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Link Cell Therapies Initiates Phase I Trial for Kidney Cancer Treatment and Expands Series A Funding

Link Cell Therapies Initiates Phase I Trial for Kidney Cancer Treatment and Expands Series A Funding

Link Cell Therapies, an oncology cell therapy company, has initiated clinical dosing for its lead program, LNK001, a logic-gated CAR-T therapy for advanced clear cell renal cell carcinoma (RCC). The Phase I study is being conducted at MD Anderson Cancer Center. LNK001 is designed to target two antigens, CAIX and ENPP3, which are highly expressed in most RCC tumors, aiming to overcome the limitations of single-antigen CAR-T approaches that can cause toxicity in healthy tissues. The company also announced a $30 million expansion of its Series A financing, increasing the total to $90 million. This additional capital will support the clinical and preclinical development of further logic-gated CAR-T programs, including a second solid tumor indication in colorectal cancer, with a first-in-human trial planned for 2027. Additionally, Link Cell Therapies has appointed Jie D'Elia, Ph.D., as Chief Executive Officer and Friedrich Graf Finckenstein, M.D., as Chief Medical Officer, while co-founder Brian Slingerland tra...

Link Cell Therapies Initiates CAR-T Trial and Expands Series A Funding to $90 Million

Link Cell Therapies Initiates CAR-T Trial and Expands Series A Funding to $90 Million

Link Cell Therapies Initiates CAR-T Trial and Expands Series A Funding to $90 Million

XYone Therapeutics Initiates First-in-Human Clinical Trial for Novel Cancer Drug XYA02

XYone Therapeutics Initiates First-in-Human Clinical Trial for Novel Cancer Drug XYA02

XYone Therapeutics, a clinical-stage biotechnology company based in greater Boston, MA, has announced that the first patient has been dosed in its first-in-human Phase 1b/2 clinical trial for XYA02 (also known as AT2021). XYA02 is a novel antibody-drug conjugate (ADC) specifically designed to target MUC1-C, a protein expressed across various solid tumors. The multicenter, open-label study aims to evaluate the safety and tolerability of XYA02, determine appropriate dose levels for future clinical development, and assess its pharmacokinetics, pharmacodynamics, and preliminary antitumor activity. The trial includes patients with advanced, relapsed, and/or refractory solid tumors, specifically non-small cell lung, ovarian, gastric/GEJ, and colorectal cancers. The U.S. Food and Drug Administration (FDA) has already granted XYA02 Orphan Drug Designation (ODD) for the treatment of pancreatic cancer and gastric cancer.

Case Western Reserve University Researchers Develop Novel mRNA Vaccine Strategy for Leukemia

Case Western Reserve University Researchers Develop Novel mRNA Vaccine Strategy for Leukemia

Researchers at Case Western Reserve University, including Dr. Shujun Liu and Dr. William Tse, have developed a new mRNA vaccine approach targeting fusion oncogenes in acute myeloid leukemia (AML). Fusion oncogenes have historically been considered 'undruggable' due to their lack of conventional drug-binding sites, despite their critical role in cancer development. The study, published in Leukemia, details an mRNA vaccination (EV-AE) designed to activate the immune system against AML1::ETO fusion gene-expressing cells. This vaccine utilizes nucleoside-modified mRNA delivered via extracellular vesicles (EVs), which improves protein expression in vivo and mitigates some limitations associated with lipid nanoparticle systems, such as low delivery efficiency and toxicity concerns. In preclinical murine models, the EV-AE vaccination significantly reduced leukemic burden, lowered white blood cell counts, and extended survival without detectable toxicity, demonstrating a proof-of-concept for targeting these challe...

Tolerance Bio Licenses Clinical-Stage Antibody TLB-33 from Tanabe Pharma to Expand Thymus-Focused Pipeline

Tolerance Bio Licenses Clinical-Stage Antibody TLB-33 from Tanabe Pharma to Expand Thymus-Focused Pipeline

Tolerance Bio Licenses Clinical-Stage Antibody TLB-33 from Tanabe Pharma to Expand Thymus-Focused Pipeline

Circle Pharma Strengthens Leadership with New Chief Scientific Officer and Head of HR

Circle Pharma Strengthens Leadership with New Chief Scientific Officer and Head of HR

Circle Pharma Strengthens Leadership with New Chief Scientific Officer and Head of HR

Texas Tech University Health Sciences Center Showcases Cancer Research to CPRIT Leadership

Texas Tech University Health Sciences Center Showcases Cancer Research to CPRIT Leadership

Researchers from Texas Tech University Health Sciences Center (TTUHSC) recently presented their cancer research projects to leadership from the Cancer Prevention and Research Institute of Texas (CPRIT). This visit allowed CPRIT CEO Kristen Doyle and her team to observe the ongoing work firsthand, moving beyond written reports to understand the passion and real-world impact of the research. TTUHSC has received nearly $67 million in CPRIT funding, which has significantly supported cancer prevention, detection, research, and treatment initiatives. The presentations included discussions on expanding access to pediatric cancer clinical trials in rural areas, developing new phase 1 trials for novel childhood cancer drugs, and research into triple-negative breast cancer and osteosarcoma, particularly focusing on alternative lengthening of telomeres (ALT).

