Aura Biosciences Announces Interim Phase 2 Data Evaluating Suprachoroidal Administration of Belzupacap Sarotalocan (AU-011) for the First-Line Treatment of Patients with Early-Stage Choroidal Melanoma Presented at AAO 2022
Aura to Host Virtual Investor Day at
“The Phase 2 interim safety and efficacy data that was presented at AAO is very encouraging for patients with primary choroidal melanoma, as the majority of patients are diagnosed with early-stage disease and have no vision-preserving treatment options. Interim data showed a statistically significant reduction in tumor growth rate and a robust tumor control response with a high rate of visual acuity preservation at the therapeutic regimen,” said Dr.
“Preliminary analysis of the data from the Phase 2 trial using suprachoroidal administration supports tolerability up to three cycles of therapy and shows a dose-dependent anti-tumor response. The results provide further clinical evidence to support the potential use of belzupacap sarotalocan as a novel targeted therapy in patients with early-stage disease with this targeted route using suprachoroidal administration,” said Dr.
The presentation can be accessed on the Company’s website: link
Interim Safety and Efficacy Data from the Ongoing Phase 2 Trial with
This Phase 2 trial (NCT04417530) is assessing the safety and preliminary efficacy of single- and multiple ascending-doses of belzupacap sarotalocan up to three cycles of treatment via SC administration for the first-line treatment of early-stage choroidal melanoma (IL/CM). A total of 20 adult patients have been enrolled in the trial including the single dose Cohorts 1-3 (n=6) and multiple dose escalation Cohorts 4-6 (n=14). Cohorts 5 and 6 received up to three cycles of therapy, which was considered the therapeutic regimen for evaluation. One patient in Cohort 5 (n=3) received two cycles of therapy and two patients in Cohort 5 received three cycles of therapy (40 μg/dose). All patients from Cohort 6 (n=8) received three cycles of therapy at the highest dose (80 μg/dose). One patient from Cohort 6, who discontinued after one cycle due to unrelated serious adverse events (SAEs), is not included. All patients in Cohorts 5 and 6 had active growth at study entry, as an enrichment strategy to evaluate preliminary efficacy. This group of patients with active growth treated at the therapeutic regimen of three cycles was evaluated for tumor growth rate, tumor control, and visual acuity preservation as the defined clinical endpoints to evaluate preliminary efficacy. These endpoints have been discussed with the
Details for the Virtual Investor Day:
The Company will host a virtual Investor Day today at
Carol Shields, MD, Chief of the Ocular Oncology Service at Wills Eye Hospitaland Professor of Ophthalmology at Thomas Jefferson University( USA)
Ivana Kim, MD, MBA, Director of the Ocular Melanoma Center, Massachusetts Eye and Ear & Associate Professor of Ophthalmology, Harvard Medical School( USA)
Martine Jager, MD, PhD, Professor of Ophthalmology, Leiden University( Netherlands) & Past President of the International Society of Ocular Oncologyand the Association for Research in Vision and Ophthalmology
To access the virtual Investor Day, please dial (888) 660-6585 (
For more information, visit aurabiosciences.com, or follow us on Twitter and LinkedIn.
Forward Looking Statement
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 belzupacap sarotalocan for the treatment of cancers including choroidal melanoma; any express or implied statements regarding the Company’s expectations for the Phase 2 clinical trial belzupacap sarotalocan; and Aura’s expectations regarding the estimated patient populations and related market opportunities for belzupacap sarotalocan.
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, an improved quality of life of patients after treatment with belzupacap sarotalocan; a potential paradigm shift in the approach to the treatment of choroidal melanoma; the urgent need for a vision preserving targeted therapy; the potential of belzupacap sarotalocan compared to the existing standard of care for patients with choroidal melanoma; 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 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; 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; risks, assumptions and uncertainties regarding the impact of the continuing COVID-19 pandemic on Aura’s business, operations, strategy, goals and anticipated timelines; Aura’s ongoing and planned pre-clinical 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