San Diego, CA (Press Release) – Poseida Therapeutics Inc., a clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on leveraging pro­pri­e­tary next-generation, non-viral gene engi­neer­ing tech­nolo­gies to create life-saving thera­peutics, today announced the U.S. Food and Drug Admin­istra­tion (FDA) has granted a Regenerative Medicine Advanced Therapy (RMAT) desig­na­tion to P-BCMA-101, Poseida’s lead CAR-T thera­peutic can­di­date cur­rently in a Phase 1 clin­i­cal trial for the treat­ment of patients with re­lapsed / refractory multiple myeloma. RMAT desig­na­tion in­cludes all of the benefits of the Fast Track and Break­through Therapy desig­na­tion pro­grams, in­­clud­ing early inter­actions with the FDA.

“P-BCMA-101 is the …

San Diego, CA (Press Release) – Sorrento Therapeutics, Inc. (NASDAQ: SRNE), an inno­va­tive immuno­therapy com­pany, announced today that the first patients were dosed in a Phase 1 study to eval­u­ate the safety and efficacy of CD38 CAR-T ther­apy in re­lapsed or refractory multiple myeloma patients at two clin­i­cal sites – University of Pennsylvania (UPenn) in Philadelphia and Roger Williams Medical Center in Rhode Island. The CD38 CAR-T cells manu­fac­tured at both Sorrento cGMP facilities (San Diego, CA and Providence, RI) met all release specifications and were used in the study.

This study is …

• Phase III MAIA study of dara­tu­mu­mab in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone in front line multiple myeloma met the pri­mary end­point (PFS) at a pre-planned interim analysis demonstrating the superiority of DRd over Rd
• Independent Data Moni­tor­ing Committee rec­om­mends releasing the interim analysis results and to follow patients for survival and long-term safety
• Data will be discussed with health author­i­ties to prepare for regu­la­tory filings

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today topline results from the Phase III MAIA study (MMY3008) of dara­tu­mu­mab in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone (DRd) versus Rd alone as treat­ment for newly diag­nosed patients who are not can­di­dates for high dose chemo­ther­apy and au­tol­o­gous stem cell trans­plant (ASCT). The study met the pri­mary end­point of im­prov­ing pro­gres­sion free survival (PFS) at a pre-planned interim analysis (Hazard Ratio (HR) = 0.55 (95% CI 0.43 – 0.72), p …

Summit, NJ (Press Release) – Celgene Corpo­ra­tion (NASDAQ: CELG) today announced results from an open-label phase II/III National Clinical Trials Network (NCTN) study led by the ECOG-ACRIN Cancer Research Group and sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health. REVLIMID® (lena­lido­mide) was provided by Celgene under a clin­i­cal trials agree­ment with the NCI’s Division of Cancer Treatment and Diagnosis.

ECOG E3A06 is a ran­dom­ized study eval­u­ating the safety and efficacy of the inves­ti­ga­tional use of REVLIMID mono­therapy versus observation in patients with asymptomatic smol­der­ing multiple myeloma. …

• Phase III CASSIOPEIA study of dara­tu­mu­mab in com­bi­na­tion with bor­tez­o­mib, thalido­mide and dexa­meth­a­sone in front line multiple myeloma met the pri­mary end­point of stringent Complete Response (sCR) after induction and con­sol­i­da­tion ther­apy
• Trial sponsored by the French Intergroupe Francophone du Myelome (IFM) in col­lab­o­ration with the Dutch-Belgian Cooperative Trial Group for Hematology Oncology (HOVON)
• Data will be discussed with health author­i­ties for poten­tial regu­la­tory filings

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today the study met its pri­mary end­point for Part 1 of the Phase III CASSI­OPEIA study (MMY3006) of dara­tu­mu­mab in com­bi­na­tion with bor­tez­o­mib, thalido­mide and dexa­meth­a­sone (VTD) versus VTD alone as frontline treat­ment for patients who are can­di­dates for au­tol­o­gous stem cell trans­plant (ASCT). The first part of the study met the pri­mary end­point of number of patients that achieved a sCR, which was reported in 28.9% of patients treated with …

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 …

• Application Seeks Accelerated Approval for Selinexor as a Treatment for Patients with Penta-Refractory Multiple Myeloma
• PDUFA Date Set for April 6, 2019

Newton, MA (Press Release) – Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clin­i­cal-stage pharma­ceu­tical com­pany, today announced that the U.S. Food and Drug Admin­istra­tion (FDA) has accepted for filing with Priority Review its New Drug Application (NDA) seeking accelerated approval for selinexor, its first in class, oral SINE com­­pound, as a new treat­ment for patients with penta-refractory multiple myeloma. The FDA also granted Karyopharm’s request for Priority Review and assigned an action date of April 6, 2019 under the Prescription Drug User-Fee Act (PDUFA). …