Clinical Trials - Phase II
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eFFECTOR Therapeutics Announces Topline Results of Phase 2 KICKSTART Trial of Tomivosertib Combined with Pembrolizumab in Non-Small Cell Lung Cancer
4/4/2024
eFFECTOR Therapeutics, Inc. today announced topline results from the primary analysis of the randomized Phase 2 KICKSTART trial which tested tomivosertib or placebo, each combined with pembrolizumab, as frontline treatment for patients with non-small cell lung cancer (NSCLC) with PD-L1 ≥50%.
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Rigel Announces Publication of Data on REZLIDHIA® (Olutasidenib) in Post-Venetoclax Patients with Mutant IDH1 AML in Leukemia & Lymphoma
4/4/2024
Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced a peer-reviewed publication in Leukemia & Lymphoma on data from an analysis of the Phase 2 study evaluating REZLIDHIA.
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CureVac Announces Promising Phase 2 Interim Data from Seasonal Influenza Vaccine Development Program in Collaboration with GSK
4/4/2024
CureVac N.V. (Nasdaq:CVAC) ("CureVac"), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced interim data from an ongoing Phase 2 part of the combined Phase 1/2 study of its seasonal influenza vaccine candidate, conducted in collaboration with GSK.
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Achilles Therapeutics Provides Interim Phase I/IIa Update on Clonal Neoantigen Reactive T Cells in Advanced NSCLC and Melanoma Including First Patients Dosed with Enhanced Host Conditioning
4/4/2024
Achilles Therapeutics plc announced interim Phase I/IIa data on the use of clonal neoantigen reactive T cells from the CHIRON study in advanced unresectable or metastatic non-small cell lung cancer and the THETIS study in recurrent or metastatic malignant melanoma.
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SpliSense Announces FDA Clearance of Investigational New Drug Application for Phase 2 Initiation of SPL84 for the Treatment of Cystic Fibrosis
4/3/2024
SpliSense today announced that the U.S. Food and Drug Administration (FDA) cleared the Investigational New Drug (IND) application for the initiation of a Phase 2 study for SPL84 in CF. SPL84 is the Company's lead antisense oligonucleotide (ASO) product for the treatment of people with CF carrying the 3849+10 kilobase (Kb) C->T splicing mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
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Neurocrine Biosciences Announces First-Patient Dosed in Phase 2 Clinical Study Evaluating NBI-1070770 in Adults with Major Depressive Disorder
4/3/2024
Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced that the first patient has been randomized for its Phase 2 clinical study to evaluate the efficacy, safety, and tolerability of investigational compound NBI-1070770 in adults with major depressive disorder.
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TRACON Pharmaceuticals Provides Update on Ongoing ENVASARC Phase 2 Pivotal Trial Following Independent Data Monitoring Committee Recommendation to Continue the Trial as Planned
4/3/2024
TRACON Pharmaceuticals (NASDAQ: TCON) today announced the independent data monitoring committee (IDMC), following a review of ongoing safety and efficacy data on April 2, recommended the ENVASARC Phase 2 pivotal trial continue as planned.
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Denovo Biopharma Announces a Major Breakthrough in Treatment-Resistant Depression with Precision Medicine
4/3/2024
Denovo Biopharma LLC (Denovo), a pioneer in applying precision medicine to the development of innovative drugs, today announced positive results for its biomarker–guided Phase 2b clinical trial (ENLIGHTEN) designed to assess the efficacy and safety of DB104 (liafensine) in patients with treatment-resistant depression (TRD).
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MacroGenics Provides Phase 2 TAMARACK Study Early Interim Safety Data and Plans for Future Disclosures
4/3/2024
MacroGenics, Inc. (NASDAQ: MGNX) today provided an update on the Phase 2 TAMARACK study of vobramitamab duocarmazine (vobra duo, previously known as MGC018) in patients with metastatic castration-resistant prostate cancer (mCRPC).
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Phase 1/2 Interim Data on Moderna’s mRNA-3927, an Investigational mRNA Therapy for Propionic Acidemia, Published in Nature
4/3/2024
Moderna, Inc. (NASDAQ:MRNA) today announced that interim data for a first-in-human, phase 1/2, open-label, dose optimization study and extension study, evaluating the safety and efficacy of mRNA-3927, an investigational mRNA therapy for propionic acidemia (PA), has been published in Nature.
