Retrospective Data Collection Based on Patient Records and Questionaire Based Data of Therapy Results of Allergen-specific Immunotherapy With Pollinex Quattro With Tree and/or Gras Pollen Extracts and Their Mixtures

Primary goal of this non-interventional study is to evaluate the change in level of allergen-specific IgE (EAST class) after allergen-specific immunotherapy with Pollinex Quattro with tree and/or grass pollen extracts and their mixtures under medial routine at adults with tree- and/or grass-medicated pollinosis.

开始日期2020-04-22

申办/合作机构

Allergy Therapeutics Plc

NCT04104828 / CompletedN/AIIT

Comparison of Innate Immune Responses Induced by Allergy Immunotherapy (AIT) With Different Adjuvants

The primary objective of the pilot study is to compare inflammatory responses in blood sera from patients receiving first allergen immunotherapy (AIT) with aluminium (Alum), microcrystalline tyrosine (MCT), or a combination of MCT and monophosphoryl lipid A (MPLA) as adjuvants. The AIT products are containing allergen extracts of grass and tree pollen). Blood is collected before as wells as one day, seven days, and 6-7 weeks after first AIT, and the blood is analysed for content of inflammatory proteins and antibodies.

开始日期2019-11-05

申办/合作机构

University of Zurich

EUCTR2017-000333-31-PL / Not yet recruiting临床2期

A multi-centre, randomised, double blind, placebo controlled study to determine the optimal effective and safe dose of Pollinex Quattro Grass 1.0 mL (Allergy Therapeutics, (UK) Ltd.) for the treatment of patients with seasonal allergic rhinoconjunctivitis due to grass pollen. - Short Title: A dose-response study of Pollinex Quattro Grass 1.0 mL

开始日期2017-08-27

申办/合作机构

Allergy Therapeutics (UK) Ltd.

100 项与注射用MPL过敏疫苗(Allergy Therapeutics Plc) 相关的临床结果

登录后查看更多信息

100 项与注射用MPL过敏疫苗(Allergy Therapeutics Plc) 相关的转化医学

登录后查看更多信息

100 项与注射用MPL过敏疫苗(Allergy Therapeutics Plc) 相关的专利（医药）

登录后查看更多信息

项与注射用MPL过敏疫苗(Allergy Therapeutics Plc) 相关的文献（医药）

2024-02-01·Clinical & Experimental Allergy

Peripheral blood mononuclear cell transcriptome profile in a clinical trial with subcutaneous, grass pollen allergoid immunotherapy

Article

作者: Skinner, Murray ; Layhadi, Janice ; Shamji, Mohamed ; Armfield, Oliver ; Lis, Katarzyna ; Starchenka, Sviatlana ; Oluwayi, Kemi ; Cadavez, Lisa ; Rusyn, Olesya ; Heath, Matthew ; De Kam, Pieter-Jan

AbstractIntroductionAllergen‐specific immunotherapy (AIT) is the only disease‐modifying treatment in allergic airway diseases. Underlying immunological mechanisms and candidate biomarkers, which may be translated into predictive/surrogate measures of clinical efficacy, remain an active area of research. The aim of this study was to evaluate Pollinex Quattro (PQ) Grass AIT induced immunomodulatory mechanisms, based on transcriptome profiling of peripheral blood mononuclear cells.Methods119 subjects with grass pollen induced seasonal allergic rhinitis (SAR) were randomized in a 2:2:1:1 ratio to receive a cumulative dose of PQ Grass as a conventional or extended pre‐seasonal regimen, placebo, or placebo with MicroCrystalline Tyrosine. Gene expression analysis was an exploratory endpoint evaluated in a subgroup of 30 subjects randomly selected from the four treatment arms. Samples were collected at three time points: screening (baseline), before the start of the grass pollen season and at the end of the season. This study was funded by the manufacturer of PQ.ResultsTranscriptome analysis demonstrated that the most significant changes in gene expression, for both treatment regimens, were at the end of the grass pollen season, with the main Th1 candidate molecules (IL‐12A, IFNγ) upregulated and Th2 signature cytokines downregulated (IL‐4, IL‐13, IL‐9) (p < .05). Canonical pathways analysis demonstrated Th1, Th2, Th17 and IL‐17 as the most significantly enriched pathways based on absolute value of activation z‐score (IzI score ≥ 2, p < .05). Upstream regulator analysis showed pronounced inhibition of pro‐inflammatory allergic molecules IgE, IL‐17A, IL‐17F, IL‐25 (IL‐17E) (IzI score ≥ 2, FDR < 0.05) and activation of pro‐tolerogenic molecules IL‐12A, IL‐27, IL‐35 (EBI3) at the end of the grass pollen season.ConclusionPeripheral blood mononuclear cells transcriptome profile showed an inhibition of Th2, Th17 pro‐inflammatory allergic responses and immune deviation towards Th1 responses. PQ Grass extended regimen exhibited a superior mechanistic efficacy profile in comparison with PQ conventional regimen.

