Phase I trial

Vaccine
#Africa #HIV #Phase I trial #Vaccines

Partners launch trial of novel HIV vaccine in Africa

A Phase I clinical trial of a novel T cell-inducing HIV vaccine candidate has launched in Africa to evaluate immune responses to highly networked HIV T-cell epitopes.  The trial is a collaboration between The Mutala Trust, ReiThera Srl (ReiThera), the Ragon Institute of Mass General Brigham, MIT,… Read More

#News

Diffuse large B-cell lymphoma
#Artificial intelligence (AI) #Lantern Pharma #Lymphoma #Oncology #Orphan drugs #Phase I trial

Complete response in heavily pre-treated lymphoma patient

A heavily pretreated patient with aggressive Grade 3 non-germinal centre diffuse large B-cell lymphoma (DLBCL) achieved a complete metabolic response in the ongoing Phase I clinical trial of Lantern Pharma’s LP-284.  Lantern uses an AI approach to determine mechanisms of action of any cancer focused molecule, identify… Read More

#Cancer Research #Editor's Choice #News

Molecular glues
#Acute inflammatory conditions #Molecular glue degrader #Monte Rosa Therapeutics #Phase I trial

Molecular glue degrader progresses to Phase I trials

Monte Rosa Therapeutics has dosed the first subjects in a Phase I study evaluating MRT-8102, a NEK7-directed molecular glue degrader (MGD) being developed for the treatment of inflammatory conditions driven by the NLRP3 inflammasome, IL-1β, and IL-6.   Initial results from the Phase I study are expected in… Read More

#News

Sickle cells
#Artificial intelligence (AI) #Cellarity #Phase I trial #Sickle cell disorder (SCD) #Transcriptomics

Globin-Switching drug reduces sickle cell disease symptoms

Biotech Cellarity has dosed its first patient in a Phase I clinical trial of CLY-124, a first-in-class Globin-Switching oral medicine designed to treat sickle cell disease (SCD).   “Initiation of our first-in-human clinical study for CLY-124 represents the delivery of our first clinical asset from our platform with… Read More

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Prostate cancer cells
#Archeus Technologies #FDA #Oncology #Phase I trial #Prostate cancer #Radiopharmaceuticals

FDA clears radiopharmaceutical for prostate cancer

The US Food and Drug Administration (FDA) has cleared Archeus Technologies’ Investigational New Drug (IND) application for ART-101, a novel receptor-based targeting small molecule for the imaging and treatment of prostate cancer.   This clearance enables the company to initiate a Phase I clinical trial in men with metastatic castration-resistant prostate… Read More

#Cancer Research #News #Regulatory

Diabetic eye disease
#Breye Therapeutics #Diabetes #Diabetic macular oedema #Ophthalmology #Phase I trial

Phase Ib trial complete in patients with diabetic retinopathy

Breye Therapeutics is a clinical-stage ophthalmology focused biopharmaceutical company developing oral therapeutics for the early treatment of vascular eye diseases. The company has now completed its Phase Ib clinical trial evaluating its lead candidate, danegaptide, in patients with non-proliferative diabetic retinopathy (NPDR) with associated oedema. Read More

#News

Liver cancer
#Moderna #mRNA #Oncology #Phase I trial #Solid tumours

Pan-tumour antigen therapy candidate enters the clinic

The first US participant has been dosed in Moderna’s Phase I study evaluating mRNA-4106, a novel pan-tumour antigen therapy candidate, in patients with advanced or metastatic solid tumours.  The first dose was administered at START Center for Cancer Research (START) in San Antonio by Dr Amita Patnaik. Read More

#Cancer Research #News

#Crohn's disease #Gastrointestinal #Inflammatory Bowel Disease #Phase I trial #Redx Pharma

Phase I data supports pan-ROCK inhibitor for Crohn’s disease

Redx Pharma has shared additional results from an RXC008 Phase I clinical trial at Digestive Disease Week 2025, San Diego, CA.  RXC008 is a highly potent pan-Rho-associated coiled-coil kinase (pan-ROCK) inhibitor that was designed to be restricted to the gastrointestinal (GI) tract.   The Phase I… Read More

