Dren Bio announced the closing of an oversubscribed $350 million private financing. The round was co-led by Juvia Group and Lightspeed Venture Partners. The funding will support late-stage clinical development, regulatory submission and the planned commercialization of dibotatug (DR-01), an investigational antibody targeting CD94 for rare blood cancers, including cytotoxic T/NK-cell lymphomas and large granular lymphocytic leukemia (LGLL). It will also accelerate the company’s broader oncology and autoimmune pipeline, including programs built on its Targeted Myeloid Engager and Phagocytosis Platform.
“Seeing dibotatug advance to this late stage of development… is deeply gratifying.”
– Nenad Tomasevic, CEO & founder of Dren Bio.
Dren Bio
Dren Bio is a privately held, clinical-stage biopharmaceutical company founded in 2019 and based in Foster City, California. The company develops antibody-based therapies for cancer, autoimmune disorders, and other serious diseases. Its lead candidate, DR-01, is being studied in large granular lymphocytic leukemia and cytotoxic lymphomas. Its proprietary Targeted Myeloid Engager and Phagocytosis Platform is designed to use the body’s myeloid cells to eliminate disease-causing cells, and has produced DR-0202, a bispecific antibody for solid tumors. Dren Bio also has preclinical programs in oncology, immunology, and neurology.
Investors
The round was co-led by Juvia Group and Lightspeed Venture Partners, with participation from Mirae Asset Capital Life Science, General Catalyst, Cormorant Asset Management, OrbiMed, 8VC, SR One, Taiho Ventures, Mission BioCapital, HBM Healthcare Investments, BVF Partners, Aisling Capital, and ArrowMark Partners.
Dibotatug (DR-01)
Dibotatug (DR-01) is an investigational, non-fucosylated IgG1 monoclonal antibody targeting CD94, a cell-surface receptor expressed on natural killer (NK) cells and subsets of cytotoxic T cells, including terminally differentiated CD8⁺ and γδ T cells.
It is designed to help the immune system find and destroy these cells. Preclinical studies also suggest that leukemic cells from patients with large granular lymphocytic leukemia (LGLL) may deplete one another. Dren Bio aims to use this approach to eliminate harmful cytotoxic cells while preserving the rest of the immune system.
Clinical Development and Unmet Need
- Large Granular Lymphocytic Leukemia (LGLL): A rare, chronic lymphoproliferative disorder characterized by the clonal expansion of cytotoxic T cells or NK cells. It can cause severe neutropenia, anemia, and recurrent infections.
- Cytotoxic T/NK-cell lymphomas: A group of rare and aggressive lymphomas, including extranodal NK/T-cell lymphoma (ENKTL), enteropathy-associated T-cell lymphoma (EATL), monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL), hepatosplenic T-cell lymphoma (HSTCL), subcutaneous panniculitis-like T-cell lymphoma (SPTCL), and primary cutaneous γδ T-cell lymphoma. These diseases are associated with significant unmet medical needs, particularly in relapsed or refractory settings.
- Non-malignant and autoimmune conditions: Dibotatug is planned for study in severe aplastic anemia and other bone marrow failure syndromes, as well as alopecia areata and vitiligo, based on the role of cytotoxic T cells in these conditions.
How These Diseases Are Treated Today
Large granular lymphocytic leukemia (LGLL)
There is no curative therapy for LGLL, and the aim of treatment is to keep patients in remission for as long as possible. Treatment is usually started for severe neutropenia, frequent infections, symptomatic or transfusion-dependent anemia, or an autoimmune disorder that needs treatment. First-line treatment is immunosuppressants: methotrexate, cyclophosphamide and cyclosporin A. A significant share of patients do not respond to frontline immunosuppressive therapy, and for refractory disease the options are limited, with alemtuzumab sometimes used.
Cytotoxic T/NK-cell lymphomas
Cytotoxic lymphomas are generally managed like other aggressive peripheral T-cell lymphomas (PTCL), whose treatment has traditionally followed the approach used for aggressive B-cell lymphomas, with poor outcomes. The options after relapse are limited: pralatrexate, belinostat, brentuximab vedotin for CD30-positive disease, and salvage combination chemotherapy, while romidepsin’s indication for relapsed or refractory PTCL was withdrawn after a failed phase 3 trial. Except for brentuximab vedotin in anaplastic large cell lymphoma, these drugs have low single-agent response rates and short progression-free survival. Prognosis after relapse is poor: median overall survival is about 7 months after first relapse or progression, and in relapsed or refractory ENKTL one cited analysis puts it at under 6 months.
Efficacy and Safety Profile
“We believe dibotatug has the potential to dramatically change the treatment paradigm in multiple hematologic and autoimmune diseases with substantial unmet need.”
Sujal Shah, Co-Founder And Managing Director of Juvia Group
Updated Phase 1/2 clinical data in patients with relapsed or refractory cytotoxic T/NK-cell lymphomas showed an overall response rate (ORR) of 53% among 47 response-evaluable patients treated at the selected 1 mg/kg dose. This included 14 complete responses and 11 partial responses. Responses were observed across multiple lymphoma subtypes, and the longest response was ongoing at 22 months.
Dibotatug demonstrated a generally manageable safety profile. Infusion-related reactions were the most frequently reported treatment-related adverse events, occurring in 27 of 81 patients with cytotoxic T/NK-cell lymphomas, primarily during the initial administration.
What comes next
The company plans to take dibotatug through registration trials in both LGLL and cytotoxic T/NK-cell lymphomas while expanding development into other blood cancers and autoimmune diseases.
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