatment of relapsed/refractory multiple myeloma: results from a phase I clinical trial

Article

Author: Lebel, Eyal ; Cohen, Yael ; Kfir-Erenfeld, Shlomit ; Dubnikov, Tatyana ; Pick, Marjorie ; Assayag, Miri ; Cohen, Cyrille ; Grisariu, Sigal ; Stepensky, Polina ; Avivi, Irit ; Asherie, Nathalie ; Zalcman, Nomi ; Shaulov, Adir ; Gatt, Moshe E ; Avni, Batia ; Zimran, Eran

Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor T-cell (CAR T) therapy shows remarkable efficacy in patients with relapsed and/or refractory (R/R) multiple myeloma (MM). HBI0101, a novel second generation optimized anti- BCMA CAR T-cell therapy, was developed in an academic setting. We conducted a phase I dose-escalation study of HBI0101 (cohort 1: 150x106 CAR T cells, n=6; cohort 2: 450x106 CAR T cells, n=7; cohort 3: 800x106 CAR T cells, n=7) in 20 heavily pre-treated R/R MM patients. Grade 1-2 cytokine release syndrome (CRS) was reported in 18 patients (90%). Neither grade 3-4 CRS nor neurotoxicity of any grade were observed. No dose-limiting toxicities were observed in any cohort. The overall response rate (ORR), (stringent) complete response (CR/sCR), and very good partial response rates were 75%, 50%, and 25%, respectively. Response rates were dose-dependent with 85% ORR, 71% CR, and 57% minimal residual disease negativity in the high-dose cohort 3. Across all cohorts, the median overall survival (OS) was 308 days (range 25-466+), with an estimated OS of 55% as of June 27th (data cut-off). The median progression-free survival was 160 days, with 6 subjects remaining progression free at the time of data cut-off. Our findings demonstrate the manageable safety profile and efficacy of HBI0101. These encouraging data support the decentralization of CAR T production in an academic setting, ensuring sufficient CAR T supply to satisfy the increasing local demand. Clinicaltrials.gov NCT04720313.

109

News (Medical) associated with NXC-201

02 Oct 2024

·www.globenewswire.com

Immix Biopharma Advances CAR-T NXC-201 to Expansion Cohort Dose Level in U.S. AL Amyloidosis Trial NEXICART-2

