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Celgene to Acquire Avila Therapeutics

By Avila, Press Release
Press Release.

 

Oral Btk inhibitor AVL-292 offers promising potential for treatment of B-cell diseases

Avilomics™ Platform enhances drug discovery capabilities

SUMMIT, NJ and BEDFORD, MA – January 26, 2012 – Celgene Corporation (NASDAQ: CELG) and Avila Therapeutics, Inc., a privately held biotechnology company developing targeted covalent drugs that treat diseases through protein silencing, today announced a definitive merger agreement under which Celgene Corporation will acquire Avila Therapeutics, Inc.

The acquisition positions Celgene to expand its leading role in the future treatment of hematologic cancers with Avila’s AVL-292, a highly-selective Bruton’s tyrosine kinase (Btk) inhibitor, currently in phase I clinical development. In addition, Avila’s proprietary Avilomics™ Platform augments Celgene’s investment in the discovery and development of novel therapeutics for managing complex disorders.

“Avila Therapeutics is a remarkable company that is aligned with our commitment to improve the lives of patients worldwide through innovative science and disease-altering therapies,”

said Tom Daniel, M.D., President of Research and Early Development for Celgene Corporation.

“In particular, we see Avila’s unique approach to protein silencing as an area of great promise for our research initiatives in hematology, oncology and immune-inflammatory diseases.”

“Celgene and Avila are uniquely matched, both strategically and scientifically,”

said Katrine Bosley, Avila’s Chief Executive Officer.

“Celgene’s global leadership in hematology and emerging franchise in immune-inflammatory diseases will accelerate and expand the clinical development of our Btk inhibitor program. Equally important, we value the high standards of creativity and rigor of Celgene’s scientists. We believe working together may accelerate the advancement of more innovative medicines from the Avilomics platform.”

The transaction has been approved by the Board of Directors of each company and is subject to customary closing conditions, including the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Under the terms of the merger agreement, Celgene will acquire Avila Therapeutics, Inc. for $350 million in cash, plus up to $195 million for milestones contingent upon the development and regulatory approval of AVL-292, as well as up to $380 million in potential milestone payments contingent upon the development and approval of candidates generated from the Avilomics platform. The acquisition of Avila Therapeutics, Inc. will be accounted for as a purchase transaction that Celgene expects to be completed during the first quarter of 2012. The Company anticipates the acquisition will be neutral to 2012 non-GAAP diluted earnings guidance.

About Celgene
Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the company’s Web site at www.celgene.com.

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. 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.

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’s 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.

About Targeted Covalent Drugs
Targeted covalent drugs are new small-molecule medicines that have the unique opportunity not simply to inhibit disease-causing proteins, but to “silence” them completely. This is because targeted covalent drugs do not merely “bind” to a protein, but they form a durable “bond,” which shuts down the protein’s activity throughout the life of the protein leading to two primary benefits; precise selectivity and retained efficacy against mutations. Avila is the first company to design and develop targeted covalent drugs robustly, systematically and across the vast majority of target classes. This is enabled by Avila’s proprietary Avilomics™ platform.

Forward-Looking Statements
This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words “expects,” “anticipates,” “believes,” “intends,” “estimates,” “plans,” “will,” “outlook” and similar expressions. Forward-looking statements are based on management’s current plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertake no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in our Annual Report on Form 10-K and our other reports filed with the Securities and Exchange Commission.

Avila Announces FDA Allowance of Partner Clovis Oncology’s IND Application

By Avila, Press Release
Press Release.

 

Avila Announces FDA Allowance of Partner Clovis Oncology’s IND Application for CO-1686,
an Oral EGFR Mutant-Selective Inhibitor

Triggers $4 Million Milestone Payment to Avila

BEDFORD, Mass.–(BUSINESS WIRE)– Avila Therapeutics™, Inc. a biotechnology company
developing targeted covalent drugs that treat diseases through protein silencing, announced
that it has achieved the first milestone in its Epidermal Growth Factor Receptor (EGFR) Mutant
-Selective Inhibitor (EMSI) alliance with Clovis Oncology triggering a $4 million milestone payment
to Avila.

