LAVA Therapeutics Presents Preclinical Data on its Gammabody™ T Cell Engager Platform at the 21st Annual PepTalk Conference
19 January 2022 - 12:30AM
LAVA Therapeutics N.V. (Nasdaq: LVTX), a clinical-stage
biotechnology company focused on developing its proprietary
Gammabody™ platform of bispecific gamma delta T cell engagers
(gamma delta bsTCEs) to transform the treatment of cancer, today
announced it will present preclinical data on its
Gammabody™ platform and data on its lead solid tumor
Gammabody™ LAVA-1207. The presentation will also include new
non-human primate data with a fully cross-reactive gamma delta
bsTCE utilizing a surrogate Fc-containing Gammabody™ format to
assess the safety of its most advanced solid tumor programs,
LAVA-1207 and LAVA-1223. Paul W.H.I. Parren, Ph.D., executive vice
president, head of research and development, will present these
data at the 21st Annual PepTalk Conference today, Tuesday, Jan. 18,
2022 from 5:00 – 5:30 p.m. PST in the Sapphire Session Room in San
Diego. The presentation will be available on the conference website
for viewing during and after the meeting.
In preclinical experiments, LAVA-1207 has shown
the ability to activate Vγ9Vδ2 (Vgamma9 Vdelta2) T cells to
exert cytotoxicity toward PSMA (prostate specific membrane
antigen)-expressing tumor cells at picomolar concentrations. Using
prostate cancer patient samples, LAVA-1207 activated
autologous Vγ9Vδ2 T cells and triggered lysis of tumor cells,
while sparing normal prostate tissue. The mechanism of preferential
tumor cell killing may be due to a demonstrated overexpression of a
range of Vγ9Vδ2 T cell ligands on tumor cells. A
first-in-human Phase 1/2a open-label trial to evaluate the safety,
tolerability, pharmacokinetics, pharmacodynamics, immunogenicity
and antitumor activity of LAVA-1207 in patients with therapy
refractory metastatic castration-resistant prostate cancer (mCRPC)
is currently recruiting.
“We are grateful for the opportunity to discuss
both our Gammabody™ technology and our first clinical-stage
solid tumor program, LAVA-1207, at the PepTalk Conference,” said
Dr. Parren. “We believe our preclinical dataset for LAVA-1207 is
highly encouraging; showing potent and precise killing of
PSMA-expressing tumor cells, most importantly including those
obtained from patients.”
In addition, data from the non-human primate
study showed an EGFR (epidermal growth factor receptor)-targeted
surrogate Gammabody™ to be safe and well-tolerated in non-human
primates. The EGFR Gammabody™ was administered at doses up to 23
mg/kg leading to high sustained plasma levels and dose-dependent
accumulation in relevant tissues with no safety-related effects and
no signs of cytokine release syndrome (CRS). LAVA’s clinical stage
PSMA Gammabody™, LAVA-1207, is an Fc-containing Gammabody™ for
which pre-clinical data from in vitro, ex vivo and in vivo models
will also be presented.
“Solid tumors have proven an especially
difficult challenge for CD3-based T cell engagers. First generation
T cell engagers have shown a relatively high risk for CRS-related
toxicities,” said Dr Parren. “Our Gammabody™ platform continues to
show data supporting a larger therapeutic window with potent
anti-tumor activity and a low risk of CRS and on-target/off-tumor
toxicity – meaning a greater potential for achieving optimal
dosing.”
In the non-human primate study, animals were
administered weekly intravenous doses of 1, 5 or 23 mg/kg of an
EGFR gamma delta bsTCE that is fully cross-reactive with EGFR and
Vγ9 T cells in non-human primates. At all doses, the EGFR gamma
delta bsTCE only induced minimal levels of cytokines such as IL-2,
IL-6 and IFN-gamma and there were no signs of CRS. No changes in
general health parameters, clinical chemistry, hematology or
histopathology were observed. The compound was pharmacologically
active in the animals, with Vγ9-positive T cells expressing markers
indicating activation (CD25 and CD69). Presence of the injected
compound in EGFR-expressing tissues, such as skin, muscle and
colon, was demonstrated using immune-histochemistry. The
elimination half-life was similar to the half-life of regular human
IgG and ranged between 84.7 and 127.4 hours.
About LAVA TherapeuticsLAVA
Therapeutics N.V. is a clinical-stage biotechnology company
utilizing its proprietary Gammabody™ platform to develop a
portfolio of bispecific gamma delta T cell engagers (gamma delta
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 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 prostate cancer 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
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.
CONTACTEdward SmithChief Financial
Officerir@lavatherapeutics.com
Catherine
Day+1-917-763-2709catherine@newdaybioconsulting.com
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