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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."

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]).

"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.

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]).

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.

Celsion Announces Upcoming Presentations at the 2nd Asian Conference on Tumor Ablation on October 30-31, 2015

On October 6, 2015 Celsion Corporation (NASDAQ: CLSN), an oncology drug development company, reported the upcoming presentations of data supporting the Company’s ongoing pivotal phase III OPTIMA Study of ThermoDox, its proprietary heat-activated liposomal encapsulation of doxorubicin in combination with optimized radiofrequency ablation (RFA) for the treatment of intermediate primary liver cancer (Press release, Celsion, OCT 6, 2015, View Source [SID:1234507651]). The data will be presented on October 30-31, 2015 at the 2015 Asian Conference on Tumor Ablation (ACTA) in Fukuoka, Japan by two leading liver cancer experts from South Korea and Taiwan, Professor Won Young Tak, MD, Ph.D., Division of Gastroenterology and Hepatology, Department of Internal Medicine, School of Medicine, Kyungpook National University, Daegu, Republic of Korea and Dr. Shi-Ming Lin, MD, co-chair ACTA 2015 and vice chairman, Department of Gastroenterology and Hepatology, Chang Gung Memorial Hospital, Taipei, Taiwan. Professor Tak’s presentation will highlight ThermoDox in an oral presentation during the Plenary Lecture Session: "Top Tips for the Liver Tumor Ablation".

"Data underscoring the value of ThermoDox in combination with RFA therapy as a potentially curative treatment for primary liver cancer, a disease with limited treatment options, will be presented once again at an internationally recognized medical conference. ILCA, WCIO, ECIO, ASCO (Free ASCO Whitepaper), and now ACTA have each provided a forum for liver cancer thought leaders to discuss the promise of ThermoDox with leading physicians and scientists from the global oncology community. Medical, surgical and interventional oncologists from N. America, Asia, and Europe have endorsed our pivotal phase III OPTIMA Study, now ongoing in 11 counties worldwide," said Michael H. Tardugno, Celsion’s chairman, president and chief executive officer. "It is a privilege to now have Professor Tak along with Dr. Lin, two internationally recognized liver cancer experts who have comprehensive experience with ThermoDox as a result of their deep involvement in Celsion’s HEAT Study, present these findings."

The three presentations include:

"Effect of Radiofrequency Ablation (RFA) Dwell Time (+/-) ThermoDox on Safety and Overall Survival (OS) Among 452 Intermediate Solitary HCC Patients With Lesions 3 to 7 cm: HEAT Study Data," by Professor Won Young Tak, MD, Ph.D., Division of Gastroenterology and Hepatology, Department of Internal Medicine, School of Medicine, Kyungpook National University, Daegu, Republic of Korea and lead investigator in South Korea for the Company’s HEAT and OPTIMA studies. Professor Tak will discuss data from Celsion’s latest HEAT Study post-hoc analysis, which suggests an overall survival benefit of over two years in the large subgroup of patients treated with ThermoDox plus optimized RFA (RFA > 45 minutes).
"Effect of Standardizing Radiofrequency Ablation and Lyso-Thermosensitive Liposomal Doxorubicin (LTLD, ThermoDox) on Overall Survival (OS) Among Patients with a Solitary 3 to 7 cm HCC Lesion: A HEAT Study Multivariate Analysis," by Dr. Shi-Ming Lin, MD, co-chair ACTA 2015, vice-chairman, Department of Gastroenterology and Hepatology, Chang Gung Memorial Hospital, Taipei, Taiwan, and lead investigator in Taiwan for the Company’s HEAT and OPTIMA studies. Dr. Lin will review the extensive data from Celsion’s HEAT Study, including the results of multivariate analyses performed which clearly suggests that RFA heating or dwell time greater than 45 minutes was the only statistically significant variable that explained the significant improvement in overall survival (79 months in the optimized RFA plus ThermoDox subgroup versus 53.6 months in the optimized RFA only subgroup) in a large, well bounded subgroup of 285 patients (41% of the HEAT Study patients).
"Importance of Heating Time on the Local Drug Deposition During RFA in Combination with Lyso-Thermosensitive Liposomal Doxorubicin (LTLD) in a Porcine Model," by Nicholas Borys, MD, Celsion’s senior vice president and chief medical officer. Dr. Borys will review findings from a preclinical study demonstrating that in a porcine model, a direct correlation was observed between the duration of RFA heating, or dwell time, and the concentration of doxorubicin localized to the liver.
The presentations will be available on Celsion’s website at View Source

Oncolytics Biotech® Inc. Announces Completion of Enrollment in Randomized Phase II Prostate Cancer Study

On October 6, 2015 Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY) reported that enrollment has been completed in a randomized Phase II study of REOLYSIN in patients with recurrent or metastatic castration resistant prostate cancer (IND 209) (Press release, Oncolytics Biotech, OCT 6, 2015, View Source [SID:1234507649]). The trial is being sponsored and conducted by the NCIC Clinical Trials Group (NCIC CTG) at Queen’s University in Kingston, Ontario.

"Prostate cancer remains a leading cause of cancer-related death in men," said Dr. Brad Thompson, President and CEO of Oncolytics. "As a result, it is important that we continue to conduct studies with late-stage patients to help improve outcomes for this group."

The study is an open-label, randomized, non-blinded, Phase II clinical study of REOLYSIN given in combination with docetaxel versus docetaxel alone. Approximately 40 response evaluable patients were enrolled in each arm.

The primary objective of the trial is to evaluate the efficacy of REOLYSIN in combination with docetaxel based on the lack of disease progression as measured at 12 weeks. Secondary objectives are to determine circulating tumour cell status at six and 12 weeks and the conversion rate of these cells, prostate-specific antigen (PSA) change rate, objective response rate (in patients with measurable disease at baseline), effect on overall survival, the tolerability and toxicity of the treatment combination, and to explore potential molecular factors predictive of response.

Although accrual is complete, patient follow-up will continue until planned analyses have been conducted.

About Prostate Cancer
Prostate cancer is among the most common cancers diagnosed in men. The Canadian Cancer Society estimates that 24,000 Canadian men will be diagnosed with prostate cancer and that 4,100 Canadian men are expected to die from the disease in 2015. The American Cancer Society estimates that 220,800 new cases of prostate cancer will be diagnosed in the United States and that 27,450 Americans are expected to die from the disease in 2015.