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Avalanche Biotechnologies Announces Appointment of Samuel B. Barone, M.D., as Chief Medical Officer

MENLO PARK, Calif., July 1, 2014 -- Avalanche Biotechnologies, Inc., a leader in the development of innovative gene therapies for serious eye diseases such as wet age-related macular degeneration (AMD), today announced the appointment of Samuel B. Barone, M.D. in the role of Chief Medical Officer. Dr. Barone will lead the company’s clinical development programs, including advancing Avalanche’s lead product, AVA-101 for the treatment of wet AMD. Dr. Barone will report to Thomas Chalberg, Ph.D., Avalanche’s Co-Founder and Chief Executive Officer.

“We are thrilled to have Dr. Barone join Avalanche as our Chief Medical Officer,” said Dr. Chalberg. “A board-certified ophthalmologist specializing in the treatment of retina and macular diseases, Dr. Barone brings an impressive combination of clinical skills as a vitreoretinal surgeon, clinical trial expertise, and regulatory understanding. With his highly relevant technical background and breadth of experience, Dr. Barone will play a critical role in helping Avalanche fulfill its mission of developing a new class of medicines for the treatment of patients suffering from sight-threatening and blinding diseases.”

Prior to joining Avalanche, Dr. Barone worked for the U.S. Food and Drug Administration (FDA) as a Medical Officer in the Office of Cellular, Tissue and Gene Therapies. During his tenure at the FDA, Dr. Barone’s responsibilities included the review of clinical investigations of stem cell and gene therapy products targeting ophthalmic diseases, particularly diseases of the retina. Concurrent with his work at the FDA, Dr. Barone was active in clinical practice as an ophthalmologist and vitreoretinal surgeon at Retina Associates P.C. Previously, Dr. Barone received several military honors for his service on active duty as a flight surgeon for the United States Air Force service personnel at Andrews Air Force Base and at bases in Korea, Afghanistan and Iraq.

Dr. Barone received his B.S. in Biology from Boston College and his M.D. from The Pennsylvania State University College of Medicine. Following his military service, Dr. Barone completed a residency in ophthalmology at The New York Eye and Ear Infirmary, where he served as Chief Resident, as well as a medical and surgical retina fellowship at the University of California, San Diego.  

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Avalanche Biotechnologies Announces Appointment of Industry Veteran Linda C. Bain as Chief Financial Officer

MENLO PARK, Calif., May 20, 2014 -- Avalanche Biotechnologies, Inc., a leader in the development of innovative gene therapies for serious eye diseases such as wet age-related macular degeneration (AMD), today announced the appointment of Linda C. Bain as Chief Financial Officer. With more than 20 years of finance, strategic business partner and audit experience in the biotech and pharmaceutical industries, Ms. Bain brings a distinguished track record of success, as a leader in both large and small company settings. Ms. Bain will report to Thomas Chalberg, Ph.D., Avalanche’s Co-Founder and Chief Executive Officer.

The executive hire follows two of Avalanche’s recent announcements: completion of a $55 million Series B financing, led by Venrock; and entering a collaboration with Regeneron Pharmaceuticals, in which Avalanche could earn up to $640 million in development and regulatory milestones.

“As a leader in gene therapy technology for ocular disease, we believe that we have a tremendous opportunity to bring new, sight-saving therapies to patients. We are thrilled to have Linda, an accomplished industry veteran, join Avalanche,” said Dr. Chalberg. “We are confident that we will benefit from Linda’s deep knowledge of the life sciences industry and finance management, and experience in growing and building companies, to help Avalanche continue this upward, positive trajectory as we work to create a new class of medicines for patients suffering from sight-threatening and blinding diseases.”

Prior to joining Avalanche, Ms. Bain was Chief Accounting Officer, Vice President of Finance and Business Operations, and Treasurer at bluebird bio in Cambridge, Massachusetts. At bluebird bio, Ms. Bain built and led finance and business operations, including finance, accounting, facilities and information technology across the company’s U.S. and French sites. Of her many noted accomplishments at bluebird bio, she helped lead the company through a successful IPO process, raising $116M and pricing above the range.

Preceding her tenure at bluebird bio, Ms. Bain was at Genzyme Corporation, where she held multiple roles, including Vice President of Finance, Global Manufacturing & Operations and Vice President of Finance of Genzyme Genetics. Previously, she held various senior leadership positions in finance at Fidelity Investments, AstraZeneca Pharmaceuticals and positions in audit at Deloitte & Touche.

