Silver Spring, MD (Press Release) – Today, the U.S. Food and Drug Admin­istra­tion granted accelerated approval to Xpovio (selinexor) tablets in com­bi­na­tion with the corticosteroid dexa­meth­a­sone for the treat­ment of adult patients with re­lapsed refractory multiple myeloma (RRMM) who have received at least four prior ther­a­pies and whose disease is resistant to several other forms of treat­ment, in­clud­ing at least two pro­te­a­some inhibitors, at least two immuno­modu­la­tory agents, and an anti-CD38 mono­clonal anti­body.

“While there is no cure for multiple myeloma, there are FDA-approved treat­ments to target the cancer and slow down …

• DARZALEX (dara­tu­mu­mab) approved by U.S. FDA in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone for the treat­ment of adult patients with newly diag­nosed multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­plant
• Approval based on Phase III MAIA study

Copenhagen, Denmark (Press Release); June 27, 2019 – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the U.S. Food and Drug Admin­istra­tion (U.S. FDA) has approved the use of DARZALEX® (dara­tu­mu­mab) in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone (Rd) for the treat­ment of adult patients with newly diag­nosed multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­plant (ASCT). The supple­mental Biologics License Application (sBLA) for this indi­ca­tion was submitted by Genmab’s licensing partner, Janssen Biotech, Inc., under the Real-Time Oncology Review (RTOR) pilot pro­gram. …

Stamford, CT (Press Release) – Spring­Works Thera­peutics, Inc., a clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on devel­op­ing life-changing med­i­cines for patients with severe rare dis­eases and can­cer, to­day an­nounced that the com­pany has entered into a clin­i­cal trial col­lab­o­ration agree­ment with GlaxoSmithKline to eval­u­ate Spring­Works Thera­peutics’ inves­ti­ga­tional gamma secretase in­hib­i­tor (GSI), niro­gace­stat, in com­bi­na­tion with GlaxoSmithKline’s inves­ti­ga­tional anti-B-cell maturation an­ti­gen (BCMA) anti­body-drug con­ju­gate (ADC), be­lan­ta­mab mafo­dotin (formerly GSK2857916), in patients with re­lapsed or re­frac­tory mul­ti­ple myeloma.

Gamma secretase is an enzyme that cleaves mul­ti­ple transmembrane pro­teins, in­clud­ing BCMA. As evi­denced in pub­li­ca­tions and pre­clin­i­cal ex­per­i­ments, …

• FDA removed the partial clin­i­cal hold based upon agree­ment on revisions to the CANOVA study protocol, in­clud­ing new risk mitigation measures, protocol-specified guidelines and updated futility criteria
• The t(11;14) genetic bio­marker is among the most common and routinely tested genetic ab­nor­mal­i­ties in patients with multiple myeloma¹

North Chicago, IL (Press Release) – AbbVie (NYSE: ABBV), a research-based global bio­pharma­ceu­tical com­pany, today announced that the U.S. Food and Drug Admin­istra­tion (FDA) has lifted the partial clin­i­cal hold placed on CANOVA (M13-494), a Phase 3 trial eval­u­ating veneto­clax (VENCLEXTA® OR VENCLYXTO®) for the inves­ti­ga­tional treat­ment of re­lapsed / refractory multiple myeloma. The CANOVA trial eval­u­ates veneto­clax in com­bi­na­tion with dexa­meth­a­sone versus poma­lido­mide in com­bi­na­tion with dexa­meth­a­sone in patients with re­lapsed / refractory multiple myeloma pos­i­tive for the translocation (11;14) ab­nor­mal­ity. The t(11;14) genetic bio­marker …

Shanghai, China (Press Release) – CARsgen Therapeutics, a clin­i­cal-stage com­pany committed to devel­op­ing Chimeric Antigen Receptor T cell ther­a­pies for cancer, today announced that one of its leading drug can­di­dates, CT053 fully human BCMA (B-Cell Maturation Antigen)-CAR-T cell for the treat­ment of patients suffering from re­lapsed / refractory multiple myeloma (rrMM), has received Inves­ti­ga­tional New Drug (IND) clearance from the United States Food and Drug Admin­istra­tion (FDA). CT053 has also received IND clearance from the National Medical Products Admin­istra­tion in China four months ago and is the subject of an ongoing phase I clin­i­cal …

New Haven, CT (Press Release) – Kleo Pharma­ceu­ticals, Inc. (Kleo), an immuno-oncology com­pany devel­op­ing next-generation syn­thet­ic bispecific com­pounds designed to emulate or en­hance the activity of biologics, announced today that CD38-ARM, a CD38 targeting anti­body recruiting molecule (ARM™) to treat multiple myeloma, will be its first prod­uct can­di­date to move into the clinic with antic­i­pated human studies to commence in 2020.

CD38-ARM is designed to recruit endogenous anti­bodies to multiple myeloma cancer cells, targeting them for destruction by natural killer (NK) cells and macrophages. CD38 is a val­i­dated multiple myeloma target, which is …

• TAK-169 Represents a Novel Mechanism of Action Targeting CD38
• Phase I Study to be Conducted in Relapsed/Refractory Multiple Myeloma Patients

Austin, TX (Press Release) – Molecular Templates, Inc., (Nasdaq: MTEM, “Molec­u­lar,” “Molec­u­lar Templates” or “MTEM”) a clin­i­cal stage bio­pharma­ceu­tical com­pany focused on the discovery and devel­op­ment of Engi­neered Toxin Bodies (ETBs), a new class of targeted biologic ther­a­pies that possess unique mech­a­nisms of action in on­col­ogy, announced that the U.S. Food and Drug Admin­istra­tion (FDA) has accepted the Inves­ti­ga­tional New Drug (IND) appli­ca­tion for TAK-169, an ETB targeting CD38.

MTEM and partner Takeda Pharma­ceu­tical Company Limited (Takeda) are co-developing TAK-169 and plan to conduct an open …