CAMBRIDGE, Mass., September 4, 2018 — Aura Biosciences, a leader in the development of novel targeted therapies in ocular oncology, today announced that Julie Feder has joined the company’s leadership team as Chief Financial Officer. In addition, the company announced the addition of Kylie Reynolds as Vice President of Finance, further augmenting Aura’s in-house finance expertise as the company finalizes its Phase 1/2 clinical trial and prepares to initiate late stage clinical development for its flagship drug in choroidal melanoma next year.

“We’re excited to welcome Julie and Kylie to our team at this important moment for our company,” said Elisabet de los Pinos, Ph.D., founder and CEO of Aura. “Their combined four-plus decades of experience in financial management will be an asset in our accelerated progress towards developing a groundbreaking new treatment for patients with choroidal melanoma.”

Ms. Feder joins Aura from Verastem, where she served as Chief Financial Officer. At Verastem, Ms. Feder was responsible for developing the company’s strategic financial plan and overseeing a rapid growth in financing and staff size. Prior to joining Verastem, Ms. Feder spent six years at the Clinton Health Access Initiative, Inc. (CHAI) as Chief Financial Officer. At CHAI, Ms. Feder was responsible for managing a global team across multiple departments. She also developed the global finance strategy and internal audit, treasury, and global payroll functions. Ms. Feder holds a Bachelor of Science in Accounting from Yeshiva University’s Sy Syms School of Business.

Ms. Reynolds comes to Aura from Forma Therapeutics, where she served as Senior Director and Controller for the company since 2015. In that role, Ms. Reynolds was responsible for assessing systems, people and processes to prepare the company for financial transformation. Ms. Reynolds holds an M.S. in Banking and Financial Management from Boston University and is a Certified Public Accountant.

About choroidal melanoma

Choroidal melanoma is a rare and aggressive type of eye cancer. Choroidal melanoma is the most common primary ocular tumor and develops in the uveal tract of the eye. No targeted therapies are available at present, and current radiotherapy treatments can be associated with severe visual loss and other long-term sequelae such as dry eye, glaucoma, cataracts and radiation retinopathy. The most common current treatment is plaque radiotherapy, which involves surgical placement of a radiation device on the exterior of the eye over the tumor. The alternative is enucleation, or total surgical removal of the eye. Choroidal melanoma metastasizes to the liver in about 40-50 percent of cases in the long term (source: OMF), and only 15 percent of patients whose melanoma has metastasized survive beyond five years after diagnosis (source: ACS).

About light-activated AU-011

AU-011 is a first-in-class targeted therapy in development for the primary treatment of choroidal melanoma. The therapy consists of proprietary viral-like particle conjugates (VPC) that are activated with an ophthalmic laser. The VPCs bind selectively to unique receptors on cancer cells in the eye and are derived from technology originally pioneered by Dr. John Schiller of the Center for Cancer Research at the National Cancer Institute (NCI), recipient of the 2017 Lasker-DeBakey Award. Upon activation with an ophthalmic laser, the drug rapidly and specifically disrupts the cell membrane of tumor cells while sparing key eye structures, which may allow for the potential of preserving patients’ vision and reducing other long-term complications of radiation treatment. AU-011 can be delivered using equipment commonly found in an ophthalmologist’s office and does not require a surgical procedure, pointing to a potentially less invasive, more convenient therapy for patients and physicians. AU-011 for the treatment of choroidal melanoma has been granted orphan drug and fast track designations by the U.S. Food and Drug Administration and is currently in clinical development.

About Aura Biosciences

Aura Biosciences is developing a new class of therapies to selectively target and destroy cancer cells. Its lead program, AU-011 in primary choroidal melanoma, is being developed under a CRADA with the National Cancer Institute (NCI), part of the National Institutes of Health. For more information, visit www.aurabiosciences.com.

Media Contact
Lisa Raffensperger, (617) 903-8783
Ten Bridge Communications
lisa@tenbridgecommunications.com

CAMBRIDGE, Mass., July 23, 2018 — Aura Biosciences, a leader in the development of novel targeted therapies in ocular oncology, presented interim data from an open-label Phase 1b/2 study of its lead program, light-activated AU-011 for the treatment of primary choroidal melanoma, at the 36th annual American Society of Retina Specialists (ASRS) meeting in Vancouver, Canada. The findings were presented by Amy Schefler, M.D., Clinical Assistant Professor at Weill Cornell Medical College/Methodist Hospital and Clinical Assistant Professor at University of Texas-Houston.

Dr. Schefler provided an update on the Phase 1b/2 open-label, multicenter trial, which has been designed to evaluate the safety and efficacy of single and multiple ascending doses in 30 adult subjects with clinically diagnosed small to medium primary choroidal melanoma.

Interim data presented at ASRS show that in an expanded set of subjects AU-011 continues to be well-tolerated with no related serious adverse events, no severe adverse events and no dose-limiting toxicities observed, including the cohorts in the multiple ascending dose phase of the study. Adverse events were manageable with standard-of-care treatments and there have been no long-term clinical sequelae. Pre-treatment visual acuity was maintained in all subjects that have been followed for 6 to 12 months.

Early efficacy results continue to be promising, with several subjects in the multiple-ascending-dose cohorts showing evidence of reduction in tumor height and 100% of the patients meeting the endpoint of stable disease at three months.

