Altimmune宣布与FDA成功进行IND前会议

StephenW

        
10:01 PM (2 minutes ago)
        

Altimmune Announces Successful Pre-IND Meeting with FDA
Meeting on HepTcell Phase 2 program for treatment of chronic hepatitis B (HBV)

GAITHERSBURG, Md., June 10, 2019 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that it successfully completed a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding its Phase 2 trial design and manufacturing plans for HepTcell. The FDA did not object to the planned study design and patient populations, as well as plans for manufacturing and product testing, and did not recommend any additional studies in preparation for an IND submission and initiation of Phase 2 trials. A recently completed Phase 1 study in chronically infected subjects was performed in the United Kingdom and South Korea. Altimmune intends to conduct a Phase 2 study in the United States and the pre-IND meeting was held to obtain feedback from the FDA on our intended development path.

“We are pleased to have completed the pre-IND meeting with the FDA and will move forward with our plans to file the IND and initiate a Phase 2 trial of HepTcell,” said Vipin K. Garg, Ph.D., President and Chief Executive Officer of Altimmune. “We appreciate the FDA’s guidance as we endeavor to find a cure for chronic hepatitis B.”

HepTcell is an immunotherapeutic product candidate composed of nine synthetic peptides chosen from across the HBV proteome with a proprietary T-cell epitope identification method. In a Phase 1 clinical study conducted under clinical trial agreement in the United Kingdom and South Korea, three monthly injections at two dose levels of HepTcell peptides were given with and without IC31® adjuvant (Valneva) as add-on therapy to entecavir or tenofovir in patients with HBe antigen negative chronic infections. All arms were well tolerated, and both high and low peptide doses given in combination with IC31® resulted in increased cellular immune responses against HBV antigens.

Breaking immune tolerance against HBV antigens is the key to clearance of infection. This occurs naturally in the majority of acute HBV infections through a T-cell immune response. However, in chronically infected patients immune tolerance prevents the clearance of the virus and these patients can progress to cirrhosis and are at risk of developing liver cancer. Currently licensed treatments do not clear infection and require lifelong therapy to control the disease. The goal of all HBV therapeutics currently in development is to achieve functional cure by reactivating the T-cell immune response, either indirectly by further lowering the HBV antigen expression, or directly, as is the goal of HepTcell.

In the planned Phase 2 trial, Altimmune will evaluate immune responses after a 6-month treatment course of HepTcell in an expanded population of HBV infected patients. The Phase 2 trial is anticipated to start in 2020.

About Altimmune

Altimmune is a clinical-stage biopharmaceutical company focused on the development of products to stimulate robust and durable immune responses for the prevention and treatment of disease. HepTcell is a synthetic peptide immunotherapeutic candidate designed to break immune tolerance in chronic Hepatitis B infection. ALT-702, a TLR7/8 agonist conjugate, is a tumor immunostimulant product candidate that has the potential to safely elicit or improve immune responses in a variety of cancer indications. NasoVAX, our influenza vaccine candidate, has unique characteristics that stimulate multiple arms of the immune system and offers the potential to stop infection and the spread of flu, while being easier to administer through an intranasal rout. NasoShield is a next-generation intranasal anthrax vaccine candidate that is designed to provide more rapid and stable protection than the only approved anthrax vaccine. By leveraging the complementary attributes of its proprietary technology platforms, Altimmune is able to design and develop products tailored to address a wide range of disease indications including both acute and chronic infections and cancer. For more information on Altimmune, please visit the website www.altimmune.com.

StephenW

Altimmune宣布与FDA成功进行IND前会议
HepTcell第2阶段治疗慢性乙型肝炎（HBV）的会议

马里兰州GAITHERSBURG，2019年6月10日（GLOBE NEWSWIRE） -  Altimmune，Inc。（纳斯达克股票代码：ALT），一家临床阶段的生物制药公司，今天宣布成功完成了一项IND前（研究性新药）会议。美国食品和药物管理局（FDA）关于其HepTcell的2期试验设计和制造计划。 FDA不反对计划的研究设计和患者人群，以及制造和产品测试计划，并且不建议任何其他研究准备IND提交和开始第2阶段试验。最近完成的一项针对慢性感染受试者的1期研究在英国和韩国进行。 Altimmune打算在美国进行第二阶段研究，并举行IND前会议，以获得FDA对我们预期发展路径的反馈。

“我们很高兴能够完成与FDA之前的IND会议，并将推进我们提交IND的计划并启动HepTcell的2期试验，”Vipin K. Garg博士，总裁兼首席执行官说。 Altimmune执行秘书。 “我们非常感谢FDA的指导，因为我们正在努力找到治疗慢性乙型肝炎的方法。”

在根据临床试验协议进行的1期临床研究中，给予两种剂量水平的HepT细胞肽，使用和不使用IC31®佐剂（Valneva）作为恩替卡韦或替诺福韦在HBe抗原阴性慢性感染患者中的附加疗法。所有的臂都具有良好的耐受性，结合IC31®给予的高和低肽剂量导致针对HBV抗原的细胞免疫应答增加。

打破对HBV抗原的免疫耐受是清除感染的关键。这通过T细胞免疫应答在大多数急性HBV感染中自然发生。然而，在慢性感染的患者中，免疫耐受可以防止病毒清除，这些患者可以进行肝硬化并有发展为肝癌的风险。目前正在开发的所有HBV治疗剂的许可是通过再次降低HBV抗原表达来间接地通过重新激活T细胞免疫应答来实现功能性治愈，或者直接地，如HepTcell的目标那样。

在计划的2期试验中，Altimmune将评估在扩大的HBV感染患者群体中6个月的HepT细胞治疗过程后的免疫反应。第二阶段试验预计将于2020年开始。

关于Altimmune

Altimmune是一家临床阶段的生物制药公司，专注于开发产品，以刺激强大和持久的免疫反应，以预防和治疗疾病。 HepTcell是一种合成肽免疫治疗候选药物，旨在打破慢性乙型肝炎感染的免疫耐受。 ALT-702是一种TLR7 / 8激动剂结合物，是一种肿瘤免疫刺激产物候选物，具有在各种癌症适应症中安全引发或改善免疫应答的潜力。 NasoVAX，我们的流感疫苗候选者，具有刺激免疫系统多臂的独特特征，并提供阻止感染和流感传播的潜力，同时通过鼻内溃疡更容易管理。 NasoShield是下一代鼻内炭疽疫苗候选药物，旨在提供比唯一批准的炭疽疫苗更快速和稳定的保护。通过利用其专有技术平台的补充属性，Altimmune能够设计和开发适合各种疾病适应症的产品，包括急性和慢性感染以及癌症。有关Altimmune的更多信息，请访问网站www.altimmune.com。

fuke

一期最终结果没有看到。一期如果可以降低表抗，应该早就公布了。

平凡之路123

回复 fuke 的帖子

一期一般都是耐受性和药代动力学，没公布适应症的结果也是有可能的。

灵魂不屈

感谢分享。希望在人生最精华的十年攻克乙肝，死而无憾！