Alphamab announced PD-L1/CTLA-4 bispecific antibody KN046 will enter new Phase II clinical trial in combination with Pfizer's Inlyta® (axitinib)

Alphamab Oncology announced that it has entered into a clinical trial collaboration and supply agreement with Pfizer to evaluate the efficacy and safety of KN046 in combination with Inlyta® (axitinib) for the first-line treatment of non-small cell lung cancer (NSCLC).

Lung cancer is one of the most dangerous malignant tumors to human health and life. In the past 50 years, many countries have reported that the incidence and mortality of lung cancer have increased significantly. Based on statistics report from the National Cancer Center, the incidence and mortality of lung cancer accounted for 20.03% and 26.99% of all malignancies respectively. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for 84% of all diagnosed lung cancer cases, with a very low 5-year overall survival rate of 24%, ranging from 61% for localized NSCLC to 6% for metastatic NSCLC.

Although, according to experience, platinum-containing combination chemotherapy is still the golden standard for the treatment of advanced NSCLC without gene mutation, with a significant unmet medical need, more and more updated treatment methods and combination therapies are constantly sought to improve the prognosis and quality of life of those patients.

PD-(L)1 and CTLA-4 are two clinically validated immune oncology targets, activating T cells more effectively and enhancing the immune anti-tumor capability. Phase II clinical trial of KN046 for advanced non-small cell lung cancer has demonstrated superior tolerability and safety, as well as PFS and OS advantages. Based on these results, a phase Ⅲ clinical trial (ENREACH-LUNG-01) has been initiated to explore new first-line standard therapies for LUNG cancer. In March 2020, company has entered a clinical supply agreement with Pfizer Inc. ("Pfizer") to advance a clinical study to investigate KN026 in combination with Ibrance® (palbociclib) and received approval for the IND application from National Medical Products Administration (NMPA) of China in December. In April 2021, Alphamab Oncology and Pfizer entered a clinical supply agreement again to advance the clinical trial of the combination therapy of KN046 and new generation of TKI Inlyta® (axitinib).

This is a multi-center, open-label phase II clinical study to evaluate the efficacy, safety and tolerability of KN046 in combination with axitinib in the treatment of advanced NSCLC patients. Professor Zhang Li from Sun Yat-Sen University Cancer Center is the principal investigator. The primary endpoints of the study are objective response rate(ORR). As a potential chemotherapy-free regimen, the trial will bring new hope to late-stage NSCLC patients.

Dr. Ting Xu, Chairman and CEO of Alphamab Oncology commented, "KN046 is a global leading PD-L1/CTLA-4 bispecific antibody, and we strive to advance its clinical development and approval process. Meanwhile, we are pleased to be working with Pfizer again, their deep expertise in cancer disease area and drug development, will definitely be a great favor to fully develop KN046 for the treatment of patients with advanced lung cancer, we expect this innovative combo therapy will become a breakthrough initiative to solve the unmet need and bring significant survival benefits to global patients."

About KN046

KN046 is PD-L1/CTLA-4 bispecific antibody independently developed by Jiangsu Alphamab. Its innovative designs include: a different mechanism CTLA-4 fused with PD-L1 single domain antibody; engineered to target the tumor microenvironment with high PD-L1 expression, and Treg(suppress tumor immunity) clearing function.

There are about 20 clinical trials of KN046 in different stages covering more than 10 types of tumors including NSCLC, TNBC, ESCC, HCC and pancreatic cancer in Australia and China. The results of these clinical trials have shown an advantage in survival for patients. Alphamab has received FDA clearance to enter phase Ⅱ trial of KN046 based on the clinical results in China and Australia. Moreover, KN046 has obtained the U.S. FDA's orphan drug designation for thymic epithelial tumor in September, 2020. Four registrational clinical trials are currently being conducted.

About Alphamab Oncology

Alphamab Oncology is a biopharmaceutical company focusing on innovative biologics medicine for oncology. On December 12, 2019, the Company was listed in the mainboard of Hong Kong, S.A.R., China Stock Exchange with stock code 9966.

Alphamab has fully integrated proprietary biologics platforms in bi-specifics and protein engineering. Its highly differentiated in-house pipeline includes fifteen tumor monoclonal antibodies and bispecific antibodies and a Covid-19 multifunctional antibody. Four products have advanced into phase I-III clinical trials or pre-marketing stage in China, the United States, Japan and Australia. The BLA for Envafolimab (KN035) has been accepted and granted Priority Review by the National Medical Products Administration (NMPA).

The Company also has state-of-the-art manufacturing capabilities designed and built to meet NMPA and EU/FDA's cGMP standards and a complete quality system which has passed the on-site inspection of an European Union qualified person. Alphamab Oncology is committed to building a global leading, multi-dimensional drug development and commercialization platform, focusing on multifunctional biological innovative drugs, and to benefit patients in China and around the world.