Vaxcyte, Inc.

根据GSK刚刚发布不久的第三季度财报，GSK已终止24价肺炎球菌候选疫苗AFX3772针对成人的2期临床研究，将重点开发仍在临床前阶段的30价以上的肺炎疫苗，GSK预计在2025年将其推进临床。 AFX3772是GSK在2022年斥资33亿美元（21亿美元的预付款和12亿美元的潜在开发里程碑付款 ）收购Affinivax公司获得的主要项目之一。 对于放弃的原因，GSK发言人对FIERCE解释是因为竞争加剧。今年9月，Vaxcyte公司公布了其31价肺炎疫苗VAX-31在针对50岁及以上成年人中的1/2期临床研究数据，与辉瑞Prevnar 20的“头对头”比较表现亮眼。 当初GSK考虑收购Affinivax的时候，其与辉瑞就肺炎疫苗的竞争已进行到了白热化阶段，最直接的压力来自辉瑞手中的肺炎疫苗Prevnar系列。彼时，GSK手中10价肺炎疫苗Synflorix销售额在下滑，而辉瑞的Prevnar系列疫苗却顶住了疫情和政府采购的压力，销售额逆势不衰。此外，默沙东的Vaxneuvance的获批也进一步加剧了竞争的激烈程度。 GSK之所以押注Affinivax公司的AFX3772，当时重要的原因之一是在Affinivax公布的一项2期临床研究中，不论是否接种过默沙东的Pneumovax 23，AFX3772对某些血清型的免疫反应比辉瑞公司上一代Prevnar 13更高。 虽然此后辉瑞Prevnar 20 上市削弱了AFX3772在血清型覆盖方面的优势。不过，Affinivax认为自家产品的优势不仅限于此，其多抗原呈递系统MAPS要比传统的结合疫苗技术能诱导更广泛的保护性免疫反应。Affinivax的首席科学官Hal Barron博士曾在一份声明中提到，该平台在诱导B细胞和T细胞反应方面的表现吸引了GSK。 尽管这次GSK战略终止了针对AFX3772针对成人的肺炎研究，但GSK的发言人仍表示，相信Affinivax的多抗原递送系统的潜力。AFX3772针对儿童的2期临床研究还在继续进行。 编辑 | 姚嘉 yao.jia@PharmaDJ.com  总第2234期 访问研发客网站，深度报道和每日新闻抢鲜看 www.PharmaDJ.com

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.

Sales of Pfizers new vaccine for respiratory syncytial virus were lower in the third quarter than during the same period last year, but the company pointed to signs of growing market share as reason for confidence in the shots market potential.Between July and September, Abrysvo brought Pfizer $356 million in sales globally, compared to last years total of $375 million, according to third quarter earnings Pfizer reported Tuesday. Revenue across the first nine months was higher, reaching $557 million versus the $375 million last year, because Abrysvo wasnt approved in the U.S. for older adults until the end of May last year.So far, Pfizer has trailed competitor GSK, which has been able to dominate the nascent RSV vaccine market with its shot Arexvy, despite it only winning approval weeks earlier.However, Pfizer said Abrysvos market share has increased, exceeding 50% of shipped volume for the third quarter. Abrysvos slice of vaccinations in the retail setting has also climbed for nine consecutive weeks through mid-October, currently reaching 43%, Pfizer CEO Albert Bourla said in prepared remarks.Both companies are working to expand the number of people eligible for vaccination. Last week, the Food and Drug Administration cleared Abrysvo for use in certain adults aged 18 years to 59 years old who are at higher risk of RSV-related disease. Previously it only had been available for adults 60 years or older, or for pregnant women.On a conference call Tuesday, Pfizers commercial chief Aamir Malik said the company is seeing really good momentum in maternal vaccination. Over the first four weeks of the season, Malik said, Pfizer shipped 56% more units of Abrysvo to obstetricians and gynecologists in health systems than during the same period last year.However, uptake among older adults has been disrupted somewhat by recommendations provided this summer by the Centers for Disease Control and Prevention. The agency narrowed its guidance to urge vaccination most heavily in adults over 75 years old and in those aged 60 to 74 years who are at higher risk.Company executives said the updated guidelines have affected uptake. [Abrysvo vaccinations] are at lower volumes, from a market perspective, than where they were last year,“ said Malik, on Tuesdays call. Malik cited the CDCs recommendation, as well as the timing of COVID vaccination this year.CDC advisers, who have since met again following that recommendation, also havent endorsed expanding their recommendations to adults younger than 60, or recommending previously vaccinated individuals to get another shot.Mikael Dolsten, Pfizers departing chief scientific officer, said Tuesday the company is accumulating evidence on revaccination and suggested that an additional dose might be appropriate after several years.Beyond RSV, Pfizer also talked up its next-generation pneumococcal vaccines that it eventually hopes will replace its top-selling Prevnar 20. One, which covers 25 serotypes of the bacteria that causes disease, is in Phase 2 testing. Another, covering more than 30 serotypes, is in preclinical development.Both shots would provide additional coverage against pneumococcal disease, but Pfizer has competitors. Merck & Co. recently won approval of a 21-valent shot called Capvaxive, while biotechnology company Vaxcyte impressed with early trial data on a rival product. In a note to clients, analysts at Jefferies said Pfizers 25-valent shot might have difficulty competing. '