Latest news with #BCMA-targeted
Yahoo
2 days ago
- Business
- Yahoo
Immix Biopharma Attends FDA CEO Forum in Washington DC
– Selected to Attend In-Person Event on June 5 led by FDA Commissioner Marty A. Makary, M.D., M.P.H. – LOS ANGELES, CA, June 06, 2025 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. ('ImmixBio', 'Company', 'We' or 'Us' or 'IMMX'), a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and other serious diseases, today announced that it was selected by FDA, and attended, the FDA CEO forum led by FDA Commissioner Marty A. Makary, M.D., M.P.H. and team at FDA headquarters in Silver Spring, MD, on June 5, 2025. Per FDA, the purpose of the meeting is to gather direct input from biotechnology and pharmaceutical leaders on how the FDA can modernize its regulatory framework to better support innovation and patient access to safe and effective therapies. FDA Commissioner Marty A. Makary, M.D., M.P.H. stated, 'These CEO Forums are a chance for the FDA to listen and gather feedback from those at the front lines of discovery. We are committed to strengthening a regulatory environment that enables breakthroughs to reach patients faster, while upholding the highest standards of safety and scientific integrity.' 'We share FDA's vision for an efficient, thoughtful regulatory framework to accelerate patient access to safe and effective therapies. Discussing this topic with FDA Commissioner Dr. Makary and team yesterday offered an unprecedented opportunity,' said Ilya Rachman, M.D., Ph.D., Chief Executive Officer of Immix Biopharma. Gabriel Morris, Chief Financial Officer of Immix Biopharma, added, 'As we progress, we were thrilled to be selected alongside other leaders of the global pharmaceutical industry. We are grateful that FDA facilitated this important, collaborative discussion.' About Immix Biopharma, Biopharma, Inc. (ImmixBio) (Nasdaq: IMMX) is a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and other serious 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. multi-center study for relapsed/refractory AL Amyloidosis NEXICART-2 (NCT06097832), with a registrational design. Interim results were presented at ASCO 2025 in an oral presentation by Heather Landau, M.D. of Memorial Sloan Kettering Cancer Center. NXC-201 has been awarded Regenerative Medicine Advanced Therapy (RMAT) by the US FDA and Orphan Drug Designation (ODD) by FDA and in the EU by the EMA. Learn more at and 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, the potential benefits of our product candidate CAR-T NXC-201 and the timing and results related clinical trials. 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 1/2 clinical trials for CAR-T NXC-201 will not be favorably consistent with the data readouts to date, (ii) the risk that the Company may not be able to continue the NEXICART-2 multi-site U.S. Phase 1/2 clinical trial; (iii) the risk that the Company may not be able to advance to registration-enabling studies for CAR-T NXC-201 or other product candidates, (iv) that success in early phases of pre-clinical and clinicals trials do not ensure later clinical trials will be successful; (v) that no drug product developed by the Company has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (vi) 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 25, 2025 and other periodic reports subsequently filed with the Securities and Exchange Commission. These reports are available at 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. ContactsMike MoyerLifeSci Advisorsmmoyer@ Company Contactirteam@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
2 days ago
- Business
- Yahoo
Immix Biopharma Attends FDA CEO Forum in Washington DC
– Selected to Attend In-Person Event on June 5 led by FDA Commissioner Marty A. Makary, M.D., M.P.H. – LOS ANGELES, CA, June 06, 2025 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. ('ImmixBio', 'Company', 'We' or 'Us' or 'IMMX'), a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and other serious diseases, today announced that it was selected by FDA, and attended, the FDA CEO forum led by FDA Commissioner Marty A. Makary, M.D., M.P.H. and team at FDA headquarters in Silver Spring, MD, on June 5, 2025. Per FDA, the purpose of the meeting is to gather direct input from biotechnology and pharmaceutical leaders on how the FDA can modernize its regulatory framework to better support innovation and patient access to safe and effective therapies. FDA Commissioner Marty A. Makary, M.D., M.P.H. stated, 'These CEO Forums are a chance for the FDA to listen and gather feedback from those at the front lines of discovery. We are committed to strengthening a regulatory environment that enables breakthroughs to reach patients faster, while upholding the highest standards of safety and scientific integrity.' 