Clinical Trials (Phase I)
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Avalyn Pharma Publishes Phase 1b ATLAS Results Demonstrating Stabilization of Lung Function at 24 and 48 Weeks with AP01 and Favorable Safety Profile
3/23/2023
Avalyn Pharma Inc., a clinical-stage biopharmaceutical company focused on the development of targeted therapies for life-threatening pulmonary diseases, today reported that results from the Phase 1b ATLAS study were published online in Thorax, an official journal of the British Thoracic Society.
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OliX Pharmaceuticals Receives Regulatory Approval to Commence Phase 1 Clinical Trial of Treatment of Androgenic Alopecia
3/23/2023
OliX Pharmaceuticals, Inc. announced today that it has eceived approval from the Human Research Ethics Committee (HREC) in Australia to initiate a Phase 1 clinical trial of OLX72021, a treatment for androgenic alopecia, also known as male-pattern baldness.
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BridgeBio Pharma Announces First Lung Cancer Patient Dosed in Phase 1 Trial for SHP2 Inhibitor BBP-398 in Combination with Bristol Myers Squibb’s OPDIVO® (nivolumab)
3/23/2023
BridgeBio Pharma, Inc. today announced that the first patient with non-small cell lung cancer (NSCLC) has been dosed in its Phase 1/2 clinical trial of BBP-398, an investigational SHP2 inhibitor, with Bristol Myers Squibb’s OPDIVO® (nivolumab) in advanced solid tumors with KRAS mutations (NCT05375084)
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Enveric Biosciences Selects Australian CRO, Avance Clinical, in Preparation for Phase 1 Study of EB-373
3/23/2023
Enveric Biosciences, Inc. today announced that it has entered into an agreement with Avance Clinical for its planned Phase 1 clinical trial of EB-373, the company’s lead candidate targeting the treatment of anxiety disorders.
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GRIN Therapeutics Announces First Patient Dosed in Phase 1B Clinical Trial with Radiprodil for Treatment of GRIN-related Disorders
3/23/2023
GRIN Therapeutics Inc. today announced that the first patient has been dosed in the Honeycomb Study, the Company’s Phase 1B clinical trial of radiprodil.
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Atreca to Host Fourth Quarter and Year End 2022 Conference Call and Webcast on March 29, 2023
3/23/2023
Atreca, Inc. announced that it will host a conference call and webcast on Wednesday, March 29, 2023, at 4:30 p.m. EDT to report financial results and provide an update on its discovery platform and pipeline, including updated data from the ongoing Phase 1b trial of ATRC-101.
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Maze Therapeutics Announces New Clinical Data Supporting MZE001 as a Potential Treatment for Pompe Disease
3/22/2023
Maze Therapeutics today announced new data from an exploratory muscle biopsy cohort of its Phase 1 clinical trial of MZE001 in healthy volunteers to evaluate the effects of MZE001 on glycogen synthesis.
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FSD Pharma Announces Its Australian Entity Receives Approval to Proceed With Phase 1 Clinical Trial of Lucid-201, a Candidate for the Potential Treatment of Major Depressive Disorder
3/22/2023
FSD Pharma Inc. today announced that its Australian entity, FSD Pharma Australia Pty Ltd. received the certificate of approval from The Alfred Ethics Committee in Australia to proceed with a Phase 1 study.
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SQZ Biotechnologies Announces Confirmed Complete Response in HPV16+ Solid Tumor Patient in the Lowest-Dose Cohort of the SQZ-AAC-HPV-101 Clinical Trial
3/22/2023
SQZ Biotechnologies Company (NYSE: SQZ), focused on unlocking the full potential of cell therapies, today announced that, according to RECIST 1.1 criteria, a confirmed complete response was observed in the first patient in the lowest-dose cohort of the Phase 1 SQZ-AAC-HPV-101 clinical trial.
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Biohaven Acquires Exclusive License for Oral, Brain-Penetrant, Dual TYK2/JAK1 Inhibitor for Immune-Mediated Brain Disorders
3/22/2023
Biohaven Ltd. (NYSE: BHVN) today announced that it acquired global rights, excluding China regions, for the development of an oral, brain-penetrant, dual inhibitor of Tyrosine Kinase 2 (TYK2) and Janus Kinase 1 (JAK1) for the treatment of brain disorders.
