Ayala Pharmaceuticals to Present Preclinical Data at AACR for AL101, a Pan-Notch Inhibitor Being Evaluated for Adenoid Cystic Carcinoma

Results support the clinical development of AL101 as a targeted monotherapy for people with tumors bearing Notch activated mutations

REHOVOT, Israel & WILMINGTON, Del.--()--Ayala Pharmaceuticals, Inc., a clinical-stage company developing medicines for cancers that are genetically defined, today announced that new data for AL101 – a gamma secretase inhibitor currently being evaluated as a potential therapy for adenoid cystic carcinoma (ACC) with Notch activating mutations – will be presented at the 2019 American Association for Cancer Research (AACR) Annual Meeting in Atlanta, Ga.

The details of the poster presentation are as follows:

Title: AL101 mediated tumor inhibition in Notch mutated ACC PDX models
Date and Time: Wednesday April 3, 2019, 8 a.m. – 12 p.m. EDT
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 19
Poster Board Number: 8
Permanent Abstract Number: 4885

The preclinical data that will be presented show that AL101 monotherapy has a significant effect on tumor growth inhibition in a mouse model using implanted ACC patient-derived xenograft (PDX) tumors. The effect of AL101 was only seen in PDX tumors with Notch activating mutations and not on PDX tumors without such mutations. These data support the clinical development of AL101 as a targeted monotherapy for ACC tumors bearing Notch activating mutations.

This proof-of-concept study in genetically-defined ACC PDX models validates our patient selection strategy in the ongoing ACCURACY Phase 2 clinical trial, testing AL101 in people with ACC tumors bearing Notch activating mutations,” said Roni Mamluk, Ph.D., Chief Executive Officer at Ayala Pharmaceuticals. “These encouraging results bring us one step closer to potentially helping people suffering from ACC, an underserved cancer with no standard of care.”

In a previous Phase 1 all-comers solid tumor study, two ACC patients were treated with AL101, the first had partial response and the second had prolonged stable disease. This study did not apply patient selection for Notch activating mutations; however, it was confirmed that both patients had tumors with activating Notch mutations. These results promoted further evaluation of the effect of AL101 in tumors that harbor/lack Notch activated mutations.

Additionally, prior research revealed that genomic alterations in the Notch pathway yield a subset of ACC patients with a distinct phenotype and a more aggressive course of disease than their wild type counterparts. In addition to Notch 1 mutations, mutations in Notch 2 and 4 have been reported in 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 to www.clinicaltrials.gov. Interested patients and physicians can contact Ayala Medical 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.


Ayala Pharmaceuticals


Ayala Pharmaceuticals