• TAK-169 Represents a Novel Mechanism of Action Targeting CD38
• Phase I Study to be Conducted in Relapsed/Refractory Multiple Myeloma Patients

Austin, TX (Press Release) – 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, announced that the U.S. Food and Drug Admin­istra­tion (FDA) has accepted the Inves­ti­ga­tional New Drug (IND) appli­ca­tion for TAK-169, an ETB targeting CD38.

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.

About Molecular Templates

Molecular Templates is a clin­i­cal-stage on­col­ogy com­pany focused on the discovery and devel­op­ment of dif­fer­en­ti­ated, targeted, biologic thera­peutics for cancer. We believe our pro­pri­e­tary biologic drug plat­form tech­nology, referred to as engi­neered toxin bodies, or ETBs, provides a dif­fer­en­ti­ated mech­a­nism of action that may address some of the limitations asso­ci­ated with cur­rently avail­able cancer thera­peutics. ETBs utilize a genetically engi­neered form of Shiga-like Toxin A subunit, or SLTA, a ribosome inactivating bacterial protein, that can be targeted to specifically destroy cancer cells. Additional in­for­ma­tion about Molecular Templates can be obtained at http://www.mtem.com.

Forward-Looking Statements

This press release con­tains for­ward-looking state­ments for pur­poses of the Private Se­cu­ri­ties Lit­i­ga­tion Reform Act of 1995 (the “Act”). Molecular Templates disclaims any intent or obli­ga­tion to update these for­ward-looking state­ments, and claims the protection of the Act’s Safe Harbor for for­ward-looking state­ments. All state­ments, other than state­ments of historical facts, in­cluded in this press release re­gard­ing strategy, future operations, future financial position, future revenue, pro­jected expenses, pros­pect­s, plans and objectives of man­agement are for­ward-looking state­ments. In addi­tion, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar ex­pres­sions and their variants, as they relate to Molecular Templates may identify for­ward-looking state­ments. Examples of such state­ments in­clude, but are not limited to, state­ments relating to the devel­op­ment of MT-3724, MT-5111, or TAK-169; the ex­pec­ted timing of submitting various IND appli­ca­tions and conducting studies; and the Company’s belief that its pro­pri­e­tary biologic drug plat­form tech­nology, or ETBs, provides for a dif­fer­en­ti­ated mech­a­nism of action that may address some of the limitations asso­ci­ated with cur­rently avail­able cancer thera­peutics.

Forward-looking state­ments are not guar­an­tees of future per­for­mance and involve risks and un­cer­tain­ties. Actual events or results may differ ma­teri­ally from those discussed in the for­ward-looking state­ments as a result of various factors in­clud­ing, but not limited to, the un­cer­tain­ties in­her­ent in the pre­clin­i­cal and clin­i­cal devel­op­ment process; whether the Company’s cash resources will be sufficient to fund its continuing operations for the periods and/or trials antic­i­pated; the ability of the Company to protect its intellectual property rights; and legislative, regu­la­tory, political and economic devel­op­ments, as well as those risks identified under the heading “Risk Factors” in the Company’s filings with the SEC. Any for­ward-looking state­ments con­tained in this press release speak only as of the date hereof, and the Company specifically disclaims any obli­ga­tion to update any for­ward-looking state­ment, whether because of new in­for­ma­tion, future events or other­wise.

Source: Molecular Templates.