SAN
DIEGO, Aug. 16, 2024 /PRNewswire/ -- Phanes
Therapeutics, Inc. (Phanes), a clinical stage biotech company
focused on innovative drug discovery and development in oncology,
announced today that the U.S. Food and Drug Administration (FDA)
has granted orphan drug designation (ODD) to PT217 for the
treatment of neuroendocrine carcinoma (NEC).
PT217 is a first-in-class bispecific antibody targeting
delta-like ligand 3 (DLL3) and cluster of differentiation 47 (CD47)
being developed for patients with NEC. NEC is known to be the most
aggressive subgroup of neuroendocrine neoplasms and defined as
cancers with poorly differentiated morphology and a high
proliferation rate. Most of them have their origin in the lung such
as SCLC. Others can develop within the gastrointestinal tract,
prostate, and pancreas.
PT217 was granted ODD for the treatment of SCLC by the FDA in
2022 and granted Fast Track designation by the agency in 2024 for
the treatment of patients with extensive-stage small cell lung
cancer (ES-SCLC) with disease progression following platinum
chemotherapy with or without a checkpoint inhibitor. Earlier this
year, Phanes entered into a clinical supply agreement with Roche to
study PT217 in combination with Roche's anti-PD-L1 therapy,
atezolizumab.
The FDA's Office of Orphan Products Development grants orphan
designation status to drugs and biologics that are intended to
treat, diagnose, or prevent rare diseases that affect fewer than
200,000 people in the United
States. Orphan drug designation provides certain benefits,
including financial incentives to support clinical development and
the potential for up to seven years of market exclusivity in the
U.S. upon regulatory approval.
ABOUT PHANES THERAPEUTICS
Phanes Therapeutics, Inc. is a clinical stage biotech company
focused on innovative drug discovery and development in oncology.
Currently, it is conducting three Phase I clinical trials,
including the MORNINGSTAR study with its best-in-class monoclonal
antibody (mAb) program, PT199, the TWINPEAK study with PT886 and
the SKYBRIDGE study with PT217. Both PT886 and PT217 are
first-in-class bispecific antibodies and have been granted orphan
drug designation as well as Fast Track designation by the FDA.
The company has built a strong pipeline by leveraging its
proprietary technology platforms: PACbody®,
SPECpair® and ATACCbody® to develop novel
biologics that address high unmet medical needs in cancer.
For more information about Phanes Therapeutics, please visit
www.phanesthera.com
For business development or media inquiries, please contact
bd@phanestx.com or media@phanestx.com, respectively.
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SOURCE Phanes Therapeutics