On August 5, 2026 SystImmune, Inc., a clinical-stage biotechnology company and subsidiary of Biokin, reported that the first patient has been dosed in BrenDeLL-Lung01 (NCT07625644), a global Phase 3 registrational trial evaluating BL-M14D1 in combination with atezolizumab for the treatment of patients with previously untreated extensive-stage small cell lung cancer (ES-SCLC).
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BL-M14D1 is an investigational DLL3-targeted antibody-drug conjugate (ADC) built on SystImmune’s proprietary brengitecan platform and is being developed globally for the treatment of small cell lung cancer and other neuroendocrine malignancies.
"The initiation of our global Phase 3 program marks an important milestone for BL-M14D1 and reflects our commitment to bringing innovative treatment options to patients with small cell lung cancer," said Jonathan Cheng, M.D., Chief Medical Officer of SystImmune. "Despite recent advances, outcomes for patients with extensive-stage small cell lung cancer remain poor, and there continues to be a significant need for more effective therapies. We believe BL-M14D1 has the potential to improve outcomes for these patients, and we are excited to begin evaluating the program in a registrational setting."
The Phase 3 study follows encouraging clinical activity observed in the ongoing Phase 1 BL-M14D1-101 trial recently presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. These results demonstrated promising anti-tumor activity and a manageable safety profile in heavily pre-treated patients with small cell lung cancer and other neuroendocrine carcinomas, supporting advancement of the program into late-stage development.
About the BrenDeLL-Lung01 Phase 3 Clinical Trial
BrenDeLL-Lung01 (NCT07625644) is a global, multi-center, randomized Phase 3 trial evaluating BL-M14D1 in combination with atezolizumab versus standard-of-care platinum and etoposide induction followed by atezolizumab maintenance, with or without lurbinectedin, in patients with previously untreated extensive-stage small cell lung cancer. The study intends to enroll approximately 580 patients and the primary endpoint for this study is progression-free survival as assessed by blinded independent central review (BICR).
About BL-M14D1
SystImmune is advancing a portfolio of next-generation antibody-drug conjugates (ADCs) built on its proprietary brengitecan platform, which utilizes a potent topoisomerase I inhibitor payload designed for targeted delivery to tumor cells. The clinical progress of izalontamab brengitecan (iza-bren) provides initial validation of this platform’s potential to deliver meaningful anti-tumor activity across multiple cancer types.
BL-M14D1 targets DLL3, which is highly expressed in small-cell lung cancer and neuroendocrine tumors, facilitating selective delivery of the brengitecan payload to DLL3-positive tumor cells.
(Press release, SystImmune, AUG 5, 2026, View Source [SID1234669748])