IDP-121 is IDP Pharma's lead asset using its proprietary intrametics™ technology platform enabling inhibition and cellular degradation of intrinsically disordered proteins (IDPs)

IDP-121是IDP Pharma使用其专有intrametics的主要资产™技术平台能够抑制和细胞降解内在无序蛋白（IDP）

Targeting cMyc, a pivotal protein in tumorigenesis, is a unique opportunity in cancer therapy

靶向cMyc是肿瘤发生中的关键蛋白，是癌症治疗中的独特机会

First patient successfully dosed in clinical Phase I/II dose escalation and expansion study in relapsed/refractory hematological malignancies

首例患者在复发/难治性血液系统恶性肿瘤的临床I/II期剂量递增和扩展研究中成功给药

BARCELONA, Spain, Oct. 26, 2023 /PRNewswire/ -- IDP Pharma, a clinical-stage biotechnology company pioneering the development of drugs that directly engage and degrade intrinsically disordered proteins (IDPs), today announced that the first patient has been successfully dosed in its IDP-121-001 CASSANDRA trial, a multi-center, open-label Phase I/II study for the treatment of cMyc driven hematological malignancies..

2023年10月26日，西班牙巴塞罗那/PRNewswire/-IDP Pharma是一家临床阶段的生物技术公司，致力于开发直接参与和降解内在无序蛋白（IDP）的药物，今天宣布第一名患者已成功在其多中心IDP-121-001 CASSANDRA试验中给药，用于治疗cMyc驱动的血液恶性肿瘤的开放标签I/II期研究。。

The cMyc oncogene is activated in most cancers by genetic, epigenetic or post- translational mechanisms, and cMyc protein function is altered in approximately 70% of all tumours. The intrinsic connection between cMyc protein and tumorigenesis highlights the potential therapeutic significance of its inhibition.

cMyc癌基因在大多数癌症中通过遗传，表观遗传或翻译后机制被激活，并且cMyc蛋白功能在所有肿瘤的约70%中被改变。cMyc蛋白与肿瘤发生之间的内在联系突出了其抑制的潜在治疗意义。

IDP-121 is designed to impair cMyc protein function and selectively degrade the target..

IDP-121旨在损害cMyc蛋白功能并选择性降解靶标。。

'IDP-121 has demonstrated the unique ability to directly engage cMyc protein, triggering antitumor response in several animal models. We are particularly interested in the exploration in hematological diseases, including multiple myeloma, that we know are heavily cMyc dependent and give us the opportunity to quickly measure the on-target effect.

'IDP-121已证明直接参与cMyc蛋白的独特能力，在几种动物模型中引发抗肿瘤反应。我们对包括多发性骨髓瘤在内的血液系统疾病的探索特别感兴趣，我们知道这些疾病严重依赖cMyc，并为我们提供快速测量目标效应的机会。

Ultimately, we hope to see biological and clinical response that will confirm the broad potential of this therapeutic approach across solid and liquid tumors' said Dr. Laura Nevola, IDP's Chief Scientific Officer. .

IDP首席科学官Laura Nevola博士说，最终，我们希望看到生物学和临床反应能够证实这种治疗方法在固体和液体肿瘤中的广泛潜力。

According to Valentin Cabañas, the PI of the Hospital Clínico Virgen de la Arrixaca (Murcia, Spain), where the first patient was dosed, the use of IDP-121 for the treatment of multiple myeloma 'could potentially represent a major shift in the disease management due to the exploitation of a mechanism of action previously uncharted for targeting myeloma cells.' The clinical trial will also include patients of non-Hodgkin lymphoma and chronic lymphocytic leukemia, as this new drug 'acts on the protein involved in the development of several hematological cancers beyond multiple myeloma.'.

根据ValentinCabañas的说法，第一名患者服用的ClínicoVirgende la Arrixaca医院（西班牙穆尔西亚）的PI，使用IDP-121治疗多发性骨髓瘤'可能代表疾病的重大转变。由于利用了以前未知的靶向骨髓瘤细胞的作用机制，管理临床试验还将包括非霍奇金淋巴瘤和慢性淋巴细胞白血病患者，因为这种新药“作用于参与多发性骨髓瘤以外的几种血液癌症发展的蛋白质”。

'This is an extremely important next step in the understanding and relevance of cMyc and its role in cancer development and progression. The ability to directly target cMyc protein in the clinic is very exciting and the exploration of IDP-121 in this Phase I study could be a landmark in oncology drug development,' said Professor Dean Felsher, Scientific Adviser to IDP Pharma and Professor in the Division of Oncology within the Departments of Medicine and Pathology at Stanford University..

“这是了解和关联cMyc及其在癌症发展和进展中的作用的极其重要的下一步。IDP Pharma科学顾问兼教授Dean Felsher教授说，在临床上直接靶向cMyc蛋白的能力非常令人兴奋，在I期研究中IDP-121的探索可能成为肿瘤药物开发的一个里程碑。斯坦福大学医学与病理学系肿瘤科。。

'IDP-121 is IDP Pharma's lead compound and the announcement today represents a major step  towards the systematic and direct inhibition of  disease drivers in cancer mediated through IDPs' said Santiago Esteban, Chief Executive Officer of IDP Pharma.

