FDA action removes partial hold on CheckMate -602, the last of holds pre­vi­ously placed on three Opdivo-based com­bi­na­tion trials in re­lapsed or refractory multiple myeloma

Princeton, NJ (Press Release) – Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Admin­istra­tion (FDA) lifted a partial clin­i­cal hold placed on CA209-602 (CheckMate -602), a ran­domized, open-label Phase 3 study eval­u­ating the addi­tion of Opdivo (nivolumab) to poma­lido­mide and dexa­meth­a­sone in patients with re­lapsed or refractory multiple myeloma. The de­ci­sion follows consultation with the FDA and agree­ment on amendments to the study protocol.

Three trials eval­u­ating Opdivo-based com­bi­na­tions in re­lapsed or refractory multiple myeloma were placed on partial clin­i­cal hold in September 2017 as an FDA …

Silver Spring, MD (Public Statement) – For patients with serious or im­medi­ately life-threatening diseases, the FDA remains committed to enhancing access to promising inves­ti­ga­tional medicines for those unable to access prod­ucts through clin­i­cal trials. This is the mission of our expanded access pro­gram. The agency is dedicated to these pur­poses, and it has been for more than three decades.

We’ve taken many steps to im­prove our process through which patients can access promising inves­ti­ga­tional drugs. We under­stand that treat­ment de­ci­sions for those facing terminal illnesses are best made by patients and families, with …

Planned Start of Clinical Program and Clearance of U.S. Food and Drug Admin­istra­tion Inves­ti­ga­tional New Drug Appli­ca­tion Reflect Progress in Strategic Partnership with Legend Bio­tech

Spring House, PA (Press Release) – The Janssen Pharma­ceu­tical Com­panies of John­son & John­son an­nounced to­day the initiation of a Phase 1b/2 clin­i­cal devel­op­ment pro­gram studying JNJ-68284528 (developed based on Legend's LCAR-B38M), a chi­meric an­ti­gen re­cep­tor T cell (CAR-T) ther­apy directed against B cell maturation an­ti­gen (BCMA), in patients with re­lapsed or re­frac­tory mul­ti­ple myeloma. The planned start of the Phase 1b/2 study (68284528MMY2001), scheduled to begin en­roll­ment in the sec­ond half of 2018, follows the U.S. Food and Drug Admin­istra­tion (FDA) clear­ance of the Inves­ti­ga­tional New Drug (IND) appli­ca­tion sub­mitted by Janssen.

As …

LCAR-B38M CAR-T ther­apy (JNJ-68284528) to be devel­oped as part of stra­te­gic part­ner­ship be­tween Legend and Janssen

Piscataway, NJ (Press Release) – Legend Bio­tech, a sub­sid­i­ary of GenScript Bio­tech Corpo­ra­tion (HKEx: 1548), an­nounced to­day that the U.S. Food and Drug Admin­istra­tion (FDA) has authorized its devel­op­ment part­ner, Janssen Bio­tech, Inc. ("Janssen"), to com­mence a Phase 1b/2 clin­i­cal trial in patients with re­lapsed or re­frac­tory mul­ti­ple myeloma (MM) to eval­u­ate the safety and ef­fi­cacy of LCAR-B38M (JNJ-68284528), a Chimeric Antigen Receptor T cell (CAR-T) ther­apy. Scheduled to begin en­roll­ment in the sec­ond half of 2018, the Phase 1b/2 study (68284528MMY2001) is part of a col­lab­o­ration be­tween Legend Bio­tech and Janssen that …

• Based on a recent planned review, the Data Monitoring Committee (DMC) rec­om­mends Phase Ib/II study of dara­tu­mu­mab plus atezo­lizu­mab (anti PD-L1 anti­body) in patients with pre­vi­ously treated non-small cell lung cancer to be terminated.
• Phase I MMY2036 study of dara­tu­mu­mab plus JNJ-63723283 (anti PD-1 anti­body) in patients with multiple myeloma, dis­con­tinued
• Health Authorities have been informed about these events and Janssen has contacted its partner com­panies conducting dara­tu­mu­mab and anti-PD-(L)1 com­bi­na­tion studies to discuss ceasing enrollment and dosing of the com­bi­na­tion while the data is being further in­ves­ti­gated

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that fol­low­ing a planned review, the DMC has rec­om­mended that the Phase Ib/II study (CALLISTO/LUC2001) of dara­tu­mu­mab in com­bi­na­tion with atezo­lizu­mab versus atezo­lizu­mab mono­therapy in patients with previ­ously treated ad­vanced or metastatic non-small cell lung cancer should be terminated. In addi­tion the phase I MMY2036 study of dara­tu­mu­mab plus JNJ-63723283, an anti PD-1 anti­body in patients with multiple myeloma will be dis­con­tinued.

The DMC de­ter­mined that there was no observed benefit within …

• Antengene Rights Include All Human Oncology Indications for Selinexor, Eltanexor and KPT-9274, and Non-Oncology Human Indications for Verdinexor
• Karyopharm to Receive $12 Million (USD) Upfront; Total Deal Valued at up to $162 Million with Karyo­pharm Eligible to Receive up to $150 Million (USD) in Future Milestones, Plus Royalties

Newton, MA and Shanghai, China (Press Release) – Karyo­pharm Thera­peutics Inc. (Nasdaq:KPTI) (Karyopharm) and Antengene Corpo­ra­tion (Antengene), to­day an­nounced their entry into an ex­clu­sive license agree­ment for the de­vel­op­ment and com­mer­cial­iza­tion of four of Karyo­pharm’s novel, oral drug can­di­dates, in­clud­ing selinexor, Karyo­pharm’s lead SINE com­pound, eltanexor, Karyo­pharm’s sec­ond-generation SINE com­pound, verdinexor, Karyo­pharm’s lead com­pound in de­vel­op­ment for viral and other non-oncology in­di­ca­tions, and KPT-9274, Karyo­pharm’s dual in­hib­i­tor of PAK4 and NAMPT. The agree­ment in­cludes the de­vel­op­ment and com­mer­cial­iza­tion of selinexor and …

New York, NY (Press Release) – SELLAS Life Sciences Group Inc. (Nasdaq:SLS) (“SELLAS”), a clin­i­cal-stage bio­pharma­ceutical com­pany focused on novel cancer immuno­therapies for a broad range of cancer indi­ca­tions, today announced that the U.S. Food and Drug Admin­istra­tion (FDA) has granted orphan drug desig­na­tion to its novel drug can­di­date, galin­pepimut-S (GPS), for the treat­ment of multiple myeloma (MM). GPS is licensed from Memorial Sloan Kettering Cancer Center and targets the Wilms Tumor 1 (WT1) protein, which is present in an array of tumor types.

“We are delighted to receive this orphan drug …