/PRNewswire/ -- Lomond Therapeutics Holdings, Inc. ('Lomond Therapeutics'), a clinical-stage biotechnology company dedicated to discovering and developing potentially best-in-class and first-in-class medicines for the treatment of hematological malignancies, today announced that the U.S. Food and Drug Administration (FDA) has cleared it's Investigational New Drug (IND) application for a Phase 1 multicenter study evaluating the feasibility, safety, and efficacy of lonitoclax in patients with relapsed/refractory acute myeloid leukemia (AML)..

/PRNewswire/ -- Lomond Therapeutics Holdings, Inc.（“Lomond Therapeutics”），一家致力于发现和开发潜在的同类最佳和首创药物以治疗血液系统恶性肿瘤的临床阶段生物技术公司，今天宣布美国食品药品监督管理局 (FDA) 已批准其新药临床试验申请 (IND)，将开展一项多中心1期研究，评估lonitoclax在复发/难治性急性髓系白血病 (AML) 患者中的可行性、安全性和有效性。

'The acceptance of our third U.S. IND is an important milestone for Lomond Therapeutics', said

“我们第三个美国IND获得受理是Lomond Therapeutics的一个重要里程碑”，

Iain Dukes

艾恩·杜克斯

, Chief Executive Officer of Lomond Therapeutics. 'This IND clearance allows us to begin the next stages of our clinical development for lonitoclax focusing on acute myeloid leukemia (AML). Through this Phase 1 study, we aim to advance our understanding of safety, tolerability, manufacturing feasibility and mechanism of action of lonitoclax.'.

Lomond Therapeutics首席执行官表示：“这一IND许可使我们能够开始lonitoclax针对急性髓系白血病（AML）的临床开发下一阶段。通过这项1期研究，我们旨在进一步了解lonitoclax的安全性、耐受性、生产可行性和作用机制。”

Lomond Therapeutics today announced that the U.S. FDA has cleared it's IND application for a Phase 1 multicenter study

洛蒙德治疗公司今天宣布，美国食品药品监督管理局（FDA）已批准其针对一期多中心研究的新药临床试验（IND）申请。

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About Lomond Therapeutics

关于洛蒙德治疗学

Lomond Therapeutics is a biopharmaceutical company co-founded by Orbimed, Torrey Pines Investment and Dr. John C. Byrd, focused on the discovery and development of best-in-class and first-in-class small molecule inhibitors that target escape mutations in hematologic and solid cancers. The company is utilizing a proprietary hybrid AI platform of Expert Systems Inc., leveraging its key partners proprietary data, chem/bio tools, knowledge and expertise to choose highly valuable molecular mechanism of pathology, to rationally design, accelerate discovery and optimize development of best-in-class and first-in-class therapies.

Lomond Therapeutics是一家由Orbimed、Torrey Pines Investment和约翰·C. 拜耳德博士共同创立的生物制药公司，专注于发现和开发针对血液癌症和实体瘤中逃逸突变的一流和首创小分子抑制剂。该公司利用Expert Systems Inc.的专有混合人工智能平台，借助其关键合作伙伴的专有数据、化学/生物工具、知识和专业技能，选择极具价值的病理分子机制，以合理设计、加速发现并优化开发一流和首创疗法。

Lomond Therapeutics' goal is to utilize its capabilities and platform to become a leader in developing novel breakthrough medicines to maximize the clinical benefit when treating hematologic and solid malignancies. For more information visit .

洛蒙德治疗学公司的目标是利用其能力和平台，成为开发新型突破性药物的领导者，以在治疗血液和实体恶性肿瘤时最大化临床效益。欲了解更多信息，请访问。

About Lonitoclax

关于Lonitoclax

Lonitoclax has earlier reported novel binding, best-in-class potency and selectivity against BCL2, a key pro-survival protein that is overexpressed in many cancers.  To mitigate the hematologic and immune toxicities observed with venetoclax, lonitoclax was designed with a unique binding to improve selectivity for Bcl-2 over Bcl-xL.

Lonitoclax 早前报道称其具有新型结合能力，对 BCL2 的效价和选择性达到同类最佳水平，BCL2 是一种在多种癌症中过度表达的关键促生存蛋白。为了减轻 venetoclax 所观察到的血液和免疫毒性，lonitoclax 被设计为通过独特的结合方式提高对 Bcl-2 相较于 Bcl-xL 的选择性。

In addition, a shorter half-life and reduced P4503A4 inhibition properties were built into the molecule to mitigate tumor lysis syndrome and drug accumulation risk, respectively. Lonitoclax has demonstrated monotherapy activity in pre-clinical models, as well as synergistic activity when combined with azacytidine, FLT3 inhibitors, and menin inhibitors in AML xenograft models.

此外，该分子还设计了较短的半衰期和降低的P4503A4抑制特性，以分别减轻肿瘤溶解综合征和药物积累风险。Lonitoclax在临床前模型中展示了单药活性，并且在AML异种移植模型中与氮杂胞苷、FLT3抑制剂和menin抑制剂联合使用时表现出协同活性。

Unlike venetoclax, lonitoclax had minimal immunosuppressive activity on B cells, CD8 T cells, and NK cells in preclinical models. Lonitoclax has completed a series of healthy volunteer studies where no significant safety signals were observed at exposures where ex vivo activation of caspase in CLL primary cells was observed, a surrogate marker of BCL-2 inhibition in tumors.

与维奈托克不同，隆尼托克在临床前模型中对 B 细胞、CD8 T 细胞和 NK 细胞的免疫抑制活性极小。隆尼托克已完成一系列健康志愿者研究，在观察到 CLL 原代细胞中 caspase 的体外激活（肿瘤中 BCL-2 抑制的替代标志物）的暴露水平下，未发现显著的安全性信号。

This emphasizes important advantages over venetoclax and venetoclax-like molecules in safety, tolerability and feasibility of outpatient treatment, enabling the molecule to safely target AML and CLL patients alone and in combination with other targeted therapies..

这强调了在安全性、耐受性和门诊治疗可行性方面相对于维奈托克和类似维奈托克分子的重要优势，使该分子能够安全地单独针对急性髓系白血病（AML）和慢性淋巴细胞白血病（CLL）患者，并与其它靶向疗法联合使用。

About the Phase 1 Clinical Trial

关于第一阶段临床试验

The Phase 1 study will evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of lonitoclax in combination with azacitidine in R/R AML.  The study will include a dose escalation and an expansion phase with up to 60 total participants. Lomond Therapeutics is planning to initiate the study in the third quarter of 2025 across multiple investigative sites..

第一阶段研究将评估洛尼托克拉克斯与阿扎胞苷联合用于复发/难治性急性髓系白血病（R/R AML）的安全性、耐受性、药代动力学和抗肿瘤活性。该研究将包括剂量递增和扩展阶段，总计最多60名参与者。Lomond Therapeutics计划于2025年第三季度在多个研究中心启动这项研究。