Congratulations to Aura Biosciences’ Scientific Founder, Deputy Chief of the Laboratory of Cellular Oncology at the National Cancer Institute and NIH Distinguished Investigator Dr. John Schiller on his election to the National Academy of Sciences for his distinguished work pioneering viral-like particle drug discovery. https://bit.ly/2YhEJaT

CAMBRIDGE, MA – February 25, 2020 – Aura Biosciences, a clinical-stage biopharmaceutical company developing a new class of tumor targeted therapies for initial application in primary tumors such as ocular and bladder cancers, today announced that Elisabet de los Pinos, Ph.D., Chief Executive Officer of Aura, will present a company overview at the Cowen 40th Annual Health Care Conference on Tuesday, March 3, 2020, at 9:30 a.m. Eastern Time in Boston, MA.

About Aura Biosciences

Aura Biosciences, Inc. is a clinical-stage biopharmaceutical company developing a new class of oncology therapies based on a novel tumor targeting technology for initial application in primary tumors such as ocular and bladder cancers with the potential to treat other cancers.  The Company’s proprietary technology platform utilizes viral-like particle bioconjugates (VPBs) that have a dual selectivity mechanism with targeted binding to cancer cells, followed by activation using a common laser.  These potent cytotoxic therapies result in acute tumor cell necrosis, while sparing surrounding healthy tissue and activating the immune system to generate an anti-tumor response.  Aura’s lead product candidate belzupacap serotalocan (AU-011) is currently in Phase 2 development for the treatment of choroidal melanoma, a vision and life-threatening form of eye cancer for which there are currently no approved therapies.  In a Phase 1b/2 study, AU-011 demonstrated compelling efficacy, including high rates of tumor control and vision preservation, along with a favorable safety profile, in patients with choroidal melanoma.  The development of AU-011 is partially supported by funding awarded under a CRADA from the U.S. National Institutes of Health’s National Cancer Institute.  Future pipeline applications for Aura’s technology include choroidal metastases and primary bladder carcinoma.  Aura is headquartered in Cambridge, MA.  For more information, visit www.aurabiosciences.com or follow us on Twitter.

Investor and Media Contact:

Joseph Rayne

Argot Partners

617.340.6075 | joseph@argotpartners.com

CAMBRIDGE, MA – February 24, 2020 – Aura Biosciences, a clinical-stage biopharmaceutical company developing a new class of tumor targeted therapies for initial application in primary tumors such as ocular and bladder cancers, today announced the presentation of updated 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 first line treatment of primary choroidal melanoma, at the 43rd Annual Macula Society Meeting, which took place February 19-22, 2020 in San Diego, CA.

“The Phase 1b/2 data being recognized at the Macular Society meeting this year show that AU-011 continues to be well tolerated, with a statistically significant reduction in tumor growth rate and vision preservation,” said Amy C. Schefler, M.D., Weill Cornell Medical College and Retina Consultants of Houston.

“The high tumor control rates observed to date, together with the high rate of vision preservation, including in patients at high risk for vision loss with sub-macular and peripapillary tumors continue to support AU-011’s significant potential to change the treatment paradigm for patients battling choroidal melanoma,” said Cadmus Rich, MD, Chief Medical Officer and Head of Research and Development of Aura Biosciences.  “I am proud of the work the company has done to make a significant progress in this ultra-rare disease.”

Updated Results from the Phase 1b/2 Study Evaluating AU-011 

Dr. Schefler gave an oral presentation titled, “Study Update of an Ongoing Phase 1b/2 Open-label Clinical Trial of AU-011 for the Treatment of Small to Medium Choroidal Melanoma,” which highlighted updated data from the ongoing open-label Phase 1b/2 clinical trial, and described the design of the planned Phase 3 trial that Aura expects to initiate during the second half of 2020.

The updated data demonstrate that multiple administrations of light-activated AU-011 were well-tolerated.  Among the patients evaluated for safety (n=52), the most common treatment-related adverse events (AEs) were expected and included anterior chamber inflammation, posterior chamber inflammation and increase in intraocular pressure; all were manageable with standard-of-care treatments and the majority 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.  There were two treatment-related serious AEs (vision loss; 3.6%). Tumor control and vision preservation data continue to be supportive of the planned Phase 3 registration trial.

