GenVivo Announces Initiation of Patient Dosing in a US Phase I/Ib Clinical Trial Evaluating GEN2, a Personalizing, Gene Vector Immunotherapy, in Patients with Advanced Solid Tumors
June 27 2024 - 5:00AM
GenVivo, Inc., a private, clinical-stage biopharmaceutical
company with breakthrough off-the-shelf platforms for cancer gene
medicine immunotherapies, announced that it has dosed the first US
patient in a Phase I/Ib, open-label, dose-escalation and expansion
clinical trial of GEN2. GEN2, GenVivo’s first product candidate to
enter clinical development, is a non-replicating mRNA gene therapy
vector being developed as a cancer immunotherapy to both kill
tumors and activate a patient’s immune system against their
individual cancer antigens (neoantigens). GEN2 is an off-the-shelf
medicine, providing the advantages of a personalizing therapy
without the time delays and expense associated with autologous
products or tumor genome sequencing.
This GEN2 Phase I/Ib, dose-escalation clinical
trial (NCT06391918) is currently enrolling US patients with
advanced solid tumors who have progressed or were non-responsive to
prior therapies. The clinical trial is primarily designed to assess
the safety and tolerability of GEN2 and to establish the
recommended Phase II dose (RP2D). Following the initial
dose-escalation phase, the expansion phase will explore the RP2D in
3 arms with defined solid tumor types, to further demonstrate
safety, tolerability, and signs of clinical activity.
Pharmacokinetic and exploratory biomarker endpoints will be
assessed. Additional data relevant to efficacy will be obtained
from paired-tumor biopsies, measuring payload expression, immune
cell infiltration and activation, and tumor killing.
“The initiation of this US trial represents an
important milestone in our efforts to systemically administer our
off-the-shelf personalizing gene medicine platform to activate a
cancer patient’s immune system against the full breadth of their
unique tumor antigens,” said Robert G. Johnson, M.D., Ph.D., Chief
Operating Officer of GenVivo, Inc. “We are encouraged by the
potential of GEN2 (demonstrated in a prior phase 1 trial,
NCT04313868) and look forward to advancing to the expansion phase
once the appropriate dose is identified.”
Daneng Li, M.D., Associate Professor, Department
of Medical Oncology & Therapeutics Research, Hepatobiliary Lead
and Co-Director, Neuroendocrine Tumor Program, City of Hope,
Duarte, CA added “We are excited to be working with the GenVivo
team on GEN2, an innovative dual-payload targeted vector, with the
goal to improve therapies for our patients with refractory
disease.”
About GEN2GenVivo’s product candidate, GEN2, is
designed to kill the tumor and trigger direct tumor release of
patient specific neoantigens in the presence of a locally produced
cytokine. The vector mRNA payload encodes an optimized
prodrug-activated enzyme (enhanced viral thymidine kinase
(HSV-eTK)) and an immunostimulatory cytokine (GM-CSF). The orally
administered prodrug, modified by the HSV-eTK, directly kills tumor
cells, releasing the patient’s full complement of unique tumor
antigens in the presence of the immunostimulatory cytokine, to then
directly stimulate tumor-specific killer cells. These tumor-lytic
immune cells amplify and maintain ongoing tumor cell killing,
including subsequently arising tumor mutations (neoantigens) and
tumors at metastatic sites. Data from 59 patients in a Phase 1
trial in Asia, demonstrated safety and tolerability with signs of
clinical benefit (NCT04313868). GVO-1102 (NCT06391918) will
complete the intravenous dose escalation started in the Phase 1
trial in Asia.
About GenVivoGenVivo is a private,
vertically-integrated biotechnology company with cGMP manufacturing
capabilities, founded to develop the latest novel gene delivery and
immune stimulation therapies, which activate the patient’s immune
system to treat cancers and prevent infectious diseases. GenVivo is
committed to developing and manufacturing products that are rapidly
deployed, and easily administered, with the goal of increasing
patient survival and improving quality of life.
For more information about GenVivo, visit
https://genvivoinc.com/
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Contact
Victor Constantinescu, M.Eng
Head of Business
DevelopmentBD@genvivoinc.com626-768-5162