The success of a vaccine, a gene editing design for an untreated disease, or achieving cell engraftment after several attempts, comes from years of accumulated basic science studies, thousands of experiments, and clinical trials. Innumerable steps precede hits in gene and cell therapies before a first-time revelation, and most of them are failures at the time. At the 27th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT) in Baltimore last week, several groups of scientists presented achievements that years ago looked impossible.
Ajax Therapeutics Inc. has received clearance for its IND application from the FDA to initiate a phase I study of AJ1‑11095, a first-in-class type II JAK2 inhibitor, for the treatment of patients with myelofibrosis.
Bioatla Inc. has received FDA clearance of its IND application for BA-3361, a conditionally active biologic (CAB)-Nectin-4 antibody-drug conjugate (ADC) for the treatment of multiple tumor types.
Eisbach Bio GmbH has announced FDA clearance of its IND application for EIS-12656, a first-in-class orally bioavailable and blood-brain barrier-penetrant allosteric inhibitor of ALC1 (CHD1L), a key molecular machine in DNA repair. Enrollment will open in the second quarter in a phase I/II trial in patients with genetically defined advanced solid tumors, including patients progressing under PARP inhibitor treatment.
Vyne Therapeutics Inc. has received IND clearance from the FDA allowing it to initiate a first-in-human phase Ia study of VYN-202, an oral small-molecule BD2-selective BET inhibitor for autoimmune diseases.
Context Therapeutics Inc. has received FDA clearance of its IND application for CTIM-76, a Claudin 6 (CLDN6) x CD3 T-cell engaging bispecific antibody.
Eluminex Biosciences Ltd. announced the FDA’s acceptance of their IND application for EB-105, a trispecific fusion antibody targeting vascular endothelial growth factor A (VEGF-A, and isomers), VEGF-B, placental growth factor (PlGF), angiopoietin-2 (Ang-2) and interleukin-6 receptor (IL-6R) for the treatment of diabetic macular edema (DME).
Replay Holdings LLC and The University of Texas MD Anderson Cancer Center report that the FDA has cleared the IND application for PRAME TCR/IL-15 NK (SY-307), an engineered T-cell receptor natural killer (TCR-NK) cell therapy for relapsed/refractory myeloid malignancies.
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