The U.S. Food and Drug Administration (FDA) has allowed an investigational new drug (IND)
application to begin clinical investigation of CO-1686, a novel, oral, targeted covalent inhibitor of
epidermal growth factor receptor (EGFR) mutations in non-small cell lung cancer (NSCLC). Initial
Phase I/II studies with CO-1686 are expected to commence in the U.S. and Europe during the
second quarter of 2012 and in Asia during the third quarter of 2012. CO-1686 is the second
covalent drug to advance to clinical development from Avila’s proprietary Avilomics™ platform,
along with Avila’s proprietary drug candidate AVL-292, a Bruton’s Tyrosine Kinase (Btk) inhibitor
in Phase Ib clinical development for the treatment of B-cell cancers.

“We are pleased with the tremendous progress that our partners at Clovis have made in
advancing CO-1686 into development, particularly in NSCLC, a disease for which novel
treatments are so sorely needed,”

said Katrine S. Bosley, CEO of Avila Therapeutics.

“With this achievement we have now successfully created two clinical development candidates using our targeted covalent drug platform. This further demonstrates our ability to design and develop innovative medicines using Avilomics.”

EGFR activating mutations occur in approximately 10 to 15 percent of NSCLC cases in Caucasian
patients and approximately 30 to 35 percent in East Asian patients. These patients experience
significant tumor response to erlotinib (Tarceva®) and gefitinib (Iressa®), which are first-
generation EGFR inhibitors. However, most patients ultimately progress on erlotinib and gefitinib
therapy, with approximately 50 percent of patients developing acquired resistance from a second,
or “gatekeeper” mutation, T790M. CO-1686 was designed and developed to selectively target
both the initial activating EGFR mutations as well as the T790M mutation, while sparing wild-type,
or “normal” EGFR. Because CO-1686 spares wild-type EGFR, it has the potential to cause a
lower incidence of skin rash and diarrhea, the primary toxicities associated with other EGFR
inhibitors.

Because CO-1686 inhibits the initial activating mutations of EGFR as well as T790M mutations, it
also has the potential to effectively treat first-line NSCLC patients. CO-1686 may prevent the
T790M resistance from occurring, which could result in responses of greater duration and,
because it does not inhibit wild-type EGFR, it may possess a more tolerable side-effect profile.
CO-1686 is a targeted covalent, or permanent, inhibitor of EGFR mutations. As a covalent drug,
CO-1686 forms a durable bond with its target mutations in a highly directed and controlled
manner. Preclinical data presented in late 2011 demonstrated that CO-1686 causes tumor
shrinkage in T790M-driven NSCLC xenograft models, and resulted in significant tumor growth
inhibition at a variety of doses.

About the Avila Alliance with Clovis Oncology

Avila and Clovis Oncology entered into a partnership for the worldwide development and
commercialization of an EGFR Mutant-Selective Inhibitor (EMSI) in May 2010. Under the terms of
the agreement, the two companies collaborated on the preclinical development of the EMSI
program and Clovis Oncology is fully responsible for worldwide development and
commercialization, including development of companion diagnostics to prospectively identify
patients with clinically-arising resistance mutations of the EGFR. Avila is eligible to receive
development, regulatory and sales-based milestone payments, with a total potential value of $209
million, as well as tiered royalties on potential future product sales.

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.

Avila Therapeutics agreement with NIAID

By Avila, Press Release
Press Release.

 

WALTHAM, MA – June 8, 2011 –Avila Therapeutics, Inc. a biotechnology company developing targeted covalent drugs that treat diseases through protein silencing, announced that it has entered into a Non‐Clinical Evaluation Agreement to access the National Institute of Allergy and Infectious Diseases’ (NIAID’s) preclinical services program to further evaluate AVL‐192, Avila’s targeted, irreversible covalent inhibitor of the HCV protease (NS3). Under the agreement, NIAID‐funded contractors are conducting preclinical studies of AVL‐192 to help enable its future clinical development, and Avila retains exclusive rights to this compound.

