San Diego, CA (Press Release) – Halozyme Thera­peutics, Inc. (NASDAQ: HALO), a bio­technology com­pany devel­op­ing novel on­col­ogy and drug-delivery ther­a­pies, to­day an­nounced that its col­lab­o­rator Janssen Biotech, Inc. (Janssen) has sub­mitted a Biologics License Appli­ca­tion (BLA) to the U.S. Food and Drug Admin­istra­tion for the sub­cu­tane­ous de­livery of DAR­ZA­LEX® (dara­tu­mu­mab) for patients with mul­ti­ple myeloma.

"Janssen's BLA sub­mission for sub­cu­tane­ous DAR­ZA­LEX® rep­re­sents an im­por­tant devel­op­ment for our ENHANZE® drug de­livery tech­nology business," said Dr. Helen Torley, pres­i­dent and chief exec­u­tive of­fi­cer. "We are delighted that an ap­­prov­al of the sub­cu­tane­ous for­mu­la­tion may soon …

• BLA sub­mitted to U.S. FDA for sub­cu­tane­ous for­mu­la­tion of dara­tu­mu­mab
• Submission based on data from Phase III COLUMBA and Phase II PLEIADES stud­ies

Copenhagen, Denmark (Company Announcement) – Genmab A/S (Nasdaq Copenhagen: GEN) an­nounced to­day that its licensing part­ner, Janssen Biotech, Inc., has sub­mitted a Biologics License Appli­ca­tion (BLA) to the U.S. Food and Drug Admin­istra­tion (U.S. FDA) for the use of the sub­cu­tane­ous (SubQ) for­mu­la­tion of dara­tu­mu­mab in mul­ti­ple myeloma indi­ca­tions where the in­tra­venous for­mu­la­tion of dara­tu­mu­mab is cur­rently approved. In August 2012, Genmab granted Janssen an ex­clu­sive world­wide license to de­vel­op, manu­fac­ture and com­mer­cial­ize dara­tu­mu­mab.

“Should this sub­mission lead to an ap­­prov­al, it would provide patients …

Paris, France (Press Release) – The U.S. Food and Drug Admin­istra­tion (FDA) has ac­cepted for review the Biologics License Application (BLA) for isatuximab for the treat­ment of patients with re­lapsed / re­frac­tory multiple myeloma (RRMM). The target action date for the FDA de­ci­sion is April 30, 2020. Isatuximab is an inves­ti­ga­tional mono­clonal anti­body that targets a specific epitope on the CD38 re­cep­tor of a plasma cell.

The BLA is based on pos­i­tive results from ICARIA-MM, an open-label pivotal Phase 3 clin­i­cal trial of isatuximab in patients with RRMM. ICARIA-MM is the first pos­i­tive ran­dom­ized …

Topline data from the ran­dom­ized Phase II GRIFFIN study in trans­plant eli­gible, newly diag­nosed patients with multiple myeloma treated with dara­tu­mu­mab in com­bi­na­tion with lena­lido­mide, bor­tez­o­mib, and dexa­meth­a­sone met the study’s pri­mary end­point with a higher per­cent­age of stringent com­plete response in the dara­tu­mu­mab arm as com­pared with patients who received lena­lido­mide, bor­tez­o­mib, and dexa­meth­a­sone alone

Copenhagen, Denmark (Company Announcement) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that topline data from the Phase II GRIFFIN (MMY2004) study of newly diag­nosed patients with multiple myeloma eli­gible for high-dose chemo­ther­apy and au­tol­o­gous stem cell trans­plan­ta­tion (ASCT), who were treated with dara­tu­mu­mab in com­bi­na­tion with lena­lido­mide, bor­tez­o­mib, and dexa­meth­a­sone (VRd), met its pri­mary end­point, demonstrating a higher per­cent­age of stringent com­plete responses (sCR) than patients who received VRd alone. Specifically, the topline data showed that 42.4% of patients treated with dara­tu­mu­mab in com­bi­na­tion with VRd achieved a sCR, com­pared to 32.0% …

• 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. …

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 …