EPALINGES, Switzerland and PARIS, Jan. 24, 2024 /PRNewswire/ -- Onward Therapeutics SA (Onward Therapeutics), a global biotechnology company focused on developing innovative immunotherapies for cancer treatment, today announced that the phase 1 clinical trial of OT-A201 (Study No. A20101), a first-in-class bispecific antibody targeting two immune checkpoints is in progress..

瑞士埃帕林格斯和巴黎，2024年1月24日/PRNewswire/--Forward Therapeutics SA（Forward Therapeutics），一家专注于开发用于癌症治疗的创新免疫疗法的全球生物技术公司，今天宣布OT-A201（研究编号A20101）的第一阶段临床试验正在进行中，OT-A201是针对两个免疫检查点的一流双特异性抗体。。

The study aims to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary anti-tumoral activity of OT-A201. The study is a European multicenter and open-label study that will be conducted in two parts. The first part is a dose escalation stage of OT-A201 as single agent in patients with selected relapsed/refractory hematological malignancies or advanced/metastatic solid tumors.

该研究旨在评估OT-A201的安全性，耐受性，药代动力学，免疫原性和初步抗肿瘤活性。该研究是一项欧洲多中心开放标签研究，将分两部分进行。第一部分是OT-A201作为单一药物在选择性复发/难治性血液系统恶性肿瘤或晚期/转移性实体瘤患者中的剂量递增阶段。

The second part is an expansion stage that will further evaluate the safety and preliminary anti-tumoral activity of OT-A201 as monotherapy or in combination in defined hematological malignancies and solid tumors at the dose(s) selected from the first part..

第二部分是一个扩展阶段，将进一步评估OT-A201作为单一疗法或以从第一部分中选择的剂量联合用于确定的血液系统恶性肿瘤和实体瘤的安全性和初步抗肿瘤活性。。

Onward Therapeutics licensed the exclusive worldwide rights of development, manufacture, and commercialization of OT-A201 from Biomunex Pharmaceuticals (Biomunex), a biopharmaceutical company discovering and developing bi- and multi-specific antibodies, in February 2021. Onward Therapeutics and Biomunex will co-develop this bispecific antibody until the completion of the phase 1 study in one of the indications.

Forward Therapeutics于2021年2月从发现和开发双特异性和多特异性抗体的生物制药公司BioMune Pharmaceuticals（BioMune）获得OT-A201的全球独家开发，制造和商业化权利。Forward Therapeutics和Biomune将共同开发这种双特异性抗体，直到其中一项适应症的1期研究完成。

Dosing of the first patient has triggered an undisclosed amount of milestone payment to Biomunex..

第一名患者的剂量引发了向Biomunex支付的里程碑金额的未披露金额。。

'With the drug development expertise and successful track records of the Onward Therapeutics team, we have moved forward from the cell line development, scale up, 1,000-liter manufacture, preclinical pharmacology and toxicology studies, as well as clinical development and regulatory application of OT-A201 rapidly and efficiently.

“凭借forward Therapeutics团队的药物开发专业知识和成功记录，我们已经从细胞系开发，规模扩大，1000升制造，临床前药理学和毒理学研究以及OT-A201的临床开发和监管应用快速有效地向前迈进。

We are enthusiastic to test OT-A201 for the first time in patients. The study marks an important milestone of Onward Therapeutics in transitioning into a clinical stage company. It also represents a step forward in advancing innovative projects based on our 'buy-to-build' business model', said Dr. C.

我们热衷于首次在患者中测试OT-A201。这项研究标志着Forward Therapeutics向临床阶段公司转型的重要里程碑。C博士说，这也代表着在推进基于我们“买来建去”商业模式的创新项目方面向前迈出了一步。

Grace Yeh, Chairman and CEO..

