Latest news with #neurotoxicity
Yahoo
11-07-2025
- Business
- Yahoo
Immix Biopharma Announces Class-Leading Safety Profile, Allowing Potential Future Indication Expansion
– Absence of neurotoxicity of any grade in low-volume disease to-date – – On track for first Biologics License Application (BLA) approved cell therapy in orphan indication relapsed/refractory AL Amyloidosis – – Potential future indication expansion planned – LOS ANGELES, July 11, 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 a class-leading safety profile for sterically-optimized CAR-T NXC-201, including absence of neurotoxicity of any grade in low-volume disease to-date, laying a foundation for potential future indication expansion. 'We are singularly focused on completing NEXICART-2 for BLA submission, where we are accelerating progress. Separately and subsequently, for potential future expansion directions, we believe NXC-201 will be able to address a range of immune-mediated and other serious diseases,' said Ilya Rachman, M.D., Ph.D., Chief Executive Officer of Immix Biopharma. Gabriel Morris, Chief Financial Officer of Immix Biopharma, added, 'Our near-term efforts are laser- focused on our path to NEXICART-2 BLA submission for FDA approval.' NEXICART-2 interim results, including safety results, were presented at the American Society for Clinical Oncology (ASCO 2025) by Heather Landau, MD of Memorial Sloan Kettering Cancer Center can be accessed on the Company's website under publications (ASCO Post article and video, MSKCC article, Cleveland Clinic article). A webcast of the Company's Key Opinion Leader (KOL) event to discuss the NXC-201 ASCO 2025 interim results, including safety results, can be accessed here. 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 with a 'digital filter' that filters out non-specific activation. 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 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. 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@
Associated Press
30-06-2025
- Business
- Associated Press
Renovaro Launches AI-Based Neurotoxin Countermeasure Initiative Addressing Emerging National Security Needs
LOS ANGELES, CALIFORNIA / ACCESS Newswire / June 30, 2025 / Renovaro Inc.'s (NASDAQ:RENB) wholly owned subsidiary BioSymetrics has unveiled a proprietary AI-based zebrafish screening platform designed to rapidly identify medical countermeasures for neurotoxic chemical agents, including weaponized substances like Sarin. The platform has been integrated into Renovaro's Defense Countermeasures Program, marking a strategic entry into the dual-use biotechnology and biodefense sector. Renovaro's platform is anchored by advanced data preprocessing coupled with in vivo toxicity testing, creating a robust, end-to-end discovery pipeline bolstered by their recently announced patent, 'Methods, Systems, and Frameworks for Unbiased Data in Drug Discovery Predictions'. This IP milestone expands the company's foundational portfolio, further protecting its machine learning infrastructure for multi-modal biomedical data integration and predictive analytics-core to its scalable drug discovery and diagnostics business. 'This is a defining moment for Renovaro as we extend the value of our AI platform from traditional life sciences into national security,' said David Weinstein, CEO of Renovaro. 'With a growing patent estate and entry into the defense market, we are unlocking new revenue channels and expanding the commercial potential of our core technologies.' Value Drivers: The AI-based platform which uses an inexpensive zebrafish-based model for validation of neurotoxicity predictions, delivers rapid, automated screening of over 1,000 compounds per week, significantly outpacing traditional animal models. It captures behavioural, cardiovascular, and muscular responses to neuroactive chemicals, enabling ML-driven compound triage and mechanism of action prediction. This capability is vital for both commercial CNS drug discovery and defense applications involving neurotoxic exposure. 'Investors increasingly seek companies with platforms that are both scientifically robust and commercially scalable,' said Weinstein. 'Our ability to serve large markets in biopharma and national security - each with deep funding pools and urgent unmet needs - creates a unique, de-risked growth trajectory.' About Renovaro Inc. Renovaro Inc. (NASDAQ: RENB) is building category-defining AI-driven platforms for precision medicine, diagnostics, and biodefense. Its proprietary technologies transform complex biomedical data into predictive insights, enabling faster discovery, greater accuracy, and strategic partnerships across the life sciences and government sectors. Investor Relations Contact: Your Name: Nathen Fuentes Title CFO [email protected] Company Website: SOURCE: Renovaro Biosciences press release
