Press Release

Aura Biosciences to Present at the 15th Annual Needham Healthcare Conference

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Aura Biosciences, a biotechnology company developing a new class of therapies to target and selectively destroy cancer cells using viral nanoparticle conjugates, announced today that Elisabet de los Pinos, founder and CEO, will present a company overview at the 15th Annual Needham Healthcare Conference in New York, N.Y.

The presentation will take place on Tuesday, April 12, 2016, at 2:40 p.m. EDT.

 

About Aura Biosciences

Aura Biosciences is developing a new class of therapies to target and selectively destroy tumor cells. Its lead program in ocular melanoma, developed under a CRADA with the National Cancer Institute (NCI), has been granted orphan drug status by the US Food and Drug Administration. For more information, visit www.aurabiosciences.com.

Media Contact

Ann Stanesa, 617-230-0347
Ten Bridge Communications
ann@tenbridgecommunications.com

Investor Contact

Mike Wyzga, Chief Financial Officer
Aura Biosciences
mswyzga@verizon.net

Aura Biosciences Forms Clinical Advisory Board in Ocular Oncology and Strengthens Clinical Team to Prepare for Clinical Development of Lead Program in Ocular Melanoma

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Aura Biosciences, a biotechnology company developing a new class of therapies to target and selectively destroy cancer cells, announced today that it has formed a Clinical Advisory Board in Ocular Oncology and bolstered its clinical development team as it prepares to initiate clinical testing of its lead program in Ocular (uveal) Melanoma.

Carol Shields, MD, co-Director of the Oncology Service at Wills Eye Hospital of Thomas Jefferson University in Philadelphia; Evangelos Gragoudas, MD, Director of Retina Service at the Massachusetts Eye and Ear Infirmary of Harvard University in Boston; and Arun D. Singh, Director of the Department of Ophthalmic Oncology in the Cole Eye Institute at the Cleveland Clinic, will make up the Clinical Advisory Board (CAB), which will help guide the clinical development of AU-011, Aura’s lead program in Ocular Melanoma. Drs. Shields, Gragoudas and Singh are recognized world leaders in the early diagnosis and clinical care of people with Ocular Melanoma.

In addition to forming its CAB, Aura has appointed Denis O’Shaughnessy, PhD, to the position of Vice President of Clinical Development. Dr. O’Shaughnessy has led the clinical development of multiple ophthalmology products over the past two decades in roles at Hoffman-LaRoche, Eyetech Pharmaceuticals, OPKO Health, and Oraya Therapeutics.

“We are pleased to have the support and guidance of three of the world’s experts as we prepare to initiate clinical testing of the first therapy ever developed for the primary treatment of Ocular Melanoma in 2016,” said Elisabet de los Pinos, founder and CEO of Aura Biosciences. “The direction of our CAB and expertise of our expanding clinical team will be invaluable to Aura as we enter this critical moment in our growth as a company.”

About Aura Biosciences

Aura Biosciences is developing a new class of therapies to target and selectively destroy tumor cells. Its lead program in ocular melanoma, developed under a CRADA with the National Cancer Institute (NCI), has been granted orphan drug status by the US Food and Drug Administration. For more information, visit www.aurabiosciences.com.

Contacts

Aura Biosciences
Dan Quinn, 781-475-7974
Ten Bridge Communications
dan@tenbridgecommunications.com

Aura Biosciences Announces Publication Describing Selective Binding of Viral-like Particles to Cancer Cells

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Aura Biosciences, a biotechnology company developing a new class of therapies to target and selectively destroy cancer cells, announced today the publication of a new paper demonstrating how its synthetic Viral-like Particles (VLP) modeled on the human papillomavirus (HPV) are able to bind uniquely to cancer cells while leaving healthy surrounding tissue unharmed.

