BiVictriX Therapeutics PLC (AIM:BVX, OTC:BVTXF) said its Bi-Cygni antibody-drug conjugate, BVX001, has shown a 126% increase in survival rates in a pre-clinical model of acute myeloid leukaemia (AML).
This announcement builds upon previously reported positive efficacy data, which demonstrated up to 97% tumour regression.
Importantly, these latest findings bolster the preclinical data package for BVX001, thereby accelerating its progress towards investigational new drug (IND)-enabling studies and clinical trials.
Researchers compared BVX001 with HiDAC, the highest accepted dose of the clinically approved AML chemotherapy drug Cytarabine (Ara C). The latter is administered only to the most robust patients due to its extreme toxicity. The research also included an untreated control group for comparison.
After a 28-day dosing period, the median survival rate for the BVX001 treatment group was found to be 129 days, compared to 91 days for the HiDAC group and 57 days for the untreated control group.
These results translate to a median survival advantage of 126% for BVX001 against the untreated control group and a 42% advantage over HiDAC.
The pre-clinical model used for this study represents a more challenging form of AML than typically found in clinical settings.
It included a greater number of cells capable of driving cancer progression, as opposed to the limited number of specialised driver cells — known as Leukaemia Initiating Cells (LICs) or Leukaemia Stem Cells (LSCs) — commonly found in AML patients.
The data significantly strengthens the case for BVX001, making it a promising candidate for future clinical studies and potential treatment for AML.
"Acute myeloid leukaemia remains a significant unmet medical need, linked to one of the poorest overall survival rates across all cancers," said BiVictriX chief executive Tiffany Thorn.
"All currently approved AML therapies are associated with severely toxic side effects, including potentially fatal infections and sepsis, limiting their use to younger, fitter patients.
"We are greatly encouraged by this recent pre-clinical data, demonstrating that BVX001 provides clear survival benefits, even in this challenging AML model.
"This data adds further strength to our existing and comprehensive pre-clinical data package, as we accelerate work towards obtaining regulatory approval to support the progression of BVX001 into human trials."