GSK Plc

GSK is setting aside a mid-stage 24-valent pneumococcal vaccine program for adults to instead focus on a preclinical option that covers 30-plus valents, the company announced Wednesday alongside its third-quarter earnings. The decision reflects “increased competition” in the pneumococcal space, a GSK spokesperson told Endpoints News. A 30-valent product for adults would put GSK in rivalry with Vaxcyte’s 31-valent candidate, which read out positive Phase 1/2 results last month. Vaxcyte said at the time that it plans to launch a Phase 3 study in mid-2025. Pfizer, which has also been a fierce competitor in the pneumococcal space, said earlier this week that it has a preclinical 30-plus-valent vaccine in the works. GSK expects to take its 30-plus candidate to the clinic next year, CSO Tony Wood said during a call with investors. The company is still developing a 24-valent candidate for use in children. Elsewhere, GSK culled three other Phase 2 programs, including an anti-CCL17 antibody for osteoarthritis pain, dubbed GSK3858279, and a gonorrhea candidate, called GSK4348413. The spokesperson said an interim Phase 2 analysis for the gonorrhea asset in patients at high risk of infection “did not meet our pre-defined efficacy criteria.” The spokesperson added that there were no safety concerns. The UK pharma also discontinued a Phase 2 program for Herpes simplex virus, GSK3943104, which “did not meet the study’s primary efficacy objective” in the Phase 2 portion of a Phase 1/2 trial. That decision was previously announced in September.

LONDON, UK I October 29, 2024 I GSK plc (LSE/NYSE: GSK) and Chimagen Biosciences (Chimagen), a privately held biotechnology company, today announced an agreement for GSK to acquire CMG1A46, a clinical-stage dual CD19 and CD20-targeted T cell-engager (TCE), from Chimagen for $300 million upfront. GSK plans to develop and commercialise CMG1A46 with a focus on B cell-driven autoimmune diseases, such as systemic lupus erythematosus (SLE) and lupus nephritis (LN), with potential to expand into related autoimmune diseases. For over a decade, GSK has been a pioneer in the treatment of lupus. This agreement underscores the importance of novel therapeutic approaches to address the heterogeneity of lupus manifestations and the continued burden, particularly in patients who suffer from severe disease and are refractory to current standard of care. 1 Tony Wood, Chief Scientific Officer, GSK, said: “Through our work in systemic lupus erythematosus and lupus nephritis, we increasingly understand the underlying drivers of B cell-driven diseases. As a novel therapeutic option directed at deep B cell depletion, CMG1A46 offers exciting potential which we are pleased to take forward to address unmet need in lupus and related autoimmune conditions.” CD20 is an established target in the treatment of autoimmune diseases and there is growing clinical evidence that CD19 shows promise as a differentiated therapeutic approach given its presence on more B cell types. 2 In preclinical studies, CMG1A46, designed to target both CD19 and CD20, has shown rapid, deep B cell depletion both in the bloodstream and in tissues which could lead to more durable responses in patients. Zhenhao Zhou, Chief Executive Officer, Chimagen, said: “We are excited by the potential of CMG1A46 to improve the lives of patients suffering from autoimmune conditions and grateful to have GSK accelerate that vision. This agreement provides further validation of our proprietary T cell-engager platform, and we are eager to continue our mission of developing novel multi-specific antibody therapeutics.” CMG1A46 is currently in phase I clinical trials in leukaemia and lymphoma in both the US and China. GSK aims to begin a phase I trial in lupus in 2025. Terms of the agreement Under the terms of this agreement, GSK will pay $300 million upfront to acquire full global rights to CMG1A46. In addition, Chimagen will be eligible to receive success-based development and commercial milestone payments for CMG1A46 totalling $550 million. This agreement is subject to customary conditions, including applicable regulatory agency clearances under the Hart-Scott-Rodino Act in the US. About CMG1A46 CMG1A46, a dual CD19 and CD20-targeted T cell-engager (TCE), is an IgG-like molecule with high affinity for CD19 and CD20 positive B cells and low affinity for CD3, which could lower toxicities typically associated with TCEs. About Chimagen Biosciences Chimagen Biosciences is a clinical-stage biotechnology company focused on the discovery and development of novel multi-specific T cell-engagers and NK cell-engagers generated by proprietary antibody engineering platforms. Its mission is to advance breakthrough therapies that improve the lives of patients with cancer and autoimmune diseases. For more information, please visit www.chimagen.com. 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 gsk.com. References SOURCE: GlaxoSmithKline

Competition is heating up in the RSV space, despite a lukewarm quarter for vaccine uptake. Pfizer beat GSK’s Arexvy for the first time in the third quarter, as Arexvy sales dipped 72% from the year prior. GSK attributed the slide to “changes in ACIP guidelines, prioritization of Covid-19 vaccinations in the quarter, lower seasonal infections and a tough comparator following launch stocking last year.” Despite a strong launch, Arexvy generated just £188 million in Q3 sales, or about $244 million, compared to $356 million for Pfizer’s Abrysvo. GSK’s stock $GSK was down nearly 4% early Wednesday morning. Nonetheless, CEO Emma Walmsley touted GSK’s “very strong market share.” The company reported on Wednesday in its third-quarter earnings that Arexvy maintains about two-thirds of retail market share year-to-date. RSV vaccine uptake this year has been sluggish overall , with Jefferies analysts reporting earlier this month that just 900,000 prescriptions have been issued compared to 1.5 million at this time last year. Moderna will report the first sales figures for its rival mResvia next week. GSK lowered its overall vaccine guidance for the second time this year, now anticipating vaccine sales to decrease by a low single-digit percentage. Sales for its shingles vaccine Shingrix were also down 7% last quarter due to lower demand in the US. Walmsley told reporters that she remains “very confident” in Arexvy’s growth prospects, even with “some pressure short-term.” The company faced a setback in June, when the CDC’s Advisory Committee on Immunization Practices declined to recommend vaccination for people aged 50 to 59, a key group where GSK hopes to expand. “We are truly in the early days of this vaccine,” Walmsley said. “We are in the foothills of geographic expansion. Eighty percent of the consumers for whom ACIP do recommend a vaccine still haven’t yet been vaccinated, so there’s more room for penetration.”