SynOx is developing emactuzumab - a potential best-in-class, next-generation CSF1(R) inhibiting monoclonal antibody

SynOx正在开发emactuzumab-一种潜在的同类最佳的下一代CSF1（R）抑制单克隆抗体

Provides flexible loan facility to support additional clinical work and activities to drive its successful registration and commercialisation

提供灵活的贷款机制，支持额外的临床工作和活动，以推动其成功注册和商业化

Funding is additional to recent $75m Series B financing

资金是最近7500万美元B系列融资的补充

DUBLIN and OXFORD, England, April 30, 2024 /PRNewswire/ -- SynOx Therapeutics Limited ('SynOx' or the 'Company'), the late-stage clinical biopharmaceutical company developing emactuzumab for the treatment of Tenosynovial Giant Cell Tumour (TGCT) and other diseases, today announces it has entered into a $35m loan facility with Hercules Capital, Inc.

都柏林和牛津，英国，2024年4月30日/PRNewswire/--SynOx Therapeutics Limited（“SynOx”或“公司”），一家开发emactuzumab治疗腱鞘巨细胞瘤（TGCT）和其他疾病的晚期临床生物制药公司，今天宣布，它已与Hercules Capital，Inc.签订了3500万美元的贷款协议。

(NYSE: HTGC) ('Hercules')..

（纽约证券交易所：HTGC）（“大力神”）。。

The transaction strengthens the Company's balance sheet as it executes TANGENT, a registrational Phase 3 study of emactuzumab, SynOx's potentially best-in-class CSF-1(R) inhibiting monoclonal antibody (mAb) for the treatment of TGCT.

该交易加强了公司的资产负债表，因为它执行了TANGENT，一项针对emactuzumab的注册3期研究，该研究是SynOx用于治疗TGCT的潜在最佳CSF-1（R）抑制单克隆抗体（mAb）。

This loan facility provides SynOx with flexibility to fund additional clinical work in TGCT to augment TANGENT, activities to support the successful registration and commercialisation of emactuzumab in TGCT, and potentially to explore the use of emactuzumab in other CSF-1 driven and macrophage-mediated diseases. .

该贷款机制为SynOx提供了灵活性，可以为TGCT的额外临床工作提供资金，以增强切线，支持在TGCT中成功注册和商业化emactuzumab的活动，并有可能探索在其他CSF-1驱动和巨噬细胞介导的疾病中使用emactuzumab。。

The term loan facility provides up to $35m, in total, in four tranches. The initial tranche was drawn on signing, with subsequent tranches available over the medium term and upon achievement of certain clinical milestones.

定期贷款分四批提供总计3500万美元。最初的部分是在签署时提取的，随后的部分在中期内以及在达到某些临床里程碑时可用。

Ray Barlow, Chief Executive Officer of SynOx Therapeutics, said: 'This funding will provide SynOx with additional capital to fulfil its mission of establishing emactuzumab as a best-in-class drug, to address significant unmet medical needs and greatly improve the quality of life for as many patients as possible.

SynOx Therapeutics首席执行官雷·巴洛（RayBarlow）表示：“这笔资金将为SynOx提供额外资金，以履行其将emactuzumab打造为一流药物的使命，解决尚未满足的重大医疗需求，并大大提高尽可能多患者的生活质量。

We are grateful for the support from Hercules, which together with the $75m we raised recently in our Series B round, puts SynOx on a strong financial footing.' .

我们非常感谢大力神的支持，加上我们最近在B轮融资中筹集的7500万美元，使SynOx拥有了强大的财务基础。”。

R. Bryan Jadot, Senior Managing Director and Group Head - Life Sciences, Hercules, said: 'We have been impressed by the quality of data SynOx has already generated on emactuzumab, which demonstrate it to be highly differentiated from other CSF-1 inhibiting drugs in development. Emactuzumab is showing great promise in treating TGCT, and we believe it has the potential to treat other related conditions as well.'.