“All current treatment options for patients with this cancer result in significant vision loss from radiation-related side effects, ” said Dr. Schefler. “A treatment that is office-based, minimally invasive, and has a low risk of side effects would be a dramatic improvement in the therapeutic landscape for this deadly disease.”

Aura plans to complete the enrollment of this trial in October and then prepare for a Phase 3 program that is planned to satisfy the registration requirements in the United States and Europe.

About choroidal melanoma

Choroidal melanoma is a rare and aggressive type of eye cancer. Choroidal melanoma is the most common primary ocular tumor and develops in the uveal tract of the eye. No targeted therapies are available at present, and current radiotherapy treatments can be associated with severe visual loss and other long-term sequelae such as dry eye, glaucoma, cataracts and radiation retinopathy. The most common current treatment is plaque radiotherapy, which involves surgical placement of a radiation device on the exterior of the eye over the tumor. The alternative is enucleation, or total surgical removal of the eye. Choroidal melanoma metastasizes to the liver in about 40-50 percent of cases in the long term (source: OMF), and only 15 percent of patients whose melanoma has metastasized survive beyond five years after diagnosis (source: ACS).

About light-activated AU-011

AU-011 is a first-in-class targeted therapy in development for the primary treatment of choroidal melanoma. The therapy consists of patented viral capsid conjugates (VCC) with IR-700DX dye molecules that are activated with an ophthalmic laser. The VCCs bind selectively to unique receptors on cancer cells in the eye and are derived from technology originally pioneered by Dr. John Schiller of the Center for Cancer Research at the National Cancer Institute (NCI), recipient of the 2017 Lasker-DeBakey Award. The IR-700DX dye molecules are produced by LI-COR Biosciences and are licensed exclusively to Aura for treating ocular cancers.  Upon activation with an ophthalmic laser, the drug rapidly and specifically disrupts the cell membrane of tumor cells while sparing key eye structures, which may allow for the potential of preserving patients’ vision and reducing other long-term complications of radiation treatment. AU-011 can be delivered using equipment commonly found in the ophthalmologist’s office and does not require a surgical procedure, pointing to a potentially less invasive, more convenient therapy for patients and physicians. AU-011 for the treatment of choroidal melanoma has been granted orphan drug and fast track designations by the U.S. Food and Drug Administration and is currently in clinical development.

About Aura Biosciences

Aura Biosciences is developing a new class of therapies to selectively target and destroy cancer cells. Its lead program, AU-011 in primary choroidal melanoma, is being developed under a CRADA with the National Cancer Institute (NCI), part of the National Institutes of Health. For more information, visit www.aurabiosciences.com.

Media Contact
Lisa Raffensperger, (617) 903-8783
Ten Bridge Communications

CAMBRIDGE, Mass., June 17, 2018 — Aura Biosciences, a biotechnology company developing a new class of therapies to target and selectively destroy cancer cells using viral capsid conjugates, today announced new interim safety and efficacy data from an open-label Phase 1b/2 study of its lead program, light-activated AU-011 for the treatment of primary choroidal melanoma. The findings were presented by Ivana Kim, M.D., Co-Director of the Ocular Melanoma Center at Massachusetts Eye and Ear, at the 2018 World Ophthalmology Congress in Barcelona.

AU-011 is an investigational, first-in-class targeted therapy in development for the treatment of primary choroidal melanoma. FDA has already granted Fast Track Designation and orphan drug designation, recognizing that there are no FDA-approved therapies and that the disease is serious and life-threatening.

AU-011 is being evaluated in a Phase 1b/2 open-label, multicenter trial designed to evaluate the safety and efficacy of single and multiple ascending doses in 30 adult subjects with clinically diagnosed small to medium primary choroidal melanoma.

Interim data presented today show that AU-011 has been generally well-tolerated with no related serious adverse events, no severe adverse events and no dose-limiting toxicities observed. Adverse events were manageable with standard of care treatments and had no further clinical sequelae. Pre-treatment visual acuity was maintained in all subjects that have been followed for 6 to 12 months.

Early efficacy results are very promising with two subjects in the first multiple-ascending-dose cohort showing evidence of reduction in tumor height at 3 months. Further evidence of preliminary efficacy has also been demonstrated with subtherapeutic doses in the single-ascending-dose cohorts providing stable disease with vision preservation up to 12 months.

“We are excited by these preliminary findings showing AU-011 provided local tumor control without loss of visual acuity for a majority of subjects dosed to date,” said Dr. Kim. “That is an encouraging sign of progress toward developing a new treatment for this cancer that could preserve much more vision than radiotherapy, which is the current standard of care but not FDA approved for this indication.”

“These findings indicate that Aura’s novel, targeted, light-activated treatment could hold real promise for patients with choroidal melanoma,” said Cadmus Rich, M.D., Chief Medical Officer of Aura. “Our team is looking forward to continuing our Phase 1b/2 study with Dr. Kim and our other collaborators at leading ophthalmology centers across the country.”

