LONDON & CHICAGO--(BUSINESS WIRE)--Anova Enterprises, Inc. (Anova), a technology enabled CRO dedicated to accelerating promising treatments, has collaborated with University of California at San Francisco (UCSF), University of California at San Diego (UCSD), the University of Southern California (USC) and Denovo Biopharma to manage a newly awarded $11.8M California Institute for Regenerative Medicine (CIRM) grant to support the development of DB107 in patients with newly diagnosed high-grade glioma..

伦敦和芝加哥--（商业新闻短讯）--Anova Enterprises，Inc.（Anova）是一家致力于加速有希望的治疗的技术支持CRO，已与加利福尼亚大学旧金山分校（UCSF），加利福尼亚大学圣地亚哥分校（UCSD），南加州大学（USC）和Denovo Biopharma合作，管理新授予的1180万美元加利福尼亚再生医学研究所（CIRM）赠款，以支持新诊断的高级别胶质瘤患者开发DB107。。

In December of 2021, Denovo Biopharma announced discovery of a novel genetic biomarker, Denovo Genomic Marker 7 (DGM7TM), by leveraging Tocagen’s randomized 403-patient Phase 3 study in recurrent high-grade glioma (HGG) that had didn’t achieve its primary endpoint, but that had subsets of patients who received clear benefit.

2021年12月，Denovo Biopharma宣布发现了一种新的遗传生物标志物，即Denovo基因组标志物7（DGM7TM），方法是利用Tocagen的403例复发性高级别胶质瘤（HGG）患者的随机3期研究，该研究尚未达到其主要终点，但有一部分患者获得了明显的益处。

DGM7 has been shown to be associated with increased overall survival with treatment of recurrent HGG, via retrospective analysis..

通过回顾性分析，DGM7已被证明与治疗复发性HGG的总生存率增加有关。。

Anova was approached to assist with the development of the product and was instrumental organizing leading neuro-scientists, developing the study plans, securing FDA approval, preparing the CIRM application, and securing the ultimate CIRM award.

方差分析被用来协助产品的开发，并有助于组织领先的神经科学家，制定研究计划，获得FDA批准，准备CIRM申请，并获得最终的CIRM奖。

The Phase 1/2a clinical trial is a multicenter, open-label study designed to confirm whether treatment DB107, when added to standard-of-care (SOC), provides clinical benefit to patients with newly diagnosed HGG when compared to historical performance.

1/2a期临床试验是一项多中心，开放标签的研究，旨在确认治疗DB107在加入标准治疗（SOC）后，与历史表现相比，是否为新诊断的HGG患者提供临床益处。

“I am excited to see DB107 heading back into the clinic” said Noriyuki Kasahara, MD, PhD, Principal Investigator, Brain Tumor Research Center (BTRC) at University of California, San Francisco (UCSF). “Outcomes in patients newly diagnosed with HGG are essentially unchanged for 40 years and confirming DB107 works in patients with the DGM7 biomarker may change outcomes in those patients for the better”.

加州大学旧金山分校（UCSF）脑肿瘤研究中心（BTRC）首席研究员、医学博士Noriyuki Kasahara说：“我很高兴看到DB107重返诊所。”。“新诊断为HGG的患者的结果在40年内基本没有变化，证实DB107对DGM7生物标志物患者有效可能会更好地改变这些患者的预后”。

“Our partnership with Denovo Biopharma, UCSD, UCSF and USC is another example of Anova’s ability to efficiently navigate the complexities of bringing newly discovered, or even orphaned, drugs through development for early to mid-stage bio pharmaceutical companies ultimately improving access to promising new treatments for patients in need” said Chris Beardmore, CEO at Anova..

Anova首席执行官克里斯·贝尔德莫尔（ChrisBeardmore）表示：“我们与Denovo Biopharma、UCSD、UCSF和USC的合作关系是Anova能够有效应对通过开发早期至中期生物制药公司带来新发现甚至孤儿药物的复杂性的另一个例子，最终改善了有希望的新疗法对有需要的患者的获取。”。。

To find out more contact info.us@anovaevidence.com.

了解更多联系人info.us@anovaevidence.com.

About Denovo’s RRV Platform and DB107

关于Denovo的RRV平台和DB107

DB107 is an innovative approach utilizing a proprietary gene therapy platform, recombinant retroviral vector (RRV) bearing cytosine deaminase, combined with a prodrug of 5-FU (5-FC), to selectively infect and kill cancer cells while stimulating a robust and durable anti-cancer immune response against a tumor with minimal toxicity.

