Updated re­­sults of a Phase 1 trial testing bb2121 in re­lapsed mul­ti­ple myeloma patients were pre­sented last Friday at the American Society of Clinical Oncology (ASCO) annual meeting. bb2121 is a poten­tial new myeloma treat­ment in the chi­meric an­ti­gen re­cep­tor (CAR) T-cell class of ther­a­pies.

The re­­sults pre­sented at this year's ASCO meeting con­firm pre­vi­ous findings in­di­cating bb2121 has sub­stan­tial anti-myeloma ac­­tiv­ity.

At some of the higher doses of bb2121 tested during the trial, for example, nearly every patient treated with the drug responded to it; the over­all re­sponse rate was almost …

Die diesjährige Jahrestagung der American Society of Clinical Oncology (ASCO) begann am Freitag, den 1. Juni, und läuft bis zum Dienstag, den 5.Juni.

Jeden Tag gab es Vorträge über das multiple Myelom. Die Hauptveranstaltung mit Vorträgen über das Myelom fand jedoch am Freitag statt. Forschung, die in Vorträgen zusammengefasst wird, ist in der Regel besonders wichtig, entweder weil das Thema selbst wichtig ist oder weil die Ergebnisse auf umfangreichen Beweisen beruhen (z.B. einer umfangreichen klinischen Studie).

Angesichts der potenziellen Bedeutung der am vergangenen Freitag vorgestellten Forschungsergebnisse befragte Myeloma Beacon drei Myelomexperten zu …

This year’s American Society of Clinical Oncology (ASCO) annual meeting began last Friday and will run through tomorrow.

Multiple myeloma-related pre­sen­ta­tions have been taking place every day of the meeting. The main myeloma-related oral pre­sen­ta­tion session of the meeting, how­ever, took place on Friday. Research summarized during oral pre­sen­ta­tion sessions usually is par­tic­u­larly im­por­tant, either because the subject itself is im­por­tant, or because the results are based on sub­stan­tial amounts of evi­dence (for example, a sizable clin­i­cal trial).

Given the poten­tial importance of the re­search results pre­sented last Friday, The Beacon asked …

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 …

• bluebird and Celgene will share 50% of U.S. costs and profits
• bluebird to re­ceive mile­stones and royalties on ex-U.S. sales

Cambridge, MA and Summit, NJ (Press Release) – bluebird bio, Inc. (Nasdaq: BLUE) and Celgene Corpo­ra­tion (Nasdaq: CELG) to­day an­nounced that the com­pa­nies have entered into an agree­ment to co-develop and co-promote bb2121, an inves­ti­ga­tional anti-B-cell maturation an­ti­gen (BCMA) chi­meric an­ti­gen re­cep­tor (CAR) T cell ther­apy for the poten­tial treat­ment of patients with re­lapsed/refractory mul­ti­ple myeloma in the United States.

“Entering into this co-development and co-promotion part­ner­ship with Celgene is a sig­nif­i­cant step for­ward in build­ing a fully integrated on­col­ogy fran­chise for bluebird and to­geth­er, …

• Legend to re­ceive an up­front pay­ment of $350 mil­lion, as well as addi­tional devel­op­ment, pro­duc­tion per­for­mance, regu­la­tory and sales mile­stone pay­ments
• Legend and Janssen to co-develop and co-promote CAR T-cell ther­apy for mul­ti­ple myeloma
• Profits and costs to be shared 50/50 world­wide, ex­clu­sive Greater China where 70 per­cent to Legend and 30 per­cent to Janssen

Nanjing, China (Press Release) – Legend Biotech, a sub­sid­i­ary of GenScript Biotech Corpo­ra­tion (HKEx: 1548) that de­vel­ops inno­va­tive CAR T-cell immuno­therapy targeting mul­ti­ple myeloma, an­nounced to­day it has executed a stra­te­gic col­lab­o­ration agree­ment to jointly de­vel­op and com­mer­cial­ize the LCAR-B38M based prod­ucts with Janssen Biotech, Inc. ("Janssen").

According to the terms of the agree­ments, the com­pa­nies have agreed to jointly share the devel­op­ment, pro­duc­tion and com­mer­cial­iza­tion ac­­tiv­i­ties, with a 50/50 profit-loss sharing agree­ment for the world-wide mar­ket …