“We thank NIAID for their foresight in supporting this innovative program,”

said Dr. Juswinder Singh, Chief Scientific Officer of Avila.

“NS3 protease is now recognized as a key target of therapeutic intervention in HCV infection, and the ability of AVL‐192 to strike at known drug‐resistant mutations will be a critical feature of next generation protease inhibitors.”

AVL‐192 is a novel, orally‐available compound that rapidly and completely silences the HCV protease through highly selective, irreversible covalent bonding to the target protein. Preclinical data generated by Avila demonstrate that it is highly potent, selective, and effectively inhibits drug‐resistant mutations of HCV protease. AVL‐192 forms an irreversible bond with Cys159, a non‐catalytic amino acid that is present in all variants of HCV protease, thus creating the potential for inhibition across all known HCV genotypes. In addition, AVL‐192 has shown unusually high potency by demonstrating the ability to clear replicon cells as a monotherapy in vitro.

NIAID conducts and supports basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. For more than 60 years, NIAID research has led to new therapies, vaccines, diagnostic tests, and other technologies that have improved the health of millions of people in the United States and around the world.

 

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.

Avila Presents New Data on its Novel, Orally-Available Targeted Covalent Drug, AVL-192

By Avila, Press Release
Press Release.

 

Covalent Inhibition Achieves Superior Potency Against Drug-Resistant HCV Mutants

 

BOSTON and WALTHAM, MA – Avila Therapeutics™, Inc., a biotechnology company developing novel targeted covalent drugs, presented results today of preclinical studies that demonstrate its orally-available targeted covalent drug candidate, AVL-192, achieves superior potency against drug-resistant mutations of the Hepatitis C Virus (HCV). These new data were presented today at the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) international meeting in Boston, Massachusetts.

HCV protease (also known as NS3) is a promising target of intervention for the treatment of hepatitis C infection. However, medicines currently in late stages of clinical development are vulnerable to drugresistant mutations. AVL-192 is a novel, orally available compound that can rapidly and completely silence the HCV protease through highly selective, irreversible covalent bonding to the target protein. Preclinical data have demonstrated that AVL-192 achieves very high potency and selectivity for NS3 and also potently and effectively inhibits the drug-resistant mutations observed clinically.

Avila’s covalent approach to silencing the NS3 protein has resulted in a product candidate with a potential best-in-class profile due to the ability to retain potency against clinically-arising resistance
mutations, and potential breadth of activity across HCV genotypes with anticipated once-per-day dosing.

In a poster presentation at the meeting, entitled, “Second Generation of Covalent Irreversible Inhibitors Have Superior Potency Across Genotypes and Drug Resistant Mutants,” data were presented from preclinical studies that evaluated the efficacy of AVL-192 in biochemical and cell culture studies.

Highlights of the data demonstrate:

• AVL-192 has a time-dependent mode of action that delivers potent and rapid inhibition of WT NS3/4A and retains high potency against drug-resistant mutant NS3/4A proteases;

• AVL-192 is able to inhibit the protease long after the compound is removed, offering the benefit of less frequent dosing;

• AVL-192 as monotherapy can be curative in the replicon clearance assay;

• AVL-192 is highly selective and spares host proteases; and

• AVL-192 has high plasma exposure following oral administration in rats and dogs. “These new data reinforce our belief that our targeted covalent drug candidate AVL-192 has the potential to be a best-in-class, pan-genotype HCV therapeutic due to its unique mechanism of action,” said Juswinder Singh, Ph.D., Avila’s Founder and Chief Scientific Officer.

About Avila Therapeutics™, Inc.
Avila focuses on design and development of targeted covalent drugs to achieve best-in-class outcomes that cannot be achieved through traditional chemistries. This approach is called “protein silencing”. The company’s product pipeline has been built using its proprietary Avilomics™ platform and is currently focused on viral infection, cancer and autoimmune disease. Avila is funded by leading venture capital firms: Abingworth, Advent Venture Partners, Atlas Venture, Novartis Option Fund, and Polaris Venture Partners.

