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Aura Biosciences Announces the Presentation of Phase 2 End of Study Data Evaluating Suprachoroidal Administration of Bel-sar for the First-Line Treatment of Patients with Early-Stage Choroidal Melanoma at The Retina Society Annual Meeting

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Aura Biosciences (NASDAQ: AURA) announced the upcoming presentation of Phase 2 end of study data for bel-sar, a treatment for early-stage choroidal melanoma, at The Retina Society Annual Meeting in Lisbon, Portugal. The presentation, titled 'Final Results of a Phase 2 Trial of Suprachoroidal Administration of Belzupacap Sarotalocan (bel-sar, AU-011) for Choroidal Melanoma', will be given by Dr. Ivana Kim on September 12, 2024.

Additionally, Aura will host a virtual ocular oncology investor event on the same day, featuring Dr. Kim and Dr. Prithvi Mruthyunjaya, to discuss the Phase 2 data. The event will include a live Q&A session and will be available for replay on Aura's website for 90 days.

Aura Biosciences (NASDAQ: AURA) ha annunciato la prossima presentazione dei dati finali dello studio di Fase 2 per bel-sar, un trattamento per il melanoma coroideale in fase iniziale, in occasione dell'Annual Meeting della Retina Society a Lisbona, Portogallo. La presentazione, intitolata 'Risultati Finali di uno Studio di Fase 2 per l'Amministrazione Suprachoroidale di Belzupacap Sarotalocan (bel-sar, AU-011) per Melanoma Coroideale', sarà tenuta dalla Dr.ssa Ivana Kim il 12 settembre 2024.

Inoltre, Aura ospiterà un evento virtuale per investitori sull'oncologia oculare lo stesso giorno, con la partecipazione della Dr.ssa Kim e del Dr. Prithvi Mruthyunjaya, per discutere i dati di Fase 2. L'evento includerà una sessione di domande e risposte dal vivo e sarà disponibile per la visione in replay sul sito web di Aura per 90 giorni.

Aura Biosciences (NASDAQ: AURA) anunció la próxima presentación de los datos finales del estudio de Fase 2 para bel-sar, un tratamiento para el melanoma coroideo en etapas tempranas, en la Reunión Anual de la Retina Society en Lisboa, Portugal. La presentación, titulada 'Resultados Finales de un Ensayo de Fase 2 de la Administración Suprachoroidal de Belzupacap Sarotalocan (bel-sar, AU-011) para Melanoma Coroideo', será realizada por la Dra. Ivana Kim el 12 de septiembre de 2024.

Además, Aura organizará un evento virtual para inversores en oncología ocular el mismo día, con la participación de la Dra. Kim y el Dr. Prithvi Mruthyunjaya, para discutir los datos de la Fase 2. El evento incluirá una sesión de preguntas y respuestas en vivo y estará disponible para su visualización en replay en el sitio web de Aura durante 90 días.

아우라 바이오사이언스(Aura Biosciences, NASDAQ: AURA)는 초기 단계의 맥락막 흑색종 치료제인 bel-sar의 2상 연구 종료 데이터 발표를 포르투갈 리스본에서 열리는 망막학회 연례 회의에서 진행한다고 발표했습니다. '벨주파카프 사로탈로칸(베를-sar, AU-011)의 피하 투여를 통한 맥락막 흑색종에 대한 2상 시험의 최종 결과'라는 제목의 발표는 2024년 9월 12일에 이바나 킴 박사에 의해 이루어질 예정입니다.

또한, 아우라는 같은 날 가상 안과 종양학 투자자 행사를 개최하며, 이 행사에서는 킴 박사와 프리트비 무르투윤자야 박사가 2상 데이터를 논의할 것입니다. 이 행사에서는 실시간 Q&A 세션도 포함되며, 아우라의 웹사이트에서 90일 동안 다시 볼 수 있습니다.

Aura Biosciences (NASDAQ: AURA) a annoncé la prochaine présentation des données finales de l'étude de Phase 2 pour bel-sar, un traitement du mélanome choroïdien à un stade précoce, lors de la Réunion Annuelle de la Retina Society à Lisbonne, Portugal. La présentation, intitulée 'Résultats Finals d'un Essai de Phase 2 sur l'Administration Suprachoroidale de Belzupacap Sarotalocan (bel-sar, AU-011) pour le Mélanome Choroïdien', sera donnée par Dr. Ivana Kim le 12 septembre 2024.

De plus, Aura organisera un événement virtuel pour les investisseurs en oncologie oculaire le même jour, mettant en vedette Dr. Kim et Dr. Prithvi Mruthyunjaya, pour discuter des données de la Phase 2. L'événement comprendra une session de questions-réponses en direct et sera disponible en rediffusion sur le site web d'Aura pendant 90 jours.