About choroidal melanoma

Choroidal melanoma is a rare and aggressive type of eye cancer. Choroidal melanoma is the most common primary ocular tumor and develops in the uveal tract of the eye. No targeted therapies are available at present, and current radiotherapy treatments can be associated with severe visual loss and other long-term sequelae such as dry eye, glaucoma, cataracts and radiation retinopathy. The most common current treatment is plaque radiotherapy, which involves surgical placement of a radiation device against the exterior of the eye over the tumor. This technique can control the melanoma but can also lead to radiation-related cataract, retinopathy, optic nerve damage and loss of vision. The alternative is enucleation, or removal of the eye. Choroidal melanoma metastasizes to the liver in about 40 percent of cases in the long term (source: OMF), and only 15 percent of patients whose melanoma has metastasized survive beyond five years after diagnosis (source: ACS).

About light-activated AU-011

AU-011 is a first-in-class targeted therapy in development for the primary treatment of choroidal melanoma. The therapy consists of patented viral capsid conjugates (VCC) with IR-700DX dye molecules that are activated with an ophthalmic laser. The VCCs bind selectively to unique receptors on cancer cells in the eye and are derived from technology originally pioneered by Dr. John Schiller of the Center for Cancer Research at the National Cancer Institute (NCI), recipient of the 2017 Lasker-DeBakey Award. The IR-700DX dye molecules are produced by LI-COR Biosciences and are licensed exclusively to Aura for treating ocular cancers.  Upon activation with an ophthalmic laser, the drug rapidly and specifically disrupts the membranes of tumor cells while sparing key eye structures, which may allow for the potential of preserving patients’ vision and reducing other long-term complications of radiation treatment. AU-011 can be delivered using equipment commonly found in the ophthalmologist’s office and does not require a surgical procedure, pointing to a potentially less invasive, more convenient therapy for patients and physicians. AU-011 for the treatment of choroidal melanoma has been granted orphan drug and fast track designations by the U.S. Food and Drug Administration and is currently in clinical development.

About Aura Biosciences

Aura Biosciences is developing a new class of therapies to selectively target and destroy cancer cells. Its lead program, AU-011 in choroidal melanoma, is being developed under a CRADA with the National Cancer Institute (NCI), part of the National Institutes of Health. For more information, visit www.aurabiosciences.com.

About Massachusetts Eye and Ear

Massachusetts Eye and Ear, founded in 1824, is an international center for treatment and research and a teaching hospital of Harvard Medical School. A member of Partners HealthCare, Mass. Eye and Ear specializes in ophthalmology (eye care) and otolaryngology–head and neck surgery (ear, nose and throat care). Mass. Eye and Ear clinicians provide care ranging from the routine to the very complex. Also home to the world’s largest community of hearing and vision researchers, Mass. Eye and Ear has pioneered new treatments for blindness, deafness and diseases of the head and neck. Our scientists are driven by a mission to discover the basic biology underlying these conditions and to develop new treatments and cures. For more information about life-changing care and research at Mass. Eye and Ear, please visit our blog, Focus or visit MassEyeAndEar.org.

Media Contact
Lisa Raffensperger, (617) 903-8783
Ten Bridge Communications
lisa@tenbridgecommunications.com

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 it closed a $30 million Series C financing. New investors Lundbeckfonden Ventures and Arix Bioscience plc led the round, with all current investors also participating. Existing investors include Advent Life Sciences, Chiesi Ventures, Ysios Capital, Alexandria Venture Investments, Columbus Venture Partners, LI-COR Biosciences and several individual investors, including the estate of Henri Termeer.

With interim positive data released at the American Academy of Ophthalmology (AAO) 2017 Annual Meeting in November for its Phase 1b/2 clinical trial for light-activated AU-011, the company plans to use proceeds from this round of financing to expand infrastructure supporting ongoing clinical development. Aura intends to continue enrolling patients who have early-stage ocular melanoma in its Phase 1b/2 study of AU-011, the first targeted therapy ever to be developed for the primary treatment of this rare and life-threatening eye cancer. This novel therapy has the potential to selectively destroy cancer cells in the eye while preserving vision. Aura is also expanding in 2018 its footprint in Cambridge, Mass., with the addition of new employees, space and equipment.

“This year has been one of incredible momentum for Aura, with interim positive data reported from our Phase 1b/2 study of AU-011 and enthusiasm from key opinion leaders in ocular oncology across the country,” said Elisabet de los Pinos, Ph.D., founder and CEO of Aura. “We are pleased to enter 2018 with the renewed support of existing investors and to welcome Lundbeckfonden Ventures and Arix Bioscience to our Series C syndicate. We look forward this year to laying the groundwork for Phase 3 clinical development, furthering our commitment to enabling earlier treatment intervention for patients with ocular melanoma.”

“The Aura team has proven nimble while retaining a strong scientific rigor as it has made the transition to a clinical-stage company,” said Casper Breum, Senior Partner at Lundbeckfonden Ventures.

“We believe that this timely investment will propel the company’s preparations for late-stage studies of AU-011, with the potential to provide a safe and effective therapy where plaque radiation or enucleation are the only options currently,” said Mark Chin, Investment Director at Arix Bioscience.

With the close of this financing, Breum and Chin will join Alan Walts, Ph.D., Joël Jean-Mairet, Ph.D., Dale Pfost, Ph.D., Arthur Pappas and Dr. de los Pinos as members of Aura’s Board of Directors.

