DongKoo Bio & Pharm Co. Ltd.

Verismo will initiate a Phase I trial of its CAR T therapy SynKIR-310 for B-cell non-Hodgkin lymphoma. According to GlobalData, there will be over 1.8 billion cases of B-cell NHL in 2027 globally. Credit: Ground Picture via Shutterstock. The US Food and Drug Administration (FDA) has cleared Verismo Therapeutics’ investigational new drug (IND) application to advance its CAR-T therapy SynKIR-310 into a Phase I clinical trial. The Phase I CELESTIAL-301 trial will enrol patients with relapsed or refractory B-cell non-Hodgkin lymphomas (B-cell NHL), whether they have had prior CAR-T therapy or not. Verismo plans to initiate the CELESTIAL-301 clinical trial in the second half of 2024. CAR-T therapies have proven to be successful in the management of select haematologic malignancies. However, many patients relapse due to a lack of long-term T cell effector function. The therapeutic avenues available post-relapse after CAR-T therapy are limited , underscoring the need for new therapies that can augment current survival outcomes. Verismo’s KIR-CAR platform uses natural killer (NK) cell-derived KIR and DAP12 split signalling to activate and stimulate the immune system, helping CAR-T cells stay active for longer and fight against both solid tumours and blood cancers. SynKIR-19 targets and destroys cells with CD19, a protein found in B lymphocytes. It binds to overexpressed tumour antigens, activating T cells and triggering targeted killing of tumour cells. See Also: Circular RNA: Vaccines, therapeutics and biomarkers could be revolutionised The cell therapy startup spun out of the University of Pennsylvania in 2020. It has since raised $50m, generating $17m in a second pre-Series A round co-led by DongKoo Bio, HLB Innovation and HLB in July 2023. Verismo established a research and development centre at CIC Philadelphia in 2022 to advance its KIR-CAR platform. Verismo’s lead candidate SynKIR-110 is under investigation in the Phase I STAR-101 clinical trial (NCT05568680) for mesothelin-expressing advanced ovarian cancer, mesothelioma, and cholangiocarcinoma. The study plans to enrol 42 subjects receiving single-dose intravenous (IV) administration, with dosing escalated using a 3 + 3 design. Additional subjects will be enrolled at the maximum tolerated dose to further evaluate safety and potential activity. According to a report on GlobalData’s Pharma Intelligence Center, the number of diagnosed prevalent cases of B-cell NHL will exceed 1.8 billion in 2027 globally. GlobalData is the parent company of Pharmaceutical Technology. In the announcement accompanying the IND, Verismo’s chief scientific officer Laura Johnson said: “The SynKIR-310 technology is designed to enhance the anti-tumour activity and extend the efficacy of T cells. This could potentially improve persistence and prevent early disease relapse in patients with aggressive lymphomas. SynKIR-310 could be especially beneficial for patients that relapsed after previous infusions of CAR T cell therapies.” Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva . Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content. Free Whitepaper Cell and gene therapies: Pipe dream to pipeline The cell and gene industry is gaining momentum, with a new wave of therapies promising to transform the way doctors treat, and even cure, disease. In this report, Cytiva and GlobalData have collaborated to explore the rise of the cell and gene therapy industries, the current state of the market, present and future opportunities for advancement, and the challenges that lie ahead. Thank you. You will receive an email shortly. Please check your inbox to download the Whitepaper. By Cytiva Thematic By downloading this case study, you acknowledge that GlobalData may share your information with Cytiva Thematic and that your personal data will be used as described in their Privacy Policy

Verismo Therapeutics has raised a total of $50M since launching PHILADELPHIA, July 18, 2023 /PRNewswire/ -- Verismo Therapeutics, a clinical-stage CAR T company, Penn spinout, and pioneer of the novel KIR-CAR platform technology, today announced it has raised $17M in a second pre-Series A financing round. The financing will support continued advancement of the clinical trial for SynKIR™-110, a first-in-class KIR-CAR T cell immunotherapy candidate for solid tumors, and pre-clinical development of SynKIR™-310, a KIR-CAR T cell immunotherapy therapeutic for blood cancers. The funding round was co-led by DongKoo Bio, HLB Innovation and HLB. The funding will be used to advance multiple programs targeting solid and liquid tumors. With this $17M investment Verismo will have secured a total of $50M in financing since launching in 2020. About the KIR-CAR Platform The KIR-CAR platform is a dual-chain CAR T cell therapy and has been shown in preclinical animal models to be capable of maintaining antitumor T cell activity even in challenging solid tumor environments. DAP12 acting as a novel costimulatory molecule for T cells, aids additional T cell stimulating pathways, further sustaining chimeric receptor expression and improving KIR-CAR T cell persistence. This continued T cell function and persistence can lead to ongoing regression of solid tumors in preclinical models, including those refractory to traditional CAR T cell therapies. Furthermore, the KIR-CAR platform can be combined with many additional emerging technologies, such as in vivo gene engineering, advanced cell manufacturing and reprogramming, combinational therapies, and even allogeneic cellular therapies to provide the next-generation multimodal targeted immunotherapy for patients in need. About Verismo Therapeutics Verismo Therapeutics is a pioneer in dual-chain KIR-CAR technology, and its lead asset, SynKIR™-110, is currently undergoing first-in-human Phase 1 clinical trial. Verismo is the only company developing the KIR-CAR T cell platform, a modified NK-like receptor designed to improve persistence and efficacy against aggressive solid tumors. The KIR-CAR T cell platform technology was developed specifically for advanced solid tumors, an area of high unmet medical need. For more information, visit: . Media contact: Alyson Kuritz, alyson@0to5.com