Aura Biosciences (NASDAQ:AURA) executives outlined the company’s strategy for its lead candidate bel-sar during a session at the H.C. Wainwright Connect Conference, emphasizing ocular oncology as the company’s initial development focus while also discussing ongoing work in non-muscle invasive bladder cancer.
Tony Gibney, Aura’s Chief Financial Officer and Chief Business Officer, said the company’s pipeline is “founded on bel-sar,” which he described as a novel compound with potential utility across a broad range of solid tumors. Aura has chosen ocular oncology as its “beachhead” for proprietary development, beginning with choroidal melanoma and extending into metastases to the choroid and ocular surface cancers.
Gibney also highlighted an ongoing Phase 1b/2 study in non-muscle invasive bladder cancer, with initial three-month data expected around mid-year. He said that program is evaluating both an immune-ablative opportunity and a neoadjuvant approach.
Bel-sar’s Role in Choroidal Melanoma
Anthony Daniels, Vice President and Therapeutic Area Head of Ocular Oncology at Aura, said bel-sar is being developed to address a treatment dilemma in early choroidal melanoma: physicians often monitor growing tumors to delay radiotherapy because current radiation-based treatment can lead to severe vision loss.
Daniels said patients with melanomas at the back of the eye ultimately face the risk of metastatic disease, most commonly involving spread to the liver. He said the current paradigm may treat too late, adding that bel-sar’s targeted tumor treatment may generate tumor-specific immune memory that could potentially help reduce the risk of later metastases.
“You can do what you do in every other type of cancer, which is diagnose early and treat early,” Daniels said, describing the intended shift in treatment practice if bel-sar can control tumors while preserving vision.
Daniels contrasted bel-sar’s vision preservation profile with radiotherapy, saying that with radiation, 87% of patients lose enough vision to fall below 20/200, the threshold for legal blindness. He said the average patient receiving radiation loses about 30 letters of vision, while in Aura’s Phase 2 study the average bel-sar-treated patient lost three letters.
CoMpass Phase 3 Trial Design
Daniels described the CoMpass Phase 3 study as a randomized, masked trial comparing three cycles of 80 micrograms of bel-sar with sham treatment. He said the regimen matches the Phase 2 regimen on which CoMpass was built.
Patients enrolled in CoMpass must have tumors that are actively growing with documentation of growth before entering the study. Daniels said that feature is intended to ensure patients randomized to sham are likely to continue progressing.
The primary endpoint is time to tumor progression. The first key secondary endpoint is a composite of tumor progression or vision loss, whichever comes first. Daniels said regulators in both Europe and the U.S. aligned on tumor progression as the primary endpoint, and that the composite secondary endpoint could support claims around vision preservation.
In discussing Phase 2 results, Daniels said patients who received the therapeutic regimen had 80% tumor control, while a lower-dose “sham-like” group had 20% of patients who did not reach the progression threshold. He said tumor control was maintained for one year after upfront bel-sar treatment was stopped.
Market Opportunity in Ocular Oncology
Daniels said current coding practices may understate the number of patients who could be candidates for treatment because physicians generally do not code a lesion as melanoma until they decide to treat with radiation. He said many patients who may need treatment are monitored longer because of concerns about radiation-related vision loss.
When asked about the potential treated population, Daniels said the incidence of patients doctors would want to treat is about 8,000 annually, split evenly between the U.S. and Europe.
Gibney said preserving vision while halting disease progression could represent a significant value proposition in an orphan disease, particularly because patients entering the study are generally in their late 50s to early 60s.
Expansion Into Other Eye Cancers
Aura is also pursuing bel-sar in metastases to the choroid and ocular surface cancers. Daniels said metastases to the choroid often involve breast and lung cancers, along with smaller percentages of other tumor types. These lesions can grow quickly, leak fluid under the retina and cause vision loss.
Daniels said the delivery approach for metastases to the choroid is the same as in choroidal melanoma, involving suprachoroidal injection and laser activation. He said the setting could allow Aura to demonstrate activity across multiple primary tumor types, with shorter endpoints because the tumors grow quickly.
For ocular surface cancers, Daniels said the indication includes melanomas on the eye surface as well as squamous cell carcinoma and precursor lesions. He described ocular surface disease as the largest of Aura’s three ocular oncology opportunities discussed during the session.
Gibney said a recent capital raise gives Aura the ability to move early pilot studies more directly into later development if results are favorable. He added that the same doctors who treat choroidal melanoma often treat the other ocular tumors, meaning many sites are already familiar with bel-sar through CoMpass.
Bladder Cancer Program and Upcoming Data
Gibney described the bladder cancer field as larger and more crowded than ocular oncology, with significant activity in adjuvant treatment settings such as carcinoma in situ and BCG-unresponsive disease. He said Aura is evaluating whether bel-sar can shift treatment earlier, including a neoadjuvant approach before transurethral resection of bladder tumor, or TURBT.
He said Aura is treating patients two weeks before TURBT and following them to see whether bel-sar can improve durability at three months and ultimately 12 months. Gibney said the company is also exploring an immune-ablative approach in patients who may be able to avoid TURBT.
Looking ahead, Gibney said Aura expects three-month bladder cancer data around mid-year, with 12-month data projected for the early second half of 2027 based on that timing. He also said the company is guiding to additional core data and initial proof-of-concept work in ocular surface disease in 2026.
About Aura Biosciences (NASDAQ:AURA)
Aura Biosciences is a clinical‐stage biopharmaceutical company focused on the development of novel virus‐like particle (VLP) therapies for the treatment of cancer. By combining proprietary VLP technology with photoactivatable dyes, Aura aims to deliver highly selective photodynamic therapies that target and destroy tumor cells while sparing healthy tissue. The company's platform is designed to address solid tumors in both ophthalmic and non‐ophthalmic settings, leveraging precision activation via near‐infrared light to induce localized tumor cell apoptosis and stimulate anti‐tumor immune responses.
The lead product candidate, AU-011, is being evaluated in patients with choroidal melanoma, a rare but potentially sight-threatening eye cancer.
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