A2 Biotherapeutics Inc. has gained IND clearance from the FDA for A2B-543 for the treatment of germline heterozygous HLA-A*02 adults with recurrent unresectable, locally advanced or metastatic solid tumors.
Having nailed down alignment with the U.S. FDA in December on a phase III trial that will start in the middle of this year, Immuneering Corp. updated the overall survival and safety data from an ongoing phase IIa trial testing atebimetinib (IMM-1-104) in combination with modified gemcitabine/nab-paclitaxel in first-line pancreatic cancer patients (n=34), with more than 13 months median follow-up time.
News of Eli Lilly and Co. purchasing Ventyx Biosciences Inc. for $14 per share arrived after market close Jan. 7, following unconfirmed rumors of the buyout that drove shares up by more than 52% at one point.
Tensive Srl reported positive data from its pivotal trial confirming the safety profile of Regenera, its bioabsorbable breast implant, and its potential to transform breast reconstruction. The pivotal trial, evaluating the Regenera in patients undergoing lumpectomy, found it to be safe, biocompatible and feasible for volume replacement in breast-conserving surgery.
Remegen Ltd. has synthesized antibody-drug conjugates consisting of anti-CDCP1 antibodies covalently linked to cytotoxic drugs through linkers reported to be useful for the treatment of cancer.
Glioblastoma (GBM) is the most common and highly aggressive primary brain tumor in adults. MicroRNAs (miRNAs) are pleiotropic post-transcriptional regulators of oncogenic pathways, and frequently lose their tumor-suppressive function in GBM. Researchers from the Istituto Italiano di Tecnologia previously identified a group of 11 pro-neurogenic miRNAs that supports adult neurogenesis by jointly regulating multiple targets in mouse neural stem cells. Writing in Molecular Therapy Nucleic Acids, they present a study where they examined the expression of these 11 miRNAs across glioma grades and GBM subtypes in patients.
Ottimo Pharma Ltd. has obtained IND clearance from the FDA and advanced OTP-01 (jankistomig), an anti-PD-1/VEGFR2 antibody, into phase I for solid tumors. The first patient has been dosed and the study is open at sites in the U.S. and Australia.
Arbele Pte Ltd.’s ARB-1002 has been awarded orphan drug designation by the FDA for the treatment of pancreatic cancer. ARB-1002 is an antibody-drug conjugate comprising an anti-CDH17 monoclonal antibody chemically linked to a potent cytotoxic agent.
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