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, Inc. is a clinical-stage biopharmaceutical company developing a new class of oncology therapies based on a novel tumor targeting technology for initial application in primary tumors such as ocular and bladder cancers with the potential to treat other cancers.  The Company’s proprietary technology platform utilizes viral-like particle bioconjugates (VPBs) that have a dual selectivity mechanism with targeted binding to cancer cells, followed by activation using a common laser.  These potent cytotoxic therapies result in acute tumor cell necrosis, while sparing surrounding healthy tissue and activating the immune system to generate an anti-tumor response.  Aura’s lead product candidate belzupacap serotalocan (AU-011) is currently in Phase 2 development for the treatment of choroidal melanoma, a vision and life-threatening form of eye cancer for which there are currently no approved therapies.  In a Phase 1b/2 study, AU-011 demonstrated compelling efficacy, including high rates of tumor control and vision preservation, along with a favorable safety profile, in patients with choroidal melanoma.  The development of AU-011 is partially supported by funding awarded under a CRADA from the U.S. National Institutes of Health’s National Cancer Institute.  Future pipeline applications for Aura’s technology include choroidal metastases and primary bladder carcinoma.  Aura is headquartered in Cambridge, MA.  For more information, visit www.aurabiosciences.com or follow us on Twitter.

 Investor and Media Contact:

Joseph Rayne

Argot Partners

617.340.6075 | joseph@argotpartners.com

CAMBRIDGE, MA – January 7, 2020 – Aura Biosciences, a clinical-stage biopharmaceutical company developing a new class of tumor targeted therapies for initial application in primary tumors such as ocular and bladder cancers, today announced the appointment of George Golumbeski, Ph.D., as Chairman of its Board of Directors.  Dr. Golumbeski is a biopharmaceutical business leader with over 25 years of experience in the biotechnology industry.

“George’s extensive experience will be invaluable to Aura as we prepare for upcoming corporate milestones,” said Elisabet de los Pinos, Ph.D., Chief Executive Officer of Aura Biosciences.  “In his prior global leadership roles at Celgene and Novartis, George has overseen successful development, growth and collaboration initiatives that have created significant value and have made a profound impact in many patients’ lives.  We welcome George to our team and look forward to working together to bring this new class of innovative therapies to patients with cancer.”

Dr. Golumbeski commented: “As an emerging leader in ocular oncology, in late stage development with a new class of targeted therapies, Aura is an exciting growth story, focused on meeting unmet medical needs in oncology.  Therefore, I am delighted to be joining the team.  I look forward to working with the Aura Board and management team to use our collective experience to build the Company and to further accelerate the Company’s growth.”

In addition to Aura’s Board, Dr. Golumbeski serves on the Board of Directors of several biotechnology companies including: Carrick Therapeutics, Enanta Pharmaceuticals, MorphoSys AG, Verseau Therapeutics, and Sage Therapeutics. Dr. Golumbeski was most recently Executive Vice President of Business Development for Celgene, where he was responsible for forging collaborations with biotechnology companies seeking to bring breakthrough medications to people suffering from cancer and chronic inflammation.  Before Celgene, Dr. Golumbeski served as Vice President of Business Development, Licensing and Strategy for Novartis and also held similar senior level business development roles at Elan Pharmaceuticals and at Schwarz Pharma. He holds a bachelor’s degree in biology from the University of Virginia, and a Ph.D. in genetics from the University of Wisconsin-Madison. He conducted his post-doctoral research in molecular biology at the University of Colorado-Boulder.

About Aura Biosciences

Aura Biosciences, Inc. is a clinical-stage biopharmaceutical company developing a new class of oncology therapies based on a novel tumor targeting technology for initial application in primary tumors such as ocular and bladder cancers with the potential to treat other cancers.  The Company’s proprietary technology platform utilizes viral-like particle bioconjugates (VPBs) that have a dual selectivity mechanism with targeted binding to cancer cells, followed by activation using a common laser.  These potent cytotoxic therapies result in acute tumor cell necrosis, while sparing surrounding healthy tissue and activating the immune system to generate an anti-tumor response.  Aura’s lead product candidate belzupacap serotalocan (AU-011) is currently in Phase 2 development for the treatment of choroidal melanoma, a vision and life-threatening form of eye cancer for which there are currently no approved therapies.  In a Phase 1b/2 study, AU-011 demonstrated compelling efficacy, including high rates of tumor control and vision preservation, along with a favorable safety profile, in patients with choroidal melanoma.  The development of AU-011 is partially supported by funding awarded under a CRADA from the U.S. National Institutes of Health’s National Cancer Institute.  Future pipeline applications for Aura’s technology include choroidal metastases and primary bladder carcinoma.  Aura is headquartered in Cambridge, MA.  For more information, visit www.aurabiosciences.com or follow us on Twitter.