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Regeneron and Avalanche Biotechnologies Announce Collaboration to Develop Next-Generation Gene Therapy Products in Ophthalmology

Tarrytown, New York and Menlo Park, Calif., (May 5, 2014) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Avalanche Biotechnologies, Inc., today announced the formation of a broad collaboration to discover, develop and commercialize novel gene therapy products for the treatment of ophthalmologic diseases.  The collaboration covers novel gene therapy vectors and proprietary molecules, discovered jointly by Avalanche and Regeneron, and developed using the Avalanche Ocular BioFactoryTM, an adeno-associated virus (AAV)-based, proprietary, next-generation platform for the discovery and development of gene therapy vectors for ophthalmology.

Under the terms of the agreement, Avalanche will receive an upfront cash payment, contingent payments of up to $640 million upon achievement of certain development and regulatory milestones, plus a royalty on worldwide net sales of collaboration products.  The collaboration covers up to eight distinct therapeutic targets, and Regeneron will have exclusive worldwide rights for each product it moves forward in clinical development.  In addition, Avalanche has the option to share in development costs and profits for products directed toward two collaboration therapeutic targets selected by Avalanche. 

As part of the agreement, Regeneron has a time-limited right of first negotiation for certain rights to AVA-101, Avalanche’s gene therapy product targeting vascular endothelial growth factor (VEGF) currently under development for the treatment of wet age-related macular degeneration (AMD), upon completion of the ongoing Phase 2a trial. 

“We look forward to the opportunity to collaborate with Avalanche, a leader in the field of next-generation gene therapy technologies,” said George D. Yancopoulos, M.D., Ph.D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories.  “This collaboration highlights the commitment by Regeneron to invest in potentially breakthrough therapies that could benefit patients with sight-threatening diseases.”

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Avalanche Biotechnologies Secures $55 Million in Oversubscribed Series B Financing

– Proceeds will Further Strengthen Avalanche’s Proprietary BioFactoryTM Platform and Advance Clinical Program in Wet Age-Related Macular Degeneration –

April 22, 2014

MENLO PARK, Calif., April 22, 2014 -- Avalanche Biotechnologies, Inc, a leader in the development of innovative gene therapies for serious eye diseases such as wet age-related macular degeneration (AMD), today announced the successful completion of a $55 million Series B financing. New investors were led by Venrock, and included Deerfield, Adage Capital Management, Redmile Group, Rock Springs Capital, Sabby Capital, as well as an affiliate of Cowen & Company and two undisclosed blue chip health care funds; joining the existing investors. Cowen & Company acted as sole placement agent for the financing.


Bong Koh, M.D., partner at Venrock, stated, “We believe Avalanche’s proprietary approach to gene therapy holds promise to meet unmet medical needs for patients suffering from wet AMD and other retinal diseases that may lead to vision loss. We are pleased to join an outstanding group of new and existing investors in supporting this experienced management team to further the clinical development and commercialization of one-time transformative gene therapies to help people with serious eye diseases.”
Proceeds from the Series B financing round will be used to advance the company’s clinical programs in retinal disorders, including Avalanche’s lead product, AVA-101, for wet AMD. In addition, the company will invest in manufacturing and clinical infrastructure for the lead program, and accelerating the development of pipeline programs based on Avalanche’s proprietary BioFactoryTM platform.


“Gene therapy has come a long way over the last several years toward realizing its potential as a powerful treatment modality,” said Mark S. Blumenkranz, M.D., H. J. Smead Professor and Chairman of the Department of Ophthalmology, and Director of the Byers Eye Institute at Stanford University. Dr Blumenkranz, who is Chairman of Avalanche’s Board of Directors, added, “The chronic management of wet AMD is a major problem for patients and one of the most significant treatment challenges in ophthalmology. Avalanche’s approach is an elegant solution that addresses this major unmet need.” Read the Full Press Release


Avalanche Raises Additional Funding in Follow-On Financing

November 22, 2013

Avalanche announced the completion of additional financing in a round consisting of both new and existing investors. Specific details of the financing, which included both preferred stock and convertible debt, were not disclosed. “Avalanche’s BioFactoryTM platform is based on powerful technology that will help address patients suffering from blinding diseases,” said Thomas Chalberg, Avalanche’s co-founder and CEO. “We are encouraged by our progress thus far, and excited to announce this additional financing, which will help us make new medicines available to patients.” Proceeds from the financing will be used to expand Avalanche’s team and advance its key programs, including AVA-101 for wet age-related macular degeneration, as well as accelerate its pipeline research and development programs. Avalanche was represented in the transaction by its corporate counsel, Latham and Watkins, LLP.


