Stamford, CT (Press Release) – Spring­Works Thera­peutics, Inc. (Nasdaq: SWTX) announced today that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 10,590,087 (the ‘087 patent), directed to niro­gace­stat, the Com­pany’s lead prod­uct can­di­date in devel­op­ment for patients with desmoid tumors and as a com­bi­na­tion ther­apy for patients with multiple myeloma. The ‘087 patent, assigned to Pfizer, Inc., expires in 2039. The ‘087 patent is a composition of matter patent that covers the polymorphic form of niro­gace­stat that is cur­rently in clin­i­cal devel­op­ment. Spring­Works has ex­clu­sive rights to the ‘087 patent pur­su­ant to an existing world­wide license with Pfizer.

“We are very pleased that the USPTO has issued this patent, which builds upon our existing in­tel­lec­tual property port­folio and extends patent pro­tec­tion for niro­gace­stat to 2039,” said Saqib Islam, Chief Executive Officer of Spring­Works. “The granting of this patent rep­re­sents an im­por­tant devel­op­ment to­wards our objective of ex­panding in­tel­lec­tual property pro­tec­tions for our port­folio of targeted on­col­ogy prod­uct can­di­dates as we seek to ad­vance promising science for underserved patient communities.”

Spring­Works is cur­rently enrolling patients in a global Phase 3, double-blind, ran­dom­ized, placebo-controlled clin­i­cal trial (the DeFi Trial) to eval­u­ate niro­gace­stat in adults with progressing desmoid tumors/aggressive fibromatosis. In addi­tion, Spring­Works is seek­ing to ad­vance niro­gace­stat as a cornerstone of B-cell maturation an­ti­gen (BCMA) com­bi­na­tion ther­apy in multiple myeloma. To date, Spring­Works has entered into two clin­i­cal col­lab­o­rations to eval­u­ate niro­gace­stat in com­bi­na­tion with GlaxoSmithKline’s BCMA anti­body-drug con­ju­gate be­lan­ta­mab mafo­dotin and with Allogene’s allo­geneic BCMA CAR-T cell ther­apy ALLO-715.

About Niro­gace­stat

Nirogacestat is an inves­ti­ga­tional, oral, selective, small molecule gamma-secretase in­hib­i­tor in Phase 3 clin­i­cal devel­op­ment for desmoid tumors, which are rare and often debilitating and disfiguring soft-tissue tumors. Gamma secretase cleaves multiple transmembrane protein complexes, in­clud­ing Notch, which is believed to play a role in activating path­ways that con­trib­ute to desmoid tumor growth.

In addi­tion, gamma secretase has been shown to directly cleave membrane-bound BCMA, resulting in the release of the BCMA extracellular domain, or ECD, from the cell surface. By inhibiting gamma secretase, membrane-bound BCMA can be preserved, in­creas­ing target density while reducing levels of soluble BCMA ECD, which may serve as decoy re­cep­tors for BCMA-directed ther­a­pies. Niro­gace­stat’s ability to en­hance the activity of BCMA-directed ther­a­pies has been observed in pre­clin­i­cal models of multiple myeloma. Spring­Works is pursuing a com­bi­na­tion ther­apy ap­proach to eval­u­ate niro­gace­stat as a BCMA potentiator across modalities by col­lab­o­rating with industry leaders. To date, Spring­Works has entered into two clin­i­cal col­lab­o­rations to eval­u­ate niro­gace­stat in com­bi­na­tion with GlaxoSmithKline’s BCMA anti­body-drug con­ju­gate be­lan­ta­mab mafo­dotin and with Allogene’s allo­geneic BCMA CAR-T cell ther­apy ALLO-715.

