Ascentage Pharma Presenting New Clinical Data of Novel Dual Bcl-2/Bcl-xL Inhibitor APG-1252 at Asia Conference on Lung Cancer 2018 (ACLC)

SUZHOU, China and HONG KONG and ROCKVILLE, Md., Nov. 13, 2018 /PRNewswire/ -- Ascentage Pharma Group Corporation, Ltd. ("Ascentage Pharma" or the "Company"), a globally-focused company in research and development of innovative drugs, announced today that the company presented the new clinical data of the dual Bcl-2/Bcl-xL inhibitor APG-1252, a new oncology drug under development, at the Asia Conference on Lung Cancer 2018 (ACLC) on 9 November 2018.

ACLC was founded by the International Association for the Study of Lung Cancer (IASLC), which is the most authoritative institution on lung cancer studies. Since 2004, the ACLC is held in Asia by the IASLC and one of the Asian countries every two years to promote exchange and cooperation among lung cancer experts in Asia-Pacific and researchers globally. The 2018 ACLC cum Annual Meeting of the Lung Cancer Committee of the China Anti-Cancer Association was held between 8 and 10 November in Guangzhou by IASLC, CTONG and the Lung Cancer Committee of the China Anti-Cancer Association.

With over 1,000 leading lung cancer researchers in Asia, the USA and Europe attending the conference showcased the latest development in lung cancer studies.

APG-1252 is a novel, highly potent small molecule drug developed by Ascentage Pharma. It restores apoptosis through selective inhibition of the Bcl-2 and Bcl-xL proteins. Bcl-xL gene mutation and overexpression were reportedly found in various types of tumors, including SCLC. In the preclinical tumor model treated with APG-1252, antitumor activity was observed in a broad range of tumor types, which include SCLC, lymphoma, colorectal cancer (CRC) and metastatic breast cancer (mBC). Given its high potency and sub-nanomolar binding affinity to Bcl-2 family of proteins, APG-1252 can be specially designed to minimize platelet toxicity and has a favorable PK/PD profile. Compared to other Bcl-2/Bcl-xL inhibitors under clinical development, it has a potentially wider therapeutic window.

Three Phase I clinical trials of APG-1252 in patients with solid tumor are in progress in China, the US and Australia. The research in China focuses on patients with small cell lung cancer. Professor Yi-Long Wu is PI of Phase I clinical research in China. An oral report on the latest clinical development of APG-1252 was given under the theme of "A Phase I Study of Novel Dual Bcl-2/Bcl-xL Inhibitor APG-1252 in Patients with Advanced Small Cell Lung Cancer (SCLC) or Other Solid Tumor" as one of the "best abstracts selected from submission" in the "SCLC: developments and challenges" session in the afternoon of 9 November. The report is the first consolidation and analysis of research data from Chinese, US and Australian studies. Its highlights include:

• Three Phase I trials of APG-1252 in patients with advanced SCLC or other solid tumors are ongoing in China, the US and Australia. The current dose level being explored is 240 mg
• A total of 35 patients including 17 SCLC patients were treated as of 31 August 2018
• MTD APG-1252 was well-tolerated across all dose levels tested. The MTD has not yet been reached
• Of 10 SCLC patients with at least one post-treatment tumor assessment, one US patient with metastatic SCLC has confirmed PR at 40mg, with target lesion continually decreased. The response is durable, and this patient is still receiving treatment for >17 cycles
• Three patients from China at 80mg dose level achieved SD with 2 patients on treatment for 4 months, and 1 patient for 6 months (confirm SD)
• PK analyses indicate that AUC and Cmax increase dose proportionally, AUC and Cmax are comparable between US and Chinese subjects at same dose level
• Phase II of APG-1252 for SCLC, and combination trials will be initiated soon

Professor Yi-Long Wu stated that, "SCLC is still a clinical problem, and most patients are already advanced or metastatic at the time of initial diagnosis. Existing clinical studies have already demonstrated the potential of APG-1252 and we will communicate and exchange on the topic with international peers. Meanwhile, we look forward to getting more data and having further development, and hope to promptly overcome the lack of specific drugs for small cell lung cancer as a major social issue with concerted efforts."

"Although SCLC accounts for only 15% of all lung cancer cases, it still lacks effective therapeutic drugs as well as is a very difficult type of tumor. It is a great recognition for us to be shortlisted for the ACLC. APG-1252 is now under dose-escalation trial as well as further assessment in patients with SCLC and other advanced solid tumors. We are enthusiastic to push forward the clinical progress so that people suffering from small cell lung cancer can enjoy safe and effective treatment soon," said by Dr. Dajun Yang, the Chairman & CEO of Ascentage Pharma.

About extensive-stage small cell lung cancer (ES-SCLC)

SCLC accounts for approximately 15% of bronchogenic carcinomas. 70% of SCLC is extensive-stage. Regardless of stage, the current prognosis for patients with SCLC is unsatisfactory despite improvements in diagnosis and therapy made during the past 25 years. Without treatment, SCLC has the most aggressive clinical course of any type of pulmonary tumor, with median survival from diagnosis of only 2 to 4 months. Especially for ES-SCLC, the median overall survival is 6-12 months under current available treatments, rare patients can maintain long term survival. Standard treatment options for patients with recurrent small-cell lung cancer (SCLC) include chemotherapy, check point inhibitor and palliative therapy. Parts of patients can response to chemotherapy, but the duration of response is short, rare patients can survive longer than 12 months, most less than 6 months. Median survival is shorter for 3^rd line patients, only 4.7 months (Simos, 2014). More information, please refer to https://www.ncbi.nlm.nih.gov/books/NBK65909/

About Ascentage Pharma

Ascentage Pharma Group Corporation, Ltd. is"), a globally-focused company in the research and development of innovative drugs dedicated to developing therapies for cancers, hepatitis B and age-related diseases. The Company has self-developed protein-protein interactions targeting drugs discovery technologies and patents related to foreign invention. The established R&D pipeline of Ascentage includes the inhibitors to a number of key proteins, including Bcl-2/Bcl-XL and MDM2-p53, that regulate programmed cell death process; 2nd and 3rd generation of kinase inhibitors that overcome mutant resistance in cancer therapy. Ascentage Pharma currently has seven new drugs in Phase I-II trials in China, the US and Australia. For more information, please visit www.ascentagepharma.com.

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SOURCE Ascentage Pharma

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