DB107是一种创新方法，利用专有的基因治疗平台，携带胞嘧啶脱氨酶的重组逆转录病毒载体（RRV）与5-FU（5-FC）的前药相结合，选择性感染和杀死癌细胞，同时刺激针对肿瘤的强大而持久的抗癌免疫反应，毒性最小。

DB107 has been tested clinically in solid tumors including recurrent high-grade GBM and colorectal cancer, most recently in a randomized 403-patient Phase 3 trial. DB107 received Orphan Drug Designation in GBM from the FDA and EMA, and Fast Track Designation from the FDA..

DB107已经在包括复发性高级别GBM和结直肠癌在内的实体瘤中进行了临床测试，最近在一项403名患者的随机3期临床试验中进行了测试。DB107获得了FDA和EMA在GBM中的孤儿药指定，以及FDA的快速通道指定。。

About Anova

关于方差分析

Anova Enterprises, Inc. (Anova) is technology enabled CRO committed to accelerating clinical development for start-up to mid-size biopharmaceutical companies utilizing the company’s proprietary technology platform (AnovaOS™). For more information, please visit www.anovaevidence.com.

Anova Enterprises，Inc.（Anova）是一家技术型CRO，致力于利用公司专有技术平台（AnovaOS™）加速中型生物制药公司的临床开发。有关更多信息，请访问www.anovaveedience.com。

About Denovo Biopharma

关于Denovo Biopharma

Denovo Biopharma LLC (Denovo) is a clinical‑stage biopharmaceutical company that uses a novel biomarker discovery platform including whole genome sequencing (WGS) and artificial intelligence (AI) to find new genetic biomarkers predictive of drug efficacy, and then uses these biomarkers to execute efficient clinical trials in targeted patient populations to increase the probability of success.

Denovo Biopharma LLC（Denovo）是一家临床阶段的生物制药公司，它使用包括全基因组测序（WGS）和人工智能（AI）在内的新型生物标志物发现平台来寻找预测药物疗效的新遗传生物标志物，然后使用这些生物标志物在目标患者人群中进行有效的临床试验，以增加成功的可能性。

Denovo has eight late‑stage drugs in its pipeline addressing major unmet medical needs in oncology and central nervous system diseases; most of the pipeline are first‑in‑class drugs with global rights. Denovo recently announced a major breakthrough in treatment‑resistant depression (TRD) with its DGM4™ biomarker‑guided DB104 drug (liafensine, a potential first‑in‑class triple reuptake inhibitor for TRD).

Denovo正在开发八种晚期药物，以满足肿瘤学和中枢神经系统疾病的主要未满足医疗需求；大多数管道是拥有全球权利的一流药物。Denovo最近宣布，其DGM4™生物标志物引导的DB104药物（利阿芬辛，一种潜在的一流TRD三重再摄取抑制剂）在治疗抵抗性抑郁症（TRD）方面取得了重大突破。

The global Phase 2b clinical trial of DB104 in DGM4‑positive patients with TRD demonstrated strikingly positive results, with highly significant improvements in symptoms of depression seen in DGM4‑positive patients. Visit www.denovobiopharma.com for additional information..

DB104在DGM4阳性TRD患者中的全球2b期临床试验显示出惊人的阳性结果，DGM4阳性患者的抑郁症状得到了显着改善。有关更多信息，请访问www.denovobiopharma.com。。

About the California Institute for Regenerative Medicine (CIRM)

关于加利福尼亚再生医学研究所（CIRM）

At CIRM, we never forget that we were created by the people of California to accelerate stem cell treatments to patients with unmet medical needs, and act with a sense of urgency to succeed in that mission. To meet this challenge, our team of highly trained and experienced professionals actively partners with both academia and industry in a hands-on, entrepreneurial environment to fast track the development of today’s most promising stem cell technologies.

在CIRM，我们永远不会忘记，我们是由加利福尼亚州人民创建的，旨在加速对未满足医疗需求的患者进行干细胞治疗，并以紧迫感行动以成功完成这项任务。为了应对这一挑战，我们的团队由训练有素且经验丰富的专业人员组成，在动手创业的环境中积极与学术界和工业界合作，以快速跟踪当今最有前途的干细胞技术的发展。

With $5.5 billion in funding and more than 150 active stem cell programs in our portfolio, CIRM is one of the world’s largest institutions dedicated to helping people by bringing the future of cellular medicine closer to reality. For more information, go to www.cirm.ca.gov..

CIRM拥有55亿美元的资金和150多个活跃的干细胞项目，是世界上最大的机构之一，致力于帮助人们实现细胞医学的未来。有关更多信息，请访问www.cirm.ca.gov。。