Clinical Trials (Phase I)
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Spago Nanomedical has Submitted Application to Start Tumorad(R) Clinical Phase I/IIa Study
5/23/2023
Spago Nanomedical AB announced that the final step in the preparations for the clinical phase I/IIa trial in cancer patients, Tumorad-01, with its leading candidate drug 177Lu-SN201 has begun in Australia.
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AnaMar Announces Positive Phase I Data for its Phase II Ready Compound AM1476 for Treating Fibrosis
5/23/2023
AnaMar, a clinical-stage biotech company developing a first-in-class, peripheral 5-HT2B receptor antagonist, AM1476, as a pan anti-fibrotic medicine, announces positive results from its Phase I study, and the completion of Phase II enabling pre-clinical studies for its initial orphan indication in systemic sclerosis characterized by lung and skin fibrosis.
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ReCode–a New Contestant in the mRNA Race
5/22/2023
ReCode plans to use its SORT LNP genetic medicines delivery technology to treat CF and PCD patients who don’t respond to current treatments. -
Clearmind Medicine Announces First US Site for its Phase I/IIa Clinical Trial Evaluating CMND-100 in Patients with Alcohol Use Disorder
5/22/2023
Clearmind Medicine Inc. today announced the selection of its first U.S. site for the company’s Phase I/IIa clinical trial of its proprietary MEAI-based CMND-100 compound for the treatment of alcohol use disorder ("AUD").
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HiberCell Doses First Patient in Phase 1b Study Exploring Novel Combination of Odetiglucan and CD40 Agonistic Monoclonal Antibody (CDX-1140) in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) in the Maintenance Setting
5/22/2023
HiberCell today announced dosing of the first patient in a Phase 1b clinical trial investigating the effects of odetiglucan, a first-in-class immunomodulatory agent, in combination with the CD40 agonistic monoclonal antibody, CDX-1140, in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) in the maintenance setting.
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Panbela Announces Clinical Trial with Moffitt Cancer Center for Phase I/II Program in STK11 Mutant Non-Small Cell Lung Cancer
5/22/2023
Panbela Therapeutics, Inc. today announced it has entered into a clinical trial agreement with Moffitt Cancer Center for a Phase I/II program in STK11 mutant non-small cell lung cancer (NSCLC).
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Icosavax Announces Positive Topline Interim Phase 1 Results for Bivalent VLP Vaccine Candidate IVX-A12 Against RSV and hMPV in Older Adults
5/22/2023
Icosavax, Inc. (Nasdaq: ICVX) today announced positive topline interim results from its Phase 1 clinical trial of IVX-A12 against respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) in older adults.
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Upstream Bio Presents New Phase 1 Clinical Data on UPB-101 at the American Thoracic Society (ATS) International Conference
5/22/2023
Upstream Bio, a clinical-stage biotech company advancing new therapies to treat inflammation, today presented new clinical data from its Phase 1 clinical study of UPB-101, a thymic stromal lymphopoietin receptor (TSLPR) inhibitor, at the American Thoracic Society (ATS) International Conference in Washington, DC.
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Acepodia Announces First Patient Dosed in Phase 1 Clinical Trial of ACE1831, an Anti-CD20 Armed Allogeneic Gamma Delta T-cell Therapy in Development to Treat Patients with Non-Hodgkin's Lymphoma
5/22/2023
Acepodia, a clinical stage biotechnology company developing first-in-class cell therapies with its unique Antibody-Cell Conjugation (ACC) platform to address gaps in cancer care, today announced that the first patient has been dosed with ACE1831 in a Phase 1, first-in-human clinical trial for patients with non-Hodgkin's lymphoma.
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BridgeBio Pharma Presents Updated Encouraging Clinical and Biomarker Data from its BBP-812 Canavan Disease Gene Therapy Program at the 2023 American Society of Gene and Cell Therapy (ASGCT) Annual Meeting
5/22/2023
BridgeBio Pharma, Inc. presented promising positive data from six participants dosed in CANaspire, its Phase 1/2 clinical trial of BBP-812, an investigational intravenous (IV) adeno-associated virus serotype 9 (AAV9) gene therapy for the treatment of Canavan disease.
