RGT-419B, a next generation CDK4 inhibitor, was safe and well tolerated in a First-in-Human Phase 1A single agent dose escalation study.

RGT-419B是一种下一代CDK4抑制剂，在首次人类1A期单药剂量递增研究中是安全且耐受性良好的。

Monotherapy clinical efficacy was observed in HR+/HER2- advanced breast cancer (ABC) patients who have progressed on CDK4/6 inhibitors (CDK4/6is) and endocrine therapy (ET).

在CDK4/6抑制剂（CDK4/6is）和内分泌治疗（ET）进展的HR+/HER2晚期乳腺癌（ABC）患者中观察到单药治疗的临床疗效。

The current data support the continued development of RGT-419B as a single agent, as well as in combination therapy with ET in HR+/HER2- ABC patients.

目前的数据支持RGT-419B作为单一药物的持续发展，以及在HR+/HER2-ABC患者中与ET的联合治疗。

BOSTON, Dec. 7, 2023 /PRNewswire/ -- Regor Therapeutics Group ('Regor'), a global innovator powered by cutting-edge drug discovery engine and differentiated clinical development pipeline, today announced the results from Phase 1A single agent dose escalation study of RGT-419B, a next generation CDK4 inhibitor, in HR+ HER2- ABC patients who have progressed on prior CDK4/6is and ET.

波士顿，2023年12月7日/PRNewswire/--Regor Therapeutics Group（“Regor”）是一家由尖端药物发现引擎和差异化临床开发渠道推动的全球创新者，今天宣布了下一代CDK4抑制剂RGT-419B在先前CDK4/6is和ET上进展的HR+HER2-ABC患者中的1A期单药剂量递增研究结果。

These results (cutoff date September 26, 2023) were presented today in poster session by Dr. Seth Wander from Massachusetts General Hospital at the San Antonio Breast Cancer Symposium (SABCS) taking place December 5-9, 2023, in San Antonio, Texas. The poster titled 'First-in-human Phase 1A study of RGT-419B, a next generation CDK4 inhibitor, in patients with HR+/HER2- ABC who have progressed on prior CDK4/6 inhibitors (PO3-18-06; NCT05304962)', highlighted that:.

这些结果（截止日期2023年9月26日）今天由马萨诸塞州总医院的SethWander博士在德克萨斯州圣安东尼奥市2023年12月5日至9日举行的圣安东尼奥乳腺癌研讨会（SABCS）的海报会议上发布。海报标题为“下一代CDK4抑制剂RGT-419B的首次人类1A期研究，用于HR+/HER2-ABC患者，这些患者在先前的CDK4/6抑制剂（PO3-18-06；NCT05304962）上取得了进展”，强调：。

Across 12 patients with HR+HER2- ABC who have progressed on CDK4/6is and ET, RGT-419B administered as oral (PO) monotherapy in continuous 28-day cycles was safe and well-tolerated with no dose-limiting toxicities. No patients discontinued treatment with RGT-419B due to an adverse event.

在12例在CDK4/6is和ET上进展的HR+HER2-ABC患者中，连续28天周期口服（PO）单药治疗的RGT-419B安全且耐受性良好，无剂量限制性毒性。由于不良事件，没有患者停止使用RGT-419B治疗。

The exposure of RGT-419B was dose proportional with long half-life and small peak to trough ratio at steady state.

RGT-419B的暴露与剂量成正比，在稳定状态下半衰期长，峰谷比小。

RGT-419B demonstrated single agent efficacy in the heavily pretreated HR+/HER2- ABC patients who have progressed on CDK4/6i and ET. Three patients achieved partial responses and are still on treatment. 6 patients received treatment > 24 weeks.

RGT-419B在经过严重预处理的HR+/HER2-ABC患者中表现出单药疗效，这些患者在CDK4/6i和ET上取得了进展。三名患者取得了部分缓解，仍在接受治疗。6名患者接受治疗>24周。

The promising single agent efficacy of RGT-419B is consistent with the preclinical data from CDK4/6i resistant breast cancer models.

RGT-419B有希望的单药疗效与CDK4/6i耐药乳腺癌模型的临床前数据一致。

'RGT-419B demonstrates its potential to be the best-in-class next generation CDK4 inhibitor for HR+/HER2- breast cancer. The results presented today is encouraging because RGT-419B is not only safe and well tolerated, but also demonstrated single agent efficacy in heavily pre-treated HR+ HER2- ABC patients who progressed on the approved CDK4/6i and ET.' said Xiayang Qiu Ph.D., Chief Executive Officer of Regor Therapeutics Group.

