Kineta Inc, a clinical stage biotechnology company, announced on Tuesday that it has successfully completed a pre-IND (Investigational New Drug) meeting with the US Food and Drug Administration (FDA) for the manufacturing, preclinical and clinical development plan for KVA12.1.
According to the company, it has gained alignment with FDA on the initial Phase 1/2 clinical trial of the safety and efficacy of its KVA12.1 as a single agent and in combination with pembrolizumab in patients with unresectable or metastatic solid tumours.
The firm plans to start the Phase 1/2 first-in-human clinical studies in mid-2022.
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients
Precision Epigenomics partners with TruDiagnostic
Illumina's GRAIL divestment plan receives EC approval
Soligenix receives orphan drug designation from FDA for active ingredient in SuVax
Candel Therapeutics granted FDA Orphan Drug Designation for CAN-2409 in pancreatic cancer treatment
Lipogems completes patient enrolment in ARISE I US FDA IDE study
Amylyx Pharmaceuticals' AMX0035 shows promising impact on Wolfram syndrome symptoms
Ondine Biomedical's Steriwave approved for use by HCA UK
Roche attains CE Mark for first companion diagnostic for HER2-low metastatic breast cancer
Cadrenal Therapeutics' tecarfarin receives US FDA Orphan Drug Designation
BioCity Biopharma's BC2027 Phase one study IND application receives US FDA approval
Seres Therapeutics completes patient enrollment for SER-155 Phase 1B trial
Syros receives Fast Track Designation from FDA for tamibarotene in AML
Ligand Pharmaceuticals announces presentation of Captisol-enabled Topiramate Injection data