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

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 secured an additional $8 million round of funding. The company also announced the addition of Henri Termeer, former CEO of Genzyme and major Aura investor, to its Board of Directors, and welcomed key new Clinical Advisory Board (CAB) members, all distinguished ocular oncologists.

The round of financing consisted of expanded funding commitments from its existing investors:  Advent Partners, Chiesi Ventures, Ysios Capital, Alexandria Venture Investments and several individual investors, including Termeer. Proceeds from the financing will be used to advance to the clinic Aura’s lead program in ocular melanoma (OM), AU-011, which is the first targeted therapy ever to be developed for the primary treatment of this rare and life-threatening disease. AU-011 has been granted orphan drug designation by the U.S. Food and Drug Administration and is expected to enter clinical testing early next year.

“Since the closing of our Series B financing over a year ago, we’ve made significant strides toward our ultimate goal of creating a safe and effective therapy that selectively eliminates cancer cells early in the OM disease course, while preserving vision for these patients,” said Elisabet de los Pinos, founder and CEO of Aura Biosciences. “With the continued support of our investors, experienced clinical advisors and Board of Directors, we are moving AU-011 rapidly toward the clinic, while additionally advancing our preclinical programs in other indications where Aura’s approach of selective tumor targeting could revolutionize treatment for patients with rare cancers who have no other treatment options.”

To help guide the company’s clinical program, Aura has also expanded its CAB with two new members who are recognized world leaders in the diagnosis and treatment of patients with OM and other ocular cancers:

• Jay S. Duker, M.D., Director of the New England Eye Center and Professor and Chairman of the department of ophthalmology at Tufts Medical Center and the Tufts University School of Medicine in Boston
• Brian Marr, M.D., Associate Professor of Ophthalmology at Weill-Cornell Medical School, and Associate Attending and key member of the ophthalmic oncology service, department of surgery at Memorial Sloan-Kettering Cancer Center

Founding members of Aura’s CAB, which was formed last year, are world-renowned ocular oncology specialists Carol Shields, M.D., Evangelos Gragoudas, M.D., and Arun Singh, M.D. José Baselga, M.D., Ph.D., Physician-in-Chief and Chief Medical Officer at Memorial Sloan Kettering Cancer Center, is the Chairman of Aura’s CAB. Additional members include Miguel Burnier, Jr., M.D., Ph.D., Richard Carvajal, M.D., and Richard Peters, M.D., Ph.D.

 

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

CAMBRIDGE, Mass.–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 Ophthalmology Innovation Summit at the American Academy of Ophthalmology 2016 Annual Meeting (OIS@AAO) in Chicago.

The presentation will take place during the Company Showcase on Thursday, October 13, 2016, at 11 a.m. EST.

 

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

CAMBRIDGE, Mass.–Aura Biosciences announced today that it will participate in the Boston Miles for Melanoma 5K Run/Walk, in support of the Melanoma Research Foundation’s (MRF) research, advocacy and education efforts. Aura has partnered with CURE OM, the Community United for Research and Education of Ocular Melanoma, to form a joint team for this event.

“Participating in this weekend’s Miles for Melanoma event here in Boston is a terrific opportunity for Aura to come together with the community to raise awareness for ocular melanoma and the Melanoma Research Foundation,” said Elisabet de los Pinos, CEO of Aura Biosciences. “We’re looking forward to walking alongside CURE OM’s co-founder and director, Sara Selig, and other fellow supporters of melanoma education and research.”

The Boston Miles for Melanoma Run/Walk will begin at 8:30 a.m. on July 9 in Brighton, Mass. This is the second-annual Miles for Melanoma 5K and is one of many events that take place around the nation to support the MRF. The MRF is a nonprofit and the largest independent organization devoted to melanoma.

 

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 U.S. Food and Drug Administration. For more information, visit www.aurabiosciences.com.