R、 赫拉克勒斯生命科学集团高级董事总经理兼集团负责人布莱恩·贾多特（BryanJadot）说：“SynOx已经在emactuzumab上产生了高质量的数据，这给我们留下了深刻的印象，这表明它与开发中的其他CSF-1抑制药物有着高度的区别。Emactuzumab在治疗TGCT方面显示出巨大的前景，我们相信它也有可能治疗其他相关疾病。”。

TGCT is a type of tumour that affects the soft tissue lining of joints and tendons. It is a highly debilitating disease that often impacts large, important joints such as the knee, hip and ankle. It seriously impacts quality of life by causing significant pain and stiffness in affected joints and limiting range of motion.

TGCT是一种影响关节和肌腱软组织衬里的肿瘤。这是一种非常虚弱的疾病，通常会影响膝盖，臀部和脚踝等重要的大关节。它通过在受影响的关节中引起明显的疼痛和僵硬以及限制运动范围而严重影响生活质量。

While most patients receive surgical intervention, more than 50% of patients with diffuse disease experience tumour recurrence within three years of surgery[1]..

虽然大多数患者接受手术干预，但超过50%的弥漫性疾病患者在手术后三年内会出现肿瘤复发[1]。。

Emactuzumab, a novel next-generation CSF-1R mAb with a potentially best-in-class profile, has demonstrated substantial clinical activity in earlier clinical work in TGCT[2], with an objective response rate (ORR) of 71%, rapid and robust tumour reduction, a long duration of effect, significant improvements in functional ability, good tolerability and a manageable safety profile.

Emactuzumab是一种新型的下一代CSF-1R单克隆抗体，具有潜在的同类最佳特征，在TGCT（2）的早期临床工作中表现出显着的临床活性，客观缓解率（ORR）为71%，快速而稳健的肿瘤减少，持续时间长，功能能力显着改善，耐受性好，安全性可控。

The Phase 3 TANGENT trial will assess its safety and efficacy in patients with localized and diffuse TGCT..

3期TANGENT试验将评估其在局限性和弥漫性TGCT患者中的安全性和有效性。。

About SynOx TherapeuticsSynOx Therapeutics Limited is a Dublin and Oxford -based, late-stage clinical biopharmaceutical company developing emactuzumab, a best-in-class monoclonal antibody against CSF-1R, for the treatment of Tenosynovial Giant Cell Tumour (TGCT) and other CSF-1 related and macrophage driven disorders. SynOx is led by an experienced team of industry professionals with a successful track record of developing and bringing products to commercialisation.

关于SynOx Therapeutics SynOx Therapeutics Limited是一家位于都柏林和牛津的晚期临床生物制药公司，开发emactuzumab，一种一流的抗CSF-1R单克隆抗体，用于治疗腱鞘巨细胞瘤（TGCT）和其他CSF-1相关和巨噬细胞驱动的疾病。SynOx由经验丰富的行业专业人员团队领导，他们在产品开发和商业化方面取得了成功。

It is backed by a strong syndicate of premier life science investors including Forbion, HealthCap, BioQube, Hercules Capital, Inc. and Medicxi..

它得到了包括Forbion、HealthCap、BioQube、Hercules Capital，Inc.和Medicxi在内的顶级生命科学投资者的强大财团的支持。。

About Tenosynovial Giant Cell Tumour (TGCT)Tenosynovial Giant Cell Tumour (TGCT), previously termed pigmented villonodular synovitis (PVNS), is a type of tumour that affects the soft tissue lining of joints and tendons. TGCTs are categorised as fibrohistiocytic tumours by the WHO classification and are subclassified based on growth patterns (localised- and diffuse types) and location (tendon sheath, and intra- and extra-articular forms).

关于腱鞘巨细胞瘤（TGCT）腱鞘巨细胞瘤（TGCT），以前称为色素沉着绒毛结节性滑膜炎（PVNS），是一种影响关节和肌腱软组织衬里的肿瘤。根据世界卫生组织的分类，TGCT被归类为纤维组织细胞肿瘤，并根据生长模式（局部和弥漫型）和位置（腱鞘以及关节内和关节外形式）进行亚分类。

TGCTs are locally destructive and can be aggressive tumours. TGCT is a chronically debilitating disease which often impacts patients throughout their lives. It causes loss of function of the affected joints, pain, stiffness, limited range of motion and a significant impact on the quality of life as a result.