2020-12-01·World Allergy Organization Journal3区 · 医学

Effectiveness and safety of a glutaraldehyde-modified, L-tyrosine-adsorbed and monophosphoryl lipid A-Adjuvanted allergen immunotherapy in patients with allergic asthma sensitized to olive pollen: A retrospective, controlled real-world study

3区 · 医学

ArticleOA

作者: Pineda, Rafael ; Escudero, Carmelo ; Rojas, Maria José ; Seoane-Rodríguez, Marta ; Florido-López, José Fernando ; Herrero-Lifona, Leticia ; Anton-Girones, Mónica ; Andreu-Balaguer, Carmen ; Hernández, Mercedes ; Torrecillas-Toro, Miguel ; Brugaletta, Dorimar ; Lara, Maria Ángeles ; López-Caballero, Julián ; Navarro-Seisdedos, Luis Ángel ; Macías, Jesús

BACKGROUNDAllergy to olive pollen is one of the primary causes of allergic asthma in Spain. Even though allergen immunotherapy (AIT) has shown clinical benefits in patients sensitized to different allergens, studies in asthmatic patients sensitized to olive pollen are insufficient.OBJECTIVETo assess the effectiveness and safety of an ultra-short course of AIT with an L-tyrosine-adsorbed and monophosphoryl lipid A-adjuvanted olive pollen and olive/grass pollen extract (Pollinex Quattro®) in patients with allergic asthma in the real-world setting.METHODSRetrospective, controlled study including patients with asthma, with and without allergic rhinitis, caused by sensitization to olive pollen from 11 centers in Spain. Patients received out-of-season (October-March) treatment with AIT in addition to their pharmacological treatment (active group) or pharmacological treatment (control group). Effectiveness variables, including unscheduled visits to the healthcare center, emergency room admissions, symptoms of asthma and rhinitis (following GEMA and ARIA classifications, respectively), and use of medication to treat asthma and rhinitis during the subsequent pollen season were compared between treatment groups.RESULTSOf 131 study patients, 42 were treated with their usual asthma medication (control group) and 89 were treated with AIT (active group), either Pollinex Quattro® 100% olive pollen (n = 43, 48.3%) or 50% olive pollen/50% grass pollen (n = 46, 51.7%). Patients' demographic and clinical characteristics were similar between groups. The mean (SD) number of unscheduled visits to a healthcare center and emergency room admissions due to allergy symptoms was 2.19 (1.40) and 0.43 (0.63) in the control group, and 1.09 (1.25) and 0.11 (0.51) in the active group (P = 0.001 and P = 0.006, respectively). Severity and control of asthma symptoms remained unchanged (P = 0.347 and P = 0.179, respectively), rhinitis type improved (P = 0.025), and severity remained unchanged in the active compared to the control group. The use of short-acting beta-agonists and inhaled corticosteroids to treat asthma symptoms decreased in the active vs. the control group (P = 0.001 and P = 0.031, respectively). Twelve (13.5%) and two (2.2%) patients in the active group experienced local adverse reactions (edema, swelling, erythema, hives, pruritus, and heat), and systemic adverse reactions (hypertensive crisis and low-grade fever) to AIT, respectively; none was serious.CONCLUSIONAIT with Pollinex Quattro® specific for olive pollen and olive/grass pollens resulted in reduced visits to the healthcare center and emergency room and the use of asthma medication during the pollen season, indicating that this treatment was safe and effective in treating asthma in patients sensitized to these pollens.

