• Genmab signs agree­ment with Janssen Biotech, Inc. to col­lab­o­rate exclusively on next-generation CD38 anti­body prod­uct, HexaBody®-CD38, incorporating Genmab’s pro­pri­e­tary HexaBody tech­nology
• New agree­ment builds on Genmab’s suc­cess­ful DARZALEX® col­lab­o­ration with Janssen
• Next-generation HexaBody-CD38 could poten­tially add to the DARZALEX multiple myeloma fran­chise and expand the poten­tial of CD38-targeted ther­a­pies in further indi­ca­tions

Copenhagen, Denmark (Company Announcement) – Genmab A/S (Nasdaq Copen­hagen: GEN) announced today it has entered into an exclusive world­wide license and option agree­ment with Janssen Biotech, Inc. (Janssen) to develop and com­mer­cial­ize HexaBody-CD38, a next-generation human CD38 mono­clonal anti­body prod­uct incorporating Genmab’s pro­pri­e­tary HexaBody tech­nology. Under the terms of the agree­ment, Genmab will col­lab­o­rate exclusively with Janssen on HexaBody-CD38, with Genmab funding research and devel­op­ment activities until completion of clin­i­cal proof of concept studies in multiple myeloma and diffuse large B-cell lym­phoma. Based on the …

• U.S. FDA grants Priority Review 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
• September 26, 2019 PDUFA date

Copenhagen, Denmark (Company Announcement) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the U.S. Food and Drug Admin­istra­tion (U.S. FDA) granted a Priority Review for the supple­mental Biologics License Application (sBLA) for the use of dara­tu­mu­mab (DARZALEX®) in com­bi­na­tion with bor­tez­o­mib, thalido­mide and dexa­meth­a­sone (VTd) as treat­ment for patients newly diag­nosed with multiple myeloma who are can­di­dates for au­tol­o­gous stem cell trans­plant (ASCT). The sBLA was submitted by Genmab’s licensing partner, Janssen Biotech, Inc. (Janssen), in March 2019. Priority Review is a …

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. …