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Liver cancer
#Macrophages #Oncology #Phase I trial #Pheast Therapeutics #Solid tumours

First patient receives anti-CD24 macrophage checkpoint inhibitor

Pheast Therapeutics has treated the first patient in its Phase I clinical trial evaluating PHST001, an anti-CD24 macrophage checkpoint inhibitor, in patients with advanced solid tumours.  The study will enrol up to 80 patients with advanced relapsed and/or refractory solid tumours.  The study’s primary objectives… Read More

#Cancer Research #News #Trending News

#AACR #Clasp Therapeutics #Oncology #Phase I trial #T cell engagers

First precision T-cell engager for solid tumours enters the clinic

Clasp Therapeutics has announced the dosing of the initial patient in the GUARDIAN-101 Phase I trial of CLSP-1025, the first tumour-specific TCE to enter clinical development.   The company also presented non-clinical data for CLSP-1025 at the 2025 American Association for Cancer Research (AACR) Annual Meeting. … Read More

#Cancer Research #Editor's Choice #News

Obese man measures his waist
#GLP-1 #MetaVia #Obesity #Phase I trial #Weight loss

New obesity drug shows superior tolerability to GLP-1 agonists

MetaVia has announced positive results from the four-week multiple ascending dose (MAD) Part 2 of its Phase I clinical trial of DA-1726 for the treatment of obesity.  DA-1726 is a novel, dual oxyntomodulin (OXM) analog agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor… Read More

#Editor's Choice #News

#circular RNAs #Phase I trial #RiboX Therapeutics #RNA

First circular RNA begins trials in radiation-induced xerostomia

RiboX Therapeutics has dosed the first patient in its first-in-human (FIH) Phase I/IIa clinical trial (SPRINX-1) evaluating the safety and efficacy of RXRG001 in patients with radiation-induced-xerostomia (RIX) and hyposalivation.  RXRG001 is the first circular RNA therapy to receive FDA IND clearance.  Xerostomia and hyposalivation… Read More

#News #Trending News

#Helicore Biopharma #Monoclonal antibodies #Obesity #Phase I trial #Weight loss

First-in-class GIP antagonist for obesity enters Phase I trials

Helicore Biopharma has reported dosing the first participant in its Phase I study of HCR-188 for the treatment of obesity.   HCR-188 is a first-in-class monoclonal antibody (mAb) designed to bind to circulating glucose-dependent insulinotropic peptide (GIP) ligand, unlike antibodies that bind the GIP receptor (GIP… Read More

#News

Duchenne muscular dystrophy
#Duchenne muscular dystrophy #Phase I trial #Satellos Bioscience

Duchenne muscular dystrophy drug shows favourable PK profile

Satellos Bioscience has shared positive initial Phase I data for its small molecule drug candidate SAT-3247 at the 2025 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference in Dallas, Texas.  SAT-3247 is designed to address progressive muscle loss in Duchenne muscular dystrophy (DMD) patients by aiming to… Read More

#News

Woman standing on scales
#Diabetes #GLP-1 #Obesity #Phase I trial #Vivani Medical #Weight loss

GLP-1 implant NPM-115 enters clinical trials for obesity

Vivani Medical has announced the successful administration of its first GLP-1 (exenatide) implant in the LIBERATE-1 clinical trial.   The company hopes to address one of healthcare’s most pressing challenges: medication adherence in metabolic diseases including chronic weight management and type 2 diabetes.   Vivani also announced… Read More

#News

Vaccine
#Immunology / Virology & Vaccines #National Institutes of Health (NIH) #NIAID #Phase I trial

Clinical trial represents a step towards a vaccine for Lassa fever

A clinical trial of a candidate vaccine to prevent Lassa fever has begun enrolling participants at the University of Maryland School of Medicine, Baltimore.   Lassa fever is a viral haemorrhagic disease that can be fatal and causes permanent hearing loss in up to one-third of those who… Read More

#Editor's Choice #News