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Plus Therapeutics Initiates Cohort 3 in Phase 1/Part A of the ReSPECT-LM Trial for Leptomeningeal MetastasesFirst data readout of Phase 1/Part A trial expected second half of 2023
3/22/2023
Plus Therapeutics, Inc. today announced treatment of the first patient in Cohort 3 of the ReSPECT-LM Phase 1/2a dose escalation clinical trial of rhenium ( 186 Re) obisbemeda for the treatment of leptomeningeal metastases (LM) from solid tumors.
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DEBIOPHARM ANNOUNCES LAUNCH OF THE PHASE 1/2 GaLuCi™ STUDY FOR ITS CA IX-TARGETED RADIOPHARMACEUTICAL PROGRAM
3/22/2023
Debiopharm (www.debiopharm.com), a Swiss-based, global biopharmaceutical company, aiming to establish tomorrow's standard-of-care to cure cancer and infectious diseases, today announced the first patient dosed of their first-in-human, phase 1/2 study, GaLuCi™.
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Proxima Clinical Research Launches Early Phase Oncology Network for New Investigational Therapies
3/21/2023
Proxima Clinical Research ("Proxima CRO") announced today it is expanding its early phase oncology clinical trials offering with its Early Phase Oncology Network, a group of oncology-specific scientific experts and early phase clinical trials clinics that allows for quick and easy site enrollment and expert insight, feedback, and guidance in first-in-human Phase I and Phase II clinical oncology trials.
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Vaccinex Announces Initiation of Single-Arm Open Label, Phase Ib/2 Study to Evaluate Pepinemab in Combination with Avelumab as Second Line Combination Immunotherapy for Patients with Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)
3/21/2023
Vaccinex, Inc. today announced the initiation of a single-arm open label, Phase Ib/2 study to evaluate pepinemab in combination with avelumab as second line combination immunotherapy for patients with metastatic pancreatic adenocarcinoma (PDAC), NCT05102721.
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Direct Biologics Announces Initiation of Phase 1 Clinical Trial for Medically Refractory Crohn’s Disease
3/21/2023
Direct Biologics, LLC announced it has dosed the first patient in its Phase 1 clinical trial evaluating ExoFlo ™ for the treatment of patients with medically refractory Crohn’s disease.
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Sensei Biotherapeutics Announces Submission of Investigational New Drug (IND) Application for SNS-101, a Conditionally Active VISTA-Blocking Antibody
3/21/2023
Sensei Biotherapeutics, Inc. today announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a Phase 1/2 clinical trial of SNS-101, a conditionally active VISTA-blocking antibody, in patients with solid tumors.
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PharmaJet Announces Clinical Results from Scancell’s COVID-19 DNA Vaccine Study Exclusively Administered with Their Needle-free Precision Delivery Systems
3/21/2023
PharmaJet®, a company engineering precision delivery systems that may overcome the challenges of nucleic acid vaccine delivery, today announced that its partner, Scancell, a developer of novel immunotherapies for the treatment of cancer and infectious diseases, reported positive results from their Phase 1 COVIDITY clinical trial.
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NUCLIDIUM and University Hospital Basel Receive NETRF Investigator Award to Initiate Phase 1 Trial with Novel Copper-based Radiotheranostic Program TraceNETTM in Neuroendocrine Tumours
3/21/2023
NUCLIDIUM announced that the Neuroendocrine Tumors Research Foundation has selected the company and its collaboration partner the University Hospital Basel as recipients of its Investigator Award.
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Vaccitech’s VTP-200 Ph 1b/2 Study Demonstrates Favorable Tolerability and Immunogenicity Profile at Interim Analysis in Women with Low-Grade Human Papillomavirus (HPV)-related Cervical Lesions
3/20/2023
Vaccitech plc today announced topline interim data from the HPV001 study (NCT04607850), a Phase 1b/2 clinical trial of VTP-200 in women with low-grade cervical human papillomavirus (HPV) lesions.
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Vaxxinity Announces First Subjects Dosed in Phase 1 Clinical Trial of VXX-401, Investigational Anti-PCSK9 Vaccine to Treat Hypercholesterolemia
3/20/2023
Vaxxinity, Inc. today announced that the first subjects have been dosed in a randomized, double-blind, placebo-controlled Phase 1 clinical trial of VXX-401.