Science

Bemcentinib › Non Small Cell Lung Cancer (NSCLC)

Bemcentinib is a first-in-class, selective, oral once-a-day inhibitor of AXL receptor tyrosine kinase (AXL) a promising therapeutic target for serious diseases. In cancer, recent studies have revealed a central role of AXL signaling in tumor proliferation, survival, metastasis, and resistance to therapy.

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Clinical Development in NSCLC

AXL expression has been established as a negative prognostic factor in a large variety of cancers, with particularly compelling evidence in NSCLC. BerGenBio is studying bemcentinib in combination with the current standard of care treatments in two key clinical settings:

1

2L Advanced adenocarcinoma lung cancer in combination with pacritinib

A investigator led clinical trial sponsored by the Mays Cancer Center at The University of Texas Health Science Center at San Antonio (UT Health San Antonio) is being conducted to study bemcentinib in combination with pacritinib. The study is led by Josephine A. Taverna, MD, a thoracic oncologist at the Mays Cancer Center and Associate Professor in the Division of Hematology and Oncology at UT Health San Antonio and is based on her ground-breaking research revealing that AXL and JAK-STAT3 work in tandem to transmit signals promoting tumor growth and metastasis in advanced lung cancer.

The trial is designed to study BerGenBio’s bemcentinib in combination with pacritinib marketed by Swedish Orphan Biovitrum AB (Sobi®) (STO:SOBI), a specialized international biopharmaceutical company. Pacritinib (marketed as VONJO®) is a JAK2 inhibitor indicated for treatment of myelofibrosis, a bone marrow disorder, and works by blocking certain growth factors and cytokines. The trial is fully funded by a grant from the National Institutes of Health.

Clinical trials identifier: NCT06516887

2

2nd Line NSCLC

In collaboration with Merck & Co, BerGenBio has conducted a Phase 2 study in recurrent NSCLC to study bemcentinib in combination with Keytruda®, the ICI therapy in NSCLC. The study included patients who have relapsed following prior ICI &/or chemotherapy treatment. Preliminary, positive data from this study was announced by BerGenBio in February 2023.

Clinical trials identifier: NCT03184571