LigaChemBio’s antibody-drug conjugate (ADC) platform technology is poised to enter clinical trials in the U.S. for a promising gastrointestinal cancer treatment candidate. This marks the third clinical trial entry for a partner company following a global technology transfer, further solidifying the platform’s competitive edge.
On Friday, LigaChemBio announced that its partner, Iksuda Therapeutics, received the U.S. Food and Drug Administration (FDA) approval for the Investigational New Drug (IND) application of IKS04, a CA242-targeted ADC candidate.
With this green light, IKS04 will undergo Phase 1 clinical trials to assess its safety and tolerability in patients with gastrointestinal cancers, including colorectal, gastric, pancreatic, and biliary cancers.
CA242 is a tumor-specific antigen highly expressed in various gastrointestinal cancers but minimally present in normal tissues. Despite the significant unmet medical need in gastrointestinal cancer treatment, existing ADC therapies have fallen short of expectations, underscoring the need for novel targets and innovative drug development.
IKS04 combines LigaChemBio’s cutting-edge ADC platform technology with a pyrrolobenzodiazepine (PBD) prodrug payload, applied to a humanized CA242 antibody. This approach selectively activates and releases the drug within tumors, minimizing toxicity to healthy tissues while maximizing therapeutic efficacy.
A key innovation in IKS04’s design is the co-administration of a non-conjugated antibody alongside the ADC to enhance penetration into solid tumors. Preclinical studies demonstrated robust anti-cancer effects and an impressive therapeutic index across various gastrointestinal cancer models, with the combination approach further amplifying its anti-cancer potency.
ADCs are at the forefront of next-generation cancer therapeutics, selectively targeting cancer cells and drawing significant attention from the global pharmaceutical industry. Companies with proprietary platform technologies can not only develop their own candidates but also forge lucrative partnerships with pharmaceutical giants, highlighting the critical importance of technological prowess in this field.
The FDA’s approval of IKS04 marks Iksuda’s third ADC candidate to advance to clinical stages, following HER2-targeted IKS014 and CD19-targeted IKS03. LigaChemBio views this milestone as a testament to the expanding clinical potential of its linker-payload platform technology across diverse pipelines.
Park Se-jin, Chief Executive Officer (CEO) of LigaChemBio, commented that the FDA IND approval for IKS04, on the heels of IKS014 and IKS03, reaffirms the versatility and efficacy of the prodrug platform technology across multiple pipelines. It’s committed to further enhancing the competitiveness and scalability of the platform through expanded collaborations with global partners.