Clinical Trials - Phase I

Found 19,483 articles

• Myrtelle Announces Positive 6-month Post-Treatment Data in Patients in Its First-in-Human Clinical Study of rAAV-Olig001-ASPA Gene Therapy in Canavan Disease

  4/19/2023

  Analyses at 6 months showed increases in myelin, white matter and other MRI and MRS measurements as well as functional improvements on validated assessment scales.

• Leyden Labs’ Intranasal PanFlu Antibody Enters the Clinic

  4/19/2023

  Leyden Laboratories B.V., (the “Company” or “Leyden Labs”) announced today the dosing of the first Phase 1 healthy volunteer cohort with a nasal spray containing PanFlu candidate CR9114.

• Plus Therapeutics Completes Enrollment of the Original Three Patients Required for Cohort 8 of ReSPECT-GBM Phase 1/2a Trial

  4/19/2023

  Plus Therapeutics, Inc. today announced the completion of enrollment of the original three patients required in Cohort 8 of the ReSPECT-GBM Phase 1/2a dose escalation clinical trial of rhenium ( 186 Re) obisbemeda for the treatment of recurrent glioblastoma (GBM).

• Oxford BioTherapeutics announces Phase 1b trial in collaboration with GORTEC to investigate OBT076 in Adenoid Cystic Carcinoma (ACC) of the head and neck

  4/19/2023

  Oxford BioTherapeutics Ltd. announces it has entered into a collaboration with Groupe d'Oncologie Radiothérapie Tête Et Cou to undertake a new Phase 1b trial investigating OBT’s lead asset, OBT076, in patients with Adenoid Cystic Carcinoma.

• IDEAYA Announces First Patient Dosed in Phase 1 Clinical Trial for IDE161 as Potential First-in-Class PARG Inhibitor Targeting HRD Solid Tumors

  4/19/2023

  IDEAYA Biosciences, Inc., a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced achievement of First-Patient-In in the Phase 1 clinical trial evaluating IDE161 and release of a poster presentation profiling IDE161 at AACR 2023.

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  FDA Adcomm Backs Innoviva's Pneumonia Antibiotic

  4/18/2023

  A unanimous FDA committee vote supported the favorable risk-benefit profile of Innoviva’s sulbactam-durlobactam for hospital-acquired A. baumannii infections.

• Assembly Biosciences Announces Additional Promising Data from Phase 1a Clinical Trial Evaluating Highly Potent Next-Generation Core Inhibitor Candidate ABI-4334 and Provides Pipeline Update

  4/18/2023

  Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative antiviral therapeutics targeting serious viral diseases, today provided an update of results from the final multiple-dose cohort in the ongoing Phase 1a study of its investigational next-generation, highly potent hepatitis B virus (HBV) core inhibitor, ABI-4334.

• Daré Bioscience Announces Publication of Positive Safety and Acceptability Data from Phase 1 Clinical Trial that Support the Potential of DARE-HRT1 Intravaginal Ring as a New Menopausal Hormone Therapy

  4/18/2023

  Daré Bioscience, Inc. today announced that Climacteric , the official journal of the International Menopause Society, published safety and acceptability results from a Phase 1 clinical trial of DARE-HRT1.

• Evaxion announces promising clinical data for DNA-based personalized cancer immunotherapy EVX-02: Phase 1/2a trial met both primary and secondary endpoints

  4/18/2023

  Evaxion Biotech A/S (NASDAQ: EVAX) (“Evaxion” or the “Company”), a clinical-stage biotechnology company specializing in the development of AI-powered immunotherapies, today presented promising clinical data from its Phase 1/2a first-in-human study of its DNA-based personalized cancer immunotherapy, EVX-02 in combination with the checkpoint inhibitor nivolumab.

• Plus Therapeutics Completes Phase 1/Part A of the ReSPECT-LM Clinical Trial for Leptomeningeal Metastases

  4/18/2023

  Plus Therapeutics, Inc. today announced the completion of Cohort 3 of the ReSPECT-LM Phase 1/2a dose-escalation clinical trial of rhenium (186Re) obisbemeda for the treatment of leptomeningeal metastases (LM) from solid tumors less than one month since its initiation, demonstrating rapid enrollment.

• Karyopharm Announces Presentation of Updated Phase 1 Selinexor Data in Patients with Treatment-Naïve Myelofibrosis at AACR 2023

  4/18/2023

  Karyopharm Therapeutics Inc. (Nasdaq: KPTI) today announced updated results from the Phase 1 study evaluating the safety and efficacy of once-weekly selinexor in combination with ruxolitinib in patients with treatment-naïve myelofibrosis (NCT04562389).

