Cambridge, MA – October 28, 2021 – Aura Biosciences, Inc. (“Aura”), a clinical-stage oncology company developing a novel class of virus-like drug conjugate therapies for multiple oncology indications, today announced the pricing of its initial public offering of 5,400,000 shares of common stock at a public offering price of $14.00 per share. The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Aura, are expected to be $75.6 million. All of the shares are being offered by Aura. In addition, Aura has granted the underwriters a 30-day option to purchase up to an additional 810,000 shares of common stock at the initial public offering price less underwriting discounts and commissions.

The shares are expected to begin trading on the Nasdaq Global Market on October 29, 2021 under the ticker symbol “AURA.” The offering is expected to close on November 2, 2021, subject to the satisfaction of customary closing conditions.

Cowen, SVB Leerink and Evercore ISI are acting as joint book-running managers for the offering, and BTIG is acting as lead manager for the offering.

The registration statements relating to these securities became effective on October 28, 2021. The offering will be made only by means of a prospectus, copies of which may be obtained from Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by telephone at (833) 297-2926, or by email at PostSaleManualRequests@broadridge.com; SVB Leerink LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at syndicate@svbleerink.com; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, New York 10055; by telephone at (888) 474-0200, or by email at ecm.prospectus@evercore.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Aura Biosciences

Aura Biosciences, Inc. is a clinical-stage oncology company developing a novel technology platform based on virus-like drug conjugates (VDCs) to target and destroy cancer cells selectively while activating the immune system to create long lasting anti-tumor immunity. The VDC technology platform is based on the discoveries of NIH Distinguished Investigator Dr. John Schiller of the Center for Cancer Research at the National Cancer Institute. The company has the goal of developing this technology in multiple cancer indications with an initial focus on primary choroidal melanoma, a rare disease for which there are no approved drugs. Aura’s lead product candidate belzupacap sarotalocan (AU-011) is currently in Phase 2 development for the first line treatment of primary choroidal melanoma, a vision and life-threatening form of eye cancer where standard of care radioactive treatments leave patients with major vision loss and severe comorbidities. AU-011 was well tolerated in a Phase 1b/2 trial, demonstrating high rates of tumor control and vision preservation. Future pipeline applications for Aura’s technology include additional ocular oncology indications like choroidal metastases and solid tumor indications like non-muscle invasive bladder cancer. Aura is headquartered in Cambridge, MA.

Investor and Media Contact:

Matthew DeYoung
Argot Partners
212-600-1902 | aura@argotpartners.com

CAMBRIDGE, MA – October 11, 2021 – Aura Biosciences, a clinical-stage oncology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, today announced the presentation of interim Phase 2 data with 7 months average follow up evaluating the safety of suprachoroidal (SC) administration of AU-011, the Company’s lead product candidate for the first-line treatment of primary choroidal melanoma, as a part of the American Society of Retina Specialists (ASRS) 2021 Annual Meeting.

There have been no related serious adverse events, dose limiting toxicities, or grade 3 adverse events observed during the study. “These interim data presented today demonstrate that suprachoroidal administration may improve the therapeutic index and optimize treatment parameters,” said Prithvi Mruthyunjaya, MD, MHS, Associate Professor of Ophthalmology and Director, Ocular Oncology Service, Byers Eye Institute at Stanford University, and presenter of the abstract. “I believe this approach may provide an opportunity for patients who need a new first line treatment for early-stage disease, where all current treatments are extremely invasive and unfortunately result in severe vision loss in many patients.”

Phase 2 Trial Design and Timing

The Phase 2 trial is comprised of an open-label, dose escalation phase and a randomized, masked dose expansion phase that is assessing the safety and efficacy of ascending single- and repeat-doses of AU-011 via SC administration, followed by one or two laser applications per treatment. The randomized, dose expansion portion will be masked, sham-controlled and is designed to evaluate the safety and efficacy of the highest dose regimen of AU-011. Cohorts 1-5 have been fully enrolled (13 patients) and cohort 6 is currently enrolling in the Phase 2 study. The primary objective of the study is to assess safety and efficacy of AU-011 via SC administration for purposes of treating primary indeterminate lesions and choroidal melanoma.