Now dosing at dose expansion level of 450 million NXC-201 CAR+T cells. First cohort at 150 million CAR+T cells already successfully completed Each of these two doses have produced complete responses in prior clinical studiesLead site Memorial Sloan Kettering Cancer Center (MSKCC); 4 disclosed clinical sites so farNXC-201 is the only one-time CAR-T treatment option being studied for relapsed/refractory AL Amyloidosis in U.S. clinical trials AL Amyloidosis, a disorder of plasma cells that leads to progressive damage to the heart, kidney and liver, affects approximately 33,000 patients in the U.S. LOS ANGELES, CA, Oct. 02, 2024 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us”, “IMMX”) (Nasdaq: IMMX), a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and select immune-mediated diseases, today announced advances in the NEXICART-2 clinical study of its CAR-T NXC-201 for relapsed/refractory AL Amyloidosis, a plasma cell disorder that leads to progressive damage to the heart, kidney and liver, which currently affects approximately 33,000 patients in the U.S. Immix Biopharma’s sterically-optimized CAR-T NXC-201 is the only one-time CAR-T treatment option being studied for relapsed/refractory AL Amyloidosis in U.S. clinical trials. “We are pleased to report that the NEXICART-2 study is making excellent progress. We are now one step closer to providing a new treatment option for patients with relapsed/refractory AL Amyloidosis, where no FDA drugs are approved today,” said Ilya Rachman, M.D., Ph.D., Chief Executive Officer of Immix Biopharma. “Robust enrollment reflects the enthusiasm of clinical investigators for CAR-T NXC-201.” “Positive data from our ex-US study of NXC-201, the largest CAR-T clinical study in relapsed/refractory AL Amyloidosis to-date, showed a 92% overall response rate (12/13) and a 28.0 month duration of response (best responder), presented at ASGCT 2024,” said Gabriel Morris, Chief Financial Officer of Immix Biopharma. “We credit the resolute efforts of our investigators, sites, and team as we continue on track for interim and final read-outs.” The NEXICART-2 study is intended to evaluate the safety and efficacy of NXC-201 in relapsed/refractory AL Amyloidosis patients with adequate cardiac function who have not been exposed to prior BCMA-targeted therapy. Advancement to the second dosing cohort of three patients at 450 million CAR-T cells will dose one patient with NXC-201 every 28-days, subsequently enabling multiple patients to be dosed per month in NEXICART-2. Each of the NEXICART-2 dose levels have produced complete responses in relapsed/refractory AL Amyloidosis patients in the ex-U.S. NEXICART-1 study presented at ASGCT 2024. NXC-201 is the only CAR-T therapy currently in development in AL Amyloidosis, mentioned in a review article entitled “Systemic Light Chain Amyloidosis” published in June, 2024 New England Journal of Medicine. About NEXICART-2 NEXICART-2 (NCT06097832) is an open-label, single-arm, multi-site U.S. Phase 1b/2 dose expansion clinical trial of CAR-T NXC-201 in relapsed/refractory AL Amyloidosis. NEXICART-2 is expected to enroll 40 patients with adequate cardiac function who have not been exposed to prior BCMA-targeted therapy. The study is designed with a standard 6 patient safety run-in to evaluate two doses (three patients each at 150 million CAR+T cells and 450 million CAR+T cells), with dose expansion at 450 million CAR+T cells following. During dose expansion, multiple patients are allowed to be dosed per month. The NXC-201 dosing