Aura Biosciences Announces Enrollment Completion in Phase 3 CoMpass Trial of Bel-sar in Early Choroidal Melanoma
Rhea-AI Summary
Aura Biosciences (NASDAQ:AURA) completed enrollment of 108 patients in the Phase 3 CoMpass trial of belzupacap sarotalocan (bel-sar) as frontline therapy for early choroidal melanoma.
Topline data for the 15‑month primary endpoint are expected in the second half of 2027. The global, randomized trial compares bel-sar with sham control under an FDA Special Protocol Assessment and has FDA/EMA orphan and FDA Fast Track designations.
Positive
- Phase 3 CoMpass trial enrollment completed with 108 patients
- Topline 15‑month primary endpoint data expected in H2 2027
- Trial evaluating bel-sar versus sham in frontline early choroidal melanoma
- Study conducted under FDA Special Protocol Assessment agreement
- Bel-sar has FDA and EMA Orphan Drug Designation
- Bel-sar has FDA Fast Track designation for early choroidal melanoma
Negative
- None.
News Market Reaction – AURA
In the Jun 1 session, AURA declined 3.75%, reflecting a moderate negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Clinical trial Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| May 04 | CEO change & trial | Positive | +19.1% | New CEO appointment and Phase 3 CoMpass nearing enrollment completion guidance. |
| Mar 24 | Phase 1 NMIBC data | Positive | -6.7% | Positive Phase 1 bel-sar safety and efficacy data in NMIBC patients. |
| Mar 03 | Data presentation plan | Neutral | -3.7% | Announcement of upcoming late-breaking Phase 1 NMIBC data presentation. |
| Oct 17 | Early NMIBC responses | Positive | +14.1% | Positive early Phase 1 NMIBC data with multiple complete responses and safety. |
| Sep 12 | Phase 2 CM results | Positive | +7.9% | Positive Phase 2 results in early-stage choroidal melanoma with strong tumor control. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Clinical updates for bel-sar often skew positive but show mixed immediate price reactions, with some strong rallies and occasional selloffs even on favorable data.
Over recent years, Aura has steadily advanced bel-sar across indications. Positive Phase 2 data in early choroidal melanoma showed 80% tumor control and 90% visual acuity preservation among Phase 3‑eligible patients, while early bladder cancer trials also reported multiple complete responses and favorable safety. A prior update on the CoMpass trial cited 86 patients enrolled and guided to completion by mid‑2026 with topline data in H2 2027. Today’s announcement confirms enrollment completion at 108 patients, reinforcing that guidance and marking a key registrational milestone.
Key Terms
phase 3 medical
randomized medical
sham control medical
special protocol assessment regulatory
spa regulatory
orphan drug designation regulatory
fast track designation regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
Enrollment of 108 patients completed in the registration-enabling Phase 3 CoMpass trial
Topline data from the 15-month primary endpoint expected in the second half of 2027
BOSTON, June 01, 2026 (GLOBE NEWSWIRE) -- Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing precision therapies for solid tumors designed to preserve organ function, today announced it has completed enrollment of 108 patients in the Phase 3 trial evaluating belzupacap sarotalocan (bel-sar) as a frontline treatment for patients with early choroidal melanoma. Topline data for the 15-month primary endpoint are anticipated in the second half of 2027.
“Completing enrollment in our Phase 3 CoMpass trial marks a significant milestone for Aura as we advance bel-sar toward a potential regulatory approval in early choroidal melanoma,” said Dr. Jill Hopkins, Chief Medical Officer and President of R&D of Aura Biosciences. “We believe bel-sar has the potential to become the first approved frontline, vision-preserving therapy for this disease, addressing a critical unmet need for patients who today often face treatment options that can result in irreversible vision loss. We are deeply grateful to the patients, investigators, and clinical sites participating in the CoMpass trial and look forward to reporting topline data in the second half of 2027.”
The ongoing CoMpass trial is the first registration-enabling study in patients with early choroidal melanoma. The global, randomized Phase 3 trial is evaluating bel-sar versus sham control in the frontline setting under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). Aura previously received Orphan Drug Designation from both the FDA and the European Medicines Agency, as well as Fast Track designation from the FDA for the treatment of early choroidal melanoma.
About Aura Biosciences
Aura Biosciences, Inc. is a clinical-stage biotechnology company focused on developing precision therapies for solid tumors that aim to preserve organ function. Aura’s lead candidate, bel-sar (AU-011), is currently in late-stage development for early choroidal melanoma and in early-stage development in other ocular oncology indications and bladder cancer. Aura is headquartered in Boston, MA. Aura’s mission is to grow as an innovative global oncology company that positively transforms the lives of patients.
For more information, visit aurabiosciences.com. Follow us on X, @AuraBiosciences, and visit us 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 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 multiple cancers; statements regarding Aura’s plans and expectations for its ongoing and future clinical trials of bel-sar; statements regarding the timing and plans for Aura’s Phase 3 CoMpass trial in early choroidal melanoma, including the timing of topline data; statements regarding the potential regulatory approval of bel-sar in early choroidal melanoma; statements regarding Aura’s expectations for an improved quality of life of patients after treatment with bel-sar and changes to the treatment paradigm for patients; and statements regarding Aura’s expectations for the estimated patient populations and related market opportunities for bel-sar.
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 early or 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 Relations Contact:
Alex Dasalla
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