A New Generation of Precisely Engineered CD74-Targeting ADC

{{image}}South San Francisco (Press Release) – Sutro Biopharma, Inc. (NASDAQ: STRO), has been granted Orphan Drug Desig­na­tion by the United States Food and Drug Admin­istra­tion (FDA) for STRO-001 for the treat­ment of multiple myeloma. STRO-001 is a poten­tial first-in-class anti­body drug con­ju­gate (ADC) targeting CD74, a protein highly ex­pressed in B-cell malig­nan­cies such as multiple myeloma.

"There is a growing need for new treat­ment options for patients with multiple myeloma," commented Bill Newell, Sutro's Chief Executive Officer. "This Orphan Drug Desig­na­tion is a great step to­wards ad­vanc­ing our uniquely designed STRO-001 that could bring new treat­ment options to patients in need."

STRO-001 was devel­oped with Sutro's pro­pri­e­tary cell-free protein synthesis and site-specific con­ju­ga­tion plat­form, XpressCF+™, which facilitate precision design and rapid empirical optimization of ADCs. Sutro's tech­nology enables design and manu­fac­ture of a highly optimized single molecular species within the prod­uct, rather than the usual mixture of imprecisely con­jugated anti­bodies that com­prise an ADC devel­op­ment prod­uct made by con­ven­tional cell-based manu­fac­tur­ing plat­forms.

"STRO-001 was designed to directly target cancer cells to deliver a cytotoxic pay­load. Building upon our XpressCF+™ plat­form we plan to develop better options to treat tumors with greater precision," Bill Newell added.

STRO-001 is cur­rently being studied in a Phase 1 clin­i­cal trial enrolling separate dose escalation cohorts for myeloma and B-cell lym­phoma.

About Orphan Drug Desig­na­tion

The Orphan Drug Desig­na­tion Program provides orphan status to drugs and biologics which are defined as those in­tended for the safe and effective treat­ment, diag­nosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but are not ex­pec­ted to recover the costs of devel­op­ing and mar­ket­ing a treat­ment drug.

About Sutro Biopharma

Sutro Biopharma, Inc., located in South San Francisco, is a clin­i­cal-stage drug discovery, devel­op­ment and manu­fac­tur­ing com­pany. Using precise protein engi­neer­ing and rational design, Sutro is ad­vanc­ing next-generation on­col­ogy thera­peutics.

Sutro's pro­pri­e­tary and integrated cell-free protein synthesis and site-specific con­ju­ga­tion plat­form, XpressCF+™, led to the discovery of STRO-001 and STRO-002, Sutro's first two internally-developed anti­body drug con­ju­gates, or ADCs. STRO-001 is a poten­tially first-in-class ADC targeting CD74, a protein highly ex­pressed in multiple myeloma and non Hodgkin's lym­phoma, and is cur­rently in a Phase I study. STRO-002 is a poten­tially best-in-class ADC targeting folate re­cep­tor alpha, a cell-surface protein highly ex­pressed in gynecological cancers.

Sutro is dedicated to transforming the lives of cancer patients by creating med­i­cines with im­proved thera­peutic profiles for areas of unmet need.

To date, Sutro has designed cytokine-based immuno-oncology ther­a­pies, anti­body-drug con­ju­gates, and bispecific anti­bodies primarily directed at clin­i­cally-validated targets for which the current standard of care is suboptimal.

Sutro's plat­form allows it to accelerate discovery and devel­op­ment of poten­tial first-in-class and best-in-class molecules through rapid and sys­tematic evaluation of protein structure-activity rela­tion­ships to create optimized homogeneous prod­uct can­di­dates.

In addi­tion to devel­op­ing its own on­col­ogy pipe­line, Sutro is col­lab­o­rating with select pharma­ceu­tical and bio­tech com­pa­nies to discover and develop novel, next generation thera­peutics. As the pace of clin­i­cal devel­op­ment accelerates, Sutro and its partners are devel­op­ing thera­peutics designed to more efficiently kill tumors without harming healthy cells.

Follow Sutro on Twitter, @Sutrobio, and at www.sutrobio.com to learn more about our passion for changing the future of on­col­ogy.

Forward-Looking Statements

This press release con­tains for­ward-looking state­ments within the meaning of the "safe harbor" pro­visions of the Private Se­cu­ri­ties Lit­i­ga­tion Reform Act of 1995, in­­clud­ing, but not limited to, planned devel­op­ment activities and the poten­tial benefits of the com­pany's prod­uct can­di­dates and plat­form. All state­ments other than state­ments of historical fact are state­ments that could be deemed for­ward-looking state­ments. Although the com­pany believes that the ex­pec­ta­tions reflected in such for­ward-looking state­ments are reason­able, the com­pany cannot guar­an­tee future events, results, actions, levels of activity, per­for­mance or achieve­ments, and the timing and results of bio­technology devel­op­ment and poten­tial regu­la­tory approval is in­her­ently uncertain. Forward-looking state­ments are subject to risks and un­cer­tain­ties that may cause the com­pany's actual activities or results to differ sig­nif­i­cantly from those ex­pressed in any for­ward-looking state­ment, in­­clud­ing risks and un­cer­tain­ties related to the com­pany's ability to ad­vance its prod­uct can­di­dates, obtain regu­la­tory approval of and ultimately com­mer­cial­ize its prod­uct can­di­dates, the timing and results of pre­clin­i­cal and clin­i­cal trials, the com­pany's ability to fund devel­op­ment activities and achieve devel­op­ment goals, the com­pany's ability to protect intellectual property and other risks and un­cer­tain­ties described under the heading "Risk Factors" in documents the com­pany files from time to time with the Se­cu­ri­ties and Exchange Com­mis­sion. These for­ward-looking state­ments speak only as of the date of this press release, and the com­pany under­takes no obli­ga­tion to revise or update any for­ward-looking state­ments to reflect events or cir­cum­stances after the date hereof.

Source: Sutro Biopharma.