UTRECHT - LAVA Therapeutics N.V. (NASDAQ: LVTX), a micro-cap immuno-oncology company with a market capitalization of $26.82 million, has announced the commencement of a Phase 1 clinical trial for LAVA-1266, its investigational agent aimed at treating hematologic cancers such as acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The first patient has been dosed in this first-in-human study. According to InvestingPro data, the company's stock has declined 46.6% over the past six months, though it maintains a strong financial health rating.
LAVA-1266 is a bispecific T cell engager (bsTCE) that targets CD123+ tumor cells. It is part of the company's proprietary Gammabody® platform, which is designed to engage gamma delta T cells in the fight against cancer. Preclinical studies have shown that LAVA-1266 can target and kill CD123+ tumor cells while activating Vγ9Vδ2-T cells, a subtype of T cells known for their anti-tumor properties. InvestingPro analysis reveals the company holds more cash than debt on its balance sheet, with a healthy current ratio of 5.36, indicating strong short-term liquidity to support its clinical development programs.
The open-label, multi-center trial is being conducted in Australia and aims to enroll approximately 50 adults with CD123+ relapsed/refractory AML and certain grades of MDS. The study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary anti-tumor activity of the drug. The initial target dose for the first cohort is 100 µg, administered every two weeks.
Stephen Hurly, President and CEO of LAVA Therapeutics, expressed optimism about the potential of LAVA-1266, citing positive preclinical results that showed limited off-target effects. Charles Morris, MD, and Chief Medical (TASE:PMCN) Officer of the company, highlighted the limitations of earlier generations of CD123-targeted therapies and the promising profile of LAVA-1266.
The company anticipates providing initial results from the dose escalation study by the end of 2025, with its next earnings update scheduled for March 20, 2025. This trial marks a significant step in LAVA Therapeutics' efforts to develop new treatments for patients with hematologic malignancies. The company's pipeline includes several other clinical-stage bispecific gamma-delta T cell engagers targeting different cancer types. For deeper insights into LAVA Therapeutics' financial health and growth prospects, investors can access additional ProTips and comprehensive analysis through InvestingPro, which offers exclusive metrics and expert research reports.
This news is based on a press release statement from LAVA Therapeutics N.V. and includes no endorsement of the claims. The information presented is subject to the inherent uncertainties of clinical trial outcomes and the development of pharmaceutical treatments.
In other recent news, Lava Therapeutics NV has experienced significant developments. The company announced the discontinuation of its LAVA-1207 program, which was in Phase 1 development for treating metastatic castration-resistant prostate cancer. This decision led to a series of analyst downgrades, with H.C. Wainwright, Leerink Partners, and JMP Securities all reducing their ratings, yet maintaining confidence in Lava Therapeutics' remaining pipeline.
The company has been adjusting its financial model, removing projected revenues from LAVA-1207 and incorporating revenues related to LAVA-1266 for relapsed/refractory acute myeloid leukemia. Furthermore, the expected launch of LAVA-1223 has been delayed to the first quarter of 2030, and the probability of its launch has been increased to around 20%.
Despite the halt of LAVA-1207, Lava Therapeutics is proceeding with the Phase 1 trial of another asset, LAVA-1266. The company reported a cash position of $78.9 million in its third-quarter results for 2024. These are recent developments that reflect the company's strategic shift and the dynamic nature of the biotech industry.
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