Aura Biosciences Takes Key Steps to Advance Lead Candidate

With a fresh infusion of capital and a new chief operating officer steeped in regulatory affairs, Aura Biosciences has put key pieces into place to advance its lead candidate, AU-011 for the treatment of ocular melanoma, through Phase II trials and move it closer to commercialization.

In the past week Aura closed an oversubscribed $80 million in financing and brought on board Mark De Rosch, PhD, as COO. Dr. De Rosch has more than 30 years in directing global and regulatory affairs in oncology and ophthalmology.

Where AU-011 Stands
Aura is developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications. Its lead candidate, AU-011 (belzupacap sarotalocan), is in Phase II development for the first-line treatment of choroidal melanoma, a vision- and life-threatening cancer of the eye for which radiation or removal of the eye are the only treatments.

“Mark joins our team during an exciting time at Aura,” company founder and CEO Elisabet de los Pinos, PhD, said of Dr. De Rosch. “His decades of experience with global regulatory strategy, as well as building successful teams and pipelines, will be invaluable as we work to realize the full potential of our VDC technology platform.”

Dr. de los Pinos added, “His proven track record and strong scientific acumen aligns well with our goals as we advance AU-011 toward late-stage pivotal development.”

Dr. De Rosch’s Regulatory Background
Dr. De Rosch’s resume includes his latest position, chief regulatory officer at Epizyme, where he led regulatory efforts for the company’s first approved product, Tazverik (tazemetostat), a methyltransferase inhibitor indicated for patients with epithelioid sarcoma and follicular lymphoma that the Food and Drug Administration approved last year.

Previously, Dr. De Rosch had a turn in ophthalmology as SVP of regulatory affairs and quality assurance for Nightstar Therapeutics, which Biogen acquired in 2019. There he developed and implemented global regulatory roadmaps for gene therapy programs in choroideremia and retinitis pigmentosa. Before that he was SVP of regulatory affairs, quality assurance, and CMC at Akebia Therapeutics.

“Aura’s experienced team and the novel VDC technology make this a compelling opportunity,” Dr. De Rosch said. “I look forward to contributing my global regulatory, operational, and organizational expertise to grow the company and advance this leading technology to transform the outcomes for cancer patients.”

Details of Financing Round
Meanwhile on the financial front, Matrix Capital Management and Surveyor Capital led the latest financing round. Also participating were new investors, including Rock Springs Capital, Adage Capital Management LP, and Velosity Capital; and existing investors Medicxi, Advent Life Sciences, Lundbeckfonden Ventures, Arix Bioscience, Chiesi Ventures, Ysios Capital, and Columbus Venture Partners.

“This funding from a syndicate of distinguished investors enables us to advance AU-011 into a pivotal Phase III program,” Dr. de los Pinos said. “It also allows us to continue to expand the reach of our VDC technology in additional ocular oncology indications and in the treatment of solid tumors like bladder cancer where there is a high unmet medical need for better targeted therapies to treat early and reduce the incidence of metastasis.”

In connection with this financing, Karan Takhar, senior managing director of Matrix Capital, will join Aura’s board of directors.

“Matrix believes in the long-term potential of Aura’s VDC technology to further strengthen the company’s position as a leader in ocular oncology and beyond within other types of cancers in need of better treatment options,” Takhar said. “We look forward to supporting Aura’s leadership team through this next stage of pipeline growth and transition into late-stage development with the commencement of the AU-011 pivotal program.”