Roche nabs priority review for Eylea competitor; Italy's Angelini eyes CNS, rare disease startups with $35M Lumira fund
The teams at Roche and Genentech are off and running at the FDA, with regulators accepting a quick pitch for what would be the first bispecific antibody designed for the eye.
Roche announced late Wednesday that its application for faricimab has been accepted under priority review to treat wet AMD and diabetic macular edema. In addition, the submission for diabetic retinopathy was also accepted, the company said.
“If approved, faricimab would be the first in a new class of eye medicines targeting two key pathways that drive retinal disorders, with the potential to offer durable vision outcomes with fewer eye injections than the current standard of care,” CMO Levi Garraway said in a statement.
Over the last several months, Roche has been doling out data in order to try to compete with Regeneron’s Eylea. In February, Roche unveiled a new dataset saying half of patients treated with the experimental faricimab in a Phase III study were able to be dosed every four months after the first year of treatment, compared to the once-every-eighth week Eylea regimen.
The faricimab program has already demonstrated non-inferiority in both diseases, and coupled with the extended time between doses, the candidate has emerged as the “top competitive threat” to the Regeneron franchise, Cowen’s Yaron Werber wrote at the time. — Max Gelmam
Italy’s Angelini eyes CNS, rare disease startups with $35M Lumira fund
When Lumira Ventures revealed its latest $220M fund, co-founder and managing partner Gerry Brunk teased a new $35 million strategic fund in partnership with an unnamed pharma company.
A few days later, we now know who that is: Italy’s Angelini Pharma is providing the money to set up Angelini Lumira Biosciences Fund, which will focus on brain health and rare diseases.
Following a search involving more than 100 VCs worldwide, Lumira stood out as one of the most active in these areas, said Angelini CEO Pierluigi Antonelli. The new fund’s direction will align with Lumira’s own strategy of pursuing “underserved” areas in the US and Europe, he added, but will look at earlier stage companies — 10 to 12 in total.
In addition to buying in at a better valuation, Antonelli hopes connecting early with startups would give Angelini an edge in co-development or commercial partnership talks, as they try to tap into a swirl of new approaches coming to the CNS space like RNA biology, antisense oligonucleotides and gene therapy, as well as technologies for crossing the blood-brain barrier.
“When possible we will also co-invest in ALBF portfolio companies and seek board seats,” he wrote to Endpoints News. “We can help create value in the portfolio companies by providing access to our multidisciplinary (or vertical) knowledge of the CNS/rare disease space.” — Amber Tong
Tonix brings vaccine production facility in-house
Tonix Pharmaceuticals has some new property.
The Chatham, NJ-based biotech acquired an approximately 48,000 square foot facility to support its “expanding infectious disease pipeline,” the company announced earlier this week. Tonix noted the aid will go toward three vaccine candidates, two of which are aimed at Covid-19 and the third being tested for smallpox and monkeypox.
Tonix acquired the facility, located in Frederick, MD, from a collaboration partner for two of their vaccine programs. The biotech expects operations to be up and running by the fourth quarter this year.
“We view control of in-house facilities as a strategic capability to ensure the speed and efficiency with which we can develop vaccines and antiviral products in the future against known, emerging or novel pathogens,” CEO Seth Lederman said in a statement. — Max Gelman