 

 

 

 

 

 

About ocular melanoma

 

Ocular melanoma, also known as uveal or choroidal melanoma, is a rare and aggressive eye cancer. Ocular melanoma is the most common primary ocular tumor and develops in the uveal tract of the eye. No targeted therapies are available at present, and current radiotherapy treatments can be associated with severe visual loss and other long-term sequelae such as dry eye, glaucoma, cataracts and radiation retinopathy. The most common current treatment is plaque radiotherapy, which involves surgical placement of a radiation device against the exterior of the eye over the tumor. This technique can control the melanoma but can also lead to radiation-related cataract, retinopathy, optic nerve damage and loss of vision. The alternative is enucleation, or removal of the eye. Ocular melanoma metastasizes to the liver in about 40 percent of cases in the long term (source: OMF), and only 15 percent of patients whose melanoma has metastasized survive beyond five years after diagnosis (source: ACS).

 

About light-activated AU-011

 

 

 

 

AU-011 is a first-in-class targeted therapy in development for the primary treatment of ocular melanoma. The therapy consists of patented viral nanoparticle conjugates with IR-700DX dye molecules that are activated with an ophthalmic laser. The viral nanoparticles bind selectively to unique receptors on cancer cells in the eye and are derived from technology originally pioneered by Dr. John Schiller of the Center for Cancer Research at the National Cancer Institute (NCI), recipient of the 2017 Lasker-DeBakey Award. The IR-700DX dye molecules are produced by LI-COR Biosciences and are licensed exclusively to Aura for treating ocular cancers.  Upon activation with an ophthalmic laser, the drug rapidly and specifically disrupts the membranes of tumor cells while sparing key eye structures, which may allow for the potential of preserving patients’ vision and reducing other long-term complications of treatment. This therapy can be delivered using equipment commonly found in the ophthalmologist’s office and does not require a surgical procedure, pointing to a potentially less invasive, more convenient therapy for patients and physicians. AU-011 for ocular melanoma has been granted orphan drug and fast track designations by the U.S. Food and Drug Administration and is currently in clinical development.

 

About Aura Biosciences

 

Aura Biosciences is developing a new class of therapies to selectively target and destroy cancer cells. Its lead program, AU-011 in ocular melanoma, is being developed under a CRADA with the National Cancer Institute (NCI), part of the National Institutes of Health. For more information, visit www.aurabiosciences.com.

About Lundbeckfonden VenturesLundbeckfonden Ventures is a part of the asset management subsidiary of The Lundbeck Foundation, which in addition to substantial financial assets, has controlling ownerships in H. Lundbeck A/S, ALK-Abelló A/S and Falck A/S. Lundbeckfonden Ventures has an evergreen structure and invests around $60 million annually in life science companies. The Lundbeckfonden Ventures team is located in Copenhagen, Denmark, and is active in both Europe and USA.

About Arix Bioscience plc

Arix Bioscience plc is a global healthcare and life science company supporting medical innovation. Headquartered in London and with an office in New York, Arix Bioscience sources, finances and builds world class healthcare and life science businesses addressing medical innovation at all stages of development. Operations are supported by privileged access to breakthrough academic science and strategic relationships with leading research accelerators and global pharmaceutical companies.

Arix Bioscience plc is listed on the Main Market of the London Stock Exchange.

For further information, please visit www.arixbioscience.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 visit www.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 visit www.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.

 

Media Contact

Lynnea Olivarez, 956-330-1917
Ten Bridge Communications
lynnea@tenbridgecommunications.com

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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, today announced that researchers at Massachusetts Eye and Ear (MEE), Emory University and the National Cancer Institute (NCI) have generated preclinical data that demonstrate the ability of light-activated AU-011 to target and selectively destroy ocular melanoma tumors, both in vitro and in vivo, in an orthotopic animal model that highly mimics the location and progression of the disease in humans. These results have been published in the peer-reviewed journal, Molecular Cancer Therapeutics.

Aura’s lead program, light-activated AU-011, is being developed for the treatment of primary ocular melanoma, a rare and life-threatening disease with no approved FDA therapies, and is currently in Phase 1b/2 clinical testing. Researchers believe AU-011’s high tumor specificity and targeting capability, due to its ability to selectively bind to heparan sulfate proteoglycans (HSPG) on the surface membrane of tumor cells, may be key to avoiding damage to the main ocular structures and preserving patients’ vision

“These data offer strong support for the basis of our clinical program, which we are currently investigating in patients with primary ocular melanoma,” said Elisabet de los Pinos, Ph.D., founder and CEO of Aura. “Our ultimate goal is to offer a first-line treatment option that can achieve local tumor control, while enabling patients to maintain their vision.”

Currently available treatment options to control local tumor growth, such as plaque radiotherapy, are highly invasive and not tumor-specific, often resulting in severe and vision-threatening complications. The data published today suggest that AU-011 may be further investigated as a novel first-line treatment option that can enable early intervention and potentially become the standard of care for patients with early-stage ocular melanoma.

