Adaptimmune Growth Leads to Long-Term Expansion Plans in Philadelphia

On October 9, 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 locate its U.S. headquarters and clinical operations in a newly developed facility to be constructed at The Navy Yard in Philadelphia (Press release, Adaptimmune, OCT 9, 2015, View Source [SID:1234507684]). The 47,400 square foot facility, located at 351 Rouse Boulevard in The Navy Yard’s Corporate Center, will house a state-of-the-art cGMP manufacturing facility designed to support the clinical development and initial commercialization of the Company’s novel engineered immunotherapies for cancer.

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Adaptimmune, represented by CBRE, has entered into a long-term lease agreement for its U.S. headquarters building being developed by Liberty Property Trust and Synterra Partners. CBRE’s Project Management Group will also advise Adaptimmune in the construction phase of the project. The official groundbreaking ceremony will take place this morning at 11:00am EDT at The Navy Yard, and the building is expected to be delivered in late 2016.

"Adaptimmune is in a period of rapid growth on both sides of the Atlantic, and we are putting in place the facilities to enable us to deliver our promising pipeline into the clinic and beyond," said James Noble, Chief Executive Officer of Adaptimmune. "This exciting new Philadelphia facility allows us to expand our clinical and early commercial manufacturing and control associated costs in anticipation of the commercialization of our product candidates. We are delighted to be working in partnership with key players in Pennsylvania and we regard our commitment to The Navy Yard as a vote of confidence in the city and the region as a powerhouse for scientific and medical achievement. We started Adaptimmune in 2008 through a partnership with the University of Pennsylvania, and we have had roots in Philadelphia ever since. The location provides us with an environment that promotes strong business growth and innovation, as well as access to a rich pool of scientific and clinical talent that we will use to place more than 110 new jobs to the area in the near future."

Adaptimmune has also announced the construction of a major new laboratory and office building in Milton Park, Oxfordshire providing approximately 67,000 square feet of rentable area. The U.K. facility will support Adaptimmune’s expanding research and development operation and is also scheduled for delivery in late 2016, complementing its U.S. clinical and manufacturing plans.

Since its inception in 2008 in Oxford, U.K., Adaptimmune has collaborated with the University of Pennsylvania and launched its own U.S. operation in February 2011. The Company rapidly expanded its clinical programs while operating out of the University City Science Center, Philadelphia, and is currently running trials in multiple cancers across the U.S. In May 2015, Adaptimmune achieved a successful IPO on NASDAQ, generating net proceeds in excess of $176M, and is advancing a promising pipeline of therapeutic candidates based on its proprietary T-cell engineering platform.

As an interim move, the Company has consolidated its offices at Two Commerce Square located at 2001 Market Street, while the development of the new facility at The Navy Yard is completed.

"Adaptimmune has shown a true commitment to Pennsylvania. Today’s announcement is great news for the commonwealth as 110 new, high-paying jobs will be created with this project," said Governor Tom Wolf. "My budget proposal includes sustained funding for the life science sector and increased support for research within the industry so that we continue to see successes like this for years to come."

"Adaptimmune’s decision to expand in Philadelphia is further evidence of our city’s reputation as a leading place for technology, innovation and life sciences," said Alan Greenberger, Deputy Mayor for Economic Development. "Companies large and small from around the region and increasingly around the world are seeing Philadelphia as the place they need to be in order to attract talent, grow their business, and build their brands."

The Navy Yard is a proud landmark of the Navy’s history and heritage in Philadelphia. It has been revitalized as an urban business campus, offering an exceptional workplace to attract new talent for rapidly growing companies like Adaptimmune. The Navy Yard offers to the Philadelphia region a unique and centrally located waterfront site committed to smart energy innovation and sustainability, providing employees with an environment that inspires innovation and collaboration.

"The Navy Yard’s vibrant campus presented a compelling option for Adaptimmune, and we are pleased to have the opportunity to collaborate with Liberty on behalf of our client," said Tony Rossi of CBRE’s Life Sciences Group. "Additionally, CBRE’s role does not end with the transaction. We are committed to ensuring developmental excellence through the engagement of our CBRE Project Management Team under the direction of John Richards."

"From its inception, Adaptimmune has been at the forefront of innovation in the life sciences, and we are delighted that the company has expanded its U.S. headquarters and manufacturing operations in Philadelphia," said John Grady, President of PIDC, Philadelphia’s public-private economic development corporation. "We look forward to Adaptimmune joining an inspiring, collaborative community at The Navy Yard."

Philadelphia-based architectural firm DIGSAU is the designer of the building, which will be the twelfth LEED building in The Navy Yard developed by Liberty/Synterra and is designed to achieve LEED Gold certification under the Core & Shell rating system from the U.S. Green Building Council. The high-quality design allows the building to have its own identity while complementing its
surroundings. The façade of textured precast concrete will feature a two-story lobby encased in glass that runs from ground to ceiling creating an open, pedestrian-friendly environment visually connected to the rest of The Navy Yard. Liberty Property Trust has a unique ability to create buildings for highly specific uses that are also cutting-edge in design and architecture. Not only will the building visually complement and enhance the look and feel of The Navy Yard, it will also function as a highly sophisticated and capable lab facility for Adaptimmune.

