近日，创新生物制药公司Apexigen宣布，其与先声药业联合开发的创新肿瘤单克隆抗体药物BD0801正式启动枢纽性3期临床（pivotal trial），并收治首位病患。BD0801是一款靶向于血管内皮生长因子（VEGF）的单抗，由Apexigen专有的APXiMAB平台获得。先声药业正通过与Apexigen的授权协议在中国开发BD0801，用于复发铂耐药卵巢癌的治疗。该药与国际上重磅级的抗肿瘤单抗安维汀（Avastin）有着相同的作用机制，但前期临床研究显示有比安维汀（Avastin）更长效及安全的潜力，具有优越的临床效益前景。

Apexigen首席执行官杨晓东医学博士说：“我们很高兴看到BD0801进入三期枢纽试验，并受到越来越多正面数据的鼓舞，这些数据强调了靶向血管生成通路（如VEGF）的治疗效果的扩大。BD0801具有广泛的潜在适应症并有望成为Best-in-Class，在铂耐药卵巢癌患者中启动3期试验是其发展的重要下一步。“

Apexigen Announces First Patient Dosed in Phase 3 Pivotal Trial for BD0801, an Anti-VEGF Monoclonal Antibody, in Combination Therapy for Ovarian Cancer

- BD0801, discovered using Apexigen’s APXiMAB™ antibody technology platform, is in development by Simcere in China through a licensing agreement -

SAN CARLOS, CA, USA I October 06, 2021 I Apexigen, Inc., a clinical-stage biopharmaceutical company focused on discovering and developing a new generation of antibody therapeutics for oncology, today announced that Simcere Pharmaceutical Co. Ltd. has initiated a Phase 3 pivotal trial evaluating BD0801 in combination with chemotherapy for patients with recurrent, platinum-resistant ovarian cancer. BD0801 is a humanized monoclonal antibody directed against vascular endothelial growth factor (VEGF), and is derived from Apexigen’s APXiMAB™ antibody discovery technology platform. Simcere is developing BD0801 in China through a licensing agreement with Apexigen.

“We are very pleased to see BD0801 advance into pivotal trials and encouraged by the growing evidence that underscores the expanded therapeutic efficacy of targeting angiogenic pathways, such as VEGF,” said Apexigen’s CEO, Xiaodong Yang, MD., Ph.D. “BD0801 is designed to overcome outstanding challenges of the class with improved durability, patient response and superior clinical benefit. BD0801 has broad potential therapeutic utility and best-in-class promise, and the initiation of the phase 3 trial in patients with platinum-resistant ovarian cancer is an important next step in its development.”

Dr. Yang continued, “This trial builds on extensive preclinical data that demonstrated higher anti-tumor efficacy in multiple cancer models as well as strong preliminary clinical data that showed favorable safety and efficacy signals. The advancement of BD0801 further demonstrates the robust value of our APXiMAB platform, designed to develop next-generation best-in-class antibody therapeutics. We look forward to seeing BD0801 progress towards commercialization in China and potentially address unmet medical needs in cancer patients with limited effective treatment options.”

The randomized, double-blind, Phase 3 trial is designed to evaluate the efficacy and safety of BD0801 combined with chemotherapy versus chemotherapy plus placebo in patients with recurrent, platinum-resistant ovarian cancer. Patients will receive 1.5 mg/kg of BD0801 or placebo in combination with one of three chemotherapies (paclitaxel, topotecan or doxorubicin liposome). The primary endpoint is progression-free survival (PFS). Additional information about this clinical trial is available at ClinicalTrials.gov using the identifier: NCT04908787.

About BD0801

BD00801 is a next-generation humanized monoclonal antibody directed against VEGF and was discovered using Apexigen’s APXiMAB platform. BD0801 achieves higher potency than the commonly used anti-VEGF therapy and is currently being developed for the treatment of solid tumors by Simcere Pharmaceutical Co. Ltd.

About Apexigen

Apexigen is a clinical-stage biopharmaceutical company focused on discovering and developing a new generation of antibody therapeutics for oncology, with an emphasis on new immuno-oncology agents that may harness the patient’s immune system to combat and eradicate cancer. Sotigalimab and Apexigen’s other programs were discovered using Apexigen’s proprietary APXiMAB™ discovery platform. This platform has enabled Apexigen and its collaboration partners to discover and develop high-quality therapeutic antibodies against a variety of molecular targets, including targets that are difficult to drug with conventional antibody technologies. Seven product or product candidates discovered using APXiMAB are currently commercially available or in clinical development, either internally by Apexigen or by its licensees. For more information, please visit www.apexigen.com.

SOURCE: Apexigen