MUNICH & GARCHING, Germany & LAUSANNE, Switzerland--(BUSINESS WIRE)--ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company and Debiopharm (www.debiopharm.com), a Swiss-based, global biopharmaceutical company, aiming to establish tomorrow’s standard-of-care to cure cancer and infectious diseases, today announced that the companies entered an agreement under which ITM gains the exclusive global license for the clinical and commercial development of the peptide-based, theranostic pair ITM-91/ITM-94D, formerly Debio 0228/0328, targeting the Carbonic Anhydrase IX (CA IX) surface protein.

德国慕尼黑&加兴和瑞士洛桑——（商业新闻短讯）——ITM同位素技术慕尼黑SE（ITM），一家领先的放射性药物生物技术公司和Debiopharm（www.Debiopharm.com），一家总部位于瑞士的全球生物制药公司，旨在建立明天治疗癌症和传染病的护理标准，今天宣布，两家公司签署了一项协议，根据该协议，ITM获得了针对碳酸酐酶IX（CA IX）表面蛋白的肽基治疗诊断对ITM-91/ITM-94D（原Debio 0228/0328）的临床和商业开发的独家全球许可。

CA IX plays a key role in the tumor microenvironment, promoting tumor growth, survival, invasion and metastasis. ITM-91 (Debio 0228) ([177Lu]Lu-DPI-4452) is a Lutetium-177-labeled radioligand therapeutic compound and ITM-94D (Debio 0328) ([68Ga]Ga-DPI-4452) is a Gallium-68-labeled imaging agent. The theranostic pair is being investigated in the phase 1/2 GaLuCi™(NCT05706129) clinical trial in patients living with locally advanced ccRCC, PDAC and CRC.

CA IX在肿瘤微环境中起关键作用，促进肿瘤生长，存活，侵袭和转移。ITM-91（Debio 0228）（[177Lu]Lu-DPI-4452）是一种镥-177标记的放射性配体治疗化合物，ITM-94D（Debio 0328）（[68Ga]Ga-DPI-4452）是一种镓-68标记的显像剂。治疗诊断对正在接受局部晚期ccRCC，PDAC和CRC患者的1/2期GaLuCi™（NCT05706129）临床试验中进行研究。

Further terms and financial details have not been disclosed..

进一步的条款和财务细节尚未披露。。

“Obtaining this clinical-stage theranostic pairing significantly bolsters our radiopharmaceutical pipeline and reinforces our commitment to delivering life-changing diagnostic and therapeutic agents to patients. Adding a clinical stage theranostic pair that targets the critical CA IX protein aligns seamlessly with our mission to expand access to innovative radiopharmaceuticals on a global scale,” said Dr.

“获得这种临床阶段-治疗诊断配对显着增强了我们的放射性药物管道，并加强了我们向患者提供改变生命的诊断和治疗药物的承诺。添加针对关键CA IX蛋白的临床阶段-治疗诊断配对与我们在全球范围内扩大创新放射性药物获取的使命无缝结合，”Dr。

Andrew Cavey, CEO of ITM. “We see great potential for CA IX-targeted radiopharmaceutical therapies. We look forward to advancing the GaLuCi™ trial and to building the optimal clinical strategy for this molecule.”.

ITM首席执行官安德鲁·卡维（AndrewCavey）。“我们看到CA IX靶向放射性药物治疗的巨大潜力。我们期待着推进GaLuCi™试验，并为这种分子建立最佳的临床策略。”。

“Curing patients is our mission. Through this agreement with ITM, we hope to bring breakthrough solutions to patients living with hard-to-treat cancer types. We’re extremely pleased that the trial data generated to-date for our imaging radiotracer have provided high-quality images with high tumor uptake and excellent tumor-to-background ratios.

“治愈患者是我们的使命。通过与ITM的协议，我们希望为难以治疗的癌症患者带来突破性的解决方案。我们非常高兴迄今为止为我们的成像放射性示踪剂生成的试验数据提供了高质量的图像，具有高肿瘤摄取率和优异的肿瘤与背景比。

Debio 0328’s outstanding potential as a stand-alone imaging agent has also boosted our confidence for the upcoming evaluation of Debio 0228, the therapeutic agent. As development continues, we are grateful to be able to rely on ITM’s radiopharmaceutical expertise to advance research for patients,” said Bertrand Ducrey, CEO of Debiopharm..

