• 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 …

• ALLO-715 Utilizes Gene-Editing of TRAC and CD52 Loci to Enable Allogeneic CAR T Therapy
• ALLO-715 will be Evaluated in Com­bi­na­tion with ALLO-647, Allogene’s Proprietary anti-CD52 Anti­body as Part of the Lymphodepletion Regimen
• Allogene Plans to Initiate the UNIVERSAL Study for ALLO-715 in Re­lapsed / Re­frac­tory Multiple Myeloma in the Second Half of 2019

South San Francisco, CA (Press Release) – Allogene Thera­peutics, Inc. (Nasdaq: ALLO), a clin­i­cal-stage bio­technology com­pany pioneering the devel­op­ment of allo­geneic CAR T (AlloCAR T™) ther­a­pies for cancer, to­day an­nounced that the U.S. Food & Drug Admin­istra­tion (FDA) has cleared Allogene’s Inves­ti­ga­tional New Drug (IND) appli­ca­tion for ALLO-715 in patients with re­lapsed / re­frac­tory mul­ti­ple myeloma. The Phase 1 portion of the UNIVERSAL study, which will in­clude ALLO-647 as part of the lym­pho­de­ple­tion regi­men, is ex­pec­ted to be ini­ti­ated in 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 …

Hyderabad, India (Press Release) – NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) is pleased to announce that it has reached a Settlement Agreement with Onyx Thera­peutics, Inc. on patent lit­i­ga­tion related to generic versions of 10mg, 30mg and 60mg of Kyprolis®. NATCO has partnered with Breckenridge Pharma­ceu­tical, Inc., who will mar­ket the prod­uct in the United States.

The parties have reached a Settlement Agreement and the District Court case has been dismissed. By virtue of the settlement, NATCO and Breckenridge have been granted a license permitting the launch of their generic car­filz­o­mib prod­uct …

Stockholm, Sweden (Press Release) – Oncopeptides AB (Nasdaq Stock­holm: ONCO) an­nounced to­day that, after dis­cus­sions with the FDA, the com­pany has ini­ti­ated the preparation for submitting a New Drug Appli­ca­tion (NDA) for ac­cel­er­ated ap­­prov­al of mel­flu­fen for the treat­ment of patients with triple-class re­frac­tory mul­ti­ple myeloma. The com­pany targets to submit the appli­ca­tion in the first quarter of 2020.

During the spring, Oncopeptides has been engaged in dialogue with the FDA to explore whether mel­flu­fen could be eli­gible for ac­cel­er­ated ap­­prov­al based on the promising data gen­er­ated in the on­go­ing phase 2 HORIZON …

The European Com­mis­sion has approved two of Celgene’s IMiD®-based com­bi­na­tion regi­mens:

• REVLIMID in combi­nation with bor­tez­o­mib and dexa­meth­a­sone (RVd) in adult patients with pre­vi­ously untreated multiple myeloma who are not eli­gible for trans­plant
• IMNOVID in com­bi­na­tion with bor­tez­o­mib and dexa­meth­a­sone (PVd), in adult patients with multiple myeloma, who have received at least one prior treat­ment regi­men in­­clud­ing REVLIMID.

Boudry, Switzerland (Press Release) – Celgene Corpo­ra­tion (NASDAQ:CELG), today announced that the European Com­mis­sion (EC) has approved two new triplet regi­mens based on Celgene’s pro­pri­e­tary IMiD treat­ments, REVLIMID (lena­lido­mide) and IMNOVID (poma­lido­mide).

REVLIMID in com­bi­na­tion with bor­tez­o­mib and dexa­meth­a­sone (RVd), is now indicated for the treat­ment of adult patients with pre­vi­ously untreated multiple myeloma who are not eli­gible for trans­plant. In addi­tion, IMNOVID, in com­bi­na­tion with bor­tez­o­mib and dexa­meth­a­sone (PVd), is now indicated for the treat­ment of adult patients with multiple myeloma who have received at …

• 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 …