Clinical Trials (Phase I)
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After a brief slump, interest in ADCs is at an all-time high, highlighted by a handful of recent multi-million- and billion-dollar acquisitions. -
The FDA’s new guidance on decentralized clinical trials clarifies how investigators and trial sponsors can use digital health technologies and involve primary healthcare practitioners. -
New Data from Phase 1/2 Trial of INO-3107 for the Treatment of Recurrent Respiratory Papillomatosis Presented at ABEA during COSM 2023
5/8/2023
INOVIO presented new data from a Phase 1/2 trial of INO-3107 (NCT:04398433) for the treatment of HPV 6 and HPV 11-associated Recurrent Respiratory Papillomatosis (RRP) on May 5th as part of the scientific program of the American Broncho-Esophagological Association (ABEA) at the Combined Otolaryngology Spring Meetings (COSM) in Boston, Massachusetts.
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FibroGen Enters into Exclusive License for FOR46 with Fortis Therapeutics
5/8/2023
FibroGen, Inc. (Nasdaq: FGEN) and Fortis Therapeutics announced that FibroGen has entered into an exclusive license with Fortis Therapeutics for FOR46, a potential first-in-class Phase 1 antibody-drug conjugate (ADC) targeting a novel epitope on CD46.
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CureVac Announces Dosing of First Participant in Combined Phase 1/2 Study of Multivalent, Modified Influenza Vaccine Candidates Developed in Collaboration with GSK
5/8/2023
CureVac N.V. today announced that the first participant was dosed in the Phase 1 part of a combined Phase 1/2 study of multivalent, modified mRNA seasonal flu vaccine candidates, developed in collaboration with GSK.
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Celcuity to Present Updated Results for Treatment-Naïve Patients from Phase 1b Study of Gedatolisib at the 2023 ESMO Breast Cancer Annual Congress
5/8/2023
Celcuity Inc. today announced publication of an abstract reporting updated results for treatment-naive patients from the Phase 1b study of gedatolisib, a pan-PI3K/mTOR inhibitor, in combination with palbociclib and letrozole in women with HR+/HER2- advanced breast cancer (ABC).
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Seres Therapeutics to Host First Quarter 2023 Financial Results and Operational Progress Conference Call and Webcast on May 9, 2023
5/5/2023
Seres Therapeutics, Inc. today announced that management will host a conference call and live audio webcast on May 9, 2023 at 8:30 a.m. ET to discuss first quarter results and provide a general business update, including initial SER-155 Phase 1b safety and pharmacology results from study Cohort 1.
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MedinCell: mdc-TJK's (Teva's codename: TEV-44749) Phase 1 study pharmacokinetics to be presented for the first time by Teva at SIRS 2023 (May 11-15, 2023, Toronto, Canada)
5/4/2023
An original presentation describing pharmacokinetic characteristics of an investigational long-acting subcutaneous formulation of olanzapine (mdc-TJK or TEV-44749) will be communicated by MedinCell’s partner Teva Pharmaceuticals at the 2023 Schizophrenia Investigational Research Society (SIRS) later this month.
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SELLAS Announces Positive Topline Data from GFH009 Phase 1 Dose-Escalation Trial in Acute Myeloid Leukemia Cohort Supporting Advancement to Phase 2 Clinical Study
5/4/2023
SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced positive topline data for the cohort of patients with acute myeloid leukemia (AML) from its Phase 1 dose-escalation trial in relapsed/refractory (r/r) myeloid malignancies for GFH009, its CDK9 inhibitor.
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Immunic Reports Positive Results From Phase 1b Clinical Trial of IMU-856 in Celiac Disease, Providing Clinical Proof-of-Concept for New Therapeutic Approach to Gastrointestinal Disorders
5/4/2023
Immunic, Inc., a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, announced positive results from the part C portion of its phase 1 clinical trial of IMU-856 in patients with celiac disease.
