Respiratory Syncytial Virus Infections

None  Welcome to this week's Chutes & Ladders, our roundup of hirings, firings and retirings throughout the industry. Please send the good word—or the bad—from your shop to Max Bayer or Gabrielle Masson, and we will feature it here at the end of each week. Voyager returns to Biogen’s orbit, plucking another executive Voyager Therapeutics You can always count on Al Sandrock to have his finger on the pulse of Biogen. The 21-year vet of the neuroscience pharma has returned (metaphorically speaking) to his old haunting grounds, leaving with fresh talent. Voyager announced it was hiring Toby Ferguson, M.D., as its chief medical officer, effective March 25. Ferguson was most recently vice president and head of neuromuscular development at Biogen, where he joined in 2013. He started as a medical director and advanced to executive medical director, before taking his current position.  His claim to fame was leading the team that produced SOD1 ALS med Qalsody, which received FDA accelerated approval based on the reduction of a disease biomarker. In light of Amylyx’s recent late-stage failure, Qalsody is arguably the most significant ALS treatment advancement in recent years. Voyager is currently working on a SOD1 gene therapy that’s entering IND-enabling studies.  Before joining Biogen, Ferguson was an assistant professor of neurology at Temple University in Philadelphia. Release Pfizer names new CSO for anti-infectives research unit  Pfizer  Despite Pfizer making its oncology ambitions clear, the New York pharma does in fact have additional assets elsewhere, including anti-infectives. Much of that work centers on COVID treatment Paxlovid, with additional candidates aimed at RSV infection and complicated urinary tract infections.  Now, the company is bolstering that team, hiring Isabel Najera, Ph.D., as chief scientific officer of the anti-infective research unit. She previously was the head of research for infectious disease at Janssen, before the pharma dismantled and divested from the work altogether.  Najera cut her teeth at Roche, where she spent a total of 19 years across a number of different positions. She started in 1999 as a research scientist working on hepatitis C virology and spent the last four years there as the deputy head of discovery and head of clinical microbiology for inflammation, immunology and infectious diseases. Rigel hires ex-Sangamo CMO for the same role  Rigel Pharmaceuticals Lisa Rojkjaer, M.D., is joining Rigel as executive vice president and chief medical officer, the biotech announced this week. She joins from Sangamo where she held the same role. Rojkjaer at Sangamo for less than a year, from May 2023 to March 2024. She spent more than six-and-a-half years at two prior CMO gigs, with Viracta Therapeutics and Nordic Nanovector, respectively. She’s also spent more than six years across two stints at Novartis. Release > FibroGen has tapped Deyaa Adib, M.D., to serve as the oncology company’s SVP and chief medical officer. Before joining FibroGen, Adib was Triumvira Immunologics’ CMO and previously held roles at Rain Therapeutics, Blueprint Medicines, Baxalta, ARIAD Pharmaceuticals, Aventis, Sanofi and Astellas Pharma. Release > Jullian Jones, Ph.D., has joined MOMA Therapeutics to serve as the platform company’s chief business officer. Jones comes from Monte Rosa Therapeutics, where she also held the CBO title and oversaw the biotech’s recent partnership with Roche Pharmaceuticals. Release > Capsida Biotherapeutics has promoted Rob Murphy from his role as VP of technical operations to chief manufacturing and quality officer. Murphy joined the biotech in 2020 and helped design, build and staff Capsida’s state-of-the-art gene therapy manufacturing site. Release > Apellis Pharmaceuticals is appointing Philip Ferrone, M.D., to serve as the company’s chief medical retina adviser, effective March 18. Ferrone currently is, and will continue to be, the director of clinical research at Vitreoretinal Consultants in New York. Release > Tim Clackson, Ph.D., is taking the top spot at IDRx, replacing founding CEO and co-founder Ben Auspitz, while Brad Dahms will step on as chief financial officer and chief business officer. Clackson and Dahms both join IDRx from Theseus Pharmaceuticals, where they served as CEO and CFO, respectively. Release > GSK’s head of biologics and devices manufacturing Bill Dawson has been appointed the new chair of the Medicines Manufacturing Industry Partnership, an organization representing medicines manufacturers in the U.K. Dawson has been with GSK for nearly 8 years, and worked at Novartis before that, according to his LinkedIn. Release > Corinne Le Goff has resigned from her position as IMUNON’s president and CEO, exiting