Investor and Media Contact:

Joseph Rayne

Argot Partners

617.340.6075 | joseph@argotpartners.com

CAMBRIDGE, MA – October 15, 2019 – Aura Biosciences, a leader in the development of novel targeted therapies in ocular oncology, today announced the presentation of updated 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 first line treatment of primary choroidal melanoma, at the American Academy of Ophthalmology (AAO) 2019 Annual Meeting, being held October 12-15, 2019 in San Francisco, CA.

“With its ability to provide tumor control and vision preservation, AU-011 holds significant potential as a new targeted therapy for the primary treatment of choroidal melanoma,” said Cadmus Rich, MD, Chief Medical Officer and Head of Research and Development of Aura Biosciences.  “The data presented this year by Dr. Duker provided information on Aura’s proprietary technology platform and key insights that will inform the design and conduct of our pivotal Phase 3 program for AU-011, which we expect to commence in the second half of 2020.  Dr. Schefler’s presentation included an update on ongoing research we are conducting into suprachoroidal delivery which, may allow us to increase the range of tumor sizes that AU-011 can treat.  Both of these presentations underscore our long-term vision and commitment to bringing this first-in-class technology to patients for this rare and life-threatening disease.”

Updated Results from the Phase 1b/2 Study Evaluating AU-011 

Jay S. Duker, M.D., Director New England Eye Center, and Professor and Chair, Tufts Medical Center, gave an oral presentation titled, “Novel Management of Choroidal Melanoma – AU-011,” which highlighted the potential of Aura’s viral like particle technology, updated data from the ongoing open-label Phase 1b/2 clinical trial, and described the novel design of the planned Phase 3 trial that Aura expects to initiate during the second half of 2020.

The Phase 1b/2 clinical data presented at AAO demonstrate that multiple administrations of light-activated AU-011 were well-tolerated.  Among the patients evaluated for safety (n=46), the most common treatment-related adverse events (AEs) were expected and included anterior chamber inflammation, posterior chamber inflammation and increase in intraocular pressure; all were manageable with standard-of-care treatments and the majority 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.  There was one treatment-related severe AE (vision loss; 2%) in one patient with a juxtafoveal tumor.

Tumor control and vision preservation data continue to be supportive of the planned Phase 3 registration trial.  In the subset of patients with documented tumor growth prior to trial enrollment (n=17), treatment with AU-011 resulted in tumor control in 15 patients (88%; p=0.0117).  The results from this ongoing Phase 1b/2 study will inform the design of Aura’s planned pivotal Phase 3 program for AU-011.

“The data presented this year at AAO show that AU-011 is well tolerated with early signals of efficacy,” said Dr. Duker.  “AU-011 is administered via a simple, two-step procedure which includes an intravitreal injection followed by a laser application; all of which is completed in the physician’s office.  If approved, AU-011 represents the first potential new treatment for choroidal melanoma in several decades.”

Exploring Suprachoroidal Delivery for AU-011

Amy C. Schefler, M.D., Weill Cornell Medical College and Retina Consultants of Houston, gave an oral presentation highlighting the data from the ongoing Phase 1b/2 study with intravitreal administration as well as new preclinical research demonstrating the potential advantages of delivering AU-011 using the suprachoroidal route of administration.  Aura recently executed a licensing agreement with Clearside Biomedical for use of Clearside’s suprachoroidal space (SCS) Microinjector™ for the treatment of intraocular cancers.  Aura believes that by delivering AU-011 into the SCS, there is the potential for treating a larger number of patients with a good safety profile and a greater range of tumor sizes.  Preliminary preclinical pharmacology data showed that AU-011 administered via the SCS Microinjector achieved full necrosis of tumor cells in all animals following laser activation.  Further preclinical studies are currently ongoing and Aura expects to initiate clinical testing using suprachoroidal delivery for AU-011 during the first half of 2020.

