Zurich-Schlieren, Switzerland (Press Release) – Molecular Partners AG (SIX:MOLN), a clin­i­cal-stage bio­tech com­pany pioneering the use of DARPin® thera­peutics to treat serious dis­eases, announces the receipt of Orphan Drug Desig­na­tion by the US Food and Drug Admin­istra­tion (FDA) for its novel thera­peutic, MP0250, for the treat­ment of multiple myeloma.

MP0250 is a first-in-class, tri-specific multi-DARPin® drug can­di­date neutralizing VEGF-A and HGF and is binding to human serum albumin to in­crease plasma half-life. The unique mech­a­nism of action of MP0250 rep­re­sents a new ap­proach to targeting the tumor microenvironment and in­crease patients' re­sponse­s to …

Toronto, ON (Press Release) – Telo Genomics Corp. (TSX-V: TELO) (the “Com­pany” or “TELO”), is pleased to announce that it has signed a col­lab­o­ration agree­ment with Mayo Clinic in Minnesota to conduct clin­i­cal studies to eval­u­ate and val­i­date the utility of the Com­pany’s pro­pri­e­tary telomere analytics as a prog­nos­tic solu­tion for Multiple Myeloma.

The col­lab­o­ration studies will be led by Dr. Shaji Kumar, MD, and were designed to in­clude two retro­spec­tive­ phases with the poten­tial of a third pro­spec­tive­ phase. For each phase, TELO’s analytics will be employed to: 1) predict the pro­gres­sion …

• IND clear­ance enables com­mence­ment of clin­i­cal trial to eval­u­ate NEXI-002 in multiple myeloma patients who have failed >3 pre­vi­ous lines of ther­apy
• FDA action rep­re­sents the Com­pany’s second IND clear­ance in 4Q2019 for its pipe­line of novel cellular ther­apy prod­ucts

Gaithersburg, MD (Press Release) – NexImmune, a clin­i­cal-stage bio­pharma­ceu­tical com­pany devel­op­ing novel immune-therapeutics based on a pro­pri­e­tary Artificial Immune Modulation (AIM) nanotechnology plat­form, has re­ceived IND clear­ance for the Com­pany’s second cellular ther­apy prod­uct. NEXI-002 is being devel­oped for the treat­ment of multiple myeloma patients that have failed at least three prior lines of ther­apy.

Scott P. Carmer, NexImmune’s Pres­i­dent and CEO, commented, “FDA clear­ance of our second IND this quarter marks another sig­nif­i­cant mile­stone for NexImmune and dem­onstrates our team’s focus and com­mitment to …

• Overall re­sponse­ rate (ORR) of 31% with 2.5 mg/kg regi­men and no new safety signals in heavily pre-treated patient pop­u­la­tion who were re­frac­tory to an immuno­modu­la­tory drug and a pro­te­a­some in­hib­i­tor, and were re­frac­tory or intolerant to an anti-CD38 anti­body
• Data pub­lished in The Lancet Oncology highlight the poten­tial of be­lan­ta­mab mafo­dotin for patients with mul­ti­ple myeloma whose dis­ease has progressed
• GSK con­firms sub­mission of a Biologics License Appli­ca­tion to the US Food and Drug Admin­istra­tion

London, United Kingdom (Press Release) – GlaxoSmithKline plc (LSE/NYSE: GSK) today an­nounced treat­ment with the inves­ti­ga­tional single-agent be­lan­ta­mab mafo­dotin re­­sulted in a clin­i­cally meaningful 31% over­all re­sponse­ rate (ORR) with the 2.5 mg/kg regi­men in patients with heavily pre-treated mul­ti­ple myeloma. Patients in the trial re­ceived a median of seven prior lines of treat­ment, were re­frac­tory to an immuno­modu­la­tory drug and a pro­te­a­some in­hib­i­tor and were re­frac­tory and/or intolerant to an anti-CD38 anti­body. The median duration of re­sponse­ has not been reached at six …

• 30% over­all re­sponse­ rate seen with an average pro­gres­sion free sur­vival of 4.5 months and an ac­ceptable and ex­pec­ted safety profile
• Additional data in patients re­ceiv­ing higher frac­tion­ated doses of CLR 131 antic­i­pated in Jan­u­ary­

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 summary data from 20 patients re­ceiv­ing a single dose of CLR 131 in its Phase 2 CLOVER-1 trial in select re­lapsed / re­frac­tory (RR) B-cell malig­nan­cies. The com­pany had pre­vi­ously an­nounced data from 10 mul­ti­ple myeloma patients re­ceiv­ing a single dose of CLR 131 in Feb­ru­ary 2019, which showed a 30% …

• 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 …

• CHMP issued pos­i­tive opinion for DARZALEX® 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
• Final de­ci­sion from European Com­mis­sion ex­pec­ted in the coming months
• Opinion based on data from Phase III CASSIOPEIA study

Copenhagen, Denmark (Company Announcement) – Genmab A/S (Nasdaq: GMAB) announced today that the Com­mit­tee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a pos­i­tive opinion rec­om­mending broadening the existing mar­ket­ing authori­za­tion for DARZALEX® (dara­tu­mu­mab) in the European Union. The recom­men­da­tion is for the use of DARZALEX in 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). …