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Cellex Expands GMP Manufacturing Capacity Following Production of Over 5,800 Cell and Gene Therapy Batches

CAR-T
  • Cellex Cell Professionals announces major facility expansion, now operating over 2,500 m² of GMP-certified manufacturing area with 43% allocated to cleanroom operations across 37 workstations.
  • The German CDMO has manufactured more than 5,800 CGT/ATMP batches including 1,300+ clinical and 4,500+ commercial products, supporting three EU-approved CAR-T therapies.
  • In 2023, Cellex successfully manufactured Europe's first allogeneic CAR-T product, demonstrating its capabilities in cutting-edge cellular therapy development.
  • The company onboarded two new clients in January 2025 with a robust pipeline of new mandates planned for the remainder of the year.

Mission Bio Secures Funding to Advance Single-Cell Tri-Omics Platform for Cancer Drug Development

Precision MedicineCAR-T
  • Mission Bio completed equity financing led by Ally Bridge Group to accelerate commercial growth and advance its Tapestri Platform's single-cell tri-omics capabilities for cancer research.
  • The company launched its industry-first Single-Cell Genotype and Targeted Gene Expression assay, enabling simultaneous profiling of DNA and RNA from over 10,000 single cells to address clinical trial failures.
  • The funding will support commercial expansion, development of tri-omics capabilities combining DNA, RNA, and protein analysis, and accelerated clinical adoption across multiple cancer segments including multiple myeloma and CAR-T therapies.

KFSHRC Achieves Breakthrough in Gene Therapy for Hemophilia A with One-Time Treatment Success

CAR-T
  • King Faisal Specialist Hospital & Research Centre successfully treated eight hemophilia A patients with one-time gene therapy, eliminating the need for preventive treatment and significantly improving quality of life.
  • The hospital became the first in Saudi Arabia to locally produce CAR-T cells in 2024, marking a major step toward national self-sufficiency in advanced cancer therapies.
  • KFSHRC now conducts 52.4% of all active clinical trials nationwide and recorded 701 active research proposals by the end of 2024, representing an 8% increase over the previous year.

Elpis Biopharmaceuticals Partners with Singapore General Hospital to Advance Next-Generation CAR-γδT Therapies for Blood Cancers

CAR-T
  • Elpis Biopharmaceuticals has entered a research collaboration with Singapore General Hospital to develop armored and bi-specific CAR-γδT therapies targeting acute myeloid leukemia and multiple myeloma.
  • The partnership involves technology transfer of Elpis's proprietary bispecific and armored CAR technologies to SGH, which will advance development into investigator-initiated clinical trials.
  • The collaboration aims to overcome key challenges in cancer treatment including immune suppression and antigen heterogeneity through next-generation allogeneic CAR technologies.
  • Both parties have expressed mutual intention to explore forming a joint venture for further development and commercialization if clinical data proves favorable.

CAR-T Immunotherapy Shows Unprecedented Five-Year Survival in Advanced Multiple Myeloma Patients

CAR-T
  • A third of 97 patients with advanced multiple myeloma achieved complete remission lasting five years or more after receiving a single infusion of CAR-T immunotherapy developed by Legend Biotech.
  • The patients had exhausted all treatment options and faced hospice care before receiving the experimental therapy in what researchers called a last-ditch effort.
  • Oncologists are using the term "potential cure" for the first time in multiple myeloma treatment, marking an unprecedented breakthrough in a disease previously considered incurable.
  • The study results were presented at the American Society of Clinical Oncology annual conference and published in The Journal of Clinical Oncology.

