The world-first trial of a fridge-free tetanus-diphtheria vaccine has produced encouraging results that could improve access worldwide to crucial treatments. Around half of vaccines are wasted globally each year, according to the World Health Organization, because of temperature changes during storage and transport. Fridge-free vaccines… Read More
A targeted antibody therapy combined with standard chemotherapy has shown early signs of tumour shrinkage and disease control in patients with advanced bowel cancer. This is according to new Phase I clinical trial results from The Institute of Cancer Research, London and The Royal Marsden NHS Foundation… Read More
Verdiva Bio has dosed the first patient in a Phase I SAD study evaluating VRB-103, a once-weekly selective oral amylin analog, as a treatment for overweight and obesity. The Phase I randomised, double-blind, placebo-controlled study will assess the safety and tolerability of VRB-103, in healthy patients with… Read More
AnHorn Medicines has dosed the first subject in the Phase I clinical trial of AH-008, a first-in-class neuroprotective candidate being developed to prevent chemotherapy-induced peripheral neuropathy (CIPN). This milestone marks the clinical advancement of a novel therapeutic approach designed to address one of the most common and debilitating complications of… Read More
Kither Biotech has announced the successful completion of its Phase I clinical study of KIT2014 for respiratory diseases in healthy participants. “We are pleased to report the successful completion of this first-in-human Phase I study with KIT2014, a significant milestone for Kither Biotech,” said Dr Dimitrios Goundis,… Read More
HAYA Therapeutics has dosed the first cohort in a Phase I trial evaluating a treatment for nonobstructive hypertrophic cardiomyopathy (nHCM). The Swiss biotechnology company is studying HTX-001, a differentiated and potentially disease-modifying approach to treating patients with nHCM. The investigational molecule is an antisense oligonucleotide… Read More
Biotechnology company HaemaLogiX has begun patient enrolment for a Phase I study evaluating a therapy for multiple myeloma. The KOALA study is a Phase I dose‑escalation trial assessing the safety and preliminary efficacy of KMCAR T‑cell, a novel autologous CAR‑T therapy targeting the Kappa Myeloma Antigen (KMA), a tumour‑specific receptor… Read More
Fractyl Health has received Clinical Trial Application authorisation in the Netherlands to initiate the Phase I/II first-in-human study of RJVA-001, the first clinical candidate from the company’s Rejuva Smart GLP-1 gene therapy platform. With this authorisation, Fractyl believes RJVA-001 is the first adeno-associated virus (AAV)-based gene therapy… Read More
The global Phase I BEHOLD-1 clinical trial for mocertatug rezetecan (Mo-Rez) has shown confirmed objective response rates (cORR) of 62% in platinum-resistant ovarian cancer (PROC) and 67% in recurrent or advanced endometrial cancer (EC). Mocertatug rezetecan is a novel antibody-drug conjugate (ADC) targeting the B7-H4 antigen. B7-H4… Read More
iBio has received approval to initiate a first-in-human clinical trial for its long-acting monoclonal antibody IBIO-600 in Australia. The Phase I study is a randomised, double-blind, placebo-controlled, single ascending dose trial designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of IBIO-600 in overweight and obese adult… Read More
Coiled Therapeutics has provided an update on its Phase I/II clinical trial evaluating AO-252, a first-in-class TACC3 inhibitor, in patients with advanced solid tumours. According to the data, the transition to a Twice-Daily (BID) dosing regimen (Cohort 4b) has delivered an 80% Clinical Benefit Rate (CBR), a… Read More
VectorY Therapeutics has announced that the first participant has been dosed in its Phase I/II PIONEER-ALS clinical trial of VTx-002 in people with amyotrophic lateral sclerosis (ALS). VTx-002 is a first-in-class vectorised antibody designed to holistically target TDP-43 pathology in ALS recently granted FDA Fast… Read More
Neomorph has commenced a Phase I/II clinical trial evaluating NEO-811, a novel investigational molecular glue degrader, in patients with locally advanced or metastatic non-resectable clear cell renal cell carcinoma (ccRCC). NEO-811 is an investigational molecular glue degrader designed to induce targeted degradation of a key disease-driving protein… Read More
The US Food and Drug Administration (FDA) has placed a clinical hold on REGENXBIO’s investigational gene therapy, RGX-111, for the treatment of MPS I, following a single case of neoplasm (intraventricular CNS tumour) in a participant treated in its Phase I/II study. The FDA also placed a clinical hold on… Read More
The US Food and Drug Administration (FDA) has cleared Siren Biotechnology’s first Investigational New Drug (IND) application for its AAV immuno-gene therapy for cancer, enabling the initiation of its first-in-human clinical trial. The IND clearance supports the evaluation of Siren’s lead investigational programme in adult patients with recurrent high-grade glioma. … Read More
The first participants have been dosed in the first-in-human Phase I clinical trial of NRG Therapeutics’ lead candidate NRG5051, which is being developed as a treatment for amyotrophic lateral sclerosis (ALS)/motor neuron disease (MND) and Parkinson’s. NRG5051 is a first-in-class, orally bioavailable and CNS-penetrant next-generation inhibitor of the mitochondrial… Read More