董事长兼首席执行官Grace Yeh。。

'Despite the recent advances in cancer immunotherapy, there is still a significant unmet need for new treatment options to improve clinical outcome. OT-A201 offers an effective strategy to overcome tumor resistance and to provide better anti-tumor effects. This bispecific antibody has shown excellent in vitro and in vivo activity and safety, opening up the possibility of a favorable therapeutic window.

“尽管最近在癌症免疫治疗方面取得了进展，但仍然需要新的治疗选择来改善临床结果。OT-A201提供了克服肿瘤抗性并提供更好的抗肿瘤作用的有效策略。这种双特异性抗体已显示出优异的体外和体内活性和安全性，开辟了有利的治疗窗口的可能性。

We are looking forward to providing clinically meaningful information from this study to bring a differentiated approach in difficult-to-treat cancer patients', said Dr. Alain Herrera, Chief Medical Officer..

我们期待着从这项研究中提供具有临床意义的信息，为难以治疗的癌症患者带来差异化的方法”，首席医疗官阿兰·埃雷拉博士说。。

About OT-A201

关于OT-A201

OT-A201 is a first-in-class humanized bispecific antibody targeting two immune checkpoints.  With the potential synergistic anti-cancer effects, it is being evaluated as a new treatment for advanced hematological malignancies and solid tumors. In preclinical studies, OT-A201 has demonstrated excellent specificity, safety and displayed significant anti-tumoral activities at different doses with the potential for a wider therapeutic window as compared to its parental antibodies.

OT-A201是针对两个免疫检查点的一流人源化双特异性抗体。它具有潜在的协同抗癌作用，正在被评估为晚期血液系统恶性肿瘤和实体瘤的新疗法。在临床前研究中，OT-A201表现出优异的特异性，安全性，并且在不同剂量下显示出显着的抗肿瘤活性，与其亲本抗体相比，具有更宽的治疗窗口的潜力。

Based on the proprietary structure generated from the BiXAb technology of Biomunex, OT-A201 possesses a functional Fc domain in contributing to ADCC activity against tumor cells. It has demonstrated good pairing, low aggregation, high stability, and good manufacturability..

基于Biomunex的BiXAb技术产生的专有结构，OT-A201具有功能性Fc结构域，有助于ADCC对肿瘤细胞的活性。它表现出良好的配对，低聚集，高稳定性和良好的可制造性。。

About Onward Therapeutics

关于前进疗法

Onward Therapeutics SA is a clinical stage company focusing on the identification and development of innovative therapies for the treatment of cancer. The company, led by an experienced team in translational science and drug development, adopts a ' buy-to-build' business model. The company has licensed a bispecific antibody (OT-A201) from Biomunex (www.biomunex.com) and also made equity investment in the company.

Forward Therapeutics SA是一家临床阶段公司，专注于识别和开发用于治疗癌症的创新疗法。该公司由一支经验丰富的转化科学和药物开发团队领导，采用“买来建去”的商业模式。该公司已从Biomune（www.biomune.com）获得双特异性抗体（OT-A201）的许可，并对该公司进行了股权投资。

It is also pursuing the development of an allogeneic, off-the-shelf natural killer cell therapy (NK-001 / OT-C001) with its majority owned company, Emercell SAS, as well as sponsoring an onco-metabolism program from Institut du Cancer de Montpellier. The company is headquartered at Biopôle (a life sciences campus in Epalinges), near Lausanne, Switzerland, has an affiliate in Paris, France, and an office in Taipei, Taiwan.

它还与其控股公司Emercell SAS合作开发同种异体现成的自然杀伤细胞疗法（NK-001/OT-C001），并赞助蒙彼利埃癌症研究所的肿瘤代谢计划。该公司总部位于瑞士洛桑附近的Biopôle（Epalinges的生命科学校区），在法国巴黎设有分支机构，在台湾台北设有办事处。

For more details, www.onward-therapeutics.com..

有关更多详细信息，请访问www.forward-therapeutics.com。。

SOURCE Onward Therapeutics

来源继续治疗