Genome & Company unveils preclinical data on three new ADC candidates, targets at least 2 licensing deals this year and next

Genome & Company has disclosed preclinical data on three new antibody-drug conjugate pipeline candidates and reaffirmed its goal of closing at least two technology licensing deals this year and next.

The South Korean biotech held a press briefing Tuesday at the Conrad Seoul hotel in Yeouido, where it outlined its first-in-class drug development strategy and provided an update on its global licensing efforts.

CEO Hong Yu-seok cited the looming patent cliff facing global pharmaceutical majors as the strategic backdrop for the company's approach. "Since 2010, the commercial success gap between first-in-class and best-in-class drugs has widened significantly," he said. "Major drugmakers are now actively seeking to in-license first-in-class pipelines to offset patent expirations on their key products — and that makes this a critical window of opportunity for Genome & Company."

Hong also pointed to structural shifts in the global ADC deal market. "Since 2024, deals centered on validated targets such as HER2 and TROP2 have been declining, while deals based on novel targets are surging," he said, adding that late-entry ADC candidates struggling to differentiate from established products face a high risk of commercial failure.

Hong also shared updates on two previously licensed assets. Debio0633, licensed to Switzerland's Debiopharm in May 2024, is advancing smoothly through preclinical development, with Debiopharm currently evaluating optimal indications across multiple cancer types. An IND submission is targeted for late 2027 to early 2028.

EP0089 (GENA-104), licensed to UK-based Ellipsis Pharma in February 2025, had its clinical plan presented in a poster session at ASCO 2026 last month. The Phase 1/2a trial will enroll 190 patients across four countries — South Korea, Australia, the United Kingdom and the United States — a scale described as unprecedented for a domestic Phase 1/2a oncology trial.

"An asset that was initially developed around a single indication is now having its potential validated across a broad range of cancer types through our partner," Hong said, adding that first patient dosing is expected before the end of this year. Ellipsis Pharma has adopted a companion biomarker diagnostic strategy, screening for CNTN4-expressing patients from the Phase 1 stage to improve the probability of clinical success.

Cha Mi-young, head of the company's drug research institute, presented the latest preclinical data on GENA-104 ADC, a candidate targeting CNTN4. The presentation marked the first public disclosure of the full profile for the confirmed lead candidate, unveiled at AACR 2026.

GENA-104 ADC combines a proprietary hydrophilic cleavable linker — for which the company holds intellectual property — with an exatecan payload. Beyond the payload-dependent cytotoxicity typical of ADCs, the candidate also activates T cell-mediated immune responses. "CNTN4 functions as an immune checkpoint protein, but unlike PD-1 and PD-L1, it is not expressed across a wide range of immune cells," Cha said. "It is a very clean target in normal tissue."

CNTN4 expression was confirmed across multiple solid tumor types, including melanoma, liver cancer, lung cancer and sarcoma. Particularly high expression was observed in patients who did not respond to the immunotherapy pembrolizumab, as well as in acral and mucosal melanoma subtypes for which no current treatment options exist. In patient-derived xenograft models, all tumors showing target expression with an H-score of 150 or above achieved a tumor growth inhibition rate of 100 percent or higher. Monkey toxicology studies showed the highest non-severely toxic dose exceeded 30 mg/kg, confirming an adequate safety margin.

The company also disclosed GENA-120, an ADC targeting integrin beta-4 (ITGB4). While Pfizer is developing an ADC targeting integrin β6 in clinical trials, the integrin β4-targeted development field remains largely uncrowded.

High target expression was confirmed in cancer types with significant unmet medical need — including HPV-negative recurrent or metastatic head and neck cancer, colorectal cancer (including microsatellite-stable tumors) and esophageal cancer. In colorectal cancer, ITGB4 expression was also elevated in patients with KRAS G12V and G12D mutations, populations that do not respond to existing immunotherapies.

The leading global competitor is SystImmune's CS5006 from China, with SystImmune planning to file an IND in China in the fourth quarter of this year. "SystImmune is ahead in development speed, but based on an indirect comparison of publicly available data, our candidate shows superior antibody selectivity and efficacy profile," Cha said, while noting that no head-to-head experiments have been conducted.

The company also introduced GENB-120, a bispecific ADC simultaneously targeting ITGB4 and TROP2. The candidate employs a "1+1" structure that maintains strong binding only in cancer cells co-expressing both targets, reducing binding to normal tissue and improving tumor selectivity. In lung squamous cell carcinoma cell lines, it showed sevenfold greater anticancer efficacy compared with existing TROP2 ADCs. The company aims to confirm the lead candidate by the end of this year or early next year.

Also presented was GENC-116, a small-molecule drug candidate targeting fibrotic diseases. The compound targets NUAK1 kinase and is currently in the lead candidate selection stage. The company said it is developing the asset "with the goal of achieving a meaningful licensing deal within two to three years."

Hong offered a direct assessment of the company's current valuation. "Our market capitalization is trading at around 200 billion to 300 billion won (approximately $194 million), and that figure does not properly reflect the development progress of our licensed assets or the value of the first-in-class ADC pipeline we are currently building," he said.

He identified two catalysts for a revaluation. The first is first patient dosing in Ellipsis Pharma's EP0089 trial, expected before the end of this year. "The fact that our partner is committing investment on a scale far beyond what the market initially understood is beginning to be gradually reflected," he said. The second catalyst is closing licensing deals for GENA-104 ADC and GENA-120. "It is difficult to give assurances before a deal is signed, but progress so far has been smooth," he added.

On the outlook for licensing terms, Hong also tempered expectations around upfront payments in the hundreds of billions of won. "Upfront payments of that scale at the preclinical stage are realistically difficult," he said, while expressing confidence that the company could secure better terms than before, given that it is now in a position to negotiate with multiple global buyers simultaneously.