The paper, The Molecular Determinants of Papillomavirus Capsid Binding to Tumor Cells, was published online in the International Journal of Cancer by authors Dr. Rhonda C. Kines of Aura, and Drs. Douglas R. Lowy, John T. Schiller and colleagues of the National Cancer Institute. Building on previous work that demonstrated the mechanism of HPV infection, the authors investigated the molecular basis for the discovery that HPVs selectively bind a wide range of solid tumors in vitro and in vivo. They determined that tumor cells differ from healthy cells in the over-expression and modifications of heparan sulfate proteoglycans on their membrane as well as on the extracellular matrix, which provides a unique binding site for HPV virions and for engineered VLPs. They demonstrated that healthy intact tissue is resistant to this kind of binding, underscoring the potential utility of these types of synthetic VLPs for selectively delivering diagnostic agents and/or cytotoxic drugs to tumor cells for the development of a novel class of targeted therapies.

“This paper is an important step forward in our understanding of why our HPV-modeled Viral-like Particles represent such a promising advance in the selective targeting of tumor cells,” said Elisabet de los Pinos, founder and CEO of Aura Biosciences. “As we prepare for clinical testing of our lead program in ocular melanoma, we are building on a strong foundation of preclinical evidence to support the potential application of our approach in a wide array of cancers, including bladder, prostate, and head and neck cancers.”

Aura’s lead product, AU-011, has the potential to be the first therapy ever developed for the primary treatment of ocular (uveal) melanoma, the most common primary cancer of the eye. AU-011 utilizes an HPV VLP to deliver a cell-killing laser-activated molecule selectively to cancer cells in the eye after a simple intra-vitreal injection. In vivo results in a rabbit model presented at the annual meeting of the Association for Research in Vision and Ophthalmology (ARVO) in 2015 demonstrated complete tumor necrosis following three administrations as confirmed by histopathology, while sparing the adjacent retina.

About Aura Biosciences

Aura Biosciences is developing a new class of therapies to target and selectively destroy tumor cells. Its lead program in ocular melanoma, developed under a CRADA with the National Cancer Institute (NCI), has been granted orphan drug status by the US Food and Drug Administration. For more information, visit www.aurabiosciences.com.

Contacts

Aura Biosciences
Dan Quinn, 781-475-7974
Ten Bridge Communications
dan@tenbridgecommunications.com

FDA Grants Orphan Drug Designation to Aura Biosciences’ Novel Treatment for Uveal Melanoma

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Aura Biosciences, a biotech company developing highly tumor-targeted breakthrough therapies for rare cancers, has been granted Orphan Disease Designation by the FDA for its drug AU-011 for the treatment of Uveal Melanoma. The FDA’s Orphan Drug Designation program provides orphan status to drugs and biologics, which demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions in the US. In addition, the first oral presentation of Aura Biosciences’ pre-clinical research, ‘Evaluating the in vivo efficacy of a first-in-class drug for the treatment of primary uveal melanoma’, was recently delivered by McGill University Health Centre researchers at the ARVO (Association for Research in Vision and Ophthalmology) Annual Meeting.

“There are currently no approved drug therapies for the treatment of uveal melanoma which is a rare but life threatening disease. We are thrilled to receive this Orphan Drug Designation that, together with the positive preclinical data, is enabling us to move this drug one step closer to the clinic,” said Elisabet de los Pinos, founder and CEO of Aura Biosciences.

Uveal Melanoma, also referred to as Ocular Melanoma (OM), is an aggressive form of cancer that develops in the uvea, or uveal tract, of the eye. The primary tumor is diagnosed when it is still in the eye but has no targeted therapies available and is usually treated with an invasive radioactive plaque placed against the exterior of the eye near the tumor. This treatment requires multiple surgeries and can lead to cataracts, retinopathy and loss of vision. The alternative is enucleation, a surgery to remove the eye.

“There is an unmet medical need in the rare cancer patient community with which we work to have access to treatments that target the primary tumor and spare vision, forgoing risky and invasive surgical intervention. Aura’s novel approach has the potential to dramatically improve the outcomes, and hope, for patients with uveal melanoma,“ said Grant Allen, Co-founder and Chairman of the Ocular Melanoma Foundation. “The Orphan Drug Designation for AU-011 is a huge step forward, enabling Aura to potentially bring this drug to patients in an expedited manner.”

“The Melanoma Research Foundation’s CURE OM initiative leads the field in OM research support. We appreciate partners who are also working to advance the OM field and applaud efforts to develop new treatments with the goal of saving lives. Today’s news about a treatment that could potentially eliminate OM tumors early in the eye brings hope for improved outcomes for patients,” said Sara Selig, MD, CURE OM Co-Founder and Director, Melanoma Research Foundation.