'We share FDA's vision for an efficient, thoughtful regulatory framework to accelerate patient access to safe and effective therapies. Discussing this topic with FDA Commissioner Dr. Makary and team yesterday offered an unprecedented opportunity,' said Ilya Rachman, M.D., Ph.D., Chief Executive Officer of Immix Biopharma. Gabriel Morris, Chief Financial Officer of Immix Biopharma, added, 'As we progress, we were thrilled to be selected alongside other leaders of the global pharmaceutical industry. We are grateful that FDA facilitated this important, collaborative discussion.' About Immix Biopharma, Biopharma, Inc. (ImmixBio) (Nasdaq: IMMX) is a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and other serious 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. multi-center study for relapsed/refractory AL Amyloidosis NEXICART-2 (NCT06097832), with a registrational design. Interim results were presented at ASCO 2025 in an oral presentation by Heather Landau, M.D. of Memorial Sloan Kettering Cancer Center. NXC-201 has been awarded Regenerative Medicine Advanced Therapy (RMAT) by the US FDA and Orphan Drug Designation (ODD) by FDA and in the EU by the EMA. Learn more at and 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, the potential benefits of our product candidate CAR-T NXC-201 and the timing and results related clinical trials. 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 1/2 clinical trials for CAR-T NXC-201 will not be favorably consistent with the data readouts to date, (ii) the risk that the Company may not be able to continue the NEXICART-2 multi-site U.S. Phase 1/2 clinical trial; (iii) the risk that the Company may not be able to advance to registration-enabling studies for CAR-T NXC-201 or other product candidates, (iv) that success in early phases of pre-clinical and clinicals trials do not ensure later clinical trials will be successful; (v) that no drug product developed by the Company has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (vi) 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 25, 2025 and other periodic reports subsequently filed with the Securities and Exchange Commission. These reports are available at 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. ContactsMike MoyerLifeSci Advisorsmmoyer@ Company Contactirteam@
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Business Standard
6 days ago
- Health
- Business Standard
Glenmark's cancer drug shows strong results in early trial for Myeloma
Glenmark Pharmaceuticals' arm, Ichnos Glenmark Innovation (IGI), shared encouraging early results from a new cancer drug being tested on patients with a difficult form of blood cancer—relapsed or refractory multiple myeloma (RRMM). The results were presented at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting. The drug, called ISB 2001, is the first of its kind to target three markers (BCMA, CD38, and CD3) in a single treatment and has shown strong response rates in patients who have already undergone multiple prior therapies. In the dose-escalation stage of the trial, 35 patients were treated, most of whom had received a median of six prior therapies. Among 33 patients who received active doses (50 micrograms and above), the overall response rate (ORR) was 79 per cent, and 30 per cent achieved a complete or near-complete response. Safety data showed that cytokine release syndrome (CRS) occurred in 69 per cent of patients, mostly at Grade 1 severity. Four patients experienced Grade 2 CRS, and no cases of severe CRS or dose-limiting toxicities were reported. One patient experienced a mild neurological side effect, and infection rates remained low. The trial is continuing with a dose-expansion phase to determine the recommended Phase 2 dose and the optimal dosing schedule. According to Professor Hang Quach of the University of Melbourne and St Vincent's Hospital, ISB 2001 showed activity in patients who had previously received multiple treatment types, including T-cell redirecting and BCMA-targeted therapies. Lida Pacaud, Chief Medical Officer at IGI, said the current focus is on identifying the appropriate dose and expanding the trial to a broader patient population.