to pursue another business opportunity. Executive Chair Michael Tardugno, who served as CEO before Le Goff, will assume daily leadership responsibilities until a successor is selected. Release > VC 4BIO Capital has promoted Natalie Johnston, Ph.D., to principal, while appointing Abbas Hussain and Leszek Lisowski, Ph.D., to its advisory board. Previously, Johnston served as an investment associate for 4BIO, while Hussain most recently worked at Vifor Pharma and Lisowski helped establish two gene therapy companies: Exigen Biotherapeutics and Sendatu Therapeutics. Release > Y-mAbs Therapeutics EVP, Chief Financial Officer, Secretary and Treasurer Bo Kruse is resigning, effective as of the day a successor is appointed or July 31, 2024. Kruse has been with the company for nearly nine years, according to his LinkedIn profile. Release > Endeavor BioMedicines is bringing on two new leaders, appointing Enoch Kariuki as president and Vishaal Turakhia as chief financial officer. Kariuki most recently served as CEO of Lengo Therapeutics (acquired by Blueprint Medicines), while Turakhia was previously managing director at Piper Sandler’s healthcare investment banking group. Release > Joseph Bertelsen is joining U.K.-based biotech Nuclera as chief commercial officer. He previously worked at the Institute for Protein Innovation, a research site in Massachusetts, where he was the director of commercialization. Release

BROOKLYN, N.Y., March 14, 2024 /PRNewswire/ -- Calder Biosciences, Inc., a next-generation vaccine company, has been published in a Nature Communications article () that debuts and validates the application of Calder's '3D Vaxlock' platform technology. When applied to the Respiratory Syncytial Virus (RSV) F protein as a vaccine immunogen, Calder's 3D Vaxlock technology achieves an unprecedented 11X more potent immune response than the standard industry comparator. Application of the technology not only dramatically improves potency, but also improves shelf-life of the vaccine at refrigerated temperatures that will facilitate distribution and delivery. The 11-fold higher responses are measured in terms of antibodies generated that neutralize the virus on contact, thus preventing infection. Calder's vaccine also demonstrates improvements in the quality of immune responses elicited, since a greater proportion of the antibodies produced neutralize the virus. 2023 was an exciting year for developments in preventing RSV, given the groundbreaking achievements of GSK and Pfizer in gaining licensure of the first-ever RSV vaccines, Arexvy and Abrysvo, for use in the elderly and maternal vaccination. While these licensures have already done a great deal to bolster human health, the published data suggest that adults over 75 represent a patient population that could benefit greatly from additional potency improvements. "There remains an urgent need for vaccines that provide 75+ older adults and the frail good protection. And protecting newborn children for a longer period through maternal vaccination also remains an important goal," said Florian Schödel, MD, a member of Calder's Scientific Advisory Board. In the Nature Communications manuscript, Calder demonstrates that a high dose of their RSV vaccine achieves responses in aged, immunosenescent animals equivalent to responses in the young animal control group. Calder's 3D Vaxlock technology engineers zero-length carbon-carbon bonds between tyrosine residues in target vaccine immunogens. This technology combines structure-based design and a novel bioprocess, and the bonds are site-specific and targeted to preserve the 3D shape of a protein in the regions that elicit the best immune responses, achieving best-in-class protection. "A new stabilization technology as clean and precise as this one is exactly what's needed to unlock the full potential of protein vaccines," Calder's co-founder and CEO Chris Marshall stated to describe the potential of the technology. Unlike disulfide bonds, dityrosine bonds are irreversible, and their formation is catalyzed after the protein is fully folded in its native state. In addition to the RSV program, Calder is applying its technology to Universal Influenza and Epstein-Barr virus vaccines. "On the heels of the Covid pandemic, the benefits of vaccination for human health are incontrovertible. Our technology is going to revolutionize the vaccine space, making vaccines that are even safer and more potent," said Calder's co-founder and CSO, Mark Yondola, who is also the senior author on the paper. Calder also plans to apply its technology more generally in protein engineering, imparting thermostability as needed to additional subunit vaccines, biologics, or other targets. Contact: [email protected] SOURCE Calder Biosciences Inc.

