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生物技术行业的成功与挫折

Triumphs and a setback in the biotech sector

startupticker | 2024-05-01 | 翻译由动脉网AI生成,点击反馈

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CDR-Life received a milestone payment, Moonlake secured a new partnership and Torque launched its phase two clinical trial of topical bimiralisib for patients suffering from actinic keratosis. Addexx Therapeutics has however not achieved its primary endpoint in the phase 2 clinical trial for its lead candidate targeting epilepsy..

CDR Life获得了里程碑式的付款,Moonlake建立了新的合作伙伴关系,Torque启动了针对光化性角化病患者的局部bimiralisib的第二阶段临床试验。然而,Addexx Therapeutics尚未在针对癫痫的主要候选药物的2期临床试验中达到其主要终点。。

The successful advancement of CDR-Life Inc.’s Phase 1 study with BI 771716, its therapeutic candidate in partnership with Boehringer Ingelheim (BI) for the treatment of geographic atrophy (GA), has triggered a milestone payment to the startup. BI 771716 is an antibody fragment-based compound. Its reduced size enables optimized retinal layer penetration to the most critical target site driving GA disease pathology.

CDR Life Inc.的第一阶段研究与BI 771716的成功推进,BI 771716是其与勃林格殷格翰(BI)合作治疗地理萎缩(GA)的治疗候选药物,这引发了该初创公司的里程碑式付款。BI 771716是一种基于抗体片段的化合物。其尺寸减小,可以优化视网膜层穿透到驱动GA疾病病理学的最关键目标部位。

CDR-Life and BI announced the collaboration and licensing agreement in May 2020, followed by the selection of an antibody fragment-based therapeutic candidate in September 2021. The companies have executed all milestones to date. The latest achievement is the fourth milestone under the collaboration and licensing agreement between the two companies..

CDR Life和BI于2020年5月宣布了合作和许可协议,随后于2021年9月选择了基于抗体片段的治疗候选药物。到目前为止,这些公司已经完成了所有里程碑。最新成就是两家公司之间合作和许可协议下的第四个里程碑。。

MoonLake Immunotherapeutics signs new partnership MoonLake, a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, has signed a three-year technology partnership with Komodo Health to advance research on inflammatory skin and joint conditions. The two companies will collaborate to maximize the impact of MoonLake’s nanobody-based therapy in hidradenitis suppurativa (HS) and active psoriatic arthritis (PsA), two underdiagnosed diseases with significant unmet patient needs..

MoonLake Immunotherapeutics签署了新的合作伙伴关系MoonLake是一家临床阶段的生物技术公司,专注于为炎症性疾病创造新的治疗方法,已与Komodo Health签署了为期三年的技术合作伙伴关系,以推进炎症性皮肤和关节疾病的研究。两家公司将合作,最大限度地发挥MoonLake基于纳米抗体的疗法对化脓性汗腺炎(HS)和活动性银屑病关节炎(PsA)的影响,这两种疾病诊断不足,患者需求严重未得到满足。。

MoonLake will utilize Komodo’s Healthcare Map and platform technologies to enable data-driven decision-making across its clinical operations, medical, marketing, and market access teams. Komodo’s data and technology applications will support MoonLake’s in-depth market research, clinical trial site selection, go-to-market strategies, and patient journey mapping – all aimed at accelerating the development of new treatment options and improving outcomes for patients with inflammatory skin and joint diseases..

MoonLake将利用Komodo的医疗地图和平台技术,在其临床运营、医疗、营销和市场准入团队中实现数据驱动的决策。Komodo的数据和技术应用将支持MoonLake的深入市场研究、临床试验地点选择、上市策略和患者旅程规划,所有这些都旨在加速开发新的治疗方案,改善炎症性皮肤和关节疾病患者的预后。。

Torqur enters phase 2 Clinical trialsTorqur AG, which is dedicated to advancing treatments for oncology and dermatology, has dosed the first patient in its Phase 2 clinical trial of topical bimiralisib, a dual PI3K and mTOR inhibitor. The Phase 2 study aims to assess the efficacy and safety of topically administered bimiralisib gel in 40 patients diagnosed with actinic keratosis lesions on the face, scalp, and/or back of hands.