Yahoo
23-05-2025
- Business
- Yahoo
Immix Biopharma Further Expands U.S. Clinical Sites for relapsed/refractory AL Amyloidosis Trial NEXICART-2
– Patient enrollment exceeding expectations – – 14 U.S. sites actively enrolling; 10 U.S. sites added since last update – – Anticipate completing NEXICART-2 clinical trial ahead of schedule – LOS ANGELES, CA, May 23, 2025 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. ('ImmixBio', 'Company', 'We' or 'Us' or "IMMX'), a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and other serious diseases, today announced that 14 U.S. sites are actively enrolling in U.S. multi-site study NEXICART-2. This milestone adds 10 sites since the Company's most recent update. The company anticipates completing NEXICART-2 clinical trial ahead of schedule. 'Based on robust enrollment and demand, we are proud to expand our NEXICART-2 clinical trial footprint to a significant number of national AL Amyloidosis centers,' said Ilya Rachman, M.D., Ph.D., Chief Executive Officer of Immix Biopharma. Gabriel Morris, Chief Financial Officer of Immix Biopharma, added, 'Working with these world-class sites, we believe we are well positioned to complete NEXICART-2 on time or even ahead of schedule.' Phase 1/2 interim readout data from its U.S. NXC-201 NEXICART-2 trial in relapsed/refractory AL Amyloidosis has been selected for oral presentation at the upcoming 2025 American Society of Clinical Oncology Annual Meeting (ASCO 2025) being held in Chicago, Illinois, May 30 – June 3, 2025, presented by lead investigator Heather Landau, M.D., Director of Amyloidosis Program and a Bone Marrow Transplant Specialist & Cellular Therapist at Memorial Sloan-Kettering Cancer Center in New York. About NEXICART-2NEXICART-2 (NCT06097832) is an ongoing single-arm multi-site U.S. Phase 1/2 clinical trial of sterically-optimized CAR-T NXC-201 in relapsed/refractory AL Amyloidosis. NEXICART-2 is expected to enroll 40 patients with preserved heart function (excluding patients with pre-existing heart failure) who have not been exposed to prior BCMA-targeted therapy. The primary endpoint of the Phase 1 portion is safety. The primary endpoint of the Phase 2 portion is efficacy. About NXC-201NXC-201 is a sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy with a 'digital filter' that filters out non-specific activation. Initial data from ex-U.S. study NEXICART-1 has demonstrated high complete response rates in relapsed/refractory AL Amyloidosis. U.S. Phase 1/2 study NEXICART-2 is ongoing. NXC-201 has been awarded Regenerative Medicine Advanced Therapy (RMAT) by the FDA, and Orphan Drug Designation (ODD) by the US FDA and in the EU by the EMA. About AL AmyloidosisAL amyloidosis is caused by abnormal plasma cells in the bone marrow, which produce misfolded amyloid proteins that circulate in the blood, then build-up in the heart, kidney, liver, and other organs. This build-up causes progressive and widespread organ damage, including heart and renal failure, leading 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, Biopharma, Inc. (ImmixBio) (Nasdaq: IMMX) is a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and other serious 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. multi-center study NEXICART-2 (NCT06097832). NXC-201 has demonstrated no neurotoxicity in AL Amyloidosis, supporting expansion into other serious diseases. NXC-201 has been awarded Regenerative Medicine Advanced Therapy (RMAT) by the US FDA and Orphan Drug Designation (ODD) by FDA and in the EU by the EMA. Learn more at and 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, the potential benefits of our product candidate CAR-T NXC-201 and the timing and results related clinical trials. 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 1/2 clinical trials for CAR-T NXC-201 will not be favorably consistent with the data readouts to date, (ii) the risk that the Company may not be able to continue the NEXICART-2 multi-site U.S. Phase 1/2 clinical trial; (iii) the risk that the Company may not be able to advance to registration-enabling studies for CAR-T NXC-201 or other product candidates, (iv) that success in early phases of pre-clinical and clinicals trials do not ensure later clinical trials will be successful; (v) that no drug product developed by the Company has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (vi) 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 25, 2025 and other periodic reports subsequently filed with the Securities and Exchange Commission. These reports are available at 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. ContactsMike MoyerLifeSci Advisorsmmoyer@ Company Contactirteam@
