Granada, Spain (Press Release) – An inter­na­tional team, in­­clud­ing researchers from the University of Granada's anthropology group led by Prof. Miguel Cecilio Botella López of the Department of Legal Medicine, Toxicology and Physical Anthropology, has discovered the world’s oldest known cases of breast cancer and multiple myeloma (a type of bone marrow cancer). The discoveries were made by conducting CT scans of two mummies found in the pharaonic necropolis of Qubbet el-Hawa in Aswan, Egypt.

Following their thorough analysis of the mummies, the inter­na­tional research team has estab­lish­ed that the woman with …

Seattle, WA (Press Release) – Juno Thera­peutics, Inc. (NASDAQ: JUNO), a bio­pharma­ceu­tical com­pany devel­op­ing inno­va­tive cellular immuno­therapies for the treat­ment of cancer, today announced three license agree­ments to ad­vance its pro­gram in multiple myeloma using gamma secretase inhibitors (GSIs) in com­bi­na­tion with BCMA-directed CAR T cells.

Gamma secretase is an enzyme that cleaves a set of transmembrane proteins, in­clud­ing BCMA. Multiple publications have shown that treat­ment with GSIs can in­crease surface ex­pres­sion of BCMA on tumors, particularly multiple myeloma. Increased cell surface BCMA may in­crease potency of a BCMA-directed CAR T ther­apy¹.

“BCMA …

Princeton, NJ (Press Release) – Bristol-Myers Squibb Company (NYSE: BMY) today announced the U.S. Food and Drug Admin­istra­tion (FDA) has lifted partial clin­i­cal holds placed on CA209 -039 (CheckMate -039) and CA204142, the phase 1 and 2 clin­i­cal trials investigating Opdivo (nivolumab)-based com­bi­na­tions in patients with re­lapsed or refractory multiple myeloma, re­spec­tive­ly. The de­ci­sion follows consultation with the FDA and agree­ment on amendments to the study protocols. Patient enrollment for the fol­low­ing trials will resume in accordance with the amendments:

• CheckMate -039: A phase 1 study to establish the tolerability of

 …

Basel, Switzerland (Investor Update) – Roche (SIX: RO, ROG; OTCQX: RHHBY): today announced that fol­low­ing close consultation and agree­ment on study modifications with the U.S. Food and Drug Admin­istra­tion (FDA), the partial clin­i­cal holds placed on the Phase Ib and Phase Ib/II studies eval­u­ating TECENTRIQ in com­bi­na­tion with an immuno­modu­la­tory medicine (IMiD) in re­lapsed/refractory multiple myeloma and re­lapsed/refractory follicular lym­phoma have been lifted. The studies will con­tinue in accordance with the protocol amendments agreed upon by the FDA.

The studies had been placed on partial clin­i­cal hold as part of an FDA evaluation …

• MorphoSys to receive a USD 20 million upfront payment and entitled to tiered, double digit royalties on net sales of MOR202 plus mile­stone payments of up to USD 100 million from I-Mab
• I-Mab receives exclusive devel­op­ment and com­mer­cial­iza­tion rights to MOR202 in China, Taiwan, Hong Kong and Macao
• I-Mab Biopharma (a fully owned affiliate of I-Mab) man­agement has extensive ex­peri­ence that is particularly well-suited to devel­op­ing MOR202 for the Greater Chinese market
• MorphoSys in­­creases its financial guidance for 2017: revenues of EUR 63 to 66 million and EBIT of EUR -66 to -71 million ex­pec­ted

Planegg / Munich, Germany (Press Release) – MorphoSys AG (FSE: MOR; Prime Standard Seg­ment, TecDAX; OTC: MPSYY) and I-Mab announced today that they have entered into an ex­clusive regional licensing agree­ment to develop and com­mer­cial­ize MOR202 in China, Taiwan, Hong Kong and Macao. MOR202 is MorphoSys's pro­pri­e­tary inves­ti­ga­tional anti­body against CD38, for which recruit­ment of a European Phase 1/2a clin­i­cal study in re­lapsed / refractory multiple myeloma has been concluded.

Under the …

Supplemental Biologics License Application (sBLA) seeks first indi­ca­tion for DARZALEX for the treat­ment of newly diag­nosed patients

Raritan, NJ (Press Release) – Janssen Biotech, Inc. today announced that it has submitted a supple­mental Biologics License Application (sBLA) to the U.S. Food and Drug Admin­istra­tion (FDA) for DARZALEX® (dara­tu­mu­mab). This appli­ca­tion seeks to expand the current indi­ca­tion, using DARZALEX in com­bi­na­tion with bor­tez­o­mib (a pro­te­a­some inhibitor [PI]), mel­phalan and pred­ni­sone, for the treat­ment of patients with newly diag­nosed multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­planta­tion (ASCT). If approved, this would be the fifth indi­ca­tion for DARZALEX in the U.S. and its first in the frontline setting.

"The addi­tion …

• sBLA submitted to U.S. FDA for dara­tu­mu­mab in combi­na­tion with bortez­omib, mel­phalan and pred­ni­sone for the treat­ment of patients with newly diag­nosed multiple myeloma in­eli­gible for au­tol­o­gous stem cell trans­plant
• Submission based on data from Phase III ALCYONE 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 (FDA) for the use of dara­tu­mu­mab (DARZALEX®) in combi­na­tion with bor­tez­o­mib, mel­phalan and pred­ni­sone for the treat­ment of patients with newly diag­nosed multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­plant (ASCT). In August 2012, Genmab granted Janssen an exclusive world­wide license to devel­op, manu­facture and com­mer­cial­ize dara­tu­mu­mab.

“We …