Clinical Trials - Phase I
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Jnana Therapeutics Reports Positive Topline Results from Phase 1a Clinical Study of JNT-517, a Potential First-in-Class Oral Treatment for PKU
5/31/2023
Jnana Therapeutics today announced positive topline results from the Phase 1a clinical trial of JNT-517 in healthy volunteers.
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Brii Biosciences Announces First Subject Dosed in Phase 1 Clinical Trial of BRII-297, Long-Acting Injectable for the Treatment of Anxiety and Depressive Disorders
5/31/2023
Brii Biosciences Limited ("Brii Bio" or the "Company", stock code: 2137.HK) today announced the first subject has been dosed in a Phase 1 clinical trial evaluating BRII-297, a first-of-its-kind long-acting injectable (LAI), in development for the treatment of various anxiety and depressive disorders.
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Celldex Announces First Patient Dosed in Phase 1 Study of CDX-585 in Patients with Advanced Malignancies
5/31/2023
Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced that the first patient has been dosed in a Phase 1 study of CDX-585. CDX-585 combines highly active PD-1 blockade with anti-ILT4 blockade to overcome immunosuppressive signals in T cells and myeloid cells.
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KAHR Reports Dose Escalation Results from Phase I Trial of DSP107 in Combination with anti-PD-L1 in Patients with Advanced Solid Tumors
5/31/2023
KAHR today announced positive results from the dose escalation Phase I study of DSP107 in combination with atezolizumab (anti-PD-L1) in patients with advanced solid tumors.
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Glyscend Therapeutics Announces Positive Topline Phase 2a Clinical Results and Progress with GLY-200, a First-in-Class Treatment for Type 2 Diabetes and Obesity
5/31/2023
Glyscend Therapeutics, a clinical-stage biotechnology company pioneering a new generation of orally administered first-in-class gut-targeted polymer therapies, today announced clinical progress with its lead candidate, GLY-200, for the treatment of type 2 diabetes (T2D) and obesity.
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Nacuity Pharmaceuticals Achieves Target Enrollment for Phase 1/2 Clinical Trial of NPI-001 for the Treatment of Retinitis Pigmentosa Associated with Usher Syndrome
5/31/2023
Nacuity Pharmaceuticals, Inc. today announced that target enrollment of 48 patients has been reached in the SLO-RP Phase 1/2 clinical trial of NPI-001 tablets in patients with retinitis pigmentosa (RP) associated with Usher syndrome (USH).
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Adiso Therapeutics Announces the Completion of a Phase 1b Multiple Ascending Dose Study of ADS051 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis
5/31/2023
Adiso Therapeutics, Inc. today announced the completion of a Phase 1b multiple ascending dose (MAD) clinical trial evaluating ADS051 (BT051) an oral, gut-restricted, small molecule modulator of neutrophil trafficking and activation.
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IRLAB has Activated all 38 Study Sites in the Phase IIb Study of Pirepemat Aiming to Improve Balance and Reduce Falls in Parkinson’s Disease
5/31/2023
IRLAB Therapeutics AB, a company discovering and developing novel treatments for Parkinson's disease, announced that all participating study sites in the Phase IIb study of pirepemat are activated and recruiting patients.
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Halberd CEO Mid-Quarter Update
5/31/2023
Halberd Corporation has been progressing rapidly on several projects in so many areas that this mid-quarter update is intended to bring the public up to date on a few of the most significant efforts.
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BiomX to Present Part 1 Data from Phase 1b/2a Study Evaluating BX004 for the Treatment of Chronic Pseudomonas aeruginosa Pulmonary Infections in Patients with Cystic Fibrosis During Late-Breaking Science Session at the 46th ECFC
5/31/2023
BiomX Inc. announced that the Company will present Part 1 data from its ongoing Phase 1b/2a study evaluating the novel phage product candidate, BX004, for the treatment of chronic Pseudomonas aeruginosa pulmonary infections in patients with cystic fibrosis during the Late-Breaking Science Session at 46th European Cystic Fibrosis Conference, which is being held June 7-10th, 2023, in Vienna, Austria.
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Coave Therapeutics announces Positive 12-months Data from Ongoing Phase I/II Clinical Trial of CTx-PDE6b in Patients with Retinitis Pigmentosa Caused by Bi-allelic Mutations in PDE6b
5/31/2023
Coave Therapeutics announces the positive 12-month results from its Phase I/II trial evaluating the safety and efficacy of its innovative gene therapy, CTx-PDE6b, for retinitis pigmentosa caused by bi-allelic mutations in the PDE6B gene.
