BVX001 / BiVictriX Therap - LARVOL DELTA

BVX001, a Bispecific ADC Targeting CD7-Positive AML with Favorable Toxicity Profile, Exhibits Significant Efficacy in Primary Patient Samples and PDX-Models (ASH 2024) - "In contrast, Mylotarg® causes a potentially fatal reduction of healthy neutrophils after single dose (0.3mg/kg), linked to one of the leading causes of death in AML patients in the clinic...BVX001 exhibited superior platform toxicity profile cf approved ADC using same conjugation/linker / payload (Blenrep™ - MTDrat 20mg/kg mass difference adjusted) with a therapeutic window >35 compared to 14.5 for Blenrep™. In conclusion, BVX001 – a First-in-Class bispecific ADC showed propitious efficacy and favorable safety profile, further supporting its potential as a therapeutic option for CD7-positive AML. The data presented here significantly strengthens the preclinical data package for BVX001, informing clinical dose selection and supporting progression to final IND-enabling studies and towards clinical studies."

Clinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • CD7 • FLT3 • PTPRC

A bispecific antibody-drug conjugate targeting CD7 and CD33 shows anti-tumor activity and improved tumor selectivity in an aggressive subtype of acute myeloid leukemia. (PubMed, MAbs) - "Finally, BVX001 showed significant blast ablation and reduced leukemic stem cell frequency in AML patient samples with both high and low target co-expression. Together, our findings support BVX001 as a new and promising approach for the treatment of this aggressive CD33+CD7+ AML subtype, currently lacking targeted therapeutic options."

Journal • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • CD33 • CD7

BiVictriX Therapeutics AML treatment granted orphan drug status by FDA (Proactiveinvestors) - "BiVictriX Therapeutics PLC...told investors that the US Food and Drug Administration (FDA) has granted an Orphan Drug Designation to BVX001, the company’s potential treatment for Acute Myeloid Leukemia...Additionally, the company said it has successfully concluded an Initial Targeted Engagement for Regulatory Advice (INTERACT) meeting with the FDA, which gave favourable guidance aligning with BiVictriX’s developmental strategy for BVX001...'We continue to advance our preclinical data package for BVX001, with plans to submit a pre-IND application, and to present further efficacy and safety data at a key Haematology Conference in the second half of 2024.'"

Orphan drug • Preclinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

BiVictriX says latest preclincial leukaemia data could accelerate progress (Proactiveinvestors) - "BiVictriX Therapeutics PLC...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)...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....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."

Preclinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

BiVictriX's Investigational Blood Cancer Drug Shows Efficacy in Preclinical Study (Market Screener) - "BiVictriX Therapeutics (BVX.L) said Monday that its experimental antibody drug BVX001 significantly shrank tumors in a murine model of acute myeloid leukemia, citing early data from an in vivo efficacy trial. The ongoing preclinical study is evaluating BVX001 in a 10 milligram per kilogram dose, administered twice a week. Initial data showed that BVX001 reduced tumor size by 89% within an 18-day treatment period. The trial is set for completion before the end of June."

Preclinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

BiVictriX announces positive data from leukemia study (Labiotech.eu) - "BVX001 was reported to be well-tolerated and showed a highly favorable safety profile across two doses of BVX001 (0.3 mg/kg and 3 mg/kg), compared with the reported maximum tolerated dose of GO (0.3 mg/kg) in a CD34-boosted humanized murine model. The results showed that the proportion of healthy human CD33 myeloid cells in the bone marrow was significantly lower with GO compared to BVX001 at both an equivalent dose to GO (0.3mg/kg) and a 10-fold higher dose (3mg/kg), at seven- and 14-days post-injection."

Preclinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology