MedPath

Tagged News

Galapagos Appoints Former Horizon CFO Aaron Cox to Lead Strategic Transformation

CAR-T
  • Galapagos NV has appointed Aaron Cox as Chief Financial Officer effective July 7, 2025, bringing over two decades of biotechnology and M&A expertise to the Belgian biotech company.
  • Cox previously served as CFO at Horizon Therapeutics, where he played a pivotal role in the company's $28 billion acquisition by Amgen in 2022.
  • The appointment positions Galapagos to leverage its $3.3 billion cash reserves for strategic acquisitions and explore value-maximizing alternatives for its cell therapy business.
  • Cox will lead efforts to accelerate pipeline growth through business development while managing the company's transformation with disciplined financial oversight.

Terumo BCT Unveils Automated CAR-T Manufacturing Platform Delivering 12 Billion Cells in 7-8 Days

CAR-T
  • Terumo BCT has developed a new automated workflow that consolidates T cell activation, viral transduction, and expansion into a single platform, streamlining CAR-T manufacturing significantly.
  • The protocol demonstrates the ability to produce over 12 billion CAR-T cells in just 7 to 8 days with doubled transduction efficiency compared to manual methods.
  • The integrated 3-in-1 approach uses serum-free culture conditions and closed-system design to reduce contamination risks while supporting generation of crucial T cell subtypes including memory cells.
  • The workflow is currently under evaluation by cell therapy developers and is expected to shorten production timelines, lower costs, and expand patient access to CAR-T treatments.

Chemotherapy-Free Regimens and CAR-T Therapies Transform B-Cell Malignancy Treatment Paradigms

CAR-TTargeted TherapyDrug Approval
  • Chemotherapy-free regimens are shifting treatment paradigms in mantle cell lymphoma, with BTK inhibitor-based therapies increasingly used for high-risk patients with TP53 mutations who respond poorly to traditional chemotherapy.
  • The FDA approval of lisocabtagene maraleucel for double-refractory chronic lymphocytic leukemia provides a new treatment option for patients who have failed both BTK inhibitors and BCL2 inhibitors like venetoclax.
  • Selective BTK inhibitors zanubrutinib and acalabrutinib are replacing ibrutinib in clinical practice, with combination regimens including venetoclax showing promising results in frontline CLL therapy.
  • Novel combination strategies including acalabrutinib plus venetoclax and triplet regimens with obinutuzumab are expanding treatment options for CLL patients, though regulatory approval is still pending.

Study of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for Previously Untreated CLL

NCT03836261Active, Not RecruitingPhase 3
Acerta Pharma BV
Posted 2/25/2019

Tisagenlecleucel in Adult Patients With Aggressive B-cell Non-Hodgkin Lymphoma

NCT03570892Active, Not RecruitingPhase 3
Novartis Pharmaceuticals
Posted 5/7/2019

Study of Effectiveness of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma

NCT03391466CompletedPhase 3
Kite, A Gilead Company
Posted 1/25/2018

Open Label Study to Evaluate the Safety and Efficacy of Lenalidomide With MOR00208 in Patients With R-R DLBCL

NCT02399085CompletedPhase 2
MorphoSys AG
Posted 3/29/2016

Comparison of the Treatments of Obinutuzumab + Venetoclax Versus Obinutuzumab + Chlorambucil in Patients With Chronic Lymphocytic Leukemia

NCT02242942Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 12/31/2014

Study Evaluating Safety and Efficacy of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

NCT03331198RecruitingPhase 1
Juno Therapeutics, a Subsidiary of Celgene
Posted 11/27/2017

Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed/Refractory B-cell Lymphoma

NCT03223610RecruitingPhase 1
National Cancer Institute (NCI)
Posted 2/9/2018

ASCT After a Rituximab/Ibrutinib/Ara-c Containing iNduction in Generalized Mantle Cell Lymphoma

NCT02858258RecruitingPhase 3
Prof. Dr. M. Dreyling (co-chairman)
Posted 7/1/2016

A Study to Compare the Efficacy and Safety of JCAR017 to Standard of Care in Adult Subjects With High-risk, Transplant-eligible Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphomas

NCT03575351CompletedPhase 3
Celgene
Posted 10/23/2018

CD5-Targeted Therapies Show Promise Across Cancer, Autoimmunity, and Transplantation with First Commercial Launch Expected by 2030

CAR-TMonoclonal Antibody
  • CD5-targeted therapies are advancing through clinical development with fewer than 10 therapies currently in trials and the highest phase reaching Phase II, with first commercial approval expected by 2030.
  • Leading CAR-T candidates MB-105 and VIPER-101 demonstrate acceptable safety profiles and encouraging antitumor activity in relapsed and refractory T-cell malignancies.
  • CD5's therapeutic versatility extends beyond oncology to autoimmune disorders and transplantation medicine, offering potential to modulate immune responses across multiple disease contexts.
  • Despite promising early results, challenges remain including fratricide effects in cancer therapy, immune balance in autoimmunity, and limited long-term safety data for novel approaches.

