Mepolizumab

A single dose of APL-10456, an adjuvanted recombinant protein subunit vaccine targeting rhinovirus, induced broad cross-reactive T cell responses against all three rhinovirus species in healthy adults, according to Phase I data reported by Apollo Therapeutics. The finding addresses a major obstacle that has frustrated rhinovirus vaccine development: the roughly 180 genetically distinct strains circulating across three species. Apollo noted that rhinovirus is responsible for an estimated 25%–50% of chronic obstructive pulmonary disease (COPD) exacerbations and over 600,000 COPD-related hospitalizations annually in the US. APL-10456 addresses the dozens of distinct rhinovirus strains across three species by using a conserved protein antigen with high sequence homology across strains, combined with Th1-polarizing adjuvants designed to generate CD4+ and CD8+ T cell responses that recognize peptide sequences shared across all three species. Rather than relying on neutralizing antibodies alone, the strategy targets cellular immunity to accelerate viral clearance after infection regardless of which strain is encountered. The Phase I randomized, double-blind, placebo-controlled study enrolled 144 participants across two parts. Part A evaluated three single dose levels in adults aged 18–54 years. Apollo reported that a single dose was well-tolerated, induced seroconversion, and generated Th1-skewed rhinovirus-specific cell-mediated immunity. T cell responses were detected against peptide pools representing RV-A, RV-B, and RV-C. The most common adverse events were mild-to-moderate injection-site reactions, and no serious adverse events were reported. No quantitative immunogenicity data — such as responder rates or fold-rise in titers — were disclosed. Part B, evaluating a two-dose regimen in adults aged 55 years and older, has completed enrollment and dosing, with results expected in Q4 2026. Apollo said it plans to initiate a randomized, double-blind, placebo-controlled Phase II trial in COPD patients in the first half of 2027. Existing approved therapies for COPD — including bronchodilators, inhaled corticosteroids, and biologics such as Sanofi and Regeneron's Dupixent (dupilumab) and GSK's Nucala (mepolizumab) — address airway inflammation or selected COPD phenotypes but do not specifically target rhinovirus, while no rhinovirus vaccine or antiviral is approved. Apollo describes APL-10456 as the only vaccine in development for this indication, and the company said the Part A findings are consistent with preclinical data showing broad cross-strain immunity and rapid clearance of heterotypic rhinovirus. Apollo Therapeutics, headquartered in Cambridge, UK and Boston, operates a portfolio model built around academic partnerships with six leading research universities. APL-10456 sits alongside four other programs in clinical development. The Part B readout in older adults will be more clinically informative than the Part A data, since the intended patient population for Phase II is adults with moderate-to-severe COPD, who are predominantly older and likely to have different immune responses to vaccination than the younger healthy volunteers in Part A. Spot something wrong? Report an issue with this article

Canada's Drug Agency (CDA-AMC) affirms the value of Nucala for adults with COPD characterized by raised blood eosinophils. This recommendation is a significant step toward securing public funding for eligible patients in Canada, with provincial and territorial governments making the final decision on public coverage. MISSISSAUGA, ON , Aug. 18, 2026 /CNW/ -- GSK is pleased to announce that Nucala (mepolizumab) has received a positive reimbursement recommendation with conditions from Canada's Drug Agency (CDA-AMC). The agency recommends that Nucala be reimbursed as an add-on maintenance treatment in adult patients with COPD characterized by raised blood eosinophils, inadequately controlled by the combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA). This recommendation follows Health Canada's approval of Nucala for this indication in June 2026. "COPD significantly impacts patients' daily lives, and despite existing treatments, many continue to suffer from exacerbations," says Dr. Michelle Horn, Country Medical Director, GSK Canada . "This positive recommendation for Nucala is a crucial step towards providing a much-needed, targeted treatment option for COPD patients with raised eosinophils who are inadequately controlled with triple therapy, helping to reduce flare-ups and improve their quality of life." The CDA-AMC recommendation is based on evidence from the MATINEE, METREX, and METREO Phase III trials. The MATINEE trial demonstrated a statistically significant reduction in the annualized rate of moderate/severe exacerbations with Nucala compared to placebo in a COPD patient population with raised blood eosinophils (rate ratio [RR], of 0.79; 95% confidence interval [CI], 0.66 to 0.94). 