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Tucked into the 4,155-page, $1.7 trillion spending bill for fiscal 2023 that U.S. President Joe Biden signed into law Dec. 23 is a small provision that may have outsized impact on future biosimilar and other drug development. Championed by lawmakers on both sides of the political spectrum, the provision modernizes the data that can be used to support drug development, including alternatives to animal studies.
Transcode Therapeutics Inc. has received clearance from the FDA to proceed with a first-in-human phase 0 trial of TTX-MC138 in cancer patients with advanced solid tumors. A single dose of radiolabeled TTX-MC138 will be followed by noninvasive PET-MRI to quantify the amount of radiolabeled TTX-MC138 delivered to metastatic lesions.
Janux Therapeutics Inc. has announced that it has submitted an IND application to the FDA for JANX-008, an epidermal growth factor receptor (EGFR)-tumor-activated T cell engager (TRACTr) in development for the treatment of EGFR-expressing solid tumors, including non-small-cell lung cancer (NSCLC), colorectal cancer (CRC), renal cell carcinoma (RCC), and squamous cell carcinoma of the head and neck (SCCHN).
Deka Biosciences Inc. has submitted an IND application to the FDA for its lead oncology asset, DK2-10 (EGFR). DK2-10 (EGFR) is the first of many experimental therapeutics developed as part of Deka’s platform of molecules, with each Diakine in Deka's platform consisting of two complementary cytokines coupled together via attachment to a single chain variable fragment, enabling the cytokines to accumulate more specifically in targeted tissues.
Mindrank Ltd. has received clearance of its IND application by the FDA for MDR-001, a small-molecule glucagon-like peptide 1 (GLP-1) receptor agonist, which was discovered using the company’s proprietary artificial intelligence (AI) platform, Molecule Pro.
The FDA has cleared an IND for a clinical trial in the U.S. of NBL-020, a fully human antibody drug independently developed by CSPC Pharmaceutical Group Ltd.'s subsidiary Novarock Biotherapeutics Ltd., for the treatment of advanced solid tumors.
Neurophth Therapeutics Inc. has received FDA clearance of its IND application for the in vivo gene replacement therapy NFS-02, a novel recombinant adeno-associated viral serotype 2 vector (rAAV2) containing a codon-optimized NADH-dehydrogenase subunit 1 (ND1) gene, for the treatment of Leber hereditary optic neuropathy (LHON) associated with ND1 mutation.
Invectys Inc. and CTMC, a joint venture between MD Anderson Cancer Center and National Resilience Inc., have announced FDA clearance of an IND application for a phase I/IIa study of IVS-3001, Invectys' lead engineered human leukocyte antigen A (HLA-G)-targeting chimeric antigen receptor (CAR) T-cell therapy for the treatment of solid tumors.
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