Yahoo
26-06-2025
- Health
- Yahoo
RFK's vaccine panel to spend days discussing and voting on an ingredient we barely use anymore
Health and Human Services Secretary Robert F. Kennedy Jr.'s vaccine advisory panel will spend days discussing and voting on an ingredient we barely use anymore. Kennedy, a vaccine skeptic, has recently overhauled the Advisory Committee for Immunization Practices, which is responsible for evaluating the safety, efficacy and clinical need of vaccines and then presenting its findings to the Centers for Disease Control and Prevention. He removed all 17 committee members earlier this month and replaced them with several people who have been critical of vaccines. Kennedy had said his picks were 'committed to evidence-based medicine, gold-standard science, and common sense.' The new committee members are now looking at a preservative called thimerosal, which is barely used in vaccines anymore. Thimerosal was introduced in the 1930s to prevent bacterial contamination in vaccines. The preservative began getting phased out of vaccines in the early 2000s. CNN reported that, at the time, there were concerns about whether the mercury-based preservative could cause neurotoxicity when used in childhood vaccines. Some critics suggested a link between thimerosal and autism. Kennedy was among those critics who published a book in 2014 about thimerosal, in which he rejected the findings of a 2004 Institute of Medicine report which concluded there was no 'causal relationship' between thimerosal and autism, according to CNN. He called for the 'immediate removal of mercury – a known neurotoxin – from vaccines,' in his book. The CDC said the Food and Drug Administration's recommendation to remove thimerosal from childhood vaccines was a 'precautionary measure' and that the agency found 'no evidence of harm.' The CDC also said thimerosal is safe and that there is no link between the preservative and autism. This flu season, 94 percent of flu shots did not contain thimerosal, per the CDC. CNN reported the vaccine advisory committee was to meet on Wednesday and Thursday to discuss thimerosal. They will vote on whether to ban the preservative on Thursday, per ABC News. Dr. Jason Goldman, president of the American College of Physicians and a liaison member to the vaccine advisory committee, told ABC News, 'It's just a mystery to me why they're even having this on the agenda."
The Independent
26-06-2025
- Health
- The Independent
RFK's vaccine panel to spend days discussing and voting on an ingredient we barely use anymore
Health and Human Services Secretary Robert F. Kennedy Jr. 's vaccine advisory panel will spend days discussing and voting on an ingredient we barely use anymore. Kennedy, a vaccine skeptic, has recently overhauled the Advisory Committee for Immunization Practices, which is responsible for evaluating the safety, efficacy and clinical need of vaccines and then presenting its findings to the Centers for Disease Control and Prevention. He removed all 17 committee members earlier this month and replaced them with several people who have been critical of vaccines. Kennedy had said his picks were 'committed to evidence-based medicine, gold-standard science, and common sense.' The new committee members are now looking at a preservative called thimerosal, which is barely used in vaccines anymore. Thimerosal was introduced in the 1930s to prevent bacterial contamination in vaccines. The preservative began getting phased out of vaccines in the early 2000s. CNN reported that, at the time, there were concerns about whether the mercury-based preservative could cause neurotoxicity when used in childhood vaccines. Some critics suggested a link between thimerosal and autism. Kennedy was among those critics who published a book in 2014 about thimerosal, in which he rejected the findings of a 2004 Institute of Medicine report which concluded there was no 'causal relationship' between thimerosal and autism, according to CNN. He called for the 'immediate removal of mercury – a known neurotoxin – from vaccines,' in his book. The CDC said the Food and Drug Administration 's recommendation to remove thimerosal from childhood vaccines was a 'precautionary measure' and that the agency found 'no evidence of harm.' The CDC also said thimerosal is safe and that there is no link between the preservative and autism. This flu season, 94 percent of flu shots did not contain thimerosal, per the CDC. CNN reported the vaccine advisory committee was to meet on Wednesday and Thursday to discuss thimerosal. They will vote on whether to ban the preservative on Thursday, per ABC News. Dr. Jason Goldman, president of the American College of Physicians and a liaison member to the vaccine advisory committee, told ABC News, 'It's just a mystery to me why they're even having this on the agenda."
