San Diego, CA (Press Release) – Fortis Therapeutics, Inc., an immuno-oncology bio­tech devel­op­ing a novel anti­body-drug con­ju­gate (ADC) against CD46, today announced the U.S. Food and Drug Admin­istra­tion (FDA) has cleared two inves­ti­ga­tional new drug (IND) appli­ca­tions for the com­pany’s lead can­di­date, FOR46, for the treat­ment of metastatic castration-resistant prostate cancer and late-stage multiple myeloma. The Phase 1 trial of FOR46 in metastatic castration-resistant prostate cancer is planned to launch by the end of the year. The second pro­gram, in late-stage multiple myeloma, is ex­pec­ted to move into clin­i­cal trials in early …

A New Generation of Precisely Engineered CD74-Targeting ADC

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 …

The Agreement Will Support the Development of a Potential New Treatment Option for Multiple Myeloma

Austin, TX (Press Release) – Molecular Templates, Inc. (Nasdaq:MTEM) today announced an agree­ment with Takeda Pharma­ceu­tical Company Limited (Takeda) for the joint devel­op­ment of CD38-targeted engi­neered toxin bodies (ETBs) for the treat­ment of patients with diseases such as multiple myeloma. The lead devel­op­ment can­di­date is a CD38-targeted ETB that resulted from a pre­vi­ous discovery col­lab­o­ration be­tween the two com­pa­nies.

The parties devel­oped pre­clin­i­cal stage ETBs targeting CD38 under the prior discovery col­lab­o­ration. Takeda and Molecular Templates will further develop the ETBs for the treat­ment of multiple myeloma under this new license, devel­op­ment and …

London, United Kingdom (Press Release) – GlaxoSmithKline plc (LSE/NYSE: GSK) to­day an­nounced that it has re­ceived Break­through Therapy Desig­na­tion from the U.S. Food and Drug Admin­istra­tion (FDA) for GSK2857916 mono­­therapy in patients with mul­ti­ple myeloma who have failed at least three prior lines of ther­apy, in­­clud­ing an anti-CD38 anti­body and are re­frac­tory to a pro­te­a­some in­hib­i­tor and an immuno­modulatory agent. In Octo­ber, the Euro­pean Medicines Agency (EMA) granted PRIME desig­na­tion to GSK2857916 for the treat­ment of re­lapsed and re­frac­tory mul­ti­ple myeloma patients whose prior ther­apy in­cluded a pro­te­a­some in­hib­i­tor, an immuno­modulatory agent …