Beijing, China April 18, 2022 - 3D Medicines Inc. (3D Medicines) announces that the multi-center, open-label phase Ib/II clinical trial of Batiraxcept (3D229) in combination with envafolimab or lenvatinib in patients with advanced solid tumor was approved by China’s National Medical Products Administration (NMPA).
This study plans to recruit approximately 250 patients with advanced None Small Cell Lung Cancer (NSCLC), clear cell Renal Cell Carcinoma (ccRCC) or Urothelial Carcinoma (UC). The study will assess efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) of 3D229 combined with envafolimab or lenvatinib.
As a globally first-in-class AXL decoy receptor, 3D229 has the potential to treat tumor types such as leukemias and solid tumors that are outside the treatment scope of PD-1/PD-L1 or may overcome resistance to PD-1/PD-L1 antibodies. In addition, the safety and tolerability profile of 3D229 in the Phase I clinical trials of 3D229 in healthy volunteers supports its good safety profile and potential for use as a combination and/or maintenance therapy. In a Phase Ib/II clinical trial of 3D229 in combination with pegylated liposomal doxorubicin (PLD) or paclitaxel (PAC) in patients with platinum-resistant recurrent ovarian cancer, 3D229 in combination with PAC showed ORR of 35%, while historically, PAC monotherapy has demonstrated an ORR of approximately 10% to 15%, suggesting synergy between envafolimab and paclitaxel in ovarian cancer.
Dr. John Gong, Chairman and CEO of 3D Medicines, said, “We are excited to sponsor this trial evaluating 3D229 in combination with envafolimab in several indications. Resistance to PD-1/PD-L1 is an important unmet medical need, and GAS6-AXL signaling is a key molecular pathway that promotes tumor invasion and metastasis, as well as development of resistance to chemotherapy, targeted therapy and immuno-therapy.”
AVB-500 is a therapeutic recombinant fusion protein that has been shown to neutralize GAS6 activity by binding to GAS6 with very high affinity in preclinical models. In doing so, AVB-500 selectively inhibits the GAS6-AXL signaling pathway, which is upregulated in multiple cancer types including ovarian cancer. In preclinical studies, GAS6-AXL inhibition has shown anti-tumor activity in combination with a variety of anticancer therapies, including radiation therapy, immuno-oncology agents, and chemotherapeutic drugs that affect DNA replication and repair. Increased expression of AXL and GAS6 in tumors has been correlated with poor prognosis and decreased survival and has been implicated in therapeutic resistance to conventional chemotherapeutics and targeted therapies. AVB-500 is currently being evaluated in clinical trials and has been granted Fast Track Designation by the U.S. Food and Drug Administration in platinum resistant recurrent ovarian cancer. Analysis of all safety data to date showed that AVB-500 has been generally well-tolerated with no dose-limiting toxicities or unexpected safety signals.
About Envafolimab （KN035）
Envafolimab is a fusion protein of humanized anti-PD-L1 single domain antibody and human IgG1 Fc independently invented by Alphamab Oncology. Envafolimab was in pre-clinical stage when the Co-Development Agreements were first entered into between the Company and Alphamab in February 2016. Since then, we took full responsibility for global clinical development of envafolimab, which has undergone clinical trials across for multiple tumor types in the U.S., China and Japan. On March 30, 2020, Alphamab Oncology, 3DMed, and Simcere reached a strategic cooperation, whereby Alphamab Oncology is responsible for production and quality control, and 3DMed is responsible for the clinical development in oncology field, and Simcere is responsible for the exclusive commercial promotion of products in mainland China.
At present, Envafolimab (KN035) is being studied in clinical trials in multiple tumor types in China, the United States and Japan, including registration/phase III clinical trials in multiple indications. Envafolimab (KN035) obtained orphan drug designation from the US FDA for the treatment of advanced biliary tract cancer and soft tissue sarcoma. In November 2021, Envafolimab obtained the market approval by the Chinese National Medical Products Administration for the treatment of previously treated MSI-H/dMMR advanced solid tumors.
About 3D Medicines, Inc.
3D Medicines, Inc. is a commercial-stage biopharmaceutical company with a mission to help people with cancer live longer and better. Envisioning a future when cancer is managed as a chronic disease, 3D Medicines focuses on the development of differentiated next-generation immuno-oncology drugs, helping cancer patients live with prolonged survival time and a better quality of life. 3D Medicines has established a pipeline with both next-generation biological macromolecule and chemotherapeutic small-molecule drugs, as well as a professional team capable of global development, registration and commercialization operation.
Aravive, Inc. is a clinical-stage oncology company developing innovative therapeutics to treat life-threatening diseases. Aravive’s lead therapeutic, AVB-500, is a first-in-class ultra-high affinity decoy protein that targets the GAS6-AXL signaling pathway associated with tumor cell growth, tumor metastasis, resistance to treatment and decreased survival. AVB-500 has the potential to be combined with multiple anti-cancer therapies across several tumor types, due to its novel mechanism of action and favorable safety profile. AVB-500 has been granted Fast Track Designation by the U.S. Food and Drug Administration in platinum resistant recurrent ovarian cancer. The Company is currently evaluating AVB-500 in a registrational Phase 3 trial in platinum resistant ovarian cancer and a Phase 1b/2 trial in clear cell renal cell carcinoma. Aravive plans to initiate a Phase 1b/2 trial evaluating AVB-500 in first-line treatment of pancreatic cancer in the second half of 2021. The Company is based in Houston, Texas and received a Product Development Award from the Cancer Prevention & Research Institute of Texas (CPRIT) in 2016.
For more information, please visit www.aravive.com.
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