Minerva Biotechnologies Advances MUC1*-Targeted CAR-T Therapy with 1XX Mutations for Solid Tumors

CAR-T
  • Minerva Biotechnologies published research demonstrating that MUC1*-targeted CAR-T cells with 1XX mutations show increased persistence and ability to kill low antigen-expressing cancer cells in animal models.
  • The novel MUC1* target is a cancer-specific growth factor receptor expressed on 75% of solid tumors, representing a significant advancement after 30 years without FDA-approved MUC1-targeting therapeutics.
  • The company has received FDA approval for an IND application for MUC1*-CAR22, which demonstrates longer in vivo persistence for more durable solid tumor treatment responses.

Allogeneic Cell Therapies Emerge as Next-Generation Cancer Treatment to Address Manufacturing and Cost Challenges

CAR-T
  • Allogeneic "off-the-shelf" cell therapies are being developed to overcome the complex manufacturing and supply chain limitations of current autologous CAR-T treatments, which require 9-14 days to produce individualized therapies.
  • TC Biopharm's allogeneic gamma-delta T-cell platform has demonstrated lower-cost and efficacy data in acute lymphoblastic leukemia, with the ability to treat broader patient populations using healthy donor cells rather than compromised patient cells.
  • The cell and gene therapy pipeline includes 147 late-stage trials with multiple allogeneic approaches nearing commercialization, while the overall field shows 36% annual growth projected through 2030 with 10-20 new approvals expected yearly.

Safety and Efficacy of ALLO-501 Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory Large B Cell or Follicular Lymphoma

NCT03939026Active, Not RecruitingPhase 1
Allogene Therapeutics
Posted 5/1/2019

Safety and Efficacy of ALLO-501A Anti-CD19 Allogeneic CAR T Cells in Adults with Relapsed/Refractory Large B Cell Lymphoma, Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma (ALPHA2)

NCT04416984Active, Not RecruitingPhase 1
Allogene Therapeutics
Posted 5/21/2020

Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL

NCT06500273RecruitingPhase 2
Allogene Therapeutics
Posted 6/18/2024

Protara Therapeutics Appoints William Conkling as Chief Commercial Officer to Lead Commercialization Strategy

CAR-T
  • Protara Therapeutics has appointed William Conkling as Chief Commercial Officer, bringing over two decades of experience in developing and commercializing cancer and rare disease therapeutics.
  • Conkling previously led commercial organizations at Rafael Holdings, Immunomedics, and Novartis, including the successful launch of Trodelvy for triple negative breast cancer and Kymriah CAR-T therapy.
  • The appointment positions Protara for potential transition to a commercial-stage organization as it advances TARA-002 for bladder cancer and lymphatic malformations through Phase 2 trials.

DLL3-Targeted CAR-T Therapy LB2102 Shows Promise in Relapsed/Refractory Small Cell Lung Cancer

CAR-T
  • LB2102, a DLL3-directed autologous CAR-T cell therapy, demonstrated preliminary antitumor activity with a 16.7% objective response rate and 66.7% disease control rate in patients with relapsed/refractory small cell lung cancer and large cell neuroendocrine carcinoma.
  • The phase 1 dose-escalation trial found no dose-limiting toxicities up to dose level 4, with responses deepening at higher dose levels, supporting continued dose escalation.
  • Treatment-related adverse events were manageable, with only mild cytokine release syndrome observed in 2 patients and no deaths due to adverse events reported in the study.

Imugene Activates First Australian Site for Phase II Colorectal Cancer Vaccine Trial

CAR-T
  • Imugene has activated its first Australian site for the Phase II Neo-POLEM trial, expanding recruitment for its PD1-Vaxx immunotherapy in both Australia and the United Kingdom.
  • The trial targets patients with mismatch repair-deficient or microsatellite instability-high colorectal cancer, a genetic subtype representing about 15% of colorectal cancer cases.
  • PD1-Vaxx is a neoadjuvant B-cell vaccine designed to trigger immune responses against PD-1, administered before surgery to evaluate major pathological response and tumor shrinkage.
  • Colorectal cancer affects more than 1.2 million new patients annually worldwide, with approximately 80% presenting with localized disease yet maintaining a 50% global mortality rate.

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