Avila Completes Dosing of First Patient Cohort in Phase 1b Clinical Study of AVL-292, a Selective Bruton’s Tyrosine Kinase

- Trial Advances AVL-292 to Second Dose Cohort in Patients with Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia -

BEDFORD, Mass.--(BUSINESS WIRE)-- Avila Therapeutics™, Inc., a biotechnology company developing targeted covalent drugs, announced today that it has completed 28 days of dosing of the first cohort of patients in its Phase 1b clinical trial of AVL-292 and is now advancing to the second dose cohort in this trial. The trial is being conducted in patients with B cell cancer malignancies including B-cell Non-Hodgkin Lymphoma (B-NHL) and Chronic Lymphocytic Leukemia (CLL). AVL-292 is a novel, orally available, and highly selective covalent inhibitor that inhibits Bruton’s tyrosine kinase (Btk). In two completed Phase 1a studies in healthy volunteers, AVL-292 demonstrated a favorable safety, tolerability, and pharmacokinetic profile.

“Selective inhibition of Btk could provide a critically needed new treatment option for patients with B cell cancers,” said Jennifer R. Brown, MD, PhD, Director of the Chronic Lymphocytic Leukemia Center at the Dana-Farber Cancer Institute. “Highly specific blockade of the B cell receptor signaling pathway is a newly emerging and promising approach to treating these cancers and Btk shows important potential as a molecular target in this pathway.”

“This is a significant step forward for both our Btk program and for Avila as a company,” said Katrine Bosley, Chief Executive Officer of Avila. “This program exemplifies what can be achieved with a targeted covalent drug – the possibility to address a difficult disease target and to deliver a differentially important new medicine. Our AvilomicsTM platform enables us to do this for a very broad range of targets and diseases, and we aspire to keep bringing forward new medicines that truly matter to patients.”

This Phase 1b multiple dose escalation trial (Avila study # AVL-292-003) is evaluating safety, tolerability and pharmacokinetics of AVL-292 as monotherapy in 28-day cycles in subjects with relapsed and/or refractory B-NHL, CLL, and Waldenstrom’s Macroglobulinemia. More information about this trial and enrollment criteria can be found at www.clinicaltrials.gov.

About AVL-292 and Bruton’s Tyrosine Kinase (Btk)

AVL-292 is a novel, orally available, covalent drug that inhibits Bruton’s tyrosine kinase (Btk). Inhibition of Btk is a promising new approach to treatment of diseases that are driven by B cells, including certain hematologic cancers such as non-Hodgkin lymphoma and B cell chronic lymphocytic leukemia and autoimmune diseases such as rheumatoid arthritis.

AVL-292 selectively and covalently bonds to Btk to inactivate and silence its activity. This mechanism of action confers greater target selectivity and a longer duration of action than is typical of conventional small molecule drugs. In preclinical studies, AVL-292 was efficacious in a variety of animal disease models. AVL-292 is in clinical development and has successfully completed two Phase 1a clinical studies to date.

Development of AVL-292 is supported in part by The Leukemia & Lymphoma Society.

About Avila Therapeutics™, Inc.

Avila Therapeutics is a clinical-stage biotechnology company focused on the design and development of targeted covalent drugs to achieve best-in class outcomes. This approach, called “protein silencing”, cannot be achieved through traditional chemistry techniques. The company’s product pipeline has been built using its proprietary Avilomics™ platform and is currently focused on cancer, viral infection and autoimmune disease. Avila’s most advanced product candidate, AVL-292, a potential treatment for cancer and autoimmune diseases, is currently in Phase 1 clinical testing. Avila is funded by leading venture capital firms: Abingworth, Advent Venture Partners, Atlas Venture, Novartis Option Fund, and Polaris Venture Partners. For additional information, please visit http://www.avilatx.com.


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Kathryn Morris, 845-635-9828

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