 

 

 

 

 

About ocular melanoma

 

Ocular melanoma, also known as uveal or choroidal melanoma, is a rare and aggressive eye cancer. Ocular melanoma is the most common primary ocular tumor and develops in the uveal tract of the eye. No targeted therapies are available at present, and current radiotherapy treatments can be associated with severe visual loss and other long-term sequelae such as dry eye, glaucoma, cataracts and radiation retinopathy. The most common current treatment is plaque radiotherapy, which involves surgical placement of a radiation device against the exterior of the eye over the tumor. This technique can control the melanoma but can also lead to radiation-related cataract, retinopathy, optic nerve damage and loss of vision. The alternative is enucleation, or removal of the eye. Ocular melanoma metastasizes to the liver in about 40 percent of cases in the long term (source: OMF), and only 15 percent of patients whose melanoma has metastasized survive beyond five years after diagnosis (source: ACS).

 

About light-activated AU-011

 

 

 

AU-011 is a first-in-class targeted therapy in development for the primary treatment of ocular melanoma. The therapy consists of viral nanoparticle conjugates that bind selectively to unique receptors on cancer cells in the eye and is derived from technology originally pioneered by Dr. John Schiller of the Center for Cancer Research at the National Cancer Institute (NCI), recipient of the 2017 Lasker-DeBakey Award. Upon activation with an ophthalmic laser, the drug rapidly and specifically disrupts the membranes of tumor cells while sparing key eye structures, which may allow for the potential of preserving patients’ vision and reducing other long-term complications of treatment. This therapy can be delivered using equipment commonly found in the ophthalmologist’s office and does not require a surgical procedure, pointing to a potentially less invasive, more convenient therapy for patients and physicians. AU-011 for ocular melanoma has been granted orphan drug and fast track designations by the U.S. Food and Drug Administration and is currently in clinical development.

 

About Aura Biosciences

 

Aura Biosciences is developing a new class of therapies to selectively target and destroy cancer cells. Its lead program, AU-011 in ocular melanoma, is being developed under a CRADA with the National Cancer Institute (NCI), part of the National Institutes of Health. For more information, visit www.aurabiosciences.com.

 

Media Contact

Lynnea Olivarez, 956-330-1917
Ten Bridge Communications
lynnea@tenbridgecommunications.com

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, today announced that Cadmus Rich, M.D., has joined the company’s leadership team as Chief Medical Officer. In this role, he will oversee all clinical research and development activities.

“We welcome Cadmus to our team during a pivotal time at Aura,” said Elisabet de los Pinos, Ph.D., founder and CEO of Aura. “As Chief Medical Officer, Cadmus will play an instrumental role as we continue to advance our Phase 1b/2 clinical trial of light-activated AU-011, following release of positive interim safety data last month. We look forward to drawing on his extensive expertise leading product development and commercialization initiatives in ophthalmology.”

Dr. Rich joins the company from Inotek Pharmaceuticals, where he was Vice President, Medical Affairs and Clinical Development, responsible for development of therapies to treat glaucoma and other serious eye diseases. Prior to Inotek, Dr. Rich held key leadership roles at Alcon, most recently as a Therapeutic Unit Head leading the intraocular lenses team and prior to this, as Global Head of Pharmaceutical Clinical Trial Management. At Alcon, he managed many development programs and clinical trials; therapeutic and device submissions; and approvals for six drugs and five devices in a number of international markets. Before that, he established a new center of excellence in ophthalmology at Quintiles Transnational (now IQVIA), the world’s largest contract research organization.

Dr. Rich earned a bachelor’s degree in psychology from Case Western Reserve University; a Doctor of Medicine from the University of North Carolina (UNC) School of Medicine, Chapel Hill; and a Master of Business Administration from Regis University. He completed his ophthalmology residency at the UNC Department of Ophthalmology, Chapel Hill and additionally, is a Certified Physician Executive. He serves on the national board of directors of Prevent Blindness, a volunteer eye health and safety organization dedicated to fighting blindness and saving sight.

“I’m pleased to help lead the important work that Aura is advancing in ocular melanoma, which has no FDA-approved, targeted therapies,” said Dr. Rich. “In partnership with our global network of ocular oncology experts, we are striving to provide a novel option for early treatment intervention of this rare disease.”

Aura also announced today that Alison Lawton has resigned from her role as Chief Operating Officer to pursue other opportunities. She will remain an advisor to Aura.

 

 

 

 

About ocular melanoma

 

Ocular melanoma, also known as uveal or choroidal melanoma, is a rare and aggressive eye cancer. Ocular melanoma is the most common primary ocular tumor and develops in the uveal tract of the eye. No targeted therapies are available at present, and current radiotherapy treatments can be associated with severe visual loss and other long-term sequelae such as dry eye, glaucoma, cataracts and radiation retinopathy. The most common current treatment is plaque radiotherapy, which involves surgical placement of a radiation device against the exterior of the eye over the tumor. This technique can control the melanoma but can also lead to radiation-related cataract, retinopathy, optic nerve damage and loss of vision. The alternative is enucleation, or removal of the eye. Ocular melanoma metastasizes to the liver in about 40 percent of cases in the long-term (source: OMF), and only 15 percent of patients whose melanoma has metastasized survive beyond five years after diagnosis (source: ACS).

