CAMBRIDGE, MA – July 24, 2019 – Aura Biosciences, a leader in the development of novel targeted therapies in ocular oncology, today announced that two-year clinical data from its ongoing Phase 1b/2 clinical trial evaluating the safety and efficacy of light-activated AU-011, the Company’s lead product candidate for the treatment of primary choroidal melanoma, will be highlighted in an oral presentation at the 37th Annual Scientific Meeting of the American Society of Retina Specialists (ASRS) being held July 26- 30, 2019 in Chicago, Illinois.

“There is an urgent unmet medical need for targeted treatment options for patients suffering from primary choroidal melanoma, a life-threatening form of eye cancer,” said Amy C. Schefler, M.D., Associate Professor of Clinical Ophthalmology, Weill Cornell Medical College/Houston Methodist Hospital and the University of Texas Health Science Center. “Emerging results from the Phase 1b/2 trial of light-activated AU-011 demonstrate tumor control and visual acuity preservation, warranting continued development of the program.”

Title: Two-Year Results of an Ongoing Phase 1b/2 Open Label Clinical Trial of AU-011 for the Primary Treatment of Small to Medium Choroidal Melanoma,

Presenter: Amy C. Schefler, M.D., Associate Professor of Clinical Ophthalmology, Weill Cornell Medical College/Houston Methodist Hospital and the University of Texas Health Science Center

Session: Ocular Oncology Symposium

Date and time: Monday, July 29, 2019; 9:35 -9:41am CDT

About Choroidal Melanoma

Choroidal melanoma is a rare and aggressive type of eye cancer. Choroidal melanoma is the most common primary intraocular tumor in adults 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 in approximately 50 percent of cases with liver involvement in 80-90% of cases and, unfortunately, metastatic disease is universally fatal (source: OMF). There is a very high unmet need for a new vision sparing targeted therapy that could enable early treatment intervention for this life-threatening rare disease given the lack of approved therapies, and the comorbidities of radioactive treatment options.

About Light-Activated AU-011 

AU-011 is a first-in-class targeted therapy in development for the treatment of primary choroidal melanoma. The therapy consists of proprietary viral-like particle bioconjugates (VPB) that are activated with an ophthalmic laser. The VPBs 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 for the treatment of 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. 

Contacts: 

Media:

David Rosen

Argot Partners

212.600.1902 | david.rosen@argotpartners.com

 

Investors:

Joseph Rayne

Argot Partners

617.340.6075 | joseph@argotpartners.com

CAMBRIDGE, MA – June 14, 2019 – Aura Biosciences, a leader in the development of novel targeted therapies in ocular oncology, today announced that interim clinical data from its ongoing Phase 1b/2 clinical trial evaluating the safety and efficacy of light-activated AU-011, the Company’s lead product candidate for the treatment of primary choroidal melanoma, will be highlighted in an oral presentation at the European Society of Ophthalmology 2019 Congress being held June 13-16, 2019, in Nice, France.

“The data with additional follow up time continues to demonstrate a good tolerability and safety profile of light-activated AU-011 at single and multiple administrations. There is also consistent evidence of tumor control and visual acuity preservation, which are key benefits of this novel treatment,” said Ivana K. Kim, M.D., Co-Director, Ocular Melanoma Center, Massachusetts Eye and Ear, Associate Professor of Ophthalmology, Harvard Medical School. “Interest in AU-011 as a potential first line treatment for early stage disease is very high as current treatments for primary choroidal melanoma typically result in severe vision loss and ocular morbidity.”

Oral presentation details are as follows:

Title: Interim Results of a Phase 1b/2 Open-Label Clinical Trial of AU-011 for the Treatment of Small to Medium Choroidal Melanoma

Presenter: Ivana K. Kim, M.D., Co-Director, Ocular Melanoma Center, Massachusetts Eye and Ear and Associate Professor of Ophthalmology, Harvard Medical School

Session: Innovation in Retina

Date and time: Friday, June 14, 2019; 3:00-3:12pm CEST

Location: Gallieni 5, Acropolis Convention Centre

About Choroidal Melanoma

Choroidal melanoma is a rare and aggressive type of eye cancer. Choroidal melanoma is the most common primary intraocular tumor in adults 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 in approximately 50 percent of cases with liver involvement in 80-90% of cases and, unfortunately, metastatic disease is universally fatal (source: OMF). There is a very high unmet need for a new vision sparing targeted therapy that could enable early treatment intervention for this life-threatening rare disease given the lack of approved therapies, and the comorbidities of radioactive treatment options.

