BiVictriX Therapeutics PLC (AIM:BVX, OTC:BVTXF) has received positive final results from the second in vivo efficacy study of its lead clinical cancer treatment candidate BVX001
BVX001 uses BiVictriX’s proprietary Bi-Cygni antibody-drug conjugate to treat Acute Myeloid Leukaemia (AML).
The objective of this latest 28-day study, conducted in a murine model of AML, was to assess the anti-tumour responses of BVX001 at a dose of 10miligrams per kilogram, twice weekly, in a more challenging setting where tumours were established at a large size.
Final data at day 28 showed that BVX001 induced highly statistically significant tumour regressions of 97% following administration of all eight scheduled doses of BVX001.
An animal group dosed with the vehicle only was used as a negative control in the study.
These final results build upon the interim preclinical efficacy data announced on June 19, 2023, which demonstrated highly statistically significant tumour regressions for BVX001 of up to 89% at day 18, following six out of the total eight planned doses of BVX001.
"This is very encouraging data, as many anti-cancer agents perform less favourably in larger tumours, due to reduced drug penetration,” said Tiffany Thorn, chief executive of BiVictriX in a statement.
“These strong results demonstrate that BVX001 retains its potent anti-tumour activity even in a more difficult setting, whilst showcasing the effectiveness of our Bi-Cygni approach.
“These results will form part of the comprehensive preclinical data package that we are building to pave the way for advancing BVX001 into human trials," he added.
BiVictriX also announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance to issue a patent which provides broad protection for the company's lead asset, BVX001, in the US.
The company is also in the process of securing intellectual property protection in a further seven global territories to provide broad protection for BVX001 across all relevant markets.