Aura Biosciences, Inc. (NASDAQ: AURA)

Aura Biosciences, Inc., often recognized by its ticker symbol AURA, is a clinical-stage biotechnology company that operates within the healthcare industry. The company is dedicated to the development and commercialization of precision immunotherapies, with a particular focus on treating a range of solid tumors, and preserving vision and preventing blindness in patients with ocular cancers.

The primary business activities of Aura Biosciences revolve around the development of bel-sar, a virus-like drug conjugate (VDC) that promotes cancer cell death through both the delivery of a cytotoxic payload and the activation of a secondary immune-mediated response. Bel-sar is currently in late-stage clinical development for the treatment of primary choroidal melanoma and other ocular oncology indications, as well as in early-stage clinical development in bladder cancer. The company's pipeline also includes other VDC candidates in various stages of development.

Bel-sar is a VDC that consists of an HPV-derived virus-like particle (VLP) and a phthalocyanine dye, a laser-activated cytotoxic payload. The VLP is created using genetically modified capsid proteins of HPV, which have been designed to avoid cross-reactivity with pre-existing immunity against the virus and bind with high affinity to modified tumor-associated glycosaminoglycans (GAGs) that are part of the heparan sulfate chain of heparan sulfate proteoglycans (HSPGs) expressed on the surface of tumor cells, including ocular melanoma cells.

Aura Biosciences is developing bel-sar as a potential first-line vision-sparing treatment option for early intervention in small choroidal melanoma and/or indeterminate lesions. This strategy aims to avoid the need for radiotherapy and reduce the risk of metastasis for these patients. Additionally, the company is evaluating bel-sar in bladder cancer, specifically focusing on treating patients with non-muscle invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC).

In the ocular oncology space, Aura Biosciences is recognized for its ability to develop bel-sar as a potential vision-sparing therapy for ocular oncology, demonstrating a tumor control rate of 80% and a visual acuity preservation rate of 90% in patients with small choroidal melanoma and/or indeterminate lesions. The company's Phase 2 suprachoroidal study showed a high local complete response, with a tumor control rate of 80% and a visual acuity preservation rate of 90%, with no dose-limiting toxicities or treatment-related serious adverse events as of August 3, 2023.

Aura Biosciences' competitive advantage in ocular oncology lies in its unique focus on early intervention in small choroidal melanoma or indeterminate lesions, as well as the treatment of choroidal metastasis—areas in which the company is not aware of any other company with a drug in clinical development. The standard of care for patients with choroidal melanoma typically involves plaque brachytherapy or proton beam therapy. Verteporfin (Visudyne) is currently used off-label in some cases of early-stage disease alone or in combination with transpupillary thermotherapy.

In urologic oncology, however, there are multiple companies with drugs in clinical development for the treatment of NMIBC and MIBC. Pembrolizumab has been approved for the treatment of BCG-unresponsive NMIBC with carcinoma in situ (CIS), with or without papillary tumors, for patients who are unfit or unwilling to undergo radical cystectomy. Ferring Pharmaceuticals has obtained FDA approval for ADSTILADRIN for the treatment of adult patients with high-risk BCG-unresponsive NMIBC with CIS, with or without papillary tumors. ImmunityBio, Inc. has presented Phase 2/3 data for their drug Anktiva in combination with BCG in patients with BCG unresponsive NMIBC and has submitted a BLA with a PDUFA date of April 23, 2024. CG Oncology's cretostimogene grenadenorepvec, or CG0070, has presented data in a global Phase 3 clinical trial as a monotherapy for the treatment of BCG-unresponsive NMIBC and has received breakthrough therapy designation and Fast Track Designation. The same drug is being studied in combination with KEYTRUDA in a Phase 2 trial in the same indication and in combination with Nivolumab in MIBC.

Aura Biosciences' robust patent portfolio includes a range of issued patents, pending patent applications, exclusive licenses, and sole ownership of two patent families. These assets are owned by the company, co-owned by the company, or licensed by the company from third parties, including LI-COR, NIH, Inserm, and DHHS/NIH.