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Cue Biopharma Appoints Dr. Usman Azam as CEO, Pivots to Autoimmune Disease Focus with CUE-401

Leadership ChangeCAR-T
  • Cue Biopharma has appointed Dr. Usman Azam as President and CEO, effective September 29, 2025, bringing over 25 years of drug development experience including CAR-T cell therapy leadership at Novartis.
  • The company is strategically pivoting to prioritize autoimmune disease development, focusing on advancing its first-in-class tolerogenic biologic CUE-401 into clinical trials.
  • CUE-401 is designed as a bifunctional molecule combining TGF-beta with IL-2 mutein to restore immune homeostasis and tolerance, with potential to disrupt standard autoimmune disease treatment.
  • The leadership transition positions the company to address significant unmet medical needs in autoimmune diseases while seeking strategic partnerships for its clinical-stage CUE-100 series assets.

ME Therapeutics Secures U.S. Patent for G-CSF Antibody Cancer Therapy and Advances Multi-Platform Pipeline

Monoclonal AntibodyCAR-T
  • ME Therapeutics received U.S. Patent No. 12,421,308 for its lead G-CSF antibody candidate H1B11-12, which targets immune suppression in the tumor microenvironment.
  • The company is advancing cell line development to meet GMP standards in preparation for clinical trials while expanding its research team with two new associate research scientists.
  • Preclinical testing shows promising results for the company's therapeutic mRNA program, with the lead candidate demonstrating immune cell recruitment into tumors.
  • The company's in vivo CAR program has confirmed in vitro activity of tumor-targeted CARs, representing a next-generation approach to reprogram cells within the tumor microenvironment.

Verismo Therapeutics Partners with Miltenyi Biotec to Advance KIR-CAR Platform for Solid Tumor Treatment

CAR-T
  • Verismo Therapeutics successfully manufactured its first clinical cell product using lentiviral vector supplied by Miltenyi Bioindustry for the STAR-101 Phase 1 trial.
  • The collaboration supports SynKIR™-110, a novel KIR-CAR therapy targeting mesothelin for solid tumor treatment, marking a major milestone in clinical development.
  • This partnership establishes a reliable supply chain for Phase 2 development and commercial applications of Verismo's unique multi-chain KIR-CAR platform technology.
  • The KIR-CAR platform uses modified NK cell-derived receptors designed to improve T cell persistence and reduce exhaustion in challenging tumor microenvironments.

SynKIR-310 for Relapsed/Refractory B-NHL

NCT06544265RecruitingPhase 1
Verismo Therapeutics
Posted 11/1/2024

SynKIR-110 for Mesothelin Expressing Ovarian Cancer, Cholangiocarcinoma or Mesothelioma

NCT05568680RecruitingPhase 1
Verismo Therapeutics
Posted 3/30/2023

Aera Therapeutics Nominates AERA-109 as First Development Candidate for In Vivo CAR-T Therapy

CAR-T
  • Aera Therapeutics nominated AERA-109, a targeted in vivo CAR-T therapy for B cell-mediated autoimmune diseases, as its first development candidate based on promising preclinical data.
  • Preclinical studies demonstrated deep B cell depletion in blood and tissues in humanized mouse models and non-human primates using the company's proprietary targeted lipid nanoparticle delivery platform.
  • The therapy aims to reprogram immune cells directly inside the body, potentially addressing logistical, safety, and scalability challenges of traditional ex vivo cell therapies.
  • Aera plans to advance AERA-109 into clinical development in mid-2026, marking a significant milestone for the Cambridge-based biotechnology company.

FAERS Analysis Reveals Lower Infection Risk with Ide-cel Compared to Other BCMA-Targeted Therapies in Multiple Myeloma

CAR-T
  • A retrospective analysis of FDA Adverse Event Reporting System (FAERS) data from 2021-2024 found that idecabtagene vicleucel (ide-cel) was associated with significantly lower infection rates compared to other BCMA-directed therapies in multiple myeloma patients.
  • The study analyzed 4,809 adverse event reports and showed teclistamab had 3.81-fold higher infection reporting odds, elranatamab had 5.67-fold higher odds, and cilta-cel had 1.78-fold higher odds compared to ide-cel.
  • Infection-related non-relapse mortality was significantly higher with teclistamab (4.02-fold) and elranatamab (5.57-fold) compared to ide-cel, while cilta-cel showed comparable rates.
  • The findings emphasize the clinical importance of integrating safety profiles into treatment decisions for immunocompromised multiple myeloma patients who face elevated infection risks.

