MedPath

Tagged News

Lyell Immunopharma Secures $100 Million Private Placement to Advance CAR T-Cell Therapy Development

CAR-T
  • Lyell Immunopharma announced a private placement agreement for up to $100 million in gross proceeds to advance its next-generation CAR T-cell therapy programs.
  • The funding includes an initial $50 million closing at $13.32 per share, with potential for an additional $50 million upon achieving clinical milestones related to the LYL314 PiNACLE pivotal trial.
  • The proceeds will fund two pivotal-stage clinical trials of LYL314 and extend the company's cash runway into mid-2027, supporting a planned Biologics License Application submission for large B-cell lymphoma treatment.
  • LYL314 is a dual-targeting CD19/CD20 CAR T-cell therapy designed to improve complete response rates and duration compared to approved CD19-targeted therapies.

Everest Medicines Raises HK$1.57 Billion to Accelerate AI+mRNA Platform and Pipeline Development

CAR-TOncology
  • Everest Medicines completed a significantly oversubscribed share placement raising approximately HK$1.57 billion to fund global R&D and commercialization efforts.
  • The company will allocate 50% of proceeds to advance its AI+mRNA platform, including EVM14 and EVM16 cancer vaccines that have achieved regulatory milestones.
  • EVM14 became Everest's first mRNA therapeutic vaccine to receive dual IND acceptance from both China's NMPA and the U.S. FDA.
  • The funding will also support commercialization of existing products including NEFECON for IgA nephropathy and the anticipated approval of VELSIPITY for ulcerative colitis.

UK Becomes First Country to Enable Point-of-Care Manufacturing for Personalized Therapies

CAR-T
  • The UK has enacted world-first legislation allowing personalized medicines to be manufactured at hospitals, clinics, and near patients' homes, reducing treatment delivery times from months to days.
  • The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 covers cell and gene therapies, tissue-engineered treatments, 3D-printed products, blood products, and medicinal gases.
  • The framework supports mobile manufacturing units and enables final manufacturing steps at the point of care, potentially preventing patients from becoming too unwell to receive CAR-T therapies due to extended wait times.
  • This legislation represents a significant advancement toward truly personalized medicine and is part of the NHS 10-year plan announced by the UK government.

Dispatch Bio Emerges with $216M to Develop Universal Solid Tumor Immunotherapy

CAR-T
  • Dispatch Bio, a new biotech company formed through collaboration between Arch Venture Partners and the Parker Institute for Cancer Immunotherapy, has raised $216 million to develop a universal solid tumor treatment approach.
  • The company's lead therapy combines gene therapy, immunotherapy, and cell therapy by using engineered viruses to tag cancer cells with a synthetic "flare" antigen that CAR-T cells can then target and destroy.
  • Founded by renowned researchers including University of Pennsylvania's Carl June and Stanford's Chris Garcia, the approach aims to overcome current limitations of checkpoint inhibitors and CAR-T therapies in treating solid tumors.
  • The therapy is expected to enter clinical testing next year and could potentially address the challenge that many "cold" tumors pose to existing immunotherapies.

Nanogel-Armed CAR-T Cells Achieve 83.2% Tumor Inhibition Rate in Solid Tumor Model

CAR-T
  • Researchers from Changchun Institute of Applied Chemistry developed hyaluronidase-loaded nanogels (H-NGs) conjugated to CAR-T cells to overcome the dense extracellular matrix barrier that limits CAR-T cell infiltration in solid tumors.
  • The engineered H-NG CAR-T cells achieved an 83.2% tumor inhibition rate in the Raji solid tumor model, significantly outperforming free nanogels or unconjugated CAR-T cells.
  • The nanogels use thioketal linkers that respond to high reactive oxygen species levels in the tumor microenvironment, enabling precise release of hyaluronidase to degrade tumor stroma.
  • This dual-mechanism approach combines CAR-T cell trafficking capabilities with targeted enzyme delivery to enhance immune cell penetration and reduce immunosuppressive tumor microenvironment.

