Ascentage Pharma’s Bcl-2 Inhibitor Enters Clinical Trials in Europe

Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are both cancers that affect lymphocytes with the only difference being the location where cancer occurs. In CLL, cancer cells are predominantly present in the bloodstream and bone marrow, while in SLL they are located mostly in the nodes. Lymphocytic lymphoma is the most common type of leukemia that affects adults above 19 years of age. Every year, around 21,000 patients get diagnosed with the disease.

On November 25th, Ascentage Pharma, a Shanghai-based biopharmaceutical company, announced that they have dosed their first patient in Europe (Ukraine) in a Phase Ib/II clinical trial to test the efficacy and safety of their B-Cell CLL/Lymphoma 2 (Bcl-2) inhibitor APG-2575 either as a stand-alone therapy or in combination with other therapies.

APG-2575

Bcl-2 is a key protein that regulates apoptosis in various cell types including lymphocytes. Modification in levels of Bcl-2 allows the cancer cells to evade apoptosis. This may lead to uncontrolled growth and propagation of cells. Hence, inhibition of Bcl-2 is a lucrative target for various types of cancer including leukemia. APG-2575 is an orally administered, first Bcl-2 inhibitor developed in China to enter clinical trials. This drug is one of the key candidates in Ascentage Pharma’s pipeline, and since the beginning of 2020, it has entered multiple clinical trials in the US and China. With the first patient injected in Europe as well, Ascentage Pharma is aiming for global approval.

Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma said, “Dosing the first patient in our first clinical study in Europe marks yet another major milestone for Ascentage Pharma. This is the first step for Ascentage to execute the expansion of clinical studies to Europe. APG-2575 is a key drug candidate in our pipeline targeting apoptosis, and it has demonstrated great therapeutic potential in the treatment of hematologic malignancies. We will expedite the clinical development of APG-2575 and make strides toward offering more treatment options to patients with CLL/SLL globally including in Europe.”

Company Outlook

Founded in 2009, Ascentage Pharma Group Corporation, Ltd. is a clinical-stage biopharmaceutical company that is involved in the discovery and development of therapies for addressing cancer, hepatitis B, and age-related diseases. It currently has eight different small molecule therapies in the pipeline and is involved in over 40 clinical trials in China, the US, and Australia. With Europe in sight as well, the company has increased its investment in R&D.

In 2018, the company raised $240 million for its pipeline of cancer drugs. Currently, they have more than 400 patents that are approved or submitted. While maintaining its own research, Ascentage Pharma has also been collaborating with pharmaceutical giants like AstraZeneca and Merck. Earlier this year, Ascentage Pharma collaborated with Merck to evaluate combination therapy with blockbuster drug KEYTRUDA.

Though APG-2575 is the first Bcl-2 inhibitor developed in China, Abbvie and Genentech’s Venclexta is already approved in the US. Going up against these pharmaceutical giants, in a global market will be an uphill task but strategic partnerships with other pharmaceutical giants may help.

By T. Chakraborty, Ph.D.

Editor: Rajaneesh K. Gopinath, Ph.D.

Related Article: FDA Approves Venetoclax Combination for New Acute Myeloid Leukemia Cases

References

1. https://www.bms.com/assets/bms/us/en-us/pdf/CLL-SLL-fact-sheet.pdf
2. https://en.prnasia.com/releases/apac/ascentage-pharma-announces-first-patient-dosed-in-europe-in-the-phase-ib-ii-study-of-the-bcl-2-inhibitor-apg-2575-in-patients-with-relapsed-refractory-chronic-lymphocytic-leukemia-small-lymphocytic-lymphoma-300167.shtml
3. https://www.prnewswire.com/news-releases/ascentage-pharma-releases-2020-interim-results-reporting-the-companys-first-new-drug-application-and-advances-in-global-strategic-collaborations-301113956.html

Author

Tulip Chakraborty