Aura Biosciences (NASDAQ: AURA) gab die bevorstehende Präsentation der Enddaten der Phase-2-Studie für bel-sar bekannt, eine Behandlung für das Frühstadium des choroidalen Melanoms, auf der Jahrestagung der Retina Society in Lissabon, Portugal. Die Präsentation mit dem Titel 'Endergebnisse einer Phase-2-Studie zur suprachoroidalen Verabreichung von Belzupacap Sarotalocan (bel-sar, AU-011) bei choroidalem Melanom' wird am 12. September 2024 von Dr. Ivana Kim gehalten.

Zusätzlich wird Aura am selben Tag ein virtuelles Investorenevent zur Augenonkologie

Positive
  • Phase 2 end of study data for bel-sar in early-stage choroidal melanoma to be presented at a major conference
  • Company is hosting a virtual investor event with key opinion leaders to discuss the Phase 2 results
  • Presentation and investor event indicate potential progress in the development of bel-sar for choroidal melanoma treatment
Negative
  • None.

Aura will Host a Virtual Ocular Oncology Investor Event Featuring Key Opinion Leaders at 8:00 am Eastern Time on September 12, 2024

BOSTON, Aug. 26, 2024 (GLOBE NEWSWIRE) -- Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing precision therapies to treat a range of solid tumors designed to preserve organ function, today announced that Phase 2 end of study data evaluating suprachoroidal administration of bel-sar for the first-line treatment of patients with small choroidal melanoma and indeterminate lesions will be presented at The Retina Society Annual Meeting being held September 11-15, 2024, in Lisbon, Portugal.

The presentation details are as follows:

Title: Final Results of a Phase 2 Trial of Suprachoroidal Administration of Belzupacap Sarotalocan (bel-sar, AU-011) for Choroidal Melanoma
Presenter: Dr. Ivana Kim, MD, Mass Eye and Ear
Date/Time: Thursday, September 12, 2024, from 11:04 am to 11:09 am Western European Daylight Time (6:04 am to 6:09 am Eastern Time)

The presentation will be available here on Thursday, September 12, 2024, following the presentation.

In addition, Aura will host a virtual ocular oncology investor event featuring Dr. Ivana Kim, MD (Mass Eye and Ear) and Dr. Prithvi Mruthyunjaya, MD, MHS (Stanford University Byers Eye Institute) to discuss the Phase 2 end of study data on Thursday, September 12, 2024, at 8:00 am Eastern Time. To register for the event, click here.

A live question and answer session will follow the formal discussion.

The live webcast of Aura’s virtual ocular oncology investor event will be available on the “Investors & Media” page under the “Events & Presentations” section of Aura’s website at https://ir.aurabiosciences.com/events-and-presentations, where a replay of the webcast will be archived for 90 days following the presentation date.

About Ivana K. Kim, MD

As a member of Mass Eye and Ear's Retina Service, Ivana K. Kim, MD specializes in the medical and surgical treatment of patients with vitreoretinal diseases, including age-related macular degeneration, retinal detachment, and uveal melanoma. In addition to her clinical responsibilities, Dr. Kim is Co-Director of the Harvard Ophthalmology Age-Related Macular Degeneration (AMD) Center of Excellence-a multidisciplinary collaboration among clinicians and scientists who are pooling their knowledge and resources with the goal of advancing breakthroughs in treatment for patients with AMD.

Dr. Kim received her medical training at Harvard Medical School. She deepened her knowledge of the eye as a resident in the Harvard Ophthalmology Residency Training Program, and subsequently, as a retina fellow at Mass Eye and Ear.

As a clinician scientist, Dr. Kim investigates genetic risk factors associated with AMD as a means to understand the mechanisms that cause the disease and further refine and advance therapies. In addition, she works to improve visual outcomes in patients with ocular melanoma-investigating strategies to reduce radiation complications-and hopes to help improve survival in these patients by studying frequently occurring mutations in this tumor type.

Dr. Kim is Director of the Ocular Oncology Fellowship at Mass Eye and Ear. Her teaching activities involve the medical and surgical training of retina fellows, as well as ophthalmology residents. She also mentors medical students and research fellows in the laboratory setting. She is frequently invited to participate in regional and national continuing education courses, such as the annual Macula course, and the American Academy of Ophthalmology Retina Subspecialty Day.

About Prithvi Mruthyunjaya MD, MHS

Prithvi Mruthyunjaya MD, MHS is Professor of Ophthalmology and Professor of Radiation Oncology (by courtesy) at Stanford University, Director of Ocular Oncology at the Byers Eye Institute, and member of the Vitreoretinal Surgery Service. He is a board-certified ophthalmologist who has completed two prestigious fellowships: the first in Vitreoretinal Surgery at Duke University and the second in Ocular Oncology at Moorfields Eye Hospital in London, England.