“RGT-419B显示出其成为HR+/HER2乳腺癌最佳的下一代CDK4抑制剂的潜力。今天公布的结果令人鼓舞，因为RGT-419B不仅安全且耐受性良好，而且在经过严重预处理的HR+HER2-ABC患者中也显示出单药疗效，这些患者在批准的CDK4/6i等方面取得了进展。”Regor Therapeutics Group首席执行官夏阳秋博士说。

'These data show that RGT-419B has monotherapy opportunity in HR+ HER2- ABC patients resistant to the approved CDK4/6i and ET.  With the favorable safety profile and promising monotherapy efficacy, RGT-419B has best-in-class potential as a single agent or in combination in HR+HER2- BC patients resistant to CDK4/6i, and in earlier lines of treatments.  Clinical studies of single agent dose expansion and combination of RGT-419B with ET are underway.'.

“这些数据表明，RGT-419B在对批准的CDK4/6i和ET耐药的HR+HER2-ABC患者中具有单药治疗机会。RGT-419B具有良好的安全性和有希望的单药治疗效果，作为单一药物或联合HR+HER2-BC患者对CDK4/6i耐药，以及早期治疗方案具有最佳的潜力。正在进行单药剂量扩大和RGT-419B与ET联合的临床研究。”。

The Phase 1 trial (NCT05304962) is a multicenter, open-label study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of RGT-419B given as monotherapy or in combination with ET in patients with HR+HER2- ABC who have progressed on CDK4/6i and ET.

第一阶段试验（NCT05304962）是一项多中心，开放标签研究，用于评估RGT-419B作为单一疗法或与ET联合用于HR+HER2患者的安全性，耐受性，药代动力学和初步抗肿瘤活性。ABC在CDK4/6i和ET上取得进展。

Copies of the posters are available on Regor's website under the Science section.

海报的副本可以在Regor的网站上的科学部分找到。

About Regor Therapeutics Group

关于Regor Therapeutics Group

Regor Therapeutics Group is a biotech founded in 2018 by a team of scientists with a proven track record in drug discovery and executive leadership covering full cycle of drug discovery and development. By leveraging its industry-leading core strength in rCARD™ (Computer Accelerated Rational Discovery), Regor has completed 8 PCCs inhouse, with 5 INDs filed, validating Regor's highly efficient ecosystem for accelerated discovery of innovative therapeutic agents..

Regor Therapeutics Group是一家生物技术公司，由一群科学家于2018年成立，他们在药物发现和执行领导方面拥有良好的业绩记录，涵盖了药物发现和开发的整个周期。利用其在rCARD行业领先的核心实力™（计算机加速理性发现），Regor已经在内部完成了8个PCC，并提交了5个IND，验证了Regor的高效生态系统，以加速创新治疗剂的发现。。

Regor's in-house pipeline encompasses leading assets in metabolism, oncology and auto-immunity, with 2 leading assets: 1) RGT-075, an orally bioavailable small molecule GLP1R full agonist with best-in-class potential for obesity & beyond; and 2) RGT-419B, a unique CDK4+ inhibitor showing outstanding single agent responses in refractory ER+/Her2- breast cancer patients..

Regor的内部管道包括代谢，肿瘤学和自身免疫方面的领先资产，有2项领先资产：1）RGT-075，一种口服生物可利用的小分子GLP1R全激动剂，具有最佳的肥胖潜力；2）RGT-419B，一种独特的CDK4+抑制剂，在难治性ER+/Her2乳腺癌患者中显示出出色的单药反应。。

With a strong focus on excellence in pharmaceutical research and global competitiveness, Regor aspires to build a world-class innovation engine that promotes a winning culture of scientific excellence, strong teamwork driven by results and delivery with shared accountability and successes.

Regor专注于卓越的药物研究和全球竞争力，致力于建立世界一流的创新引擎，促进卓越科学文化的形成，以成果和交付为驱动的强大团队合作，共同承担责任和取得成功。

IR Contact:Investor Relations and Communications[email protected]

IR联系人：投资者关系和通信[受电子邮件保护]

SOURCE Regor Therapeutics Group

SOURCE Regor Therapeutics集团