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 or follow us on Twitter. 

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 – September 26, 2019 – Aura Biosciences, a leader in the development of novel targeted therapies in ocular oncology, today announced multiple data presentations at the upcoming American Academy of Ophthalmology (AAO) 2019 Annual Meeting, being held October 12-15, 2019 in San Francisco, CA.  Aura’s lead clinical asset, AU-011, will also be highlighted in presentations at related medical meetings taking place in San Francisco around AAO 2019, including the Ophthalmology Innovation Summit taking place October 10, 2019, and the American Association of Ophthalmic Oncologists and Pathologists (AAOOP) 2019 Annual Meeting taking place October 13, 2019.

Two key presentations at the AAO meeting include study updates by key opinion leaders Dr. Jay S. Duker, Director New England Eye Center, Professor and Chair Tufts Medical Center and Dr. Amy C. Schefler, Weill Cornell Medical College and Retina Consultants of Houston, which will include updated clinical data from Aura’s ongoing Phase 1b/2 clinical trial evaluating the safety and efficacy of light-activated AU-011, the Company’s lead product candidate for the first line treatment of primary choroidal melanoma.  An additional presentation will be given at AAOOP 2019 by Dr. Abdhish Bhavsar, Board Certified Ophthalmologist at The Retina Center and an investigator for Aura’s Phase 1b/2 clinical trial.

“There are no FDA approved therapies for the treatment of choroidal melanoma, the most common type of primary eye cancer,” said Cadmus Rich, MD, Chief Medical Officer of Aura Biosciences.  “Patients are currently treated with radiotherapy and surgery which typically results in severe vision loss, along with many other significant adverse effects and comorbidities.  If approved, AU-011 will be the first targeted therapy for the treatment of choroidal melanoma, with the potential to not only provide tumor control, but also preserve vision.  We are excited to have these presentations  on our AU-011 program and we look forward to sharing our novel technology, clinical data and an update on new delivery methods for AU-011 with the ophthalmology community at AAO and the accompanying events this year.”

The details for the AAO 2019 presentations are as follows:

Title: Aura Biosciences

Presenter: Jay S. Duker, MD, New England Eye Center, Tufts Medical Center

Session: SYM22 The Innovators Symposium

Date and time: Sunday, October 13, 2019 from 2:47 – 2:54 PM PT

Location: Moscone Center, Esplanade Room

Title: Virus-Like Particles for Uveal Melanoma

Presenter: Amy C. Schefler, MD, Weill Cornell Medical College/Retina Consultants of Houston

Session: SYM50 Delivery of Therapeutics to the Posterior Ocular Segment

Date and time: Tuesday, October 15, 2019 from 9:35 – 9:45 AM PT

Location: Moscone Center, West 2002

Additional presentations taking place at other events in San Francisco around AAO 2019 include:

Event: Ophthalmology Innovation Summit (OIS) @ AAO

Title: Update on Aura Biosciences

Presenter: Elisabet de los Pinos, PhD, Chief Executive Officer of Aura Biosciences

Session: Innovation Showcase 1

Date and time: Thursday, October 10, 2019 from 8:40-8:47 AM PT

Location: Hilton San Francisco Union Square, 333 O’Farrell Street

Event: American Association of Ophthalmic Oncologists and Pathologists (AAOOP) 2019 Annual Meeting

Title: Study Update of an Ongoing Phase 1b/2 Open-label Clinical Trial of AU-011 for the Treatment of Small to Medium Choroidal Melanoma

Presenter: Abdhish Bhavsar, MD, The Retina Center

Date and time: Friday, October 11, 2019

Location: Grand Hyatt San Francisco, 345 Stockton Street

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 or follow us on Twitter.

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 – August 1, 2019 – Aura Biosciences, a leader in the development of novel targeted therapies in ocular oncology, today announced that members of Aura’s executive team will participate in the following upcoming investor conferences:

• Canaccord Genuity’s 39th Annual Growth Conference on August 8, 2019 in Boston, MA and will present at 2:00 p.m. Eastern Time

• BTIG Biotechnology Conference on August 12, 2019 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 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 – 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