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.

CTI BioPharma has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, CTI BioPharma, MAY 6, 2015, View Source [SID1234503656]).

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— AbbVie plans to submit regulatory applications for venetoclax to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) before the end of 2015
— Venetoclax is currently in development for the treatment of relapsed or refractory chronic lymphocytic leukemia, including patients with 17p deletion

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May 6, 2015

NORTH CHICAGO, Ill., May 6, 2015 /PRNewswire/ — AbbVie (NYSE: ABBV) reported its investigational medicine venetoclax, an inhibitor of the B-cell lymphoma-2 (BCL-2) protein that is being developed in partnership with Genentech and Roche, has been granted Breakthrough Therapy Designation by the FDA for the treatment of chronic lymphocytic leukemia (CLL) in previously treated (relapsed/refractory) patients with the 17p deletion genetic mutation (Press release, AbbVie, MAY 6, 2015, View Source [SID:1234503964]).

CLL is a slow-progressing cancer of the bone marrow and blood in which the bone marrow makes too many lymphocytes, a type of white blood cell.1 CLL accounts for approximately one quarter of the new cases of leukemia diagnosed in the United States.2 Approximately 3-10 percent of CLL patients have 17p deletion at diagnosis, and it occurs in 30-50 percent of patients with relapsed/refractory CLL.3 The 17p deletion mutation is a genomic alteration in which a part of chromosome 17 is absent.4 The median life expectancy for CLL patients with 17p deletion is less than 2-3 years.5

"The Breakthrough Therapy Designation of venetoclax supports the continued development of this investigational medicine in CLL patients with 17p deletion," said Michael Severino, M.D., executive vice president of research and development and chief scientific officer, AbbVie. "The continuing advancement of the venetoclax development program is one example of AbbVie’s focus on delivering innovative medicines that address unmet clinical needs."

According to the FDA, Breakthrough Therapy Designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for Breakthrough Therapy Designation includes preliminary clinical evidence demonstrating a drug may have substantial improvement on at least one clinically significant endpoint compared to available therapy. A Breakthrough Therapy Designation conveys all of the fast track program features, as well as more intensive FDA guidance on an efficient drug development program.

Additional information regarding the venetoclax clinical trials is available on www.clinicaltrials.gov.

About Venetoclax
Venetoclax is an investigational oral B-cell lymphoma-2 (BCL-2) inhibitor being evaluated for the treatment of patients with various cancer types. The BCL-2 protein prevents apoptosis of some cells, including lymphocytes, and can be expressed in some cancer types. Venetoclax is designed to selectively inhibit the function of the BCL-2 protein. Venetoclax is being developed in collaboration with Genentech and Roche. Together, the companies are committed to BCL-2 research with venetoclax, which is currently being evaluated in Phase 2 and Phase 3 clinical trials for the treatment of CLL, along with studies in several other cancers. Venetoclax is an investigational compound and its safety and efficacy have not been evaluated by the FDA or any other health authority.

About AbbVie Oncology
AbbVie’s oncology research is focused on the discovery and development of targeted therapies that work against the processes cancers need to survive. By investing in new technologies and approaches, AbbVie is breaking ground in some of the most widespread and difficult-to-treat cancers, including multiple myeloma and chronic lymphocytic leukemia. AbbVie’s oncology pipeline includes multiple new molecules in clinical trials being studied in more than 15 different cancers and tumor types. For more information on AbbVie’s oncology portfolio, please visit View Source

Delcath Systems has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Delcath Systems, MAY 6, 2015, View Source [SID1234503659]).

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BioMarin has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, BioMarin, MAY 5, 2015, View Source [SID1234503599]).

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