BiVictriX Therapeutics PLC (AIM:BVX, OTC:BVTXF) made significant operational progress in the year's first half as researchers working on its lead candidate delivered positive preclinical safety and efficacy data.
Additionally, the group also had its first interaction with regulators at the US Food & Drug Administration.
BiVictriX is a pioneer in what's known as bispecific antibody-drug conjugates (Bi-Cygni ADCs), designed to be highly selective and potent while reducing treatment-related toxicities.
The safety and efficacy data mentioned above was for BVX001 and supports its advancement into clinical trials.
This read-out compared favourably to approved antibody-drug conjugates with similar linkers and cytotoxic payloads, aiding in the selection of clinical doses before final studies.
BVX001 has also received Orphan Drug Designation from the FDA for treating acute myeloid leukemia (AML), offering both commercial and regulatory advantages.
During the period, the company had a successful INTERACT meeting with the FDA, providing a clear path for submitting an investigational new drug (IND) application for BVX001.
Additionally, BiVictriX received a grant from Innovate UK, which will accelerate the development of its second drug candidate, BVX002, targeting solid tumours.
BiVictriX has also expanded its target discovery platform, identifying Bi-Cygni target pairs in over ten different cancer types, including lung, breast, and bladder cancer.
"In the first half of the year, BiVictriX has continued to execute on its strategy of discovering and developing novel, potentially best-in-class bispecific ADCs targeting multiple cancer types," said CEO Tiffany Thorn.
In common with most drug discovery companies, BiVictriX was loss-making for the six months ended June 30 - to the tune of £1.3 million.
More importantly, it exited the period with £1.7 million in the bank.