About Light-Activated AU-011

AU-011 is a first-in-class targeted therapy in development for the treatment of primary choroidal melanoma. The therapy consists of proprietary viral-like particle bioconjugates (VPB) that are activated with an ophthalmic laser. The VPBs 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 for the treatment of 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.

Contacts:

Media:

David Rosen

Argot Partners

212.600.1902 | david.rosen@argotpartners.com

Investors:

Joseph Rayne

Argot Partners

617.340.6075 | joseph@argotpartners.com

CAMBRIDGE, MA – May 28, 2019 – Aura Biosciences, a leader in the development of novel targeted therapies in ocular oncology, today announced that Elisabet de los Pinos, Ph.D., Chief Executive Officer of Aura, will present a company overview at the Jefferies 2019 Global Healthcare Conference on Tuesday, June 4, 2019, at 2:00 p.m. Eastern Time in New York, NY.

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.   

Contacts: 

Media:

David Rosen

Argot Partners

212.600.1902 | david.rosen@argotpartners.com 

Investors:

Joseph Rayne

Argot Partners

617.340.6075 | joseph@argotpartners.com

CAMBRIDGE, MA – April 22, 2019 – Aura Biosciences, a leader in the development of novel targeted therapies in ocular oncology, today announced that two year clinical data from its ongoing Phase 1b/2 clinical trial evaluating the safety and efficacy of light-activated AU-011, the Company’s lead product candidate for the primary treatment of primary choroidal melanoma, will be highlighted in a poster presentation at the Association for Research in Vision and Ophthalmology (ARVO) 2019 Annual Meeting being held April 28-May 2, 2019, in Vancouver, British Columbia.

Poster presentation details are as follows:

Title: Two Year Results of a Phase 1/2 Open-Label Clinical Trial of AU-011 for the Treatment of Small to Medium Choroidal Melanoma

Poster Number: B0197

Poster Presenter: Tara McCannel, M.D., Ph.D, Director of the Ophthalmic Oncology Center, Jules Stein Eye Institute, UCLA School of Medicine

Session: Clinical Melanoma – Therapy and Complications

Date and time: Sunday, April 28, 2019; 1:00-2:45pm PT

Location: Vancouver Convention Centre, Western Exhibition Hall

About Choroidal Melanoma 

Choroidal melanoma is a rare and aggressive type of eye cancer. Choroidal melanoma is the most common primary intraocular tumor in adults 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 in approximately 50 percent of cases with liver involvement in 80-90% of cases and, unfortunately, metastatic disease is universally fatal (source: OMF). There is a very high unmet need for a new vision sparing targeted therapy that could enable early treatment intervention for this life-threatening rare disease given the lack of approved therapies, and the comorbidities of radioactive treatment options.

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 bioconjugates (VPB) that are activated with an ophthalmic laser. The VPBs 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.   

Contacts: 

Media:

David Rosen

Argot Partners

212.600.1902 | david.rosen@argotpartners.com 

Investors:

Joseph Rayne

Argot Partners

617.340.6075 | joseph@argotpartners.com

CAMBRIDGE, MA – April 2, 2019 – Aura Biosciences, a leader in the development of novel targeted therapies in ocular oncology, today announced that it closed a $40 million Series D financing. New investor Medicxi led the round, with current investors also participating.

The Company plans to use the proceeds from the Series D financing to support the late stage clinical development of their lead asset, light-activated AU-011, for the treatment of primary choroidal melanoma.

“The additional funding provided by this Series D financing enables Aura to continue to execute on our goals of developing the first targeted treatment for patients with primary choroidal melanoma, a life and vision threatening rare disease with no drugs approved,” said Elisabet de los Pinos, Ph.D., Chief Executive Officer of Aura. “We are delighted to have the support from lead investor Medicxi, along with our existing investors, as we enter this next stage of the company’s growth.”

In conjunction with the closing of the financing, Giovanni Mariggi, Ph.D., a Partner at Medicxi, will join Aura’s Board of Directors.