IASO Biotherapeutics Reports Sustained 36-Month Efficacy Data for Fucaso CAR-T Therapy in Multiple Myeloma

CAR-TDrug Approval
  • IASO Biotherapeutics presented three-year follow-up data for Fucaso (Equecabtagene Autoleucel) at the 2025 International Myeloma Society Annual Meeting, demonstrating sustained efficacy in heavily pretreated relapsed/refractory multiple myeloma patients.
  • The complete response/stringent complete response rate among BCMA CAR-T-naïve patients increased to 88.4%, with a median progression-free survival of 35.9 months in this population.
  • The therapy maintained a manageable long-term safety profile with no new safety signals identified over the 36-month follow-up period.
  • Fucaso represents the world's first fully human anti-BCMA CAR-T therapy, approved by China's NMPA in June 2023, with ongoing global registration efforts across multiple countries.

Advanced Liver Cancer Pipeline Shows Robust Growth with 50+ Companies Developing Novel Therapies

Targeted TherapyCAR-T
  • DelveInsight's 2025 pipeline report reveals over 50 active companies developing 52+ advanced liver cancer therapies, indicating strong industry commitment to addressing this challenging malignancy.
  • Recent regulatory milestones include Tempest Therapeutics receiving FDA fast track and orphan drug designations for amezalpat, while Bayer initiated Phase I trials for targeted alpha radiopharmaceutical BAY 3547926.
  • The pipeline features diverse therapeutic approaches including immunotherapy combinations, targeted therapies, and novel mechanisms like STAT3 inhibitors and CAR-T cell therapies.
  • Advanced liver cancer affects patients with disease spread beyond the liver, requiring systemic treatments focused on slowing progression and maintaining quality of life with median survival often limited to months.

Cevostamab Consolidation After CAR-T Therapy Shows 93% MRD-Negative Response Rate in Heavily Pretreated Multiple Myeloma

CAR-T
  • Fixed-duration cevostamab consolidation following BCMA-directed CAR-T cell therapy demonstrated feasibility and tolerability in heavily pretreated multiple myeloma patients, with a 93% MRD-negative complete response rate at one year.
  • The phase 2 STEM trial enrolled 27 patients who received cevostamab for 8 cycles after standard CAR-T therapy, showing improved response rates from 63% pre-treatment to 93% at one-year follow-up.
  • Safety profile was manageable with predominantly hematologic adverse events, while over 90% of evaluable patients sustained MRD-negative complete responses at one year post-CAR-T therapy.

Cevostamab Following CAR T Cell Therapy for RRMM

NCT05801939RecruitingPhase 2
University of Pennsylvania
Posted 7/11/2023

CARsgen's Zevor-cel Shows Exceptional 5-Year Survival Data in Relapsed Multiple Myeloma Patients

CAR-TDrug Approval
  • CARsgen presented updated long-term follow-up results for zevor-cel at the International Myeloma Society Annual Meeting, showing a 100% overall response rate in 14 relapsed/refractory multiple myeloma patients.
  • The BCMA-targeting CAR T-cell therapy demonstrated exceptional durability with median progression-free survival of 44.1 months and one patient remaining in stringent complete response at 59.3 months.
  • Safety profile remained manageable with no Grade 3 or higher cytokine release syndrome, neurotoxicity, or delayed adverse events reported during the 53.3-month median follow-up period.
  • Survival rates at 24, 36, 48, and 60 months post-infusion were 100%, 92.3%, 84.6%, and 76.9% respectively, with median overall survival not yet reached.

MagicRNA's In Vivo CAR-T Therapy HN2301 Shows Promise in First-in-Human Lupus Trial

CAR-T
  • MagicRNA's HN2301 successfully reprogrammed up to 60% of CD8+ T-cells into CAR-T cells within six hours in lupus patients, marking the first clinical demonstration of in vivo CAR-T therapy for autoimmune diseases.
  • The therapy achieved complete depletion of circulating B cells lasting 7-10 days and significantly reduced disease activity scores by up to 20 points in all five patients after three months.
  • Treatment was well-tolerated with no severe adverse events, grade ≥3 cytokine release syndrome, or neurotoxic effects observed during the study.
  • The results support continued dose-escalation studies as MagicRNA advances toward achieving immune reset and long-term drug-free remission for lupus patients.

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