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Therapies to transform today’s treatment options for rare tumors and aggressive cancers

At Ayala, we’re focused on developing and commercializing small molecule therapeutics for patients living with rare tumors and aggressive cancers.

Our Targeted Approach to Treating Rare Cancers

Our current portfolio of investigational product candidates, AL101 and AL102, targets aberrant activation of the Notch-pathway with gamma secretase inhibitors.


When gamma secretase, the enzyme responsible for Notch activation, is inhibited, it turns off the Notch-pathway activation. Aberrant activation of the Notch-pathway has long been implicated in multiple solid tumor and hematological cancers and has often been associated with more aggressive cancers. Notch serves as a critical facilitator in processes, such as cellular proliferation, survival, migration, invasion, drug resistance and metastatic spread - all of which contribute to poorer patient prognosis.


AL101 and AL102 are designed to address the underlying key drivers of tumor growth by targeting Notch-pathway activation directly.


We’re working on therapies that, if approved by regulatory authorities, could transform today’s treatment options for people living with rare tumors and aggressive cancers.

Disease Focus Areas

Ayala is currently developing potential therapies to treat these rare tumors and aggressive cancer types

Publications

  • Gounder, M., et al., Initial Results of Phase 2/3 Trial of AL102 for Treatment of Desmoid Tumors (DT). ESMO 2022 mini-oral presentation
  • Chan, D., et al., Activity of the Gamma Secretase Inhibitor AL101 in Desmoid Tumors: A Case Report of 2 Adult Cases. Curr Oncol, 2021. 28(5): p. 3659-3667
  • Ho, A.L., et al., ACCURACY: A phase II trial of AL101, a selective gamma secretase inhibitor, in subjects with recurrent/metastatic (R/M) adenoid cystic carcinoma (ACC) harboring Notch activating mutations (Notchmut): Results of 6-mg cohort. 2021.
  • Hapuarachi, B.S., et al., Clinical disease course and survival outcomes following disease recurrence in adenoid cystic carcinoma (ACC) with NOTCH signaling pathway activation. Journal of Clinical Oncology, 2021. 39(15_suppl): p. 6072-6072.
  • Ferrarotto, R., et al., 1789P - The gamma secretase inhibitor AL101 combined with other drugs for dual targeting of Notch dysregulated tumors. Annals of Oncology, 2021. 32: p. S1211-S1226.
  • Ferrarotto, R., et al., 919MO ACCURACY a phase II trial of AL101, a selective gamma secretase inhibitor, in subjects with recurrent/metastatic (R/M) adenoid cystic carcinoma (ACC) harboring Notch activating mutations (Notchmut). Annals of Oncology, 2020. 31: p. S663.
  • Ferrarotto, R., et al., ACCURACY: phase (P) 2 trial of AL101, a pan-Notch inhibitor, in patients (pts) with recurrent/metastatic (R/M) adenoid cystic carcinoma (ACC) with Notch activating mutations (Notchact mut). Journal of Clinical Oncology, 2019. 37(15_suppl): p. TPS6098-TPS6098.
  • Ferrarotto, R., et al., Abstract 4885: AL101 mediated tumor inhibition in Notch mutated ACC PDX models. Cancer Research, 2019. 79(13 Supplement): p. 4885-4885.
  • Broner, E.C., et al., AL101 mediated tumor inhibition in notch-altered TNBC PDX models. Journal of Clinical Oncology, 2019. 37(15_suppl): p. 1064-1064.
  • Aung, K.L., et al., A multi-arm phase I dose escalating study of an oral NOTCH inhibitor BMS-986115 in patients with advanced solid tumours. Invest New Drugs, 2018. 36(6): p. 1026-1036.
  • Morgan, K.M., et al., Gamma Secretase Inhibition by BMS-906024 Enhances Efficacy of Paclitaxel in Lung Adenocarcinoma. Mol Cancer Ther, 2017. 16(12): p. 2759-2769.
  • Knoechel, B., et al., Complete hematologic response of early T-cell progenitor acute lymphoblastic leukemia to the gamma-secretase inhibitor BMS-906024: genetic and epigenetic findings in an outlier case. Cold Spring Harb Mol Case Stud, 2015. 1(1): p. a000539.
  • Gavai, A.V., et al., Discovery of Clinical Candidate BMS-906024: A Potent Pan-Notch Inhibitor for the Treatment of Leukemia and Solid Tumors. ACS Med Chem Lett, 2015. 6(5): p. 523-7.

Learn more about Ayala

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Investigational Therapies

- Gary Gordon, MD, PhD, Chief Medical Officer, Ayala Pharmaceuticals

“We're very excited for what the future may hold for AL101 and AL102. Our team of oncologists and researchers are hoping to change the landscape for how we can identify and address the underlying drivers of tumor growth. Through our unique approach, we’re striving to make a real difference for people living with rare and aggressive cancers.”