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IDEAYA Announces IND Clearance Enabling Phase 1/2 Clinical Trial for Combination of IDE397 and AMG 193 in MTAP-Deletion Solid Tumors
5/22/2023
IDEAYA Biosciences, Inc. announced that the U.S. Food and Drug Administration has completed its review of the Amgen-sponsored Investigational New Drug application and concluded that the proposed clinical study may proceed to evaluate IDE397 in combination with AMG 193 in solid tumors having MTAP deletion.
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AiViva Biopharma Initiates Phase 1 Clinical Trial of AIV007 for Age-Related Macular Degeneration and Diabetic Macular Edema
5/22/2023
AiViva Biopharma Inc., a clinical-stage biotechnology company, announced that it has begun a Phase 1 trial and completed dosing the first cohort of patients diagnosed with wet age-related macular degeneration, and/or diabetic macular edema.
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Keros Therapeutics Presents Preclinical and Clinical Data from its KER-012 Program at the American Thoracic Society International Conference
5/22/2023
Keros Therapeutics, Inc. (“Keros”) (Nasdaq: KROS) today announced that it presented additional biomarker data from its completed Phase 1 clinical trial of KER-012 in healthy post-menopausal women at the American Thoracic Society (“ATS”) 2023 International Conference.
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Nexcella Announces Positive NXC-201 Clinical Results at ASGCT: 100% Overall Response Rate in DARZALEX-Relapsed/Refractory AL Amyloidosis with Zero ICANs in Ongoing NEXICART-1 Phase 1b/2a Clinical Trial
5/21/2023
Nexcella, Inc. announced updated AL Amyloidosis clinical data from its ongoing Phase 1b/2a 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 multiple myeloma and light chain amyloidosis.
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Immix Biopharma Announces Positive NXC-201 Clinical Results at ASGCT: 100% Overall Response Rate in DARZALEX-Relapsed/Refractory AL Amyloidosis with Zero ICANs in Ongoing NEXICART-1 Phase 1b/2a Clinical Trial
5/21/2023
Immix Biopharma, Inc., announced updated AL Amyloidosis clinical data from its ongoing Phase 1b/2a 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 multiple myeloma and light chain amyloidosis.
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Neurimmune: Promising Phase 1 Results for Antibody NI006 in ATTR Cardiomyopathy Published in the New England Journal of Medicine
5/20/2023
Neurimmune announced that primary results of its Phase 1 proof-of-concept study of NI006, a recombinant human antibody to deplete amyloid deposits in ATTR cardiomyopathy, have been presented in Prague at Heart Failure 2023, a scientific congress of the European Society of Cardiology, and published in The New England Journal of Medicine.
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Salubris Biotherapeutics Presents Positive Updates from Phase 1b Clinical Trial of JK07 in Late-Breaking Session at the European Society of Cardiology Heart Failure 2023 Congress
5/20/2023
Salubris Biotherapeutics, Inc., a clinical-stage biotechnology company dedicated to discovering and developing novel complex biologic therapeutics, announced positive updated results from the ongoing Phase 1b study of JK07 in heart failure with reduced ejection fraction.
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Celularity Announces Phase 1 Data Showing That MLASC Therapy in Patients With Crohn’s Disease May Be a Therapeutic Option to Manage Inflammatory Bowel Diseases and Prevent Fistula Formation
5/19/2023
Celularity Inc. (Nasdaq: CELU) (“Celularity”) announced results from an exploratory analysis of Phase 1 data evaluating alterations in gene and protein signatures associated with reduced inflammation and fistula formation resulting from therapy with mesenchymal‐like adherent stromal cells (MLASCs) in adult patients with Crohn’s disease (CD).
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Alpine Immune Sciences to Present Data from RUBY-1, a Phase 1 Study of Povetacicept, at Upcoming Scientific Congresses
5/19/2023
Alpine Immune Sciences, Inc. (NASDAQ: ALPN) announced the Company will present data from RUBY-1, a phase 1 study of povetacicept in healthy adult volunteers, at multiple upcoming scientific congresses, including participation in a poster tour at the European Congress of Rheumatology (EULAR) and an oral presentation at the European Hematology Association (EHA).
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Kymera Therapeutics Doses First Patient in Phase 1 Oncology Trial of MDM2 Degrader KT-253
5/19/2023
Kymera Therapeutics, Inc. has recently dosed the first patient in the Phase 1 multicenter, open-label, dose-escalation clinical trial evaluating its investigational MDM2 degrader KT-253.