• First healthy volunteer cohort cleared in Phase 1 first-in-human study of BION-1301 for the treat­ment of IgA nephropathy (IgAN); initial data in healthy volunteers ex­pec­ted in H1 2020 and IgAN patients in H2 2020
• Results from the dose escalation portion of the Phase 1/2 study in re­lapsed or refractory multiple myeloma (MM) patients whose disease progressed after at least three prior ther­a­pies indicated BION-1301 was well tolerated across a wide dose range and no dose limiting toxicities (DLTs) were observed
• 95% target engagement achieved and main­tained; no objective responses observed in the MM patient setting
• Phase 1 dose escalation data in MM to be presented at the 2019 ASCO Annual Meeting

Berkely, CA (Press Release) – Aduro Biotech, Inc. (NASDAQ: ADRO), a clin­i­cal-stage bio­pharma­ceu­tical com­pany focused on devel­op­ing ther­a­pies targeting the Stimulator of Interferon Genes (STING) and A Proliferation Inducing Ligand (APRIL) path­ways for the treat­ment of cancer, auto­immune and inflammatory diseases, today provided an update on its clin­i­cal devel­op­ment pro­grams for BION-1301, a first-in-class humanized IgG4 mono­clonal anti­body that fully blocks APRIL binding to both the BCMA and TACI re­cep­tors.

“We believe the …

Shanghai, China and Munich, Germany (Press Release) – I-Mab Bio­pharma (I-Mab), a China-based clin­i­cal stage bio­pharma­ceu­tical com­pany ex­clu­sively focused on the devel­op­ment of inno­va­tive biologics in immuno-oncology and auto­immune dis­eases, and MorphoSys AG (FSE: MOR; Prime Standard Segment, MDAX & TecDAX;NASDAQ: MOR), an­nounced to­day that the first patient has been dosed in a phase 3 ran­dom­ized and multi-center clin­i­cal study in Taiwan to eval­u­ate MorphoSys's inves­ti­ga­tional human CD38 anti­body TJ202 / MOR202 in com­bi­na­tion with lena­lido­mide in patients with re­lapsed or re­frac­tory multiple myeloma. I-Mab has the ex­clu­sive rights for devel­op­ment and com­mer­cial­iza­tion of TJ202 / …

Rockville, MD (Press Release) – CASI Pharma­ceu­ticals, Inc. (Nasdaq: CASI), a U.S. pharma­ceu­tical com­pany with a plat­form to develop and accelerate the launch of inno­va­tive thera­peutics and pharma­ceu­tical prod­ucts in China, the U.S., and through­out the world, announces the signing of a license agree­ment for exclusive world­wide rights to the inves­ti­ga­tional anti-CD38 mono­clonal anti­body (Mab) TSK011010 pro­gram from Black Belt Therapeutics Limited.

Under the terms of the agree­ment, CASI has obtained global rights to TSK011010 for an up­front pay­ment of 5 million euros and an equity investment of 2 million euros, as well …

• Supplemental new drug appli­ca­tion (sNDA) submitted in Japan for dara­tu­mu­mab in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone as treat­ment for patients newly diag­nosed with multiple myeloma who are not can­di­dates for high-dose chemo­ther­apy and au­tol­o­gous stem cell trans­plant
• Submission based on data from Phase III MAIA study

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that Janssen Pharma­ceu­tical K.K. has submitted a supple­mental new drug appli­ca­tion (sNDA) to the Ministry of Health, Labor and Welfare (MHLW) in Japan, for the use of dara­tu­mu­mab (DARZALEX®) in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone (Rd) as treat­ment for patients newly diag­nosed with multiple myeloma who are not can­di­dates for high-dose chemo­ther­apy and au­tol­o­gous stem cell trans­plant (ASCT). The MHLW will grant a priority review of the appli­ca­tion, based on the …

First DARZALEX com­bi­na­tion treat­ment regi­men being pursued in the frontline setting for trans­plant eli­gible patients with multiple myeloma

Raritan, NJ (Press Release) – The Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson announced today the sub­mission of a supple­mental Biologics License Application (sBLA) to the U.S. Food and Drug Admin­istra­tion (FDA) seeking approval of DARZALEX® (dara­tu­mu­mab) in com­bi­na­tion with bor­tez­o­mib, thalido­mide and dexa­meth­a­sone (VTd) for newly diag­nosed patients with multiple myeloma who are eli­gible for au­tol­o­gous stem cell trans­plant (ASCT). The Phase 3 CASSIOPEIA (MMY3006) clin­i­cal study, which sup­ports the sBLA sub­mission, met its pri­mary end­point – the proportion of patients that achieved stringent Complete Response (sCR) after in­duction and con­sol­i­da­tion …

• sBLA submitted to U.S. FDA for dara­tu­mu­mab in com­bi­na­tion with bor­tez­o­mib, thalido­mide and dexa­meth­a­sone as treat­ment for newly diag­nosed patients with multiple myeloma who are can­di­dates for au­tol­o­gous stem cell trans­plant
• Submission based on data from Phase III CASSIOPEIA study

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that its licensing partner, Janssen Biotech, Inc., has submitted a supple­mental Biologics License Application (sBLA) to the U.S. Food and Drug Admin­istra­tion (U.S. FDA) for the use of dara­tu­mu­mab (DARZALEX®) in com­bi­na­tion with bor­tez­o­mib, thalido­mide and dexa­meth­a­sone (VTD) as treat­ment for newly diag­nosed patients with multiple myeloma who are can­di­dates for au­tol­o­gous stem cell trans­plant (ASCT). In August 2012, Genmab granted Janssen an exclusive world­wide license to develop, manu­fac­ture and com­mer­cial­ize dara­tu­mu­mab. …

Application sup­ported by the Phase 3 MAIA study for dara­tu­mu­mab in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone for the treat­ment of patients newly diag­nosed with multiple myeloma who are in­eligible for au­tol­o­gous stem cell trans­plant

Beerse, Belgium (Press Release) – The Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson today announced the sub­mission of a Type II variation appli­ca­tion to the European Medicines Agency (EMA) for DARZALEX®▼ (dara­tu­mu­mab) in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone (Rd) for the treat­ment of patients newly diag­nosed with multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­plant (ASCT).

“Today’s sub­mission brings us one step closer to our goal of im­prov­ing treat­ment out­comes for people newly diag­nosed with multiple myeloma,” said José Antonio Burón Vidal, VP Medical Affairs, Europe, Middle East and …