The randomized phase of the trial is planned to begin in the second half of 2022 in patients with documented growth to establish the safety and efficacy of AU-011 and serve as the first pivotal trial for the treatment of indeterminate lesions and choroidal melanoma. The maximum treatment regimen anticipated for the randomized phase is three cycles of three weekly treatments of AU-011 at a dose of 80µg with 2 laser administrations.

Details from the ASRS 2021 Presentation:

Title: A Phase 2 Safety and Efficacy Trial of AU-011, a Virus-Like Drug Conjugate (VDC), with a Dose Escalation and a Randomized, Masked Expansion Phase
Presenter: Prithvi Mruthyunjaya, Stanford University
Session: Ocular Oncology Symposium
Date and Time: Monday, October 11, 2021 at 4:35pm ET

The presentation can be accessed by visiting the “Presentations” section of “News and Publications” page of the Aura Biosciences website.

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 mortality rate in metastatic disease, lack of approved therapies, and the comorbidities of radioactive treatment options.

About AU-011

AU-011 is a first-in-class virus-like drug conjugate (VDC) therapy in clinical development for the first line treatment of choroidal melanoma. The virus-like component of the VDC selectively binds unique heparin sulphate proteoglycans (HSPGs), which are modified and overexpressed on the tumor cell surface of malignant cells in the choroid and AU-011 delivers a potent cytotoxic drug that is activated with infrared light. Upon activation with an ophthalmic laser, the cytotoxic drug rapidly and specifically disrupts the cell membrane of malignant cells with a pro-immunogenic cell death that can activate the immune system generating long term anti-tumor immunity. The unique specificity of tumor binding by the VDC enables the preservation of 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 is currently in Phase 2 clinical development and the company plans to expand the clinical program into choroidal metastasis.

About Suprachoroidal Administration

The suprachoroidal space (SCS^®) injection treatment approach offers unprecedented access to the back of the eye where sight-threatening disease often occurs. Aura believes that delivering AU-011 into SCS within the eye, has the potential to offer certain advantages, including higher bioavailability at the tumor site and reduced exposure of non-targeted tissues, which may lead to an improved therapeutic index for AU-011. Collectively, these features could allow for the treatment of a wider range of tumor sizes, and, therefore, a larger number of patients. The Company is partnered with Clearside Biomedical for use of Clearside’s SCS Microinjector® for administration of AU-011 into the SCS. In preclinical research presented as part of the ARVO 2020 virtual program, AU-011 showed excellent distribution in the SCS, complete necrosis of tumors following laser activation in an animal model of choroidal melanoma and no clinical signs of anterior segment or posterior segment inflammation.

About Aura Biosciences

Aura Biosciences, Inc. is a clinical-stage oncology company developing a novel technology platform based on virus-like drug conjugates (VDCs) to target and destroy cancer cells selectively while activating the immune system to create long lasting anti-tumor immunity. The VDC technology platform is based on the discoveries of NIH Distinguished Investigator Dr. John Schiller of the Center for Cancer Research at the National Cancer Institute (NCI). The company has the goal of developing this technology in multiple cancer indications with an initial focus in ocular oncology, a group of rare diseases for which there are no approved drugs. Aura’s lead product candidate belzupacap sarotalocan (AU-011) is currently in Phase 2 development for the first line treatment of choroidal melanoma, a vision and life-threatening form of eye cancer where standard of care radioactive treatments leave patients with major vision loss and severe comorbidities. AU-011 was well tolerated in a Phase 1b/2 trial, demonstrating high rates of tumor control and vision preservation. Future pipeline applications for Aura’s technology include additional ocular oncology indications like choroidal metastases and solid tumor indications like non-muscle invasive bladder cancer. Aura is headquartered in Cambridge, MA. For more information, visit www.aurabiosciences.com or follow us on Twitter.

Investor and Media Contact:
Matthew DeYoung
Argot Partners
212-600-1902 | matthew@argotpartners.com

Chris Primiano, J.D., Appointed as Chief Business Officer

Antony Mattessich Appointed to the Board of Directors

CAMBRIDGE, MA – September 29, 2021 – Aura Biosciences, a clinical-stage oncology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, today announced the appointment of Chris Primiano, J.D., as Chief Business Officer and the appointment of Antony Mattessich to its Board of Directors.

