June 16, 2023 Source: drugdu 116
By Connor Lynch
Pictured: Person holding a cell phone in front of computer with stock data/iStock
Just two days after releasing late-breaking Phase I/II data for one of its flagship drugs, biopharma Kura Oncology on Tuesday announced plans for a $100 million underwritten public offering.
The company intends to use the public offering to fund the development of its three candidate drugs, in invest pipeline research and development, and provide a source of general working capital.
According to first-quarter 2023 financial results, Kura has roughly $406 million in cash, cash equivalents and investments, which the company expects will fund current operations until the fourth quarter of 2025. The pre-market share value slipped by 8.1% to $11.7 after the public offering.
The offering’s bookrunning managers are BofA Securities, Jefferies and SVB Securities. The lead managers are Cantor and BTIG, while JMP Securities—a Citizens Company—and H.C. Wainwright, are the co-managers.
The announcement comes on the heels of a late-breaking oral session of the 2023 European Hematology Association’s Annual Congress on June 11, where the company presented updated clinical and pre-clinical data on ziftomenib, a selective menin inhibitor designed for the treatment of mixed-lineage leukemias.
The data, gathered as of April 12, 2023, showed 7 of the 20 patients, or 35%, treated with ziftomenib at the recommended Phase II dose of 600 mg achieved complete remission with full count recovery. In addition, a third of patients with FLT3 mutations and half of patients with IDH co-mutations also achieved full recovery (two and four patients, respectively).
The company currently has three drugs in development, which all target cancer-signaling pathways.
The first is ziftomenib, which blocks the interaction between the proteins encoded by the lysine K-specific methyl transferase 2A gene, also known currently as the KMT2A gene and formerly as the mixed-lineage 1 leukemia 1 gene, and the protein menin. This drug is currently undergoing Phase II studies as well as combination studies with other drugs including gilteritinib, fludarabine, cytarabine, granulocyte-colony stimulating factor, idarubicin, and low-dose cytarabine, according to the SEC filing.
Kura is also studying tipifarnib, a farnesyl transferase inhibitor, and KO-2806, a next-generation farnesyl transferase inhibitor.
Tipifarnib is currently undergoing a Phase I/II trial where it is being used in combination with alpelisib to treat PIK3CA-dependent head and neck squamous cell carcinoma, based on a preliminary proof of concept reported last year. KO-2806 is expected to undergo its first in-human trials, a Phase I dose-escalation trial, in the second half of 2023, having received FDA approval in January to test the drug in solid tumors.
Reference: https://www.biospace.com/
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