Heidelberg Pharma AG

Ladenburg, Germany, 4 September 2025 – Heidelberg Pharma AG (FSE: HPHA), a clinical stage company developing innovative Antibody Drug Conjugates (ADCs), today announces that new data from its Phase I/IIa clinical study with lead Amanitin-based ADC candidate, HDP-101, will be presented at the 22st International Myeloma Society (IMS) Annual Meeting, being held in Toronto, Canada, on 17 to 20 September 2025. HDP-101 is an Anti-BCMA antibody-Amanitin drug conjugate for the treatment of relapsed or refractory multiple myeloma, a bone marrow cancer with a high unmet medical need. Phase I of the trial is a dose escalation study to determine an optimal and safe dose level of HDP-101 in patients in preparation for Phase II clinical studies. Professor Jonathan L. Kaufman, MD, David Bankes Glass Professor, Department of Hematology and Medical Oncology, Emory University, Atlanta, USA and clinical investigator of the study will present new findings from eight patient cohorts of the ongoing open-label, multicenter Phase I/IIa trial evaluating HDP-101 in multiple myeloma. Details of the presentation are as follows: Presentation title: The Anti-BCMA Antibody-Drug Conjugate HDP-101 with a Novel Amanitin Payload Shows Promising Data in Relapsed/Refractory Multiple Myeloma in a Phase 1/2a clinical trial as it advances into Cohort 7 Session: Abstract session 9 Speaker: Professor Jonathan L. Kaufman, MD Date and time: Saturday, 20 September 2025, 9:30 am - 09:40 am (ET) Location: Metro Toronto Convention Center; Room: 701 Session: Abstract session 9 Speaker: Professor Jonathan L. Kaufman, MD Date and time: Saturday, 20 September 2025, 9:30 am - 09:40 am (ET) Location: Metro Toronto Convention Center; Room: 701 The first seven patient cohorts and dose levels have been completed. Treatment with HDP-101 was well tolerated and the study has shown very encouraging results, including one patient from the fifth cohort in whom no tumor cells are detectable on a permanent basis. She had been treated with multiple other therapies and is since then being treated continuously with HDP-101 alone. In addition, several patients from different cohorts showed promising anti-tumor activity and objective improvements.

恒瑞医药 WO2025176180 HER2-艾日布林衍生物 SHR-4602 8月28日，恒瑞医药公开一篇ADC专利，涉及靶点HER2，抗体为 Pertuzumab，有效载荷为艾日布林衍生物，该 ADC 旨在治疗抗 HER2 ADC 耐药的肿瘤，包括乳腺癌、胃癌、结直肠癌、尿路上皮癌、胆管癌、肺癌等。 SHR-4602 是恒瑞自主研发的一种新型抗 HER2 ADC，抗体采用帕妥珠单抗，利用肽连接子偶联有效载荷 ER300（艾日布林衍生物）。恒瑞在2024年的 AACR 会议摘要中披露该药物的临床前数据。2024年12月，SHR-4602 的新药临床申请获 NMPA 批准，用于晚期实体瘤，目前该药物正在进行临床  2 期研究。 SONY WO2025177173 抗体-聚合物偶联物 8月28日，Sony 集团公开一篇抗体聚合物偶联药物专利，靶点涉及 CD33、CD30、CD7、CD123。聚合物含有侧链的脱氧尿苷基团，有效载荷为 MMAE，通过 VC 连接子裂解释放，同时聚合物含有高亲水性结构 HEG（即磷酸-PEG），通过灵调整长度可以根据需要提高或降低 ADC 药物整体水溶性。 日内瓦大学 WO2025176733 ATR或CHK1抑制剂 ADC 8月28日，日内瓦大学公开一篇 ADC 专利，涉及非细胞毒载荷，专利公开采用 ATR 或 CHK1 抑制剂为 ADC 有效载荷，其中 ATR 抑制剂优选 camonsertib、Elimusertib；CHK1抑制剂优选 Prexasertib。实施例将 ATR 或 CHK1 抑制剂通过肽连接子与抗 HER2 抗体偶联，其中肽连接子包括GPVK、GGFG、GGNN、GNLK、GLVK、GPLK、GGGF、GPVR、VC-PABC 等。 Abdera WO2025179051、WO2025179031 DLL3 RDC ABD-147、5T4 RDC 8月28日，Abdera Therapeutics 公开两篇 RDC 专利，涉及靶点 DLL3 和 5T4，靶向部分为抗体片段 VHH-Fc，与螯合剂 DOTA-linker 通过四氟苯酯（OTFP）接头偶联，螯合剂-抗体比（CAR）值约为4，然后分别 111In、177Lu 或 225Ac 进行放射性标记后得到 RDC 药物。 Abdera Therapeutics 的核心研发项目之一 ABD-147 是一款靶向 DLL3 的 RDC 药物，其基于公司独特的 ROVEr™ 平台（设计和开发具有可调节药代动力学特性的放射性药物）开发，以提高治疗效果并减少副作用。ABD-147 的 IND 申请在2024年04月获得美国 FDA 批准，目前正在进行临床 1 期研究，用于治疗小细胞肺癌和肺大细胞神经内分泌癌。 ABD-147 对应的诊断性核药和治疗性核药分别为 111In-ABD147 和 225Ac-ABD147。 往期分享： 专利动态|XDC的新linekr或新靶点 专利动态|偶联药物新专利（2025.08.14） 专利动态|新一周的ADC专利（2025.08.07） 专利动态|最新偶联药物（XDC）专利（2025.07.31） 专利动态 | 新ADC专利公开：新机制载荷/新靶点/新项目(2025.07.24) 专利分享|糖基偶联新型二糖连接子：齐鲁 vs GlycoT 专利动态 | 最新ADC药物相关专利 专利动态 | 在研ADC最新专利公开 专利分享 | 先声药业FGFR2b ADC药物SIM0686 专利分享 | 亲合力生物的白蛋白偶联药物 QHL-1618，肿瘤微环境释放 专利分享 | 新型ADC载荷靶向破解肿瘤耐药 专利分享 | "孤勇者"的妥协？Heidelberg Pharma获华东医药投资后转向TOP1i ADC 专利分享 | 先声药业ADC偶联"接头"新技术公开 专利分享 | MTG酶定点偶联+点击化学：Hummingbird 双载荷ADC技术公开 上海诗健生物新一代ADC平台专利公开 **说明：本公众号内容基于公开信息的整理和分析，如涉及侵权请联系处理；作者水平有限，对专利或文献的解读可能存在疏漏之处，请以原文为准；欢迎个人转发分享，如需转载至公众号或其他平台，请注明出处并遵守版权规范。** 参考资料：      Tian Y, Sun X, Yang C, Liao C. Abstract 3195: SHR-4602, next generation of HER2-targeting ADC with potent anti-tumor efficacy overcoming the resistance of HER2 ADC with Topo I inhibitor payload in xenograft models. Cancer Research. 2024;84(6_Supplement):3195-3195. doi:10.1158/1538-7445.am2024-3195  药物临床试验登记与信息公示平台官网 clinicaltrials 官网 公司官网 END 欢迎关注，与您分享偶联药物领域最新突破

Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Roche revealed further information on how it would spend its multibillion-dollar manufacturing investment in the US, announcing on Monday that its subsidiary Genentech has started building a new site in Holly Springs, NC, worth $700 million. The new facility is expected to create more than 1,900 jobs and is scheduled to be operational in 2029, according to Roche. The FDA handed Telix Pharmaceuticals a complete response letter for its PET agent, codenamed TLX250-CDx, the company said Thursday. TLX250-CDx is being considered for the diagnosis and characterization of clear cell renal cell carcinoma. The agency cited issues in the company’s chemistry, manufacturing and controls, and requested further information on the scaling-up process for TLX250-CDx’s commercial use. Further, the FDA filed two Form 483s for two of Telix’s third-party manufacturers. Telix’s stock sank almost 19% on the Australian stock exchange. Telix’s license partner, Heidelberg Pharma, was due to receive a $70 million milestone payment upon the asset’s approval. Sandoz is spending CAD $220 million ($160 million) to “modernize” its partner Delpharm’s facilities in Boucherville, Canada, with help from the Government of Quebec, according to a Thursday release. CAD $60 million ($43.6 million) is being invested by the provincial government, another CAD $60 million ($43.6 million) from the federal government and CAD $100 million ($72.6 million) from private investors. Sai Life Sciences has completed the second phase of its so-called Production Block at its API manufacturing facility in Bidar, India, the CDMO said Thursday. The latest expansion has brought its total reactor capacity to around 700 kiloliters. Cambrex’s subsidiary Snapdragon Chemistry has expanded its peptide API factory in Waltham, MA, according to a Monday release. This increases the facility’s footprint by 20%. WuXi AppTec completed its 1 billion RMB ($139.8 million) share repurchase agreement, the company said Wednesday. Since June 26, WuXi AppTec has repurchased 11.9 billion shares, representing 0.4% of its total share capital. Nusano has opened its 190,000-square-foot radioisotope facility in Utah, according to an Aug. 21 release. Access to Advanced Health Institute has tapped CDMO Quratis to manufacture its preclinical and clinical vaccines, with the option to expand into commercial supply, the companies said on Aug. 21. ChemPartner has opened a new R&D facility in Watertown, MA, which will start operations in September, according to an Aug. 20 release.