Median over­all sur­vival of 22.0 months observed in Cohorts 1-4

Florham Park, NJ (Press Release) – Cellectar Biosciences (Nasdaq: CLRB), a clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on the discovery, devel­op­ment and com­mer­cial­iza­tion of drugs for the treat­ment of cancer, to­day an­nounced median over­all sur­vival (mOS) in Cohorts 1-4 of the com­pany’s on­go­ing Phase 1 clin­i­cal trial eval­u­ating CLR 131 for the treat­ment of re­lapsed / re­frac­tory (R/R) mul­ti­ple myeloma (MM). The results showed mOS of 22.0 months among 15 patients, all of whom were heavily pre­treated, averaging five prior lines of sys­temic ther­apy. Each patient in Cohorts 1-4 of this dose-escalation study re­ceived a …

• Phase III MAIA study of dara­tu­mu­mab in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone in front line multiple myeloma met the pri­mary end­point (PFS) at a pre-planned interim analysis demonstrating the superiority of DRd over Rd
• Independent Data Moni­tor­ing Committee rec­om­mends releasing the interim analysis results and to follow patients for survival and long-term safety
• Data will be discussed with health author­i­ties to prepare for regu­la­tory filings

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today topline results from the Phase III MAIA study (MMY3008) of dara­tu­mu­mab in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone (DRd) versus Rd alone as treat­ment for newly diag­nosed patients who are not can­di­dates for high dose chemo­ther­apy and au­tol­o­gous stem cell trans­plant (ASCT). The study met the pri­mary end­point of im­prov­ing pro­gres­sion free survival (PFS) at a pre-planned interim analysis (Hazard Ratio (HR) = 0.55 (95% CI 0.43 – 0.72), p …

Summit, NJ (Press Release) – Celgene Corpo­ra­tion (NASDAQ: CELG) today announced results from an open-label phase II/III National Clinical Trials Network (NCTN) study led by the ECOG-ACRIN Cancer Research Group and sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health. REVLIMID® (lena­lido­mide) was provided by Celgene under a clin­i­cal trials agree­ment with the NCI’s Division of Cancer Treatment and Diagnosis.

ECOG E3A06 is a ran­dom­ized study eval­u­ating the safety and efficacy of the inves­ti­ga­tional use of REVLIMID mono­therapy versus observation in patients with asymptomatic smol­der­ing multiple myeloma. …

• Phase III CASSIOPEIA study of dara­tu­mu­mab in com­bi­na­tion with bor­tez­o­mib, thalido­mide and dexa­meth­a­sone in front line multiple myeloma met the pri­mary end­point of stringent Complete Response (sCR) after induction and con­sol­i­da­tion ther­apy
• Trial sponsored by the French Intergroupe Francophone du Myelome (IFM) in col­lab­o­ration with the Dutch-Belgian Cooperative Trial Group for Hematology Oncology (HOVON)
• Data will be discussed with health author­i­ties for poten­tial regu­la­tory filings

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today the study met its pri­mary end­point for Part 1 of the Phase III CASSI­OPEIA study (MMY3006) of dara­tu­mu­mab in com­bi­na­tion with bor­tez­o­mib, thalido­mide and dexa­meth­a­sone (VTD) versus VTD alone as frontline treat­ment for patients who are can­di­dates for au­tol­o­gous stem cell trans­plant (ASCT). The first part of the study met the pri­mary end­point of number of patients that achieved a sCR, which was reported in 28.9% of patients treated with …

Madison, WI (Press Release) – Cellectar Biosciences (Nasdaq: CLRB), a clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on the discovery, devel­op­ment and com­mer­cial­iza­tion of drugs for the treat­ment of cancer, to­day up­dates interim over­all sur­vival (OS) data from the com­pany’s on­go­ing Phase 1b clin­i­cal trial eval­u­ating CLR 131 for the treat­ment of re­lapsed/refractory (R/R) mul­ti­ple myeloma (MM).

The results to date show that OS is cur­rently at 19.4 months. Cellectar con­tinues to monitor these patients and in­tends to up­date OS results as data be­come avail­able. All 15 patients from the Phase 1b, single-dose cohorts were …

• Efficacy and safety con­tinue to be a major ad­van­tage, with a very high response rate, no dose limiting toxicities and only a single in­ci­dence of sus­pected cytokine release syn­drome
• P-BCMA-101 clin­i­cal data as well as pre­clin­i­cal data from MUC1C and PSMA solid tumor pro­grams and BCMA allo­geneic pro­gram presented at the CAR-TCR Summit

San Diego, CA (Press Release) – Poseida Therapeutics Inc. (“Poseida”), a clin­i­cal-stage bio­tech­nology com­pany translating best-in-class gene engi­neer­ing tech­nolo­gies into lifesaving cell ther­a­pies, announced data results from the first eleven patients treated in its ongoing Phase 1 study of its P-BCMA-101 stem cell memory chi­meric an­ti­gen re­cep­tor T-cell (CAR-T) prod­uct in re­lapsed / refractory multiple myeloma. All eleven patients remain on study with seven of ten patients evaluable by Inter­na­tional Myeloma Work­ing Group (IMWG) criteria achieving at least a partial response. The remaining patient also dem­onstrated …

Data from first lead-in patient cohort prompts Data Monitoring Com­mit­tee to rec­om­mend early con­tin­u­a­tion to ran­dom­ized placebo-controlled part 2 of trial

Tel Aviv, Israel (Press Release) – BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on on­col­ogy and immunology, an­nounced to­day pos­i­tive re­sults from the lead-in period of the GENESIS trial, a double-blind, placebo-controlled Phase 3 trial com­par­ing BL-8040 in com­bi­na­tion with granulocyte colony-stimulating factor (G-CSF), to G-CSF alone, for the mobili­za­tion of hema­to­poietic stem cells (HSCs) used for au­tol­o­gous trans­plan­ta­tion in mul­ti­ple myeloma patients.

The open-label, single-arm, lead-in period of the study was de­signed to in­clude up to 30 patients, with Data Monitoring Com­mit­tee (DMC) re­view after com­ple­tion of …