MEI Pharma Announces Data from Phase II Clinical Studies of Pracinostat Accepted for Oral Presentation at American Society of Hematology Annual Meeting

On October 6, 2015 MEI Pharma, Inc. (Nasdaq: MEIP), an oncology company focused on the clinical development of novel therapies for cancer, reported that data from the Company’s Phase II clinical studies of Pracinostat in elderly acute myeloid leukemia (AML) and previously untreated myelodysplastic syndrome (MDS) have been selected by the American Society of Hematology (ASH) (Free ASH Whitepaper) Program Committee for oral presentation at the 57th ASH (Free ASH Whitepaper) Annual Meeting & Exposition in Orlando on December 7, 2015 (Press release, MEI Pharma, OCT 6, 2015, View Source [SID:1234507652]).

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Final Results from a Phase 2 Study of Pracinostat in Combination with Azacitidine in Elderly Patients with Acute Myeloid Leukemia (AML)
Abstract: 453
Session: 613. Acute Myeloid Leukemia: Clinical Studies: Advances in Therapy
Presentation: Monday, December 7, 2015 at 7:30 am Eastern time

A Randomized, Placebo-Controlled, Phase II Study of Pracinostat in Combination with Azacitidine (AZA) in Patients with Previously Untreated Myelodysplastic Syndrome (MDS)
Abstract: 911
Session: 637. Myelodysplastic Syndromes – Clinical Studies I
Presentation: Monday, December 7, 2015 at 7:15 pm Eastern time

Abstracts are expected to be available at www.hematology.org on Thursday, November 5, 2015 at 9:00 am Eastern time. In addition, the abstracts will be published online in the December 3, 2015 supplemental volume of Blood.

Cancer Research UK’s ‘Create the Change’ campaign receives £100,000 from Elsevier

On October 6, 2015 Cancer Research UK reported taht it has received a major donation of £100,000 from Elsevier (link is external), a world-leading provider of scientific, technical and medical information products and services, towards its fundraising campaign to help build the Francis Crick Institute, a pioneering medical research facility in the heart of London (Press release, Cancer Research UK, OCT 6, 2015, View Source [SID:1234507653]).

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"This donation from Elsevier, a world-leading research information company, marks a significant step in our effort to bring together a multitude of stakeholders united by a common goal to tackle the hardest problems in biomedical research today." – Harpal Kumar, Cancer Research UK

The new state-of-the-art biomedical research institute, currently being built in King’s Cross and due to open in 2016, will see more than 1,200 scientists collaborating to discover the biology underlying major human diseases – cancer, heart disease, lung disease, infectious diseases such as HIV and malaria and many more.

Elsevier’s donation towards the campaign will help fund Cancer Research UK’s contribution towards the Crick’s development, helping to establish this significant and distinctive new biomedical research institute. The Crick aims to make the next leap forward in biomedical research by "translating the latest laboratory discoveries into the next generation of medical breakthroughs", a mission strongly shared by Elsevier.

Harpal Kumar, chief executive of Cancer Research UK, said: "This donation from Elsevier, a world-leading research information company, marks a significant step in our effort to bring together a multitude of stakeholders united by a common goal to tackle the hardest problems in biomedical research today."

Ron Mobed, chief executive at Elsevier, said: "Elsevier is interested not just in the publication of research findings, but in the utility of those findings in the practical implementation of new research and in policy decision making. The Crick’s commitment to excellence, emphasis on multidisciplinary research, focus on young and emerging talent and new ways of collaborating are very much aligned with our mission. It represents the future of how science could be applied to benefit society and is an endeavor we very much want to support."

The Francis Crick Institute is a collaboration between six of the world’s leading medical research organisations: Cancer Research UK, The Medical Research Council, The Wellcome Trust, UCL (University College London), King’s College London and Imperial College London. With a unique multidisciplinary approach to unravelling the mysteries behind major diseases and dedicated to research excellence, the institute will have the scale, vision and expertise to tackle challenging scientific questions underpinning health and disease.

