• 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% …

• Study met its pri­mary end­point and key sec­ond­ary end­point, demonstrating deep and durable re­sponse­s in a heavily pre-treated mul­ti­ple myeloma patient pop­u­la­tion
• Safety results are con­sis­tent with the data pre­sented in CRB-401 study

Princeton, NJ and Cambridge, MA (Press Release) – Bristol-Myers Squibb Com­pany (NYSE: BMY) and bluebird bio, Inc. (Nasdaq: BLUE) to­day an­nounced pos­i­tive top-line results from KarMMa, a pivotal, open-label, single arm, multi­center, Phase 2 study of idecabtagene vicleucel (ide-cel; bb2121). KarMMa, which eval­u­ated the ef­fi­cacy and safety of the com­pa­nies’ lead inves­ti­ga­tional BCMA-targeted chi­meric an­ti­gen re­cep­tor (CAR) T cell ther­apy can­di­date for patients with re­lapsed and re­frac­tory mul­ti­ple myeloma, met its pri­mary end­point and key sec­ond­ary end­point.

KarMMa en­rolled 140 patients, of whom 128 …

I find the Myeloma Beacon patient columns and forum very in­for­ma­tive and use­ful, but they are surprisingly short on what comes with relapse when there are no more realistic treat­ment options. I’m facing that situation now and thought I’d chronicle my journey along this next part of the road in a regular column, in hopes that it will be of use to others.

I am 81 years old, diag­nosed in June 2017, at age 79, when I sneezed and broke two ribs. I went on a reduced-dose …

Shanghai, China (Press Release) – CARsgen Thera­peutics Co. Ltd., a clin­i­cal-stage bio­pharma­ceu­tical com­pany to­day an­nounced that the United States Food and Drug Admin­istra­tion (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) desig­na­tion to its inves­ti­ga­tional CT053 CAR-T cell ther­apy. CT053 is a fully human anti-BCMA (B Cell Maturation Antigen) au­tol­o­gous chi­meric an­ti­gen re­cep­tor (CAR) T Cell ther­apy for the treat­ment of re­lapsed and/or re­frac­tory mul­ti­ple myeloma (rrMM).

RMAT desig­na­tion was based on clin­i­cal data from an on­go­ing CT053 phase 1 study in heavily pre-treated mul­ti­ple myeloma patients in China. Updated data from CT053 …

San Francisco, CA (Press Release) – Nektar Thera­peutics (NASDAQ: NKTR) today announced the initiation of a first-in-human, Phase 1 clin­i­cal study eval­u­ating NKTR-255, an interleukin-15 (IL-15) re­cep­tor agonist, as mono­therapy for patients with re­lapsed or re­frac­tory non-Hodgkin lym­phoma (NHL) or multiple myeloma (MM). The study will also combine NKTR-255 with multiple targeted anti­bodies, that function through an anti­body-dependent cell-mediated cyto­tox­icity (ADCC) mech­a­nism, to eval­u­ate the safety and efficacy in adults with re­lapsed or re­frac­tory MM. NKTR-255 is designed to activate the IL-15 path­way and ex­pand functionally superior natural killer (NK) cells and promote …

Nanjing, China (Press Release) – IASO Biotherapeutics (IASO BIO), a clin­i­cal stage bio­technology com­pany ad­vanc­ing the devel­op­ment of inno­va­tive ther­a­pies for cancer, and Innovent Biologics, Inc. (Innovent) (HKEX:01801), a world-class bio­pharma­ceu­tical com­pany that de­vel­ops and com­mer­cial­izes high quality med­i­cines, an­nounced to­day that IASO BIO has re­ceived National Medical Products Admin­istra­tion (NMPA) ap­prov­al for an Inves­ti­ga­tional New Drug Appli­ca­tion (IND) for CT103A – an inno­va­tive ther­apy for the treat­ment of re­lapsed re­frac­tory mul­ti­ple myeloma (rr/mm) patients. IASO Bio and Innovent will start a Phase Ib/II study to con­firm the R2PD and move to phase II …

Stockholm, Sweden (Press Release) – Oncopeptides AB (Nasdaq Stock­holm: ONCO) an­nounced to­day that the last patient has been in­cluded in the OP-106 HORIZON pivotal phase 2 clin­i­cal study eval­u­ating mel­flu­fen with dexa­meth­a­sone in patients with re­lapsed / re­frac­tory mul­ti­ple myeloma (RRMM). Oncopeptides has pre­vi­ously com­mu­ni­cated a target en­roll­ment of 150 patients in the study be­fore the end of Sep­tem­ber, which now has been achieved.

Oncopeptides is engaged in preparations for submitting a New Drug Appli­ca­tion (NDA) to the U.S. Food & Drug Admin­istra­tion (FDA) for ac­cel­er­ated mar­ket ap­­prov­al in the United States based on …