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ACC is a rare form of malignant cancer with limited treatment
options available -
Investigational new drug AL101 is in Phase 2 study as a targeted
monotherapy for people with ACC tumors bearing Notch activated
mutations
REHOVOT, Israel & WILMINGTON, Del.–(BUSINESS WIRE)–Ayala Pharmaceuticals, a clinical-stage company developing medicines for
cancers that are genetically defined, announced today that it has been
granted Orphan Drug Designation from the U.S. Food and Drug
Administration’s (FDA) Office of Orphan Products Development (OOPD) for
AL101, a potent and selective inhibitor of gamma secretase-mediated
Notch signalling, for the treatment of ACC.
Orphan Drug Designation is granted to drug therapies intended to treat
diseases or conditions that affect fewer than 200,000 people in the
United States. Orphan Drug Designation by the FDA entitles Ayala
to seven years of market exclusivity for the use of AL101 for the
treatment of ACC, if approved, plus significant development incentives,
including tax credits related to clinical trial expenses, an exemption
from the FDA-user fee, and FDA assistance in clinical trial design.
“Receiving Orphan Drug Designation from the FDA signifies our continued
progress and commitment to develop AL101 as a potential treatment for
people with ACC,” said Roni Mamluk, Ph.D., Chief Executive Officer at
Ayala Pharmaceuticals. “Given the proof of concept demonstrating that
AL101 has a significant inhibitory effect on tumor growth in a mouse
model using implanted ACC patient-derived xenograft tumors coupled with
the significant unmet need in ACC, we look forward to accelerating AL101
development for patients in the U.S.”
ACC is a rare form of cancer. In the U.S., there are
approximately 566,000 people diagnosed with cancer each year, and only
about 1,224 of them are diagnosed with ACC. According to the Adenoid
Cystic Carcinoma Organization International, there are approximately
14,873 Americans alive today living with this disease. Current treatment
options include surgery, chemotherapy and/or radiation therapy;
however, there is no approved drug for the treatment of ACC.
About AL101
AL101 is a gamma secretase inhibitor developed as a Notch inhibitor for
oncology indications. Notch signaling pathway plays an important role in
tumorigenesis in several solid and hematological malignancies. Upon
ligand binding of the Notch receptor, an important step in the
activation of Notch receptors is cleavage by gamma secretase, which
frees the Notch intracellular signaling domain.
AL101 is currently in Phase 2 for adenoid cystic carcinoma patients with
tumor bearing Notch activating mutations (ACCURACY). For additional
information about AL101 ACCURACY clinical trial, please go to www.clinicaltrials.gov.
Interested patients and physicians can contact Medical Affairs at Ayala
for more information at: accuracy@ayalapharma.com
or call refer +1-857-444-0553.
About Ayala Pharmaceuticals
Ayala Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical
company dedicated to developing targeted cancer therapies for people
living with genetically defined cancers. Ayala is broadly developing its
product candidates, AL101 and AL102, best-in-class gamma secretase
inhibitors, with clinical and preclinical studies underway in both solid
tumors (AL101) and hematologic malignancies (AL102).
As a precision oncology company, Ayala was founded in November 2017 with
an experienced global management team and a strong investor base. For
more information, visit www.ayalapharma.com.
Contacts
Investors
Ayala Pharmaceuticals
+1-857-444-0553
info@ayalapharma.com
Media
Katie Dodge
+1 617-657-1304
kdodge@jpa.com