Novartis sponsors Avila Therapeutics’ covalent drug candidate

Avila Therapeutics Inc. has entered into an option agreement with the Novartis Option Fund focused on Avila’s advancement of a novel covalent drug program from Avila’s research pipeline in conjunction with an equity investment

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BASEL, Switzerland—Avila Therapeutics Inc. has entered into an option agreement with the Novartis Option Fund focused on Avila's advancement of a novel covalent drug program from Avila's research pipeline in conjunction with an equity investment. The agreement includes upfront and potential milestones payments to Avila totaling more than $200 million plus royalties. Avila's covalent drugs offer the potential to treat many serious diseases through protein silencing.

"We are excited about the opportunity presented by Avila's innovative approach to the design and development of covalent drugs," says Dr. Henry Skinner, managing director of the Novartis Option Fund. "We selected an early program that validates the Avilomics platform and offers a unique product opportunity for Novartis."

"This relationship both enables us to advance our third program and also underscores the value of our platform to create covalent drugs," says Katrine S. Bosley, CEO of Avila Therapeutics. "We anticipate establishing a select number of strategic relationships in order to take full advantage of the breadth and depth of the Avilomics platform, and we're very pleased to have Novartis as the first."

Bosley points out that covalent drugs have been relatively little explored. The Avilomics platform, she stresses, integrates available data to inform the design process.

"It's not random screening," she emphasizes.

Unlike most drugs, where inhibition only occurs when the drug is bound to the target, which is an equilibrium function, covalent drugs bind selectively, strongly and permanently. With broad applicability across multiple disease areas, the Avilomics platform is a three-step process that includes proprietary informatics technologies that uniquely identify sites amenable to selective covalent modification and target silencing; a unique library of highly selective chemistries for target silencing; and design tools that integrate target analysis and covalent chemistry to create novel medicines. Together, these components provide a platform for efficient design and testing that yields covalent drug candidates with broad applicability to a variety of targets and diseases, Bosley states.

In April 2009 at the American Association for Cancer Research (AACR) annual meeting, Avila presented results of preclinical studies that demonstrate that two compounds, AVL-291 and CNX-222, silence specific cancer-causing proteins. The presentations showed results of studies with AVL-291, a Bruton's Tyrosine Kinase ("Btk") inhibitor for the treatment of B cell malignancies, and CNX-222, a Pan-ErbB inhibitor that inhibits the ErbB family of targets, including EGFR and Her-2, for the treatment of breast and non-small cell lung cancer. With the compounds' ability to covalently modify their protein targets, leading to irreversible inhibition and overcoming known resistance mechanisms, they may represent a new therapeutic option for the treatment of many prevalent and aggressive cancers.

Also coming through the Avila pipeline is a covalent drug designed to bind to NS3, a protein encoded by the hepatitis C virus. The World Health Organization estimates that 170 million people worldwide are chronically infected with HCV and another 3 to 4 million are newly infected every year The current standard of care is only effective in approximately half of infected individuals, but clinical studies have validated the NS3 protease, a protein encoded by the virus, as an important target of pharmaceutical intervention for vastly improved outcomes. Avila's covalent approach to silencing the NS3 protein has resulted in a product candidate with a potential best-in-class profile due to superior duration of action, breadth of activity against multiple HCV genotypes and the ability to retain potency against clinically-arising resistance mutations.

Bosley notes that in vitro testing has already demonstrated activity against several HCV mutants. Avila's HCV program and its Btk inhibitor program are on track to enter the clinic next year, she states.

Novartis acquires Opexa's stem cell technology

BASEL, Switzerland—In August, Novartis also acquired the stem cell technology of Opexa Therapeutics Inc., a company developing a novel T-cell immunotherapy for multiple sclerosis.

This technology, which has generated preliminary data showing the potential to generate monocyte derived islet cells from peripheral blood mononuclear cells, was in early preclinical development at Opexa.

Novartis will have full responsibility for funding and carrying out all research, development and commercialization activities. Opexa will receive an upfront cash payment of $3 million, plus an additional $1 million as a technology transfer fee to be paid over the course of a six-month period. Total payments to Opexa, including the upfront payment, the technology transfer fee and development and commercial milestone payments could exceed $50 million not including royalties. Opexa is also eligible to receive royalty payments from the sale of any products resulting from the use of the technology and retains an option on certain manufacturing rights.

"This represents a great opportunity for Opexa," says Neil K. Warma, Opexa's president and CEO. "Novartis is one of the premier pharmaceutical companies and the expertise they bring to this program will undoubtedly advance the technology significantly. This agreement will also allow us to firmly focus our attention on our key clinical asset, Tovaxin."

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