BELOIT, Wis. & CAMBRIDGE, Mass.--(BUSINESS WIRE)--NorthStar Medical Radioisotopes, LLC, a global innovator in the development, production, and commercialization of radiopharmaceuticals used for therapeutic applications and medical imaging, and Convergent Therapeutics, Inc., a clinical stage radiopharmaceutical company, today announced the signing of a strategic contract manufacturing services agreement.

威斯康星州贝洛伊特（BELOIT）和马萨诸塞州剑桥（CAMBRIDGE），北星医用放射性同位素有限责任公司（NorthStar Medical Radiosopes，LLC），一家用于治疗应用和医学成像的放射性药物开发、生产和商业化的全球创新者，以及临床阶段放射性药物公司Convergent Therapeutics，Inc.，今天宣布签署战略合同制造服务协议。

Convergent’s lead asset CONV01-α is a prostate-specific membrane antigen (PSMA)-targeted monoclonal antibody linked to Ac-225 and is currently being investigated as a treatment for prostate cancer..

Convergent的主要资产CONV01-α是一种与Ac-225相连的前列腺特异性膜抗原（PSMA）靶向单克隆抗体，目前正在研究作为前列腺癌的治疗方法。。

Under the terms of the expanded collaboration, NorthStar will:

根据扩大合作的条款，北极星将：

Provide Convergent with its environmentally preferred, high purity non-carrier-added (n.c.a) Ac-225 for use in CONV01-α,

为Convergent提供环境优选的高纯度非载体添加（n.c.a）Ac-225，用于CONV01-α，

Utilize its new, state-of-the-art contract development and manufacturing facility to manufacture CONV01-α to serve patients in Convergent’s clinical trials, and

利用其最新、最先进的合同开发和制造设施制造CONV01-α，为Convergent的临床试验中的患者提供服务，以及

Perform research and development activities to support continued development of CONV01-α and other Convergent assets.

开展研发活动，支持CONV01-α和其他融合资产的持续开发。

In March of this year, Convergent received U.S. Food and Drug Administration ('FDA') clearance for its investigational new drug ('IND') application for CONV01-α, a key milestone that enables Convergent to advance CONV01-α into Phase 2 studies and expand the scope of clinical development of CONV01-α as a monotherapy and in combination with other cancer therapies.

今年3月，Convergent获得美国食品和药物管理局（FDA）批准其研究性新药（IND）申请CONV01-α，这是Convergent将CONV01-α推进2期研究的关键里程碑，并扩大了CONV01-α作为单一疗法以及与其他癌症疗法相结合的临床开发范围。

The manufacturing supply agreement announced today will support these trials and, if U.S. FDA approved, the manufacturing of CONV01-α for commercial purposes..

今天宣布的制造供应协议将支持这些试验，如果美国食品和药物管理局批准，将支持用于商业目的的CONV01-α的制造。。

“The last several years have seen an explosion of research and clinical trials in the area of radiotherapies, especially those using Ac-225,” said Frank Scholz, Chief Executive Officer of NorthStar, “and yet today there are still far too few effective therapies for patients suffering from a variety of serious diseases including many cancers.

NorthStar首席执行官弗兰克·斯科尔斯（FrankScholz）表示：“过去几年，放射治疗领域的研究和临床试验呈爆炸式增长，尤其是那些使用Ac-225的放射治疗领域。然而，对于患有多种严重疾病（包括许多癌症）的患者来说，有效的治疗方法仍然太少。

Why? Because the processes to develop, manufacture and deliver therapeutically effective radiopharmaceuticals like Convergent’s CONV01-α to market – in particular at a scale able to meet patient demand for an approved, marketed medicine -- are highly specialized and complex. At NorthStar, our passion is to reduce technological and operational barriers to help companies like Convergent Therapeutics not only secure a reliable source of Ac-225, but manufacture a finished, patient-ready drug product and continue to develop new and additional therapeutic indications for the patients who need new and better medicines.

为什么？因为开发、制造和向市场交付Convergent的CONV01-α等具有治疗效果的放射性药物的过程，特别是能够满足患者对已批准上市药物的需求的规模，是高度专业化和复杂的。在北极星，我们的热情是减少技术和运营障碍，以帮助像Convergent Therapeutics这样的公司不仅获得Ac-225的可靠来源，而且制造成品，为患者准备好的药物产品，并继续为需要新药和更好药物的患者开发新的和额外的治疗适应症。

We are proud to be supporting Convergent and look forward to working with them to help make new medicines like CONV01-α therapeutic reality.”.

我们很自豪能够支持Convergent，并期待与他们合作，帮助制造像CONV01-α治疗现实这样的新药。”。

“We are excited to expand our partnership with NorthStar and the opportunity to leverage NorthStar’s unique position to scale both Ac-225 generation and manufacturing capacity,” said Caitlyn Harvey, Head of Manufacturing at Convergent. “Convergent will begin enrolling patients into the CONVERGE-01 Phase 2 clinical trial in the next couple of months as we continue building on extensive clinical experience which will allow us to rapidly move into our Phase 3 study.”.

