On May 7, 2015 Roche reported that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation for venetoclax (RG7601, GDC-0199/ABT-199), an investigational medicine being developed in partnership with AbbVie, for the treatment of people who have relapsed or refractory chronic lymphocytic leukemia (CLL) with a genetic abnormality known as 17p deletion (Press release, Hoffmann-La Roche , MAY 7, 2015, View Source [SID:1234503676]). Breakthrough therapy designation is designed to accelerate the development and review of medicines intended to treat serious and life-threatening diseases with evidence showing that the medicines may provide a substantial improvement over current treatment options. Schedule your 30 min Free 1stOncology Demo! "People who have relapsed or refractory CLL with a 17p deletion typically have a poor prognosis, and do not respond to many currently available treatment options," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Clinical Development. "We are pleased that the FDA has granted venetoclax Breakthrough Therapy designation and hope this regulatory pathway will help us bring venetoclax to people with this difficult-to-treat disease soon." Know more, wherever you are: About CLL and 17p deletion
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CLL is a slow-growing cancer of the blood and bone marrow that is generally considered incurable, and is one of the most common adult leukemias worldwide.1,2 Most cases of CLL (95 percent) start in white blood cells called B-cells.1 In certain cases of CLL, a part of chromosome 17 is lost and along with it an important gene that controls apoptosis called p53.3 The 17p deletion is found in 3 to 10 percent of previously untreated cases and approximately 30 to 50 percent of relapsed or refractory cases.4 People with 17p deletion CLL have poor results with conventional chemotherapy regimens and a median life expectancy of less than three years.5
About venetoclax
Venetoclax (RG7601, GDC-0199/ABT-199) is an investigational small molecule designed to selectively bind and inhibit Bcl-2 proteins, an important regulator of a process called programmed cell death, or apoptosis. These proteins are thought to impact how certain blood cancers form, develop and become resistant to treatment. Bcl-2 proteins are expressed at high levels in CLL, non-Hodgkin’s lymphoma (NHL) and in other cancers caused by blood cells called B-cells. Venetoclax is being developed in collaboration with AbbVie and currently being studied in Phase II and Phase III studies for CLL and in Phase I and II studies for several other blood cancers.
Kymab secures US$90 million funding
On May 6, 2015 Kymab ,a leading monoclonal antibody biopharmaceutical company reported that US$50 million is being invested by Woodford Patient Capital Trust plc (LSE:WPCT,"Woodford") and Malin Corporation plc (ISE:MLC, "Malin") (Press release, Kymab, MAY 6, 2015, View Source [SID1234537013]). The additional investment follows the first US$40 million Series B investment from the Wellcome Trust and the Bill & Melinda Gates Foundation to complete a US$90 million Series B financing.
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The funds will enable Kymab to maximize the potential of its Kymouse platform and advance its proprietary pipeline of first-in-class therapeutic human monoclonal antibodies in areas of significant unmet medical need.
In association with the financing, Kymab has added two pre-eminent life science executives to the Board. G. Kelly Martin, former CEO of Elan Corporation, plc, and Director of Malin; and, Dr. Adrian Howd, CEO of Malin.
"We believe Kymab has one of the most comprehensive humanised transgenic antibody platforms underpinned by strong intellectual property," explained Adrian Howd, CEO of Malin. "We are pleased to invest in a world leading antibody company."
Kymab is using the Kymouse transgenic human antibody platform to discover and develop fully human monoclonal antibody drugs. Recent data published in Nature Biotechnology demonstrate that the KymouseTM technology yields an antibody library constituted from 100 trillion different antibodies. From this deep library rare high-quality antibodies can be selected and developed into therapeutics.
"We are delighted to welcome high quality investors of the calibre of Malin and Woodford to Kymab which support our goal to build Kymab into a sustainable biopharmaceutical company," said David Chiswell, Chairman and interim CEO of Kymab. "The funds will be used to maximise the potential of the Kymab pipeline as we develop and commercialise monoclonal antibody medicines for difficult and novel drug targets."
"Kymab has assembled a talented leadership team; an efficient and effective discovery platform with broad application demonstrated by the pipeline of product opportunities already established," commented Kelly Martin, Director of Malin. "We look forward to working with David and his team to fully realize the potential of the Company’s programs, initially in immune-oncology and immunology, and the broader technology platform."
Antibodies are one of the best-selling classes of drugs today; five of the top ten best selling drugs are antibodies. This is because antibodies are natural products with exquisite specificity and potency, and generally have superior safety profiles. The challenge has been to capture the full human antibody repertoire and to recapitulate all its attributes.
10-Q – Quarterly report [Sections 13 or 15(d)]
Supernus has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Supernus, MAY 6, 2015, View Source [SID1234503688]).
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10-Q – Quarterly report [Sections 13 or 15(d)]
Portola Pharmaceuticals has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Portola Pharmaceuticals, MAY 6, 2015, View Source [SID1234503682]).
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10-Q – Quarterly report [Sections 13 or 15(d)]
Array BioPharma has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Array BioPharma, MAY 6, 2015, View Source [SID1234503677]).
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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
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