 

About light-activated AU-011

 

 

AU-011 is a first-in-class targeted therapy in development for the primary treatment of ocular melanoma. The therapy consists of viral nanoparticle conjugates that bind selectively to unique receptors on cancer cells in the eye and is derived from technology originally pioneered by Dr. John Schiller of the Center for Cancer Research at the National Cancer Institute (NCI), recipient of the 2017 Lasker-DeBakey Award. Upon activation with an ophthalmic laser, the drug rapidly and specifically destroys the membranes of tumor cells while sparing key eye structures, which may allow for the potential of preserving patients’ vision and reducing other long-term complications of treatment. This therapy can be delivered in the ophthalmologist’s office and does not require a surgical procedure, enabling a less invasive, more convenient therapy for patients and physicians. AU-011 for ocular melanoma has been granted orphan drug and fast track designations by the U.S. Food and Drug Administration and is currently in clinical development.

 

About Aura Biosciences

 

Aura Biosciences is developing a new class of therapies to selectively target and destroy cancer cells selectively. Its lead program, AU-011 in ocular melanoma, is being developed under a CRADA with the National Cancer Institute (NCI), part of the National Institutes of Health. For more information, visit www.aurabiosciences.com.

 

Media Contact

Lynnea Olivarez, 956-330-1917
Ten Bridge Communications
lynnea@tenbridgecommunications.com

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, today announced interim safety data from an open-label Phase 1b/2 study of its lead program, light-activated AU-011 for the treatment of primary ocular melanoma. The findings were presented by Carol Shields, M.D., Director of the Ocular Oncology Service at Wills Eye Hospital and Professor of Ophthalmology of Thomas Jefferson University in Philadelphia, during a late-breaking session at the American Academy of Ophthalmology (AAO) 2017 Annual Meeting in New Orleans. The first and second patients in this study were dosed earlier this year by Dr. Shields at Wills Eye Hospital in Philadelphia. The subsequent patients were dosed at centers in Boston, Detroit, Houston and Denver.

AU-011, an investigational, first-in-class targeted therapy, is in development for the treatment of primary ocular melanoma, a rare and life-threatening disease. The Phase 1b/2 open-label, ascending single and repeat dose trial of AU-011, will evaluate the safety (primary objective) and preliminary efficacy (secondary objective) in up to 24 adult patients who have a clinical diagnosis of ocular melanoma.

Interim data presented today at AAO show that the drug candidate was generally well-tolerated, with no serious adverse events reported, in the first six patients at three to six months post-treatment of AU-011. The most commonly reported adverse events consisted of anterior and posterior intraocular inflammation, which was managed with administration of topical and/or oral steroid treatment. All patients maintained visual acuity. The preliminary efficacy measurement of tumor thickness on B-scan ultrasound at three months post-treatment shows that all patients had stable disease at three months, and only one patient experienced tumor progression at five months.

“These preliminary findings are an encouraging step forward in our effort to evaluate the potential of AU-011 for the treatment of ocular melanoma,” said Dr. Shields. “Today there are no treatment options available for patients that can effectively target tumor cells while still preserving vision. We are excited to build on these initial results as this important research progresses.”

“Aura’s goal is to give physicians first-in-class tools that can transform the treatment of ocular melanoma and other cancers when the disease is diagnosed early,” said Cadmus Rich, M.D., Chief Medical Officer of Aura. “These are promising early data, and our team is pleased to continue our Phase 1b/2 study with Dr. Shields and our other collaborators at leading ophthalmology centers of excellence across the country.”

 

 

 

About ocular melanoma

 

Ocular melanoma, also known as uveal or choroidal melanoma, develops in the uvea, or uveal tract, of the eye, and is a rare and aggressive eye cancer. No targeted therapies are available at present, and current radiotherapy treatments can be associated with severe visual loss and other long-term sequelae such as dry eye, glaucoma, cataracts and radiation retinopathy. The most common current treatment is plaque radiotherapy, which involves surgical placement of a radiation device against the exterior of the eye over the tumor. This technique can control the melanoma but can also lead to radiation-related cataract, retinopathy and loss of vision. The alternative is enucleation, or removal of the eye. Ocular melanoma metastasizes to the liver in about 40 percent of cases in the long-term (source: OMF), and only 15 percent of patients whose melanoma has metastasized survive beyond five years after diagnosis (source: ACS).

 

About light-activated AU-011

 

AU-011 is a first-in-class targeted therapy in development for the primary treatment of ocular melanoma, also known as uveal or choroidal melanoma, a rare and life-threatening disease. The therapy consists of viral nanoparticle conjugates that bind selectively to cancer cells in the eye and is derived from technology originally pioneered by Dr. John Schiller of the Center for Cancer Research at the National Cancer Institute (NCI). Upon activation with an ophthalmic laser, the drug rapidly and specifically destroys the membranes of tumor cells while sparing key eye structures, which may allow for the potential of preserving patients’ vision. AU-011 for ocular melanoma has been granted orphan drug and fast track designations by the U.S. Food and Drug Administration and is currently in clinical testing.

 

About Aura Biosciences

 

Aura Biosciences is developing a new class of therapies to target and destroy cancer cells selectively. Its lead program, AU-011 in ocular melanoma, is being developed under a CRADA with the National Cancer Institute (NCI), part of the National Institutes of Health. For more information, visit www.aurabiosciences.com.

