Enrollment to cease im­medi­ately; top­line data antic­i­pated in H1 2021

Tel Aviv, Israel (Press Release) – Bio­LineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on on­col­ogy, to­day an­nounced pos­i­tive re­sults from a planned interim analysis of the on­go­ing GENESIS Phase 3 trial of motix­a­fortide for stem cell mo­bi­li­za­tion (SCM) in mul­ti­ple myeloma patients.

At a meeting of the study's in­de­pen­dent Data Monitoring Com­mit­tee (DMC), a planned interim analysis of the study's pri­mary end­point was con­ducted in­de­pen­dent­ly by the DMC. Based on the statistically sig­nif­i­cant evi­dence favoring treat­ment with motix­a­fortide, the DMC issued a recom­men­da­tion to the Com­pany that patient …

• Second part of the Phase 3 CASSI­O­PEIA study of dara­tu­mu­mab as main­te­nance treat­ment for patients with newly diag­nosed mul­ti­ple myeloma eli­gible for au­tol­o­gous stem cell trans­plant met the pri­mary end­point of pro­gres­sion-free sur­vival at a pre-planned interim analysis
• Independent Data Mon­i­tor­ing Com­mit­tee rec­om­mends unblinding the study re­sults
• Based on the data, Janssen plans to discuss the po­ten­tial for a regu­la­tory sub­mission with health author­i­ties

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq: GMAB) an­nounced to­day pos­i­tive top­line re­sults from the sec­ond part of the Phase 3 CASSI­O­PEIA (MMY3006) study of dara­tu­mu­mab mono­therapy as main­te­nance treat­ment versus observation (no treat­ment) for patients with newly diag­nosed mul­ti­ple myeloma eli­gible for au­tol­o­gous stem cell trans­plant (ASCT). The sec­ond part of the study, which is being con­ducted by the French Intergroupe Francophone du Myelome (IFM) in col­lab­o­ration with the Dutch-Belgian Cooperative Trial Group for He­ma­tol­ogy On­col­ogy (HOVON) and …

TOURMALINE-MM2 Data Presented Virtually at the Society of Hema­to­logic Oncology (SOHO) Eighth Annual Meeting

Cambridge, MA and Osaka, Japan (Press Release) – Takeda Pharma­ceu­tical Com­pany Limited (TSE:4502/NYSE:TAK) (“Takeda”) to­day an­nounced re­­sults from the Phase 3 TOUR­MA­LINE-MM2 trial eval­u­ating the addi­tion of NIN­LARO™ (ix­az­o­mib) to lena­lido­mide and dexa­meth­a­sone versus lena­lido­mide and dexa­meth­a­sone plus placebo in newly diag­nosed mul­ti­ple myeloma patients not eli­gible for au­tol­o­gous stem cell trans­plant. These data will be pre­sented at the virtual sci­en­tif­ic meeting of the Society of Hema­to­logic Oncology (SOHO) on Wednesday, Sep­tem­ber 9, 2020 at 6:15 p.m. CT.

The study found the addi­tion of NIN­LARO to lena­lido­mide and dexa­meth­a­sone re­­sulted in a 13.5 …

40% over­all re­sponse rate (ORR) with a total admin­istered dose of 60 mCi or greater

Forham 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 a clin­i­cally meaningful 40% over­all re­sponse rate (ORR) was ob­served in the subset of re­frac­tory mul­ti­ple myeloma patients deemed triple class re­frac­tory who re­ceived a total admin­istered dose of 60 mCi or greater. Triple class re­frac­tory is defined as patients re­frac­tory to immuno­modu­la­tory, pro­te­a­some in­hib­i­tors and anti-CD38 anti­body drug classes.

The 40% ORR (6/15 patients) rep­re­sents triple class re­frac­tory …

• TTI-622 (SIRPa-IgG4 Fc) com­pleted 8 mg/kg safety assess­ment in the on­go­ing dose escalation study in re­lapsed / re­frac­tory lym­phoma; now es­ca­lat­ing to 12 mg/kg dose level.
• TTI-622 mono­therapy shows 6/18 (33%) objective re­sponses at 0.8 to 8 mg/kg dose levels, in­clud­ing 3/6 (50%) objective re­sponses at 8 mg/kg.
• TTI-621 (SIRPa-IgG1 Fc) well tol­er­ated at 1.4 mg/kg; con­tinues to show mono­therapy signal and dose-depen­dent im­prove­ment in skin dis­ease scores in the on­go­ing dose escalation study in re­lapsed / re­frac­tory CTCL.
• Trillium to host conference call at 5:30 p.m. ET to­day

Cambridge, MA (Press Release) – Trillium Thera­peutics Inc. (“Trillium” or the “Company”) (NASDAQ/TSX: TRIL), a clin­i­cal stage immuno-oncology com­pany devel­op­ing inno­va­tive ther­a­pies for the treat­ment of can­cer, to­day an­nounced up­dated data from its on­go­ing TTI-622 and TTI-621 dose escalation stud­ies.

“We are exceedingly en­cour­aged by the evolving profile of TTI-622, our SIRPa-IgG4 Fc fusion pro­tein, as dem­onstrated in the on­go­ing dose escalation study in re­lapsed and re­frac­tory lym­phomas,” said Jan Skvarka, Trillium’s Pres­i­dent and Chief Exec­u­tive Of­fi­cer. “TTI-622 is showing sub­stan­tial …

• Phase 3 APOLLO ran­dom­ized study eval­u­ating sub­cu­tane­ous dara­tu­mu­mab in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone versus poma­lido­mide and dexa­meth­a­sone alone in re­lapsed or re­frac­tory mul­ti­ple myeloma met the pri­mary end­point of im­prov­ing pro­gres­sion-free sur­vival
• Janssen in­tends to discuss the data with health author­i­ties for po­ten­tial regu­la­tory sub­missions

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq: GMAB) an­nounced to­day that the Euro­pean Myeloma Network (EMN) in col­lab­o­ration with Janssen Re­search & De­vel­op­ment, LLC (Janssen) re­ported pos­i­tive re­­sults from the Phase 3 APOLLO (MMY3013) study of the sub­cu­tane­ous (SC) for­mu­la­tion of dara­tu­mu­mab in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone (Pd) versus Pd alone as treat­ment for patients with re­lapsed or re­frac­tory mul­ti­ple myeloma who have pre­vi­ously been treated with lena­lido­mide (an immuno­modu­la­tory drug) and a pro­te­a­some in­hib­i­tor (PI). The study met the pri­mary …

• IKEMA trial results released early based on recom­men­da­tion of an Independent Data Monitoring Com­mit­tee
• Addition of Sarclisa sig­nif­i­cantly reduced the risk of dis­ease pro­gres­sion or death com­pared to car­filz­o­mib and dexa­meth­a­sone alone
• Results will be sub­mitted to an upcoming medical meeting and form the basis for regu­la­tory sub­missions later this year

Paris, France (Press Release) – The Phase 3 IKEMA clin­i­cal trial eval­u­ating Sarclisa® (isatuximab) added to car­filz­o­mib and dexa­meth­a­sone met the pri­mary end­point at its first planned interim analysis, demonstrating sig­nif­i­cantly prolonged pro­gres­sion-free sur­vival com­pared to standard of care car­filz­o­mib and dexa­meth­a­sone alone in patients with re­lapsed multiple myeloma. There were no new safety signals identified in this study.

“When Sarclisa was added to standard-of-care treat­ment car­filz­o­mib and dexa­meth­a­sone in this phase 3 trial, results clearly dem­onstrated a sig­nif­i­cant re­duc­tion in …