levels being evaluated in NEXICART-2 study have been evaluated in the NEXICART-1 study and have produced complete responses in relapsed/refractory AL Amyloidosis patients. The study aims to evaluate the safety and efficacy of NXC-201 in this patient population. Primary endpoints are complete response rate and overall response rate, according to consensus recommendations (Palladini et al. 2012). About NXC-201 NXC-201 is a sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy. Initial NXC-201 clinical data in relapsed/refractory AL Amyloidosis from Phase 1b/2 ex-U.S. study NEXICART-1 has demonstrated a high overall and complete response rate, as well as no neurotoxicity of any kind and short duration of cytokine release syndrome, presented at the American Society of Hematology (ASH) and the American Society of Gene and Cell Therapy (ASGCT) annual meetings. NXC-201 is being studied in a comprehensive clinical development program for the treatment of patients with relapsed/refractory AL amyloidosis, with the potential to expand into select immune mediated diseases. The NXC-201 NEXICART-2 U.S. clinical trial builds on an existing robust clinical dataset. NXC-201 has been awarded Orphan Drug Designation (ODD) in the US by the FDA and in the EU by the EMA in AL Amyloidosis. About AL Amyloidosis AL amyloidosis is caused by abnormal plasma cells in the bone marrow, which produce misfolded amyloid proteins that build-up in the heart, kidney, liver, and other organs. This build-up causes progressive and widespread damage to multiple organs, including heart failure, and leads to high mortality rates. The U.S. observed prevalence of relapsed/refractory AL Amyloidosis is estimated to be growing at 12% per year according to Staron, et al Blood Cancer Journal, to approximately 33,277 patients in 2024. The Amyloidosis market was $3.6 billion in 2017, and is expected to reach $6 billion in 2025, according to Grand View Research. About Immix Biopharma, Inc. Immix Biopharma, Inc. (ImmixBio) (Nasdaq: IMMX) is a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and select immune-mediated diseases. Our lead candidate is sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201. NXC-201 is being evaluated in the U.S. Phase 1b/2 trial NEXICART-2 (NCT06097832) as well as the ex-U.S. study NEXICART-1 (NCT04720313). NXC-201 has demonstrated a high overall and complete response rate, as well as no neurotoxicity of any kind and short duration of cytokine release syndrome, presented at the American Society of Hematology (ASH) and the American Society of Gene and Cell Therapy (ASGCT) annual meetings. NXC-201 has been awarded Orphan Drug Designation (ODD) in the U.S. by the FDA and in the EU by the EMA in AL Amyloidosis. Learn more at www.immixbio.com and www.BeProactiveInAL.com. Forward Looking StatementsThis press release contains forward-looking statements regarding Immix Biopharma, Inc., including the potential benefits of our product candidate CAR-T NXC-201. 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 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 CAR-T NXC-201 or other product candidates, (iii) that success in early phases of pre-clinical and clinicals trials do not ensure later clinical trials will be successful; (iv) that 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 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 29, 2024 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. Contacts Mike Moyer LifeSci Advisors mmoyer@lifesciadvisors.com Company Contact irteam@immixbio.com