AU-011 consists of Viral-like Nanoparticles that demonstrate highly selective targeting of solid tumors while leaving normal epithelium untouched. Aura’s lead product incorporates its Viral-like Nanoparticle conjugated with a potent cell-killing laser-activated molecule that is delivered efficiently and selectively to cancerous cells, thereby reducing or eliminating the risk of non-specific activity and undesirable toxicity. The molecule is activated by a standard ophthalmologic laser and treatment will be administered in an outpatient visit. A video explaining how Aura’s technology is applied to Uveal Melanoma can be accessed at the Aura Biosciences website at aurabiosciences.com.

ARVO Presentation – Data on AU-011

In vivo research behind the ARVO oral presentation last week was conducted by Patrick T. Logan, Sultan Aldrees, Mohammed F. Qutub, Natalia Vila, Vasco Bravo-Filho, and Miguel N. Burnier at the Henry C Witelson Lab, Ocular Pathology, McGill University, Montreal, QC, Canada. In this study, the data showed that AU-011 is efficacious for treating uveal melanoma tumors in an orthotopic xenograft model.

Key findings of the research include:

  • Complete response – following three administrations of AU-011 complete tumor eradication was observed by histopathology.
  • The treatment appeared to be “retina sparing.”
  • The observation of tumor necrosis is consistent with the mechanism of action of AU-011.

“In all of our years running this pre-clinical uveal melanoma animal model that we established more than a decade ago, this is the first time that we have seen such promising and encouraging results for the treatment of primary uveal melanoma. We are very excited about the positive impact this might have in uveal melanoma patients,” says Dr. Logan, who is managing the Henry C. Witelson Ocular Pathology pre-clinical unit.

About Aura Biosciences

Aura Biosciences is applying nanotechnology to the fight against cancer. Its novel Viral-like Nanoparticle technology, developed in partnership with the National Cancer Institute (NCI), harnesses the potential of viral evolution and tumor targeting for the treatment of cancer. For more information, visit www.aurabiosciences.com.

Contacts

Aura Biosciences
Matt Burke, 1-603-315-0618
mburke@aurabiosciences.com

Aura Biosciences Closes $21M Series B Financing

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Aura Biosciences, a biotech company developing highly tumor-targeted breakthrough therapies for rare cancers, has secured a $21M Series B round of funding. The financing was led by Advent Life Sciences, with participation from new investors, Chiesi Ventures, Ysios Capital, and Alexandria Venture Investments. Existing investors, including LI-COR Biosciences and Henri Termeer, former Chief Executive Officer of Genzyme, also participated in the financing. The financing will be used to advance Aura’s unique and novel therapies into clinical trials for the treatment of rare cancers of the eye, and to further develop for additional cancer indications its first-in-class technology that was discovered and developed in partnership with Dr. John Schiller at the National Cancer Institute (NCI).

“Our investors share our vision and our conviction that our technology will uniquely enable the development of breakthrough therapies for orphan cancers that have no effective treatments,” said Elisabet de los Pinos, founder and CEO of Aura Biosciences. “Our lead product is focused on treating ocular cancers that are life-threatening, yet for which patients have no targeted or FDA-approved therapies available. We are dedicated to bringing to this patient population first-in-class therapies that can both eliminate the tumor and preserve vision.”

Aura Biosciences’ platform is based on viral nanoparticles, a new class of drugs that harness the potential of a unique cell targeting for the treatment of cancer. The technology was discovered and developed in partnership with Dr. John Schiller’s lab at the National Cancer Institute (NCI). Dr. Schiller is the recipient of the National Medal of Technology and Innovation by President Obama, the nation’s highest honor for technological achievement.

The nanoparticles demonstrate highly selective targeting of solid tumors and metastases while leaving normal epithelium untouched. Aura’s lead product incorporates a viral nanoparticle conjugated with a potent cell-killing laser-activated molecule (IRDye 700DX, LI-COR Biosciences) that is delivered efficiently and selectively to cancerous cells, thereby reducing or eliminating the risk of non-specific activity and/or undesirable toxicity. Aura Biosciences and the NCI have generated a considerable body of data in vitro and in vivo that shows highly selective tumor uptake in multiple animal models and provides a strong preclinical validation of the technology platform.

