Teva Italia SRL

Agomab Therapeutics is benefiting from Sanofi’s push to become an immunology powerhouse. The Antwerp-based biotech said Friday that the French drug giant and Invus are new investors in its $89 million Series D that arrived one year after its $100 million Series C . Pfizer and Boehringer Ingelheim have also backed Agomab. The company wasn’t seeking additional money. “The $100 million is still in the bank,” Agomab CEO Tim Knotnerus said in an interview. But after receiving inbound interest from Sanofi, the biotech’s execs discussed it with the board and then did a “very selective reach-out” to other investors. It took only a month to close the round, the CEO said. The new financing will fund an ongoing Phase 2a of Agomab’s lead therapy — an oral small molecule for a subset of Crohn’s disease patients — and another oral drug candidate already in Phase 1 for idiopathic pulmonary fibrosis. It also plans to take a MET agonistic antibody into human studies in the first half of next year for liver cirrhosis. Agomab anticipates interim data for the first 40 of 90 patients from the Phase 2a of AGMB-129 in early 2025. Investigators are testing the gut-restricted ALK5 inhibitor in patients with fibrostenosing Crohn’s disease, which impacts about half the people with the inflammatory bowel disease. It has the FDA fast track tag. “Can we indeed avoid the known cardio toxicity that is associated with ALK5?” Knotnerus said. “We believe we can because of the way our compound has been designed, so that we have high local exposure of our ALK5 asset in the gastrointestinal tract and very low systemic exposure.” In the first half of next year, the biotech also expects to have the first batch of healthy volunteer data from the Phase 1 trial in IPF for its ALK5 inhibitor that is lung-restricted, according to Knotnerus. IPF leads to difficulties with breathing and impairs multiple other functions, eventually leading to death for many patients within about five years. Boehringer and Roche each market medicines for IPF, and both were approved by the FDA 10 years ago. Many drug developers are following up with next-generation medicines. Amid a broader restructuring of its business, Sanofi has continued to bet on oncology and I&I. In recent months, it invested in several companies developing IPF medicines like Vicore Pharma and Graviton Bioscience . The company also earmarked up to $1.5 billion for the anti-TL1A race in a partnership with Teva . Agomab broke cover in 2019 with a $23 million Series A. It snagged a $74 million Series B in 2021 and bought Spanish startup Origo Biopharma later that year. The 60-employee startup also now has an office in Cambridge, MA. It added former Seagen leader David Epstein to its board this summer, and Pierre Kemula — who headed finance at CureVac when it went public — is set to start as CFO on Nov. 1.

Pfizer’s Abryso is designed to stimulate an immune response against RSV prefusion conformation (pre-F), thereby providing protection against lower respiratory tract disease caused by RSV. Image credit: Jonathan Weiss / Shutterstock. The US Food and Drug Administration (FDA) has expanded the indication for Pfizer ’s respiratory syncytial virus (RSV) vaccine Abrysvo to include adults aged 18–59 years who have chronic conditions that place them at increased risk of lower respiratory tract disease caused by the virus. The label expansion adds to the existing label for Abrysvo that allows for vaccine use in adults over 60 years of age and pregnant women (between 32 and 36 weeks of gestation). The approval comes just in time for the current RSV season in the US, which typically runs from October to April. Abrysvo generated $515m in sales in the fourth quarter of last year, as per Pfizer’s financials. While these are nowhere close to the profits Pfizer saw with products such as its Covid-19 vaccine developed with BioNTech , and the antiviral treatment Paxlovid, at their peak, with weakening demand for the Covid-19 products , Pfizer has touted Abrysvo as one of the primary revenue driver. Abrysvo’s main competitor is GSK ’s Arexvy, which is approved in the same indication . However, its use is limited to adults over 50 years of age. Arexvy raked in $1.2bn in sales last year, as per GSK’s financials. GlobalData expects Arexvy to have higher sales of $3.3bn in 2030, compared to $2.2bn of Abrysvo over the same period. GlobalData is the parent company of Pharmaceutical Technology . See Also: Ocuphire and Opus Genetics merge to develop IRD gene therapy FDA approves Alvotech and Teva’s SELARSDI for new indications The FDA approval of the indication was based on the positive data from the Phase III MONeT study (NCT05842967). The trial was divided into two substudies; substudy A, which evaluated Abrysvo in patients with chronic medical conditions, including asthma and diabetes; and substudy B , which investigated the vaccine in immunocompromised patients. Pfizer has not disclosed detailed results from the trial, stating its intention to publish these in a peer-reviewed scientific journal and present the same at a scientific conference. In August, the company reported that a single 120µg dose of the vaccine led to “strong neutralising” responses against RSV-A and RSV-B. The commonly reported treatment-associated side effects were pain at the injection site, muscle pain, joint pain and nausea. Pfizer is also evaluating Abrysvo in children aged between two and 17 years in an open-label Phase I PICASSO trial (NCT05900154). The trial enrolled 128 participants across the US, according to ClinicalTrials.gov .

The merger is set to create a company dedicated to gene therapy development for inherited retinal diseases. Credit: elenavolf/Shutterstock. Ocuphire Pharma has announced the acquisition of Opus Genetics to create a biotech company dedicated to gene therapy development for inherited retinal diseases (IRDs). The combined entity will be named Opus Genetics. Ocuphire has issued 5.2m common stock shares and 14,100 shares of its convertible preferred stock to Opus Genetics’ stockholders. The preferred shares will be convertible into common stock, pending approval at the annual meeting in April 2025. Post-merger, Ocuphire’s pre-acquisition stockholders will hold 58% of the fully diluted capitalisation of the combined company, while Opus Genetics’ stockholders will own almost 42%. See Also: FDA approves Alvotech and Teva’s SELARSDI for new indications AAO 2024: NMA reveals Vabysmo’s superior CST improvement over Eylea HD Newly combined company president Ben Yerxa stated: “With the Ocuphire team’s late-stage ophthalmic drug development and regulatory approval experience and resources, we believe we are well-positioned to accelerate our pipeline of potentially transformative gene therapies for inherited retinal diseases. “We see this transaction as a win for patients with IRDs around the world, and we look forward to efficiently progressing our combined pipeline.” The expanded pipeline of the new company includes adeno-associated virus (AAV)-based gene therapy assets for IRDs and Ocuphire’s late-stage product candidate RYZUMVI (phentolamine ophthalmic solution 0.75%), which is being assessed for presbyopia and dim light vision disturbances following keratorefractive surgery. RYZUMVI is designed to reduce pupil size by blocking alpha-1 receptors on the radial iris dilator muscles. The combined company’s expected cash runway is extended into 2026, anticipating clinical data readouts for several trials. Leerink Partners is the exclusive financial advisor to Ocuphire. Sidley Austin and Smith Anderson are serving as legal counsels to Ocuphire and Opus Genetics, respectively. In 2022, Opus Genetics signed an agreement with National Resilience for developing and manufacturing AAV vector-based gene therapies for IRD. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva . Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content. Free Whitepaper Cell and gene therapies: Pipe dream to pipeline The cell and gene industry is gaining momentum, with a new wave of therapies promising to transform the way doctors treat, and even cure, disease. In this report, Cytiva and GlobalData have collaborated to explore the rise of the cell and gene therapy industries, the current state of the market, present and future opportunities for advancement, and the challenges that lie ahead. Thank you. You will receive an email shortly. Please check your inbox to download the Whitepaper. By Cytiva Thematic By downloading this Whitepaper, you acknowledge that GlobalData may share your information with Cytiva Thematic and that your personal data will be used as described in their Privacy Policy