About Ayala
We are a clinical-stage oncology company founded in November 2017 after acquiring an exclusive, worldwide license to our product candidates, AL101 and AL102, from Bristol-Myers Squibb. We’re focused on developing and commercializing potentially best-in-class small molecule therapeutics for patients suffering from rare and aggressive cancers, especially in genetically defined patient populations.
What makes us different lies in our development approach. It’s rooted in identifying and addressing indications in which Notch is a known tumorigenic driver, using a combination of our bioinformatics platform and next-generation sequencing to help deliver targeted therapies to underserved patient populations. Advances in molecular testing and sequencing have enabled the discovery of Notch-activating mutations in multiple tumor types – this provides us with additional tools to identify the patients that are most likely to respond to the gamma secretase inhibitors that we are developing.
How our therapies can help
Our product candidates, AL101 and AL102, are designed to target cancer by addressing the underlying key drivers of tumor growth. Both product candidates target the aberrant activation of the Notch pathway with gamma secretase inhibitors (GSIs). Gamma secretase is the enzyme responsible for Notch activation and, when inhibited, turns off the Notch pathway activation.
By developing drugs designed to inhibit Notch pathway activation, we’re enabling personalized therapy for cancer patients. Currently, we have two product candidates in development for a variety of cancers:
Adenoid Cystic Carcinoma (ACC)
Triple Negative Breast Cancer (TNBC)
T-cell Acute Lymphoblastic Leukemia (T-ALL)
Desmoid Tumors
In addition to Notch pathway, gamma secretase may be targeted to increase levels of B-cell maturation antigen (BCMA), which is expressed in most multiple myeloma patients. Therefore, AL102 is being studied to evaluate its clinical role in enhancing anti-BCMA therapies in Multiple Myeloma (MM), in collaboration with Novartis.
The history of the Notch pathway
Aberrant activation of the Notch pathway has long been connected to multiple solid tumors and hematological cancers, and has often been associated with more aggressive cancers. In cancers, Notch is known to serve as a critical facilitator in processes such as cellular proliferation, survival, migration, invasion, drug resistance and metastatic spread, which all contribute to poorer patient outcomes.
Our mission
At Ayala, we are focused on developing best-in-class targeted therapies for people with cancer in whom the Notch pathway is activated. We target genetically defined, clinically underserved cancers where we can have the most impact.
We are guided by strongly held values:
Impact
Improve treatment outcomes for patients with aggressive cancers
Compassion
Be compassionate to the patients we serve
Integrity
Be open, honest, and ethical in all our endeavors – always
Efficiency
Bring innovative products to market efficiently, for the benefit of our patients
Collaboration
Work with patients, physicians and support groups to develop meaningful treatment advancements
Our people
Ayala is proudly driven by established biotech leaders with proven experience in building and operating clinical and commercial organizations, particularly in oncology and rare diseases.
Roni Mamluk, PhD
Roni Mamluk, PhD is a senior biopharmaceutical executive with 16 years of experience in drug development companies and background in all aspects of R&D, general management and fundraising. Prior to Ayala Roni was at Chiasma (NASDAQ: CHMA) a biopharmaceutical company focused on orphan diseases where she fulfilled multiple positions including CEO (2013-2015). She is an inventor of their oral delivery technology, led the development of their lead product through all stages of development, including NDA submission. She was a key player in fundraising for the company including several private financing rounds and led a $70 million crossover financing and a successful IPO of over $100 million in 2015. Roni is now a board member at Chiasma. Prior to that she was heading preclinical development of an oncology product at Adnexus (which was later acquired by Bristol-Myers Squibb (NYSE:BMY)) in Waltham, MA and prior to that did her post doc at Children’s Hospital/Harvard Medical School in the field on angiogenesis. Roni received her PhD, summa cum laude from the Hebrew University in Jerusalem.
