Imvax Announces Completion of Enrollment in Phase 2b Clinical Trial of IGV-001 and Successful Financing
21 May 2024 - 6:30PM
Business Wire
– Enrollment completed within planned timeframe
of 14 months –
– IGV-001 granted Fast Track designation by
U.S. FDA –
– $35 million financing completed in 2024 to
fund operations beyond expected Phase 2b data readout in mid-2025
–
Imvax, Inc., a clinical-stage biotechnology company developing
personalized, whole tumor-derived immunotherapies, today announced
the completion of enrollment in its randomized, multicenter,
double-blind, placebo-controlled Phase 2b clinical trial of IGV-001
in patients with newly diagnosed glioblastoma (ndGBM). IGV-001 is
derived from Imvax’s proprietary Goldspire™ immuno-oncology
platform, which is designed to use a patient’s own tumor cells to
induce a broad and durable immune response against tumors. The
primary endpoint of the Phase 2b trial is Progression Free Survival
(PFS) and top-line data is expected by mid-2025.
Separately, the Company today announced that the U.S. Food and
Drug Administration (FDA) has granted Fast Track designation to
IGV-001 for the treatment of ndGBM based on the Company’s existing
Phase 1b data supporting its therapeutic potential in this
underserved and life-threatening condition.
Imvax also announced the closing of an approximately $35 million
financing round, with half of the capital coming from new
investors. Over the past 15 months, the Company has raised $57
million to support the completion of the Phase 2b trial.
“We are very pleased to announce full enrollment of the trial in
less than 14 months, which speaks to both the clinical interest in
this potential therapy and the efficient execution of our novel
approach to treating GBM patients,” said John P. Furey, Chief
Executive Officer. “We are grateful to the investigators, patients,
and their families for their commitment to this study and look
forward to seeing top-line data next year. We are also delighted
that the FDA has granted Fast Track designation to IGV-001. The
last significant advancement in the standard of care for GBM –
about an 8-week improvement in PFS – was nearly 20 years ago,
highlighting the need for continued innovation and treatment
options. We believe IGV-001 may offer meaningful clinical benefit
for patients diagnosed with this deadly disease.”
Mr. Furey continued, “We are grateful for the support of both
existing and multiple new investors in our recent fundraising,
which reflects their belief in the promise of IGV-001 and their
commitment to patients facing a GBM diagnosis. We now have
sufficient resources to support the completion of the trial and
carry us beyond the reporting of top-line results in mid-2025.”
About the Phase 2b Trial
The Phase 2b clinical trial is a randomized, multicenter,
double-blind, placebo-controlled study (NCT04485949) designed to
assess the safety and efficacy of IGV-001, an autologous
biologic-device combination product, in ndGBM patients. The trial
enrolled approximately 100 participants in a 2:1 randomization
across 20 sites in the United States. Approximately 48 hours after
surgical resection, participants in the IGV-001 arm were implanted
with biodiffusion chambers containing a combination of personalized
whole tumor-derived cells with an antisense oligonucleotide
(IMV-001); in the placebo arm, the chambers contained an inactive
solution only. In both arms, the biodiffusion chambers were
explanted approximately 48 hours later, and after six weeks all
patients were treated with standard of care (adjuvant radiotherapy
and temozolomide followed by maintenance temozolomide). The primary
endpoint of the trial is progression-free survival (PFS) and key
secondary endpoints include overall survival (OS) and safety.
About IGV-001
IGV-001 is an autologous biologic-device combination product
derived from Imvax’s proprietary Goldspire™ immuno-oncology
platform for solid tumors, which involves a unique approach to
inducing a broad and durable immune response against tumors. Phase
1 studies showed that IGV-001 was safe and well tolerated, and a
Phase 1b ndGBM study also yielded several efficacy signals,
including significant improvements in PFS, OS, radiographic
evidence of tumor response, and multiple biomarker changes that
supported the presence of an immune response (Andrews DW, et al.,
Clin Cancer Res. 2021;27(7):1912-1922). In ten Stupp-eligible ndGBM
patients in the highest dose cohort treated with IGV-001, median
PFS was 17.1 months, compared with 6.5 months in historical
standard-of-care (SOC) treatment, and median OS was 38.2 months,
compared with 16.2 months in historical SOC.
About Fast Track Designation
Fast Track is a process designed by the FDA to facilitate the
development and expedite the review of investigational treatments
that have the potential to treat serious conditions and address
recognized areas of unmet medical need. Programs with Fast Track
designation can benefit from early and more frequent interactions
with the FDA to discuss the product candidate’s development plan in
addition to a rolling submission of the marketing application.
Product candidates with Fast Track designation also may be eligible
for priority review and accelerated approval.
About Imvax, Inc.
Imvax is a clinical-stage biotechnology company with a unique
platform technology, Goldspire™, focused on delivering
personalized, whole tumor-derived immunotherapies across a range of
solid tumors. Imvax’s most advanced program, IGV-001, is currently
being evaluated in a Phase 2b clinical trial in newly diagnosed
glioblastoma patients. Imvax’s portfolio also includes several
other programs designed to stimulate a patient’s immune system
against the entire antigen signature of their tumor. Imvax is
headquartered in Philadelphia, PA. For additional information,
please visit www.imvax.com.
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