Johnson Johnson's Janssen Supply Chain Group Expands CAR-T Manufacturing in Europe

Johnson Johnson's Janssen Supply Chain Group Expands CAR-T Manufacturing in Europe

Johnson Johnson's Janssen Supply Chain Group Expands CAR-T Manufacturing in Europe

FDA Approves Mirum's Atebrioz, Offering Third Treatment Option for Ultra-Rare Bone Disease

FDA Approves Mirum's Atebrioz, Offering Third Treatment Option for Ultra-Rare Bone Disease

The U.S. Food and Drug Administration (FDA) has granted approval to Mirum Pharmaceuticals for Atebrioz (zilurgisertib), an ALK2 inhibitor designed to treat fibrodysplasia ossificans progressiva (FOP). This approval marks the third treatment option available for the ultra-rare bone-forming disease, often referred to as 'stone man syndrome,' which causes soft tissue to turn into bone, leading to pain, stiffness, and immobility. Atebrioz is a once-daily pill that inhibits the activin receptor-like kinase 2 (ALK2) protein, a key factor in abnormal bone growth in FOP. The approval was based on data from the Phase 2 PROGRESS study, which demonstrated an 81% reduction in new lesion volume and a 99% reduction in total volume compared to placebo at 24 weeks. Mirum acquired full ownership of Atebrioz in April, having previously been licensed by Incyte for clinical development. The drug is approved for patients aged 12 years and older.

Georgia Tech and Emory University Researchers Develop Targeted GI Delivery for mRNA Therapies and Vaccines

Georgia Tech and Emory University Researchers Develop Targeted GI Delivery for mRNA Therapies and Vaccines

Researchers at Georgia Tech and Emory University have discovered that delivering lipid nanoparticle (LNP) medicines directly to various areas of the gastrointestinal (GI) tract can precisely alter where these therapies travel in the body. This innovation opens new possibilities for mRNA therapies and vaccines by enabling more precise targeting of specific organs while limiting unwanted side effects in others. Traditionally, LNPs are delivered subcutaneously or intravenously, which can lead to drug interactions with organs like the liver, lungs, and spleen, causing side effects and limiting dosage. By using mouse models, the researchers mapped how nanoparticles traveled after microneedle injections into different parts of the GI tract, including the cheeks, stomach, and rectum. They found that this method allowed them to target organs such as the pancreas and lymph nodes more effectively, while reducing uptake in the liver, lungs, and spleen. For example, delivering glucagon-like peptide-1 (GLP-1) mRNA dose...

Research Reveals Racial Disparities in Cancer Immunotherapy Adverse Events

Research Reveals Racial Disparities in Cancer Immunotherapy Adverse Events

New research indicates significant racial disparities in the occurrence of immune-related adverse events (irAEs) following cancer immunotherapy. A study analyzing a nationwide health insurance database of over 80 million members and an electronic health records database found that Black patients experienced higher odds of irAEs compared to Hispanic patients, while Asian patients had lower odds compared to white patients. Specifically, Black patients showed higher rates of musculoskeletal and connective tissue disorders, but markedly lower odds of cardiac disorders compared to Asian patients. The study also highlighted that clinical trials often lack sufficient representation from Black and Hispanic groups, creating gaps in understanding how irAEs manifest in these populations. This under-representation limits the evidence base for developing race-specific guidelines for managing irAEs, despite existing consensus guidelines from organizations like the American Society of Clinical Oncology (ASCO) and the Soc...

Nkarta Receives FDA Protocol Amendments for Outpatient CAR NK Therapy Trials

Nkarta Receives FDA Protocol Amendments for Outpatient CAR NK Therapy Trials

Nkarta, a clinical-stage biotechnology company, has announced that the Food and Drug Administration (FDA) has agreed to protocol amendments for its CAR natural killer (NK) cell therapy trials for autoimmune diseases. According to CEO Paul Hastings, these amendments remove several previous restrictions, including patient-by-patient dosing staggers, a 24-hour observation period post-cell administration, and a requirement for patients to remain within 60 miles of the treatment center for 30 days. Under the revised protocol, patients can now receive off-the-shelf cells, be observed for only two hours, and return home. Nkarta is currently studying this treatment across two investigational new drug applications: Ntrust-1, focusing on lupus nephritis, and Ntrust-2, a basket study for conditions like scleroderma, myositis, vasculitis, and rheumatoid arthritis. The company aims to present initial clinical data from these autoimmune disease programs at the American College of Rheumatology's 2026 Convergence meeting ...