“We are delighted to welcome Chris to our team and Antony to the Board during an important transformational period for Aura. Both of their experiences in strategic advisory, drug development and commercialization in oncology and ophthalmology will be crucial as we work to advance AU-011 to pivotal development and expand our oncology pipeline,” said Elisabet de los Pinos, Ph.D., founder and CEO of Aura.

“I am eager to be joining the Aura team to help expand its novel targeted oncology platform and global reach across multiple indications,” said Mr. Primiano. “AU-011 presents an opportunity to offer a new therapy that may eliminate the need for treatment with local radiotherapy for many patients with choroidal melanoma. This could be transformative in preserving vision and improving quality of life for these patients. I look forward to working with the rest of the management team to achieve Aura’s goal of advancing innovative oncology therapies to patients with life-threatening cancers.”

“It is a privilege to join the Board at this exciting time in the Company’s evolution,” said Mr. Mattessich. “I look forward to working alongside the Board and supporting Aura’s executive team as it lays the groundwork to transform Aura into a commercial-stage oncology company.”

Mr. Primiano joins Aura from Karyopharm Therapeutics, where he served in roles of increasing responsibility, most recently as Executive Vice President, Chief Business Officer, General Counsel and Secretary. Mr. Primiano played an important role in transitioning Karyopharm from 40 employees in a preclinical and early clinical development setting to 400 employees commercializing XPOVIO® (selinexor) across multiple indications. Prior to Karyopharm, Mr. Primiano was Counsel in the Boston office of Wilmer Cutler Pickering Hale and Dorr LLP. Mr. Primiano holds a Juris Doctor from Boston College Law School, a Master of Business Administration from the Boston College Carroll School of Management and a Bachelor of Arts in Political Economy and English from Georgetown University. He is a member of the bars of the Commonwealth of Massachusetts and the State of New York.

Mr. Mattessich is currently the Chief Executive Officer at Ocular Therapeutix. Prior to Ocular Therapeutix, he was Managing Director of Mundipharma International based in Cambridge, England. Previous to his time at Mundipharma, Mr. Mattessich ran the U.S. respiratory, dermatology and pediatrics group at Novartis. He also held several positions at Bristol-Myers Squibb, among them, Managing Director roles in Malaysia/Singapore and The Netherlands, and Head of Operations for the International Medicines Group. Mr. Mattessich holds a BA from the University of California at Berkeley and a master’s in international affairs from Columbia University.

About Aura Biosciences

Aura Biosciences, Inc. is a clinical-stage oncology company developing a novel technology platform based on virus-like drug conjugates (VDCs) to target and destroy cancer cells selectively while activating the immune system to create long lasting anti-tumor immunity. The VDC technology platform is based on the discoveries of NIH Distinguished Investigator Dr. John Schiller of the Center for Cancer Research at the National Cancer Institute (NCI). The company has the goal of developing this technology in multiple cancer indications with an initial focus in ocular oncology, a group of rare diseases for which there are no approved drugs. Aura’s lead product candidate belzupacap sarotalocan (AU-011) is currently in Phase 2 development for the first line treatment of choroidal melanoma, a vision and life-threatening form of eye cancer where standard of care radioactive treatments leave patients with major vision loss and severe comorbidities. AU-011 was well tolerated in a Phase 1b/2 trial, demonstrating high rates of tumor control and vision preservation. Future pipeline applications for Aura’s technology include additional ocular oncology indications like choroidal metastases and solid tumor indications like non-muscle invasive bladder cancer. Aura is headquartered in Cambridge, MA. For more information, visit www.aurabiosciences.com or follow us on Twitter.

 

Investor and Media Contact:

Matthew DeYoung
Argot Partners
914-330-6516 | matthew@argotpartners.com

Prominent, Multi-Disciplinary Clinicians and Scientists Bring Extensive Strategic Expertise in Urologic Oncology Across All Stages of Research and Development

CAMBRIDGE, MA – June 17, 2021 – Aura Biosciences, a clinical-stage oncology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, today announced the formation of a new, urologic oncology focused Scientific Advisory Board (SAB). The new SAB will work closely with Aura’s senior management team to advance the Company’s novel VDC technology for the treatment of non-muscle invasive bladder cancer (NMIBC).

