LAVA Therapeutics signed agreement with CATO SMS to conduct its Phase I/IIa trial with T-cell engager LAVA-051 in hematologic malignancies

Utrecht, the Netherlands & Philadelphia, USA and Schiphol, the Netherlands 24 November 2020 – LAVA Therapeutics (“LAVA”) and CATO SMS today announced that CATO SMS is supporting LAVA’s Phase I/IIa open-label trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and antitumor activity of LAVA-051 in patients with relapsed or refractory CD1d-positive chronic lymphocytic leukemia (CLL), multiple myeloma (MM), or acute myeloid leukemia (AML).

LAVA-051 is the lead program from LAVA’s proprietary platform which generates bispecific antibodies that uniquely bind to both the T-cell receptor (TCR) of Vγ9Vδ2 T-cells and antigens that are overexpressed on tumor cells. Gamma delta T-cells activated by LAVA’s drugs directly induce selective, potent killing of tumor cells and the production of proinflammatory cytokines which promote the antitumor activity of other immune cells. LAVA’s approach avoids generalized T-cell activation that can cause substantial toxicities. LAVA-051 is a first-in-class therapy that binds to both the Vγ9Vδ2 TCR and CD1d, which is known to be overexpressed on several hematological malignancies. Based on strong preclinical data, LAVA plans to file a CTA for LAVA-051 by 1Q 2021.

The LAVA-051 Phase I study will be conducted in renowned oncology centers in Europe, including the Netherlands. Site selection is ongoing. Phase I is planned to enroll up to 42 patients across nine sites in Europe. Phase IIa will be expanded to the United States with the goal of having 15 global sites open to enroll another 40 patients at the recommended Phase II dose (RP2D).

LAVA’s CMO Benjamin Winograd, MD, PhD said: “We’re excited to be initiating our first-in-human trial with LAVA-051. We believe that LAVA’s therapeutics have the potential to improve standard of care and patient outcomes across multiple malignancies. We have been impressed by the breath of oncology expertise and professionalism of CATO SMS, and look forward to partnering with them to achieve our clinical milestones.”

Dr. Mark A. Goldberg, MD, Executive Chairman of CATO SMS: “We are delighted that LAVA Therapeutics, an exciting immuno-oncology biotech, selected us to support this innovative global study. The LAVA-051 clinical development program of a next-generation gamma-delta T-cell engager is truly exciting. We eagerly look forward to leveraging the extensive experience and proven resources in our oncology center of excellence to deliver this important program for LAVA and patients around the world.”

LAVA Therapeutics is developing a proprietary T-cell engager therapeutics platform for the treatment of hematological and solid cancers. The company’s first-in-class immuno-oncology approach uses bispecific antibodies that activate Vγ9Vδ2 T-cells upon binding to membrane-expressed tumor targets. LAVA was founded in 2016 based on intellectual property originating from the Amsterdam University Medical Center. The company has established a highly experienced research and development team located in Utrecht, the Netherlands and Philadelphia, USA. For more information, please visit www.lavatherapeutics.com.

Contact info:
Keely Zipp, VP Corporate Development and Portfolio Strategy
k.zipp@lavatherapeutics.com

CATO SMS is a provider of specialized regulatory and clinical research solutions formed by the merger of Cato Research and SMS-oncology in 2019. With more than 30 years of experience focusing on the needs of small and emerging biopharmaceutical companies, CATO SMS effectively designs and executes studies – from strategy to approval – in complex indications and modalities across a variety of therapeutic areas, with a proven center of excellence in oncology. CATO SMS recently acquired Array Biostatistics to expand its offering with highly regarded biostatistical capabilities. Its regulatory, therapeutic and operational expertise enables CATO SMS to meet goals and exceed expectations. Visit www.CATO-SMS.com for more information.

Contact info:
Lindy Bosch, Director Business Development
lindy.bosch@cato-sms.com