MENLO PARK, Calif., FOSTER CITY, Calif. and HANGZHOU, China, Oct 1, 2021 - (亚太商讯 via SEAPRWire.com) - Edison Oncology Holding Corp. (Edison Oncology),一家致力于开发针对癌症的新疗法的公司,和冠科美博(Apollomics Inc.),一家致力于发现和开发肿瘤靶向和免疫新药及其组合疗法的创新生物制药公司,今天宣布,EO1001 (APL-122)已经完成首例患者研究给药,这是一项在晚期实体瘤患者中进行的 I/IIa 期临床试验, EO1001是一款高效不可逆酪氨酸激酶抑制剂 (TKI),在实验室研究中已经证实作为单药对EGFR(ErbB1)、HER2 (ErbB2) 和 HER4 (ErbB4) 有不可逆的抑制作用。Edison Oncology联合创始人兼首席执行官Jeffrey Bacha表示,“我们很高兴看到我们的首位患者接受了EO1001治疗,希望我们在临床前研究中显示出的安全性和疗效潜力能够转化为对癌症患者的临床获益。我们的临床前研究表明,EO1001对EGFR细胞内结构域的多个激活突变有效。我们期待首次人体临床试验的结果,我们相信EO1001有潜力解决许多瘤种尚未满足的医疗需求,包括非小细胞肺癌、乳腺癌和胶质母细胞瘤。”I/IIa 期临床试验将招募最多 50 名患者,由 Senz Oncology Pty Ltd.以服务合同外包的形式在澳大利亚进行。这项首次人体临床试验的目的是评估EO1001在转移性或晚期ErbB-1 (EGFR)、ErbB-2 (HER2) 和/或 ERbB-4 (HER4) 阳性癌症患者中的安全性和耐受性。澳大利亚的几个临床研究中心将入组复发性ErbB 阳性实体瘤患者,包括中枢神经系统受累的患者。冠科美博联合创始人兼总裁 Sanjeev Redkar 博士补充道,“我们很高兴EO1001实现开发过程中的这一重要里程碑,EO1001在我们公司代号为APL-122。在临床前模型中,APL-122 在 ErbB 阳性肿瘤中表现出活性,以及穿透血脑屏障治疗中枢神经系统肿瘤的能力,因此,I/IIa期临床试验纳入了脑转移的肿瘤患者。进入人体临床试验阶段标志着该前景非常看好的癌症疗法迈出了关键一步。”本项临床试验的主要研究者,澳大利亚墨尔本Monash Cancer Center 的肿瘤学专家兼临床研究员 Sophia Frentzas 博士表示:“ErbB 阳性肿瘤代表着一个重要的医疗需求未满足的患者人群,其中包括对一线靶向治疗难治或获得性耐药的 HER2(ErbB2)阳性乳腺癌和 EGFR(ErbB1)突变肺癌患者,还包括那些逐渐被证明 ErbB 通路起着重要致癌驱动作用的其它肿瘤(例如多形性胶质母细胞瘤、子宫内膜癌、卵巢癌和膀胱癌等)。ErbB 家族成员之间的串扰和耐药相关,而中枢神经系统转移发生率的增长在患者发病和死亡中发挥着重要作用,特别是后者目前可用的靶向治疗有限。EO1001 是一种口服、可穿透脑屏障、独特高效的广谱 ErbB 抑制剂,我们期待在这项首次人体试验中探索它的安全性和疗效。”2021年2月9 日,Edison Oncology和冠科美博宣布了一项独家许可协议,据此冠科美博将在全球(中国大陆、香港和台湾除外)开发和商业化 EO1001 (APL-122)。关于 APL-122(EO1001)EO1001是一款不可逆酪氨酸激酶抑制剂 (TKI),已在实验室研究中证实作为单药对 EGFR (ErbB1)、HER2 (ErbB2) 和 HER4 (ErbB4) 的抑制作用。EO1001 不仅可以抑制 EGFR 细胞内结构域中的突变,如非小细胞肺癌 (NSCLC) 中典型的 T790M、L858R 和 d746-750 突变,以及乳腺癌中的重要的 HER2 (ErbB2) 突变,还能抑制胶质母细胞瘤中典型的 EGFR-突变株 III (EGFRvIII) 突变。在临床前试验中,EO1001具有良好的耐受性,并被证明在口服给药后能够进入中枢神经系统 (CNS),在体内实验中对EGFR-突变株III (EGFRvIII) 突变驱动的肿瘤(包括中枢神经系统恶性肿瘤)具有活性。EO1001在冠科美博的代号为 APL-122。关于 Edison OncologyEdison Oncology 成立于 2018 年,由一个在生命科学行业经验丰富的团队创立,致力于抗肿瘤新疗法的开发和商业化。Edison Oncology利用对癌症生物学和癌症药理学的深入理解,识别和挖掘有潜力克服耐药性的未开发候选药物,以改善癌症患者生存结果和生活质量。关于冠科美博(Apollomics Inc.)冠科美博( Apollomics Inc.)是一家创新型生物制药公司,致力于研发肿瘤靶向和免疫单药及其组合疗法。公司产品管线有多个处于不同开发阶段的项目,包括为恢复机体免疫系统识别能力和杀死癌细胞的新型人源化单克隆抗体和针对失控的生长信号通路的靶向疗法。公司在中国杭州市、上海市和美国加州福斯特市均有运营实体。欲了解更多信息,请访问www.apollomicsinc.com。Edison Oncology 联系方式:公司联系人:Jeffrey Bacha首席执行官电话: (650) 690-1927Email: jb@eohc.com媒体和投资者关系联系人:Amato & Partners, LLC投资者关系顾问Email: admin@amatoandpartners.com冠科美博联系方式:投资人联系人:Wilson W. Cheung首席财务官电话: (650) 209-4436Email: wcheung@apollomicsinc.com公司联系人:张立平高级市场总监电话: (86) 0571-83521933Email: liping.zhang@apollomicsinc.com中国媒体联系:博达浩华国际财经传讯集团冯嘉莉总经理电话: (852) 3150 6763Email: kelly.fung@pordahavas.com冯静仪副总裁电话: (852) 3150 6773Email: phoenix.fung@pordahavas.com Copyright 2021 亚太商讯. All rights reserved. (via SEAPRWire)
MENLO PARK, CA and HELSINKI, FINLAND, Oct 1, 2021 - (ACN Newswire via SEAPRWire.com) - Edison Oncology Holding Corp. ("Edison Oncology"), a company established to develop new therapies targeting the fight against cancer, and Apollomics Inc. ("Apollomics"), an innovative biopharmaceutical company committed to the discovery and development of mono- and combination oncology therapies, reported that the first patient was dosed with EO1001 (APL-122) in a Phase I/IIa clinical trial in patients with advanced solid tumors. EO1001 is a potent irreversible tyrosine kinase inhibitor (TKI) that has demonstrated inhibition of EGFR (ErbB1), HER2 (ErbB2) and HER4 (ErbB4) as a single agent in laboratory studies."We are thrilled to see our first patient treated with EO1001 and hope that the potential safety and efficacy suggested