Following the US, Sillajen received approval for the phase 1 clinical trial IND (clinical trial plan) for ‘BAL0891’, a newly introduced anti-cancer candidate, in Korea.
Sillajen announced on the 12th that it had received approval from the Ministry of Food and Drug Safety for phase 1 BAL0891 monotherapy and combination therapy with chemotherapy. The clinical trial was conducted by Seoul National University Hospital and Yonsei University Severance Hospital. The projected end date is January 2024.
Sillajen plans to evaluate the safety, tolerability, and pharmacokinetics of BAL0891 by conducting single intravenous (IV) administration of BAL0891 or combined administration with carboplatin or paclitaxel in 120 adult patients with advanced solid cancer. In addition, BAL0891 maximum tolerated dose (MTD) and 2-phase appropriate dose (RP2D) will be derived.
BAL0891 is an anti-cancer candidate that Sillajen acquired technology from Vasilia, a Swiss pharmaceutical company, last year for a total down payment of approximately KRW 437 billion (USD 335 million). It’s a new pipeline.
Sillajen received approval for phase 1 IND from the US Food and Drug Administration (FDA) and is currently conducting phase 1 BAL0891 in the US. In late February, the Oregon Health and Science University Cancer Institute (OHSU) opened its first patient enrollment.
An official from Sillajen said, “Since the domestic regulatory body following the U.S. has also approved BAL0891 for phase 1, we expect future clinical trials to gain momentum.” class)’ I will try to become a new drug.”
Meanwhile, Shillazen held the 17th regular shareholders’ meeting on the 31st of last month.
On this day, CEO Kim Jae-kyung explained, “The preclinical study of the anti-cancer virus platform SJ-600 series has been completed early, and follow-up research will be completed successfully.”
“The clinical trial of Pexa-Vec and Regeneron’s Libtayo combination is expected to produce results in the second half of this year,” he said. said.