“Aura Biosciences is developing first-in-class drugs for rare ocular cancers that can improve patient outcomes and positively impact patient lives,” said Dale Pfost, general partner at Advent Life Sciences. “The data generated from Aura’s platform suggests that there is great potential to treat ocular cancers in a completely novel way with high tumor specificity along with maximal drug and laser penetration that can eliminate tumors with no damage to other ocular structures.”

“There is a tremendous unmet need for therapies that can help those with rare diseases,” said Henri Termeer, former Chief Executive Officer of Genzyme, a pioneer in drug development for orphan indications. “With Aura’s technology, once the product is confirmed in the clinic, patients with rare ocular cancers will have for the first time and in the near future a non-invasive targeted therapy available to them.”

In conjunction with the financing, Dale Pfost, General Partner at Advent Life Sciences, Art Pappas, CEO of A.M. Pappas & Associates, and Joël Jean-Mairet, Managing Partner at Ysios Capital will join Aura’s Board of Directors. Current Board member Alan Walts, former head of Genzyme Ventures, will become Executive Chairman. In addition, Alison Lawton, former Genzyme executive and former COO of OvaScience, will be appointed as Chief Operating Officer.

About Aura Biosciences

Aura Biosciences is applying nanotechnology to the fight against cancer. Its novel viral nanoparticle technology, developed in partnership with the National Cancer Institute (NCI), harnesses the potential of viral evolution and tumor targeting for the treatment of cancer. For more information, visit www.aurabiosciences.com.

About Advent Life Sciences

Advent Life Sciences is one of Europe’s leading venture teams investing in life sciences businesses. The team consists of professionals with extensive scientific, medical and operational experience, and a long-standing track record of entrepreneurial and investment success across the UK, Europe and the US. The firm invests in a range of sectors within life sciences, principally in new drug discovery, enabling technologies and med tech. Realizations in the last three years include Algeta, Avila, CN Creative, EUSA and Micromet. Current investments include Acutus, Biocartis, Cellnovo, f2G, NeRRe, and Versartis. For more information, please visitwww.adventls.com.

About Chiesi Ventures

Chiesi Ventures is a venture capital firm focused on the area of rare and orphan disorders. Our goal is to complement the strategic interest of the Chiesi Group by investing in early stage development opportunities. Chiesi Ventures also aim to accelerate the expansion of the Chiesi network in the US among universities, venture capital investors, rare disease patient organizations and entrepreneurial companies developing treatments for rare diseases. For more information, please visit www.chiesiventures.com.

About Ysios Capital

Ysios Capital is a leading Spanish venture capital firm that provides private equity financing to early- and mid-stage human healthcare and life science companies with a special focus on pharmaceuticals, diagnostics and medical devices. Founded in 2008, Ysios Capital has € 118 million in assets under management distributed over two funds. The second fund has a target size of € 100 million and will remain open to new investors until September 2015. For further information see www.ysioscapital.com

About Alexandria Venture Investments

Alexandria Venture Investments is the strategic venture capital arm of Alexandria Real Estate Equities, Inc. (NYSE: ARE). Founded in 1994, Alexandria is the largest and leading investment-grade real estate investment trust (REIT) focused principally on owning, operating, and developing high-quality, sustainable real estate for the broad and diverse life science and technology industries. In 1996, Alexandria founded Alexandria Venture Investments to actively invest at the cutting edge of novel, breakthrough discoveries in biopharmaceuticals, diagnostics, research tools, medical devices, digital health, and technology. Alexandria is uniquely positioned to fund life science and advanced technology companies based on its experience and in-depth understanding of these industries, its long-term relationships with leading investors, and its world-class international scientific advisory network. For more information, please visitwww.are.com.

About LI-COR Biosciences

LI-COR Biosciences is a leading manufacturer of near-infrared and chemiluminescence imaging platforms, analysis software, and IRDye® infrared dye reagents for drug discovery, life science research, and pre-clinical imaging. Founded in 1971, the privately held company is based in Lincoln, Nebraska.

Contacts

Aura Biosciences
Matt Burke, +1 603-315-0618
mburke@aurabiosciences.com