Adaptimmune announces New Research and Development Facility in Oxfordshire

On October 6, 2015 Adaptimmune Therapeutics plc (Nasdaq: ADAP), ("Adaptimmune" or the "Company"), a clinical stage biopharmaceutical company focused on the use of T-cell therapy to treat cancer, reported plans to expand its research and development operation into a major new purpose-built facility at Milton Park, Oxfordshire (Press release, Adaptimmune, OCT 6, 2015, View Source [SID:1234507656]).

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Construction of Adaptimmune’s 67,000 square foot ‘Enterprise Zone’ building is already under way following a traditional groundbreaking ceremony. The flagship facility will provide laboratory space with associated offices, meeting rooms and a café area to accommodate a team of around 200 highly-skilled research and development specialists.

The new building is designed to support the Company’s continuing growth of its research and development operation and is scheduled for delivery in late 2016.

Adaptimmune has signed a 25-year agreement with break options to lease the building from developer MEPC, which owns Milton Park, one of Europe’s largest business parks and home to over 7,500 employees and 250 organizations.

"We are delighted to be working closely with MEPC on this exciting new building, which will provide best-in-class laboratories to support the expansion of our R&D team and enable continuing progress with our research programs," said James Noble, Chief Executive Officer of Adaptimmune.

Following its foundation in the U.K., Adaptimmune launched its U.S operation in 2011 after a longstanding research collaboration with the University of Pennsylvania. The Company has rapidly expanded its clinical programs and is currently running five Phase I/II trials in multiple cancers across the U.S. targeting the NY-ESO-1 cancer antigen in both solid and hematologic cancers with promising early results. Adaptimmune also has an IND open with its second therapeutic candidate, MAGE-A10,
and a third candidate in planning for IND submission in 2016.

In May 2015, the Company achieved a successful IPO on NASDAQ, generating net proceeds in excess of $176 million, and is advancing a pipeline of therapeutic candidates based on its proprietary T-cell engineering platform.

"This is great news for both Adaptimmune and the continuing development of Oxfordshire’s thriving biotech industry and economy," said James Dipple, Chief Executive Officer, MEPC Milton Park.

"Adaptimmune was established at Milton Park in 2008 in a small laboratory, and we have watched this pioneering company expand into a globally recognized business. We are delighted that we are able to accommodate their growth plans by building a bespoke, state of the art new building."

MD Anderson, Theraclone Sciences form OncoResponse

On October 6, 2015 OncoResponse, an immuno-oncology antibody discovery company, has been launched jointly by The University of Texas MD Anderson Cancer Center and Theraclone Sciences, of Seattle, Washington (Press release, OncoResponse, OCT 6, 2015, View Source [SID1234516434]).

OncoResponse will use Theraclone’s I-STAR immune repertoire screening technology to identify therapeutic antibodies against novel targets from immuno-oncology treated patients. I-STAR technology rapidly screens antibodies made by the human immune system to identify those with exceptional reactivity that may lead to cancer treatment development. MD Anderson will provide access to samples and physiologic, prognostic and genotypic data from patients that have responded well to cancer immunotherapies, along with oncology and translational medicine expertise.

"The immune system of patients who have responded exceptionally well to cancer immunotherapies may hold the key within their memory repertoire as to what gives them an edge over other patients with less robust immune responses. It could provide us with a way to increase success rates in treating cancer," said Clifford J. Stocks, CEO of Theraclone and interim CEO of OncoResponse. "I-STAR immune repertoire screening technology has the unique capability to identify rare cancer-fighting antibodies and new targets. We’re extremely excited to have teamed up with MD Anderson experts to make a difference in the lives of patients with cancer and their families."

"Immunotherapy will continue to be of utmost significance for our patients who rely on us to provide them with the very latest in treatment options," said Ronald DePinho, M.D., president of MD Anderson. "Through strategic alliances, we aim for more timely delivery of therapies that will enhance their quality of life and successfully treat their disease."

The new company announced the closing of a $9.5 million Series A financing co-led by ARCH Venture Partners, Canaan Partners and MD Anderson. William Marsh Rice University and Alexandria Real Estate Equities also participated.