Avila Initiates Phase 1 Clinical Study of AVL-292, a Targeted Covalent Drug and Novel Potential Treatment for B Cell Cancers and Autoimmune Diseases

By Avila, Press Release
Press Release.

 

WALTHAM, Mass. – Avila Therapeutics™, Inc., a biotechnology company developing targeted covalent drugs, announced today that it has initiated a phase 1 clinical trial to assess the safety, tolerability and pharmacokinetic profile of AVL-292, a novel, orally available, covalent drug that targets Bruton’s tyrosine kinase (Btk). AVL-292 is the first product candidate to enter clinical evaluation from Avila’s proprietary covalent drug platform, Avilomics™.

“Initiating clinical development of AVL-292 is an important milestone in our development of a new generation of rationally-designed, targeted covalent drugs,”

said Katrine Bosley, Chief Executive Officer of Avila.

“By addressing a target that has been difficult for others to address successfully AVL-292 has the potential to help patients in need of new therapies for B cell cancers and autoimmune diseases like rheumatoid arthritis.”

B cells are implicated in multiple diseases, and Btk plays a critical role in the signaling and proliferation of B cells. Potent, selective inhibition of Btk has the potential to be therapeutically important in the treatment of B cell-related hematological cancers such as non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL), as well as autoimmune diseases such as rheumatoid arthritis. In preclinical studies, AVL-292 selectively and potently inhibited Btk in vitro and was efficacious in a variety of different animal disease models.

The first clinical study of AVL-292, which is being conducted in the U.S., is a double-blind, placebo-controlled, single ascending dose study and will evaluate the safety, tolerability, and pharmacokinetic profile of AVL-292 in healthy volunteers. In addition, this study will use Avila’s unique covalent probe technology to evaluate quantitatively the relationships among dose level, systemic exposure and occupancy of the target by AVL-292. This combination of analyses is designed to provide a powerful and rigorous understanding of AVL-292 action at the molecular and cellular levels and may serve to guide future clinical development.

“The Leukemia & Lymphoma Society is very excited about AVL-292 moving into clinical evaluation. There remains a great need for therapies that work by new mechanisms to treat patients who are fighting blood cancers, and we believe that targeting Bruton’s tyrosine kinase may be an important new approach to benefit the patients we serve,”

said Louis DeGennaro, Ph.D., Chief Mission Officer of The Leukemia & Lymphoma Society, with whom Avila established a collaboration in March 2010.

 

About Avila Therapeutics
Avila focuses on design and development of targeted covalent drugs to achieve best-in-class outcomes that cannot be achieved through traditional chemistries. This approach is called “protein silencing”. The company’s product pipeline has been built using its proprietary Avilomics™ platform and is currently focused on cancer, autoimmune disease, and hepatitis C infection. Avila is funded by leading venture capital firms: Abingworth, Advent Venture Partners, Atlas Venture, Novartis Option Fund, and Polaris Venture Partners.

The Leukemia & Lymphoma Society and Avila Therapeutics Enter Partnership to Accelerate Development of AVL-292 For Patients with Cell B Malignancies

By Avila, Press Release
Press Release.

 

White Plains, NY and Waltham, Mass. – The Leukemia & Lymphoma Society (LLS) and Avila Therapeutics, Inc., today announced they have established a collaboration to support development of one of Avila’s lead product candidates, AVL-292, for treatment of adults with B cell cancers.

Through the partnership, LLS will provide up to $3.2 million to support Avila’s clinical development of AVL-292. Avila anticipates the drug entering clinical trials in 2010.

B cells are an important component of the body’s immune system. B cells can become cancerous, leading to diseases such as non-Hodgkin lymphoma. Approximately 85 percent of non-Hodgkin lymphomas originate from B cells. AVL-292 is a targeted covalent drug designed to bind specifically to the protein target Bruton’s Tyrosine Kinase (Btk). Btk plays a critical role in B cell development and activation, and it is believed the inhibition of Btk will provide benefits in treating B cell cancers.

