HONG KONG – Two Chinese biotech companies, Hutchison China Meditech Ltd. (Chi-Med) and Beigene Ltd., are teaming up to evaluate their therapies as combination treatments for several cancers and in different key markets. The companies plan to look at how Chi-Med's drug candidates, surufatinib and fruquintinib, might work with Beigene's anti-PD-1 antibody, tislelizumab, for the treatment of a number of indications.
“The companies will evaluate the candidates for the treatment of various solid tumor cancers, beginning with dose-escalation studies,” a Chi-Med spokesperson told BioWorld.
Under the terms of the deal, Hong Kong-based Chi-Med and Beijing-based Beigene will also provide mutual drug supply and other support through the process.
The spokesperson said the companies are already preparing IND filings in the U.S., EU, Australia and China.
"By working together with a partner like Chi-Med, we hope to understand and develop innovative combination therapies that may bring meaningful treatments to cancer patients around the world,” said Lai Wang, senior vice president and head of global research, clinical operations & biometrics and APAC clinical development at Beigene. “Through this collaboration we plan to further evaluate tislelizumab in combination with oral VEGFR inhibitors to target a variety of solid tumor cancers."
The collaboration stems from findings from existing studies, which “suggest that a combination therapy of VEGFR and PD-1 inhibitors will produce synergistic antitumor activity, which we look forward to investigating further in global collaboration with Beigene,” said the Chi-Med spokesperson. “As global leaders in oncology drug development and innovation, Chi-Med and Beigene are natural collaborators. By combining Chi-Med's novel compounds with Beigene's immunotherapy, we believe that we can better meet patient needs in a number of solid tumor indications.”
All three compounds are in late-stage global clinical development across many countries outside of China.
According to the companies, tislelizumab and fruquintinib have both been approved by the China National Medical Products Administration (NMPA). The agency is also in the process of reviewing the NDA for surufatinib that was submitted late last year.
Beigene’s tislelizumab has yet to be approved for use outside of China. But there are currently 15 potentially registration-enabling clinical trials being conducted in China and globally, including 11 phase III trials and four pivotal phase II trials.
Chi-Med retains all rights to its fruquintinib outside of China, though the drug has yet to be approved elsewhere. It is partnered with Eli Lilly and Co. in China, which has greenlighted it. Lilly has launched fruquintinib under the brand name Elunate as treatment for patients with metastatic colorectal cancer.
Chi-Med currently retains all rights to surufatinib worldwide. It is currently being investigated as a treatment for several indications. On June 1, 2020, Chi-Med announced that it has held its pre-NDA meeting with the U.S. FDA for surufatinib for the treatment of patients with advanced neuroendocrine tumors (NET). The FDA agreed that the completed SANET-ep (non-pancreatic NET) and SANET-p (pancreatic NET) studies, along with existing data from surufatinib in U.S. non-pancreatic and pancreatic NET patients, could form the basis to support an NDA submission.
In November 2019, an NDA for surufatinib for the treatment of patients with advanced non-pancreatic NET was accepted for review by the NMPA and granted priority review status in December 2019.
Outside of those efforts, Chi-Med is collaborating with Astrazeneca plc in the development of another first-in-class oncology drug candidate, the selective MET inhibitor savolitinib, for the treatment of non-small-cell lung cancer (NSCLC), papillary renal cell carcinoma and other MET-driven tumors.
“Savolitinib has demonstrated encouraging responses in combination with Tagrisso (osimertinib) in EGFR mutation-positive NSCLC patients with MET-driven acquired resistance to tyrosine kinase inhibitors (Tatton study), and the companies continue to investigate the potential treatment benefit of savolitinib in combination with Tagrisso in a similar patient population in an ongoing global phase II registrational study (Savannah),” said the Chi-Med spokesperson.
On May 29, Chi-Med said the NDA for savolitinib for the treatment of NSCLC with MET exon 14 skipping mutations has been accepted for review by the NMPA. The NDA is the first filing of savolitinib globally.
“Chi-Med's pipeline includes another six drugs in clinical development, including in hematological malignancies, and several drug candidates in preclinical development,” said the company spokesperson.