[ASCO] The innovation on/off switch: Verismo’s 메이저 바카라 사이트 therapy targets first-in-class approval for solid tumors

[by Lee, Young Sung] Verismo Therapeutics, a U.S. subsidiary of HLB Group, has announced its objective of commercializing 'SynKIR-110' as a 'first-in-class' treatment for solid tumors. SynKIR-110 is a next-generation 메이저 바카라 사이트 (chimeric antigen receptor T cell) therapy developed using the company's proprietary KIR-CAR platform.

Verismo announced the progress of the phase 1 clinical trial of SynKIR-110, its next-generation 메이저 바카라 사이트 candidate, at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting held in Chicago, U.S., from May 30 to June 3 (local time).

During the event, Laura Johnson, Chief Scientific Officer (CSO) and Chief Operating Officer (COO) of 메이저 바카라 사이트, outlined the commercialization blueprint for SynKIR-110 in an interview with <THE BIO on June 2 (local time).

"Once the optimal dose for Phase 2 clinical trials is determined soon, we will evaluate the initial efficacy in dose-expansion cohorts targeting mesothelioma, cholangio메이저 바카라 사이트cinoma, and ovarian cancer patients," Johnson stated. "We are preparing a Phase 2 pivotal design with the aim of obtaining potential accelerated approval of SynKIR-110. We have already secured Orphan Drug Designation (ODD) and Fast Track Designation from the FDA, which will streamline our interactions with regulatory agencies," she added.

메이저 바카라 사이트 plans to complete the Phase 2 clinical trials of SynKIR-110 and subsequently submit a Biologics License Application (BLA) for commercialization to the U.S. Food and Drug Administration (FDA). Given that this indication represents an unmet medical need, the company explained that approval could be applied for with only Phase 2 results.

Verismo intends to release the initial clinical data by the end of this year or early 2026, with expectations of obtaining preliminary efficacy data for Phase 2 clinical trial within about a year. According to the announcement, SynKIR-110 is currently undergoing a Phase 1 clinical trials in patients with advanced mesothelin-expressing ovarian cancer, mesothelioma, or cholangio메이저 바카라 사이트cinoma. This study includes a recommended phase 2 dose expansion cohort to confirm early efficacy and assess key safety evaluation endpoints. At present, patient dosing for cohorts 1 to 3 has been completed without the occurrence of dose-limiting toxicity (DLT), while cohort 4 is in progress and preparations for the next phase are underway.

"We are collaborating closely with the FDA to prepare a global 메이저 바카라 사이트 2 or higher trial design that supports commercial manufacturing," Johnson particularly explained. "We have already established a companion diagnostic that is commercially scalable."

"Given this pace of clinical development, achieving first-in-class status is within reach. Going forward, we will evaluate SynKIR-110’s responses to mesothelioma, cholangio메이저 바카라 사이트cinoma, and ovarian cancer based on phase 1 clinical data, and if meaningful responses are observed for all three indications, we plan to pursue approval applications for these cancers collectively, grounded in biomarker-based strategies," Johnson emphasized. "For instance, we could seek simultaneous approval for multiple cancers that express mesothelin antigens, leveraging a precedent in which the FDA recently granted approval based on biomarker-based criteria."

Currently, there are no 메이저 바카라 사이트 therapies approved by the FDA for solid cancers. In contrast, more than six 메이저 바카라 사이트 therapies have been approved for blood cancers to date.

The primary reason for Verismo’s enthusiasm about SynKIR-110 lies in its core platform technology. SynKIR-110 leverages the KIR-CAR platform to address and overcome the limitations associated with existing 메이저 바카라 사이트 cell therapies.

Specifically, SynKIR-110 features a multi-chain chimeric antigen receptor (메이저 바카라 사이트) structure that incorporates the KIR (Killer Immunoglobulin-like Receptor) signaling system of natural killer cells (NK cells) into T cells, thereby enhancing their cancer cell killing capability. This design effectively separates 'antigen recognition' from the 'T cell activation signal,’ functioning as a sort of 'on/off switch' mechanism.

Specifically, SynKIR-110 is activated when the 'antigen recognition' receptor binds to the 메이저 바카라 사이트 antigen, mesothelin, killing the tumor cell. Following tumor cell elimination, the absence of antigen recognition allows SynKIR-110 to revert to a 'resting' state. This mechanism is believed to prevent T cell exhaustion and maintain its therapeutic effect over an extended period.

In contrast, first-generation single-chain 메이저 바카라 사이트 therapies are described as causing rapid exhaustion and loss of T cell function because they continuously produce activation signals regardless of whether the receptor is bound to the target antigen.

"In solid tumors, 메이저 바카라 사이트 therapies frequently experience rapid exhaustion and functional decline, yielding minimal or no clinical benefit," stated Johnson. "One of the reasons for this limitation is the excessive activation and subsequent exhaustion of T cells, driven by continuous signaling from the 'single-chain receptor.’”

"Once we establish proof of concept (PoC) for treating mesothelin-expressing tumors, we intend to initiate additional biomarker-based clinical trials to assess broader indications, including gastric and lung cancer," emphasized Johnson. "We believe that now is the moment to fundamentally transform the treatment landscape by applying the lessons from existing 메이저 바카라 사이트s to develop KIR-CAR T cell therapies," she added.

Verismo was spun off from the research team at the University of Pennsylvania that developed Kymriah, the first commercial 메이저 바카라 사이트 T product. HLB Innovation completed the acquisition in December 2024, securing a 100% stake in the company.