Cell TherapyClinical ResultASHClinical StudyImmunotherapy

19 Sep 2024

·www.globenewswire.com

Immix Biopharma Announces Dr. Raymond Comenzo, Internationally Recognized AL Amyloidosis Expert, Director of the Myeloma and Amyloid Program at Tufts Medical Center, Joins Scientific Advisory Board

Dr. Comenzo was the senior author of the landmark Andromeda trial results published in the New England Journal of Medicine in 2021, resulting in the first FDA-approved therapy for AL amyloidosis Dr. Comenzo was the lead author on the landmark 2012 publication of consensus guidelines, including response criteria, for conduct and reporting of clinical trials in AL Amyloidosis LOS ANGELES, CA, Sept. 19, 2024 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“Immix Biopharma”, “Company”, “We” or “Us”, Nasdaq: IMMX), announced that effective today, Dr. Raymond Comenzo, internationally recognized AL Amyloidosis expert and Director of the Myeloma and Amyloid Program at Tufts Medical Center, joined ImmixBio subsidiary Nexcella Scientific Advisory Board. Dr. Comenzo is internationally recognized for his pioneering work in developing consensus guidelines for clinical trials and response criteria in AL Amyloidosis, and was the senior author of the landmark Andromeda trial results published in the New England Journal of Medicine in 2021, resulting in the first FDA-approved therapy for AL amyloidosis. “CAR-T represents a novel approach to treat AL Amyloidosis. I am thrilled to see focus on developing treatment options for relapsed/refractory AL Amyloidosis, where no drugs are approved today. I am excited to join the Nexcella team’s efforts to advance CAR-T NXC-201," commented Dr. Comenzo. "We are thrilled that Dr. Comenzo has joined our scientific advisory board. We believe we will benefit greatly from Dr. Comenzo’s counsel," stated Ilya Rachman, MD, PhD, Chief Executive Officer of Immix Biopharma. Gabriel Morris, Chief Financial Officer of Immix Biopharma, added, “Dr. Comenzo’s foundational contributions to the AL Amyloidosis field are internationally recognized. We are excited to be working with Dr. Comenzo.” Dr. Comenzo is Director of the Myeloma and Amyloid Program; Director, the Cell Therapy Laboratory at Tufts Medical Center; and Professor of Medicine at Tufts University School of Medicine. He is principally responsible for the clinical care of all plasma cell disease patients and for clinical research for these diseases at Tufts Medical Center. Dr. Comenzo completed his residency at Boston City Hospital and his fellowship in hematology/oncology and transfusion medicine at Tufts Medical Center. Prior to coming to Tufts MC, Dr. Comenzo was medical director of the cell therapy laboratory, and an attending member at Memorial Sloan Kettering Cancer Center; a professor of medicine at Weil-Cornell School of Medicine; and an attending physician in hematology, the founder of the Stem Cell Transplant Program, and the director of the Blood Bank at Boston Medical Center. Dr. Comenzo is board certified in Internal Medicine and Hematology. About Immix Biopharma, Inc.Immix Biopharma, Inc. (ImmixBio) (Nasdaq: IMMX) is a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and immune-mediated diseases. Our lead candidate is sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201. NXC-201 is being evaluated in the U.S. Phase 1b/2 trial NEXICART-2 (NCT06097832) as well as the ex-U.S. study NEXICART-1 (NCT04720313). NXC-201 has demonstrated no neurotoxicity of any kind in AL Amyloidosis and short duration of cytokine release syndrome (CRS), supporting expansion into immune-mediated diseases. NXC-201 has been awarded Orphan Drug Designation (ODD) in AL Amyloidosis by the US FDA and in the EU by the EMA. Learn more at www.immixbio.com and www.BeProactiveInAL.com. About Nexcella, Inc.Nexcella, Inc. is a wholly-owned subsidiary of, and the cell therapy division of, Immix Biopharma, Inc. (ImmixBio) (Nasdaq: IMMX). Forward Looking StatementsThis press release contains forward-looking statements regarding Immix Biopharma, Inc., its results of operations, prospects, future business plans and operations and the matters discussed above, including, but not limited to, potential benefits of our product candidate CAR-T NXC-201. These statements involve risks and uncertainties, and actual results may differ materially from any future results expressed or implied by the forward-looking statements. Forward-looking statements also 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/2 clinical trials for CAR-T NXC-201 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 CAR-T NXC-201 or other product candidates, (iii) that success in early phases of pre-clinical and clinicals trials do not ensure later clinical trials will be successful; (iv) that 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 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 29, 2024 and other periodic reports subsequently filed with the Securities and Exchange Commission. These reports are available at www.sec.gov. Immix Biopharma cautions that the foregoing list of important factors is not complete. 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. If we update one or more forward-looking statements, no inference should be drawn that we will make additional updates with respect to those or other forward-looking statements. Contacts Mike Moyer LifeSci Advisors mmoyer@lifesciadvisors.com Company Contactirteam@immixbio.com