The OncoResponse launch is the latest in collaborative efforts by MD Anderson that are facilitating further development of a biotech hub in Houston, attracting blue chip investors such as ARCH, Canaan and others. They represent a growing trend in alliances between the pharmaceutical industry and biomedical research and healthcare institutions.

"With MD Anderson, OncoResponse has partnered with an institution and people with countless years of experience in research and treatment in oncology. We’ll gain access to data, information and the immune system memory cells from those patients who are elite responders to cancer immunotherapies. That, coupled with the experience of the Theraclone team, who has overseen the discovery and development of several relevant product candidates from the I-STAR technology in multiple therapeutic area, make OncoResponse a sound investment," commented Steve Gillis, Ph.D., managing director of ARCH Venture Partners.

Roche's investigational combination of Cotellic and Zelboraf helped people with advanced melanoma live significantly longer than Zelboraf alone

On October 6, 2015 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported final survival data from the Phase III coBRIM study showing that Cotellic (cobimetinib), when used with Zelboraf (vemurafenib), helped people with previously untreated BRAF V600 mutation-positive advanced melanoma live significantly longer (overall survival, OS) compared to Zelboraf alone (Press release, Hoffmann-La Roche , OCT 6, 2015, View Source [SID:1234507645]). Ongoing study monitoring did not identify any new safety signals. Long-term safety data are expected later this year.

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"Overall survival is the gold standard endpoint in oncology, and the results we’ve seen in coBRIM show how the combination of Cotellic and Zelboraf can help people with BRAF V600 mutation-positive advanced melanoma live longer than Zelboraf alone," said Sandra Horning, M.D., Chief Medical Officer and Global Head of Product Development. "We are currently working with health authorities in their review of the Cotellic marketing applications and hope to bring this combination to people with advanced melanoma around the world in the coming months."

The coBRIM overall survival results will be presented at an upcoming medical meeting. Cotellic received approval in Switzerland in August for use in combination with Zelboraf as a treatment for patients with advanced melanoma. Last month, the EU Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Cotellic in combination with Zelboraf; a decision by the European Commission is expected by the end of 2015. A decision from the U.S. Food and Drug Administration (FDA) on Roche’s new drug application is expected by November 11, 2015.

About melanoma
Melanoma is less common, but more aggressive and deadlier than other forms of skin cancer.1,2 A V600 mutation of the BRAF protein occurs in approximately half of melanomas, and should therefore be tested to identify the best treatment option.3 When melanoma is diagnosed early, it is generally a curable disease,4,5 but most people with advanced melanoma have a poor prognosis.2 More than 232,000 people worldwide are currently diagnosed with melanoma each year.6 In recent years, there have been significant advances in treatment for metastatic melanoma, and people with the disease have more options. However, it continues to be a serious health issue with a high unmet need and a steadily increasing incidence over the past 30 years.7

About Cotellic and Zelboraf in combination
Zelboraf was the first approved treatment for patients with unresectable or metastatic melanoma with BRAF V600 mutation as detected by a validated test, such as Roche’s cobas 4800 BRAF Mutation Test. Zelboraf is not indicated for use in patients with wild-type BRAF melanoma. Cotellic (cobimetinib) is designed to selectively block the activity of MEK8, one of a series of proteins inside cells that make up the MAPK signaling pathway that helps regulate cell division and survival.9 In the majority of patients, resistance to BRAF-inhibitor monotherapy will eventually occur through re-activation of the MAPK pathway via MEK.10 Cotellic was developed to overcome resistance to BRAF-inhibition and prevent re-activation of the pathway. Cotellic binds to MEK, while Zelboraf binds to mutant BRAF, to interrupt abnormal signalling that can cause tumours to grow.11,12
Cotellic is also being investigated in combination with several investigational medicines, including immunotherapy, in several tumour types such as non-small cell lung cancer and colorectal cancer. Cotellic was discovered by Exelixis Inc. and is being developed by Roche in collaboration with Exelixis.