Key Takeaways:
Sino Biopharmaceutical Ltd. (1177.HK) has enrolled the first patient in a Phase III registrational clinical trial for its first-in-class CCR8 monoclonal antibody, cafelkibart, also known as LM-108, for treating advanced gastric cancer.
The announcement from the company's subsidiary, LaNova Medicines, confirms the trial is actively recruiting patients for the second of two pivotal registrational studies for the drug.
The Phase III study will evaluate cafelkibart as a second-line treatment for patients with CCR8-positive locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma. The drug is being administered in combination with a PD-1 inhibitor to enhance its anti-tumor effects. Cafelkibart has already received two Breakthrough Therapy Designations in China, expediting its development and review.
This advancement into late-stage trials is based on promising data from earlier Phase I/II studies. Those results showed that cafelkibart combined with the PD-1 inhibitor toripalimab led to notable improvements in response rates, disease control, and survival compared to current paclitaxel-based standard of care. The benefit was particularly pronounced in patients with higher expression of the CCR8 biomarker. By selectively depleting immunosuppressive regulatory T cells within the tumor, the drug aims to overcome resistance to existing immunotherapies.
The successful development of cafelkibart could offer a significant new treatment option for patients with advanced gastric cancer who have progressed after initial therapies. For Sino Biopharmaceutical, it represents a key asset in its expanding oncology pipeline and a potential global first-in-class therapy. Investors will now watch for the trial to complete enrollment, with the next major catalyst being the final data readout.
This article is for informational purposes only and does not constitute investment advice.
