Iksuda

Iksuda Therapeutics is a clinical-stage biotechnology company specializing in the development of next-generation Antibody-Drug Conjugates (ADCs) for cancers that are difficult to treat. The company originated as a spin-out from the University of Bath in 2007, initially named Glythera Ltd., based on bioconjugation technologies developed by Dr. Andy Watts and Dr. Amanda Mackenzie. In 2012, David Simpson co-founded the business, refocusing it on ADC development. Simpson, who serves as CEO, has over two decades of experience in the biopharmaceutical industry, including roles where he developed and commercialized biotherapeutics at companies like Eden Biodesign and Allergan. The company officially rebranded from Glythera to Iksuda Therapeutics in 2018, marking a strategic shift from technology licensing to in-house drug development. Headquartered in Newcastle upon Tyne, UK, Iksuda also has operations in Boston, USA.

Iksuda's business model centers on creating a pipeline of advanced ADCs and progressing them through clinical trials, with a strategy that includes both in-house development and strategic partnerships. The company's revenue generation is based on licensing its ADC programs and forming commercialization partnerships with larger pharmaceutical and biotech firms. This is exemplified by its relationship with South Korea-based LigaChem Biosciences (LCB), which started with technology licensing and evolved into a strategic investment, giving LCB substantial ownership and control over Iksuda's pipeline development. Iksuda has also secured significant funding, including a $47 million Series A round in 2021 co-led by Mirae Asset Capital and Celltrion, to advance its clinical programs.

The company's core focus is designing ADCs with a superior therapeutic index, meaning they are more effective at killing tumor cells while minimizing harm to healthy tissue. This is achieved through a multi-platform "ADC engine" that carefully selects the optimal combination of antibody, payload (the cytotoxic drug), and linker technology for specific cancer targets and tumor types. Key proprietary technologies include the PermaLink® platform for highly stable conjugation, which prevents the premature release of the toxic payload, and the ProAlk™ platform, which features tumor-selective prodrug payloads. These prodrugs are activated by glucuronidase, an enzyme often overexpressed in tumors, ensuring the payload is released specifically at the cancer site. This approach allows Iksuda to use ultra-potent payloads while enhancing patient safety. The pipeline targets cancers with high relapse rates and limited treatment options, such as ovarian, lung, breast, and various gastrointestinal cancers. Lead candidates include IKS014 (a HER2-targeting ADC for solid tumors), IKS03 (a CD19-targeting ADC for B-cell cancers), and others targeting CA242 and B7H3 for various solid tumors. IKS014 has received IND clearance from the FDA and is in Phase 1 trials across multiple countries, showing promising early results in patients who have relapsed after other treatments.

Keywords: Antibody-Drug Conjugates, ADC development, oncology therapeutics, cancer treatment, Iksuda Therapeutics, bioconjugation, PermaLink, ProAlk, clinical-stage biotechnology, HER2-positive cancers, B-cell malignancies, solid tumors, targeted therapy, payload technology, linker chemistry, David Simpson, Robert Lutz, LigaChem Biosciences, Celltrion, Newcastle upon Tyne, difficult-to-treat cancers, therapeutic index, tumor-selective activation