The new SAB will be comprised of seven members: John T. Schiller, PhD, Deputy Chief and Head of the Neoplastic Disease Section, Laboratory of Cellular Oncology at the National Cancer Institute (NCI), National Institutes of Health (NIH); Piyush K. Agarwal, MD, Director, Bladder Cancer Program, University of Chicago; Trinity J. Bivalacqua, MD, PhD, Director, Urologic Oncology, Johns Hopkins Medicine; Isaac Kim, MD, PhD, MBA, Chief, Urologic Oncology, Rutgers Cancer Institute of New Jersey; Seth P. Lerner, MD, Beth and Dave Swaim Chair in Urologic Oncology, Baylor College of Medicine; and Andrea B. Apolo, MD, Head, Bladder Cancer Section, Genitourinary Malignancies Branch, NCI, NIH. This newly formed SAB builds upon Aura’s existing ocular oncology focused SAB that has helped advance the Company’s lead development candidate belzupacap sarotalocan (AU-011) into a Phase 3 ready asset for the treatment of choroidal melanoma.

“The creation of this Scientific Advisory Board is an important step for our continued growth as a leading innovative oncology company,” said Cadmus Rich, MD, MBA Chief Medical Officer and Head of R&D of Aura Biosciences. “We are both excited and fortunate to have brought together such an esteemed group of prominent oncology advisors as we advance our VDC platform for the treatment of bladder cancer. These newly assembled members of the SAB bring complementary areas of urologic oncology, drug development and strategic expertise and will be invaluable as we reach the next phase of growth at Aura.”

“On behalf of all of the members of the new SAB, we look forward to working together with the Aura senior leadership team to draw on our complementary expertise and insights to support a shared vision for Aura and drive innovation for patients with bladder cancer,” said Dr. Agarwal.

The following is more detail about the Aura SAB members:

John T. Schiller, PhD – Dr. Schiller is Deputy Chief and Head of the Neoplastic Disease Section, Laboratory of Cellular Oncology at the National Cancer Institute, NIH, and an NIH Distinguished Investigator. He has received numerous awards for his contributions to papillomavirus virus molecular biology and HPV vaccine development, including the Lasker DeBakey Award in 2017, the American Society for Microbiology’s Joseph Public Health Award in 2014, and National Medal of Technology and Innovation in 2014. Dr. Schiller graduated from the University of Wisconsin-Madison with a B.S. in molecular biology and received a Ph.D. from the Department of Microbiology of the University of Washington in Seattle.

Piyush K. Agarwal, MD – Dr. Agarwal is a highly respected urologic surgeon who specializes in the multidisciplinary management of bladder cancer as Director of both the Bladder Cancer Program and the Urologic Oncology Fellowship. He is also an expert in all urologic cancers and was the previous Head of the Bladder Cancer Section in the Center for Cancer Research of the National Cancer Institute. He has conducted several investigator-initiated clinical trials and has served on the U.S. Food and Drug Administration’s oncologic drug advisory committee.  Dr. Agarwal earned his MD degree from Weill Cornell College of Medicine in New York, completed his residency in Urology at University Hospital Cleveland Medical Center in Cleveland and his Urologic Oncology fellowship at MD Anderson Medical Center in Houston.

Andrea Apolo, MD – Dr. Apolo is an internationally recognized expert in bladder cancer research who is a Lasker Clinical Research Scholar in the Genitourinary Malignancies Branch of the Cancer Research Center at the NCI, NIH.  She is Head of the Bladder Cancer Section and the Director of the Bladder Cancer and Genitourinary Tumors Multidisciplinary Clinic. She holds an MD degree from Albert Einstein College of Medicine, completed her internal medicine residency at New York-Presbyterian Hospital/Weill Cornell Medical Center and a medical oncology fellowship at Memorial Sloan Kettering, all in New York.

Trinity J. Bivalacqua, MD, PhD – Dr. Bivalacqua is the R. Christian B. Evensen Professor of Urology and Oncology and Director of Urologic Oncology at the James Buchanan Brady Urologic Institute. As a member of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Dr. Bivalacqua participates in multidisciplinary approaches to the treatment of a variety of genitourinary cancers. He has a special interest in cancers of the prostate and bladder. His research laboratory focuses on the tumor immune microenvironment and mechanisms of BCG-resistance namely T-cell signaling and macrophage polarization. He holds graduate and medical degrees from Tulane University, completed his general surgery and urology training at Johns Hopkins Hospital in Baltimore and completed an American Urological Association (AUA) Foundation post-doctoral fellowship from the AUA Care Foundation in Linthicum.

