Celldex Announces First Patient Dosed in Phase 1 Study of CDX-585 in Patients with Advanced Malignancies
May 31 2023 - 7:01AM
Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced that the
first patient has been dosed in a Phase 1 study of CDX-585. CDX-585
combines highly active PD-1 blockade with anti-ILT4 blockade to
overcome immunosuppressive signals in T cells and myeloid cells.
Celldex plans to develop CDX-585 for the treatment of solid tumors
either as monotherapy or in combination with other oncologic
treatments. CDX-585 is the first compound from Celldex’s research
and collaboration agreement with Biosion, Inc. and combines
Celldex’s ILT4 mAb with Biosion’s PD-1 mAb.
"We are excited to advance CDX-585 into clinical development as
we continue to build our experience with our bispecific platform,"
said Diane C. Young, M.D, Senior Vice President and Chief Medical
Officer of Celldex Therapeutics. "Targeting both myeloid and T cell
checkpoints with a bispecific is a novel approach that we believe
could provide benefit for patients that are either refractory to or
not likely to benefit from PD-1 blockade alone.”
This open-label, multi-center, intravenous study of CDX-585 is
being evaluated in patients with advanced or metastatic solid
tumors that have progressed during or after standard of care
therapy. The dose-escalation phase of the study (n=~30 patients) is
designed to determine a maximum tolerated dose (MTD) and to select
CDX-585 dose(s) for future evaluation in tumor specific expansion
cohorts. In the first phase, increasing doses of CDX-585 will be
administered intravenously (0.03 mg/kg up to 10.0 mg/kg) every 2
weeks until confirmed disease progression, intolerance, or for a
maximum of 2 years. In the second phase, potential expansion
cohorts will evaluate the safety, tolerability and biologic
effects, including anti-tumor activity, of selected dose level(s)
of CDX-585 in specific tumor types.
Preclinical data recently presented at the American Association
of Cancer Research (AACR) Annual Meeting 2023 demonstrated that
CDX-585 is a potent antagonist of both PD-1 and ILT4, and CDX-585
is more potent than the combination of PD-1 and ILT-4 mAbs in
several model systems. CDX-585 also demonstrated a good
pharmacokinetic profile and no evidence of toxicity supporting
initiation of clinical development.
For additional information on this trial (NCT05788484), please
visit www.clinicaltrials.gov.
About CDX-585CDX-585 is a dual targeting
PD-1/ILT4 bispecific antibody from Celldex’s bispecific antibody
platform. Expression of ILT4 in several tumor types is associated
with poor outcome and in preclinical models, antagonist antibodies
to ILT4 have demonstrated immune enhancing and antitumor effects.
Preclinical studies have shown that CDX-585 is a potent antagonist
of both PD-1 and ILT4, and CDX-585 is more potent than the
combination of PD-1 and ILT-4 mAbs in several model systems.
CDX-585 is being developed as part of a research and collaboration
agreement with Biosion, Inc. and combines Celldex’s ILT4 mAb with
Biosion’s PD-1 mAb.
About Celldex’s Bispecific Antibody
PlatformCelldex’s deep antibody experience and in-house
manufacturing capabilities support efficient development of next
generation bispecific antibody programs for inflammatory/autoimmune
diseases and oncology. Bispecific antibodies can engage two
independent pathways involved in controlling immune reactions and
combining these into one molecule can result in stronger activity
than a combination of the independent antibodies. Targets are being
selected based on new science as well as their compatibility to be
used in bispecific antibody formats with Celldex’s existing
antibody programs. Lead targets in development are emerging as
important pathways controlling inflammatory diseases or immunity to
tumors.
About Celldex Therapeutics, Inc.Celldex is a
clinical stage biotechnology company dedicated to developing
monoclonal and bispecific antibodies that address devastating
diseases for which available treatments are inadequate. Our
pipeline includes antibody-based therapeutics which have the
ability to engage the human immune system and/or directly affect
critical pathways to improve the lives of patients with
inflammatory diseases and many forms of cancer. Visit
www.celldex.com.
Forward Looking Statement This release contains
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Company ContactSarah CavanaughSenior Vice
President, Corporate Affairs & Administration(508)
864-8337scavanaugh@celldex.com
Patrick TillMeru Advisors(484)
788-8560ptill@meruadvisors.com
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