Chiesi Farmaceutici SpA has agreed to pay Affibody AB up to $214 million in a collaboration and licensing agreement to develop an inhaled treatment for respiratory diseases, with a further $423 million also in the cards if the deal is extended to two further programs. Affibody plans to develop the preclinical programs for chronic respiratory diseases with high unmet medical needs, such as asthma, chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis and pulmonary hypertension. Italian firm Chiesi is to fund all discovery, development and subsequent commercialization worldwide, whilst Solna, Sweden-based Affibody has retained the option to co-promote in the Nordic region.
Protagonist eyes a phase III in psoriasis after a phase II success
Protagonist Therapeutics Inc. got a win in its phase II study and is making plans for a phase III. JNJ-2113 (formerly PN-235), an oral, interleukin-23 receptor antagonist peptide, hit its primary efficacy endpoint in treating moderate to severe plaque psoriasis. A statistically significant greater proportion of the participants receiving JNJ-2113 saw a 75% improvement in their skin lesions compared to placebo at week 16. Dinesh Patel, Protagonist’s CEO, said he expects the treatment to now move into a phase III registrational study. Shares (NASDAQ:PTGX) were trading upward at midday by 30% to about $19.90 each. The study is in collaboration with Janssen Biotech Inc.
Newco news: Rapport launches with $100M series A and a J&J precision neuroscience platform
Rapport Therapeutics Inc. launched with $100 million in series A funding and ambitious plans to bring a hitherto unprecedented level of precision to therapies for neurological disease. Although the Boston-based company is new to the world, its underlying platform has been a decade in the making, and it already has one clinical-stage asset, which is in development for seizure disorders. It is currently undergoing a phase I trial. The company’s founder and chief scientific officer David Bredt spent a decade as global head of neuroscience discovery at Johnson & Johnson Co., of New Brunswick, N.J., where he pioneered research into receptor-associated proteins. This work is now being spun into Rapport.
‘Execution play’ Noema closes $110M series B round for diverse CNS pipeline
Noema Pharma AG raised CHF103 million (US$110.3 million) in a series B round to continue moving forward its bulging pipeline of clinical stage assets in development for multiple central nervous system disorders. The Basel, Switzerland-based company is now funded through early 2025, by which time it will have at least some clinical data that will help it to determine its next steps. “It’s an execution play now,” Antoine Papiernik, chairman and managing partner at Paris-based Sofinnova Partners, Noema’s founding investor, told BioWorld. The breadth and diversity of the indications it is pursuing is an important aspect of the company’s risk profile.
ESMO TAT: Tumor therapies find new ways into the brain, by finesse or force
Whether as primary tumors or metastases, brain tumors remain stubbornly intractable to the progress that has occurred in many other tumor types. As Igor Vivanco, who is a senior lecturer in the Institute of Pharmaceutical Science at King’s College London, noted in his talk at the European Society for Medical Oncology Targeted Anticancer Therapies (ESMO TAT) meeting in Paris this week, the last win in glioblastoma was the addition of temozolomide to the radiotherapy standard of care in 2005. And temozolomide’s benefit is measured in months, not years. Part of the problem, though not the whole problem, is the blood-brain barrier.
Hanall’s bataclimab meets endpoints in phase III myasthenia gravis trial
Hanall Biopharma Co Ltd.’s batoclimab met the primary and key secondary endpoints in a pivotal phase III trial in generalized myasthenia gravis in China, marking the first positive phase III data for the candidate globally. Hanall’s licensing partner, Harbour Biomed Ltd., reported the top-line data that will be sufficient for filing a BLA to China’s National Medical Products Administration in the next few months, Harbour founder and CEO Jingsong Wang told BioWorld. Originated by Seoul, South Korea-based Hanall, batoclimab is a fully human, subcutaneously administered antibody, which selectively binds to and inhibits the neonatal Fc receptor.
Gilead antiviral IPR win upheld on appeal
The U.S. Court of Appeals for the Federal Circuit once again delved into genus claims as it affirmed Gilead Sciences Inc.’s win in an inter partes review (IPR) challenge of several claims in a patent held by the University of Minnesota. Had the appellate court overturned the Patent Trial and Appeal Board’s decision, Gilead could have been on the hook for licensing fees for its hepatitis C antiviral, Sovaldi (sofosbuvir), which fell under the genus of claim 1 of the university’s ’830 patent that was filed in 2014 but claimed priority to patents filed in 2004 and 2005.
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