LAVA Therapeutics Presents Initial LAVA-051 Clinical Data at the ESMO Targeted Anticancer Therapies Congress 2022
March 07 2022 - 8:35AM
LAVA Therapeutics N.V. (Nasdaq: LVTX), an immuno-oncology company
focused on developing its proprietary Gammabody™ platform of
bispecific gamma delta T cell engagers (bsTCEs) to transform the
treatment of cancer, today announced initial data from its first
clinical study with LAVA-051. LAVA chief scientific officer Hans
van der Vliet, M.D., Ph.D. will deliver the presentation
“Bispecific γδ T cell engagers for the treatment of
cancer” during the Bispecifics and T cell Engagers session in the
Channel 1 virtual room today from 14.35 – 14.55 CET at the ESMO
Targeted Anticancer Therapies Congress 2022. The presentation will
include data from the first three cohorts of the LAVA-051 Phase
1/2a clinical trial along with preclinical data on its two lead
programs, LAVA-051 and LAVA-1207, that illustrate characteristics
of its Gammabody™ platform.
The first three dose-escalation cohorts showed
LAVA-051 to be safe and well tolerated with no dose limiting
toxicities or cytokine release syndrome (CRS) observed. Per the
study protocol, the cohort three dose was 33-times that of the
cohort one dose. Drug exposure and Vγ9Vδ2 T cell receptor
occupancy of LAVA-051 increased with LAVA-051 dose increases and
peripheral blood Vγ9Vδ2 T cells also expressed higher levels
of activation markers after LAVA-051 dosing. One patient with
chronic lymphocytic leukemia (CLL) experienced multiple enlarged
tender diseased lymph nodes one week after first dosing that
subsequently regressed, reminiscent of tumor flare. “We are
encouraged by these initial clinical data for LAVA-051, which
showed that LAVA-051 was well tolerated early in dose escalation
with on-mechanism pharmacodynamics consistent with Vgamma9 Vdelta2
T cell engagement,” said Hans van der Vliet, M.D., Ph.D.
The Phase 1/2a clinical trial currently includes
patients with relapsed or refractory CLL and multiple myeloma (MM).
The first three cohorts enrolled one patient per dose escalation
and future cohorts will enroll at least three patients per cohort.
Acute Myeloid Leukemia (AML) patients will be included later in the
study. Additional data from the dose escalation phase of the trial
is expected in the second quarter of 2022 and from the
disease-specific expansion cohorts in the second half of 2022.
The Phase 1/2a clinical trial for LAVA-051 is
initially being conducted in Europe and LAVA expects to file an
Investigational New Drug (IND) application with the U.S. Food and
Drug Administration (FDA), which, if accepted, will subsequently
include patients in the United States. In October 2021, the FDA
granted orphan drug designation for LAVA-051 for the treatment of
CLL.
About LAVA-051LAVA-051 is a
Gammabody™ designed to activate both Vγ9Vδ2 (Vgamma9 Vdelta2)
T cells and type 1 NKT cells to kill CD1d-expressing tumor cells.
LAVA-051 consists of two humanized single domain antibodies linked
via a short five amino acid glycine-serine linker. One domain
antibody recognizes the Vδ2 chain of the Vγ9Vδ2 T cell
receptor, and the other domain antibody is specific for CD1d, a
glycoprotein involved in the presentation of (glyco)lipid antigens
to distinct T cell populations including type 1 NKT cells, and that
can be expressed on a wide range of hematological malignancies,
including CLL, MM and AML.
About LAVA Therapeutics
LAVA Therapeutics N.V. is an immuno-oncology
company utilizing its proprietary Gammabody™ platform to develop a
portfolio of gamma delta bispecific T cell engagers (bsTCEs) for
the potential treatment of solid tumors and hematological
malignancies. The company’s innovative approach utilizes bispecific
antibodies engineered to selectively kill cancer cells via the
triggering of Vγ9Vδ2 (Vgamma9 Vdelta2) T cell antitumor
effector functions upon their cross-linking to tumor associated
antigens. A Phase 1/2a clinical study evaluating LAVA-051 in
patients with certain hematological malignancies is currently
enrolling (NCT04887259). The company currently anticipates
additional data from the Phase 1 dose escalation phase of the
LAVA-051 study in the second quarter of 2022 and data from the
Phase 2a expansion cohorts in the second half of 2022. A Phase 1/2a
clinical study to evaluate LAVA-1207 in patients with metastatic
castration-resistant prostate cancer (mCRPC) is enrolling with data
from the Phase 1 dose escalation phase of the trial expected in the
second half of 2022 and data from the Phase 2a expansion cohort
expected in the first half of 2023. For more information, please
visit www.lavatherapeutics.com and follow us on
LinkedIn, Twitter and YouTube.
LAVA’s Cautionary Note on Forward-Looking
Statements
This press release contains forward-looking
statements, including in respect of the company’s anticipated
growth and clinical developments plans, including the timing of
clinical trials. Words such as “anticipate,” “believe,” “could,”
“will,” “may,” “expect,” “should,” “plan,” “intend,” “estimate,”
“potential” and similar expressions (as well as other words or
expressions referencing future events, conditions or circumstances)
are intended to identify forward-looking statements. These
forward-looking statements are based on LAVA’s expectations and
assumptions as of the date of this press release and are subject to
various risks and uncertainties that may cause actual results to
differ materially from these forward-looking statements.
Forward-looking statements contained in this press release include,
but are not limited to, statements about the preclinical data,
clinical development and scope of clinical trials, and the
potential use of our product candidates to treat various tumor
targets. Many factors, risks and uncertainties may cause
differences between current expectations and actual results
including, among other things, the timing and results of our
research and development programs and preclinical and clinical
trials, our ability to obtain regulatory approval for and
commercialize our product candidates, our ability to leverage our
initial programs to develop additional product candidates using our
Gammabody™ platform, and the failure of LAVA’s collaborators to
support or advance collaborations or our product candidates. In
addition, the COVID-19 pandemic may disrupt our business and that
of the third parties on which we depend, including delaying or
otherwise disrupting our clinical trials and preclinical studies,
manufacturing and supply chain, or impairing employee productivity.
LAVA assumes no obligation to update any forward-looking statements
contained herein to reflect any change in expectations, even as new
information becomes available.
CONTACTSEdward SmithChief Financial
Officerir@lavatherapeutics.com
Catherine
Day+1-917-763-2709catherine@newdaybioconsulting.com
LAVA Therapeutics NV (NASDAQ:LVTX)
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