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 …

Durham, NC (Press Release) – Pre­ci­sion BioSciences, Inc. (Nasdaq: DTIL), a clin­i­cal stage bio­technol­ogy com­pany ded­i­cated to im­prov­ing life with its novel and pro­pri­e­tary ARCUS® genome edit­ing plat­form, to­day an­nounced the U.S. Food and Drug Admin­istra­tion (FDA) has granted Fast Track Desig­na­tion to PBCAR269A for the treat­ment of re­lapsed / re­frac­tory mul­ti­ple myeloma. This is the com­pany’s sec­ond allo­geneic chi­meric an­ti­gen re­cep­tor (CAR T) cell ther­apy to re­ceive Fast Tack Desig­na­tion for which the FDA pre­vi­ously granted Orphan Drug Desig­na­tion.

“Fast Track Desig­na­tion will help us expedite our allo­geneic CAR T cell ther­apy pro­gram …

• 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 …

• Human trials begin to­day in California using Celularity's CYNK-001 inves­ti­ga­tional immuno­therapy as part of a national clin­i­cal trial that will en­roll approx­i­mately 86 adults who tested COVID-19 pos­i­tive
• CYNK-001 is the only cryo­pre­served allo­geneic, off-the-shelf NK cell ther­apy devel­oped from pla­cen­tal hema­to­poietic stem cells.

Warren, NJ (Press Release) – Celularity an­nounced to­day that the first patient was dosed in a Phase I/II study of human pla­cen­tal hema­to­poietic stem cell derived NK cells (CYNK-001) for the treat­ment of adults with COVID-19 as part of a national clin­i­cal trial. The patient was treated at UC Irvine in California, the first CA site to open for patient en­roll­ment with sup­port from a COVID-19 Project grant awarded to Celularity by the California In­sti­tute for Regenerative Medicine (CIRM). Par­tic­i­pat­ing trial sites in­clude …

CD38-Targeting Molecule To Be Evaluated In Multiple Patient Populations

New Haven, CT (Press Release) – Kleo Pharma­ceu­ticals, a targeted immuno­therapy com­pany devel­op­ing fully syn­thet­ic bispecific ther­a­pies to redirect, en­hance or re­place anti­bodies, an­nounced to­day that its lead com­pound, KP1237, has re­ceived Orphan Drug desig­na­tion from the U.S. Food and Drug Admin­istra­tion (FDA) in mul­ti­ple myeloma. KP1237 is an anti­body-redirecting mol­e­cule (ARM) that targets CD38, a clin­i­cally val­i­dated target for mul­ti­ple myeloma.

“We are pleased to re­ceive this Orphan Drug desig­na­tion for KP1237, which is ad­vanc­ing to Phase 1 clin­i­cal testing in the fourth quarter of 2020,” said Doug Manion, MD, CEO of Kleo …

Stockholm, Sweden (Press Release) – Oncopeptides AB (publ) (Nasdaq Stock­holm: ONCO) to­day an­nounces that the last patient has been suc­cess­fully en­rolled in the pivotal phase 3 study OCEAN in re­lapsed re­frac­tory mul­ti­ple myeloma (RRMM). The original en­roll­ment target of 450 patients was reached in May 2020, but an analysis in­di­cated that patients were staying longer on treat­ment than ini­tially esti­mated. Thus, a de­ci­sion was made to leave recruitment open to ensure that the num­ber of dis­ease pro­gres­sion events needed to com­plete the study would be reached within a reason­able time­frame. An addi­tional 45 …