2019-11-01·World Allergy Organization Journal3区 · 医学

Strong dose response after immunotherapy with PQ grass using conjunctival provocation testing

3区 · 医学

ArticleOA

作者: Kuna, P ; Aberer, W ; Klimek, L ; Kramer, M F ; de Kam, P J ; Wade, A ; Gunawardena, K ; Zielen, S ; Raab, J ; Lee, D ; Wessiepe, D ; Lassmann, S ; Higenbottam, T ; Pfaar, O ; Kluehr, K ; Heath, M D ; Skinner, M A

BACKGROUNDPollinex Quattro Grass (PQ Grass) is an effective, well-tolerated, short pre-seasonal subcutaneous immunotherapy to treat seasonal allergic rhinoconjunctivitis (SAR) due to grass pollen. In this Phase II study, 4 cumulative doses of PQ Grass and placebo were evaluated to determine its optimal cumulative dose.METHODSPatients with grass pollen-induced SAR were randomised to either a cumulative dose of PQ Grass (5100, 14400, 27600 and 35600 SU) or placebo, administered as 6 weekly subcutaneous injections over 31-41 days (EudraCT number 2017-000333-31). Standardized conjunctival provocation tests (CPT) using grass pollen allergen extract were performed at screening, baseline and post-treatment to determine the total symptom score (TSS) assessed approximately 4 weeks after dosing. Three models were pre-defined (Emax, logistic, and linear in log-dose model) to evaluate a dose response relationship.RESULTSIn total, 95.5% of the 447 randomized patients received all 6 injections. A highly statistically significant (p < 0.0001), monotonic dose response was observed for all three pre-specified models. All treatment groups showed a statistically significant decrease from baseline in TSS compared to placebo, with the largest decrease observed after 27600 SU (p < 0.0001). The full course of 6 injections was completed by 95.5% of patients. Treatment-emergent adverse events were similar across PQ Grass groups, and mostly mild and transient in nature.CONCLUSIONSPQ Grass demonstrated a strong curvilinear dose response in TSS following CPT without compromising its safety profile.