1, 2 In a pre-defined secondary endpoint in MATINEE, the annualized rate of COPD exacerbations requiring emergency department visits and/or hospitalization was numerically reduced in the Nucala group compared with placebo but did not meet statistical significance (rate ratio [RR] of 0.65; 95% CI: 0.43, 0.96). 1 "For too long, patients with COPD have faced limited options, especially those who continue to experience debilitating exacerbations despite optimal inhaled therapies," notes Henry Roberts, Managing Director of COPD Canada . "This recommendation offers renewed hope for a more personalized approach to treatment, recognizing the specific needs of COPD patients with raised eosinophils. Access to Nucala can help these individuals better manage their condition and avoid hospitalizations." Full details on the reimbursement recommendation, including clinical criteria and conditions, can be accessed on the CDA-AMC website. About COPD COPD is a progressive and heterogeneous inflammatory lung disease that includes chronic bronchitis and/or emphysema. 3 It affects more than two million Canadians, 26% of them over 85. 4 Patients with COPD experience persistent respiratory symptoms that impact daily life such as breathlessness, cough and sputum along with progressive airflow obstruction due to chronic inflammation. 3,5 Despite inhaled triple therapy, many patients experience persistent symptoms and exacerbations. 6 Exacerbations are acute episodes of worsening COPD symptoms that can result in hospitalization and irreversible lung damage.3 Early intervention is important in preventing exacerbations and cumulative lung damage. 3 About Nucala Nucala is a monoclonal antibody that targets and binds to interleukin-5 (IL-5), one of the messenger proteins (cytokines) involved in eosinophilic inflammation. Nucala is currently approved for use in Canada across four other IL-5 mediated conditions. Please consult the Product Monograph at for complete safety information. The Product Monograph is also available by calling 1-800-387-7374. About GSK in respiratory GSK continues to build on decades of pioneering work to deliver more ambitious treatment goals, develop the next-generation standard of care and redefine the future of respiratory medicine for hundreds of millions of people with respiratory diseases. With an industry-leading respiratory portfolio and pipeline of vaccines, targeted biologics and inhaled medicines, we are focused on improving outcomes and the lives of people living with all types of asthma and COPD or rarer conditions like systemic sclerosis with interstitial lung disease. GSK is harnessing the latest science and technology with the aim of modifying underlying disease dysfunction and preventing progression. About GSK GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. Find out more at . Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the "Risk Factors" section in GSK's Annual Report on Form 20-F for 2025, and GSK's Q1 Results for 2026. References _______________________ 1 Sciurba F, et al. Mepolizumab to Prevent Exacerbations in COPD with an Eosinophilic pPenotype. N Engl J Med. Apr 2025;392:1710-1720. 2 Pavord ID, et al. Mepolizumab for Eosinophilic Chronic Obstructive Pulmonary Disease. N Engl J Med. Oct 2017;377:1613-1629. DOI: 10.1056/NEJMoa1708208 . 3 Global Initiative for Chronic Obstructive Lung Disease (GOLD). 2025 Gold Report. Available at: goldcopd.org. Last accessed May 2025. 4 What is COPD? | Canadian Lung Association 5 2023-CTS-COPD-Pharmacotherapy-Guideline-1.pdf 6 Chen S, Miravitlles M, Rhee CK, et al. Patients with Chronic Obstructive Pulmonary Disease and Evidence of Eosinophilic Inflammation Experience Exacerbations Despite Receiving Maximal Inhaled Maintenance Therapy. Int J Chron Obstruct Pulmon Dis. Sep 9, 2022 ;17:2187–2200. DOI: 10.2147/COPD.S378649. SOURCE GlaxoSmithKline Inc.