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Cocrystal Pharma Presents New Data from its CC-42344 Phase 1 Influenza A Study at the 7th Annual ISIRV Antiviral Group Conference
5/4/2023
Cocrystal Pharma, Inc. announces that new data from its CC-42344 Phase 1 influenza A Study was presented by Sam Lee, Ph.D., President and co-CEO, at the 7th Annual International Society for Influenza and Other Respiratory Virus Diseases’ Antiviral Group Conference.
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Trellis Bioscience Announces Positive Interim Phase 1 Results for TRL1068, a Novel Native Human Monoclonal Antibody Which Reduces Bacterial Biofilm Burden in Chronic Prosthetic Joint Infections
5/4/2023
Trellis Bioscience Inc announced a clinical proof-of-concept milestone from a planned interim analysis of the company's Phase 1 trial of its lead antibody, TRL1068, in patients with prosthetic joint infections.
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Endogena Therapeutics Completes Enrollment Ahead of Schedule in its Phase 1/2a Trial of EA-2353 for Retinitis Pigmentosa
5/4/2023
Endogena Therapeutics Inc., a clinical-stage biotech company, is pleased to announce that it has completed patient enrollment ahead of schedule in its Phase 1/2a trial of EA-2353 for the treatment of retinitis pigmentosa.
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SAB Biotherapeutics Presents Positive Phase 1 and 2a Data for SAB-176 Influenza Immunotherapy at ISIRV-AVG Conference
5/4/2023
SAB Biotherapeutics (Nasdaq: SABS), (SAB) today announced the presentation of positive safety and efficacy data from Phase 1 and 2a clinical trials of its influenza immunotherapy, SAB-176 at the AVG conference, which is hosted by the International Society for Influenza and other Respiratory Virus Diseases (ISIRV) in Seattle, Wash.
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Zevra Therapeutics Announces FDA Acceptance of IND Application for KP1077 in Narcolepsy
5/3/2023
Zevra Therapeutics, Inc. today announced the acceptance of an Investigational New Drug (“IND”) application by the U.S. Food and Drug Administration (“FDA”) to begin a Phase 1 clinical trial of KP1077 in narcolepsy which is expected to provide additional information regarding the optimal dosing regimen.
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Incannex Company Presentation – Results from Phase 1 Clinical Trial to Assess Proprietary IHL-675A
5/3/2023
Incannex Healthcare Ltd is pleased to announce a company presentation containing data and analysis of the results from the Phase 1 clinical trial undertaken to assess safety and pharmacokinetics of IHL-675A as an anti-inflammatory drug candidate.
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Scorpion Therapeutics Announces First Patient Dosed in Phase 1/2 Clinical Trial of STX-478, Its Mutant-Selective PI3Kα Inhibitor for the Treatment of Breast Cancer and Other Solid Tumors
5/2/2023
Scorpion Therapeutics, Inc. today announced that the first patient has been dosed in a Phase 1/2 first-in-human dose escalation and expansion clinical trial evaluating STX-478.
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EirGenix's Second Breast Cancer Biosimilar EG1206A Successfully Reaches Phase 1 Clinical Trial Objectives
5/2/2023
EirGenix, Inc. (6589.TT) announced on 28th of April that it has completed the phase 1 clinical trial (EGC101) of its second breast cancer biosimilar EG1206A in Europe.
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Verismo Therapeutics Announces the Activation of its STAR-101 Clinical Trial at the University of Pennsylvania
5/2/2023
Verismo Therapeutics, a clinical-stage CAR-T company and University of Pennsylvania spinout developing novel KIR-CAR platform technology, today announced that it has activated its STAR-101 Phase 1 clinical trial at the University of Pennsylvania.
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Moleculin Successfully Completes First Cohort in Phase 1b/2 Trial Evaluating Annamycin in Combination with Cytarabine (Ara-C) for the Treatment of Acute Myeloid Leukemia (AML)
5/2/2023
Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company") today announced the successful completion of the first cohort in the Phase 1b portion of its Phase 1b/2 clinical trial using Annamycin in combination with Cytarabine for the treatment of AML (MB-106).