TAK-169

Specifically Engineered to Eliminate CD38 Expressing Cells

TAK-169 is a second generation engineered toxin body (ETB) that is a single-chain variable fragment (scFv) with an 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 consistent with SLTA mediated cellular cytotoxicity. TAK-169 is being developed through a collaboration with Takeda Pharmaceuticals.

TAK-169 is designed to avoid competition with and to overcome the primary mechanisms of tumor resistance to daratumumab. The TAK-169 candidate is active in the presence of daratumumab, which we believe demonstrates its potential to be combined with approved CD38 targeted therapies.

TAK-169 mediates enzymatic and irreversible ribosomal inhibition and induces direct cell death 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.

Program	Partner	Indication (Target)	Preclinical	Phase 1	Phase 2	Phase 3	Next Stage
TAK-169		Multiple Myeloma (CD38)	Preclinical Phase complete	Phase 1 Phase in progress	Phase 2 Phase not started	Phase 3 Phase not started

a) Potential for Phase 2 to be pivotal in relapsed/refractory setting as monotherapy

Completed

In-progress

Planning

Phase 2 is potentially pivotal

Key Benefits

A Potential New CD38 Targeting Agent

TAK-169’s mechanism of action (MOA) efficiently internalizes against low-or high-expressing CD38.
It has reduced ADA and innate response (de-immunized STLA scaffold).
TAK-169’s MOA is distinct from that of antibodies and enables potential use following post-daratumumab failure and in combo with SOC.
Its activity is retained in the presence of daratumumab in pre-clinical models.
TAK-169 is active in patient samples (including dara-refractory samples).
It has shown activity in multiple xenograft models when dosed weekly or bi-weekly.

Clinical Overview

Dosing was initiated for the Phase 1 clinical trial for TAK-169 in the first quarter of 2020. Although TAK-169 is more potent than MT-3724 (our first generation CD20-targeted ETB), it was tolerated at much higher doses than was MT-3724 in non-human primates. The protocol for the dose escalation for TAK-169 starts at 50 mcg/kg, which is also the maximum tolerated dose (MTD) for MT-3724. The protocol includes once weekly and once every two-week dosing schedules.

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A Promising Collaboration with Takeda

Our partnership with Takeda began in October 2016 upon entering into a collaborative agreement to discover and develop CD38-targeted engineered toxin bodies (ETBs) for the treatment of multiple myeloma.

On September 18, 2018, we entered into a development collaboration and exclusive license agreement with Takeda for the development and commercialization of products comprised of one or more CD38 SLT-A fusion proteins.

Posters & Presentations

To learn more about the TAK-169 candidate, explore our research publications.

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