 

Media Contact

Lynnea Olivarez, 956-330-1917
Ten Bridge Communications
lynnea@tenbridgecommunications.com

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 Carol Shields, M.D., Director of the Ocular Oncology Service at the Wills Eye Hospital in Philadelphia, will present data from the Phase 1b clinical safety study of AU-011 during a late-breaking session at the American Academy of Ophthalmology (AAO) Annual Meeting in New Orleans, Nov. 11-14.

Light-activated AU-011, an investigational, first-in-class targeted therapy is in development for the treatment of ocular melanoma, a rare and life-threatening disease. The first patient in this study was dosed this past March by Dr. Shields at the Wills Eye Hospital.

Dr. Shields’ presentation, titled “A Phase 1b Clinical Safety Study of a Novel Tumor Targeted Therapy (AU-011) for the Treatment of Primary Choroidal Melanoma,” will take place on Saturday, Nov. 11, at 9:03 a.m. CT in The Great Hall, as part of the session, “Section XIII: Late Breaking Development – Part II.”

Additional information, including the presentation schedule, may be found in the AAO Mobile Meeting Guide.

 

 

About ocular melanoma

 

Ocular melanoma, also known as uveal or choroidal melanoma, develops in the uvea, or uveal tract, of the eye, and is a rare and aggressive eye cancer. No targeted therapies are available at present, and current treatments can be associated with severe visual morbidities. The most common current treatment is plaque radiotherapy, which involves surgical placement of a radiation device against the exterior of the eye over the tumor. This technique can control the melanoma but can also lead to radiation-related cataract, retinopathy and loss of vision. The alternative is enucleation, or removal of the eye. Ocular melanoma metastasizes to the liver in about 40 percent of cases in the long-term (source: OMF), and only 15 percent of patients whose melanoma has metastasized survive beyond five years after diagnosis (source: ACS).

 

About light-activated AU-011

 

AU-011 is a first-in-class targeted therapy in development for the primary treatment of ocular melanoma, also known as uveal or choroidal melanoma, a rare and life-threatening disease. The therapy consists of viral nanoparticle conjugates that bind selectively to cancer cells in the eye and is derived from technology originally pioneered by Dr. John Schiller of the Center for Cancer Research at the National Cancer Institute (NCI). Upon activation with an ophthalmic laser, the drug rapidly and specifically destroys the membranes of tumor cells while sparing key eye structures, which may allow for the potential of preserving patients’ vision. AU-011 for ocular melanoma has been granted orphan drug and fast track designations by the U.S. Food and Drug Administration and is currently in clinical testing.

 

About Aura Biosciences

 

Aura Biosciences is developing a new class of therapies to target and destroy cancer cells selectively. Its lead program, AU-011 in ocular melanoma, is being developed under a CRADA with the National Cancer Institute (NCI), part of the National Institutes of Health. For more information, visit www.aurabiosciences.com.

 

Media Contact

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

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 it has enrolled and dosed the first patient in its Phase 1b clinical trial of light-activated AU-011, an investigational, first-in-class targeted therapy in development for the treatment of ocular melanoma, a rare and life-threatening disease. Aura additionally announced today that the U.S. Food and Drug Administration (FDA) has granted AU-011 fast track designation for the treatment of primary ocular melanoma, also known as uveal or choroidal melanoma. This designation enables Aura to have more frequent interactions with the FDA throughout AU-011’s drug development process, as well as priority review of the New Drug Application (NDA). Fast track designation is granted to drugs that are for serious or life-threatening diseases and that the FDA believes demonstrate the potential to address unmet medical needs.

“Patients with ocular melanoma currently have few treatment options available that can effectively destroy tumor cells while still preserving vision. Aura’s trial is an important step in understanding the potential of AU-011 as a safe and novel therapeutic option to improve the outlook for these patients,” said Carol Shields, M.D., Co-Director of the Ocular Oncology Service at Wills Eye Hospital in Philadelphia, where the first patient in this trial was dosed. She is also a professor of ophthalmology at Thomas Jefferson University and a member of Aura’s Clinical Advisory Board.

Dr. Shields’ work with AU-011 builds on years of pioneering research in early diagnosis of ocular melanoma using clinically relevant risk factors for timely recognition and treatment. The doctors at Wills Eye Hospital and other ocular oncology leaders across the country have pursued early diagnosis in an effort to reduce treatment-related visual loss and prevention of metastatic disease. Writing in a recent issue of Nature Eye, Dr. Shields and her team advocate for the development of new treatment options that can be used earlier in the course of disease while preserving vision for patients, based on the advances in earlier diagnosis of ocular melanoma using established risk factors.

“We look forward to evaluating and advancing AU-011 alongside Dr. Shields and other renowned researchers at ocular oncology centers of excellence in the U.S.,” said Elisabet de los Pinos, Ph.D., founder and CEO of Aura. “Moreover, we will continue to work closely with the FDA under AU-011’s fast track designation to shape our clinical program with their input. Ultimately, our goal is to equip the physicians who diagnose ocular melanoma early with a new targeted therapy that both prevents tumor growth and leaves other key ocular structures unaffected, thereby preserving vision for patients.”