Data published in Advanced Science and Bioengineering and Translational Medicine evaluates the efficacy of intranasal delivery of antibodies to RSV-infected neonatal lambs and SARS-CoV-2 infected hamsters DURHAM, N.C.--(BUSINESS WIRE)-- Inhalon Biopharma (Inhalon), a clinical-stage company advancing a proprietary inhaled antibody platform for treating acute respiratory infections, today announced the publication of preclinical data showcasing the advantages and efficacy of its “muco-trapping” technology in animal models of respiratory syncytial virus (RSV) and SARS-CoV-2 infections. The data, published in Advanced Science and in Bioengineering and Translational Medicine, underscore the potential therapeutic benefits from leveraging inhaled delivery of antibodies to treat a range of acute respiratory infections, including not only RSV and SARS-CoV-2 variants, but also influenza, human metapneumovirus (hMPV), and parainfluenza (PIV). “Inhalon’s approach rethinks the use of antibodies for the treatment of acute respiratory infections by delivering antibodies directly to the site of the infection,” said John Whelan, president and chief executive officer, Inhalon Biopharma. “Our studies in Advanced Science and in Bioengineering and Translational Medicine demonstrate the exceptional effectiveness of our inhaled antibody platform, which offers the potential to treat a wide array of acute respiratory infections. With the results from these studies, we are advancing candidates against RSV and all variants of SARS-CoV-2 into the clinic.” There remains a high unmet need for new outpatient treatments for acute respiratory infections despite the availability of vaccines for influenza, RSV, and COVID-19. The U.S. Centers for Disease Control and Prevention estimates that 360,000 people were hospitalized with influenza during the 2022-2023 season.1 RSV is responsible for 58,000-80,000 hospitalizations in children ages five and under, as well as 60,000-160,000 hospitalizations in older adults every year.2 While COVID-19 is harder to estimate on an annual basis, there are currently more than 15,000 hospitalizations per week in the U.S.3 The preclinical data published in Advanced Science evaluates the efficacy of treating an established RSV infection with inhaled antibodies. In the study, RSV-infected neonatal lambs received daily nebulized delivery of Mota-MT, Inhalon’s muco-trapping antibody against RSV. Treatment was delayed until three days post infection when the virus was at peak levels in the lung. Following three days of once-per-day nebulized treatment, Mota-MT reduced viral load by 10,000-fold to 100,000-fold compared to the placebo group, with most animals exhibiting no detectable virus in the respiratory tract. This directly correlated with reduced inflammation, bronchiolitis, neutrophil infiltration, and airway remodeling; the lungs of many animals treated with Mota-MT appeared no different than uninfected animals, despite the very late initiation and short duration of treatment. Inhalon has completed IND-enabling studies with a derivative of Mota-MT and is planning to start a Phase 1 study later this year. The study published in Bioengineering and Translational Medicine assesses the efficacy of a muco-trapping ACE2-(G4S)6-FC decoy that binds and neutralizes SARS-CoV-2, without risk of viral escape. The molecule has shown picomolar potencies against all strains of SARS-CoV-2 tested, including Omicron variants. In the study, hamsters that received intranasal dosing as late as two days post infection saw at least a ten-fold viral load decrease by day four. With the support of the USAMRDC, Inhalon has begun preclinical activities and manufacturing to advance this candidate into the clinic in 2025. About Inhalon Biopharma Inhalon Biopharma is a private, clinical-stage company advancing a proprietary inhaled antibody platform for treating a variety of acute respiratory infections. Inhalon Biopharma’s intellectual property includes approved U.S. and EU patents covering the composition and use of aerosolized muco-trapping antibodies. Inhalon Biopharma is supported by the Thiel Foundation’s Breakout Labs, Cambrian Growth Partners, Berkeley Catalyst Fund, JSR Life Sciences and Life Science Angels, as well as several federal grants from the NIH and USAMRDC. The muco-trapping mAb technology, Mota-MT and the ACE2-(G4S)6-FC decoy were originally developed by Prof. Sam Lai at the University of North Carolina (UNC) - Chapel Hill, and licensed exclusively by Inhalon. Centers for Disease Control and Prevention, “Burden of Flu.” Available: . Centers for Disease Control and Prevention, “Respiratory Syncytial Virtus Infection (RSV).” Available: . Centers for Disease Control and Prevention, “COVID Data Tracker.” Available: .