Milestone Triggers $10 Million Payment to Molecular Templates

Austin, TX (Press Release) – Molecular Templates, Inc. (Nasdaq: MTEM, “Molecular Templates” or “MTEM”), a clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on the discovery and devel­op­ment of the com­pany’s pro­pri­e­tary engi­neered toxin bodies (ETBs), which are dif­fer­en­ti­ated, targeted, biologic thera­peutics for cancer and other serious dis­eases, today announced the initiation of dosing in a Phase I study investigating TAK-169 in patients with re­lapsed / re­frac­tory multiple myeloma. Co-developed with Takeda Pharma­ceu­tical Com­pany Limited (“Takeda”), TAK-169 is a poten­tial first-in-class CD38-targeting ETB. As a result of achieving this mile­stone, MTEM will re­ceive a $10 million pay­ment from Takeda.

“TAK-169, which leverages MTEM’s second generation, de-immunized ETB tech­nology, rep­re­sents a promising thera­peutic ap­proach for multiple myeloma patients with sig­nif­i­cant unmet medical needs. We are pleased that dosing is underway in the Phase I study,” said Eric Poma, Ph.D., Molecular Templates’ Chief Executive and Scientific Officer. “This prod­uct can­di­date is designed to de­liver a potent, direct, cell-killing mech­a­nism to cells that express CD38, a re­cep­tor that is known to be central to myeloma dis­ease.”

This study is a Phase 1, open-label, dose-escalation, multi­center study to eval­u­ate TAK-169 in patients with re­lapsed or re­frac­tory multiple myeloma. The pri­mary end­points are to eval­u­ate safety and tolerability. Secondary end­points in­clude pre­lim­i­nary efficacy, phar­ma­co­ki­netic, phar­ma­co­dy­nam­ic, and immuno­gen­icity measures. Patients will be followed up for 30 days after the last dose of study drug for a follow-up assess­ment. For more in­for­ma­tion, refer to ClinicalTrials.gov identifier: NCT04017130.

“TAK-169 has ad­vanced to clin­i­cal devel­op­ment by pairing Takeda’s multiple myeloma ex­per­tise with Molecular Templates’ novel ETB tech­nology,” said Chris Arendt, Ph.D., Head, Oncology Thera­peutic Area Unit, Takeda. “This pro­gram is a prime example of Takeda’s emphasis on work­ing with world-class partners to discover and de­vel­op transformational new ther­a­pies for multiple myeloma and other hema­to­logic malig­nan­cies.”

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 is designed to bind and kill 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, the first approved mono­clonal anti­body targeting CD38. In pre­clin­i­cal in­ves­ti­ga­tion 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 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 com­pany focused on the discovery and devel­op­ment of targeted biologic thera­peutics. Molecular Templates’ pro­pri­e­tary drug plat­form tech­nology, known as engi­neered toxin bodies, or ETBs, leverages the resident biology of a genetically engi­neered form of Shiga-like Toxin A subunit to create novel ther­a­pies with potent and dif­fer­en­ti­ated mech­a­nisms of action for cancer and other serious dis­eases.

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 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.