Gadeta announces significant progress in advancing pipeline and TEG platform development

Gadeta announces significant progress in advancing pipeline and TEG platform development

·      Aim is to develop gamma delta (γδ) T-cell receptor (TCR)-based immunotherapies for solid tumors

·      Ph1/2 update on lead product GDT002 as well as nomination of second pipeline program GDT201

Utrecht, Netherlands and Boston, Mass., 15 March 2022: Gadeta B.V. (‘Gadeta’), a clinical-stage company developing innovative, gamma delta (γδ) T-cell receptor (TCR)-based immunotherapies for every cancer patient, today provides an update on its development pipeline and strategy.

Gadeta is developing a pipeline of cell therapies based on its TEG platform. Its first-in-class lead compound, GDT002, is a pan-tumor cell therapy currently undergoing phase 1/2 trials for safety and efficacy in relapsed/refractory multiple myeloma at Dana-Farber Cancer Institute, Mass General Brigham Cancer Care and Beth Israel Deaconess Medical Center in the US. The first dose cohort has been completed and dose escalation is ongoing. More details of the trial can be found at clinicaltrials.gov NCT04688853. Subsequently, Gadeta aims to start GDT002 Phase 1/2 studies in a solid tumor indication.

Gadeta is also completing IND-enabling studies for its second program, GDT201, in colorectal cancer, and plans to file an IND towards the end of the year to begin clinical studies. GDT201 is based on a newly discovered γδ TCR showing very promising preclinical results. In vivo data show the ability of GDT201 to eradicate colorectal cancer in a preclinical model (100% CR) suggesting potential to address well-known clinical hurdles such as lack of tumor restricted antigens and safety. GDT201 uses a proprietary bi-directional co-stimulatory mechanism (MiDis) to enhance cytotoxicity in the suppressive tumor microenvironment. Gadeta has also made significant strides in discovering novel tumor-specific γδ TCRs through its proprietary discovery platform and will select further candidates as part of further building its pipeline. In parallel, Gadeta has been exploring the application of its platform in allogeneic settings.

Marcel Zwaal, Chief Executive Officer of Gadeta, said: “Gadeta’s goal is to develop transformative cell therapies for any type of tumor using its proprietary TEG platform. Gadeta has made significant progress over the last five years, with the support of Kite Pharma which remains a long-term, committed shareholder, in building a discovery engine for new gamma delta T-cell receptor targets and moving its first compound from preclinical into clinical development. Our strategy is clear, to maximize the potential of our pipeline and deliver on our mission of reinventing cell therapy by opening up a new universe of tumor targeting agents.” 

In 2020, Kite Pharma returned, for strategic reasons, rights granted to it by Gadeta under a TEG technology collaboration agreement but retains certain notice rights and remains a shareholder. Importantly, this provides Gadeta with full control over its programs and pipeline. Gadeta aims to start GDT002 Phase 2 studies in a solid tumor indication based on proof-of-concept in multiple myeloma. Over the last few months this transition has been led by CEO Marcel Zwaal who joined from Kiadis Pharma, the Dutch NK cell therapeutics company acquired by Sanofi for $358 million. Together with Mark Throsby, CSO & COO (CSO Merus and Crucell), they have strengthened the Company’s management team to progress its products into the clinic.

Giovanni Mariggi, Partner at Medicxi, and member of Gadeta’s Supervisory Board, said: “We are very excited by Gadeta’s progress and future plans to become a leader in the γδ TCR space. Marcel and Mark bring a wealth of experience in the field, particularly in advancing cell immunotherapies of high clinical and commercial interest. The team’s experience and track record will be key to drive Gadeta through its next stages of growth as its lead programs progress through clinical development. I look forward to working together with them on Gadeta's next phase of development.”