Isaac Kim, MD, PhD, MBA – Dr. Kim is a board certified urologist who serves as the Chief and Associate Professor of the Division of Urology at Rutgers Robert Wood Johnson Medical School and Chief of the Section of Urologic Oncology and director of the Prostate Cancer Center at the Rutgers Cancer Institute of New Jersey. He runs a thriving clinical practice and has established a robust research program focused on the biology of castration-resistant prostate cancer. He holds a PhD and MD from Northwestern University, completed a urology residency at Baylor College of Medicine in Houston, a research fellowship in Urologic Oncology at the National Cancer Institute in Bethesda and clinical fellowship in endourology, laparoscopy and robotics at the University of California in Irvine.

Seth P. Lerner, MD – Dr. Lerner is Professor of Urology and holds the Beth and Dave Swalm Chair in Urologic Oncology, in the Scott Department of Urology, Baylor College of Medicine. He is Director of Urologic Oncology and the Multidisciplinary Bladder Cancer Program and Vice-chair for Faculty Affairs for Urology. His clinical practice, education, and research activities are devoted to urologic oncology and particularly lower and upper tract urothelial cancer. He holds an MD from Baylor College of Medicine in Houston and completed a two-year fellowship at the University of Southern California in urologic oncology and reconstructive surgery in Los Angeles.

About Aura Biosciences

Aura Biosciences, Inc. is a clinical-stage oncology company developing a novel technology platform based on virus-like drug conjugates (VDCs) to target and destroy cancer cells selectively while activating the immune system to create long lasting anti-tumor immunity. The VDC technology platform is based on the discoveries of NIH Distinguished Investigator Dr. John Schiller of the Center for Cancer Research at the National Cancer Institute (NCI). The company has the goal of developing this technology in multiple cancer indications with an initial focus in ocular oncology, a group of rare diseases for which there are no approved drugs. Aura’s lead product candidate belzupacap sarotalocan (AU-011) is currently in Phase 2 development for the first line treatment of choroidal melanoma, a vision and life-threatening form of eye cancer where standard of care radioactive treatments leave patients with major vision loss and severe comorbidities. Aura has demonstrated the efficacy and safety of AU-011 in a Phase 1b/2 trial, including high rates of tumor control and vision preservation. Future pipeline applications for Aura’s technology include additional ocular oncology indications like choroidal metastases and solid tumor indications like non-muscle invasive bladder cancer.  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 – June 8, 2021 – Aura Biosciences, a clinical-stage oncology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, today announced the appointment of Sapna Srivastava, Ph.D., to its Board of Directors.

“Sapna is a recognized leader in the biopharmaceutical industry with over two decades of broad experience in corporate and financial strategy,” said David Johnson, Chairman of the Board of Aura Biosciences. “We welcome Sapna to the Board and look forward to her contributions as we look to further build our position as a leader in ocular oncology and expand the research of our VDC technology into additional cancers in need of better treatments to improve patient outcomes.”

“I believe that Aura’s novel approach to treat ocular cancers while preserving vision can transform the treatment paradigm for patients with these life-threatening diseases,” said Dr. Srivastava. “It is a privilege to be joining Aura’s Board of Directors as the Company advances into a pivotal program for the early treatment of choroidal melanoma and prepares for this next phase of growth.”

Dr. Srivastava is currently the Chief Financial and Strategy Officer at eGenesis. Prior to eGenesis, she held similar roles as the Chief Financial and Strategy Officer at Abide Therapeutics (acquired by Lundbeck) and at Intellia Therapeutics. In these positions, she has played a key role in equity financings including a successful initial public offering, strategic alliances, mergers and acquisitions, and shaping the strategic direction of the company. Before Intellia, Dr. Srivastava spent more than a decade on Wall Street as a senior biotechnology analyst for Goldman Sachs, Morgan Stanley and ThinkEquity Partners. She began her career as a research associate at J.P. Morgan. Dr. Srivastava received her Ph.D. in neuroscience from the New York University School of Medicine and her B.S. in biology from St. Xavier’s College at the University of Mumbai.

