Akari Therapeutics, Plc (Nasdaq: AKTX) announced that the Intellectual Property India (IPI) has issued Patent No. 562,919 titled "Thailanstatin Analogs," providing patent protection for the company's novel immuno-oncology payload technology. The patent covers claims for Akari's potent PH1 payload, proprietary non-cleavable and cleavable linkers, and ADC technology with applications across various cancer targets.
Novel Mechanism of Action Differentiates PH1 Payload
The PH1 payload represents a differentiated approach to cancer treatment as a spliceosome inhibitor designed to inhibit RNA splicing, leading to cancer cell death and activation of the immune system through multiple mechanisms. This mechanism of action is highly differentiated from current ADC payloads that use Topoisomerase1 inhibitors or tubulin inhibitors.
According to Abizer Gaslightwala, President and CEO of Akari Therapeutics, "We believe our innovative ADC payload PH1 has the potential to provide therapies that disrupt cellular function, trigger cancer cell death and most importantly, enhance the immune system to fight cancer beyond the cells targeted by the ADC molecule."
Strategic Market Expansion in India
The patent issuance comes at a critical time as India represents a key territory with rapidly growing cancer incidence rates. Cancer cases in India are projected to increase to 2.08 million by 2040, creating significant demand for innovative cancer therapies.
"As cancer rates and diagnosis continue to rise significantly in India, we believe the need for innovative cancer therapies continue to increase. We are pleased to bolster our intellectual property portfolio to include this key market for future opportunities to potentially help cancer patients with our immuno-oncology ADCs," Gaslightwala commented.
Expanding Global IP Portfolio
The issued India patent is a divisional patent of the company's R&D toxin portfolio on PH1 and builds on previously issued patents including Patent No. US 10,815,246 B2, Patent No. US 10,301,319 B2, and Patent No. US 11,691,982 B2. Grant patent rights for the PCT/US2018/051721 family were issued by China National Intellectual Property Administration in August 2023 and in Israel in September 2023.
Corresponding foreign patent applications are currently pending and undergoing examination in Patent Cooperation Treaty countries including Brazil, Canada, member states of the European Patent Organisation, Hong Kong, Japan, New Zealand, Singapore, and South Africa.
Lead Candidate Shows Promising Preclinical Results
Akari's lead candidate, AKTX-101, targets the Trop2 receptor on cancer cells and delivers the novel PH1 payload directly into tumors using a proprietary linker. In preclinical studies, AKTX-101 has demonstrated significant activity and prolonged survival relative to ADCs with traditional payloads.
The splicing inhibition mechanism has been shown in preclinical animal models to induce cancer cell death while activating immune cells to drive robust and durable activity. Additionally, AKTX-101 has shown potential for synergy with checkpoint inhibitors, demonstrating prolonged survival both as a single agent and in combination with checkpoint inhibitors compared to appropriate controls.
Pipeline Development Strategy
Leveraging its innovative payload platform, Akari is advancing a pipeline of potentially first-in-class, best-in-class ADC candidates across a wide range of cancer tumor targets. The initial candidates have shown significant tumor-killing activity in preclinical models with the ability to robustly activate the immune system to drive durable and sustained outcomes.
Using the novel PH1 payload, Akari has the ability to generate multiple ADC molecules based on the desired application to a range of cancer targets of interest. The company is generating validating data on its novel payload PH1 to continue advancing its lead asset as well as other undisclosed targets with this novel payload.