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VBI Vaccines Presents Encouraging Early Tumor Response Data From Randomized Controlled Phase 2b Study of VBI-1901 in Recurrent Glioblastoma
4/3/2024
VBI Vaccines Inc. today announced that David E. Anderson, Ph.D., VBI’s Chief Scientific Officer, will present early tumor response data from the ongoing Phase 2b study of VBI-1901, VBI’s cancer vaccine immunotherapeutic candidate, in recurrent glioblastoma (rGBM) at the World Vaccine Congress Washington at 1:10pm ET on April 3, 2024.
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Alto Neuroscience Announces Initiation of Phase 2 Study of ALTO-203 in Patients with Major Depressive Disorder
4/3/2024
Alto Neuroscience, Inc. (“Alto”) (NYSE: ANRO) today announced the initiation of its Phase 2 double-blind, single- and multiple-dose study to determine the pharmacodynamic effects of ALTO-203 in MDD patients as well as assess its safety, tolerability, and pharmacokinetics.
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UHN Joins the Phase II Trial of LSALT Peptide Targeting Cardiac Surgery Associated-Acute Kidney Injury
4/3/2024
Arch Biopartners Inc., announced that Anesthesia Clinical Trials Unit, an academic research organization in the Department of Anesthesia and Pain Management at the University Health Network, has joined the Phase II trial for LSALT peptide targeting the prevention and treatment of cardiac surgery-associated acute kidney injury.
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Can-Fite: Submits FDA with an IND Application to Conduct Phase IIb Clinical Trial of Namodenoson in MASH Patients
4/3/2024
Can-Fite BioPharma Ltd., a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, announced submission of an investigational new drug application to the U.S. Food and Drug Administration for the treatment of metabolic dysfunction-associated steatohepatitis, also known as non-alcoholic steatohepatitis, for the Company’s ongoing Phase IIb clinical study.
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Aligos Therapeutics Announces First Subjects Dosed in the Phase 2a HERALD Study of ALG-055009 in MASH Subjects
4/3/2024
Aligos Therapeutics, Inc. today announced that dosing in the Phase 2a HERALD study of ALG-055009 has been initiated in subjects with metabolic dysfunction-associated steatohepatitis (MASH).
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EnteroBiotix Initiates Phase 2 Study of EBX-102-02 in Patients with Irritable Bowel Syndrome (IBS)
4/3/2024
EnteroBiotix Limited announced that the first patient has been dosed in a multi-centre randomised double-blind placebo controlled clinical trial designed to evaluate EBX-102-02 for the treatment of IBS.
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Awakn Life Sciences Announces Launch of Licensing Partnership Agreement with Oklahoma Based Clinic
4/3/2024
Toronto, Ontario--(Newsfile Corp. - April 3, 2024) - Awakn Life Sciences Corp. (CSE: AWKN) (OTCQB: AWKNF) (FSE: 954) ("Awakn" or the "Company") a clinical-stage biotechnology company developing medication-assisted treatments for addiction with a near-term focus on Alcohol Use Disorder (AUD), announces today the launch of an additional Licensing Partnership agreement in North America.
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REJOICE-Ovarian01 Phase 2/3 Trial of Raludotatug Deruxtecan Initiated in Patients with Platinum-Resistant Ovarian Cancer
4/3/2024
Daiichi Sankyo (TSE: 4568) and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the first patient has been dosed in the REJOICE-Ovarian01 phase 2/3 trial evaluating the efficacy and safety of investigational raludotatug deruxtecan (R-DXd) in patients with platinum-resistant ovarian cancer.
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Roivant has chalked up a mid-stage victory for its Pfizer-partnered dual TYK2/JAK1 inhibitor, setting it up to start a Phase III trial in non-anterior non-infectious uveitis this year.
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The biotech’s personalized neoantigen vaccine for colorectal cancer did not demonstrate a molecular response difference from the control arm. Gritstone blames trial protocol and plans for a Phase III study.