About Aura Biosciences

Aura Biosciences, Inc. is a clinical-stage oncology company developing a novel technology platform based on virus-like drug conjugates (VDCs) to target and destroy cancer cells selectively while activating the immune system to create long lasting anti-tumor immunity. The VDC technology platform is based on the discoveries of NIH Distinguished Investigator Dr. John Schiller of the Center for Cancer Research at the National Cancer Institute (NCI). The company has the goal of developing this technology in multiple cancer indications with an initial focus in ocular oncology, a group of rare diseases for which there are no approved drugs. Aura’s lead product candidate belzupacap sarotalocan (AU-011) is currently in Phase 2 development for the first line treatment of choroidal melanoma, a vision and life-threatening form of eye cancer where standard of care radioactive treatments leave patients with major vision loss and severe comorbidities. Aura has demonstrated the efficacy and safety of AU-011 in a Phase 1b/2 trial, including high rates of tumor control and vision preservation. Future pipeline applications for Aura’s technology include additional ocular oncology indications like choroidal metastases and solid tumor indications like non-muscle invasive bladder cancer.  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

AU-011 Demonstrates Targeted Cytotoxicity In Vitro and In Vivo in Both Breast and Lung Tumors, Demonstrating the Potential to Treat Human Choroidal Metastases

Tumor Distribution of AU-011 in the Treatment of Choroidal Melanoma Also Presented Using Intravitreal and Suprachoroidal Administration

CAMBRIDGE, MA – May 3, 2021 – Aura Biosciences, a clinical-stage oncology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, today announced the presentation of supportive preclinical data in multiple tumor models of choroidal metastases and in choroidal melanoma using suprachoroidal administration. The data will be featured in two virtual poster presentations at the Association for Research in Vision and Ophthalmology (ARVO) 2021 Annual Meeting, taking place May 1-7, 2021.

Choroidal metastasis is a second ocular oncology indication for Aura’s lead VDC candidate AU-011, which is also currently in Phase 2 development for the treatment of choroidal melanoma. New preclinical data presented at the meeting demonstrates the potential of AU-011 for the treatment of choroidal metastases from breast and lung cancer, which are the most common causes of metastases in the choroid.

 “Thanks to recent advances with treatment options for metastatic cancer, patients are living longer, and the incidence of choroidal metastases from breast and lung cancer has become an increasingly important issue that dramatically impacts patient’s vision and their overall quality of life,” said Amy Schefler, MD, FACS, Associate Professor of Clinical Ophthalmology, Weill Cornell Medical College and Ocular Oncology Specialist, Retina Consultants of Houston. “The data show that AU-011 has the potential to offer a new, vision preserving targeted therapy that may eliminate the need for the treatment with local radiotherapy for many patients with choroidal metastases. We believe these data support the further clinical development of AU-011 in this additional ocular oncology indication which has the potential to transform visual outcomes and the quality of life for patients with cancer and we look forward to sharing these results with the medical and scientific community at the meeting.”

Effect of AU-011 on Preclinical Models of Choroidal Metastases

The purpose of this study was to evaluate the potential of AU-011 to treat choroidal metastases by evaluating its effect on a panel of human breast and lung cancer cell lines in vitro and in vivo in a murine breast cancer model. In both cell line panels, AU-011 demonstrated potent cell binding and cell killing activity with EC50 in the picomolar range. In vivo, a single systemic administration of AU-011 in a syngeneic breast cancer mouse model demonstrated potent cytotoxic activity with significant reduction of tumor growth, further corroborating data previously obtained in other cancer models.  These results suggest that AU-011 can bind to and kill tumor cells derived from the most common cancer types known to metastasize to the choroid and supports further development of AU-011 as a vision preserving therapy for the treatment of choroidal metastases.

Tumor distribution of AU-011 with IVT and SC Administration in an Orthotopic Rabbit Model of Uveal Melanoma

Aura evaluated the distribution of AU-011 with both intravitreal (IVT)  and suprachoroidal (SC) administration in an orthotopic rabbit model of choroidal melanoma, which demonstrated both routes of administration achieved tumor distribution to the choroid and to the tumor. Following SC administration, negligible levels of AU-011 were observed in the vitreous, but high exposure levels were observed in the tumor and choroid/retina. The exposure of AU-011 in the tumor was approximately 5 times higher when AU-011 was administered by SC injection compared to IVT injection. The exposure remained high in the tumor up to 48 hours post injection for both routes of administration.

