An anti-TIGIT clinical trial launches in China
Cancer drug developer Innovent Biologics initiated an early-stage clinical trial for its monoclonal antibody IBI939, the first anti-TIGIT drug to be tested in China.
The Suzhou biotech is hoping to develop the antibody into a potential treatment for advanced forms of cancer, either as a monotherapy or in combination with Tyvyt, its approved PD-1 drug for Hodgkin's lymphoma.
IBI939 is a monoclonal antibody that works by binding to TIGIT, another checkpoint protein on immune cells. This binding blocks TIGIT’s cancer-promoting interaction with CD155, a binding domain on the tumor cell.
By combining an anti-TIGIT drug with another checkpoint inhibitor, researchers theorize that blocking two checkpoint proteins will make these cancer treatments even more effective. One reason for hope: Roche’s Phase 2 study combining tiragolumab with PD-L1 blocker Tecentriq.
Since 2018, immune checkpoint inhibitors have been an area of focus in China oncology, with Tyvyt becoming one of the first PD-1 inhibitors to launch here. Innovent is hoping to repeat this success with its anti-TIGIT antibody.
“TIGIT is expected to be one of the most promising targets for a new generation of tumor immune drugs, and we are looking forward to the clinical results of IBI939,” Lin Shen, vice president of Peking University Cancer Hospital, where the trial will take place, said in a statement.
The Suzhou biotech is hoping to develop the antibody into a potential treatment for advanced forms of cancer, either as a monotherapy or in combination with Tyvyt, its approved PD-1 drug for Hodgkin's lymphoma.
IBI939 is a monoclonal antibody that works by binding to TIGIT, another checkpoint protein on immune cells. This binding blocks TIGIT’s cancer-promoting interaction with CD155, a binding domain on the tumor cell.
By combining an anti-TIGIT drug with another checkpoint inhibitor, researchers theorize that blocking two checkpoint proteins will make these cancer treatments even more effective. One reason for hope: Roche’s Phase 2 study combining tiragolumab with PD-L1 blocker Tecentriq.
Since 2018, immune checkpoint inhibitors have been an area of focus in China oncology, with Tyvyt becoming one of the first PD-1 inhibitors to launch here. Innovent is hoping to repeat this success with its anti-TIGIT antibody.
“TIGIT is expected to be one of the most promising targets for a new generation of tumor immune drugs, and we are looking forward to the clinical results of IBI939,” Lin Shen, vice president of Peking University Cancer Hospital, where the trial will take place, said in a statement.
Sino Biopharm gets China approval for PD-1, ALS drug
Hong Kong-based Sino Biopharm, not to be confused with state-owned Sinopharm, celebrated the approval of penpulimab, the sixth PD-1 drug now approved in China.
China’s National Medical Products Administration (NMPA) approved the drug to treat patients with recurrent or refractive classical Hodgkin's lymphoma after second-line chemotherapy.
Originating from Akeso Biopharma’s pipeline, Sino Biopharm struck a deal with the recently listed Zhongshan biotech in 2019 to help develop and commercialize penpulimab through its subsidiary Chia-Tai Tianqing Pharmaceutical. The PD-1 inhibitor will be Akeso’s first marketed product. Other ongoing trials are testing the drug as a first-line option for non-small cell lung cancer and liver cancer.
Chinese regulators also signed off on Sino Biopharm’s generic version of edaravone for treating amyotrophic lateral sclerosis. Mitsubishi Tanabe Pharma’s original version was only approved in China less than a year ago. Sino Biopharm’s version will be marketed as Yibitan.
China’s National Medical Products Administration (NMPA) approved the drug to treat patients with recurrent or refractive classical Hodgkin's lymphoma after second-line chemotherapy.
Originating from Akeso Biopharma’s pipeline, Sino Biopharm struck a deal with the recently listed Zhongshan biotech in 2019 to help develop and commercialize penpulimab through its subsidiary Chia-Tai Tianqing Pharmaceutical. The PD-1 inhibitor will be Akeso’s first marketed product. Other ongoing trials are testing the drug as a first-line option for non-small cell lung cancer and liver cancer.
Chinese regulators also signed off on Sino Biopharm’s generic version of edaravone for treating amyotrophic lateral sclerosis. Mitsubishi Tanabe Pharma’s original version was only approved in China less than a year ago. Sino Biopharm’s version will be marketed as Yibitan.
