Abdera Therapeutics Announces FDA Fast Track Designation for ABD-147, a Next-Generation Precision Radiopharmaceutical Therapy, for the Treatment of Patients with Extensive-stage Small Cell Lung Cancer
June 27 2024 - 8:00AM
Business Wire
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
granted Fast Track designation to ABD-147 for the treatment of
patients with extensive stage small cell lung cancer (ES-SCLC) who
have progressed on or after platinum-based chemotherapy. ABD-147 is
a next-generation precision radiopharmaceutical biologic therapy
designed to deliver Actinium-225 (225Ac) to solid tumors expressing
DLL3, a protein found on the surface of neuroendocrine tumors, but
rarely expressed on the surface of normal cells or tissues.
The FDA’s Fast Track program is designed to facilitate the
development, and expedite the review of drugs to treat serious
conditions and fill an unmet medical need. Clinical programs with
Fast Track designation may benefit from early and frequent
communication with the FDA throughout the regulatory review process
and may also be eligible for Accelerated Approval and Priority
Review if relevant criteria are met.
“Aggressive neuroendocrine cancers such as SCLC carry a poor
prognosis and new treatment options are urgently needed,” said Lori
Lyons-Williams, president and chief executive officer. “These
cancers have the most aggressive clinical course of any type of
pulmonary tumor and often rapidly metastasize to other parts of the
body. We are thrilled the FDA has recognized the potential of
ABD-147 to become a transformative treatment option for SCLC and we
are excited to begin clinical development and provide ABD-147 to
patients in need.”
In the second half of 2024, Abdera plans to initiate a
first-in-human Phase 1 clinical trial with ABD-147 in patients with
SCLC or large cell neuroendocrine carcinoma (LCNEC) who previously
received platinum-based therapy.
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
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