Notch 1

Ayala Pharmaceuticals Presents Preliminary Clinical Data from the Ongoing Phase 2 ACCURACY Trial and Announces Pre-Clinical Proof of Concept Data for Enhanced Activity of AL101 in Combination with Approved Cancer Therapies in ACC

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Thursday, September 16, 2021
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REHOVOT, Israel and WILMINGTON, Del., Sept. 16, 2021 (GLOBE NEWSWIRE) -- Ayala Pharmaceuticals, Inc. (NASDAQ: AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, today announced new preliminary clinical data from the 6mg cohort of its ongoing Phase 2 ACCURACY trial of AL101 for the treatment of recurrent/metastatic (R/M) adenoid cystic carcinoma (ACC) harboring Notch-activating mutations. The data is being presented at the 2021 ESMO Virtual Congress as an ePoster. In a separate ePoster presentation, Ayala presented new preclinical results evaluating the potential of AL101 in combination with approved cancer therapies for dual targeting of ACC tumours.

Key Points: 
  • In a separate ePoster presentation, Ayala presented new preclinical results evaluating the potential of AL101 in combination with approved cancer therapies for dual targeting of ACC tumours.
  • R/M ACC remains a significant area of unmet need, and I am encouraged by the preliminary results that AL101 monotherapy has demonstrated to-date.
  • The preliminary safety and efficacy data from the 6mg cohort of our ongoing ACCURACY trial of AL101 highlights a favourable profile.
  • Preliminary Safety and Efficacy Data from 6mg Cohort of ACCURACY Phase 2 Trial:
    Ayala presented new preliminary 6mg data from its ongoing ACCURACY Phase 2 clinical trial evaluating the safety and efficacy of AL101 monotherapy for the treatment of patients with R/M ACC harboring Notch-activating mutations.

Ayala Pharmaceuticals to Present Clinical Data from Ongoing Phase 2 ACCURACY Trial and New Preclinical Results from Combination Study of AL101 at the European Society for Medical Oncology (ESMO) Virtual Congress 2021

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Wednesday, September 1, 2021
European Society for Medical Oncology, Fast track (FDA), GSI, ACC, Therapy, Cancer, GLOBE, T-ALL, TNBC, T-Cell Acute Lymphoblastic Leukemia, Phase II, ESMO, Clinical trial, Pivotal, NASDAQ, Notch 1, Patient, Oncology, AYLA, MM, Plantar fibromatosis, Novartis, Neoplasm, Bristol Myers Squibb, Adenoid cystic carcinoma, FDA, Ayala, Multiple myeloma, Pharmaceutical industry

Ayala will present preliminary data from the 6mg cohort of the ongoing Phase 2 ACCURACY clinical trial of AL101 for the treatment of recurrent/metastatic (R/M) adenoid cystic carcinoma (ACC) harbouring Notch-activating mutations in addition to preclinical results from Ayalas new study of AL101 in combination with other drugs for dual targeting of Notch dysregulated tumors.

Key Points: 
  • Ayala will present preliminary data from the 6mg cohort of the ongoing Phase 2 ACCURACY clinical trial of AL101 for the treatment of recurrent/metastatic (R/M) adenoid cystic carcinoma (ACC) harbouring Notch-activating mutations in addition to preclinical results from Ayalas new study of AL101 in combination with other drugs for dual targeting of Notch dysregulated tumors.
  • AL101 is designed to inhibit the expression of Notch gene targets by blocking the final cleavage step by the gamma secretase required for Notch activation.
  • Ayala obtained an exclusive, worldwide license to develop and commercialize AL101 from Bristol-Myers Squibb Company in November 2017.
  • AL101 was granted U.S. FDA Fast Track Designation and Orphan Drug Designation for the treatment of ACC.