IDP Pharma的首席执行官圣地亚哥·埃斯特班（Santiago Esteban）说：“IDP-121是IDP Pharma的主要化合物，今天的公告是系统和直接抑制通过IDP介导的癌症疾病驱动因素的重要一步。

The study will assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary clinical activity of IDP-121. The principal investigator is Professor Enrique Ocio, Head of Hematology of the Hospital Universitario Marqués de Valdecilla, and the study includes other four medical facilities in Spain: Hospital Vall d'Hebron, Hospital Universitario 12 de Octubre, Hospital Universitario of Salamanca, and Hospital Universitario Virgen de la Arrixaca..

该研究将评估IDP-121的安全性，耐受性，药代动力学（PK），药效学（PD）和初步临床活性。学术带头人是Enrique Ocio教授，Valdecilla大学医院血液学系主任，该研究包括西班牙其他四个医疗机构：Vall d'Hebron医院，12 de Octubre大学医院，萨拉曼卡大学医院和Universitario Virgen de la Arrixaca。。

To learn more about the IDP-121 clinical trial, visit clinicaltrials.gov (Identifier: NCT05908409).

要了解有关IDP-121临床试验的更多信息，请访问clinicaltrials.gov（标识符：NCT05908409）。

About IDP-121

关于IDP-121

IDP-121 is a potent, selective peptidomimetic that acts by simultaneously obstructing the formation of the cMyc/Max complex while also augmenting cMyc degradation through the intrinsic cellular machinery. This effectively counters the oncogenic impact of elevated cMyc protein levels that fuel the proliferation of cancer cells.

IDP-121是一种有效的选择性肽模拟物，其作用是同时阻止cMyc/Max复合物的形成，同时还通过内在的细胞机制增加cMyc降解。这有效地抵消了促进癌细胞增殖的cMyc蛋白水平升高的致癌影响。

Preclinical investigations of IDP-121 have revealed strong anti-tumor efficacy across various hematological and solid tumors, including multiple myeloma, non-small cell lung cancer (NSCLC), and small cell lung cancer (SCLC). IDP-121-001 (CASSANDRA) is the first clinical study involving IDP-121. Planned future clinical trials will include exploration in solid tumors and in combination with standard of care therapies..

IDP-121的临床前研究显示，在各种血液学和实体瘤中具有很强的抗肿瘤功效，包括多发性骨髓瘤，非小细胞肺癌（NSCLC）和小细胞肺癌（SCLC）。IDP-121-001（CASSANDRA）是第一项涉及IDP-121的临床研究。计划的未来临床试验将包括实体瘤的探索以及与标准治疗相结合。。

About IDP Pharma

关于IDP Pharma

IDP Pharma is a clinical-stage biotech company developing the first direct inhibitors and degraders of intrinsically disordered proteins (IDPs), a novel class of disease drivers previously considered undruggable. Thanks to its proprietary intrameticstm platform, the company has successfully developed a pipeline of first in class drugs targeting IDPs, leading the field since its foundation.

IDP Pharma是一家临床阶段的生物技术公司，开发第一种内在无序蛋白（IDPs）的直接抑制剂和降解剂，这是一种以前被认为是不可药用的新型疾病驱动因素。由于其专有的intrameticstm平台，该公司已成功开发出针对IDP的一流药物管道，自成立以来一直处于领先地位。

The company is headquartered in Parc Científic de Barcelona (PCB), in Barcelona, Spain..

该公司总部设在西班牙巴塞罗那的Parccientíficde Barcelona（PCB）。。

More information please visit www.idp-pharma.com

更多信息请访问www.idp-pharma.com

Forward-looking statements

前瞻性声明

The forward-looking statements made in this press release relate only to the events or information as of the date on which the statements are made in this article. You should read this article completely and with the understanding that actual future results with IDP-121 may be materially different from what we expect.

本新闻稿中的前瞻性声明仅涉及截至本文声明日期的事件或信息。您应该完全阅读本文，并了解IDP-121的实际未来结果可能与我们的预期有很大不同。

Statements contained in this press release are made as of the date of this document and any further interpretation may change considering future developments..

本新闻稿中所载的声明自本文件发布之日起生效，考虑到未来的发展，任何进一步的解释都可能发生变化。。

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For further inquiries please contact:IDP PharmaSantiago Esteban, Ph.D., Chief Executive OfficerE-mail: [email protected]

如需进一步查询，请联系：IDP PharmaSantiago Esteban博士，首席执行官办公室邮件：[电子邮件保护]

LifeSpring Life Sciences Communication, AmsterdamLéon MelensTel: +31 6 538 16 427E-mail: lmelens@lifespring.nl

LifeSpring Life Sciences Communication，AmsterdamLéonMelenstel:+31 6 538 16 427E mail：lmelens@lifespring.nl

SOURCE IDP Pharma

来源IDP Pharma