HLB Group is weeks away from two U.S. cancer drug decisions that could define whether the Korean biotech can move beyond a long dependence on rivoceranib, its lead cancer asset.
HLB on Tuesday highlighted its U.S. cell therapy subsidiary Verismo Therapeutics as part of its next oncology push, presenting early clinical data for a CAR-T platform designed for solid tumors -- a cancer setting where the technology has so far failed to match its success in blood cancers.
HLB is awaiting U.S. FDA decisions this year on two oncology drugs: rivoceranib plus camrelizumab for liver cancer and rilafugratinib for bile duct cancer.
HLB Chairman Jin Yang-gon said at Tuesday’s company forum that FDA approval would mark the group’s “first success” after 20 years of cancer drug development.
Rhee Ji-hwan, managing director at HLB, explains Verismo’s KIR-CAR platform at the 2026 HLB Forum in Seoul on Tuesday. (Credit: HLB)
Rhee Ji-hwan, managing director at HLB, said Verismo’s KIR-CAR platform was developed by researchers linked to the University of Pennsylvania team behind Novartis’ Kymriah (tisagenlecleucel), the first approved CAR-T therapy.
He said the group had recognised early that while CAR-T produced “dramatic” effects in blood cancers, solid tumours presented harder biological barriers.
CAR-T therapy takes a patient’s T cells, engineers them to recognise cancer and puts them back into the body. The approach has changed treatment for some blood cancers, but no CAR-T therapy has yet been approved by the U.S. FDA for solid tumors.
One problem is “tonic signaling,” Rhee said, where engineered T cells remain weakly activated before they meet cancer cells. By the time they reach the tumor, they may already be exhausted.
Verismo’s platform uses a multi-chain structure inspired by natural killer cell signaling. The company says the design allows the therapy to activate only when it recognises a tumour target, potentially reducing exhaustion and improving durability.
Verismo is testing SynKIR-110, a mesothelin-targeted CAR-T therapy for solid tumors including ovarian cancer, mesothelioma and bile duct cancer, in a U.S. phase 1 trial. It is also testing SynKIR-310, a CD19-targeted therapy for B-cell blood cancers.
The SynKIR-110 study is being run at four U.S. medical centers in adults with advanced ovarian cancer, mesothelioma or bile duct cancer who have few remaining treatment options, according to Verismo’s forum materials.
The company recently presented interim SynKIR-110 data at the American Association for Cancer Research (AACR) meeting in Chicago in April.
According to Verismo, nine patients with mesothelin-positive solid tumors had been treated, with no dose-limiting toxicities reported. Some patients showed tumor shrinkage, including reductions of up to 47 percent.
Laura Johnson, Verismo’s chief operating and scientific officer, speaks with reporters after presenting early clinical data for SynKIR-110. (Credit: HLB)
Laura Johnson, Verismo’s chief operating and scientific officer, said the company’s role sits “between target identification through translation into first-in-human and then into proof of clinical concept.”
“At that point, we were hoping to either out-license or partner with a larger partner in order to have someone with more experience -- and not just the experience, but the ability and the infrastructure -- to be able to support commercialization and being able to get this to the patients who need it,” Johnson said.
Rhee said platform-level licensing would be unlikely because KIR-CAR is Verismo’s core asset.
Handing over the platform, he said, would be like giving away “the heart of the company” and would more closely resemble an acquisition. But he said HLB remains open to licensing or co-development deals for individual pipeline assets.
He said "major drugmakers" had shown interest after Verismo presented preclinical data last winter, but wanted human data before serious review.
Asked whether Verismo had contact with big pharma after the AACR presentation, Johnson gave a short answer: “To be continued.”
Kim Ji-hye
댓글
0