Taking an active role in accelerating development of novel therapies for patients, LLS has committed substantial, multi-year funding to support this collaboration as part of its Therapy Acceleration Program (TAP). TAP is LLS’s bold initiative designed to advance therapies with high prospects of providing near-term benefit to patients suffering from blood cancers. By partnering directly with biotechnology companies, LLS is taking a results-oriented approach to more quickly identify potential breakthrough therapies and advance them along the FDA drug approval pathway.

“Avila, with its targeted covalent approach to Btk, hopes to develop, and ultimately deliver to patients, a cancer treatment with optimal efficacy and safety. We believe AVL-292 is a therapeutic candidate with significant opportunity to benefit the patients that we serve, and that Avila is an excellent partner for the LLS. Together the LLS and Avila hope to change the standard of care and improve the quality of life for patients suffering from blood cancer,”

said Louis DeGennaro, Ph.D., LLS’s chief mission officer.

“We are very honored that The Leukemia & Lymphoma Society recognizes the potential of AVL-292 and is making this substantial investment with Avila, which will significantly enhance the drug’s development,”

says Katrine Bosley, Avila’s chiefexecutive officer.

“In pursuing their mission, LLS is combining scientific advancement with connecting to doctors and patients – that ‘translational thinking’ helps companies like Avila cross the bridge from research into development much more effectively forpeople battling blood cancers.”

 

About The Leukemia & Lymphoma Society
The Leukemia & Lymphoma Society® (LLS) is the world’s largest voluntary health agency dedicated to blood cancer. The LLS mission: Cure leukemia, lymphoma, Hodgkin’s disease and myeloma, and improve the quality of life of patients and theirfamilies. LLS funds lifesaving blood cancer research around the world and provides free information and support services.

Founded in 1949 and headquartered in White Plains, NY, LLS has chapters throughout the United States and Canada. To learn more, visit www.LLS.org or contact the Information Resource Center at (800) 955-4572, Monday through Friday, 9a.m. to 6 p.m. ET. www.lls.org.

About Avila Therapeutics™, Inc.
Avila focuses on design and development of targeted covalent drugs to achieve best-inclass outcomes that cannot be achieved through traditional chemistries. This approach is called “protein silencing”. The company’s product pipeline has been built using its proprietary Avilomics™ platform and is currently focused on viral infection, cancer and autoimmune disease. Avila is funded by leading venture capital firms: Abingworth, Advent Venture Partners, Atlas Venture, Novartis Option Fund, and Polaris Venture Partners.

Avila presents data on its novel, orally-available protease inhibitor, AVL-181, demonstrating viral clearance of hepatitis C virus in preclinical models

By Avila, Press Release
Press Release.

 

BOSTON & WALTHAM, Mass. – Avila Therapeutics™, Inc., a biotechnology company developing novel covalent drugs that treat diseases through protein silencing, presented results of preclinical studies on its highly selective, small molecule Hepatitis C Virus (HCV) protease inhibitor, AVL-181. Avila showed that AVL-181 promoted complete viral clearance in vitro when used at clinically-relevant concentrations in combination with other HCV therapies. Additionally, using an innovative technology for measuring the extent of covalent bond formation, Avila showed that AVL-181 bonds selectively and irreversibly to HCV protease in vivo in a novel rodent model, thus silencing a key protein necessary for successful viral replication and resulting in a prolonged duration of action in vivo. These new data were presented today at the 60th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) international meeting in Boston, Massachusetts.

“Our clinical candidate, AVL-181, demonstrated inhibition across multiple genotypes and drug-resistant mutations of the HCV protease. In addition, the data showing complete viral clearance in conjunction with other cutting edge therapies are striking,”

said Katrine Bosley, Chief Executive Officer, Avila.

“These data provide additional support for the clinical evaluation of AVL-181, and we are on track to advance into clinical development next year.”

