Alphamab Oncology announced that data from phase Ib/II clinical study (clinical trial No.: KN046-203) of PD-L1/CTLA-4 bispecific antibody KN046 in combination with nab-paclitaxel for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) presented as a poster at the 112th American Association for Cancer Research (AACR 2021 virtual meeting).

Founded in 1907, the American Association for Cancer Research (AACR) is one of the largest cancer meetings in the world and widely considered by the global cancer community to be the touchstone event that sets the cancer research agenda. It attracts nearly 20,000 professionals from all over the world each year with its spectrum of cancer science and excellent reputation, accelerates the dissemination of new research findings among scientists and others dedicated to the conquest of cancer; promotes science education and training; and advances the public understanding of cancer. The preliminary results of the KN046-203 study were published online on April 10 (ET, U.S. time). 

KN046-203 is a phase Ib/II, open label, multi-center clinical study, evaluating the efficacy, safety, and tolerability of KN046 in combination with nab-paclitaxel in patients with TNBC. A total of 27 female patients who are systemic treatment na?ve for locally advanced inoperable or metastatic TNBC were enrolled. The results showed that KN046 plus nab-paclitaxel is well tolerated and efficacious, especially in PD-L1-positive mTNBC patients, showing potentially clinically meaningful benefits in progression-free survival (PFS) and overall survival (OS):

As of March 8, 2021, the objective response rate (ORR) from 25 efficacy evaluable TNBC patients was 40.0%, and the disease control rate (DCR) was 96.0%. The median follow-up time was 13.7 months. The median progression-free survival (PFS) from intent to treat (ITT) population was 7.3 months (95%CI: 3.7~NE). The median overall survival (mOS) was not reached, and the 15-month OS rate in ITT population was 73.4% (95% CI: 46.1-88.4%). In PD-L1 positive (IC PD-L1≥1%) patients, the median PFS was 13.8 months (95% CI: 1.6~NE), and the 15-month OS rate was 77.1% (95% CI: 34.5~ 93.9%).

As of March 8, 2021, no treatment-related adverse events (TRAEs) leading to death occurred. Grade 3 or 4 TRAEs occurred in 13 patients (48.1%). Immune-related adverse events (irAEs) occurred in 11 patients (40.7%). All the irAEs were of grade 1 or 2 except that 3 patients experienced two grade 3 immune-mediated hepatic disorders and one grade 3 rash.

Dr. Johannes Nippgen, Chief Medical Officer of Alphamab Oncology, commented, "Breast cancer is the most common malignant tumor in women both in China and around the world. TNBC accounts for about 15% of all breast cancers, and it has the highest rate of metastatic occurrence and poorest overall survival of all subtypes of breast cancer. Alphamab Oncology strived to exploring innovative anti-tumor medicines that address unmet clinical needs. In the KN046-203 trial, KN046 combined with nab-paclitaxel for the treatment of TNBC showed encouraging progression-free survival and overall survival data, demonstrating favorable clinical benefits for patients with TNBC. We will continue to carry out follow-up studies of bispecific antibody, both mono or in combination, to bring new treatment options to more patients in need."

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. Two pivotal clinical trials are currently being conducted.

About Alphamab Oncology

Alphamab Oncology is focusing on innovation, production and commercialization of anti-tumor drugs. 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.