Avalanche’s Novel Technology Restores Vision in Pre-Clinical Models of Blindness

June 12, 2013

In this week’s issue of Science Translational Medicine, UC Berkeley scientists report on vector-mediated delivery to the outer retina using proprietary technology licensed by Avalanche. The paper, which appeared in this week’s issue of Science Translational Medicine, describes a novel AAV variant that has the potential to greatly expand DNA delivery to the eye. Through directed evolution, David Schaffer and colleagues created millions of variations of the AAV virus, and selected variants for their ability to cross the retina. The resulting variant capsid, called 7m8, demonstrated strong transduction of photoreceptors and RPE cells following a simple intravitreal injection. The delivery was superior to other AAV capsids, and restored vision in mouse models of Xlinked retinoschisis and Leber’s Congenital Amaurosis. Furthermore, the variant showed effective transduction in macaques, which closely mirrors the retinal anatomy found in humans.

Find out more from The Scientist magazine: http://www.the-scientist.com/?articles.view/articleNo/35995/title/Genes-Get-inYour-Eye/

Read the journal article in Science Translational Medicine: http:// stm.sciencemag.org/content/5/189/189ra76


Avalanche Biotechnologies, Inc. Announced That it Has Been Awarded Two Grants from the National Eye Institute to Fund Pre-clinical Studies Related to its Novel AAV Variant Technology

October 1, 2012

Avalanche Biotechnologies, Inc. announced that it has been awarded two grants from the National Eye Institute to fund pre-clinical studies related to its novel AAV variant technology. The first grant, funded through the SBIR program with Dr. Thomas W. Chalberg as Principal Investigator, is geared toward pre-clinical development of anti-VEGF vectors for diabetic macular edema. The second grant investigates Avalanche’s delivery technology in animal models of glaucoma; this grant was funded through the STTR program and is being coordinated by Avalanche in collaboration with Cornell Weill Medical College, with Dr. Anna-Maria Demetriades as Principal Investigator. The two grants, totaling approximately $600,000, will help advance Avalanche’s technology platform for development and manufacture of AAV variants for long-term protein delivery to the eye. Avalanche’s AAV variants, which can successfully transduce retinal cells following intravitreal injection, represent a promising platform technology with multiple product opportunities for large-market and orphan disorders in ophthalmology.


Avalanche Biotechnologies, Inc. and Lonza Announce Global Manufacturing Collaboration for Adeno-associated Viral Vectors for Gene Therapy

May 16, 2012

Avalanche Biotechnologies, Inc., a leader in the area of long-term protein delivery for ocular diseases, and Lonza, a global leader in the field of biologics manufacturing, today announced a manufacturing collaboration focused on process development and scale-up efforts for the manufacturing of adeno-associated viral (AAV) vectors for gene therapy.

As part of the agreement, Avalanche and Lonza will make the technology available to third parties and share in the revenue. The Avalanche/Lonza manufacturing collaboration will focus on the development and high-yield production of AAV vectors based on a novel technology that uses stable baculovirus... Read the Full Press Release


Avalanche Announces Collaboration with Lions Eye Institute and Merck to Develop AVA-101

November 1, 2011

Avalanche Biotechnologies, Inc. announced initiation of a collaboration with Lions Eye Institute, University of Western Australia to develop treatments for ocular diseases. The collaboration will initially focus on the development of AVA-101 for the treatment of wet age-related macular degeneration (AMD). Following a single injection, AVA-101 creates an Ocular BiofactoryTM that continuously secretes a therapeutic protein over an extended period, avoiding the need for frequent intraocular injections of recombinant anti-VEGF protein. Technology for the Ocular Biofactory™ has been pioneered under the leadership of Elizabeth P. Rakoczy, Winthrop Professor of Molecular Ophthalmology at the Lions Eye Institute. Plans are underway for an initial clinical trial at Lions Eye under the leadership of Professor Rakoczy and clinical ophthalmologist Professor Ian J. Constable. The therapeutic protein is a potent inhibitor of vascular endothelial growth factor (VEGF), a clinically validated target in wet AMD, exclusively licensed by Avalanche from Merck Sharp & Dohme Corp, formerly Merck & Co., Inc.


Top Names Join Avalanche Scientific Advisory Board

September 1, 2011

Avalanche Biotechnologies, Inc. is pleased to announce the addition of three renowned scientific leaders in academia and industry to its scientific advisory board: Dr. Jean Bennett, F.M. Kirby professor of ophthalmology at the University of Pennsylvania; Dr. Estuardo Aguilar-Cordova, CEO of Advantagene; and Dr. J. Fraser Wright, Director of the Clinical Vector Core at Children's Hospital of Philadelphia. They will join an august group of colleagues on Avalanche's Scientific and Clinical Advisory Boards.