Torqur进入2期临床试验Torqur AG致力于推进肿瘤学和皮肤病学的治疗,在其局部bimiralisib(一种双重PI3K和mTOR抑制剂)的2期临床试验中为第一名患者服用了药物。这项2期研究旨在评估40例被诊断患有面部,头皮和/或手背光化性角化病病变的患者局部使用比米拉西布凝胶的疗效和安全性。

Actinic keratosis (AK) is a common pre-cancerous condition that develops on sun-damaged skin, with potential progression to invasive cutaneous squamous cell carcinoma. This multi-center, randomized, open-label study builds upon promising results from earlier preclinical and Phase 1 studies. This milestone represents a significant advancement in addressing the unmet medical needs of patients suffering from actinic keratosis..

光化性角化病(AK)是一种常见的癌前疾病,在阳光受损的皮肤上发展,可能发展为浸润性皮肤鳞状细胞癌。这项多中心,随机,开放标签的研究建立在早期临床前和第一阶段研究的有希望的结果的基础上。这一里程碑标志着在解决光化性角化病患者未满足的医疗需求方面取得了重大进展。。

Far from the desired endpointAddex Therapeutics’s lead drug candidate, ADX71149 (mGlu2 positive allosteric modulator or PAM), developed in collaboration with Janssen Pharmaceuticals Inc., is a selective metabotropic glutamate subtype 2 (mGlu2) receptor positive allosteric modulator (PAM). Glutamate is the primary excitatory neurotransmitter in the brain and plays a key role in the initiation and spread of seizures.

与Janssen Pharmaceuticals Inc.合作开发的ADX71149(mGlu2阳性变构调节剂或PAM)远远不是所需的endpointAddex Therapeutics的主要候选药物,它是一种选择性代谢型谷氨酸亚型2(mGlu2)受体阳性变构调节剂(PAM)。谷氨酸是大脑中主要的兴奋性神经递质,在癫痫发作的发生和传播中起着关键作用。

When activated, the mGlu2 receptor decreases the release of glutamate and, consequently, helps to maintain neurotransmitter balance. In the presence of agonist-induced activation, positive allosteric modulation of mGlu2 receptors could result in the normalization of the excessive glutamate release seen during a seizure..

激活后,mGlu2受体会减少谷氨酸的释放,从而有助于维持神经递质的平衡。在存在激动剂诱导的激活的情况下,mGlu2受体的正变构调节可能导致癫痫发作期间过量谷氨酸释放的正常化。。

The phase 2 study evaluating adjunctive ADX71149 (JNJ-40411813) administration in patients with focal onset seizures with suboptimal response to levetiracetam or brivaracetam did not achieve statistical significance for the primary endpoint of time for patients to reach baseline seizure count when ADX71149 was added to standard of care.

当ADX71149被添加到标准护理中时,评估对左乙拉西坦或brivaracetam反应不佳的局灶性发作性癫痫患者辅助ADX71149(JNJ-40411813)给药的2期研究对于患者达到基线癫痫发作计数的主要时间终点没有统计学意义。

The data were reported from a total of 110 evaluable patients, who each received either 50 mg or 100 mg of ADX71149 twice daily (100 mg or 200mg twice daily, respectively, for patients receiving CYP3A4 inducing anti-seizure medication) in addition to their standard dose of levetiracetam or brivaracetam and up to three other anti-seizure drugs.

这些数据来自总共110名可评估的患者,除了标准剂量的左乙拉西坦或布利伐拉西坦以及多达三种其他抗癫痫药物外,他们每人每天两次接受50 mg或100 mg ADX71149(对于接受CYP3A4诱导的抗癫痫药物的患者,分别每天两次100 mg或200mg)。

Adjunctive administration of ADX71149 was safe and well tolerated.(Press release/RAN).

ADX71149的辅助给药是安全且耐受性良好的。(新闻稿/运行)。

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