CytoMed Therapeutics Advances Novel CAR Gamma Delta T Cell Therapy to Phase I Dose Level 2

CAR-T
  • CytoMed Therapeutics successfully completed dose level 1 of its first-in-human Phase I ANGELICA trial for CTM-N2D therapy in four late-stage cancer patients.
  • The company's novel allogeneic CAR gamma delta T cell therapy targets NKG2DL antigens commonly present in many cancers without requiring donor-patient compatibility matching.
  • CTM-N2D represents a significant advancement over conventional CAR-T therapies by using donor-derived gamma delta T cells rather than patient-derived cells.
  • The trial is scheduled to advance to dose level 2 in the third quarter of 2025, evaluating safety and tolerability in advanced solid and hematological malignancies.

Allogeneic NKG2DL-targeting CAR γδ T Cells (CTM-N2D) in Advanced Cancers (ANGELICA)

NCT05302037RecruitingPhase 1
CytoMed Therapeutics Pte Ltd
Posted 11/19/2024

BioNTech Chief Strategy Officer Ryan Richardson to Step Down After Seven-Year Tenure

OncologyCAR-T
  • Ryan Richardson will step down as Chief Strategy Officer from BioNTech's Management Board on September 30, 2025, after serving since January 2020.
  • Richardson played a pivotal role in BioNTech's transformation from a private clinical-stage biotech to a publicly listed company, contributing to over $1 billion in capital raising through IPO and subsequent financings.
  • The departure comes as BioNTech positions itself to become a multi-product company focused on cancer therapeutics, with the transition of Richardson's responsibilities already underway.
  • BioNTech's stock has shown resilience with a 13.9% quarterly increase and 30.09% annual return, outperforming the broader biotechnology sector despite ongoing challenges.

Johnson & Johnson Raises 2025 Outlook as Oncology Portfolio Drives 24% Growth

CAR-TOncology
  • Johnson & Johnson reported strong Q2 2025 results with total sales of $23.7 billion, driven by 24% growth in oncology and 15.1% growth in neuroscience divisions.
  • The company raised its full-year 2025 sales guidance from $91-91.8 billion to $93.2-93.6 billion and set an ambitious target to grow oncology sales to $50 billion by 2030.
  • Multiple myeloma drug Darzalex led oncology growth with $3.54 billion in sales, while CAR-T therapy Carvykti generated $439 million and new bispecific antibodies contributed to portfolio expansion.
  • Despite strong performance in growth areas, Stelara sales declined 42.7% to $1.65 billion due to biosimilar competition, creating an 1,170 basis point impact on overall growth.

Avalon GloboCare Secures Hong Kong Patent for Bispecific CAR-T and CAR-NK Cell Technology

CAR-T
  • Avalon GloboCare Corp. received a 20-year patent from Hong Kong Intellectual Property Department for proprietary CAR-T and CAR-NK cell technology, effective through 2040.
  • The patented technology features bispecific anti-CD19xCD22 CAR design targeting both antigens to reduce tumor escape risk in hematologic malignancies.
  • The innovation includes localized cytokine induction intended to enhance CAR cell proliferation, cytotoxicity, and persistence at tumor sites.
  • The patent was co-developed with strategic partner Arbele Limited and complements existing protections in the United States and other PCT jurisdictions.

Imugene's Azer-cel Achieves 75% Response Rate in Phase 1b Trial for Relapsed DLBCL

CAR-T
  • Imugene's azer-cel, an allogeneic off-the-shelf CAR T therapy, demonstrated a 75% overall response rate with 55% complete response rate in patients with relapsed/refractory diffuse large B-cell lymphoma who had failed multiple prior therapies.
  • The first patient remains cancer-free at 15 months with additional patients showing durable responses at 2, 5, and 11 months, indicating sustained therapeutic benefit in this high-unmet-need population.
  • Based on these positive results and FDA Fast Track Designation, Imugene plans to meet with the FDA in Q4 2025 to discuss pivotal trial design for potential registration.
  • The trial is expanding to include CAR T-naïve patients with other B-cell lymphoma subtypes including primary central nervous system lymphoma and chronic lymphocytic leukemia.

Dose-escalation, Dose-expansion Study of Safety of Azer-cel (PBCAR0191) in Patients with R/r NHL and R/r B-cell ALL

NCT03666000RecruitingPhase 1
Imugene Limited
Posted 3/11/2019

MedPath

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

© 2025 MedPath, Inc. All rights reserved.