项与注射用MPL过敏疫苗(Allergy Therapeutics Plc) 相关的新闻（医药）

2022-12-22

·生物探索

不必每天用药，提前打六针就能让你不再草花粉过敏！Allergy Therapeutics开启关键III期给药！

慢性鼻炎患者中，近一半为过敏性鼻炎，其中又有不少属于花粉过敏。春天对于他们来说，不是可以放松身心的踏青出游，而是避之不及的花粉、草种带来的打喷嚏、流鼻涕、眼睛痒等摆脱不掉的烦恼。好在，市面上已经有许多效果不错的抗过敏药物可以缓解上述症状，比如最常用的口服或鼻喷剂型的抗组胺类药物，可治疗发痒、打喷嚏、流鼻涕，但对于鼻塞效果有限。抗组胺类药物可分为三代：第一代如苯海拉明、扑尔敏、异丙嗪等，价格低廉但副作用较大；第二代如氯雷他定、西替利嗪；第三代如左旋西替利嗪、地氯雷他定等，药效较好，副作用少，但价格稍贵。此外还可口服白三烯受体拮抗剂治疗，与口服抗组胺药联合使用，效果更显著；用糖皮质激素治疗，可直接在患处用药，持续控制炎症反应，遵医嘱使用时副作用较低；可口服或鼻用的解充血药物则能快速疏通鼻塞，如麻黄碱滴鼻剂，但长期使用会有副作用；鼻腔冲洗治疗则是一种安全、方便的辅助疗法，能够清除鼻内过敏原和炎症分泌物，减轻鼻粘膜水肿。除此之外，还有一种免疫疗法，即通过皮下注射或舌下含服，反复接触引起过敏的过敏原以提高患者机体对过敏原的耐受性，但需要长达三至五年的规律治疗，是唯一有可能长期摆脱部分过敏原引起的过敏的办法。Allergy Therapeutics启动关键G306 Grass MATA MPL III 期试验 2022年12月8日，专门从事过敏症诊断和治疗的英国商业生物技术公司Allergy Therapeutics宣布，在其关于短程皮下过敏原特异性免疫疗法（Subcutaneous allergen-specific immunotherapy，SCIT）候选药物Grass MATA MPL的关键性III期G306试验中，已完成第一位受试者的给药，以评估该候选药物的有效性和安全性。该药物用于治疗由草花粉引起的季节性过敏性鼻炎和/或鼻结膜炎。Grass MATA MPL由微晶酪氨酸吸附的过敏原和新型佐剂单磷酰脂质 A（Monophosphoryl-lipid A，(MPL）结合形成。该技术只需要患者在过敏季节之前接受六次注射即可得到保护。根据先前公布的探索性实地研究G309的主要结果，两个积极治疗组（治疗分别持续6周和14周）与安慰剂组的“花粉高峰季节的综合症状药物评分”之间存在统计学显著差异，为G306的顺利展开提供了有力的支撑。G306是一项多中心、随机、平行组、双盲、安慰剂对照的临床试验，将在美国和欧洲大约120个临床试验地点进行，将招募约1200名患者，将在13周内完成患者的六次注射，预计在2023年第四季度进行数据读出。Allergy Therapeutics的最终目的很明确，就是要获得欧洲和美国的批准，包括在欧洲扩大处方范围，以及在美国成为第一个短程、皮下、无铝的草过敏疗法。管理层预计Grass MATA MPL在美国的最高销售额将达到 300-400亿美元，有望对Allergy Therapeutics产生变革性影响。不过，该Allergy Therapeutics在草粉花粉过敏疗法的开发上并非一帆风顺。2007年，该公司旗下Pollinex Quattro草粉花粉过敏药物因患者使用后出现麻木和虚弱等症状，遭到FDA叫停整整五年。2009年，该公司还面临巨额债务和现金流断裂的双重危机。但即便中间启动了转型计划，Allergy Therapeutics仍然把重点放在Pollinex Quattro 平台上，据统计，大约30%的欧洲人和25%的美国人对花草粉过敏。功夫不负有心人，2018年5月，其开发长期停滞不前的草花粉过敏候选药物在中期试验中显示出“非常显著”的剂量反应，公司股价也因此大幅上涨。然而，在2019年3月，其桦树花粉过敏产品III期 B301 试验未能达到其主要目标，公司股价在消息发布当天下跌约43%。Allergy Therapeutics的另一个研发重点是基于新型病毒样颗粒（virus-like particle，VLP）的短程花生过敏疫苗候选VLP Peanut，在今年1月26日获得了FDA的IND申请，目前I期PROTECT试验的受试者已经过筛选，预计2023年公布数据。花生过敏是最常见的过敏食物之一，症状可从轻微到危及生命。据估计，全球花生过敏市场规模高达80亿美元。图1 Allergy Therapeutics产品管线（图源：Allergy Therapeutics官网）Allergy Therapeutics 首席执行官 Manuel Llobet表示：“关键性III期G306试验的启动标志着我们正在尽最大的努力将这一创新疗法推广给美国和欧洲数百万受草过敏影响的患者。探索性实地研究G309的结果鼓舞着我们继续推动这一疗法进步。VLP Peanut PROTECT试验的启动则是一个重要的里程碑，不仅证明了Allergy Therapeutics的努力和实力，更有望改变我们以往治疗和对待过敏的方式。”图2 Allergy Therapeutics 首席执行官 Manuel Llobet（图源：Allergy Therapeutics官网）撰文|风立宵排版|风立宵End参考资料：[1]https://www.labiotech.eu/trends-news/allergy-therapeutics-peanut-grass-pollen-allergy-trials/[2]https://www.trinitydelta.org/research-notes/g309-exploratory-grass-trial-on-course-for-h221-read-out/[3]https://www.pmlive.com/pharma_news/positive_mid-stage_trial_gives_allergys_investors_some_welcome_relief_1236309?SQ_DESIGN_NAME=2#[4]https://www.pmlive.com/pharma_news/allergy_tx_hit_hard_as_birch_pollen_product_stumbles_1281861[5]https://www.biospace.com/article/releases/allergy-therapeutics-announces-fda-clearance-of-ind-application-for-novel-peanut-allergy-vaccine-candidate-vlp-peanut/ 本文系生物探索原创，欢迎个人转发分享。其他任何媒体、网站如需转载，须在正文前注明来源生物探索。往期精选围观到2045年男性精子数量将“归零”？避免生育力危机很关键热文 mRNA疫苗下半场： Moderna已转向癌症治疗，临床降低44%复发和死亡风险热文世界首例！碱基编辑改造CAR-T细胞，成功杀死体内癌变T细胞！热文开创多个第一，总缓解率100%！新CAR-T疗法获FDA授予两项认定，患者连续6个月无癌热文点击“阅读原文”，了解更多~

免疫疗法临床3期临床结果

2022-07-08

·PRNewswire

Rational Vaccines Herpes Simplex Type 2 (HSV-2) Therapeutic Vaccine Candidate Demonstrates Efficacy in a Therapeutic Animal Study