About Choroidal Melanoma

Choroidal melanoma is a rare and aggressive type of eye cancer. Choroidal melanoma is the most common primary intraocular tumor in adults and develops in the uveal tract of the eye. No targeted therapies are commercially available at present. The most common current treatment for choroidal melanoma is plaque radiotherapy, which involves surgical placement of a radiation device on the exterior of the eye over the tumor and is associated with severe visual loss and other long-term sequelae such as dry eye, glaucoma, cataracts and radiation retinopathy. The only other alternative is enucleation, or total surgical removal of the eye. Choroidal melanoma metastasizes in approximately 50 percent of cases with liver involvement in 80-90% of cases and, unfortunately, metastatic disease is universally fatal (source: OMF). There is a very high unmet need for a new vision-sparing targeted therapy that could enable early treatment intervention for this life-threatening rare disease given the lack of approved therapies, and the comorbidities of radioactive treatment options.

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 bioconjugates (VPB) that are activated with an ophthalmic laser. The VPBs 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 VPB 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. Current institutional investors participating in the financing includes Advent Life Sciences, Arix Bioscience, Chiesi Ventures, Columbus Venture Partners, Lundbeck Ventures and Ysios Capital. For more information, visit www.aurabiosciences.com.

About Medicxi

Medicxi is a European venture capital firm with the mission to create and invest in companies along the full drug development continuum. Medicxi was established by the former Index Ventures life sciences team, which has been active for over 20 years, and invests in both early and late-stage assets with a product vision that can fulfill a clear unmet need. GSK, Johnson & Johnson, Novartis and Verily, an Alphabet company, have invested in Medicxi funds. Please see www.medicxi.com for more information.

Contacts:

Media:

David Rosen

Argot Partners

212.600.1902 | david.rosen@argotpartners.com

 

Investors:

Joseph Rayne

Argot Partners

617.340.6075 | joseph@argotpartners.com

CAMBRIDGE, MA – March 21, 2019 – Aura Biosciences, a leader in the development of novel targeted therapies in ocular oncology, today announced that interim clinical data from its Phase 1b/2 clinical trial evaluating the safety and efficacy of light-activated AU-011, the Company’s lead product candidate for the primary treatment of primary choroidal melanoma, will be highlighted in an oral presentation at the International Society of Ocular Oncology (ISOO) 2019 Annual Meeting being held March 22-26, 2019, in Los Angeles.

“These 18-month safety and efficacy data demonstrate that light-activated AU-011 is well-tolerated, including with multiple administrations, and has shown initial evidence of tumor control and preservation of visual acuity even in high risk patients whose tumors are close to the fovea and optic disk,” said Ivana K. Kim, M.D., Co-Director, Ocular Melanoma Center, Massachusetts Eye and Ear, Associate Professor of Ophthalmology, Harvard Medical School, and lead author of the presentation.

“Light-activated AU-011 continues to show a compelling degree of tumor control, tolerability and vision preservation as a potential first line treatment option for patients with small choroidal melanoma and indeterminate lesions, especially given the lack of targeted treatment options for these patients,” commented Cadmus Rich, M.D., Chief Medical Officer of Aura.  “It is also remarkable that no drug-related severe adverse events, serious adverse events or dose limiting toxicities have been observed in the study to date. We are excited to share these data with the medical community at ISOO this year.”

This open-label, multicenter trial is designed to investigate single and multiple ascending doses of light-activated AU-011 in approximately 52 adult subjects with clinically diagnosed primary choroidal melanoma.  The details for the ISOO 2019 presentation are as follows:

Title: Eighteen Month Results of a Phase 1b/2 Open-Label Clinical Trial of AU-011 for the Treatment of Small to Medium Choroidal Melanoma

Date and time: Sunday, March 24, 2019; 11:10-11:15am PT

Location: The Ritz-Carlton Marina del Rey

About Choroidal Melanoma

Choroidal melanoma is a rare and aggressive type of eye cancer. Choroidal melanoma is the most common primary intraocular tumor in adults 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 in approximately 50 percent of cases with liver involvement in 80-90% of cases and, unfortunately, metastatic disease is universally fatal (source: OMF). There is a very high unmet need for a new vision sparing targeted therapy that could enable early treatment intervention for this life-threatening rare disease given the lack of approved therapies, and the comorbidities of radioactive treatment options.

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 bioconjugates (VPB) that are activated with an ophthalmic laser. The VPBs 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.

Contacts:

Media:

David Rosen

Argot Partners

212.600.1902 | david.rosen@argotpartners.com

 

Investors:

Joseph Rayne

Argot Partners

617.340.6075 | joseph@argotpartners.com

CAMBRIDGE, MA – March 5, 2019 – Aura Biosciences, a leader in the development of novel targeted therapies in ocular oncology, today announced that management will present a company overview at the following investor conferences:

• Cowen and Company 39th Annual Health Care Conference on Tuesday, March 12, 2019, at 10:00 a.m. Eastern Time in Boston, MA
• Oppenheimer’s 29th Annual Healthcare Conference on Tuesday, March 19, 2019, at 9:10 a.m. Eastern Time in New York, NY

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.