• Primmune Therapeutics Presents New Clinical Data from Phase 1 Study Evaluating PRTX007 in Healthy Volunteers at the 2023 American Association for Cancer Research (AACR) Annual Meeting

  4/18/2023

  Primmune Therapeutics today presented new clinical data from a first-in-human, Phase 1 study evaluating PRTX007, an orally administered prodrug of a novel, small molecule toll-like receptor 7 (TLR7)-specific agonist, at the American Association of Cancer Research (AACR) Annual Meeting in Orlando, Florida.

• Immuneering Announces Positive Initial Phase 1 Pharmacokinetic, Pharmacodynamic and Safety Data for IMM-1-104 Universal-RAS Program; Accelerates Study Timeline

  4/18/2023

  Immuneering Corporation announced positive initial pharmacokinetic (PK), pharmacodynamic (PD) and safety data from the Phase 1 trial of IMM-1-104 (NCT05585320), which are being shared today in a poster presentation titled “Humanized 3D tumor models that are mutationally aligned with AACR GENIE patients predict IMM-1-104 activity in RAS-addicted tumors” (abstract #4265) at the American Association for Cancer Research (AACR) annual meeting.

• Autobahn Therapeutics Advances ABX-002, its Lead Oral Treatment for Major Depressive Disorder, into Multi-Ascending Dose Portion of Phase 1 Trial

  4/18/2023

  Autobahn Therapeutics today announced that it has initiated the multiple ascending dose (MAD) portion of its Phase 1 study of ABX-002 in healthy subjects.

• ImCheck Achieves the Primary Objectives of Phase I of the EVICTION-2 Trial of ICT01 in Combination with Low Dose IL-2, Data Presented at AACR 2023

  4/18/2023

  ImCheck Therapeutics announced today data from its ongoing Phase I/IIa clinical trial EVICTION-2 at the American Association for Cancer Research (AACR) Annual Meeting 2023 in a poster presentation (CT179) titled: “First-in-Human Study of ICT01, an Anti-BTN3A Activating Monoclonal Antibody in Combination with Low Dose IL-2 in Patients with Advanced Solid Tumors (EVICTION-2 Study)”.

• Nouscom Presents New Positive Translational Phase 1b Data of NOUS-PEV, a Personalized Neoantigen Cancer Immunotherapy, in a Late-Breaking Abstract at AACR 2023

  4/18/2023

  Nouscom announced new translational and biomarker data obtained from the ongoing Phase 1b trial evaluating NOUS-PEV in patients with metastatic melanoma.

• Innovent Announces Updated Data of Phase 1 Clinical Trial for IBI351 (KRAS[G12C] Inhibitor) as Monotherapy for Solid Tumors at the AACR Annual Meeting 2023

  4/18/2023

  Innovent Biologics, Inc. announced the updated results of IBI351 from a phase 1 clinical trial in an oral presentation at the 2023 American Association for Cancer Research Annual Meeting.

• Palleon Pharmaceuticals Presents Initial Phase 1 Results from the GLIMMER-01 Clinical Trial for E-602, the First Ever Glyco-Immune Checkpoint Inhibitor

  4/18/2023

  Palleon Pharmaceuticals, a clinical-stage company pioneering glyco-immunology drug development to treat cancer and inflammatory diseases, today announced the initial Phase 1 results from the GLIMMER-01 trial of its lead EAGLE oncology platform program, E-602, at the American Association for Cancer Research (AACR) Annual Meeting 2023 in Orlando, Florida.

• Sonnet BioTherapeutics Announces Updated Clinical Data for SON-1010 at the 2023 American Association for Cancer Research (AACR) Annual Meeting

  4/18/2023

  Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) (the "Company" or "Sonnet"), a clinical-stage company developing targeted immunotherapeutic drugs, announced today that the safety of SON-1010 dosing has been formally reviewed in both of the current Phase 1 clinical trials, and the Company is now enrolling the final dose cohort in the cancer trial.

• Repare Therapeutics Presents Initial Clinical Data from the Phase 1/2 TRESR and ATTACC Trials Evaluating Camonsertib in Combination with Three PARP Inhibitors at the 2023 AACR Annual Meeting

  4/18/2023

  Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq: RPTX), a leading clinical-stage precision oncology company, today presented initial data from its ongoing Phase 1/2 TRESR clinical trial evaluating camonsertib (RP-3500/RG6526, partnered with Roche).