Trial investigators will focus on evaluating the safety of two dose levels of AU-011 for the treatment of patients with small-to-medium primary ocular melanoma. The Phase 1b open-label trial will enroll up to a total of 12 adult patients at Wills Eye Hospital and other ocular oncology centers across the country. Potential participants must have a confirmed ocular melanoma diagnosis not  previously treated. Study investigators will conduct patient follow-up throughout a two-year observation period. For more information, visit www.clinicaltrials.gov or contact clinical@aurabiosciences.com.

 

About ocular melanoma

 

Ocular melanoma, also known as uveal or choroidal melanoma, develops in the uvea, or uveal tract, of the eye, and is a rare and aggressive eye cancer. No targeted therapies are available at present, and current treatments can be associated with potential visual morbidities. The most common current treatment is plaque radiotherapy, which involves surgical placement of a radiation device against the exterior of the eye over the tumor. This technique can control the melanoma but can also lead to radiation-related cataracts, retinopathy and loss of vision. The alternative is enucleation, or removal of the eye. Ocular melanoma metastasizes to the liver in about 40 percent of cases in the long-term (source: OMF), and only 15 percent of patients whose melanoma has metastasized survive beyond five years after diagnosis (source: ACS).

 

About light-activated AU-011

 

AU-011 is a first-in-class targeted therapy in development for the primary treatment of ocular melanoma, also known as uveal or choroidal melanoma, a rare and life-threatening disease. The therapy consists of viral nanoparticle conjugates that bind selectively to cancer cells in the eye and is derived from technology originally pioneered by Dr. John Schiller of the Center for Cancer Research at the National Cancer Institute (NCI). Upon activation with an ophthalmic laser, the drug rapidly and specifically destroys the membranes of tumor cells while sparing key eye structures, which may allow for the potential of preserving patients’ vision. AU-011 for ocular melanoma has been granted orphan drug and fast track designations by the U.S. Food and Drug Administration and is currently in clinical testing.

 

About Aura Biosciences

 

Aura Biosciences is developing a new class of therapies to target and destroy cancer cells selectively. Its lead program, AU-011 in ocular melanoma, is being developed under a CRADA with the National Cancer Institute (NCI), part of the National Institutes of Health. For more information, visit www.aurabiosciences.com.

 

Media Contact

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

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 the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug application (IND) for the company’s lead program, light-activated AU-011 in ocular melanoma (OM). This active IND enables Aura to begin initial clinical testing of AU-011, a unique targeted therapy that could transform the primary treatment of patients with OM, a rare and life-threatening disease.

“Early detection of ocular melanoma, combined with the administration of AU-011 as a potential vision-sparing therapy, could transform the treatment of patients with this devastating disease,” said Brian Marr, M.D., Director of the Ophthalmic Oncology Service at Columbia University Medical Center. Dr. Marr is the principal investigator for the AU-011 clinical trial and also is a member of Aura’s Clinical Advisory Board.

“Receiving IND clearance to enter the clinic for AU-011 is an important step in the development pathway for this novel class of drugs, and I’m thankful to our team of dedicated employees, as well as to our distinguished scientific and clinical advisors, for their contributions that have propelled us to this point,” said Elisabet de los Pinos, Ph.D., founder and CEO of Aura. “With the advancement of AU-011, we are opening the door for innovation in a completely new therapeutic area where there are no FDA drugs approved today. Our hope is that AU-011 could be used to treat small primary melanomas early, with the potential to eliminate the tumor and preserve vision for patients.”

The Phase 1b open-label, single ascending dose clinical trial currently enrolling is designed to evaluate the safety, immunogenicity and preliminary efficacy of two dose levels of AU-011 for the treatment of small-to-medium primary OM. Screening procedures for eligible patients are underway at five clinical trial sites across the country. For more information, visit www.clinicaltrials.gov or contact clinical@aurabiosciences.com.

About ocular melanoma (OM)

 

Ocular melanoma (OM), also known as uveal or choroidal melanoma, develops in the uvea, or uveal tract, of the eye, and is an aggressive and rare eye cancer. No targeted therapies are currently available, and current treatments are associated with serious morbidities. The most common treatment today is placing an invasive radioactive plaque against the exterior of the eye near the tumor, which requires multiple surgeries and can lead to cataracts, retinopathy and loss of vision. The alternative is enucleation, the removal of the eye. OM metastasizes to the liver in about half of all cases (source: OMF), and only 15 percent of patients whose OM has metastasized survive beyond five years after diagnosis (source: ACS).

About light-activated AU-011

 

AU-011 is a first-in-class targeted therapy in development for the primary treatment of ocular melanoma (OM), also known as uveal or choroidal melanoma, a rare and life-threatening disease. The therapy consists of viral nanoparticle conjugates that bind selectively to cancer cells in the eye. AU-011 has a necrotic mechanism of action and is administered through an intravitreal injection into the eye. Upon activation with an ophthalmic laser, the drug rapidly and specifically destroys the membranes of tumor cells while sparing key eye structures, which may allow for the potential of preserving patients’ vision. AU-011 for OM has been granted orphan drug designation by the U.S. Food and Drug Administration and is currently in clinical testing.

About Aura Biosciences

 

Aura Biosciences is developing a new class of therapies to target and destroy cancer cells selectively. Its lead program, AU-011 in ocular melanoma (OM), is being developed under a CRADA with the National Cancer Institute (NCI). For more information, visit www.aurabiosciences.com.

Media Contact

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