TiumBio, a Korean biotech firm, is speeding up clinical trials of TU2218, investigational immunotherapy, in the U.S. and Korea.
In the U.S., the Kosdaq-listed company is testing TU2218 in a phase 1a study. The company enrolled the first patient in January. The patient enrollment and drug administration are ongoing simultaneously.
Also, the company plans to start a phase 1b study of combination therapy, testing TU2218 with anti-PD-1 antibody, in the third quarter. The company did not disclose the name of the anti-PD-1 antibody.
TU2218 is a new immunotherapy candidate, inhibiting both TGF-ß and VEGFR-2. TiumBio plans to evaluate the efficacy and safety of TU2218 in 50 or more patients with advanced solid tumors in the phase 1 study in the U.S.
The phase 1 study, consisting of monotherapy and combination therapy, will confirm the optimal dose and indication, and the company hopes to enter a phase 2 study in 2023.
In Korea, TiumBio received the regulatory nod for a phase 1/2 trial of TU2218 late last year.
The company said it would start patient recruitment for the local study within a month.
In the Korean trial, the company will use MSD’s Keytruda (pembrolizumab) combined with TU2218. The study will occur at Seoul National University Hospital and Asan Medical Center.
“We’re enrolling patients and administering the drug at the same time in the U.S. phase 1 study. We will also start recruiting patients in Korea soon,” an official at TiumBio said.
The company is actively searching for a partner company for combination therapy to improve the efficacy of immunotherapy.
On Feb. 8, TiumBio signed an agreement with BeiGene to jointly research immunotherapy.
Under the agreement, TiumBio will conduct a trial of combination therapy using TU2218 and PD-1 antibody tislelizumab. BeiGene will provide tislelizumab for the trial for free.
TiumBio said tislelizumab was a promising treatment because BeiGene inked a $2.2 billion deal with Novartis for rights to develop and commercialize tislelizumab in North America, Europe, and Japan last year.
Tislelizumab has already obtained Chinese approval for six types of cancer and is seeking the U.S. FDA nod, TiumBio said.
The company said it hoped to clinch joint R&D deals with multinational pharmaceutical companies in the future.
TiumBio will release results of the preclinical trial of TU2218 through an online poster presentation at the upcoming meeting of the American Association for Cancer Research (AACR) in April.
“TiumBio is likely to gain momentum for clinical trials, joint R&D, and business development from 2022,” Shinhan Investment Corp. said in a report on Monday. “There will be R&D synergy effects coming from investment from SK Plasma. As TiumBio has multiple business portfolios, it has sufficient factors to be re-evaluated in the future.”