BioNTech Shuts Down Maryland Cell Therapy Manufacturing Following CAR-T Trial Failure

CAR-TOncology
  • BioNTech will lay off 63 employees and wind down cell therapy manufacturing at its Gaithersburg, Maryland facility by the end of 2025 following disappointing Phase 1 trial results.
  • The company discontinued development of its CAR-T candidate BNT211 targeting CLDN6 in testicular cancer and germ cell tumors due to insufficient efficacy data.
  • Despite the setback, BioNTech continues studying BNT211 in other CLDN6-expressing cancers including ovarian, sarcoma, endometrial, and gastric cancers.
  • The facility closure is part of broader oncology pipeline restructuring as BioNTech realigns resources and reduces global workforce by up to 1,350 jobs by 2027.

MD Anderson Study Identifies Three B-Cell Lymphoma Subgroups with Distinct CD19 CAR-T Response Patterns

CAR-TPrecision Medicine
  • Researchers at MD Anderson Cancer Center analyzed 232 patients with large B-cell lymphoma to identify three distinct tumor microenvironment subgroups with different responses to CD19 CAR-T therapy.
  • The study profiled over 1.8 million cells and validated findings using ZUMA-7 Phase III trial data, revealing that the lymph node subgroup benefits most from CAR-T therapy while the T cell exhausted group shows no significant benefit.
  • The findings provide a precision medicine framework to guide treatment selection and identify patients who may need alternative therapeutic approaches beyond CAR-T cell therapy.
  • The research opens opportunities for targeted therapies in development to address the needs of patients in subgroups with poorer CAR-T outcomes.

UCSF Researchers Develop CAR-T Therapy for Aggressive Bladder Cancer Variant Using Novel Biomarkers

CAR-TPrecision Medicine
  • UCSF scientists identified CA125 and TM4SF1 as novel biomarkers in histologic variant bladder cancer, which affects up to 25% of bladder cancer patients but is typically excluded from clinical trials.
  • Researchers developed CAR-T cell therapy targeting TM4SF1 protein that successfully eliminated bladder tumors in preclinical mouse models.
  • The breakthrough uses single-cell sequencing technology to characterize previously untreatable bladder cancer subtypes that resist conventional therapy and frequently recur after surgery.
  • This discovery could transform treatment options for patients with histologic variant bladder cancer who currently have limited therapeutic alternatives beyond radical surgery.

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

Monoclonal AntibodyCAR-T
  • DelveInsight's 2025 pipeline report reveals over 50 companies are actively developing 51+ therapies for thyroid cancer treatment, indicating a robust therapeutic landscape.
  • Novartis announced a Phase III study evaluating dabrafenib plus trametinib for BRAFV600E mutation-positive differentiated thyroid cancer patients refractory to radioactive iodine.
  • Children's Hospital of Philadelphia initiated a study combining larotrectinib with 131I therapy for NTRK fusion differentiated thyroid cancer patients.
  • Emerging therapies include CAR-T cell therapy AIC100 from AffyImmune Therapeutics and novel BRAF inhibitor RX208 from Suzhou NeuPharma.

AstraZeneca's Surovatamig Shows Promise as Next-Generation BiTE Therapy for Relapsed/Refractory B-ALL

CAR-TOncology
  • AstraZeneca's surovatamig demonstrated promising efficacy in the Phase I/II SYRUS trial, achieving complete remission rates of 46%, 58%, and 83% at dose levels 1, 2, and 3 respectively in patients with relapsed/refractory B-cell acute lymphoblastic leukemia.
  • The next-generation CD19xCD3 bispecific T-cell engager showed a manageable safety profile with cytokine release syndrome occurring in 31% of patients at dose level 1, and no patients discontinued treatment due to drug-related adverse events.
  • Surovatamig's Fc-engineered design enables intermittent dosing and controlled T-cell activation, offering a potentially more convenient alternative to Blincyto's continuous infusion requirement.
  • Despite promising results, surovatamig faces significant market competition with projected global sales of $138 million by 2031 compared to Blincyto's $1.7 billion, though Blincyto's patent expiry may create opportunities.

A trial to understand if AZD0486 is safe and helps in people with Relapsed or Refractory B-cell acute lymphoblastic leukemia (B-ALL)

2023-505840-20-00RecruitingPhase 1/2
Astrazeneca AB
Posted 12/29/2023

Liso-cel Achieves 95.5% Response Rate in Relapsed/Refractory Marginal Zone Lymphoma

CAR-TOncology
  • Lisocabtagene maraleucel (liso-cel) demonstrated a 95.5% overall response rate and 62.1% complete response rate in 66 patients with relapsed/refractory marginal zone lymphoma in the TRANSCEND FL trial.
  • The therapy showed durable responses with 24-month duration of response, progression-free survival, and overall survival rates of 88.6%, 85.7%, and 90.4%, respectively.
  • Safety profile remained consistent with previous reports, with 76% experiencing any-grade cytokine release syndrome and only 4% experiencing grade 3 events.
  • The results address a significant unmet need for patients with marginal zone lymphoma, where median overall survival after multiple relapses is currently 3 to 5 years.

A Study to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL)

NCT04245839RecruitingPhase 2
Celgene
Posted 7/14/2020

Study Evaluating the Safety and Pharmacokinetics of JCAR017 in B-cell Non-Hodgkin Lymphoma (TRANSCEND-NHL-001)

NCT02631044CompletedPhase 1
Juno Therapeutics, a Subsidiary of Celgene
Posted 1/6/2016

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.