Release Date: 22-Apr-2023
Immune checkpoint inhibition has become a common strategy for treating cancer, particularly solid tumors and the market success of the previously approved immune checkpoint inhibitors has stimulated the development of more medications that target these proteins. As a result, therapeutics that target immune checkpoints in conjunction with other cancer-related proteins have also been developed. Ivonescimab, a potential first-in-class inhibitor for the set of proteins it has been developed to target, is one such cutting-edge immune inhibitor therapeutic candidate. Ivonescimab is undertaking clinical trials outside of the US and the EU while it is still in the experimental stage. Therefore, even though it still has time to receive regional approvals before receiving approval from any major drug regulatory body, those approvals will help to increase its credibility. Ivonescimab is projected to receive approval in the next 2-3 years with support from clinical trial data, taking into account the recent speedy approval of novel pharmaceuticals as well as patient acceptance of these revolutionary drugs.
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Ivonescimab is a novel, possibly first-in-class bispecific antibody that combines the benefits of immunotherapy through the inhibition of PD-1 along with anti-angiogenesis effects linked to VEGF inhibition into a single molecule. It has been developed by Akeso and is referred to as AK112 in China or SMT112 internationally. Ivonescimab is also the most advanced bispecific antibody targeting the two drugs in the global pharmaceutical pipelines. In addition, Ivonescimab is also on path to become the first PD-1 targeting bispecific antibody since neither the FDA nor the EMA has approved any bispecific antibody of this type. In addition, Ivonescimab has been granted Breakthrough Therapy Designation Status for three lung cancer indications in China.
In December 2022, a definitive deal was announced between Akeso and Summit Therapeutics to in-license Ivonescimab. The deal supported Summit's goal of creating and marketing innovative oncology pipeline therapeutics with the intention of enhancing patients' quality of life while meeting important unmet medical needs. The agreement gives Akeso the chance to bring its highly creative antibodies to markets in the US, Canada, Europe, and Japan, which is a crucial step in achieving its ultimate objective of becoming a global biopharmaceutical company. As part of this deal, Summit Therapeutics received exclusive development licensing rights for Ivonescimab. It was recently announced that the total upfront payment made to Akeso was equal to US$ 500 Million, while the contract's potential worth might reach US$ 5 Billion.
Moreover, the phase III clinical trial for Ivonescimab with chemotherapy compared to chemotherapy alone in advanced non-squamous non-small cell lung cancer (NSCLC) with EGFR mutations that failed prior treatment with tyrosine kinase inhibitors against the EGFR has finished enrolling patients. In addition, the Phase III trial of Ivonescimab with chemotherapy against a PD-1 inhibitor combined with chemotherapy for advanced squamous non-small cell lung cancer has been approved, and an ongoing trial comparing Ivonescimab monotherapy against pembrolizumab monotherapy as the initial therapy for non-small cell lung cancer patients with positive PD-L1 expression is proceeding well.
Therefore, China-based biopharmaceutical companies have been making strides in the global pharmaceutical industry with their innovative drugs, and through partnerships and collaborations, they are slowly spreading their feet into the international market. The development and clinical evaluation of Ivonescimab and the collaboration between Akeso and Summit Therapeutics is a prime example of this. Ivonescimab is an anti-PD-1/VEGF bispecific antibody that has the potential to become the first-in-class in class drug targeting this set of proteins. The drug is being evaluated in many solid cancers and results from these clinical trials are anticipated to help it get approval from drug regulatory bodies around the world.