Debio 0328作为独立成像剂的巨大潜力也增强了我们对即将进行的治疗剂Debio 0228评估的信心。随着发展的继续，我们很高兴能够依靠ITM的放射性药物专业知识来推进患者的研究，”Debiopharm首席执行官Bertrand Ducrey说道。。

Debiopharm is a drug development expert with an evolving radioligand therapy pipeline and strong pre-clinical and clinical competence in this field. Their unique business model allows Debiopharm to continuously bridge the gap between innovative discoveries and leading pharmaceutical companies for commercialization.

Debiopharm是一位药物开发专家，拥有不断发展的放射性配体治疗流程，在该领域具有强大的临床前和临床能力。他们独特的商业模式使Debiopharm能够不断弥合创新发现与领先的商业化制药公司之间的差距。

As the globally leading manufacturer of n.c.a. Lutetium-177 and with a broad pipeline of radiopharmaceutical diagnostic and therapeutic candidates, ITM will use its production capabilities and clinical expertise to advance this theranostic pair..

作为全球领先的n.c.a.Lutetium-177制造商，拥有广泛的放射性药物诊断和治疗候选产品，ITM将利用其生产能力和临床专业知识来推进这一治疗诊断对。。

“Patients with advanced renal cancer often have a long and difficult journey, with recurrence after surgery not infrequent and limited treatment options following immune-oncology or tyrosine kinase inhibitor therapy. I have high hopes for trials like GaLuCi™ will finally shift the odds defining both a new PET/CT scan and targeted treatment option,” said Prof.

“晚期肾癌患者通常经历漫长而艰难的旅程，手术后复发并不罕见，免疫肿瘤学或酪氨酸激酶抑制剂治疗后的治疗选择有限。我对GaLuCi™等试验寄予厚望，希望它们最终改变定义新PET/CT扫描和靶向治疗选择的可能性，”教授说。

Michael Hofman, Peter MacCallum Cancer of Melbourne and investigator of the Phase 1/2 GaLuCi™ study..

墨尔本的迈克尔·霍夫曼（MichaelHofman）、彼得·麦卡勒姆（PeterMacCallum）癌症研究者和1/2期GaLuCi™研究的研究员。。

“Theranostic approaches are a very exciting treatment modality for patients with hard-to-treat malignancies due to their potential to target specific surface proteins, often regardless of tumor origin. This technique has been shown to improve outcomes for patients with advanced-staged prostate cancer and we are hoping to bring it to the forefront of treatment for kidney cancer,” added Darren R.

Darren R补充道：“对于难以治疗的恶性肿瘤患者，治疗诊断方法是一种非常令人兴奋的治疗方式，因为它们具有靶向特定表面蛋白的潜力，通常与肿瘤起源无关。这项技术已被证明可以改善晚期前列腺癌患者的预后，我们希望将其带到肾癌治疗的前沿。”。

Feldman, MD, Medical Oncologist, Genitourinary Oncology Service at Memorial Sloan Kettering Cancer Center and investigator of the Phase 1/2 GaLuCi™ study..

医学博士费尔德曼（Feldman），纪念斯隆·凯特琳癌症中心泌尿生殖系统肿瘤服务医学肿瘤学家，1/2期GaLuCi™研究研究员。。

About ITM-91/ ITM-94D (Debio 0228/0328)

关于ITM-91/ITM-94D（Debio 0228/0328）

ITM-91/ ITM-94D (Debio 0228/0328) is an investigational theranostic pair originally discovered by 3B Pharmaceuticals GmbH and now exclusively licensed to ITM. ITM-94D (Debio 0328) ([68Ga]Ga-DPI-4452) is a PET imaging agent that may be used independently and is designed to identify patients whose cancers overexpress CA IX.

ITM-91/ITM-94D（Debio 0228/0328）是一对研究性治疗诊断对，最初由3B Pharmaceuticals GmbH发现，现已独家许可给ITM。ITM-94D（Debio 0328）（[68Ga]Ga-DPI-4452）是一种PET显像剂，可以独立使用，旨在识别癌症过度表达CA IX的患者。

Once identified, these patients may be treated with the lutetium-labelled radioligand, ITM-91 (Debio 0228) ([177Lu]Lu-DPI-4452), which is designed to deliver targeted radiation to the tumor with the aim to destroy it from the inside..

