LAVA Therapeutics Announces Treatment of First Patient in Phase 1/2a Clinical Trial of LAVA-1207 for Metastatic Castration-Resistant Prostate Cancer
February 01 2022 - 6:30AM
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 dosing of the first patient in
the company’s Phase 1/2a clinical trial of LAVA-1207 in patients
with metastatic castration-resistant prostate cancer (mCRPC).
LAVA-1207 is a Gammabody™ that targets the prostate-specific
membrane antigen (PSMA) and has demonstrated preclinical
proof-of-concept driving antitumor responses in a variety of
prostate cancer models.
“The dosing of the first patient with LAVA-1207
is an important step toward unlocking the therapeutic potential of
our Gammabody™ platform that pairs potent and selective tumor cell
killing with an anticipated low risk for on-target/off-tumor
toxicity and cytokine release syndrome. This can potentially
translate into improved anti-cancer therapeutics with a wider
therapeutic window. Our off-the-shelf GammabodyTM, LAVA-1207, has
preclinically demonstrated dose dependent, potent and selective
anti-cancer activity against PSMA-expressing tumors through the
triggering of gamma delta T cell-mediated immunity,” said Benjamin
Winograd, M.D., Ph.D., chief medical officer, LAVA Therapeutics.
“Despite current treatment options for prostate cancer, there is an
unmet need for the many patients who experience relapse or become
refractory to existing therapies.”
“Bispecific gamma delta T cell engaging
therapies have the potential to bring novel immunotherapy
approaches to those tumors that have not benefitted from the
advancement of other immunotherapies. We are thrilled to work with
LAVA and initiate a trial of LAVA-1207 for mCRPC,” said Martijn
Lolkema, M.D., Ph.D., medical oncologist, Erasmus MC Cancer
Institute, Rotterdam, The Netherlands and one of the study’s
principal investigators. “I am delighted the Erasmus MC Cancer
Institute is participating in this important study and to have the
first patient treated.”
The open-label, multi-center, Phase 1/2a
clinical trial will evaluate safety, tolerability,
pharmacokinetics, pharmacodynamics, immunogenicity and preliminary
antitumor activity of LAVA-1207 in patients with mCRPC. The Phase 1
dose-escalation portion of the study will determine the optimal
Phase 2 dose to be used in the subsequent Phase 2a expansion
cohort. The Phase 1/2a clinical trial for LAVA-1207 was initiated
in Europe and will subsequently expand to enroll patients in the
United States.
“This is a major milestone for LAVA,” said
Stephen Hurly, president and chief executive officer, LAVA
Therapeutics. “Solid tumors have presented a significant challenge
for prior T cell engager efforts. Based on the compelling
preclinical data of LAVA-1207 in prostate cancer, we believe our
Gammabody™ platform has the potential to provide effective
treatment options for patients with mCRPC, the second leading cause
of cancer-related death among men. We are pleased to have treated
the first patient and look forward to continuing to progress the
trial."
About
LAVA-1207LAVA-1207 is a GammabodyTM that
conditionally activates Vγ9Vδ2 (Vgamma9 Vdelta2) T cells upon
crosslinking to PSMA to trigger the potent and preferential killing
of PSMA positive tumor cells. LAVA- 1207 is a bispecific antibody
of 78 kDa, comprising two heavy chains, each consisting of a
humanized VHH domain antibody and a human IgG1 modified hinge
region, CH2 and CH3 domain.
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 (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 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 data
from the Phase 1 dose escalation phase of the LAVA-051 study in the
first half of 2022 with top line clinical data from the Phase 2a
expansion cohorts expected 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. 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 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
GammabodyTM 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.
CONTACTEdward SmithChief Financial
Officerir@lavatherapeutics.com
Catherine
Day+1-917-763-2709catherine@newdaybioconsulting.com
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