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