The First LANCL2-based therapeutic for influenza

首个基于LANCL2的流感治疗药物 生物治疗公司(BTI)是一家临床阶段的生物技术公司，它协同结合了 先进的计算建模和平移实验加速了小说的发展 精准医疗和健康产品。这一阶段的SBIR应用出现在大量的临床前 数据显示兰硫氨酸合成酶C-样2(LANCL2)激动剂作为宿主疗法的潜力 病毒性疾病。 我们的产品：新型先导LANCL2激动剂配体BT-63选择性地与LANCL2结合，具有广阔的应用前景 对甲型流感病毒(IAV)小鼠模型的治疗效果。在第一阶段，我们将重点关注流感病毒 研究LANCL2作为具有广泛抗病毒作用的治疗靶点的作用。 背景：由新出现和重新出现的病毒引起的传染病是一个重要的公共卫生问题 挑战。尽管有抗病毒药物和疫苗，流感仍然是一个重大的公共卫生威胁。这个 缺乏有效的通用疫苗和抗病毒药物，加上抗病毒耐药性的上升，证明有理由 开发基于宿主的新型抗病毒药物的必要性。BTI将LANCL2确定为病毒感染的新靶点。 LANCL2激动剂在保护病毒诱导的同时下调病毒的进入和复制 细胞因子风暴、死亡率、病理学和疾病。 此SBIR第1阶段应用的具体目标是： 目的1.验证LANCL2作为治疗流感感染的新宿主靶点：我们将优化剂量 和治疗窗，验证LANCL2作为BT-63的分子靶点。 目的2：评估Bt-63的抗病毒机制和谱：我们将检验Bt-63的假设 通过调节宿主细胞的代谢反应发挥广谱的抗病毒作用。 市长预期结果：BT-63提供至少50%的死亡率保护，将 促炎症标志物IL-6和肿瘤坏死因子α的表达，其机制是LANCL2依赖的，而BT-63有 广泛的抗病毒谱，对抗依赖于pH的病毒。 。 SBIR第二阶段将评估与现有抗病毒药物和 疫苗，将LANCL2的效力和抗病毒知识扩展到其他病毒，并推动铅衍生物的发展 FDA通过ADME-Tox和安全性评估的监管途径，其中一个关键里程碑是提交 IND申请在资助后1年内完成。 商业应用：这个研发项目产生的技术可能会扰乱每年500亿美元的市场。

The First LANCL2-based therapeutic for influenza Biotherapeutics, Inc (BTI) is a clinical-stage biotech company that synergistically combines the power of advanced computational modeling with translational experimentation to accelerate the development of novel products for precision medicine and health. This Phase 1 SBIR application emerges from substantial preclinical data showing the potential of lanthionine synthetase C-like 2 (LANCL2) agonists as host-based therapeutics for viral diseases. Our Product: BT-63, a novel lead LANCL2 agonist ligand, selectively binds to LANCL2 and exerts promising therapeutic efficacy in mouse models of influenza A virus (IAV). In this Phase I we will focus on influenza virus to characterize the role of LANCL2 as therapeutic target with broad antiviral effects. Background: infectious diseases caused by emerging and re-emerging viruses are a significant public health challenge. Influenza remains a significant public health threat despite available antivirals and vaccines. The absence of effective universal vaccines and antivirals coupled with the rising rates of antiviral resistance justifies the need to develop novel host-based antivirals. BTI identified LANCL2 as a novel target during viral infections. LANCL2 agonistic drugs down-regulate viral entry and replication while protecting against the virus-induced cytokine storm, mortality, pathology and disease. The Specific Aims of this SBIR Phase 1 application are to: AIM 1. Validate LANCL2 as a new host target for treating influenza infections: we will to optimize dosing and therapeutic window and validate LANCL2 as the molecular target of BT-63. AIM 2: Evaluate the antiviral mechanisms and spectrum of BT-63: we will test the hypothesis that BT-63 exerts broad spectrum antiviral effect by modulating metabolic responses of the host cell. Mayor expected outcomes: BT-63 offers at least a 50% protection against mortality, suppresses by 10-fold the expression of proinflammatory markers IL-6 and TNFα, the mechanism is LANCL2-dependent, and BT-63 has broad antiviral spectrum against pH-dependent viruses. . SBIR Phase II will assess the potential for synergism with and comparison against current antivirals and vaccines, expand LANCL2 efficacy and antiviral knowledge into other viruses and advance lead derivatives along the FDA regulatory pathway through ADME-Tox and safety assessments with a key milestone of submitting an IND application within 1 year of funding. Commercial Application: Technology generated by this R&D project could disrupt a $50B annual market.