LAVA Therapeutics Highlights Encouraging Clinical Updates on Lead Program, LAVA-051, in Chronic Lymphocytic Leukemia and Multiple Myeloma Patients
17 June 2022 - 6:05AM
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, hosted a clinical update call
focused on encouraging initial Phase 1/2a clinical data for
LAVA-051 in patients with chronic lymphocytic leukemia (CLL) and
multiple myeloma (MM) patients following poster presentations at
the 2022 American Society of Clinical Oncology (ASCO) Annual
Meeting held June 3-7, 2022, and the European Hematology
Association (EHA) 2022 Congress, held June 9-12, 2022.
“While treatment options for hematologic
malignancies such as CLL and MM have advanced in recent years, a
large number of patients who do not respond adequately to current
therapies need new options,” 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. “Although
preliminary, these data support our view of LAVA-051 as a promising
therapeutic candidate that has the potential to overcome challenges
of existing T-cell approaches which frequently show cytokine
release syndrome very close to their efficacious dose. The early
clinical data from the first four cohorts presented at this year’s
ASCO and EHA meetings demonstrate early signals of potential
anti-tumor activity in CLL and MM patients, as well as an
attractive safety profile. Importantly, the pharmacodynamic
determinations gathered from the patients in this early clinical
study reflect the mechanism of action of LAVA-051.”
LAVA’s chief scientific officer, Hans van der
Vliet, M.D., Ph.D., and Benjamin Winograd, M.D., Ph.D., chief
medical officer, reviewed LAVA-051’s mechanism of action (MOA) and
clinical trial design and objectives on the call.
Dr. van der Vliet remarked, “LAVA-051 has been
designed to target CD1d, which is expressed on tumors cells in a
high proportion of patients with CLL, MM and acute myeloid leukemia
(AML), and to selectively activate the strong antitumor properties
of both Vγ9Vδ2 (Vgamma9 Vdelta2) T cells and type 1 NKT cells.
Based on extensive preclinical work, we believe our approach has
the potential to lead to substantial improvement for
patients.”
In the Phase 1/2a clinical study of LAVA-051 in
patients with CLL and MM, the primary objectives are to investigate
safety and tolerability and determine the recommended Phase 2 dose,
while the secondary objectives are to evaluate pharmacokinetics,
pharmacodynamics, immunogenicity and preliminary anti-tumor
activity. Following intravenous dosing, subcutaneous dosing will
also be evaluated. AML patients will be included later in the
study.
Dr. Winograd commented, “The LAVA Therapeutics
team is intent on transforming treatment for people living with
cancer with our Gammabody platform drug candidates. We are
encouraged by the early Phase 1/2a clinical data for LAVA-051 as we
enroll patients for additional dose-finding cohorts in Europe and
the U.S., and we look forward to providing additional clinical data
updates in 2022.”
This event follows the Company’s presentation of
new early clinical data during poster presentations at the 2022
ASCO Annual Meeting and the EHA 2022 Congress. The ASCO and EHA
posters can be found here and here, respectively.
A replay of the presentation is accessible on
the “Events” tab on the Investor Relations section of the LAVA
Therapeutics website and will be archived for at least 30 days at:
https://ir.lavatherapeutics.com/news-events/events.
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
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