On June 17, 2019 Molecular Templates, Inc., (Nasdaq: MTEM, "Molecular," "Molecular Templates" or "MTEM") a clinical stage biopharmaceutical company focused on the discovery and development of Engineered Toxin Bodies (ETBs), a new class of targeted biologic therapies that possess unique mechanisms of action in oncology, reported that the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application for TAK-169, an ETB targeting CD38 (Press release, Molecular Templates, JUN 17, 2019, View Source [SID1234537112]).
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MTEM and partner Takeda Pharmaceutical Company Limited (Takeda) are co-developing TAK-169 and plan to conduct an open label Phase I dose escalation and expansion study in relapsed/refractory multiple myeloma patients.
"We are excited to continue our collaboration with Takeda advancing the development of TAK-169 for the treatment of multiple myeloma patients," said Eric Poma, Ph.D., CEO and CSO of Molecular Templates. "It represents a novel CD38 targeted therapy which could provide benefit in patients with multiple myeloma and overcome mechanisms of resistance to existing CD38 targeted therapies."
About TAK-169
TAK-169 is an ETB consisting of a single chain variable fragment (scFv) with affinity for CD38, fused to the enzymatically active de-immunized Shiga-like toxin-A subunit (SLTA). TAK-169 specifically binds and kills CD38 expressing cells in a manner consistent with SLTA mediated cellular cytotoxicity. TAK-169 has been specifically designed to avoid competition with and to overcome the primary mechanisms of tumor resistance to daratumumab and other monoclonal antibodies targeting CD38. TAK-169 has been shown to be active in the presence of daratumumab. As such, TAK-169 may have the potential to be combined with approved CD38 targeted therapies. TAK-169 mediated ribosomal inhibition and cell death take place intracellularly so changes in the tumor microenvironment, such as CD55/59 upregulation, which inhibit immune-mediated mechanisms such as antibody-dependent cell-mediated cytotoxicity (ADCC) or complement dependent cytotoxicity (CDC) are not expected to inhibit TAK-169 activity.
About the CD38 Co-Development Partnership with Takeda
On September 19, 2018, MTEM announced an agreement with Takeda for the joint development of CD38-targeted ETBs for the treatment of multiple myeloma. TAK-169, the lead development candidate, is a CD38-targeted ETB that resulted from a previous discovery collaboration between the two companies. Under the terms of the agreement, Takeda has made an upfront payment of $30 million and Molecular Templates is eligible to receive development, regulatory and commercial milestone payments of up to $632.5 million if Molecular Templates exercises its co-development option or $337.5 million if Molecular Templates does not exercise or opts out of its co-development option. Takeda has also agreed to pay royalties on sales of the commercial product developed through the collaboration. Molecular Templates and Takeda will share equally in the development costs. MTEM has been awarded a $15.2 million grant from the Cancer Prevention and Research Institute of Texas (CPRIT) to fund development and manufacturing of CD38-targeted ETBs including TAK-169.