Clinical Trials – Talk Bio

Image Analysis Group Partners with Better Medicine for AI-Driven Oncology Clinical Trial Imaging

3 days ago talkbio0Tagged AI oncology imaging, central reads, Clinical Trials, DYNAMIKA, Image Analysis Group

Image Analysis Group; Better Medicine; AI oncology imaging; clinical trials; DYNAMIKA; central reads

Ventus Therapeutics Doses First Patient in Phase 2 Trial of VENT-03, an Oral cGAS Inhibitor, in Lupus

4 days ago talkbio0Tagged Autoimmune Diseases, Biological Markers, cardiometabolic, cGAS inhibitor, Clinical Trials, Immunology, inflammaging, interferon pathway, Lupus Erythematosus, Cutaneous, Lupus Vulgaris, oral small molecule, Phase 2 trial, VENT-03, Ventus Therapeutics

Ventus Therapeutics; VENT-03; cGAS inhibitor; Phase 2 trial; lupus; cutaneous lupus erythematosus; autoimmune disease; interferon pathway; biomarkers; oral small molecule; clinical trial; immunology; cardiometabolic; inflammaging

PathAI’s AIM-MASH AI Assist Receives Historic FDA Qualification for MASH Clinical Trials

5 days ago talkbio0Tagged AI Assist, AIM-MASH, biomarker qualification, Biopsy of liver (procedure), Clinical Trials, Drug Development Tool, EMA qualification, Histology, MASH, MASLD, metabolic dysfunction-associated steatohepatitis, Nonalcoholic Steatohepatitis, PathAI, Pathology, Qualification, United States Food and Drug Administration

PathAI; AIM-MASH; AI Assist; FDA qualification; Drug Development Tool; biomarker qualification; MASH; MASLD; NASH; metabolic dysfunction-associated steatohepatitis; AI pathology; clinical trials; EMA qualification; liver biopsy; histology

Dyne Therapeutics Reports Positive Results for Duchenne Drug DYNE-251, Plans FDA Approval Submission

6 days ago talkbio0Tagged Accelerated, Approved, Biological Factors, Breakthrough Therapy Designation, Clinical Trials, DELIVER (veterinary product), Dyne Therapeutics, DYNE-251, License Application, Muscular Dystrophy, Duchenne, United States Food and Drug Administration

Dyne Therapeutics; DYNE-251; Duchenne muscular dystrophy; exon 51 skipping; DELIVER trial; FDA Breakthrough Therapy Designation; Biologics License Application; accelerated approval

AstraZeneca’s dual-targeting CAR-T AZD0120 shows similar response rates in Western and Chinese patients

7 days ago talkbio0Tagged AstraZeneca, Autologous Bispecific BCMA/CD19-targeted CAR-T Cells GC012F, AZD0120, BCMAxCD19, CAR-T, China, Clinical Trials, dual-targeting CAR-T, DURGA-1, Frequency of Responses, Multiple Myeloma, Western patients

AstraZeneca; AZD0120; GC012F; dual-targeting CAR-T; BCMAxCD19; multiple myeloma; DURGA-1; China; Western patients; response rate; clinical trial; CAR-T

Capricor Therapeutics Reports Positive Phase 3 HOPE-3 Trial Results for Deramiocel in Duchenne Muscular Dystrophy, Planning FDA Resubmission

2 weeks ago talkbio0Tagged Capricor Therapeutics, cardiac function preservation, Clinical Trials, deramiocel, HOPE-3 trial, Muscular Dystrophy, Duchenne, Phase 3 clinical trial, regulatory approval pathway, Rejection, United States Food and Drug Administration, upper limb function

Capricor Therapeutics; Deramiocel; Duchenne muscular dystrophy; HOPE-3 trial; Phase 3 clinical trial; FDA rejection; cardiac function preservation; upper limb function; clinical trial results; regulatory approval pathway

Imvax Shares Positive Phase 2b Data for IGV-001 Glioblastoma Treatment and Plans FDA Meeting

2 weeks ago talkbio0Tagged Clinical Trials, Glioblastoma, IGF-1R Antisense Oligodeoxynucleotide-treated Autologous Glioma Cells IGV-001, Immunotherapy, Imvax, meeting, Overall Survival, United States Food and Drug Administration

Imvax; IGV-001; glioblastoma; Phase 2b trial; overall survival; FDA meeting; immunotherapy; clinical trial; glioblastoma treatment

Cognition Therapeutics Presents Phase 3 Plan for Zervimesine (CT1812) in Alzheimer’s Disease at CTAD Conference

2 weeks ago talkbio0Tagged access program, Alzheimer 's disease, Clinical Trials, Cognition Therapeutics, CTAD, Lewy bodies, Neurodegenerative Disorders, Phase 3 clinical trial, Presenile dementia, sigma-2 receptor, Zervimesine

Cognition Therapeutics; Zervimesine; CT1812; Phase 3 clinical trial; Alzheimer’s disease; Clinical Trials on Alzheimer’s Disease (CTAD); neurodegenerative diseases; sigma-2 receptor; dementia with Lewy bodies; expanded access program

Whitehawk Therapeutics Appoints Margaret Dugan as Chief Medical Officer

2 weeks ago talkbio0Tagged Chief Medical Officer, Chronic multifocal osteomyelitis, Clinical Trials, Dracen Pharmaceuticals, Drug Development, Margaret Dugan, Neoplasms, Novartis, Schrödinger, therapeutic autologous dendritic cells, Whitehawk Therapeutics

Whitehawk Therapeutics; Margaret Dugan; Chief Medical Officer; CMO; oncology; ADC; drug development; clinical trials; Novartis; Dracen Pharmaceuticals; Schrödinger

Tessera Therapeutics Advances Gene Writing Technology with Major Funding and Strategic Partnerships

2 weeks ago talkbio0Tagged alpha 1-Antitrypsin Deficiency, ARPA-H grant, CAR-T, Clinical Trials, Gene Writing, genome engineering, in vivo, Lipid Nanoparticles, Partnership, Regeneron, Tessera, TSRA-196

Tessera Therapeutics; Gene Writing; in vivo CAR-T; ARPA-H grant; Regeneron partnership; TSRA-196; alpha-1 antitrypsin deficiency; Lipid Nanoparticles; in vivo genome engineering; clinical trials