Silver Spring, MD (Press Release) – Today, the U.S. Food and Drug Admin­istra­tion approved Sarclisa (isatuximab-irfc), in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone, for the treat­ment of adult patients with multiple myeloma who have re­ceived at least two prior ther­a­pies in­clud­ing lena­lido­mide and a pro­te­a­some in­hib­i­tor. Sarclisa, admin­istered through in­tra­venous (IV) in­fusion, is a CD38-directed cytolytic anti­body that works by helping cer­tain cells in the immune sys­tem attack multiple myeloma cancer cells.

“Targeting cells has led to the devel­op­ment of im­por­tant on­col­ogy treat­ments. While there is no cure for multiple myeloma, Sarclisa is …

Milestone Triggers $10 Million Payment to Molecular Templates

Austin, TX (Press Release) – Molecular Templates, Inc. (Nasdaq: MTEM, “Molecular Templates” or “MTEM”), a clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on the discovery and devel­op­ment of the com­pany’s pro­pri­e­tary engi­neered toxin bodies (ETBs), which are dif­fer­en­ti­ated, targeted, biologic thera­peutics for cancer and other serious dis­eases, today announced the initiation of dosing in a Phase I study investigating TAK-169 in patients with re­lapsed / re­frac­tory multiple myeloma. Co-developed with Takeda Pharma­ceu­tical Com­pany Limited (“Takeda”), TAK-169 is a poten­tial first-in-class CD38-targeting ETB. As a result of achieving this mile­stone, MTEM will re­ceive a $10 million pay­ment …

Application is based on pos­i­tive data from the Phase 3 CANDOR study, which were pre­sented at the 2019 American Society of Hematology Annual Meeting

Raritan, NJ (Press Release) – The Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson announced today the sub­mission of a supple­mental Biologics License Application (sBLA) to the U.S. Food and Drug Admin­istra­tion (FDA) seeking approval of DARZALEX® (dara­tu­mu­mab) in com­bi­na­tion with Kyprolis® (car­filz­o­mib) and dexa­meth­a­sone (DKd) for re­lapsed / re­frac­tory multiple myeloma. The sBLA is sup­ported by results from the Phase 3 CANDOR study, which com­pared treat­ment with DKd to car­filz­o­mib and dexa­meth­a­sone (Kd) in patients with multiple myeloma who re­lapsed after one to three prior lines of ther­apy.

"While we con­tinue to …

KP1237, a CD38-Targeting Anti­body Recruiting Molecule (ARM™), to Be Tested in Com­bi­na­tion with NK Cells to Treat Post-Transplant Multiple Myeloma Patients

New Haven, CT (Press Release) – Kleo Pharma­ceu­ticals, Inc., an immuno-oncology com­pany devel­op­ing next-generation, fully syn­thet­ic bispecific com­pounds designed to emulate or en­hance the activity of biologics, announced today that it has re­ceived Inves­ti­ga­tional New Drug (IND) authori­za­tion to proceed from the U.S. Food and Drug Admin­istra­tion (FDA) to ini­ti­ate a safety and tolerability clin­i­cal study combining KP1237, a CD38-targeting anti­body recruiting molecule (ARM™), with patients' own Natural Killer (NK) cells to treat multiple myeloma (MM) in post-transplant patients.

The single-arm study will be conducted in 25-30 patients with exploratory end­points that assess the …

• DARZALEX® (dara­tu­mu­mab) approved in Europe in com­bi­na­tion with bor­tez­o­mib, thalido­mide and dexa­meth­a­sone for the treat­ment of adult patients with newly diag­nosed multiple myeloma who are eli­gible for au­tol­o­gous stem cell trans­plant
• Approval follows pos­i­tive opinion by European Com­mit­tee for Medicinal Products for Human Use (CHMP) in De­cem­ber
• Approval based on data from Phase III CASSIOPEIA study

Copenhagen, Denmark; Jan­u­ary­ 20, 2020 – Genmab A/S (Nasdaq: GMAB) announced today that the European Com­mis­sion (EC) has granted mar­ket­ing authori­za­tion for DARZALEX® (dara­tu­mu­mab) in com­bi­na­tion with bor­tez­o­mib, thalido­mide and dexa­meth­a­sone for the treat­ment of adult patients with newly diag­nosed multiple myeloma who are eli­gible for au­tol­o­gous stem cell trans­plant (ASCT). The EC approval follows a pos­i­tive opinion issued for DARZALEX by the CHMP of the European Medicines Agency (EMA) in De­cem­ber 2019. In August 2012, Genmab granted Janssen Biotech, …

Shanghai, China (Press Release) – I-Mab Bio­pharma­ ("I-Mab"), a global bio­pharma­ceu­tical com­pany based in China and the United States and focused on the discovery and devel­op­ment of novel or highly dif­fer­en­ti­ated biologics in immuno-oncology and auto­immune dis­eases today announced the dosing of the first patient in mainland China in its reg­is­tra­tional study eval­u­ating its human CD38 anti­body (TJ202/MOR202) in patients with re­lapsed or re­frac­tory multiple myeloma (MM).

I-Mab ini­ti­ated two reg­is­tra­tional trials with TJ202 / MOR202 in re­lapsed or re­frac­tory MM in Taiwan in early 2019 and ex­panded these trials into mainland China in …

• If approved by the European Com­mis­sion, the dara­tu­mu­mab-VTd regi­men would rep­re­sent the first thera­peutic option in­di­cated for newly diag­nosed patients who are eli­gible for a stem cell trans­plant in six years¹
• Since launch, dara­tu­mu­mab has been used to treat more than 100,000 patients world­wide²

Beerse, Belgium (Press Release) – The Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson announced today that the Com­mit­tee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has rec­om­mended broadening the existing mar­ket­ing authori­sa­tion for Darzalex®▼ (dara­tu­mu­mab) to in­clude the use of dara­tu­mu­mab in com­bi­na­tion with bor­tez­o­mib, thalido­mide and dexa­meth­a­sone (VTd) for the treat­ment of adult patients with newly diag­nosed patients with multiple myeloma who are eli­gible for au­tol­o­gous stem cell trans­plant (ASCT).

The Positive Opinion is sup­ported by data …