Genome&Company Immuno-Oncology Drug 'GENA-104' Selected as an Excellent National New Drug Development Project

Genom&Company announced on the 13th that its new target immuno-oncology drug ‘GENA-104’ has been selected as one of the top 10 outstanding projects by the National New Drug Development Project Group.

Chamiyeong, Head of New Drug Research at Genome & Company, is presenting at the Excellent Project Presentation of the National New Drug Development Industry held on the 12th in Yongsan-gu, Seoul.
[Photo by Genome & Company]

The National New Drug Development Project is a government-wide research and development (R&D) initiative supporting all stages of new drug development. On the 12th, the project group selected the top 10 outstanding projects out of a total of 347 supported projects and held the ‘2023 National New Drug Development Project Outstanding Project Presentation’ to highlight the excellence of these projects. Genom&Company also shared its research and development achievements through an oral presentation at the event.

GENA-104, selected as an outstanding project this time, was previously chosen in November last year as a non-clinical development project under the National New Drug Development Project. Non-clinical development projects support non-clinical toxicity studies and the securing of clinical samples, ultimately aiming for approval of the clinical trial application (IND). Genom&Company submitted the IND for the Phase 1 clinical trial of GENA-104 to the Ministry of Food and Drug Safety in August. The trial plans to demonstrate the primary endpoints of safety and tolerability through dose escalation cohorts involving up to 80 patients with solid tumors, and confirm the secondary endpoint of efficacy through backfill cohorts.

GENA-104 is a new target anticancer drug inspired by reversing the ‘programmed cell death protein (PD)-(L)1 inhibitor’ class, which currently holds a dominant position in the immune checkpoint inhibitor field. The PD-(L)1 class is recognized as the broadest range anticancer drug, with the representative drug ‘Keytruda (generic name pembrolizumab)’ by U.S. Merck (MSD) expected to achieve sales of $24 billion (approximately 32 trillion KRW) this year, making it the top-selling drug globally.

However, PD-(L)1 inhibitors have limitations, as about 80-90% of patients do not respond to treatment even when selected based on high expression levels. In analyzing the characteristics of these non-responding patients, the company discovered a new protein target called ‘Contactin 4 (CNTN4).’ They found that even if PD-(L)1 expression is high, patients with simultaneously high CNTN4 expression do not respond to PD-(L)1 inhibitors.

Accordingly, Genom&Company confirmed in preclinical studies that CNTN4 is expressed exclusively from PD-(L)1 in various cancer types and that administration of GENA-104 inhibits CNTN4, resulting in an immuno-oncology effect. Based on data secured through various other preclinical studies, the company is developing GENA-104 as a therapeutic agent to overcome the low response rates of already approved immuno-oncology drugs.

Mi-Young Cha, head of new drug research at Genom&Company, said, “We are grateful to the project group for recognizing our technological capabilities and providing an opportunity to widely promote GENA-104, a new target immuno-oncology drug first discovered through our proprietary platform ‘GENOCLE,’ by selecting it as one of the top 10 outstanding projects of the National New Drug Development Project.” She added, “We will continue discovering new targets to become a sustainable new drug development specialist company.”

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