IKS04 / Iksuda Therap - LARVOL DELTA

IKS04 Regimen in Advanced Solid Tumors That Express CA242 (clinicaltrials.gov) - P1 | N=120 | Not yet recruiting | Sponsor: Iksuda Therapeutics Ltd.

New P1 trial • Biliary Cancer • Cholangiocarcinoma • Colorectal Cancer • Esophageal Cancer • Gallbladder Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Pancreatic Cancer • Solid Tumor

Iksuda Therapeutics (Iksuda)…announces that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for IKS04, a CA242-directed ADC, enabling assessment in a Phase 1 trial in patients with gastrointestinal (GI) cancers (Businesswire) - "IKS04 is a novel CA242-targeting ADC comprising an anti-CA242 humanized antibody and a highly potent pyrrolobenzodiazepine (PBD) prodrug payload."

IND • New P1 trial • Gastrointestinal Cancer

IKS04, an antibody drug conjugate with a highly potent DNA crosslinker payload for the treatment of gastrointestinal cancers (AACR 2025) - "The ADC was active against gastric and colorectal cancer xenograft models at single doses of 0.5 to 1 mg/kg, while the maytansinoid-based ADC benchmark cantuzumab ravtansine was inactive even at 2 mg/kg. Consistent with this concept, co-administration of the unconjugated antibody with the ADC at a 5 to 50-fold excess improved the minimally effective dose in the CA242-high SNU16 gastric and HT29 colon cancer models compared to ADC alone while the antibody itself had no anti-tumor activity.IKS04 is an ADC with a DNA crosslinker payload that shows potent in vitro and in vivo efficacy against gastric and colorectal cancer tumor models. Co-administration of the unconjugated antibody can improve ADC delivery which drives increased efficacy in preclinical models without increasing toxicity."

ADC • Colon Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

IKS04, a CanAg-Targeting Antibody-Drug Conjugate with Pyrrolobenzodiazepine, Shows Enhanced Efficacy with Unconjugated Antibody Coadministration in Animal Models. (PubMed, Mol Cancer Ther) - "This improved distribution correlated with increased efficacy in vivo, where increasing doses of unconjugated antibody resulted in greater efficacy until apparent tumor saturation was reached. These results support the use of antibody coadministration to improve the efficacy of ADCs targeting high-expression antigens with highly potent payloads."

Journal • Preclinical • Gastrointestinal Cancer • Oncology

Iksuda to Present Growing ADC Pipeline at AACR (Businesswire) - "Iksuda Therapeutics (Iksuda)...announces that it will present three posters at the American Association for Cancer Research (AACR) Annual Meeting in Chicago, Illinois (25-30 April). The posters cover the Company’s new payload class, the ProAlk series, its CA242-directed ADC, IKS04, being developed for the treatment of gastrointestinal (GI) cancers, and its proprietary PermaLink conjugation chemistry....In preclinical trials, IKS04 is associated with in vivo efficacy which is substantially improved over benchmark ADCs in all tumour models, and a superior therapeutic index over all other PBD-based solid tumour ADC programs....IKS04 is expected to enter clinical development in GI cancers by the end of 2025."

New trial • Preclinical • Gastrointestinal Cancer

Ligachem Bio Strengthens Global Position with Preclinical Results of LCB39 and ADC Candidates [Google translation] (Nate) - "Biotechnology company Ligachem Biosciences will present the results of a total of five preclinical studies, including the next-generation immunotherapy STING agonist 'LCB39', at the '2025 American Association for Cancer Research (AACR)' held in Chicago, USA from the 25th to the 30th....This presentation includes oral and poster presentations on candidates such as LCB39, an immune-oncology drug candidate independently developed by Ligachembio, as well as SOT106 (LRRC15 ADC) and IKS04 (CA242 ADC), which were derived through the transfer of antibody-drug conjugate (ADC) platform technology."

Preclinical • Oncology

Evaluating Comprehensive Preclinical Development of IKS04: the First Anti-CA242 Ultra-Low DAR ADC Against Solid Tumours (ADC London 2025) - "• Introducing IKS04 ultra-low DAR approach co-dosed with antibodies • Applying concepts of increased tumour penetration to highly potent PBDnprodrug payloads • Reviewing the preclinical profile of IKS04 targeting GI solid tumours and highlighting future plans for clinical investigation"

Preclinical • Oncology • Solid Tumor

Iksuda Therapeutics Closes $47 Million Financing Round (Businesswire) - “Iksuda Therapeutics….announced it has completed a US $47 million (circa GB £34 million) financing round…The funding will support the advancement of Iksuda’s lead ADC assets and expansion of its payload and conjugation platform technologies…The investment will enable progression of IKS03 to first-in-human phase 1 clinical trials. It will also be used to accelerate the Company’s earlier-stage programmes including IKS04 and IKS012 to IND filing.”

Financing • Oncology