Contacts:

Media:

David Rosen

Argot Partners

212.600.1902 | david.rosen@argotpartners.com

 

Investors:

Joseph Rayne

Argot Partners

617.340.6075 | joseph@argotpartners.com

CAMBRIDGE, MA – January 4, 2019 – Aura Biosciences, a leader in the development of novel targeted therapies in ocular oncology, today announced that it has received written confirmation from the U.S. Food and Drug Administration (FDA) regarding agreement on the design of its Phase 3 registration trials designed to evaluate light-activated AU-011 for the treatment of patients with choroidal melanoma.  This written confirmation is the result of successful outcome of an “End of Phase 2” meeting with the FDA.

The STARBRIGHT registration program will consist of two small identical clinical trials designed to assess the safety and efficacy of AU-011 versus sham control for the treatment of patients with small choroidal melanoma and high risk indeterminate lesions.  Both trials, which will be titled STARBRIGHT1 and STARBRIGHT3, will be global, multicenter, randomized and masked, and will be conducted in parallel.   The primary endpoint will be comprised of a combination of tumor control and vision preservation.

In addition to the design of the Phase 3 trials, the FDA agreed with Aura’s proposed safety database.  The FDA also agreed that no further non-clinical studies are needed.

“We are pleased to have received such clear guidance from the FDA with respect to the Phase 3 STARBRIGHT program to be able to meet the scientific and regulatory requirements for marketing approval in the U.S.” said Elisabet de los Pinos, Ph.D., Chief Executive Officer of Aura.

The currently available treatments for choroidal melanoma come with the risk of severe vision loss, especially for patients with melanomas located close to the fovea or optic disk.  The ongoing Phase 1b/2 study with light-activated AU-011 has shown that the drug was well-tolerated, with clear evidence of tumor control and preservation of visual acuity at long term follow up.

“We believe that a minimally invasive, non-radiation-based treatment option that enables early intervention while preserving vision has the potential to transform the therapeutic landscape for this difficult to treat, often deadly form of melanoma,” said Cadmus Rich, M.D., Chief Medical Officer of Aura.  “Overall, the meeting removed any remaining uncertainty on the regulatory path to approval and highlighted FDA’s commitment to guide Aura toward a potential first drug approved for patients with this highly unmet medical need.”

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 bioconjugates (VPB) that are activated with an ophthalmic laser. The VPBs 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.

Contacts:

Media:

David Rosen

Argot Partners

212.600.1902 | david.rosen@argotpartners.com

 

Investors:

Joseph Rayne

Argot Partners

617.340.6075 | joseph@argotpartners.com

CAMBRIDGE, MA – October 29, 2018 – Aura Biosciences, a leader in the development of novel targeted therapies in ocular oncology, today announced that updated clinical data from its Phase 1b/2 clinical trial evaluating the safety and efficacy of light-activated AU-011, the Company’s lead product candidate for the primary treatment of choroidal melanoma, was highlighted in an oral presentation at the American Academy of Ophthalmology (AAO) 2018 Annual Meeting being held October 27-30, 2018, at McCormick Place in Chicago.

Brian P. Marr, M.D. , Director, Division of Ophthalmic Oncology, New York-Presbyterian/Columbia University Medical Center, and principal investigator of the study, gave the oral presentation titled, “One-Year Results of a Phase 1b/2 Open-Label Clinical Trial of AU-011 for the Treatment of Primary Choroidal Melanoma.”  This open-label, multicenter trial is designed to investigate single and multiple ascending doses of light-activated AU-011 in approximately 36 adult subjects with clinically diagnosed primary choroidal melanoma.

The data presented at the meeting show that multiple administrations of light-activated AU-011 are well-tolerated with no related serious adverse events, severe adverse events or dose-limiting toxicities observed.  Drug related adverse events were all expected and included anterior chamber inflammation, posterior chamber inflammation and increase in intraocular pressure, but all were manageable with standard-of-care treatments and resolved without clinical sequelae.  Notably, the posterior inflammation appears to originate within and/or around the tumor which is consistent with AU-011’s mechanism of action of acute tumor necrosis.

