Pipeline
Dren develops therapeutic antibodies to execute robust depletion of disease-causing
cells and agents. We selectively engage an effector cell for the targeted depletion in correlation with
the pathogenesis and status of immune cells in the disease. Our pipeline is currently comprised of two
distinct drug discovery programs.
- DR-01: Utilizes enhanced antibody-dependent cellular cytotoxicity (“ADCC”)
- DR-02: Targeted Myeloid Engager and Phagocytosis Platform derived bispecific antibodies
DR-01
DR-01 is a high affinity, fully human, nonfucosylated antibody that binds to a cell
surface receptor selectively expressed on cytotoxic cells which have been aberrantly proliferated in a
variety of NK and T-cell disorders. Upon binding, DR-01 induces fratricide of these malignant cells
via antibody-dependent cellular cytotoxicity (“ADCC”).
- DR-01 has been specially engineered to enhance its ADCC mechanism, resulting in rapid and robust target cell depletion.
- Initial clinical development efforts for DR-01 are focused on the treatment of serious conditions in patients with unmet medical needs, starting with a first-in-human basket oncology study comprised of several rare, hematologic malignancies for which there no current approved therapies.
- Dren Bio initiated a Phase 1/2 study during mid-2022 to evaluate the use of DR-01 in subjects with Large Granular Lymphocytic leukemia (“LGLL”) or cytotoxic lymphomas (NCT05475925). Based on the results of this trial, the Company may qualify for accelerated approval when submitting its initial marketing application with the FDA.
DR-0201
DR-0201: Targeted Myeloid Engager and Phagocytosis Platform for the treatment of B
cell malignancies (click on platform link
to learn more)
- B cell lymphomas are characterized by high levels of CD163+ M2-like macrophages and myeloid-derived suppressor cells (MDSCs) in patients with late-stage disease
- Elevated levels of these immuno-suppressive myeloid cells are associated with disease severity and poor prognosis
- DR-0201 bispecific antibody binds on one arm to a phagocytic receptor on myeloid cells, and on the second arm to a surface receptor that is highly expressed on B cells in various B cell malignancies, including DLBCL, MCL, FL, and CLL
- DR-0201 demonstrated superior B cell depletion and cytokine release compared to benchmark therapies like Rituximab, Obinutuzumab, and T cell engagers
- DR-0201 induced target antigen cross-presentation suggesting the potential to activate effector and memory T cells, and therefore promote lasting anti-tumor immunity
- In exploratory non-human primate studies, DR-0201 demonstrated robust pharmacodynamic activity and excellent tolerability with no adverse clinical signs, suggesting a broad therapeutic index than typically seen with other immune cell engagers
- Fundamentally differentiated MOA of DR-0201 may warrant benefit for patients with B cell malignancies
DR-02 Solid Cancer
Targeted Myeloid Engager and Phagocytosis Platform for the treatment of solid
tumors (click on platform link to learn
more)
- Bispecific Abs for clinically-validated; cell surface receptor that is highly expressed in multiple solid tumors, including breast, urothelial, glioblastoma, and endometrial cancers
- Approved therapies in some of the cancers have low response rates and result in adverse reactions, such as neutropenia, diarrhea, and vomiting
- Bispecific candidates demonstrated robust cytokine release and cancer cell depletion in multiple tumor biopsies
- Bispecific candidates cross-presentation and activation of cytotoxic CD8+ T cells in ex vivo assays, highlighting the potential to achieve lasting anti-tumor immunity
- Notably, DR-0202 has the potential to restrict anti-tumor activity to the tumor microenvironment where target cancer cells and myeloid cells are abundant
- DR-02 bispecifc Abs activity is tightly regulated by the presence of cancer cells; after cancer cells are eliminated, the antibody activity is attenuated
