LAVA Therapeutics Announces Updated Data from the Phase 1/2a Clinical Trial of LAVA-051 at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition
December 10 2022 - 10:00AM
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 a poster
presentation highlighting updated data, including safety,
pharmacodynamics (PD) and pharmacokinetics (PK) from the ongoing
Phase 1/2a clinical trial of LAVA-051 in patients with
relapsing/refractory (R/R) chronic lymphocytic leukemia (CLL) and
multiple myeloma (MM) at the 64th American Society of Hematology
(ASH) Annual Meeting and Exposition, taking place in New Orleans,
Louisiana and virtually December 10–13, 2022. The presentation
includes initial data from patients receiving LAVA-051
subcutaneously, along with updates on the intravenous
dosing-cohorts.
“To date, the Phase 1 data, as presented, showed that dose
escalation of LAVA-051 up to 200 µg could be achieved in patients
with R/R MM and CLL without evidence of dose-limiting toxicity and
cytokine release syndrome (CRS). Often, such toxicities are a
significant safety challenge for T-cell engager therapies,” said
Arnon Kater, M.D., Ph.D., chairman of the Dutch/Belgium HOVON CLL
working group and professor of translational hematology at the
Amsterdam University Medical Center, and LAVA-051 clinical trial
investigator. “I am pleased that this first clinical study with a
gamma delta T-cell engager has progressed into more relevant dose
levels.” In the phase 1/2a study of LAVA-051 in patients with
relapsed/ refractory (R/R) CLL, MM and AML (NCT04887259), the
primary objectives are to investigate safety and tolerability of
LAVA-051 and determine the recommended Phase 2 dose (RP2D) of
LAVA-051. The secondary objectives include evaluation of PK, PD,
immunogenicity, and preliminary anti-tumor activity.
In addition to the favorable safety profile demonstrated as of
the data cutoff (November 11, 2022), LAVA-051 showed predictable
and linear pharmacokinetics and on-mechanism pharmacodynamic
parameters consistent with Vγ9Vδ2-T cell engagement, including
increasing occupancy of patient Vγ9Vδ2-T cells with LAVA-051 and
consistent increases in the expression of T-cell activation
markers. Moreover, potential signs of clinical activity of LAVA-051
were seen.
“The LAVA Therapeutics team is committed to transforming
treatment for people living with cancer,” said Stephen Hurly,
president and chief executive officer of LAVA Therapeutics. “We are
pleased with the encouraging findings so far from this clinical
trial and dose escalation is continuing in the US and EU. I am
excited about the potential of LAVA-051 as a novel therapy that may
overcome the challenges associated with current T cell-engager
approaches.”
Details of the poster presentation session are as follows:
Abstract #: 2014Abstract
Title: LAVA-051, a Novel Bispecific Gamma-Delta
T-Cell Engager (Gammabody™), in Relapsed/Refractory MM and CLL:
Pharmacodynamic and Early Clinical DataSession
Name: Cellular Immunotherapies: Early Phase and
Investigational Therapies: Poster ISession #:
704Session Date: Saturday, December 10,
2022Session Time: 5:30 p.m.–7:30 p.m.
CTPresenter: Arnon P. Kater, M.D., Ph.D., chairman
of the Dutch/Belgium HOVON CLL working group and professor of
translational hematology at the Amsterdam University Medical
Center
A PDF copy of the presentation is available here.
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, that can be expressed on a
wide range of hematologic malignancies, including chronic
lymphocytic leukemia, multiple myeloma, and acute myeloid
leukemia.
About LAVA TherapeuticsLAVA Therapeutics N.V.
is a clinical-stage 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 hematologic malignancies. The Company 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, the Company’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 (NCT05369000). 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. 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.
In addition, there may be adverse effects on our business condition
and results from general economic and market conditions and overall
fluctuations in the United States and international equity markets,
including deteriorating market conditions due to investor concerns
regarding inflation and hostilities between Russia and Ukraine.
LAVA assumes no obligation to update any forward-looking statements
contained herein to reflect any change in expectations, even as new
information becomes available.
CONTACTSInvestor
Relationsir@lavatherapeutics.com
Argot Partners
(IR/Media)212-600-1902lava@argotpartners.com
LAVA Therapeutics NV (NASDAQ:LVTX)
Historical Stock Chart
From Sep 2024 to Oct 2024
LAVA Therapeutics NV (NASDAQ:LVTX)
Historical Stock Chart
From Oct 2023 to Oct 2024