Surrozen Inc. scored a deal with Boehringer Ingelheim GmbH to research and develop SZN-413 for the treatment of retinal diseases. The deal brings an up-front payment to Surrozen of $12.5 million, plus up to $586.5 million in potential development, regulatory and commercial milestone payments, along with mid-single-digit to low-double-digit royalties on sales. After an initial period of joint research, Boehringer will take over development and commercial responsibilities. SZN-413 in preclinical models of retinopathy showed that frizzled class receptor 4 agonist SZN-413 potently stimulated Wnt signaling in the eye, induced normal retinal vessel regrowth, suppressed pathological vessel growth and reduced vascular leakage. Shares of Surrozen (NASDAQ:SRZN) were trading midday at $2.26, up 4 cents.

Nested Therapeutics launches with $125M for next-level precision oncology

Nested Therapeutics Inc. emerged from stealth, revealing $125 million in equity funding and plans to bring precision oncology to the next level by probing the genomics and structural biology of key cancer targets more deeply than before, in an ambitious bid to find new driver mutations, new druggable pockets, and new chemistry that will expand the current arsenal of targeted therapies. The company arose from longstanding efforts on the part of founding investor Versant Ventures to woo Klaus Hoeflich, who has held a variety of scientific leadership roles at the Genentech unit of Roche Holding AG and, more recently, at Blueprint Medicines Inc., where he was senior vice president of biology.

Taurx sees path to regulatory filings in AD, despite invalidation of phase III control arm

Despite clinical responses undermining the placebo arm of its phase III Alzheimer's disease (AD) study, Lucidity, Taurx Pharmaceuticals Ltd. executives Oct. 6 said they still see the data as supporting their ability to pursue regulatory submissions for hydromethylthionine mesylate (HMTM), an oral tau aggregation inhibitor. For people with mild cognitive impairment especially, they said, "HMTM treatment resulted in sustained improvement in cognition over pretreatment baseline, and normalization of brain atrophy to a rate similar to healthy individuals."

FDA user fees increasing in FY 2023 under new fee agreements 

The U.S. Congress has reauthorized several user fee programs at the FDA, and the agency has published the user fee levels for several product types, with most of those fees increasing significantly. One example of this is the increase for new drug applications requiring clinical data from $3.12 million to $3.24 million, while fees for medical device PMA filings will jump from $375,000 to $442,000, including some hefty adjustments for persistent inflation.

Connect eying China NDA as pivotal atopic dermatitis trial hits endpoints

Connect Biopharma Holding Ltd. said a pivotal test of it IL-4Rα binding candidate CBP-201 in patients with moderate to severe atopic dermatitis (AD) in China successfully achieved all primary and secondary efficacy endpoint with highly statistically significant results at week 16 of the study. “We anticipate engaging with the Center for Drug Evaluation in the next several months to determine the potential for a new drug application filing, which can be filed as early as 2024,” Zheng Wei, co-founder and CEO of Connect Biopharma, said during a company conference call.

Biosimilars: Portrait of a maturing landscape

Although it’s a make-or-break market for many novel drugs, the U.S. is still testing the waters with biosimilars to some extent. That’s expected to change when at least seven biosimilars, including an interchangeable, referencing Abbvie Inc.’s Humira (adalimumab) are set to launch in the U.S. within the first seven months of next year. Next week, BioWorld will look at the significance of that looming competition and how the global biosimilars market is evolving amid a changing landscape of players, policies and pipelines.

Also in the news

Abionyx, ABVC, Acer, Allecra, Alzamend, Anaptysbio, Andrews Medicine, Ascletis, Atai, Benevolentai, Biolink, Boehringer Ingelheim, Celltex, Clarametyx, Covira, Cyclerion, Eiger, Eliem, GATC, Global Blood Therapeutics, Heartbeat.Bio, Icosavax, Immugenia, Immutep, Innopole, Intravacc, MBX, Mindset, Monopar, Newamsterdam, Neximmune, Nextcure, NFL Biosciences, Ocean, Oncosec, Pfizer, Red Tree, Sanofi, Shionogi, Takeda, Tempus, Themis, Transcenta, Trialspark, Vir, Voyager