On August 11, 2022 Aura Biosciences Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, reported financial results for the second quarter ended June 30, 2022, and provided clinical development and operational highlights (Press release, Aura Biosciences, AUG 11, 2022, View Source [SID1234618173]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We have made significant progress in advancing the clinical development of belzupacap sarotalocan and remain on track to dose the first patient this quarter in the Phase 1 trial in non-muscle invasive bladder cancer (NMIBC), which represents our second indication in the clinic," said Elisabet de los Pinos, Ph.D., Chief Executive Officer of Aura. "Current treatments leave patients with a high risk of recurrence and progression, which in many cases leads to cystectomy (the entire removal of the bladder and some surrounding tissues). We look forward to further developing a potential targeted treatment option for patients with this high unmet medical need. Notably, we recently received FDA Fast Track designation in NMIBC, which will further support our development efforts. Beyond NMIBC, we remain on track to initiate our pivotal trial of belzupacap sarotalocan in early-stage choroidal melanoma and file an Investigational New Drug application (IND) for choroidal metastases, our second ocular oncology indication, in Q4 of this year."

Recent Pipeline Developments

Belzupacap sarotalocan (AU-011) is being developed for the treatment of early-stage choroidal melanoma (CM), a life-threatening rare disease with no approved therapies. Aura plans to select the route of administration and treatment regimen to initiate the pivotal program in Q4 of 2022.

Multiple clinical studies of belzupacap sarotalocan were presented at the International Society of Ocular Oncology (ISOO) 2022 Bi-Annual Meeting, the largest global ocular oncology meeting. The presentations included updated safety data from the Phase 2 trial using suprachoroidal (SC) administration, final safety and efficacy data from the Phase 1b/2 trial using intravitreal (IVT) administration, as well as top-line data from the Retrospective Match Case Control study comparing the long-term visual acuity outcomes following treatment with belzupacap sarotalocan versus treatment with plaque brachytherapy, the current standard of care. Collectively, these studies support the value of a vision-preserving therapy for the treatment of patients with early-stage choroidal melanoma.

Aura plans to dose the first patient in a Phase 1 clinical trial of belzupacap sarotalocan for the treatment of NMIBC in Q3 2022.

NMIBC is an area of high unmet need with no approved targeted therapies. The Phase 1 trial will evaluate safety and early proof of mechanism, exploring distribution, local necrosis and evidence of immune activation of belzupacap sarotalocan. Aura expects to report initial Phase 1 data in 2023.

FDA (Division of Oncology) granted Fast Track designation for belzupacap sarotalocan for the treatment of NMIBC.

Beyond early-stage CM, we continue to build our ocular oncology franchise, with choroidal metastases being the second potential ocular indication. Aura plans to file an IND for choroidal metastases, an unmet medical need with no approved therapies, with the FDA in Q4 of 2022.

Recent presentations in both choroidal metastases and in broader oncology indications include:

Preclinical data highlighting belzupacap sarotalocan’s anti-tumor activity were presented at the 2022 Association of Research in Vision and Ophthalmology (ARVO) Annual Meeting. Preclinical results highlighted belzupacap sarotalocan’s targeted cytotoxicity in tumor cells derived from the most common cancer types known to metastasize to the choroid in the eye. Belzupacap sarotalocan showed dose dependent activity in vivo using cognate tumor models. These results support further evaluation of belzupacap sarotalocan as a potential treatment for choroidal metastases, the most common type of intraocular malignancy in adults.

Abstract highlighting belzupacap sarotalocan’s activity as a single agent and as a combination therapy with checkpoint inhibitors was selected for publication at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The published data showed that belzupacap sarotalocan, in combination with immune checkpoint inhibition, had anti-tumor activity against both primary tumors and distant untreated lesions by an abscopal effect in a preclinical model, demonstrating its clinical potential for the treatment of both early-stage tumors and also metastatic cancers.
Second Quarter 2022 Financial Results

As of June 30, 2022, Aura had cash and cash equivalents and marketable securities totaling $122.1 million. Aura believes its current cash and cash equivalents and marketable securities are sufficient to fund its operations into 2024.

Research and development expenses increased to $9.5 million for the three months ended June 30, 2022 from $6.6 million for the three months ended June 30, 2021, primarily due to ongoing preclinical costs, clinical costs for belzupacap sarotalocan, and higher personnel expenses from growing headcount.

General and administrative expenses increased to $4.3 million for the three months ended June 30, 2022 from $2.2 million for the three months ended June 30, 2021. General and administrative expenses include $0.8 million and $0.2 million of stock-based compensation for the three months ended June 30, 2022 and 2021, respectively. The increase was primarily driven by personnel expenses, as well as increases in general corporate expenses related to operating as a public company.

Net loss for the three months ended June 30, 2022 was $13.5 million compared to $8.9 million for the three months ended June 30, 2021.