Genome & Company said it would discontinue its phase 2 clinical trial for GEN-001, a microbiome-based immunotherapy, in patients with bile duct cancer. The strategic decision reflects shifts in the treatment landscape, including recent approvals of new therapies, and aligns with the company's revised focus on antibody-drug conjugate (ADC) development.
Genome & Company halts its phase 2 trial for GEN-001 in bile duct cancer, shifting focus to antibody-drug conjugate (ADC) development amid an evolving treatment landscape. The picture shows Hong Yoo-seok, CEO of Genome & Company, speaking at Genome & Company’s 2024 Strategy Presentation in June 2024.
Genome & Company halts its phase 2 trial for GEN-001 in bile duct cancer, shifting focus to antibody-drug conjugate (ADC) development amid an evolving treatment landscape. The picture shows Hong Yoo-seok, CEO of Genome & Company, speaking at Genome & Company’s 2024 Strategy Presentation in June 2024.
On Wednesday, Genome & Company announced the early termination of the phase 2 trial for GEN-001 in bile duct cancer patients in Korea.
The trial was initially designed to evaluate the safety and efficacy of GEN-001 in combination with MSD’s blockbuster immunotherapy Keytruda (ingredient: pembrolizumab) and chemotherapy. It was set to enroll up to 148 patients across eight hospitals in Korea between August 2023 and October 2026.
The company cited the recent approval of Keytruda in combination with chemotherapy agents gemcitabine and cisplatin as a first-line treatment for bile duct cancer as a key factor behind the decision. Given the evolving treatment landscape, Genome & Company reassessed the feasibility and commercial viability of continuing the trial and opted to shift its focus toward ADC development.
While the bile duct cancer trial has now been halted, Genome & Company recently completed a phase 2 trial evaluating GEN-001 with Bavencio for gastric cancer, with results expected in the first half of this year. The company will determine whether to continue the program based on the trial outcomes.
As Genome & Company shifts away from microbiome-based drug development, it has refocused on ADCs targeting novel antigens.
In 2023, the company licensed out its novel CD239-targeting ADC antibody, GENA-111, to Switzerland-based Debiopharm in a deal valued at $426 million. Additionally, in February 2024, Genome & Company successfully out-licensed GENA-104, a CNTN4-targeting immune-oncology therapy, to the UK-based Ellipses Pharma after securing phase 1 trial approval.
During a corporate presentation in February, Genome & Company CEO Hong Yoo-seok outlined the company’s strategy to prioritize early-stage licensing deals over the next two to three years to reduce clinical trial investment risks while strengthening cash flow.
"We have successfully executed at least two deals, and our goal is to enhance financial and R&D capabilities through these partnerships," Hong said. "In the long run, once we have secured enough resources, we plan to conduct in-house ADC trials and pursue large-scale licensing deals."
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Lee Han-soo corea022@docdocdoc.co.kr
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