NIH-funded study shows RVX201 exhibits robust protection against recurrent HSV-2 disease in guinea pig model WOBURN, Mass. and OXFORD, England, July 8, 2022 /PRNewswire/ -- Rational Vaccines, a company focused on revolutionizing the treatment and prevention of herpes to eradicate the disease, today announced findings from an National Institutes of Health (NIH)-funded pilot study of RVX201, the Company's lead therapeutic vaccine candidate for herpes simplex virus type 2 (HSV-2). Results showed that treatment with RVX201 led to a reduction in recurrent genital lesions when compared to gD2-alum/MPL vaccine or placebo in vivo. In addition, RVX201 appears to generate a robust cellular immune response equivalent to that elicited by wild-type HSV-2 on Day 7 post-infection. Results showed that in comparison to no vaccine, animals that received RVX201 had the number of symptomatic days reduced by 45 percent while those that received gD2-alum/MPL vaccine only had a 24 percent reduction in symptomatic days. "HSV is one of the most prevalent sexually transmitted infections. It is a cause of severe neonatal infections and a leading infectious cause of blindness in the Western world," said Konstantin G. Kousoulas, Ph.D., professor of virology and biotechnology, Louisiana State University (LSU) School of Veterinary Medicine, and vice president of scientific affairs at Rational Vaccines. "This therapeutic study shows that RVX201 confers significant protection from HSV-2 reactivation in latently infected animals. Specifically, results indicate significant reduction in viral titers and lesion scores in genital tissues of immunized guinea pigs in comparison to animals vaccinated with purified glycoprotein D (gD) with adjuvant. Additional prophylactic studies in mice have shown drastic protection against lethal HSV-2 genital challenge. Overall, these results as well as available limited human studies indicate that RVX201 can be an effective prophylactic and therapeutic vaccine approach against HSV-2/HSV-1 infections." "In this pilot study we demonstrate that RVx's lead candidate, RVX201, performs significantly better than gD-2 when delivered via the same route" said Dr. Edward Gershburg, Chief Technology Officer for Rational Vaccines. "RVX201 reduced recurrences and number of symptomatic days by almost two-fold when compared to placebo. These results are consistent with our earlier observations, and warrant further testing of this candidate in humans." About Herpes Simplex Virus (HSV) The herpes simplex virus (HSV), commonly referred to as herpes, is categorized into two types: herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2). HSV-1 is the primary cause of oral herpes but can also cause genital herpes. HSV-2 is the primary cause of genital herpes. According to a 2020 report by the World Health Organization (WHO), herpes infects billions globally – about a half a billion people worldwide are living with genital herpes, and several billion have an oral herpes infection. Both HSV-1 and HSV-2 infections are lifelong. While most herpes infections are asymptomatic, a significant number of people experience a range of symptoms that vary in frequency and severity. The most common symptoms for both types of herpes are painful blisters or ulcers. In addition, many patients experience debilitating neuralgia, skin splits, fissures, minor abrasions, erythema, fever, chills, and myalgias. Both viruses are most contagious during a symptomatic outbreak, but they can still be transmitted in the absence of symptoms. There is no cure for herpes. There are no approved vaccines or immunotherapies or sufficiently reliable diagnostics currently available1. Antiviral medications developed in the 1970s can help to reduce the severity and frequency of symptoms but cannot cure the infection. About Rational Vaccines Rational Vaccines is revolutionizing the treatment, prevention, and diagnosis of herpes and herpes-related diseases with its rationally engineered, live-attenuated viral immunotherapeutic and prophylactic vaccine candidates. Led by a team of world-renowned scientists, the Company is headquartered in Woburn, MA with locations in Miami, FL and Oxford, UK. For more information, please visit 1https:/ and Herpes - STI Treatment Guidelines (cdc.gov) 2 SOURCE Rational Vaccines

疫苗

100 项与注射用MPL过敏疫苗(Allergy Therapeutics Plc) 相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
-	-	V01AA02	-

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
变应性结膜炎	德国	-	2016-04-01
季节性过敏性鼻炎	德国	-	2016-04-01

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
季节性过敏性鼻炎	药物发现	美国	Allergy Therapeutics Plc	2017-01-16
速发型超敏反应	药物发现	加拿大	Allergy Therapeutics Plc	2007-03-01