Dr. Mruthyunjaya is actively involved in research in ocular cancer imaging, genetics, and new modalities of tumor biopsy. He actively participates in early phase clinical trial development in ocular oncology and has brought cutting-edge treatment options to his patients at Stanford. He has published extensively in the field of ocular oncology, ophthalmic imaging, and complex retinal surgery. In addition, he holds leadership positions in the American Academy of Ophthalmology (AAO), the Retina Society, and the International Society of Ocular Oncology.

He joined the faculty of the Byers Eye Institute where he established a state-of-the-art ocular oncology service at Stanford University in Palo Alto, CA. His passion includes teaching the next generation of students, residents and fellows and currently serves as the retinal surgery fellowship director at Stanford.

About Aura Biosciences

Aura Biosciences is a clinical-stage biotechnology company developing precision therapies to treat a range of solid tumors designed to preserve organ function. Our lead candidate bel-sar is in late-stage clinical development for the treatment of patients with primary choroidal melanoma, and other ocular oncology indications as well as in early-stage clinical development in bladder cancer. We are evaluating the safety and efficacy of bel-sar as a potential vision-sparing therapy in an ongoing global Phase 3 CoMpass trial for the first-line treatment of adult patients with early-stage choroidal melanoma. Bel-sar is also being evaluated in additional solid cancers, including bladder cancer. Our mission is to develop vision and organ-sparing therapies to improve patient outcomes in cancer. Aura is headquartered in Boston, MA. For more information, visit aurabiosciences.com. Visit us @AuraBiosciences and on LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, and other federal securities laws. Any statements that are not statements of historical fact may be deemed to be forward looking statements. Words such as “may,” “will,” “could,” “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “seeks,” “endeavor,” “potential,” “continue” or the negative of such words or other similar expressions that can be used to identify forward-looking statements. These forward-looking statements include express or implied statements regarding Aura’s future expectations, plans and prospects, including, without limitation, statements regarding the therapeutic potential of bel-sar for the treatment of cancers including early-stage choroidal melanoma and statements regarding the timing of the announcement of end of study data for the Phase 2 clinical trial of bel-sar for the treatment of early-stage choroidal melanoma.

The forward-looking statements in this press release are neither promises nor guarantees, and investors should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties and other factors, many of which are beyond Aura’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements, including, without limitation, uncertainties inherent in clinical trials and in the availability and timing of data from ongoing clinical trials; the expected timing for submissions for regulatory approval or review by governmental authorities; the risk that the results of Aura’s preclinical and clinical trials may not be predictive of future results in connection with future clinical trials; the risk that interim data from ongoing clinical trials may not be predictive of final data from completed clinical trials; the risk that governmental authorities may disagree with Aura’s clinical trial designs, even where Aura has obtained agreement with governmental authorities on the design of such trials, such as the Phase 3 special protocol assessment agreement with the U.S. Food and Drug Administration; whether Aura will receive regulatory approvals to conduct trials or to market products; whether Aura’s cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements; Aura’s ongoing and planned preclinical activities; and Aura’s ability to initiate, enroll, conduct or complete ongoing and planned clinical trials. These risks, uncertainties and other factors include those risks and uncertainties described under the heading “Risk Factors” in Aura’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the United States Securities and Exchange Commission (SEC) and in subsequent filings made by Aura with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, Aura disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Aura’s current expectations and speak only as of the date hereof and no representations or warranties (express or implied) are made about the accuracy of any such forward-looking statements.

Investor and Media Contact:

Alex Dasalla
Head of Investor Relations and Corporate Communications
IR@aurabiosciences.com


FAQ

What is the purpose of Aura Biosciences' Phase 2 trial for bel-sar (AU-011)?

The Phase 2 trial evaluates the suprachoroidal administration of bel-sar for the first-line treatment of patients with small choroidal melanoma and indeterminate lesions.

When and where will Aura Biosciences (AURA) present the Phase 2 end of study data for bel-sar?

Aura Biosciences will present the Phase 2 end of study data for bel-sar at The Retina Society Annual Meeting in Lisbon, Portugal, on September 12, 2024.

Who will be presenting the Phase 2 results for Aura Biosciences' (AURA) bel-sar treatment?

Dr. Ivana Kim from Mass Eye and Ear will be presenting the Phase 2 results for Aura Biosciences' bel-sar treatment.

What is the date and time of Aura Biosciences' (AURA) virtual ocular oncology investor event?

Aura Biosciences' virtual ocular oncology investor event will be held on September 12, 2024, at 8:00 am Eastern Time.

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