Applications based on pos­i­tive results from pivotal KarMMa study in re­lapsed and re­frac­tory mul­ti­ple myeloma and QUAZAR®-AML-001 study in acute myeloid leukemia

Princeton, NJ (Press Release) – Bristol Myers Squibb (NYSE: BMY) to­day an­nounced that the Euro­pean Medicines Agency (EMA) has val­i­dated its Marketing Authori­za­tion Appli­ca­tions (MAA) for both idecabtagene vicleucel (ide-cel, bb2121) and CC-486. Validation of each appli­ca­tion con­firms the re­spec­tive sub­missions are com­plete and begins the EMA’s centralized review process.

The MAA for ide-cel, the com­pany’s inves­ti­ga­tional B-cell maturation an­ti­gen (BCMA)-directed chi­meric an­ti­gen re­cep­tor (CAR) T cell immuno­therapy co-developed with bluebird bio, Inc., is for the treat­ment of adult patients with mul­ti­ple myeloma who have re­ceived at least three prior ther­a­pies, in­clud­ing an immuno­modu­la­tory …

Stockholm, Sweden (Press Release) – Oncopeptides AB (Nasdaq Stock­holm: ONCO) an­nounces a suc­cess­ful com­ple­tion of en­roll­ment in the pivotal phase 3 study OCEAN for the treat­ment of re­lapsed re­frac­tory mul­ti­ple myeloma. The study in­cludes 450 patients from more than 100 hos­pi­tals around the world. Top line re­­sults are ex­pected to be pre­sented later this year.

OCEAN is a ran­dom­ized, comparative study be­tween mel­flu­fen and poma­lido­mide in patients with re­lapsed re­frac­tory mul­ti­ple myeloma (RRMM). The patients have been treated with immuno­modu­la­tory in­hib­i­tors (IMiD) and pro­te­a­some in­hib­i­tors (PI), they have devel­oped re­sis­tance to their last …

Synergistic Potential of Kleo’s Anti­body Recruiting Molecule (ARM™) and Celularity’s Placental-Derived NK Cells to Be Evaluated in the Context of COVID-19 and Multiple Myeloma

New Haven, CT (Press Release) – Kleo Pharma­ceu­ticals, Inc., a lead­ing com­pany in the field of devel­op­ing next-gener­a­tion, fully syn­thet­ic bispecific com­pounds de­signed to emulate or en­hance the ac­­tiv­ity of bio­log­ics, and Celularity, Inc., a lead­ing de­vel­oper of allo­geneic, or “off-the-shelf”, natural killer (NK) cell ther­a­pies, to­day an­nounced a pre­clin­i­cal re­search col­lab­o­ration to rapidly ad­vance syn­­er­gis­tic com­bi­na­tions of each com­pany’s tech­nology plat­form as poten­tial treat­ments for COVID-19 and mul­ti­ple myeloma.

The col­lab­o­ration comes at an opportune time for both com­pa­nies. Earlier this year, Kleo re­ceived IND authori­za­tion from the U.S. Food and Drug Admin­istra­tion (FDA) …

• Phase 1 Clinical Study to Evaluate Multiple Doses of FT538 as Monotherapy for Acute Myeloid Leukemia and in Com­bi­na­tion with Anti-CD38 Monoclonal Anti­body Therapy for Multiple Myeloma
• Off-the-shelf NK Cell Product Candidate Derived from Clonal Master iPSC Line Engineered with Three Functional Components to Enhance Innate Immunity

San Diego, CA (Press Release) – Fate Thera­peutics, Inc. (NASDAQ: FATE), a clin­i­cal-stage bio­pharma­ceu­tical com­pany ded­i­cated to the de­vel­op­ment of pro­grammed cellular immuno­therapies for cancer and immune disorders, an­nounced to­day that the U.S. Food and Drug Admin­istra­tion (FDA) has cleared the Com­pany’s Inves­ti­ga­tional New Drug (IND) appli­ca­tion for FT538, the first CRISPR-edited, iPSC-derived cell ther­apy. FT538 is an off-the-shelf natural killer (NK) cell cancer immuno­therapy that is derived from a clonal master induced pluripotent stem cell (iPSC) line engi­neered with three functional components …

Newton, MA (Press Release) – Karyo­pharm Thera­peutics Inc. (Nasdaq:KPTI), an inno­va­tion-driven pharma­ceu­tical com­pany, to­day an­nounced it has sub­mitted a supple­mental New Drug Appli­ca­tion (sNDA) to the U.S. Food and Drug Admin­istra­tion (FDA) seek­ing ap­prov­al for XPOVIO® (seli­nexor), its first-in-class, oral Sel­ective Inhibitor of Nuclear Export (SINE) com­pound, as a new treat­ment for pa­tients with pre­vi­ously treated mul­ti­ple myeloma.

“Earlier this year, we reported pos­i­tive top-line results from the pivotal Phase 3 BOSTON study eval­u­ating the com­bi­na­tion of XPOVIO (seli­nexor), once-weekly Velcade® (bor­tez­o­mib) and low-dose dexa­meth­a­sone (SVd) as a sec­ond line treat­ment for patients …

Patent covers the phos­pho­lipid ether (PLE) de­livery vehicle com­bined with I-131 and I-125

Florham Park, NJ (Press Release) – Cellectar Biosciences, Inc. (NASDAQ: CLRB), a clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on the discovery, de­vel­op­ment and com­mer­cial­iza­tion of drugs for the treat­ment of cancer, to­day an­nounced that the Euro­pean Patent Office has granted pat­ent num­ber EP 2440253 titled “Ether and Alkyl Phospholipid Compounds for Treating Cancer and Imaging and Detection of Cancer Stem Cells." The pat­ent provides composition of mat­ter and use pro­tec­tion for the treat­ment and/or diag­nosis of cancer and cancer stem cells for the com­pany’s Phase 2 lead asset CLR 131 and the pro­pri­e­tary PLE analogs …

• Bristol Myers Squibb to host an in­vestor call to­day at 8:00 a.m. EDT
• bluebird bio to host an in­vestor call to­day at 8:45 a.m. EDT

Princeton, NJ and Cambridge, MA (Press Release) – Bristol Myers Squibb (NYSE: BMY) and bluebird bio, Inc. (Nasdaq: BLUE) to­day an­nounced that the com­pa­nies re­ceived a Refusal to File letter from the U.S. Food and Drug Admin­istra­tion (FDA) re­gard­ing the Biologics License Appli­ca­tion (BLA) for idecabtagene vicleucel (ide-cel; bb2121) for patients with heavily pre-treated re­lapsed and re­frac­tory mul­ti­ple myeloma, which was sub­mitted in March 2020.

Upon pre­lim­i­nary review, the FDA de­ter­mined that the Chemistry, Manufacturing and Control (CMC) module of the BLA re­quires fur­ther …