Nirogacestat has re­ceived Orphan Drug Desig­na­tion from the U.S. Food and Drug Admin­istra­tion (FDA) for the treat­ment of desmoid tumors (June 2018) and from the European Com­mis­sion for the treat­ment of soft tissue sarcoma (September 2019). The FDA also granted Fast Track and Break­­through Therapy Desig­na­tions for the treat­ment of adult patients with progressive, unresectable, recurrent or re­frac­tory desmoid tumors or deep fibromatosis (November 2018 and August 2019).

About Spring­Works Thera­peutics

Spring­Works is a clin­i­cal-stage bio­pharma­ceu­tical com­pany applying a pre­ci­sion med­i­cine ap­proach to acquiring, devel­op­ing and com­mer­cial­iz­ing life-changing med­i­cines for underserved patient pop­u­la­tions suffer­ing from dev­as­tat­ing rare dis­eases and cancer. Spring­Works has a dif­fer­en­ti­ated port­folio of small molecule targeted on­col­ogy prod­uct can­di­dates and is ad­vanc­ing two poten­tially reg­is­tra­tional clin­i­cal trials in rare tumor types, as well as several other pro­grams addressing highly prevalent, ge­net­ic­ally defined cancers. Spring­Works’ stra­te­gic ap­proach and operational excellence in clin­i­cal devel­op­ment have enabled it to rapidly ad­vance its two lead prod­uct can­di­dates into late-stage clin­i­cal trials while simultaneously entering into multiple shared-value part­ner­ships with industry leaders to ex­pand its port­folio. For more in­for­ma­tion, please visit www.springworkstx.com.

Follow Spring­Works Thera­peutics on social media: @Spring­WorksTx and LinkedIn.

Spring­Works Forward-Looking Statements

This press release con­tains for­ward-looking state­ments within the meaning of the Private Se­cu­ri­ties Lit­i­ga­tion Reform Act of 1995, as amended, in­clud­ing, without limitation, state­ments re­gard­ing Spring­Works’ clin­i­cal trials and its strat­e­gy, business plans and focus. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar ex­pres­sions are in­tended to identify for­ward-looking state­ments, although not all for­ward-looking state­ments con­tain these identifying words. Any for­ward-looking state­ments in this press release are based on man­agement’s current ex­pec­ta­tions and beliefs and are subject to a number of risks, un­cer­tainties and im­por­tant factors that may cause actual events or results to differ ma­teri­ally from those ex­pressed or im­plied by any for­ward-looking state­ments con­tained in this press release, in­clud­ing, without limitation, state­ments re­gard­ing Spring­Works’ in­tel­lec­tual property, its future re­search and devel­op­ment activities, the timing for com­ple­tion of Spring­Works’ clin­i­cal trials of its prod­uct can­di­dates, whether and when, if at all, Spring­Works’ prod­uct can­di­dates will re­ceive ap­­prov­al from the U.S. Food and Drug Admin­istra­tion, or FDA, or other foreign regu­la­tory author­i­ties, com­pe­ti­tion from other bio­pharma­ceu­tical com­pa­nies, and other risks identified in the section entitled “Risk Factors” in Item 1A of Part II of Spring­Works’ Quarterly Report on Form 10-K for the quarter ended De­cem­ber 31, 2019, as well as discussions of poten­tial risks, un­cer­tainties and other im­por­tant factors in Spring­Works’ sub­se­quent filings with the Se­cu­ri­ties and Ex­change Com­mis­sion. Spring­Works cautions you not to place undue reliance on any for­ward-looking state­ments, which speak only as of the date they are made. Spring­Works disclaims any obli­ga­tion to pub­licly update or revise any such state­ments to reflect any change in ex­pec­ta­tions or in events, con­di­tions or cir­cum­stances on which any such state­ments may be based, or that may affect the like­li­hood that actual results will differ from those set forth in the for­ward-looking state­ments. Any for­ward-looking state­ments con­tained in this press release rep­re­sent Spring­Works’ views only as of the date hereof and should not be relied upon as rep­re­senting its views as of any sub­se­quent date.

Source: Spring­Works Thera­peutics.