In one presentation, “Potential for Rapid and Prolonged Therapeutic Benefit in HCV through Protein Silencing of NS3 Protease with AVL-181”, the data show that the orally-available, novel HCV protease inhibitor, AVL-181:

selectively bonds the HCV NS3 protease to completely and irreversibly inactivate proteolytic activity, essentially silencing the HCV protease complex; forms a highly specific covalent bond across HCV genotypes and clinically-described drug-resistant mutant proteases; inhibits protease activity in cultured replicon cells for >48 hours after very brief exposure and removal of AVL-181; demonstrates prolonged pharmacodynamic activity for both wild-type and drug-resistant mutations (e.g. R155K); and; results in clearance of HCV RNA from replicon cells in conjunction with a non-nucleoside polymerase inhibitor, contributing to a profile that differentiates AVL-181 from clinically investigated agents.

In a second presentation, “AVL-181 Demonstrates Prolonged Inhibition of HCV NS3 Protease Activity In Vivo that Directly Correlates with Prolonged Molecular Target Occupancy”, the data demonstrate that the orally available, novel HCV protease inhibitor, AVL-181: potently and irreversibly silences HCV proteases, and that the level of protease inhibition is directly correlated with the extent of target bonding; durably inhibits the HCV protease for at least 10 hours in vivo after a single exposure as measured in a novel model in which NS3/4A is expressed in the mouse liver; and this duration of action coupled with the low plasma levels of AVL-181 at this late timepoint confirm that the covalent mechanism does not depend on the near-continuous drug exposure such as that required by the reversible HCV protease inhibitors currently in late-stage clinical trials.

 

About the Avilomics™ Platform and Covalent Drugs

The Avilomics platform is Avila’s powerful approach to design and develop covalent drugs that strongly, selectively, and resiliently bond to disease?causing proteins, thereby silencing their activity and producing superior pharmacological outcomes. Covalent drugs inherently provide prolonged duration of action through this silencing of the disease target, and they can solve the critical therapeutic challenges of drugging difficult targets and addressing resistance mutations. The three components of Avilomics are:

Compositions: Innovative chemical structures for forming highly selective, not indiscriminate, covalent bonds
Design: Proprietary informatics to uniquely identify sites amenable to selective covalent modification and target silencing
Testing: Empirical methods to demonstrate covalent specificity at both target and proteomic levels

Together, these components provide a platform for efficient design and testing of covalent drugs. Avilomics opens up the broad potential of covalent drugs across target classes and disease areas, as demonstrated with the company’s emerging pipeline of novel, protein silencing covalent drugs.

 

About Avila Therapeutics™, Inc.

Avila focuses on design and development of covalent drugs to achieve best-in-class outcomes that cannot be achieved through traditional chemistries. This approach is called “protein silencing”. The company is developing a pipeline of novel, protein-silencing covalent drugs with a current focus on viral infection, cancer and autoimmune disease. Avila is funded by leading venture capital firms: Abingworth, Advent Venture Partners, Atlas Venture, Novartis Option Fund, and Polaris Venture Partners.

Contact:
Yates Public Relations
Adriana Jenkins,
617-710-8350

Avila Therapeutics Announces Agreement with Novartis to Develop Novel Covalent Drug Candidate

By Avila, Press Release
Press Release.

 

WALTHAM, Mass.–(BUSINESS WIRE)– Avila Therapeutics, Inc., an emerging biotechnology company, announced today that it 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 over $200 million plus royalties. Avila’s covalent drugs offer the potential to treat many serious diseases through a novel mechanism called protein silencing.

“We are excited about the opportunity presented by Avila’s innovative approach to the design and development of covalent drugs,”

said Henry Skinner, Ph.D., 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,”

said Katrine S. Bosley, CEO of Avila Therapeutics.

“The agreement is a strong complement to Novartis’ equity investment in Avila, and together these steps represent an important evolution in Avila’s strategic development. 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.”

 

About the Avilomics™ Platform and Covalent Drugs

With broad applicability across multiple disease areas, the Avilomics platform is Avila’s powerful approach to design and develop selective drugs with superior pharmacology. The three components of Avilomics are: i) proprietary informatics technologies that uniquely identify sites amenable to selective covalent modification and target silencing, ii) a unique library of highly selective chemistries for target silencing, and iii) 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. Using Avilomics, the company designs and develops covalent drugs that strongly, selectively, and resiliently bond to disease-causing proteins, thereby silencing their activity and producing superior pharmacological outcomes.