Cell TherapyOrphan DrugExecutive ChangeDrug Approval

31 Aug 2024

·www.globenewswire.com

Immix Biopharma Expands U.S. Clinical Sites for relapsed/refractory AL Amyloidosis Trial NEXICART-2

New Sites Expand Opportunities for Patient Access and Enrollment Clinical Trial Sites Added Include Cleveland Clinic, UC Davis, and Sutter Health Lead site Memorial Sloan Kettering Cancer Center (MSKCC) Data from ex-U.S. clinical trial reported at ASGCT 2024 showed a 92% overall response rate Aug. 28, 2024 -- Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us”, “IMMX”) (Nasdaq: IMMX), a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and immune-mediated diseases, today announced the addition of three additional clinical trial sites for its U.S. relapsed/refractory AL Amyloidosis clinical trial NEXICART-2. The newly added centers include some of the leading programs in the world in AL Amyloidosis. New sites expand opportunities for patient access to CAR-T NXC-201 across the U.S. MSKCC remains the lead clinical site. The NEXICART-2 study is intended to evaluate the safety and efficacy of CAR-T NXC-201 in relapsed/refractory AL Amyloidosis patients with adequate cardiac function who have not been exposed to prior BCMA-targeted therapy. The study builds on positive data from the initial ex-U.S. study, NEXICART-1, presented at the 27th Annual Meeting of The American Society of Gene and Cell Therapy (ASGCT 2024) which showed a 92% overall response rate in relapsed/refractory AL Amyloidosis patients (12/13). The best responder experienced a 28.0 month duration of response (as reported May 10, 2024). “In our mission to advance treatment options for relapsed/refractory AL Amyloidosis patients, we are proud to expand our NEXICART-2 clinical trial footprint to a national scale with the addition of these world-class sites and exceptional principal investigators,” said Ilya Rachman, M.D., Ph.D., Chief Executive Officer of Immix Biopharma. Gabriel Morris, Chief Financial Officer of Immix Biopharma, added, “Working with our outstanding team and partners, these additional sites support upcoming interim and final read-outs of NEXICART-2.”NXC-201 is the only CAR-T therapy currently in development in AL Amyloidosis, mentioned in a review article entitled “Systemic Light Chain Amyloidosis” published in June, 2024 New England Journal of Medicine. NEXICART-2 (NCT06097832) is an open-label, single-arm, multi-site U.S. Phase 1b/2 dose expansion clinical trial of CAR-T NXC-201 in relapsed/refractory AL Amyloidosis. NEXICART-2 is expected to enroll 40 patients with adequate cardiac function who have not been exposed to prior BCMA-targeted therapy. The study is designed with a standard 6 patient safety-run in to evaluate two doses (three patients each at 150 million CAR+T cells and 450 million CAR+T cells), with the potential for further escalation to 800 million CAR+T cells (all 3 dose levels were evaluated in the NEXICART-1 study and have produced complete responses in relapsed/refractory AL Amyloidosis patients). The study aims to evaluate the safety and efficacy of NXC-201 in this patient population. Primary endpoints are complete response rate and overall response rate, according to consensus recommendations (Palladini et al. 2012). NEXICART-1 (NCT04720313) is an open-label, ex-U.S. Phase 1b/2 clinical trial of NXC-201 (formerly HBI0101) in patients with relapsed/refractory multiple myeloma and relapsed/refractory AL amyloidosis (including AL Amyloidosis patients with impaired cardiac function and including AL Amyloidosis patients exposed to prior BCMA-targeted therapy). The primary objective of the study is to characterize the safety and efficacy, as well as confirm the recommended Phase 2 dose (RP2D) of NXC-201 (which has already been confirmed). NEXICART-1 clinical results, most recently from ASGCT 2024, are available at https://immixbio.com/pipeline/#publications. NXC-201 is a sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy. Initial data from Phase 1b/2 ex-U.S. study NEXICART-1 has demonstrated no neurotoxicity of any kind in AL Amyloidosis. NXC-201 is being studied in a comprehensive clinical development program for the treatment of patients with relapsed/refractory AL amyloidosis, with the potential to expand into immune-mediated diseases. The NXC-201 NEXICART-2 (NCT06097832) U.S. clinical trial builds on a robust clinical dataset. NXC-201 has been awarded Orphan Drug Designation (ODD) in AL Amyloidosis by the US FDA and in the EU by the EMA. AL amyloidosis is caused by abnormal plasma cells in the bone marrow, which produce misfolded amyloid proteins that build-up in the heart, kidney, liver, and other organs. This build-up causes progressive and widespread damage to multiple organs, including heart failure, and leads to high mortality rates. The U.S. observed prevalence of relapsed/refractory AL Amyloidosis is estimated to be growing at 12% per year according to Staron, et al Blood Cancer Journal, to approximately 33,277 patients in 2024. The Amyloidosis market was $3.6 billion in 2017, and is expected to reach $6 billion in 2025, according to Grand View Research. Immix Biopharma, Inc. (ImmixBio) (Nasdaq: IMMX) is a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and immune-mediated diseases. Our lead candidate is sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201. NXC-201 is being evaluated in the U.S. Phase 1b/2 trial NEXICART-2 (NCT06097832) as well as the ex-U.S. study NEXICART-1 (NCT04720313). NXC-201 has demonstrated no neurotoxicity of any kind in AL Amyloidosis and short duration of cytokine release syndrome (CRS), supporting expansion into immune-mediated diseases. NXC-201 has been awarded Orphan Drug Designation (ODD) in AL Amyloidosis by the US FDA and in the EU by the EMA. Learn more at www.immixbio.com and www.BeProactiveInAL.com. The content above comes from the network. if any infringement, please contact us to modify.

