LAVA Therapeutics Announces FDA IND Clearance for LAVA-051 for the Treatment of Hematologic Malignancies
12 May 2022 - 09:00PM
LAVA Therapeutics N.V. (Nasdaq: LVTX), a clinical-stage
immuno-oncology company focused on developing its proprietary
Gammabody™ platform of bispecific gamma delta T cell engagers to
transform the treatment of cancer, today announced that the U.S.
Food and Drug Administration (FDA) has cleared its investigational
new drug (IND) application for LAVA-051, the Company’s lead product
candidate for the treatment of relapsed or refractory chronic
lymphocytic leukemia (CLL), multiple myeloma (MM) and acute myeloid
leukemia (AML).
“FDA clearance of our IND application for LAVA-051 marks the
second IND for LAVA and enables us to expand patient enrollment
into the U.S. for our ongoing Phase 1/2a clinical trial,” said
Stephen Hurly, president and chief executive officer of LAVA
Therapeutics. “Supported by encouraging preclinical and preliminary
clinical data, we believe in the potential of LAVA-051 to address
unmet patient needs. We look forward to providing updates at the
2022 ASCO Annual Meeting, where we will present additional interim
data from the dose-escalation phase of this trial.”
The Phase 1/2a clinical trial currently includes patients with
relapsed or refractory CLL and MM. AML patients will be included
later in the study. In October 2021, the FDA granted Orphan Drug
Designation for LAVA-051 for the treatment of CLL.
About LAVA-051LAVA-051 is a humanized
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 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 TherapeuticsLAVA Therapeutics N.V.
is an immuno-oncology company utilizing its proprietary Gammabody™
platform to develop a portfolio of bispecific gamma delta T cell
engagers for the potential treatment of solid and hematological
malignancies. LAVA utilizes bispecific antibodies engineered to
selectively kill cancer cells by triggering Vγ9Vδ2 (Vgamma9
Vdelta2) T cell antitumor effector functions upon cross-linking to
tumor-associated antigens. LAVA-051, LAVA’s lead candidate for the
treatment of multiple myeloma, chronic lymphocytic leukemia and
acute myeloid leukemia, is enrolling patients in a Phase 1/2a
clinical study (NCT04887259). A Phase 1/2a clinical study to
evaluate LAVA-1207 in patients with metastatic castration-resistant
prostate cancer (mCRPC) is also enrolling. For more information,
please visit www.lavatherapeutics.com, and follow us
on LinkedIn, Twitter and YouTube.
LAVA’s Cautionary
Note on
Forward-Looking StatementsThis
press release contains forward-looking statements, including with
respect to the company’s anticipated growth and clinical
development 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
Argot Partners (IR/Media)212-600-1902lava@argotpartners.com
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