Gary Gordon, MD, PhD
Gary Gordon, MD, PhD is a senior biopharmaceutical executive with vast experience in the development of drugs from first in-human studies to approval and commercialization. Most recently, Gary served as Vice President of Oncology Development at AbbVie Inc. (NYSE: ABBV), where he advanced the organizations oncology pipeline through the FDA approval of venetoclax, obtained four Break Through Designations and several Orphan Drug Designations. Prior to AbbVie, Gary held a position at Abbott Laboratories (NYSE: ABT) as Divisional Vice President of Global Oncology Development, where he advanced numerous compounds from Phase 0 through Phase 3 and developed partnerships to support programs, as well as at Ovation Pharmaceuticals Inc. as Chief Scientific Officer and Vice President of Clinical Affairs. Gary earned his B.S. at State University of New York at Stony Brook and his PhD and MD from The Johns Hopkins University School of Medicine where he was also an Assistant Professor of Oncology.
Yossi Maimon, CPA, MBA
Yossi Maimon is a senior executive with over 20 years of experience in corporate finance including private financing, IPO, follow on offerings, strategic collaborations and M&A. Yossi previously served as Chief Financial Officer at Protalix BioTherapeutics (NYSE: PLX), where he led the company’s IPO process, multiple follow on offerings and various strategic licensing and collaboration agreements. Prior to Protalix, Yossi was the Chief Financial Officer of ColBar LifeScience where he led corporate finance activities, fund raisings and legal aspects of the Company including the sale of Colbar to Johnson & Johnson (NYSE: JNJ). Yossi earned a B.A from the City University of New York and an MBA from Tel Aviv University. Yossi is licensed as a Certified Public Accountant in New York and Israel.
Dana Gelbaum, MSc, MBA
Dana Gelbaum is a biopharmaceutical executive with 20 years of experience in pre-commercial and business development. Previously Dana was Vice President, Global Marketing and Corporate Development at Chiasma (NASDAQ:CHMA), a biopharmaceutical company focused on orphan diseases. Dana led pre-commercial planning of octreotide capsules and select business development activities. Prior to Chiasma, Dana was Director of Business Development at Recoly N.V., a biopharmaceutical company focused on hemophilia. Previously, Dana was an Associate at Johnson & Johnson Development Corporation (JJDC), J&J’s investment arm, focusing on investments in biopharmaceutical and medical devices in Europe and Israel. Prior to JJDC, she was Associate in Ernst & Young Corporate Finance Life Science Department. Dana received her MSc, cum laude, and MBA from Tel Aviv University.
David Caron, PharmD
David Caron, PharmD, is a senior CMC executive with 30 years of experience in drug development. Previously David served as VP, CMC & Pharmaceutical Development at Chiasma (NASDAQ:CHMA), a biopharmaceutical company focused on orphan diseases. At Chiasma, David set up the company’s CMC and pharmaceutical development programs and managed timelines; was responsible for the formulation and analytical development of new products, in analytical chemistry and product stability, shipment validation to point of up to commercialization, including its human, budget and technology resources; plan and execute scale up and technical transfer of development of stage products; and plan and execute performance process qualification of a commercial product, among others. David has also held senior CMC roles at Mother’s Choice, Aposense (TASE:APOS), Cobalt Pharmaceuticals, Merck Generics, Perio Products and ABIC/Teva Pharmaceuticals (NYSE:TEVA). David earned a Doctor of Pharmacy, specializing in Pharmaceutical Technology, at the University of Pharmacy, Lyon, France.
Joel Kaye, PhD
Joel Kaye, PhD, joins Ayala with extensive experience in pharmacology and drug development. Prior to Ayala, Joel held various leadership positions at the Global R&D, Teva Pharmaceutical (NYSE: TEVA), focusing on nonclinical and pharmacological development of numerous products. In his last role, Joel was a Director at the Pharmacology Department, Discovery & Product Development and was the head of Cancer Pharmacology and new model development. Joel’s experience in drug development extends across the clinical development pathway, from discovery to Phase 3 and post-marketing life cycle management. Joel is an inventor or co-inventor of 13 patents and has published 20 articles. Joel did his Post-Doctoral Fellowship at Massachusetts General Hospital and Harvard Medical School and has a PhD in Immunology from the Weizmann Institute of Science, Israel.
