Multiple companies are chasing Akeso Inc. and Summit Therapeutics Inc. in the battle to potentially dethrone Keytruda (pembrolizumab, Merck & Co. Inc.) as the top cancer immunotherapy for patients with non-small-cell lung cancer with bispecific antibodies targeting PD-(L)1 and VEGF.
Akeso Inc.’s first-in-class trispecific antibody, AK-150, has received IND clearance from China’s National Medical Products Administration (NMPA) for clinical trials in patients with advanced solid tumors. Engineered using Akeso’s AI-driven drug discovery platform and its proprietary Tetrabody technology, AK-150 is a humanized anti-CSF-1R, ILT2 and ILT4 trispecific antibody that achieves multipathway blockade of both innate and adaptive immunity.
Akeso Inc. has received clearance from China’s National Medical Products Administration (NMPA) to initiate clinical trials with AK-152 for Alzheimer’s disease.
China has proved to be a fertile ground for innovation as evidenced by some big deals in the antibody-drug conjugate (ADC) space, and the number of candidates entering clinical trials in China or being advanced in the U.S. by Chinese companies.
China has proved to be a fertile ground for innovation as evidenced by some big deals in the antibody-drug conjugate (ADC) space, and the number of candidates entering clinical trials in China or being advanced in the U.S. by Chinese companies.
For the second time in as many months, the lack of statistically significant overall survival data sent shares of Summit Therapeutics Inc. sliding, despite otherwise positive findings for PD-1/VEGF bispecific candidate ivonescimab in non-small-cell lung cancer. But analysts noted the stock reaction overlooks the consistency of the efficacy data to date, as well as the fact that the phase III Harmoni study marks the first pivotal trial testing ivonescimab in a global population.
The intriguing VEGFxPD-1 bispecific antibody space gained oomph with phase III results disclosed April 23 by Akeso Pharmaceuticals Inc. related to Harmoni-6, testing ivonescimab in combination with platinum-based chemotherapy compared with Tevimbra (tislelizumab, Beigene Ltd.), a PD-1 inhibitor also paired with platinum-based chemo in patients with locally advanced or metastatic squamous non-small-cell lung cancer irrespective of PD-L1 expression. Those data were followed by a green light from the U.S. FDA April 24 for marketing the PD-1 monoclonal antibody penpulimab in combination with cisplatin or carboplatin and gemcitabine for the first-line treatment of adult recurrent or metastatic non-keratinizing nasopharyngeal carcinoma.
The intriguing VEGFxPD-1 bispecific antibody space gained oomph with phase III results disclosed April 23 by Akeso Pharmaceuticals Inc. related to Harmoni-6, testing ivonescimab in combination with platinum-based chemotherapy compared with Tevimbra (tislelizumab, Beigene Ltd.), a PD-1 inhibitor also paired with platinum-based chemo in patients with locally advanced or metastatic squamous non-small-cell lung cancer irrespective of PD-L1 expression. Those data were followed by a green light from the U.S. FDA April 24 for marketing the PD-1 monoclonal antibody penpulimab in combination with cisplatin or carboplatin and gemcitabine for the first-line treatment of adult recurrent or metastatic non-keratinizing nasopharyngeal carcinoma.
Chinese pharmaceutical companies are making significant inroads into the global oncology market, particularly with the development and approval of immune checkpoint inhibitors. These treatments, which have shown strong efficacy in various cancer indications, are not only transforming the oncology landscape in China but are also gaining traction in high-value international markets, including the U.S.
Akeso Inc. has received IND approval by China’s National Medical Products Administration (NMPA) for AK-139, an IL-4Rα/ST2 bispecific antibody under investigation for a number of indications, including respiratory and skin diseases.
