SAN DIEGO, Aug. 8, 2024 /PRNewswire/ -- Angiex, a
developer of Nuclear-Delivered Antibody-Drug Conjugate™ (ND-ADC)
therapies for solid cancers, announced that patient dosing has
begun for their Phase 1 clinical trial of AGX101, a first-in-class
TM4SF1-directed Antibody-Drug Conjugate (ADC). Angiex partnered
with Abzena, the leading end-to-end integrated CDMO for
complex biologics and bioconjugates, to support the development,
manufacture and supply of clinical trial material for the
study.
AGX101 is a TM4SF1-directed ADC that targets two compartments of
the tumor, cancer cells and the tumor vasculature. AGX101 has three
mechanisms of action: eliminating tumor blood vessels, killing
tumor cells capable of invasion and metastasis, and directing the
immune system to attack the cancer. Abzena has supported the
development of AGX101 with an integrated program that included
linker-payload design and synthesis, bioconjugation, process
development, and cGMP manufacturing for Angiex's Phase 1 trial.
Paul Jaminet, co-founder and CEO
of Angiex, said: "We are very excited to have dosed our first
patient in our first-in-human study of our novel TM4SF1 ADC,
AGX101. Throughout the development of AGX101, Abzena has worked
closely with us to achieve successful GMP manufacturing and quality
control. We could not have reached this milestone without Abzena's
expertise, cooperation, and support. Both companies have extensive
expertise in their respective fields and an aligned mission, and we
look forward to continuing our partnership to ensure that AGX101 is
available to meet the needs of clinical cancer patients. We
are delighted that Abzena shares our vision that no one should die
of cancer."
Matt Stober, CEO of Abzena, said:
"The Abzena team is incredibly proud to have helped Angiex achieve
this significant milestone. Our unique ability to support Angiex
with a fully integrated approach allowed us to de-risk and rapidly
progress AGX101 into the clinic for patient dosing. We will
continue supporting Angiex with our extensive ADC expertise and
integrated capabilities to accelerate the development timeline of
AGX101, and ultimately get this life-changing treatment to cancer
patients faster."
The Phase 1 study for AGX101 is an open-label, dose-escalation,
and expansion study designed to assess the safety, pharmacokinetics
(PK), pharmacodynamics (PD), and preliminary anti-tumor activity of
AGX101 monotherapy. The dose escalation portion of the study is
designed to assess doses up 10 mg/kg in an all-comers, solid tumor
patient population. The dose expansion portion of the study is
designed to evaluate treatment at the Recommended Phase 2 Dose in
multiple indications.
About Abzena
Abzena is the leading end-to-end bioconjugate and complex
biologics CDMO + CRO. From discovery through commercial launch, we
support customers with fully integrated programs or individual
services designed to de-risk and streamline the development of new
treatments for patients in need. With the ability to tailor its
strategy and customer experience to each project, Abzena develops
and implements innovative solutions that enable biotech and
biopharma companies to realize the full potential of their molecule
and move medicines forward faster. The company has research,
development, and cGMP facilities across locations in San Diego, CA, Bristol, PA, and Cambridge, UK. Abzena is owned by Welsh,
Carson, Anderson & Stowe, one of the world's leading private
equity investors. Learn more at abzena.com.
About Angiex
Angiex, Inc. is a privately held biotech startup whose mission
is to exploit newly discovered biological transport mechanisms to
make drugs with revolutionary power over cancer. Based in
Cambridge, Mass., Angiex was
founded by leading scientific experts in angiogenesis, vascular
biology, and oncology. The company is developing a portfolio of
Nuclear-Delivered Antibody-Drug Conjugates™ (ND-ADCs) that release
therapeutic payloads directly into the nucleus or cytosol, where
the site of payload action is located. This direct delivery holds
the promise of enhancing the efficacy and therapeutic margin of
conventional ADCs. Angiex's lead product, AGX101, has advanced
through pre-clinical development and is now in Phase 1 clinical
trials.
Angiex, Inc.
www.angiex.com
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