Avila Therapeutics is developing an innovative and proprietary therapeutic approach to covalent drug development, called “protein silencing”. Avila’s science has the potential to deliver covalent drugs with unique therapeutic benefits because they are highly targeted, are effective against mutations in disease targets, and have long duration of action. The company is developing a pipeline of novel, protein silencing covalent drugs with a current focus on viral infection, cancer and autoimmune disease. Avila is funded by leading venture capital firms: Abingworth, Advent Venture Partners, Atlas Ventures, Novartis Option Fund, and Polaris Venture Partners. For additional information, please visit http://www.avilatx.com.

 

About the Novartis Option Fund

The Novartis Option Fund is a $200 million fund that is part of the Novartis Venture Funds. Established in 1996, the Novartis Venture Funds currently manage over $650 million in committed capital and is invested in more than 50 private companies. The objective of the Novartis Option Fund is to seed innovative companies through initial and follow on investments. The initial investment is coupled with an option to a specific therapeutic program providing early validation for the company’s technology by a larger pharmaceutical partner. The Novartis Venture Funds’ team of eight investment professionals located in Basel, Switzerland and Cambridge, Massachusetts, brings together extensive expertise in the biotech and pharmaceutical industry and venture capital.

 

Source: Avila Therapeutics, Inc.

Avila Therapeutics, Inc. Closes $30 Million Series B Financing

By Avila, Press Release
Press Release.

 

Company to Advance Novel Class of Protein-Silencing Covalent Drugs into Clinic Development

 

WALTHAM, Mass.–(BUSINESS WIRE)– Avila Therapeutics, Inc., an emerging biotechnology company, announced today that it has raised $30 million in a Series B equity financing. The Novartis Option Fund, a new investor, led the round and all existing Avila investors participated: Abingworth, Advent Venture Partners, Atlas Venture and Polaris Venture Partners. Avila’s powerful platform technology, which was designed to create a broad set of covalent drug product opportunities that fight disease through protein silencing, has demonstrated preclinical activity with two programs, one targeting hepatitis C virus protease and the other targeting Btk, an emerging target in autoimmune disease and certain cancers, and has also generated multiple additional early-stage programs across a range of targets.

“Avila’s innovations and proprietary know-how make it possible to intelligently pursue covalent drugs, a broad product class that has been underutilized to date. The Avila team has already developed promising drug candidates against important targets in cancer, autoimmune disease and hepatitis C, and we see opportunities for Avila’s platform to be applied to many target types across a range of diseases,”

said Henry Skinner, Ph.D., Managing Director of the Novartis Option Fund.

“I look forward to working with Avila’s leadership team as they move programs forward that have the potential to offer a truly significant advance over current treatments.”

“With the Novartis Option Fund we are very pleased to expand our circle of industry-leading investors,”

said Katrine S. Bosley, CEO of Avila Therapeutics.

“Avila has made tremendous progress in developing and demonstrating the promise of covalent drugs. This financing provides us with a strong financial foundation and firmly validates our investors’ belief in Avila’s future and the best-in-class potential of covalent drugs.”

 

Proceeds from the financing will be used to advance Avila’s first program into clinical development while continuing to advance the proprietary Avilomics™ drug discovery platform. In conjunction with this financing transaction, Henry Skinner, Ph.D., Managing Director of the Novartis Option Fund, has joined the Avila board of directors. He joins board members Daniel Lynch (Executive Chairman); Michael F. Bigham (Abingworth); Bruce L. Booth, D.Phil. (Atlas Venture); Katrine Bosley; Roy Lobb, D.Phil.; Amir Nashat, Ph.D. (Polaris Venture Partners); Raj Parekh, D.Phil. (Advent Venture Partners) and Vicki Sato, Ph.D.

 

About the Avilomics™ Platform and Covalent Drugs

With broad applicability across multiple disease areas, the Avilomics platform is Avila’s powerful approach to design and develop selective drugs with superior pharmacology. The three components of Avilomics are: i) proprietary informatics technologies that uniquely identify sites amenable to selective covalent modification and target silencing, ii) a unique library of highly selective chemistries for target silencing, and iii) 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. Using Avilomics, the company designs and develops covalent drugs that strongly, selectively, and resiliently bond to disease-causing proteins, thereby silencing their activity and producing superior pharmacological outcomes.