Treatment with light-activated AU-011 achieved preservation of best corrected visual acuity (BCVA) with a mean change of -1.06 letters at 6 months and a mean change of -0.75 letters at 12 months. BCVA was preserved even in high risk patients with tumors close to the fovea or the optic disk, a factor that typically correlates with a higher risk of irreversible severe vision loss following radioactive treatments. Importantly, all patients (100%) achieved stable disease at the prespecified preliminary efficacy endpoint at 3 months. Biological activity has been confirmed with long term tumor control in those patients with documented growth before treatment, reduction in tumor thickness and localized inflammation around the tumor.  An expansion cohort of the study is currently underway.   The Company plans to initiate a pivotal Phase 3 clinical program following the Phase 1b/2 study.

“The currently available treatments for choroidal melanoma come with the risk of severe vision loss, especially for patients with melanomas that are located close to the fovea or optic disk,” commented Dr. Marr.  “These 12-month data demonstrate that light-activated AU-011 continues to be well-tolerated, including with multiple administrations, has evidence of tumor control and preservation of visual acuity.  We look forward to executing on the expansion phase of the study and generating more clinical data for this innovative targeted therapy.”

“To date, light-activated AU-011 has shown a compelling degree of tolerability and vision preservation, especially given the alternative radioactive treatment options for choroidal melanoma,” said Cadmus Rich, M.D., Chief Medical Officer of Aura.  “We believe that a minimally invasive, non-radiation-based treatment option that enables early intervention while preserving vision has the potential to transform the therapeutic landscape for this difficult to treat, often deadly form of melanoma.  We are actively preparing the Phase 3 study designs and look forward to initiating this pivotal program.”

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 bioconjugates (VPB) that are activated with an ophthalmic laser. The VPBs 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.   

Contacts: 

Media:

David Rosen

Argot Partners

212.600.1902 | david.rosen@argotpartners.com 

Investors:

Joseph Rayne

Argot Partners

617.340.6075 | joseph@argotpartners.com

CAMBRIDGE, MA – October 15, 2018 – Aura Biosciences, a leader in the development of novel targeted therapies in ocular oncology, today announced that it will be highlighting its Phase 1b/2 clinical data for AU-011, the Company’s lead product candidate for the primary treatment of choroidal melanoma, in two oral presentations at the American Academy of Ophthalmology (AAO) 2018 Annual Meeting being held October 27-30, 2018, at McCormick Place in Chicago.

“Following the positive interim results reported in July 2018 from this ongoing Phase 1b/2 study evaluating AU-011 in patients with choroidal melanoma, we are pleased to be sharing these updated, one-year results with the medical community at AAO this year,” said Elisabet de los Pinos, Ph.D., Founder and Chief Executive Officer of Aura.  “There are no FDA approved therapies for the treatment of choroidal melanoma, the most common type of primary eye cancer.  Patients are currently treated with  radiotherapy and surgery which typically results in severe vision loss, along with a plethora of other severe adverse effects and comorbidities.  If approved, AU-011 will be the first targeted therapy for the treatment of choroidal melanoma, with the potential to preserve vision and transform the treatment paradigm for these patients.”

In addition to the AAO clinical data presentations, Aura has been selected to present its innovative technology for the treatment of choroidal melanoma as part of the Innovation Showcase during the Ophthalmology Innovation Summit (OIS@AAO) taking place Thursday, October 25, 2018, at the Marriot Marquis Chicago.  Dr. de los Pinos will give the presentation which will provide an update on Aura Biosciences.

Details for the oral presentations at AAO 2018:

Title: One-Year Results of a Phase 1b/2 Open-Label Clinical Trial of AU-011 for the Treatment of Primary Choroidal Melanoma

Presenter: Brian P. Marr, M.D., Columbia University Medical Center

Session: Ocular Oncology

Date and Time: Saturday, October 27, 2018, from 3:21 – 3:29 PM CT

Location: Room E350

 

Title: One-Year Results of a Phase 1b/2 Open-Label Clinical Trial of AU-011 for the Treatment of Primary Choroidal Melanoma

Presenter: Brian P. Marr, M.D., Columbia University Medical Center

Session: Ocular Pathology, Oncology

Date and Time: Monday, October 29, 2018, from 3:57 – 4:04 PM CT

Location: Room E350

 

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 bioconjugates (VPB) that are activated with an ophthalmic laser. The VPBs 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.   

Contacts: 

Media:

David Rosen

Argot Partners

212.600.1902 | david.rosen@argotpartners.com

 

Investors:

Joseph Rayne

Argot Partners

617.340.6075 | joseph@argotpartners.com