2024-04-09On April 9, 2024, Genhouse Bio, a biotech company focusing on development of next-generation anti-cancer therapeutics, announced today that it has entered into a clinical collaboration with AstraZeneca to evaluate SHP2 inhibitor GH21 in combination with EGFR inhibitor Osimertinib in patients with non-small cell lung cancer (NSCLC).
This open-label, multi-center Phase Ib/II clinical trial is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of this combination for advanced NSCLC patients with EGFR mutations. First patient has already been dosed recently.
GH21 is an allosteric inhibitor of SHP2 which is located downstream of most RTK pathways, transducing cell proliferative and survival signals. SHP2 is also at the downstream of multiple immune checkpoint pathways, such as PD-1 and BTLA, transducing immune escape signals in cancer cell. Thus, this target has gained great attention in recent years for cancer therapeutics. In vitro and in vivo studies show that GH21 has low off-target risk, high oral bioavailability and a wide therapeutic window. GH21 alone or in combination with other anti-tumor drugs was effective for a variety of solid tumors in preclinical studies. Currently, GH21 is in clinical development in both China and the U.S. The molecule has demonstrated initial efficacy signal, good PK and safety in human.
Osimertinib, as the third generation of EGFR TKI, has brought remarkable clinical benefits to NSCLC patients. However, drug resistance would gradually emerge with long-term use. It remains a critical need to develop effective treatments to overcome drug resistance of the third generation EGFR TKI.
Studies have shown that the combination of SHP2 inhibitor and Osimertinib may improve the clinical benefits for patients.
Dr. Haidan Wang, CMO of Genhouse Bio, said, “many tumors are evolving during treatment, and it is difficult for a single therapeutic drug to achieve a long-term therapeutic goal. The combination of some therapeutic drugs has brought exciting clinical benefits both in clinical trials and in real-world practice. Combination therapy is also considered as one of the main directions for future cancer treatment development. This collaboration between Genhouse and AstraZeneca is expected to explore if the combination of GH21 and Osimertinib can improve treatment outcomes for NSCLC patients.”
Dr. Mike Liu, CBO of Genhouse Bio, said, “We are delighted to enter into this collaboration with AstraZeneca. With the advancement of Genhouse’s innovative drug pipeline, we look forward to establishing more strategic partnerships with multinational pharmaceutical and biotech companies.”
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