"We are delighted to welcome three new members to Avalanche's Scientific Advisory Board," said Thomas Chalberg, Avalanche's Chief Executive Officer. "Dr. Bennett is a renowned leader in the area of ocular gene therapy, whose landmark studies in Leber's Congenital Amaurosis have pioneered the way for future studies, including ours. Dr. Aguilar-Cordova is a well-known biotechnology leader, with extensive experience in academia and industry, and particular expertise in gene therapy product development and regulatory affairs. Dr. Wright is a world leader in viral manufacturing and process development for AAV. We look forward to these leaders joining our team as we sharpen our focus on development of breakthrough products for retinal diseases."


Avalanche Opens Offices in San Francisco

September 1, 2011

Avalanche Biotechnologies, Inc., a company focused on the research and development of products for sustained delivery of proteins to the eye, opened new office and research facilities in San Francisco, California on September 1. The company's offices, located in the Bioscience Laboratories facility near the biotechnology hotbed at UCSF's Mission Bay campus, will serve as both corporate headquarters and laboratories for research and development. Before moving to San Francisco, the company was incubated at the Berkeley Entrepreneurship Laboratory at the University of California, Berkeley - Haas School of Business.


Avalanche Licenses Key Intellectual Property from UC Berkeley

June 1, 2011

Avalanche Biotechnologies, Inc. has entered into an agreement with the University of California, Berkeley, to license key intellectual property related to AAV (adeno-associated virus) vectors for use with the company's proprietary BioFactoryTM drug delivery technology. The intellectual property includes access to a pipeline of next-generation vectors for non-invasive delivery to the retina.


Thomas W. Chalberg, PhD Joins Avalanche as President & CEO

October 11, 2010

Effective October 11, 2010, Thomas W. Chalberg, Jr., Ph.D. will join Avalanche Biotechnologies, Inc. on a full-time basis as President and Chief Executive Officer. A co-founder of Avalanche, Dr. Chalberg formerly worked on the ophthalmology team at Genentech, where he helped to launch Lucentis, a novel therapeutic for age-related macular degeneration. He earned a PhD in genetics from the Stanford University of Medicine, where he was a Howard Hughes Medical Institute fellow, and an MBA from UC Berkeley Haas School of Business. He also holds a BA from Harvard University, where he graduated magna cum laude and Phi Beta Kappa.


Avalanche Names the Founding Members of its Scientific and Clinical Advisory Boards

October 1, 2010

Avalanche Biotechnologies, Inc. is pleased to announce the founding members of its Scientific and Clinical Advisory Board. The Scientific Advisory Board will be chaired by Dr. Elizabeth Rakoczy, Winthrop Professor of Molecular Ophthalmology at the Lions Eye Institute, University of Western Australia. Joining her is Dr. Mitchell Finer, Chief Scientific Officer of bluebird bio and a founder of Avalanche.

The Clinical Advisory Board will be chaired by Dr. Ian J. Constable, Founder and Professor at the Lions Eye Institute, University of Western Australia. Joining him is Dr. Mark S. Blumenkranz, Chairman of Ophthalmology at the Byers Eye Institute at Stanford, Dr. Steven D. Schwartz, Chief of the Retina Division at the UCLA Jules Stein Eye Institute, Dr. Judy Gordon, a clinical regulatory consultant with extensive experience in Ophthalmology products, and Dr. Steven Butler, Consulting Senior Biostatistician.

"We are thrilled to announce the esteemed members of our Scientific Advisory Board," said Thomas Chalberg, Avalanche's Chief Executive Officer. "The team we have assembled has deep domain expertise in key areas of ophthalmic drug development and gene therapy, including research, clinical development, regulatory, and commercialization. We are proud to be working with an extremely talented team to develop Avalanche's Ocular BiofactoryTM technology. The technology has delivered promising results in pre-clinical experiments, and we look forward to advancing our treatments toward the clinic."


Avalanche Closes Series A Financing

September 7, 2010

Avalanche Biotechnologies, Inc., a company focused on the research and development of products for sustained delivery of proteins to the eye, today announced completion of a Series A financing. Specific investors and details of the financing were not disclosed. Proceeds will be used to fund the company's research and development efforts related to its Ocular BiofactoryTM technology for drug delivery to the retina, including advancing its lead product for macular degeneration to clinical trials. Avalanche was represented in the transaction by its corporate counsel, Cooley LLP.

Avalanche Biotechnologies to Present at the Jefferies Global Healthcare Conference

November 13, 2014

MENLO PARK, CA – November 13, 2014 – Avalanche Biotechnologies, Inc. (Nasdaq: AAVL), a clinical-stage biotechnology company focused on discovering and developing novel gene therapies to transform the lives of patients with sight-threatening ophthalmic diseases, today announced that Linda C. Bain, Chief Financial Officer, will present at the Jefferies Global Healthcare Conference on Thursday, November 20, 2014 at 8:40 am GMT in London, England.

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