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Myrtelle to Present Positive 6-month Post-Treatment Data in Its First-in-Human Clinical Study of rAAV-Olig001-ASPA Gene Therapy in Canavan Disease at the National Tay-Sachs and Allied Diseases Annual Family Conference
5/31/2023
Myrtelle Inc. today announced that updated positive data in its open-label Phase 1/2 First-in-Human (FIH) clinical trial for Canavan disease (CD) using the Company’s recombinant adeno-associated virus (rAAV) vector-based investigational gene therapy will be presented at the National Tay-Sachs and Allied Diseases Annual Family Conference, taking place in Reston, Virginia June 1-4, 2023.
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A2 Bio Announces First Patient Dosed in Phase 1 Clinical Trial of A2B530, a Novel Cell Therapy for the Treatment of Colorectal, Pancreatic and Non-small Cell Lung Cancers
5/30/2023
A2 Biotherapeutics, Inc. today announced the first patient has been dosed in the Phase 1 clinical trial of A2B530.
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PepGen Inc. Announces Clinical Hold in the U.S. on IND Application to Initiate a Phase 1 Study of PGN-EDODM1 for Myotonic Dystrophy Type 1 (DM1)
5/30/2023
PepGen Inc. (Nasdaq: PEPG) today announced that the Company received a clinical hold notice from the U.S. Food and Drug Administration (FDA) regarding their Investigational New Drug Application (IND) to initiate a Phase 1 study of PGN-EDODM1 in patients with Myotonic Dystrophy Type 1 (DM1).
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Xencor Presents Clinical Results from Phase 1a Study of XmAb®564 at the EULAR 2023 Congress
5/30/2023
Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies and cytokines for the treatment of patients with cancer and autoimmune diseases, today announced the presentation of results from its Phase 1a single-ascending dose study of XmAb®564 in healthy volunteers.
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Immorna Announces First Subject Dosed in a Phase 1 Study of JCXH-105, a Self-Replicating RNA-Based Vaccine Developed for the Prevention of Shingles
5/30/2023
Immorna today announced that the first subject has been dosed in the Company's First-In-Human (FIH) Phase 1 multi-center study of JCXH-105, a self-replicating RNA (srRNA) vaccine being developed for the prevention of Shingles (Herpes Zoster; HZ).
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Pyxis Oncology Advances PYX-106 and PYX-201 Clinical Programs
5/30/2023
Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company focused on developing next-generation therapeutics to target difficult-to-treat cancers, today announced dosing of the first subject in the Phase 1 trial of PYX-106.
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Genprex Receives Safety Review Committee Approval to Advance to Phase 2 Expansion Portion of Acclaim-1 Clinical Trial of REQORSA® in Combination with Tagrisso® in Advanced Non-Small Cell Lung Cancer
5/30/2023
Genprex, Inc. today announced that it has completed the Phase 1 portion of the Acclaim-1 Phase 1/2 clinical trial of REQORSA® in combination with Tagrisso® (osimertinib) to treat late-stage non-small cell lung cancer (NSCLC), and the Safety Review Committee (SRC) has approved continuation to the Phase 2 expansion portion of the trial.
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DEBIOPHARM LAUNCHES PHASE 1 RESEARCH IN SMALL CELL LUNG CANCER WITH WEE1 INHIBITOR DEBIO 0123 TO OUTSMART DDR IN SMALL CELL LUNG CANCER
5/30/2023
Debiopharm today announced the first patient dosed in its open-label, multicenter, Phase 1 study evaluating Debio 0123, an oral, potent, highly selective and brain penetrant WEE1 inhibitor, in combination with carboplatin and etoposide in patients with recurrent or progressive SCLC following standard platinum-based chemotherapy.
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ConSynance Therapeutics Reports Positive Phase 1 Results for CSTI-500 in Prader-Willi Syndrome Patients
5/30/2023
ConSynance Therapeutics, Inc., an emerging biopharmaceutical firm focused on developing novel therapies for rare central nervous system (CNS) disorders, today announced positive results from its Phase 1 trial for CSTI-500, a potential groundbreaking treatment for Prader-Willi Syndrome (PWS).