by our preclinical data has the potential to translate into clinical benefits for patients suffering from cancer," said Jeffrey Bacha, B.Sc., MBA, Co-Founder and Chief Executive Officer of Edison Oncology. "Our preclinical studies have shown that EO1001 is potent against multiple activating mutations in the intracellular domain of EGFR. We look forward to the results from this first clinical trial as we believe EO1001 has the potential to address unmet medical needs in many types of cancer including non-small cell lung cancer, breast cancer and glioblastoma."The Phase I/IIa clinical trial will enroll up to 50 patients and is being conducted in Australia under contract service provided by Senz Oncology Pty Ltd. The objective of this first-in-human clinical trial is to examine the safety and tolerability of EO1001 in patients with metastatic or advanced stage ErbB-1(EGFR), ErbB-2(HER2) and/or ERbB-4 (HER4) positive cancer. Patients with relapsed ErbB-positive cancers in solid tumors, including patients with central nervous system (CNS) involvement, will be enrolled at several clinical sites in Australia.Sanjeev Redkar, PhD, Co-Founder and President of Apollomics, added, "We are pleased to achieve this important milestone in the development of EO1001 which we refer to as APL-122. In preclinical models, APL-122 demonstrated activity in ErbB positive tumors and the ability to penetrate and treat cancers in the CNS. Therefore, this Phase I/IIa study is inclusive of patients with brain metastases. Advancing into human clinical trials marks a pivotal step in our development of this promising cancer therapy."Dr. Sophia Frentzas, medical oncologist and clinical researcher at Monash Cancer Center in Melbourne, Australia and Principal Investigator for the clinical trial said, "ErbB positive tumors represent a significant patient population with unmet clinical needs. These include patients with HER2 (ErbB2) positive breast cancer and EGFR (ErbB1) mutant lung cancer who have acquired resistance, or are refractory, to frontline targeted therapy. They also include those patients with other tumour types where the ErbB pathway has been increasingly shown to be a clinically significant oncogenic driver (e.g. GBM, endometrial, ovarian, bladder cancer and others). Cross-talk between ErbB family members is implicated in resistance to treatment and the growing incidence of central nervous system metastases plays a significant role in patient morbidity and mortality. In particular, the latter presents a significant limitation with currently available targeted therapies. EO1001 is an oral, brain-penetrating, uniquely potent, pan-ErbB inhibitor. We look forward to exploring its safety and efficacy in this first-in-human trial."On February 9, 2021, Edison Oncology and Apollomics announced an exclusive licensing agreement whereby Apollomics will develop and commercialize EO1001 (APL-122) globally, except in Mainland China, Hong Kong and Taiwan.About EO1001EO1001 is an irreversible tyrosine kinase inhibitor (TKI) that has demonstrated inhibition of EGFR (ErbB1), HER2 (ErbB2) and HER4 (ErbB4) as a single agent in laboratory studies. EO1001 is potent against mutations in the intracellular domain of EGFR that are typically found in diseases such as Non-Small Cell Lung Cancer (NSCLC) including T790M, L858R and d746-750, HER2 (ErbB2) which is prominent in breast cancer, and against the EGFR-variant III (EGFRvIII) that is characteristic of glioblastoma. In preclinical trials, EO1001 has been