Abdera Therapeutics Announces FDA Clearance of IND Application for ABD-147
May 23 2024 - 8:00AM
Business Wire
First Precision Radiopharmaceutical Therapy
Targeting DLL3 Being Advanced for the Treatment of Small Cell Lung
Cancer and Large Cell Neuroendocrine Carcinoma
Abdera Therapeutics Inc., a biopharmaceutical company leveraging
its advanced antibody engineering ROVEr™ platform to design and
develop tunable, precision radiopharmaceuticals for cancer, today
announced that the U.S. Food and Drug Administration (FDA) has
cleared the company’s Investigational New Drug (IND) application
for ABD-147, the first delta-like ligand 3 (DLL3) targeting
radiopharmaceutical for the treatment of small cell lung cancer
(SCLC) and large cell neuroendocrine carcinoma (LCNEC). Abdera
plans to initiate a Phase 1 clinical trial in the second half of
2024.
ABD-147 is a next-generation precision radiopharmaceutical
biologic therapy designed to deliver Actinium-225 (225Ac), a highly
potent alpha-emitting radioisotope, to solid tumors expressing
DLL3. DLL3 is a protein found on the surface of neuroendocrine
tumors, but rarely expressed on the surface of normal cells or
tissues.
“ABD-147 represents a potential best-in-class treatment for SCLC
and other aggressive neuroendocrine tumors,” said Philippe Bishop,
M.D., chief medical officer. “Leveraging our ROVEr platform, we
custom-engineered ABD-147 with optimized pharmacokinetic properties
and tumor penetration to destroy tumor cells while limiting
radiation toxicity to the body. We are hopeful this highly potent
next generation radiotherapeutic will provide a potential
breakthrough addressing a critical medical need for the treatment
of SCLC and other high-grade neuroendocrine cancers. We look
forward to initiating a Phase 1 clinical trial of ABD-147 later
this year.”
The Phase 1, first-in-human, open-label clinical study aims to
evaluate the safety and preliminary efficacy of 225Ac-ABD-147 in
patients with SCLC or LCNEC who previously received platinum-based
therapy. The study will determine the recommended dose regimen for
future development.
“FDA clearance of our first IND marks a major milestone for
Abdera as we transition into a clinical-stage radiopharmaceutical
company,” said Lori Lyons-Williams, president and chief executive
officer. “We believe our ROVEr™ platform uniquely enables a new
wave of innovation in targeted radiotherapeutics, with ABD-147
representing the first in a robust pipeline of custom-engineered
programs we are advancing to the clinic.”
About Small Cell Lung Cancer and Large Cell Neuroendocrine
Carcinoma
The global incidence for SCLC and LCNEC has been reported to
represent approximately 325,000 patients and is expected to
increase 4% annually through 2029. In the U.S., the incidence has
been reported to be approximately 35,000 new cases annually.
Fifteen percent of all lung cancer cases are high-grade
neuroendocrine cancers. These cancers have the most aggressive
clinical course of any type of pulmonary tumor and often
metastasize to other parts of the body, including the brain, liver
and bone. Without treatment, the median survival from diagnosis has
been reported to be only two to four months. With treatment, the
overall survival at five years is 5% to 10% for SCLC, and 15% to
25% for LCNEC. SCLC and LCNEC generally carry a poor prognosis and
new treatment options are urgently needed.
About ABD-147
ABD-147 is a targeted radiopharmaceutical biologic therapy
designed to deliver Actinium-225 (225Ac), a highly potent
alpha-emitting radioisotope, to solid tumors expressing delta-like
ligand 3 (DLL3) with high affinity. DLL3 is a protein in the Notch
pathway that is critical for the development and regulation of
neuroendocrine versus epithelial cell differentiation in the lungs.
In certain high grade neuroendocrine carcinomas including small
cell lung cancer (SCLC), DLL3 is upregulated and specifically
expressed on the cell surface in more than 80% of cases. In
contrast, DLL3 is absent or very rarely expressed on the surface of
nonmalignant cells. Given the high specificity of DLL3 expression
on cancer cells and the distinct mechanism of action, DLL3
represents a compelling target for treating SCLC and other DLL3+
solid tumors with targeted radiotherapy.
About the ROVEr™ Platform
Abdera’s Radio
Optimized Vector Engineering (ROVEr™) platform enables the company to
custom-engineer targeted radiopharmaceuticals with tunable
pharmacokinetic (PK) properties to achieve high tumor uptake while
minimizing renal exposure and mitigating other systemic
radiotoxicities such as myelosuppression. Abdera can optimize the
delivery and therapeutic index of potent radioisotopes capable of
emitting powerful alpha or beta particles to selectively destroy
tumor cells while sparing healthy cells, providing patients with
potentially transformative new cancer treatments.
Abdera’s approach offers the ability to design radiotherapeutics
against virtually any cancer target expressed on the cell surface.
Coupled with a highly potent mechanism of cell killing, the ROVEr
platform is uniquely poised to exploit both high- and
low-expressing targets to selectively deliver therapeutic levels of
radioisotope to cancer cells.
About Abdera
Abdera Therapeutics is a biopharmaceutical company leveraging
antibody engineering to design and develop new precision
radiopharmaceuticals for cancer. Abdera’s Radio Optimized Vector Engineering (ROVEr™) platform enables the company to
engineer potential best-in-class therapies for both clinically
validated and novel targets that deliver potent radioisotopes
capable of emitting alpha or beta particles to selectively destroy
cancer cells. Abdera’s lead program, ABD-147, is a next-generation
precision radiopharmaceutical biologic therapy designed to deliver
Actinium-225 (225Ac) to solid tumors expressing delta-like ligand 3
(DLL3) for the treatment of small cell lung cancer (SCLC) and large
cell neuroendocrine carcinoma (LCNEC). Headquartered in South San
Francisco, CA, Abdera also has offices in Vancouver, British
Columbia, Canada. To learn more, please visit www.abderatx.com and
follow us on LinkedIn and X.
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Media: 1AB Katie Engleman katie@1abmedia.com
Investors: 1AB Steve Klass Steve@1abmedia.com