Lund, Sweden (Press Release) – BioInvent Inter­na­tional (STO:BINV) is today providing an update on its clin­i­cal and pre­clin­i­cal drug pro­grams. Several positive inter­actions with regu­la­tory author­i­ties have taken place and clin­i­cal trials with three of the Company’s anti­bodies are ex­pec­ted to start in 2016. A scientific advice meeting with the UK Medicines and Healthcare Products Regulatory Agency (MHRA) was held in preparation for the first clin­i­cal study of BI-1206. The study plan presented to the regulator, as well as BioInvent’s data, were well received. Cancer Research UK plans to submit the Clinical …

Emerging Data Support Conducting Additional, Later Stage Studies in Multiple Myeloma

Calgary (Press Release) – Oncolytics Biotech® Inc. ("Oncolytics") (TSX:ONC) (OTCQX:ONCYF) (FRA:ONY) today announced that Dr. D.W. Sborov and colleagues made a poster presentation at the 57th American Society of Hematology (ASH) Annual Meeting. The poster presentation, titled "REOLYSIN^® Combined with Carfilzomib for Treatment of Relapsed Multiple Myeloma Patients," discloses updated findings from a pilot study (NCI-9603) in patients with re­lapsed or refractory multiple myeloma treated using the com­bi­na­tion of car­filz­o­mib and REOLYSIN^®. The ASH Annual Meeting runs from December 5th to …

Interim Results from Phase 1b/2 ACE-MM-102 and Phase 1a/1b ACE-MM-200 Studies to be Presented at the 57th Annual Meeting of the American Society of Hematology

Boston (Press Release) Acetylon Pharma­ceu­ticals, Inc., the leader in the devel­op­ment of selective histone deacetylase (HDAC) inhibitors for en­hanced thera­peutic out­comes, today announced that it will present clin­i­cal data demonstrating promising tolerability and over­all response rates from a Phase 1b/2 study of a selective HDAC6 inhibitor, ricolinostat (ACY-1215), in com­bi­na­tion with poma­lido­mide (Pomalyst^®, Celgene) and dexa­meth­a­sone for the treat­ment of re­lapsed-and-refractory multiple myeloma (ACE-MM-102 study). These data …

Findings Presented at the 57th American Society of Hematology Annual Meeting Demonstrate Activity of KEYTRUDA Therapy in Previously-Treated Multiple Myeloma Patients When Combined with Lena­lido­mide and Dexamethasone

Kenilworth, NJ (Press Release) – Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today new study findings investigating the use of KEYTRUDA® (pem­bro­lizu­mab), the com­pany’s anti-PD-1 ther­apy, in com­bi­na­tion with lena­lido­mide and low-dose dexa­meth­a­sone (two com­monly used treat­ments for multiple myeloma) in patients whose dis­ease has progressed after at least two lines of prior ther­apy, in­clud­ing a pro­te­a­some inhibitor and an IMiD (immune modulatory drug). The initial findings from the ongoing Phase 1 KEYNOTE-023 study showed an over­all response rate (ORR) of 76 per­cent (n=13/17), as assessed by …

• Early com­bi­na­tion data from Phase 1b/2 dose-finding study indicate poten­tial efficacy in pre­vi­ously treated patients with multiple myeloma
• This release corresponds to abstract #377

North Chicago, IL (Press Release) – Today, AbbVie (NYSE: ABBV), a global bio­pharma­ceu­tical com­pany, announced pre­lim­i­nary data from the ongoing Phase 1/2b PCYC-1119 trial suggesting that the com­bi­na­tion of ibrutinib (IMBRUVICA®) plus car­filz­o­mib with or without dexa­meth­a­sone was well tolerated in re­lapsed or refractory patients with multiple myeloma (MM), with an initial objective response rate (ORR) of 62%. These data will be presented today in an oral presentation at the 57th Annual American Society of Hematology (ASH) Meeting and Exposition in Orlando, …

Results featured at the 57th Annual American Society of Hematology Meeting and Exposition:

• 72 per­cent of re­lapsed or refractory multiple myeloma patients treated with dara­tu­mu­mab com­bi­na­tion ther­apy did not progress or relapse after 18 months of treat­ment (GEN 503)
• Daratumumab in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone produced rapid, deep and durable responses in re­lapsed and refractory multiple myeloma patients who had received at least two (median of 3.5) prior lines of ther­apy, in­­clud­ing two or more consecutive cycles of lena­lido­mide and bor­tez­o­mib, and were refractory to their last line of treat­ment (MMY1001 Phase1b)
• Single-agent dara­tu­mu­mab dem­onstrated a median over­all survival of 20 months in heavily pre-treated re­lapsed and refractory multiple myeloma patients who have exhausted other approved treat­ment options. A partial response or better was achieved by 31 per­cent of patients, and 83 per­cent achieved stable disease or better (GEN 501 & MMY2002)

Beerse, Belgium (Press Release) – Janssen-Cilag Inter­na­tional NV announced new data from the ongoing Phase 1/2 GEN503 inves­ti­ga­tional study showing the human CD38-directed mono­clonal anti­body dara­tumumab, in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone, yielded an over­all response rate (ORR) of 81 per­cent in re­lapsed or refractory multiple myeloma patients who had received a median of two prior ther­a­pies. After 18 months of treat­ment, investigators observed an over­all survival (OS) rate of 90 per­cent, with 72 per­cent …

Additional Presentation: Phase 2 Results From an Investigational study of Ixazomib plus Cyclophosphamide and Low-Dose Dexamethasone in Patients with Newly Diagnosed Multiple Myeloma

Orlando, FL (Press Release) – Takeda Pharma­ceu­tical Company Limited (TSE:4502) today announced results from the TOURMALINE-MM1 trial presented at the 57^th Annual Meeting and Exposition of the American Society of Hematology (ASH), showing that treat­ment with NINLARO^® (ixazomib) capsules is effective in extending pro­gres­sion free survival (PFS) with a man­age­able tolerability profile in patients with re­lapsed and/or refractory multiple myeloma. The TOURMALINE-MM1 trial is an inter­na­tional, ran­dom­ized, double-blind, placebo-controlled Phase 3 clin­i­cal trial designed to eval­u­ate once-weekly oral ixazomib plus lena­lido­mide and dexa­meth­a­sone compared to placebo plus lena­lido­mide and dexa­meth­a­sone.

NINLARO …