Clinical Trials - Phase I
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Regeneron and Alnylam Report Positive Interim Phase 1 Clinical Data on ALN-APP, an Investigational RNAi Therapeutic for Alzheimer’s Disease and Cerebral Amyloid Angiopathy
4/26/2023
Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) and Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY) announced today positive interim results from the ongoing single ascending dose part of the Phase 1 study of ALN-APP, an investigational RNAi therapeutic targeting amyloid precursor protein (APP) in development for the treatment of Alzheimer’s disease and cerebral amyloid angiopathy (CAA).
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Alnylam and Regeneron Report Positive Interim Phase 1 Clinical Data on ALN-APP, an Investigational RNAi Therapeutic for Alzheimer’s Disease and Cerebral Amyloid Angiopathy
4/26/2023
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY) and Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) announced today positive interim results from the ongoing single ascending dose part of the Phase 1 study of ALN-APP, an investigational RNAi therapeutic targeting amyloid precursor protein (APP) in development for the treatment of Alzheimer’s disease and cerebral amyloid angiopathy (CAA).
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ContraFect Announces First Patient Dosed in the Phase 1b/2 Study of Exebacase in Patients with Chronic Prosthetic Joint Infections of the Knee
4/26/2023
ContraFect Corporation (Nasdaq: CFRX) today announces the first patient has been dosed in the Phase 1b/2 of exebacase in the setting of an arthroscopic debridement, antibiotics, irrigation, and retention (DAIR) procedure in patients with chronic prosthetic joint infections (PJI) of the knee due to Staphylococcus aureus (S. aureus) or Coagulase-Negative Staphylococci (CoNS).
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Erasca Announces Two Poster Presentations at the 2023 ASCO Annual Meeting
4/26/2023
Erasca, Inc. announced the company will present two poster presentations at the upcoming American Society of Clinical Oncology Annual Meeting, taking place June 2-6, 2023, in Chicago, Illinois.
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eFFECTOR to Present Updated Clinical Data from Phase 2 Expansion Cohorts for Zotatifin in Patients with ER+ Metastatic Breast Cancer at ASCO 2023 Annual MeetingeFFECTOR to host conference call following ASCO presentation
4/26/2023
eFFECTOR Therapeutics, Inc. announced a poster highlighting results from Phase 2 expansion cohorts of a Phase 1/2 dose escalation and expansion trial with zotatifin in patients with ER+ Metastatic Breast Cancer has been selected for presentation at the American Society of Clinical Oncology 2023 Annual Meeting.
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Bolt Biotherapeutics to Present Clinical Data from Phase 1 Dose-Escalation Trial of BDC-1001 in HER2-Expressing Tumors at 2023 ASCO Annual Meeting
4/26/2023
Bolt Biotherapeutics, Inc. announced that it will present a poster with clinical data from its completed Phase 1 dose-escalation study of BDC-1001 at the 2023 American Society for Clinical Oncology Annual Meeting.
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Alentis Therapeutics Reports Positive Topline Results From Phase 1 Multiple-ascending Dose Cohorts Study
4/26/2023
Alentis Therapeutics announced results from the multiple-ascending dose part of its first-in-human Phase 1 clinical study of ALE.F02 targeting Claudin-1.
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Nexcella Announces Positive 58-Patient NXC- 201 Clinical Data: 100% Overall Response Rate in light chain (AL) Amyloidosis; 92% Overall Response Rate in Multiple Myeloma at the EBMT 49th Annual Meeting in Paris
4/26/2023
Nexcella Inc., announced new positive clinical data from its ongoing Phase 1b/2 NEXICART-1 study of its novel, autologous, BCMA-targeted chimeric antigen receptor T cell therapy NXC-201 for the treatment of patients with relapsed or refractory light chain amyloidosis and multiple myeloma.
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Allogene Therapeutics Announces Presentation of Phase 1 Data from the ALLO-501/501A Trials in Large B Cell Lymphoma at the American Society of Clinical Oncology (ASCO) Annual Meeting
4/26/2023
Allogene Therapeutics, Inc. today announced it will present updated data from the Phase 1 ALPHA/ALPHA2 trials of ALLO-501/501A at the American Society of Clinical Oncology (ASCO) Annual Meeting June 2 – 6, 2023 in Chicago, Illinois.
