HONG KONG – South Korea’s Qurient Co. Ltd., located in Gyeonggi-do, is preparing to send its novel drug, Q-702, into the clinic after receiving clearance from the U.S. FDA, roughly a month after submitting the application on April 24.
Q-702 is an oral, selective AxI/Mer/CSF1R triple kinase inhibitor that can be used in combination with anti-PD-1 antibodies. The inhibitor is designed to not only modulate innate immune components such as myeloid-derived suppressor cells and tumor-associated macrophage in the tumor microenvironment, but also to increase MHC I expression in tumor cells.
“IND clearance for Q-702 is an important milestone, presenting a novel drug candidate that not only boosts immune cells in the tumor microenvironment but also makes tumor cells more visible to the immune system,” Kiyean Nam, CEO of Qurient, said. “We believe Q-702 may have an important role in the cancer immunotherapy, improving clinical responses in patients who are unresponsive and/or refractory to currently available immunotherapy.”
The open-label phase I trial will evaluate Q-702’s safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary antitumor activity. The company aims to start the trials in the third quarter of 2020. Around 80 patients with advanced solid tumors who have not responded to standard-of-care therapies will take part in the trials in five hospitals around the U.S.
Nam told BioWorld that the trial’s “basic goal is to determine the maximum tolerated dose and the recommended phase II dose, and as the trials will be conducted on an open-study basis, we can deduce the efficacy based on the patients’ response [to the treatment].”
As the COVID-19 virus continues to impact the U.S., Nam said that “although there are concerns about recruiting patients [for the trial] in the midst of COVID-19, after extensive discussions with our CRO, we will choose relatively ‘safe’ cities in the U.S., as well as potentially opening a site in Korea with the same protocol.”
Although he confessed that it would be difficult to predict Q-702’s potential impact on the U.S. market, Nam expects that the market potential for big pharma could exceed expectation due to the potential of an AxI inhibitor to slow down solid tumor growth and the spread of blood cancers, as well as its ability to treat resistant cancers. Once the trial taps Q-702’s potential, the company will prepare to launch it in other markets. Nam said that the immediate priority is gathering data from the U.S. trials, but discussions are currently underway to conduct clinical trials in the firm’s home country as well.
The company disclosed phase II data for its antibiotic candidate, telacebec, which could be the first universal regimen to treat tuberculosis regardless of drug resistance, in March 2020.
The company is currently also working on an IND-enabling study for Q-901, its selective CDK7 inhibitor, as well as early stage studies for an immunoproteasome inhibitor; it is aiming at eventual FDA clearance for both.
Qurient formed a joint venture with Germany’s Max Planck Society, Lead Discovery Center GmbH (LDC) and 1988 Nobel laureate Robert Huber in October 2019. The parties will develop novel proteasome inhibitors targeting hematologic and solid tumors as well as for autoimmune diseases. The three companies inked a license agreement for both Q-702 and Q-901, while they are developing the immunoproteasome inhibitor through the joint venture.
“We are excited to see the progress in this project and are looking forward to the application in humans in the near future,” Matthias Stein-Gerlach, senior patent and licensing manager at Max-Planck Innovation GmbH, said.
“Reaching a clinical candidate for development is one of the most important milestones in our partnerships. Starting an early stage collaboration with Ullrich’s lab from Max Planck, leading to a licensing agreement with Qurient, we jointly mastered the pharmaceutical research phase and are now very eager to receive the results from this drug candidate in patients,” added Bert Klebl, CEO and chief scientific officer of Lead Discovery Center. “Starting with this program, we have since built a sustainable and strong partnership with our partner Qurient, focusing on the translation of innovative biology and drug discovery programs from LDC’s academic network.”