Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and Sarah Cannon Research Institute (Sarah Cannon) announced today that the first patient has been dosed in a first-in-human phase 1 study evaluating DS-6157, an investigational GPR20 directed antibody drug conjugate (ADC), in patients with advanced gastrointestinal stromal tumor (GIST) who have progressed on, or are intolerant to, standard treatment.
Treatment guidelines for patients with advanced GIST recommend surgery where possible and targeted therapy with tyrosine kinase inhibitors (TKIs).1 For the majority of patients who eventually develop resistance to available therapies, there are few remaining options and new types of treatments may help address refractory disease.2
“We are proud to build upon our relationship with Sarah Cannon to initiate this trial evaluating the potential of DS-6157 as a new type of targeted therapy for patients with advanced GIST,” said Arnaud Lesegretain, Vice President Oncology R&D and Head, Alpha Portfolio, Daiichi Sankyo. “Based on preclinical assessments, biomarker research and the demonstrated portability of our DXd ADC technology, we believe that DS-6157 could potentially play a major role in the treatment of patients with GIST that is resistant to TKIs.”
DS-6157 is the fifth DXd ADC from the oncology pipeline of Daiichi Sankyo to enter clinical development and the second being evaluated in the strategic oncology collaboration between Daiichi Sankyo and Sarah Cannon. DS-6157 was designed utilizing Daiichi Sankyo’s proprietary and portable DXd ADC technology to target and deliver chemotherapy inside cancer cells that express GPR20, particularly gastrointestinal stromal tumors, which highly express this target.3
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“Through the development of the DS-6157 targeted therapy, we are taking a critical step in finding more effective therapies for GIST patients,” said Johanna Bendell, MD, Chief Development Officer and Director of Drug Development, Sarah Cannon Research Institute. “In partnership with Daiichi Sankyo, we look forward to providing access to this novel therapy for patients who vitally need these treatment options.”
GIST is a rare soft tissue sarcoma that originates in the digestive tract, usually in the stomach. The annual worldwide incidence of GIST is estimated to be 10 to 15 cases per million, depending on the published series, and similar rates have been reported for Asian, European and Western countries.4
GPR20 (G protein-coupled receptor 20) is a seven-pass transmembrane protein, which is selectively and abundantly expressed in GIST.3 GPR20 expression is detected in more than 80% of all GIST tumor samples irrespective of the number of prior lines of TKI treatments received.5 In preclinical studies, DS-6157 demonstrated activity in GPR20 expressing tumor cells. No GPR20 directed therapies are currently approved for treatment of GIST or any cancer.
Source: BioSpace