$Immix Biopharma Expands U.S. Clinical Sites for relapsed/refractory AL Amyloidosis Trial NEXICART-2$

Cell TherapyClinical StudyImmunotherapyOrphan DrugASH

100 Deals associated with NXC-201

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Immunoglobulin Light-Chain Amyloidosis	Phase 2	-	Nexcella, Inc.	-
Multiple Myeloma	Phase 2	US	Immix Biopharma, Inc.	-
Autoimmune Diseases	Preclinical	IL	Nexcella, Inc.	12 Mar 2024

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04720313 (NEXICART-1, Biospace) Manual	Phase 1	Immunoglobulin Light-Chain Amyloidosis	13	NXC-201	(pdasmhozgo) = gotiuqdvna fsosvgkuxo (ikaydmtctm ) View more	Positive	10 May 2024
NCT04720313 (NEXICART-1, Biospace) Manual	Phase 1	Immunoglobulin Light-Chain Amyloidosis	13	NXC-201 (pts not exposed to prior BCMA-targeted bispecific)	(pdasmhozgo) = attcblzyww fsosvgkuxo (ikaydmtctm ) View more	Positive	10 May 2024
ASH2023	Phase 1/2	Relapse multiple myeloma	51	HBI0101	wrtmlmyofw(ctpaqesgxl) = lyugmsibfl xhooqhtyfv (qqyrzuyhtn ) View more	-	11 Dec 2023
NCT04720313 (ASH2023)	Phase 1/2	Immunoglobulin Light-Chain Amyloidosis	9	HBI0101 therapy	(xswncrnjll) = wrifglhtvs fnswgqcvib (zfymiqopyj ) View more	Positive	10 Dec 2023
NCT04720313 (NEXICART-1, Corporate Publications) Manual	Phase 1/2	Immunoglobulin Light-Chain Amyloidosis	9	NXC-201 (heavily pre-treated patients with daratumumab relapsed/refractory AL Amyloidosis)	(yeretayifb) = kvfejqkmsb lzzrkhuobn (yfggauzdow ) View more	Positive	03 Oct 2023
NCT04720313 (NEXICART-1, Corporate Publications) Manual	Phase 1/2	Immunoglobulin Light-Chain Amyloidosis	9	NXC-201 (t(11;14) relapsed/refractory AL Amyloidosis)	(yeretayifb) = khzookbide lzzrkhuobn (yfggauzdow ) View more	Positive	03 Oct 2023
NCT04720313 (IMS2023)	Phase 1	Relapse multiple myeloma	50	HBI0101	ggphantguv(swjaefktjd) = phtqcywsvj yvhiljrpch (aqgnmpiijf ) View more	-	26 Sep 2023
NCT04720313 (GlobeNewswire) Manual	Phase 1	Multiple Myeloma	42	NXC-201	(nomdqanoqm) = ydlmgdkhqa phrpcuiunm (ffztxcjzlj ) View more	Positive	09 Feb 2023
NCT04720313 (GlobeNewswire) Manual	Phase 1	Multiple Myeloma	42	NXC-201 (800 million CAR+T cells)	(nomdqanoqm) = uaqxwgwzrs phrpcuiunm (ffztxcjzlj ) View more	Positive	09 Feb 2023
NCT04720313 (Pubmed) Manual	Phase 1	Multiple Myeloma	20	HBI0101	qwtstxlipg(wteosjknzw) = mnvjkxrfpv ycxosslyvh (wzyyznokzh ) View more	Positive	06 Oct 2022
NCT04720313 (Pubmed)	Phase 1	Immunoglobulin Light-Chain Amyloidosis	4	HBI0101	(qrzqyrplbx) = qstirgyqxn kstlexjydr (vyipqgzjqv )	Positive	15 Sep 2022
NCT04720313 (EHA2022) Manual	Phase 1	Plasma cell myeloma refractory	20	HBI0101 (cohort 1: 150 x 10^6 cells)	(qzshqbalqv) = yfqtmyxbjc nsmbemytgf (zjflqsmhak ) View more	Positive	12 May 2022
NCT04720313 (EHA2022) Manual	Phase 1	Plasma cell myeloma refractory	20	HBI0101 (cohort 2: 450 x 10^6 cells)	(qzshqbalqv) = frbwofebge nsmbemytgf (zjflqsmhak ) View more	Positive	12 May 2022

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Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

NXC-201

Overview

Basic Info

Structure

Related

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation