Delhi, April 27, 2023 (GLOBE NEWSWIRE) -- PD-1 and CTLA-4 were the first immune checkpoints that were used as therapeutic targets by drug makers. Years later, a new generation of immune checkpoint proteins is dawning upon us represented by checkpoint proteins such as LAG-3, TIM-3 and B7-H3. The TIGIT is another novel immune checkpoint that was discovered a little over a decade ago. As in the case of the PD-1 and CTLA-4, drugs that can inhibit signaling from the TIGIT are being developed and finding use in cancer treatment. Ociperlimab is one of the two TIGIT inhibitors that has progressed the farthest in clinical trials and based on data from clinical and preclinical trial, is anticipated to gain regulatory approval in the next few years.
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Ociperlimab (BGB-A1217) is a humanized IgG1-variant monoclonal antibody under study that is directed towards the TIGIT protein. It was developed by BeiGene and has exhibited strong selectivity and affinity for the TIGIT protein. As one of the most futuristic anti-TIGIT antibodies currently in research, Ociperlimab has an unaltered IgG Fc binding region to execute the best possible antibody-mediated anti-tumor action. It binds to the TIGIT and prevents it from interacting with the CD155 and CD112 ligands of the poliovirus receptor on cancer cells, which activates antitumor immune responses mediated by T-cells.
BeiGene is currently conducting many clinical trials for Ociperlimab in different parts of the globe to have a generalized result highlighting the anti-cancer effects of the drug in different ethnicities with various cancers. Most of these clinical trials are late phase clinical trials. Moreover, a majority of these trials are being conducted to evaluate the combination of Ociperlimab with Tislelizumab, an anti–PD-1 monoclonal antibody, also developed by BeiGene, which has regulatory approval in China. Along with Tislelizumab, Ociperlimab is also being evaluated in combination with other immunotherapy drugs and chemotherapies to find the optimum drug combination to manage and treat different cancers. The development program for Ociperlimab is reportedly running in 17 countries and these clinical trials have enrolled more than 1,600 participants according to BeiGene.
While the company has not filed any application for Ociperlimab in and outside of China, it has planned some clinical trials highlights for 2023. BeiGene wants to complete the enrollment of patients to conduct the Phase 3 AdvanTIG-302 clinical trial to evaluate Ociperlimab as a first-line treatment for non-small cell lung cancer (NSCLC). Additionally, it plans to announce the clinical trial results for its ongoing clinical trials assessing Ociperlimab in second-line treatment of patients with esophageal cancer (ESCC) with tumors expressing PD-L1. In addition, it also plans to announce the results for clinical trials using Ociperlimab for the first-line treatment of hepatocellular carcinoma (HCC) and non-small cell lung cancer (NSCLC)
In recent years, BeiGene has also entered agreements with both domestic and international companies to conduct clinical trials for Ociperlimab. In December 2021, BeiGene entered into license and collaboration agreements with Leads Biolabs and Novartis to evaluate combination of Ociperlimab with different immunotherapies. As part of the agreement with Leads Biolabs, BeiGene conducted clinical trials of Ociperlimab in combination with Tislelizumab and Leads’ LBL-007, a novel inhibitor of the LAG-3 immune checkpoint. On the other hand, the partnership with Novartis allowed the expansion of Novartis’ clinical pipeline by adding a TIGIT inhibitor to its ever-expanding pipeline and agreeing to commercialize Novartis’ drugs in the Chinese Mainland.
As part of this agreement, BeiGene was eligible for an upfront payment of $300 million from Novartis along with an additional payment of US$ 600 or US$ 700 million on the exercise by Novartis of an exclusive time-based option. Moreover, BeiGene will also receive up to US$ 745 million on the achievement of regulatory approval milestones, US$ 1.15 billion on the achievement of sales milestones, and royalties on yet to come sales of Ociperlimab in the licensed territory.
Ociperlimab is a promising candidate finding use in several solid cancers. BeiGene has focused on the combination of Ociperlimab with their PD-1 inhibitor Tislelizumab, which has demonstrated favorable results in clinical trials. It is highly likely that the company will opt to file for regulatory approval for the combination of the two drugs rather than the Ociperlimab monotherapy and this is anticipated to be done by next years. Immune checkpoint inhibitors have shown to be promising modalities for the treatment of cancer and TIGIT inhibitors, led by Ociperlimab, are the newest set of checkpoint inhibitors awaiting entry into this promising drug class.
