LAVA Therapeutics to Present Initial Phase 1/2a Clinical Trial Dose Escalation Data of LAVA-051 in Chronic Lymphocytic Leukemia and Multiple Myeloma Patients at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting
01 June 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 the presentation
of initial dose-escalation data from the Phase 1/2a clinical trial
of LAVA-051 in patients with chronic lymphocytic leukemia (CLL) and
multiple myeloma (MM) at the 2022 American Society of Clinical
Oncology (ASCO) Annual Meeting taking place in Chicago and
virtually June 3-7, 2022.
“These dose-escalation data from the first four cohorts of our
Phase 1/2a clinical trial demonstrate a favorable safety profile to
date and early encouraging signs of potential anti-tumor activity
of LAVA-051, as well as a desirable pharmacokinetic and
pharmacodynamic profile, in patients with chronic lymphocytic
leukemia and multiple myeloma. Importantly, while reaching 100
times the starting dose, LAVA-051 was well-tolerated without
observing dose-limiting toxicity and without incurring any cytokine
release syndrome, a 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, LAVA-051 clinical trial
investigator and lead author of the ASCO abstract. “We are pleased
with these initial data as we continue to enroll patients for
additional cohorts in our trial.”
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. Acute myeloid leukemia (AML) patients will be included
later in the study.
In addition to the favorable safety profile demonstrated to
date, LAVA-051 showed predictable and linear pharmacokinetics and
on-mechanism pharmacodynamic parameters consistent with Vγ9Vδ2-T
cell engagement, including increasing occupancy of LAVA-051 on
patient Vγ9Vδ2-T cells and consistent increases in the expression
of T-cell activation markers. In these initial data, potential
signs of clinical anti-tumor activity were also observed: a CLL
patient experienced early enlargement and tenderness of several
CLL-affected lymph nodes followed by a regression of those lymph
nodes, resulting in a stable disease assessment after 12 weeks of
therapy in combination with a reduction in the peripheral blood
leukemic cell count over five cycles of LAVA-051; a MM patient
showed a 23% reduction in myeloma cell-produced M-protein levels in
the blood.
“These clinical data from the LAVA-051 study in patients with
therapy-refractory CLL and MM, supported by comprehensive
preclinical data, strengthen our expectation that targeting
Vγ9Vδ2 T cells using our Gammabody™ platform has the potential
to trigger anti-tumor responses in patients within a favorable
safety profile,” said Stephen Hurly, president and chief executive
officer of LAVA Therapeutics. “We are also encouraged by the
potential signs of anti-tumor activity occurring this early during
the dose escalation. We anticipate the release of additional
clinical data in 2022 and initial Phase 2a expansion cohort data in
the first half 2023.”
Details for the ASCO 2022 presentation
are as follows:
Poster #: 2577Poster
Title: Phase I dose escalation of LAVA-051, a novel
bispecific gamma delta T-cell engager (Gammabody™), in
relapsed/refractory hematological malignanciesSession
Title: Developmental Therapeutics —
ImmunotherapySession Date: Sunday, June 5,
2022Session Time: 9 a.m.–12 p.m. EDT/8–11
a.m. CESTPresenter: Arnon Kater, M.D., Ph.D.
Conference Call InformationLAVA Therapeutics
management will host a conference call to review and discuss data
presented at ASCO on June 16 at 8:00 a.m. EDT/2:00 p.m.
CEST. Analysts and investors are invited to participate in the
conference call by dialing 1-877-270-2148 from
the U.S. and Canada or 1-412-902-6510
internationally and asking to be joined into the LAVA Therapeutics
call. The live webcast can be accessed under the "Events" tab on
the investor relations section of the LAVA Therapeutics website
at: https://ir.lavatherapeutics.com/news-events/events. A
replay of the webcast will be available on LAVA’s website
approximately two hours after the completion of the event and will
be archived for at least 30 days.
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 is 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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