Two Chinese pharmas join forces for cancer meds synergy
Beijing’s BeiGene and Hong Kong’s Hutchison China MediTech, or Chi-Med, have partnered to explore potential combination therapies with their respective cancer medicines.
The collaboration between the globally listed Chinese biotechs will see BeiGene’s PD-1 drug tislelizumab combine with Chi-Med’s fruquintinib or surufatinib in a number of clinical trials for different solid tumors in the U.S., China, Europe, and Australia. All three drugs have ongoing global late-stage trials.
BeiGene’s tislelizumab is approved in China for patients with classical Hodgkin’s lymphoma who have received at least two prior therapies, and for patients with certain types of urothelial carcinoma. Chi-Med’s fruquintinib, marketed as Elunate, is approved in China for patients with late-stage colorectal cancer who have failed prior chemotherapies, while surufatinib is under NMPA’s review for treating non-pancreatic neuroendocrine tumors.
The collaboration between the globally listed Chinese biotechs will see BeiGene’s PD-1 drug tislelizumab combine with Chi-Med’s fruquintinib or surufatinib in a number of clinical trials for different solid tumors in the U.S., China, Europe, and Australia. All three drugs have ongoing global late-stage trials.
BeiGene’s tislelizumab is approved in China for patients with classical Hodgkin’s lymphoma who have received at least two prior therapies, and for patients with certain types of urothelial carcinoma. Chi-Med’s fruquintinib, marketed as Elunate, is approved in China for patients with late-stage colorectal cancer who have failed prior chemotherapies, while surufatinib is under NMPA’s review for treating non-pancreatic neuroendocrine tumors.
Junshi reports early data for Covid-19 antibodies
Junshi Biosciences’ development of antibody therapies against Covid-19 is off to a good start after the company unveiled positive data from its early animal study.
Published last week in Nature, the Shanghai biotech’s monoclonal antibody CB6, isolated from a recovered Covid-19 patient, showed in vitro neutralizing activity against the novel coronavirus. The antibody also reduced virus levels in monkeys if it is given one day before the infection, as is the case if given after.
“Both prevention and therapeutic indications will be developed,” Junshi’s CEO Ning Li told STAT, adding that the company could pursue an accelerated approval pathway to expedite the therapies’ approval process.
With the diminishing number of Covid-19 cases in China, the company could conduct multiregional clinical trials to include non-Chinese patients for registration trials, he added.
Junshi and co-developer Eli Lilly expect to file for an investigational new drug application and start trials in the U.S. and China in the second quarter.
To date, a number of Chinese biotechs have announced antibody programs targeting the novel coronavirus. These include Brii Biosciences in collaboration with Tsinghua University, Innovent Biologics, Harbour BioMed with Utrecht University, and Shanghai Henlius Biotech in partnership with Sanyou Biopharma and Shanghai ZJ Bio-Tech.
Published last week in Nature, the Shanghai biotech’s monoclonal antibody CB6, isolated from a recovered Covid-19 patient, showed in vitro neutralizing activity against the novel coronavirus. The antibody also reduced virus levels in monkeys if it is given one day before the infection, as is the case if given after.
“Both prevention and therapeutic indications will be developed,” Junshi’s CEO Ning Li told STAT, adding that the company could pursue an accelerated approval pathway to expedite the therapies’ approval process.
With the diminishing number of Covid-19 cases in China, the company could conduct multiregional clinical trials to include non-Chinese patients for registration trials, he added.
Junshi and co-developer Eli Lilly expect to file for an investigational new drug application and start trials in the U.S. and China in the second quarter.
To date, a number of Chinese biotechs have announced antibody programs targeting the novel coronavirus. These include Brii Biosciences in collaboration with Tsinghua University, Innovent Biologics, Harbour BioMed with Utrecht University, and Shanghai Henlius Biotech in partnership with Sanyou Biopharma and Shanghai ZJ Bio-Tech.
What to read around the web today
- IPO preview: Burning Rock Biotech seeks U.S. IPO (The Street)
- CSPC Pharma proposes listing on Shanghai’s STAR market (HKEX News)
- China building secure facilities to fast track coronavirus vaccine production (South China Morning Post)
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