LAVA Administers First Dose in Phase 1 LAVA-1266 Hematological Cancer Study

LAVA Therapeutics N.V., a clinical-stage company specializing in immuno-oncology, has announced significant progress in the development of its novel treatment for certain hematologic cancers. The company, which operates out of Utrecht, Netherlands, and Philadelphia, has initiated the dosing of the first patient in a Phase 1 trial for LAVA-1266. This innovative therapeutic, part of LAVA's proprietary Gammabody® platform, is being investigated for its potential to treat acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).

LAVA-1266 is a bispecific T cell engager that leverages the body’s immune system to target cancer cells. It is specifically designed to attack CD123+ tumor cells by directing Vγ9Vδ2-T cells, a potent type of immune cell, towards these targets. The treatment aims to effectively destroy cancer cells while minimizing harmful effects on healthy cells. This approach is expected to overcome limitations seen with earlier CD123-targeted therapies, which have faced challenges due to off-tumor toxicity and other side effects.

Stephen Hurly, the President and CEO of LAVA Therapeutics, expressed optimism about the potential of LAVA-1266. The preclinical studies have shown promising results with significant tumor cell destruction and minimal off-target effects. Hurly stated that these initial findings support the potential of LAVA-1266 in treating AML and MDS, and he looked forward to evaluating its safety and efficacy further as the study progresses.

The chief medical officer of LAVA, Charles Morris, also highlighted the advanced preclinical profile of LAVA-1266. He emphasized the importance of targeting CD123 due to its recognition as a viable therapeutic target for AML. Morris revealed that the company is enthusiastic about working with clinical study sites across Australia to further this research.

The ongoing Phase 1 study of LAVA-1266 is a critical step towards understanding its full potential. Conducted in multiple centers across Australia, the study will assess the therapy's safety, pharmacokinetics, and pharmacodynamics among approximately 50 adult patients. These individuals are suffering from CD123+ relapsed or refractory AML and specific grades of MDS. The trial includes a dose escalation phase, starting with an initial target dose of 100 micrograms every two weeks, to identify an optimal dosing strategy.

The primary goal of this study is to evaluate the safety and tolerability of LAVA-1266, as well as its preliminary efficacy in combating cancer cells. The trial will also explore the therapy’s pharmacokinetic and pharmacodynamic properties, including how the drug is absorbed, distributed, metabolized, and excreted by the body.

LAVA Therapeutics is committed to developing its Gammabody® platform, which represents a significant step forward in cancer treatment. The platform is designed to selectively kill cancer cells by activating the Vγ9Vδ2-T cells once they are linked to tumor-associated antigens. This method aims to treat both solid tumors and hematologic malignancies effectively.

The company’s pipeline features multiple bispecific T cell engagers, with LAVA-1266 being one of the key candidates. Alongside this, LAVA is also developing other therapeutics targeting various cancers, including those affecting solid tumors, in collaboration with other pharmaceutical companies. This comprehensive approach underscores LAVA's dedication to advancing cancer treatment and improving patient outcomes.

As the year progresses, LAVA Therapeutics anticipates releasing initial data from the ongoing study. These findings will be crucial in determining the future development and potential approval of LAVA-1266 as a new treatment option for patients with AML and MDS, offering hope for improved outcomes in these challenging conditions.