Irit Klipper-Avni, MA
Irit Klipper-Avni is a human resources executive with 20 years of experience within global companies, including those in the life sciences industry. Most recently she served as Executive Vice President, HR for Israel Aerospace Industries where she was responsible for developing and implementing innovative and cross-organizational processes that supported thousands of employees. Previously, Irit held the position of HR Executive Director for Teva Pharmaceutical (NYSE: TEVA) leading global operations in Europe and Israel. In this role, she was involved in building organizational capabilities, developing and training management and shaping high performance cultures. Irit is a member of numerous professional forums including the Executive VP HR Forum and Senior Women’s Forum. She regularly speaks at professional and academic events, and serves as a judge in HR competitions. Irit earned her bachelor’s degree from Ben-Gurion University of the Negev and holds a master’s degree from Tel Aviv University.
David Sidransky, MD
David Sidransky, MD is the Co-Founder and General Partner of the Israel Biotech Fund. David is a renowned oncologist, research scientist and Professor of Oncology and Cellular & Molecular Medicine at Johns Hopkins University and Hospital. David was Vice Chairman of ImClone Systems until its acquisition by Eli Lilly (NYSE:LLY) for $6.5 billion in 2008. He founded several biotechnology companies, including Oncormed Inc, a genetic testing company that was sold to Gene Logic in 1998, and Response Genetics (NASDAQ: RGDX), a developer of markers for cancer therapy.
Roni Mamluk, PhD
Roni Mamluk, PhD is a senior biopharmaceutical executive with 16 years of experience in drug development companies and background in all aspects of R&D, general management and fundraising. Prior to Ayala Roni was at Chiasma (NASDAQ: CHMA) a biopharmaceutical company focused on orphan diseases where she fulfilled multiple positions including CEO (2013-2015). She is an inventor of their oral delivery technology, led the development of their lead product through all stages of development, including NDA submission. She was a key player in fundraising for the company including several private financing rounds and led a $70 million crossover financing and a successful IPO of over $100 million in 2015. Roni is now a board member at Chiasma. Prior to that she was heading preclinical development of an oncology product at Adnexus (which was later acquired by Bristol-Myers Squibb (NYSE:BMY)) in Waltham, MA and prior to that did her post doc at Children’s Hospital/Harvard Medical School in the field on angiogenesis. Roni received her PhD, summa cum laude from the Hebrew University in Jerusalem.
Robert Spiegel, MD, FACP
Robert Spiegel, MD is a physician and oncologist with over 30 years of biopharma experience. At Schering-Plough he was Senior Vice President of Worldwide Clinical Research, prior to becoming Chief Medical Officer and Senior Vice President of Schering-Plough Research Institute in 1998, a position he held until his retirement from Schering-Plough in 2009. Robert has deep experience in clinical product development, has been involved in filing over 30 New Drug Applications, and has extensive familiarity with regulatory authorities in the US and globally. Robert currently serves as Chairman of the Board of the private company Vidac Pharma and is on the Board of Directors of the public companies Geron Corporation (NASDAQ:GERN) and Edge Therapeutics (NASDAQ:EDGE). Robert is a venture advisor to the Israel Biotechnology Fund, Senior Advisor to Warburg Pincus as well as a consultant to various biopharma companies. Robert is also an Associate Professor at Weill Cornell Medical College. Earlier in his career, Robert was a Research Fellow at the NIH, National Cancer Institute and Assoc. Professor at NYU Cancer Center.
Murray A. Goldberg
Murray A. Goldberg has financial and operational experience at leading global pharmaceutical companies. Murray served as Senior Vice President-Administration and Chief Financial Officer of Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN), Chief Financial Officer, Treasurer & VP-Finance of PharmaGenics, Inc., and as a Managing Director-Structured Finance Group of The Chase Manhattan Bank NA. He currently serves as an advisor at the Israel Biotech Fund and as a board of director at Teva Pharmaceutical Industries, Ltd. (NASDAQ:TEVA) and at Aerie Pharmaceuticals (NASDAQ:AERI). Murray received his undergraduate degree from New York University, a graduate degree from the London School of Economics & Political Science, and an MBA from the University of Chicago.