well-tolerated and demonstrated the ability to enter the central nervous system (CNS) following oral dosing and activity against treatment-resistant EGFRvIII-driven tumors, including malignancies in CNS, in vivo. EO1001 is referred to as APL-122 by Apollomics.About Edison Oncology Edison Oncology was founded in 2018 by experienced life science industry veterans to develop and commercialize new therapies targeting the fight against cancer. Edison Oncology leverages a deep understanding of cancer biology and cancer pharmacology in order to identify and advance underdeveloped drug candidates with the potential to overcome treatment resistance and improve survival outcomes and quality of life for cancer patients.About Apollomics Inc.Apollomics Inc. is an innovative biopharmaceutical company committed to the discovery and development of monotherapies and combination therapies of tumor-targeting and immuno-oncology agents. The Company's product pipeline has several programs at different stages of development, including novel, humanized monoclonal antibodies that restore the body's immune system to recognize and kill cancer cells, and targeted therapies against uncontrolled growth signaling pathways. Apollomics has operating entities in Foster City, California, USA, Hangzhou and Shanghai, China. For more information, please visit www.apollomicsinc.com.Edison Oncology Contacts:Company Contact:Jeffrey BachaChief Executive Officer(650) 690-1927jb@eohc.comMedia and Investor Relations Contact:Amato & Partners, LLCInvestor Relations Counseladmin@amatoandpartners.comApollomics Contacts:Investor Contact:Wilson W. CheungChief Financial Officer(650) 209-4436wcheung@apollomicsinc.comU.S. Media Contact:Remy BernardaCorporate Communications(415) 203-6386remy.bernarda@apollomicsinc.comChina Media Contact:Porda Havas International Finance Communications GroupKelly FungGeneral Manager(852) 3150 6763kelly.fung@pordahavas.comPhoenix FungVice President(852) 3150 6773phoenix.fung@pordahavas.com Copyright 2021 ACN Newswire. All rights reserved. (via SEAPRWire)
FOSTER CITY, Calif. and HANGZHOU, China and MENLO PARK, CA, Feb 10, 2021 - (ACN Newswire) - Apollomics, Inc., an innovative biopharmaceutical company committed to the discovery and development of mono- and combination- oncology therapies, and Edison Oncology Holding Corp., today announced that Apollomics has been granted worldwide rights, excluding China, Hong Kong and Taiwan, for the development and commercialization of EO1001. EO1001 is a protein tyrosine kinase inhibitor (TKI) that has demonstrated irreversible inhibition of EGFR (ErbB1), HER2 (ErbB2) and HER4 (ErbB4) as a single agent. "We are excited to add EO1001 to our clinical development portfolio as its pan-erbB inhibition and well-tolerated preclinical safety profile makes it a potential targeted therapy for the treatment of solid tumor malignancies that overexpress EGFR and/or HER2," said, Sanjeev Redkar, PhD, Co-Founder and President of Apollomics. "In preclinical models, EO1001 is potent against mutations in both the intracellular and extracellular domain of EGFR and has demonstrated activity in tumors with the ability to penetrate the central nervous system. As we advance our clinical development pipeline, we continue to seek assets like EO1001 with clearly defined mechanisms of action and differentiating attributes that we believe can make a difference for cancer patients worldwide. Looking ahead, a Clinical Trial Notification (CTN) Application in Australia will be submitted