Cadmus Rich, MD, MBA, Chief Medical Officer and Head of Research and Development at Aura Biosciences commented, “The suprachoroidal delivery route has the potential to offer certain advantages over intravitreal injection, including superior distribution, higher bioavailability and less unintended exposure in the vitreous and other key ocular structures. We believe these characteristics may lead to less intraocular inflammation, an improved safety profile and a broader therapeutic index. A Phase 2 clinical trial evaluating SC administration of AU-011 in patients with choroidal melanoma is currently ongoing.”

Details for the ARVO 2021 presentations are as follows:

Title: Development of AU-011 for Choroidal Metastasis

Presenter: Cadmus Rich, Aura Biosciences

Abstract #: 3547059

Session:  Advances in intra and extra ocular pathologies

Date and time:  May 5, 2021 from 2:45 – 4:30 PM EDT

URL: https://arvo2021.arvo.org/meetings/virtual/rX366WKTbayR7Pehy

Title: Ocular Distribution and Exposure of AU-011 After Suprachoroidal or Intravitreal Administration in an Orthotopic Rabbit Model of Human Uveal Melanoma

Presenter: Anneli Savinainen, Aura Biosciences

Abstract #: 3543497

Session: Recent Advances in Uveal Melanoma

Date and time:  May 2, 2021 from 9:00 to 10:45 AM EDT

URL: https://arvo2021.arvo.org/meetings/virtual/Kicj9AczkcowRfxLs

The presentations can be accessed by ARVO members on the ARVOLearn website.  The presentations can also be accessed by visiting the “Presentations” section of “News and Publications” page of the Aura Biosciences website.

About Choroidal Melanoma and Choroidal Metastasis

Choroidal melanoma is a rare and life-threatening type of eye cancer. It is the most common primary intraocular cancer 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 patients with liver involvement in 80-90% of cases and, unfortunately, metastatic disease is universally fatal (source: OMF). Choroidal metastases is when cancer that started elsewhere in the body spreads to the eye.  The common primary cancers that metastasize to the choroid include, in descending order, breast, lung, gastrointestinal, kidney, skin and prostate. In 31% of cases a primary cancer diagnosis is not made at the time of the choroidal metastasis diagnosis. 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 virus-like drug conjugate (VDC) therapy in clinical development for the first line treatment of choroidal melanoma. The virus-like component of the VDC selectively binds unique heparin sulphate proteoglycans (HSPGs) that are modified and overexpressed on the tumor cell surface of malignant cells in the choroid and delivers a potent cytotoxic drug that is activated with infrared light. Upon activation with an ophthalmic laser, the cytotoxic drug rapidly and specifically disrupts the cell membrane of malignant cells with a pro-immunogenic cell death that can activate the immune system generating long term anti-tumor immunity. The unique specificity of tumor binding by the VDC enables the preservation of 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 is currently in Phase 2 clinical development and the company plans to expand the clinical program into choroidal metastasis.

About Aura Biosciences

Aura Biosciences, Inc. is a clinical-stage oncology company developing a novel technology platform based on virus-like drug conjugates (VDCs) to target and destroy cancer cells selectively while activating the immune system to create long lasting anti-tumor immunity. The VDC technology platform is based on the discoveries of NIH Distinguished Investigator Dr. John Schiller of the Center for Cancer Research at the National Cancer Institute (NCI). The company has the goal of developing this technology in multiple cancer indications with an initial focus in ocular oncology, a group of rare diseases for which there are no approved drugs. Aura’s lead product candidate belzupacap sarotalocan (AU-011) is currently in Phase 2 development for the first line treatment of choroidal melanoma, a vision and life-threatening form of eye cancer where standard of care radioactive treatments leave patients with major vision loss and severe comorbidities. Aura has demonstrated the efficacy and safety of AU-011 in a Phase 1b/2 trial, including high rates of tumor control and vision preservation. Future pipeline applications for Aura’s technology include additional ocular oncology indications like choroidal metastases and solid tumor indications like non-muscle invasive bladder cancer.  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