Todd Sone
Todd Sone is a partner at aMoon and has over fifteen years of healthcare investment experience. Prior to joining aMoon, Todd was a Managing Director at Signet Healthcare Partners, a NYC-based investment fund that provides growth capital to commercial stage life-science companies. Todd has served on the boards of Arbor Pharmaceuticals (Sold to KKR), Apicore (Sold to Medicure), Impopharma, and Smart Medical Systems. He also helped oversee the investment in Claris Lifesciences (sold to Baxter). Prior to joining Signet, Todd was an Investment Director at Joddes Limited, a family investment holding company with interests in a number of healthcare companies, including Pharmascience, Paladin Labs, Medicom, and Oral Science. Todd was previously a large-cap pharmaceutical analyst at Morgan Stanley. Todd started his career at Mercer Management Consulting serving clients across North America in the transportation and healthcare industries. Todd received a BCom (with High Distinction) from the University of Toronto and an MBA from The Wharton School at the University of Pennsylvania with concentrations in healthcare management and finance.
Guy Harmelin, MD
Guy Harmelin, MD leads the Alternative Investments at Harel Insurance & Finance since 2017. Previously, he was the Co-Founder and CEO of RondinX, a microbiome drug target discovery company from 2015 to 2017 (acquired by BiomX). Prior to RondinX, Guy served as a Resident Physician at Tel Aviv Medical center and as a principal at 7-Health Ventures, a Life Science Venture Capital Fund.
Renata Ferrarotto, MD
Clinical Advisor
Renata Ferrarotto is an Associate Professor and the Director of the Head and Neck Clinical Research Program at MD Anderson Cancer Center. In this role, she dedicates time to patient care as well as to clinical and translational research. Her work focuses on clinical development of new personalized cancer therapies for patients with head and neck malignancies, particularly rarer subtypes.
Renata currently leads a project to investigate the importance of Notch1 mutations in patients diagnosed with adenoid cystic carcinoma (ACC), a rare salivary gland tumor. Her work demonstrated that Notch1 mutations in ACC define a subgroup of patients with an aggressive disease. She has received numerous awards for her work, including a Conquer Cancer Career Development Award and a Khalifa Scholar Grant.
Renata received her MD degree and completed her Clinical Residency and Fellowship in São Paulo in internal medicine and medical oncology.
Jon Aster, MD, PhD
Scientific Advisor
Jon Aster is a Professor of Pathology and Chief of the Division of Hematopathology at Brigham and Women’s Hospital and Harvard Medical School. He is also Director of the Specialized Histopathology Core, a CLIA licensed research facility that supports the 1100+ PIs of the Dana Farber/Harvard Cancer Center. For over 20 years, Jon has studied Notch signaling in various cancers, therapeutic targeting of Notch, and Notch related biomarker test development and implementation.
Jon’s lab has led or collaborated on work that has produced a number of firsts in Notch signaling, including production of the first mouse model of Notch leukemia; demonstrating that Notch signals can induce T cell development from bone marrow progenitors; demonstrating that T-ALL cells depend on continued Notch signaling for growth; detecting and characterizing frequent Notch1 mutations in human and murine T-ALL; solving key Notch structures at high resolution, including the structures of Notch transcription complexes on DNA; identification of Myc and mTOR as important downstream targets of leukemogenic Notch signaling; development of the first selective antibody inhibitor of specific Notch receptors; report of genome-wide Notch1 binding patterns in cancer cell genomes; and the description of Notch1 loss-of-function mutations in human squamous cell carcinomas.
Evgeny (Eugene) Izumchenko, PhD
Scientific Advisor
Evgeny Izumchenko is an Assistant Professor in the Department of Otolaryngology, Division of Head and Neck Cancer Research, Johns Hopkins School of Medicine. Eugene is a a leading researcher in the field of Notch signaling and carcinogenesis, and has an extensive background in tumor biology, molecular oncology, immunogenetics and genomics technologies.
Eugene’s research focus is on understanding the complex interplay between the genetic and epigenetic alterations in carcinogenesis and disease progression, and on exploiting this understanding for developing novel biomarkers for diagnosis and risk stratification as well as in identifying targets for therapeutic intervention. He has multiple publications, including in Nature Communications, Cancer Research, Clinical Cancer Research, Annals of Oncology and Cancer Discoveries.
Eugene received his PhD from Ben-Gurion University via the BGU /Fox Chase Cancer Center (FCCC) Partnership Graduate Research Program, where he provided some of the earliest insights on biomarkers for early assessment of breast tumor aggressiveness, and completed his postdoctoral training at the University of Florida, where he described novel mechanism by which dysregulation of genomic stability drives cancer development.