 

About Avila Therapeutics™, Inc.

Avila Therapeutics is developing an innovative and proprietary therapeutic approach to covalent drug development, called “protein silencing”. Avila’s science has the potential to deliver covalent drugs with unique therapeutic benefits because they are highly targeted, are effective against mutations in disease targets, and have long duration of action. The company is developing a pipeline of novel, protein-silencing covalent drugs with a current focus on viral infection, cancer and autoimmune disease. Avila is funded by leading venture capital firms: Abingworth, Advent Venture Partners, Atlas Ventures, Novartis Option Fund, and Polaris Venture Partners. For additional information, please visit http://www.avilatx.com.

 

About the Novartis Option Fund

The Novartis Option Fund is a $200 million fund that is part of the Novartis Venture Funds. Established in 1996, the Novartis Venture Funds currently manage over $650 million in committed capital and is invested in more than 50 private companies. The objective of the Novartis Option Fund is to seed innovative companies through initial and follow on investments. The initial investment is coupled with an option to a specific therapeutic program providing early validation for the company’s technology by a larger pharmaceutical partner. The Novartis Venture Funds’ team of eight investment professionals located in Basel, Switzerland and Cambridge, Massachusetts, brings together extensive expertise in the biotech and pharmaceutical industry and venture capital.

 

Source: Avila Therapeutics, Inc.

Avila Therapeutics Appoints Katrine S. Bosley as Company’s First CEO

By Avila, Press Release
Press Release.

 

WALTHAM, Mass.–(BUSINESS WIRE)– Avila Therapeutics, an emerging biopharmaceutical company developing a revolutionary new class of medicines known as covalent drugs, announced today that Katrine S. Bosley has been appointed as Chief Executive Officer. Ms. Bosley is a biotechnology executive experienced in corporate development of emerging and established biopharmaceutical companies and joins Avila as it advances its business strategy, product pipeline, and proprietary platform.

“Avila’s focus on the design and development of covalent drugs is an area that has been only modestly explored by traditional pharmaceutical companies. This has given us a very broad set of unique product opportunities,”

commented Katrine Bosley, Chief Executive Officer.

“We’ve shown with our lead programs that we can deliver products with novel pharmacologic profiles that have the potential to provide unprecedented therapeutic benefits for patients. Furthermore, our strong investor base and experienced leadership team bring to bear the resources and expertise necessary to successfully advance our pipeline.”

Ms. Bosley joins Avila from Adnexus where she served as Vice President, Business Development and later as VP, Strategic Operations, establishing an alliance with and subsequent acquisition by Bristol-Myers Squibb. During her career she has worked with products from discovery through commercialization, including Avonex®, Tysabri®, and the emerging Adnectin™ class of targeted biologics. Ms. Bosley was at Biogen Idec for many years where she held leadership roles in business development, commercial operations, and portfolio strategy in both the U.S. and Europe. She also held positions at Highland Capital Partners, a venture capital firm, and Alkermes, a drug delivery company. Ms. Bosley is a graduate of Cornell University.

 

About Avila Therapeutics

Avila Therapeutics is developing a new therapeutic approach called ‘protein silencing’ based on a proprietary platform for developing covalent drugs that strongly and resiliently bond to disease-causing proteins, resulting in drugs that can be highly effective.

Avila’s covalent drugs have the potential to deliver unique therapeutic benefits because they are highly targeted, are effective against mutations, and have long duration of action. Avila is developing a pipeline of novel, protein silencing drugs with a current focus on viral infection, cancer, and autoimmune diseases. Avila is funded by four leading venture capital firms: Abingworth, Advent Venture Partners, Atlas Ventures, and Polaris Venture Partners. For additional information, please visit http://www.avilatx.com.

 

Source: Avila Therapeutics

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http://www.businesswire.com/news/home/20090515005123/en