to initiate a clinical trial in the second quarter of this year."Under the terms of the agreement, Apollomics has the exclusive rights to develop and commercialize EO1001 globally, except in China, Hong Kong and Taiwan. Edison Oncology will receive an upfront cash payment and will be eligible to receive potential development and sales milestone payments, as well as tiered royalties on net sales. Apollomics will be responsible for all costs related to development, regulatory approvals, and commercialization activities for EO1001 in the territories. "Our extensive and successful preclinical work with EO1001 has led us to this collaboration with Apollomics who will now advance the asset into clinical trials with their experienced development team. Over 90% of solid tumors overexpress erbB pathways, and with the data we have produced to date, we are confident that EO1001 has the potential to improve treatment outcomes for patients suffering from life-threatening cancers," concluded Jeffrey A. Bacha B. Chief Executive Officer of Edison Oncology.About EO1001 EO1001 is a protein tyrosine kinase inhibitor (TKI) that has demonstrated irreversible inhibition of EGFR (ErbB1), HER2 (ErbB2) and HER4 (ErbB4) as a single agent. EO1001 is potent against mutations in the intracellular domain of EGFR that are typically found in diseases such as Non-Small Cell Lung Cancer (NSCLC) including T790M, L858R and d746-750, and against mutations in the extracellular domain of EGFR including the EGFR-variant III (EGFRvIII) mutation that is characteristic of glioblastoma. In preclinical trials, EO1001 has been well tolerated and demonstrated activity against treatment-resistant ErbB-driven tumors, including malignancies in the central nervous system, in vivo. About Edison Oncology Edison Oncology was founded in 2018 by experienced life science industry veterans to develop and commercialize new therapies targeting the fight against cancer. Edison Oncology leverages a deep understanding of cancer biology and cancer pharmacology in order to identify and advance underdeveloped drug candidates with the potential to overcome treatment resistance and improve survival outcomes and quality of life for cancer patients. About Apollomics, Inc.Apollomics, Inc. is an innovative biopharmaceutical company committed to the discovery and development of mono- and combination- oncology therapies to harness the immune system and target specific molecular pathways to eradicate cancer. The company's existing pipeline consists of several development-stage assets, including novel, humanized monoclonal antibodies that restore the body's immune system to recognize and kill cancer cells, and targeted therapies against uncontrolled growth signaling pathways. For more information, please visit www.apollomicsinc.com.Edison Oncology Contacts:Company Contact:Jeffrey BachaChief Executive Officer(650) 690-1927jb@eohc.comMedia and Investor Relations Contact:Amato and Partners, LLCInvestor Relations Counseladmin@amatoandpartners.comApollomics Contacts:Investor Contact:Wilson W. CheungChief Financial Officer(650) 209-4436wcheung@apollomicsinc.comU.S. Media Contact:Remy BernardaCorporate Communications(415) 203-6386remy.bernarda@apollomicsinc.comChina Media Contact:Porda Havas International Finance Communications GroupKelly FungGeneral Manager(852) 3150 6763kelly.fung@pordahavas.comPhoenix FungAssistant Vice President(852) 3150 6773phoenix.fung@pordahavas.com Copyright 2021 ACN Newswire. All rights reserved. www.acnnewswire.com



