A company developing a form of cancer immunotherapy using genetically engineered viruses and partnered with Merck & Co. has closed a $22 million round of funding.
Santa Ana, California-based Cold Genesys said Monday it had closed the Series C funding round. Lead investor ORI Healthcare Fund led the round, with participation from Perseverance Capital Management.
The company plans to use the money for continuing the development of its oncolytic immunotherapy, CG0070, which has completed a Phase II study in non-muscle-invasive bladder cancer, also known as NMIBC.
CG0070 is based on a modified common cold adenovirus, which contains a promoter specific to the cancer and a GM-CSF transgene. It is designed to replicate inside the tumor’s cells, causing them to die. When they rupture, they release tumor-derived antigens and the GM-CSF, which thus stimulates a systemic anti-tumor immune response via the body’s own white blood cells.
The mechanism of action is similar to that of an approved oncolytic virus therapy, Amgen’s Imlygic (talimogene laherparepvec), which the Food and Drug Administration approved in 2015 for treatment of melanoma that has recurred after initial surgery, but can no longer be surgically removed. However, Imlygic has not been shown to improve overall survival.
Like CG0070, Imlygic has a GM-CSF gene added, but unlike Cold Genesys, it uses a herpes virus instead of a common cold virus.
CG0070 will also be explored in muscle-invasive bladder cancer, in combination with a monoclonal antibody targeting CTLA4. The company is developing a CTLA4 antibody in-house, CG0161. Bristol-Myers Squibb has an approved drug with the same target, Yervoy (ipilimumab).
In November, the company announced a partnership with Merck to combine CG0070 with the PD-1 checkpoint inhibitor drug Keytruda (pembrolizumab) in a Phase II study, also in NMIBC. The trial is enrolling patients whose disease is unresponsive to bacillus Calmette-Guerin, who represent an unmet medical need, with no treatment approved by the FDA for about 20 years. According to the ClinicalTrials.gov database, the completed Phase II study of CG0070 was also in patients who failed on BCG treatment. Keytruda is approved for certain patients with urothelial carcinoma, the most common form of bladder cancer.
一家公司利用基因工程病毒开发出一种癌症免疫疗法，并与默克公司（ Merck & Co .）合作，已经完成了一轮2200万美元的资助。
总部位于加州圣安娜的 ColdGenesys 周一表示，已经结束了 C 轮融资。主要投资者 ORI 医疗基金在 Perstance Capital Management 的参与下，引领了本轮融资。
公司拟使用该笔资金继续开展溶瘤免疫治疗， CG0070，已完成无肌肉侵袭性膀胱癌 II 期研究，也称 NMIBC 。
CG0070是基于一种改良的普通冷腺病毒，它含有一种针对癌症的启动子和一种转基因的 GM-CSF 基因。它被设计成在肿瘤细胞内复制，导致肿瘤细胞死亡。当它们破裂时，它们释放肿瘤源性抗原和 GM-CSF ，从而通过自身的白细胞刺激系统性抗肿瘤免疫反应。
其作用机制类似于经批准的溶瘤病毒疗法 Amgen's Imlygic ( talmobilene laherparepvec )，该疗法于2015年获得食品药品监督管理局（Food and Drug Administration）批准，用于治疗首次手术后复发但无法手术切除的黑色素瘤。然而， Imlygic 并未被证明能改善整体生存。
和 CG0070一样， Imlygic 有一个 GM-CSF 基因，但与 ColdGenesys 不同，它使用疱疹病毒而不是普通感冒病毒。
CG0070还将被用于肌肉浸润性膀胱癌，结合针对 CTLA4的单克隆抗体。公司正在自行研发 CTLA4抗体 CG0161。百时美施贵宝（ Bristol-MyersSquibb ）拥有相同靶点的批准药物 Yervoy 。
11月，公司宣布与默克（Merck）公司合作，将 CG0070与 PD-1检查点抑制剂药物可瑞达（Keytruda）（ pembrolizumab ）进行二期研究，也在 NMIBC 。该试验正在招募患者，他们的疾病没有反应芽孢杆菌 Calmette-Guerin ，谁代表了一个未满足的医疗需要，没有得到 FDA 批准的治疗大约20年。根据临床试验。政府数据库，完成第二阶段研究 CG0070也是在患者谁失败的 BCG 治疗。可瑞达（Keytruda）被批准用于某些尿路上皮癌，最常见的膀胱癌。