一旦确定，这些患者可以用镥标记的放射性配体ITM-91（Debio 0228）（[177Lu]Lu-DPI-4452）治疗，该配体旨在向肿瘤提供靶向辐射，目的是从内部破坏肿瘤。。

About the GaLuCi™ trial

关于GaLuCi™试验

The GaLuCi™ trial is the first-in-human, multicenter, non-randomized phase 1/2 clinical trial assessing safety and tolerability, imaging characteristics, and the efficacy of the theranostic pair ITM-91/ ITM-94D (Debio 0228/0328) in patients with unresectable, locally advanced, or metastatic solid tumors.

GaLuCi™试验是第一项评估安全性和耐受性，影像学特征以及治疗诊断对ITM-91/ITM-94D（Debio 0228/0328）的疗效的人类，多中心，非随机1/2期临床试验。不可切除，局部晚期或转移性实体瘤患者。

This theranostic trial is being carried out in three stages. The ongoing Part A is evaluating the safety and performance of the imaging agent in detecting CA IX-expressing solid tumors. Part B will assess escalating doses of the therapeutic agent, ITM-91 (Debio 0228) in patients, whose tumors show high uptake of imaging tracer.

这项治疗诊断试验分三个阶段进行。正在进行的A部分是评估显像剂在检测表达CA IX的实体瘤中的安全性和性能。B部分将评估肿瘤显示高摄取成像示踪剂的患者中治疗剂ITM-91（Debio 0228）的剂量增加。

Finally, based on the recommended dose from Part B, Part C of the study will further assess the safety and preliminary efficacy of ITM-91 (Debio 0228) in ccRCC, PDAC and CRC..

最后，根据B部分的推荐剂量，研究的C部分将进一步评估ITM-91（Debio 0228）在ccRCC，PDAC和CRC中的安全性和初步疗效。。

About ITM Isotope Technologies Munich SE

关于ITM同位素技术慕尼黑SE

ITM, a leading radiopharmaceutical biotech company, is dedicated to providing a new generation of radiomolecular precision therapeutics and diagnostics for hard-to-treat tumors. We aim to meet the needs of cancer patients, clinicians and our partners through excellence in development, production and global supply.

ITM是一家领先的放射性药物生物技术公司，致力于为难治性肿瘤提供新一代放射性分子精确治疗和诊断。我们的目标是通过卓越的开发、生产和全球供应来满足癌症患者、临床医生和合作伙伴的需求。

With improved patient benefit as the driving principle for all we do, ITM advances a broad precision oncology pipeline, including two phase III studies, combining the company’s high-quality radioisotopes with a range of targeting molecules. By leveraging our nearly two decades of pioneering radiopharma expertise, central industry position and established global network, ITM strives to provide patients with more effective targeted treatment to improve clinical outcome and quality of life.

ITM将改善患者利益作为我们所有工作的驱动原则，推进了广泛的精准肿瘤学管道，包括两项III期研究，将公司的高质量放射性同位素与一系列靶向分子相结合。通过利用我们近二十年来开创性的放射制药专业知识，中心行业地位和建立的全球网络，ITM致力于为患者提供更有效的靶向治疗，以改善临床结果和生活质量。

www.itm-radiopharma.com.

www.itm-radiopharma.com.

Debiopharm’s commitment to patients

Debiopharm aims to develop innovative therapies that target high unmet medical needs in oncology and bacterial infections. Bridging the gap between disruptive discovery products and real-world patient reach, we identify high-potential compounds and technologies for in-licensing, clinically demonstrate their safety and efficacy, and then select large pharmaceutical commercialization partners to maximize patient access globally..

Debiopharm旨在开发针对肿瘤学和细菌感染中高度未满足的医疗需求的创新疗法。弥合破坏性发现产品与现实世界患者接触之间的差距，我们确定了用于许可的高潜力化合物和技术，临床证明了它们的安全性和有效性，然后选择了大型药物商业化合作伙伴，以最大限度地提高全球患者的接触率。。

For more information, please visit www.debiopharm.com

有关更多信息，请访问www.debiopharm.com

We are on X. Follow us @DebiopharmNews at http://twitter.com/DebiopharmNews or on LinkedIn

我们在X上。请关注我们@DebiopharmNewshttp://twitter.com/DebiopharmNews或在LinkedIn上