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Cullinan Oncology to Present First Clinical Data Evaluating Novel Anti-MICA/B Antibody, CLN-619, in Patients with Advanced Solid Tumors at ASCO 2023
4/26/2023
Cullinan Oncology, Inc. today announced that the first clinical data from its Phase 1 clinical study of CLN-619 in patients with advanced solid tumors will be presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting taking place in Chicago from June 2-6.
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Bicara Therapeutics Announces Oral Presentation of Head and Neck Cancer Dose Expansion Data from Phase 1/1b Study of BCA101 at Upcoming 2023 ASCO Annual Meeting
4/26/2023
Bicara Therapeutics today announced that it will present dose expansion data from the ongoing Phase 1/1b clinical trial of its lead investigational candidate, BCA101, in combination with pembrolizumab in patients with recurrent, metastatic head and neck squamous cell carcinoma.
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Theseus Pharmaceuticals Initial Dose Escalation Results from Ongoing Phase 1/2 Trial of THE-630 Accepted for Online Publication at 2023 ASCO Annual Meeting
4/26/2023
Theseus Pharmaceuticals, Inc. today announced that initial dose escalation data from the ongoing phase 1/2 study of THE-630 in advanced gastrointestinal stromal tumors (GIST) were accepted for online publication at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place June 2-6, in Chicago, Illinois.
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Artiva Biotherapeutics Announces Presentation of Data from First-in-Human Phase 1/2 Clinical Trial of AB-101 at the 2023 ASCO Annual Meeting
4/26/2023
Artiva Biotherapeutics, Inc., a clinical stage company whose mission is to deliver highly effective, off-the-shelf, allogeneic natural killer (NK) cell-based therapies, announced today that a poster describing initial data from the Phase 1/2 trial of AB-101 will be presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting taking place June 2-6 in Chicago.
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Atreca Announces Oral Presentation of ATRC-101 Phase 1b Study Data at ASCO 2023 Annual Meeting
4/26/2023
Atreca, Inc. (Atreca) (NASDAQ: BCEL) today announced that data from the Phase 1b study of ATRC-101 will be presented during an oral abstract session at the American Society of Clinical Oncology 2023 Annual Meeting, being held June 2-6, 2023 in Chicago, Illinois.
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The partial clinical hold follows Foghorn’s voluntary pause of the study and is due to one patient developing irregular heartbeat following treatment with FHD-609. -
The regulatory filing puts the company alongside Vertex and CRISPR, which also await FDA approval for their SCD gene therapy. -
Atsena Therapeutics Announces Positive 6-month Data from Ongoing Phase I/II Clinical Trial of ATSN-101 in Patients with Leber Congenital Amaurosis Caused by Biallelic Mutations in GUCY2D (LCA1)
4/25/2023
Atsena Therapeutics today announced positive 6-month safety and efficacy data from the ongoing Phase I/II clinical trial of ATSN-101, the company’s investigational gene therapy for the treatment of GUCY2D-associated Leber congenital amaurosis (LCA1).
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Bloom Science Completes Enrollment in Phase 1 Trial of BL-001, a First-in-Class Therapy Being Developed for Dravet Syndrome
4/25/2023
Bloom Science, Inc., a clinical-stage, central nervous system (CNS) company focused on discovering and developing breakthrough therapeutics that target the Gut-Brain Axis, today announced that the company has completed enrollment in all four cohorts of healthy adult participants as part of its Phase 1 clinical trial.
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Arrowhead Pharmaceuticals’ Proprietary Pulmonary TRiM™ Platform Achieves High Levels of Target Gene Knockdown and Long Duration of Effect
4/25/2023
Arrowhead Pharmaceuticals’ Proprietary Pulmonary TRiM ™ Platform Achieves High Levels of Target Gene Knockdown and Long Duration of Effect.
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Omeros Corporation Reports Interim Data with Alternative Pathway Inhibitor OMS906 as Monotherapy in Patients with Paroxysmal Nocturnal Hemoglobinuria
4/25/2023
Omeros Corporation (Nasdaq: OMER) today announced positive results from a pre-specified interim analysis of its ongoing Phase 1b clinical trial of OMS906, the company’s lead MASP-3 inhibitor, in complement-inhibitor-naïve adults with paroxysmal nocturnal hemoglobinuria (PNH), a rare and life-threatening hemolytic blood disorder.