Convergent制造主管凯特琳·哈维（CaitlynHarvey）表示：“我们很高兴扩大与北极星的合作关系，并有机会利用北极星的独特地位来扩大Ac-225的发电量和制造能力。”。“Convergent将在未来几个月开始招募患者参加Convergene-01 2期临床试验，因为我们将继续积累丰富的临床经验，这将使我们能够迅速进入我们的3期研究。”。

About CONV01-α

关于CONV01-a

CONV01-α, Convergent's alpha emitting radioantibody, combines the precision and pharmacokinetics of antibodies with the tumor-killing potential of alpha emitting radionuclides. Specifically, CONV01-α uses a humanized monoclonal antibody targeted at prostate-specific membrane antigen (PSMA) which is highly overexpressed in prostate cancer cells.

CONV01-α是Convergent的α发射放射性抗体，它将抗体的精确度和药代动力学与α发射放射性核素的肿瘤杀伤潜力相结合。具体而言，CONV01-α使用靶向前列腺特异性膜抗原（PSMA）的人源化单克隆抗体，其在前列腺癌细胞中高度过表达。

Since PSMA is a validated target, several therapeutics are directed at this antigen and CONV01-α is differentiated by its use of both an antibody and alpha emitter. CONV01-α is linked to a powerful radionuclide called Ac-225, which releases alpha particles which kill cancer cells through DNA double strand breaks.

由于PSMA是经过验证的靶标，因此有几种治疗方法针对该抗原，而CONV01-α通过使用抗体和α发射器来区分。CONV01-α与一种强大的放射性核素Ac-225有关，Ac-225释放α粒子，通过DNA双链断裂杀死癌细胞。

Unlike other radioactive sources, alpha particles deliver high-energy radiation over very short distances, thereby minimizing radiation exposure to healthy neighboring cells and tissues. Pairing highly selective antibodies with such a powerful yet precise payload offers the ideal combination to treat many types of cancers..

与其他放射源不同，α粒子在很短的距离内传递高能辐射，从而最大程度地减少对健康邻近细胞和组织的辐射暴露。将高选择性抗体与如此强大而精确的有效载荷配对，是治疗多种癌症的理想组合。。

About Convergent Therapeutics, Inc.

关于Convergent Therapeutics，Inc。

Convergent Therapeutics Inc. is a clinical-stage biotechnology company focused on developing tumor-selective alpha radioantibodies to target cancer. The company was founded by world-renowned experts in clinical care and research, drug development and cancer biology and its proprietary platform is licensed from Cornell University.

Convergent Therapeutics Inc.是一家临床阶段生物技术公司，专注于开发针对癌症的肿瘤选择性α放射性抗体。该公司由临床护理和研究、药物开发和癌症生物学领域的世界知名专家创建，其专有平台由康奈尔大学授权。

In harnessing the selectivity of antibodies and tumor-destructive potential of alpha radioisotopes, Convergent's radioantibodies precisely target cancer cells with potent, localized radiation. For more information, please visit www.convergentrx.com and follow us on Twitter and LinkedIn..

在利用抗体的选择性和α放射性同位素的肿瘤破坏潜力时，Convergent的放射性抗体精确地靶向具有有效局部辐射的癌细胞。有关更多信息，请访问www.convergentrx.com，并在Twitter和LinkedIn上关注我们。。

About NorthStar Medical Radioisotopes, LLC (NorthStar)

关于北极星医用放射性同位素有限责任公司（北极星）

NorthStar Medical Radioisotopes is a commercial-stage radiopharmaceutical company at the forefront of advancing patient care by utilizing novel technologies to produce commercial-scale radioisotopes that, once attached to a molecule, have the ability to detect and treat cancer and other serious diseases.

NorthStar Medical Radiosopes是一家处于商业阶段的放射性制药公司，它利用新技术生产商业规模的放射性同位素，一旦附着在分子上，就能够检测和治疗癌症和其他严重疾病，处于推进患者护理的最前沿。

NorthStar’s expanding industry-leading position in the emerging field of radiopharmaceutical therapy is supported by its unique capabilities in the sophisticated production of radioisotopes, proven management team, and state-of-the-art, environmentally preferable technologies. NorthStar routinely produces copper-67 (Cu-67) and is poised to be the first commercial-scale producer of non-carrier-added (n.c.a.) actinium-225 (Ac-225).

北极星在新兴的放射性药物治疗领域不断扩大的行业领先地位，得益于其在复杂的放射性同位素生产、成熟的管理团队以及最先进的环保技术方面的独特能力。北极星通常生产铜-67（Cu-67），并有望成为第一家非载体添加（n.c.a.）锕-225（Ac-225）的商业规模生产商。

The Company’s Radiopharmaceutical Contract Development and Manufacturing Organization (CDMO) services unit provides customized service offerings and specialized radiopharmaceutical expertise to help biopharmaceutical companies rapidly advance their development and commercial programs. For more information about NorthStar’s comprehensive portfolio and patient-focused services, visit: www.northstarnm.com..

该公司的放射性药物合同开发和制造组织（CDMO）服务部门提供定制服务和专业的放射性药物专业知识，以帮助生物制药公司快速推进其开发和商业计划。有关北极星综合投资组合和以患者为中心的服务的更多信息，请访问：www.northstarnm.com。。