TGCT具有局部破坏性，可能是侵袭性肿瘤。TGCT是一种慢性衰弱性疾病，通常会影响患者的一生。它会导致受影响关节的功能丧失，疼痛，僵硬，运动范围有限，并因此对生活质量产生重大影响。

Most patients receive surgical intervention, with 3-year post-surgery recurrence rates in more than 50% of patients[3]. Symptoms typically progress slowly but can be aggressive and destructive. If left untreated complications include moderate to severe joint deformity, degenerative articular changes, and osteoarthritis, which if severe enough, can lead to cortical bone destruction and occasionally the need for arthrodesis or amputation..

大多数患者接受手术干预，超过50%的患者术后3年复发率（3）。症状通常进展缓慢，但可能具有侵略性和破坏性。如果不及时治疗，并发症包括中度至重度关节畸形，退行性关节改变和骨关节炎，如果足够严重，可能导致皮质骨破坏，偶尔需要进行关节融合术或截肢。。

About CSF-1 and EmactuzumabCSF-1 (or macrophage colony-stimulating factor) is a cytokine that binds to the CSF-1 receptor (CSF-1R), expressed on macrophages and certain other cells, with effects on production, differentiation, and function of these cells. Emactuzumab is a humanised IgG1 CSF-1R targeted antibody that inhibits and depletes macrophages in the tumour tissue.

关于CSF-1和EmactuzumabCSF-1（或巨噬细胞集落刺激因子）是一种与巨噬细胞和某些其他细胞上表达的CSF-1受体（CSF-1R）结合的细胞因子，对这些细胞的产生，分化和功能有影响。Emactuzumab是一种人源化IgG1 CSF-1R靶向抗体，可抑制和消耗肿瘤组织中的巨噬细胞。

Emactuzumab was originally discovered and developed by Roche and has been tested in several phase 1/b studies as a monotherapy and in combination with other agents, including chemotherapeutics and immunotherapies. In clinical studies as a monotherapy in 63 patients with TGCT, emactuzumab has shown a substantial effect on tumour response (ORR ~71%) and was well tolerated2.

Emactuzumab最初由罗氏公司发现和开发，并已作为单一疗法和与其他药物（包括化学疗法和免疫疗法）联合使用，在多个1/b期研究中进行了测试。在63例TGCT患者的单药治疗临床研究中，emactuzumab对肿瘤反应有显着影响（ORR〜71%），耐受性良好2。

Emactuzumab is a novel monoclonal antibody inhibiting CSF-1R that offers a short course of treatment. Phase I/II studies indicated good tolerability and a manageable safety profile and substantial preliminary efficacy in TGCT patients with rapid, robust tumour reduction and durable response. Emactuzumab may also have utility in other macrophage driven diseases and the company is actively considering potential options in these areas..

Emactuzumab是一种抑制CSF-1R的新型单克隆抗体，可提供短期治疗。I/II期研究表明，TGCT患者具有良好的耐受性和可控的安全性，并且具有快速，强大的肿瘤减少和持久的反应。Emactuzumab也可能用于其他巨噬细胞驱动的疾病，该公司正在积极考虑这些领域的潜在选择。。

Lin F, et. al. JHEOR, 2022.

林F等人，乔尔，2022年。

Cassier et al. 'Long-term clinical activity, safety and patient-reported quality of life for emactuzumab-treated patients with diffuse-type tenosynovial giant-cell tumour' European Journal of Cancer 141:162-170, 2020

Cassier等人，《emactuzumab治疗的弥漫型腱鞘巨细胞瘤患者的长期临床活动，安全性和患者报告的生活质量》，欧洲癌症杂志141:162-1702020

SOURCE SynOx Therapeutics

来源SynOx Therapeutics