"Adaptimmune’s decision to relocate to The Navy Yard is another striking example of how the campus continues to attract top talent and the companies seeking that talent," said John Gattuso, Liberty Property Trust Senior Vice President and Regional Director. "Our Philadelphia team has been successful in creating a strong ‘sense of place’ at The Navy Yard which was a major draw for our new tenant and has been influential in generating interest from many other leading-edge companies. Throughout the process, we worked closely with Adaptimmune to design a flexible and innovative facility that accommodates its very specific requirements while creating an exciting and inspiring work environment for its growing workforce."

By leveraging its integrated T-Cell Receptor (TCR) engineering platform, Adaptimmune has established an enviable pipeline of immunotherapy candidates and is already generating promising early data in both solid and hematologic cancers. The Company has five phase I/II clinical trials ongoing with its NY-ESO therapeutic candidate, an IND open with its second therapeutic candidate, MAGE-A10, and a third candidate in planning for IND submission in 2016.

ARIA® Oncology Information System Certified for Use to Demonstrate "Meaningful Use" of an Electronic Health Record

On October 9, 2015 Varian Medical Systems (NYSE:VAR) reported that its ARIA oncology information system has been certified as a Complete Electronic Health Record (EHR). As a result, hospitals and clinics can use ARIA to qualify for financial incentives from the Medicare and Medicaid programs when they demonstrate meaningful use of the technology (Press release, Varian Medical Systems, OCT 9, 2015, View Source [SID:1234507685]).

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"Varian is committed to the creation of digital tools that connect the entire oncology community, and enable coordinated care," said Sukhveer Singh, vice president of Varian’s Oncology Continuum Solutions group. "The ARIA system provides a seamless flow of information for managing the patient’s entire journey—from diagnosis through follow-up. This certification means that our customers in the U.S. can continue to use ARIA to attest for the Meaningful Use 2014 measures, and thereby qualify for incentive payments from the federal government."

ARIA is a comprehensive electronic medical record and image management system that aggregates patient data into an organized, oncology-specific medical chart with functional components for managing clinical, administrative and financial operations for medical, radiation and surgical oncology.

The ARIA oncology information system (version 13.6 MR1), coupled with the Equicare Health Patient Portal for providing patients with secure web-based access to important portions of their medical records, were certified together to meet the federal requirements for Complete Ambulatory EHR.

Additional Information

The ARIA system for both medical and radiation oncology (version 13.6 MR1) was tested and certified in accordance with applicable certification criteria adopted by the U.S. Department of Health and Human Services. The software is compliant with the Office of National Coordinator (ONC) 2014 Edition criteria. ARIA received certification for Complete EHR from the Drummond Group, an ONC Authorized Certification Body. The ONC 2014 Edition criteria support both Stage 1 and Stage 2 meaningful use measures required to qualify eligible professionals for Medicare and Medicaid HIT incentive payments. This certification does not represent an endorsement by the U.S. Department of Health and Human Services or guarantee the receipt of incentive payments.

ARIA version 13.6 MR1 was certified on September 17, 2015. Certified ID numbers are 0917201526316 (for radiation oncology) and 0917201526306 (for medical oncology). The modules tested were: 170.314 (a)(115); (b)(15, 7); (c)(13); (d)(18); (e)(13); (f)(13); (g)(24). Clinical Quality Measures tested were: 2v3; 50v2; 68v3; 69v2; 124v2; 125v2; 129v3; 130v2; 138v2; 139v2; 140v2; 141v3; 154v2; 156v2; 157v2; 165v2.

Price Transparency

These certified products generally involve one-time license fees plus some ongoing costs:

ARIA Disease Management, a one-time initial license fee and ongoing Software Support Agreement (SSA) fees.
Equicare Health Solutions Active Patient Portal, a one-time initial license fee and ongoing SSA fees.
ePrescribing, a one-time initial license fee and ongoing SSA fees.
Interfaces: In and Outbound Laboratory, Immunization, Syndromic Health, a one-time initial license fee/interface and ongoing SSA fees.
DIRECT, a one-time initial license fee and ongoing service fees.

Agios to Webcast R&D Day on October 16, 2015

On October 8, 2015 Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the fields of cancer metabolism and rare genetic metabolic disorders, reported that the company will webcast presentations from its Research and Development (R&D) Day on Friday, October 16, 2015 starting at 9:00 a.m. ET in New York City (Press release, Agios Pharmaceuticals, OCT 8, 2015, View Source;p=RssLanding&cat=news&id=2095350 [SID:1234507668]).

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Presentations will include a review of Agios’ research approach and clinical development strategy for the company’s lead cancer metabolism and rare genetic metabolic disorders programs. Along with the Agios team, external speakers will review the reported clinical data from these programs and the diseases that these investigational medicines aim to treat, including acute myeloid leukemia, advanced solid tumors and pyruvate kinase deficiency.

Agios speakers scheduled to present include:

David Schenkein, M.D., Chief Executive Officer
Scott Biller, Ph.D., Chief Scientific Officer
Chris Bowden, M.D., Chief Medical Officer
Sam Agresta, M.D., Vice President, Head of Clinical Development
Ann Barbier, M.D., Ph.D., Vice President, Clinical Development, Rare Genetic Diseases
External speakers:

Timothy Cloughesy, M.D., Director, UCLA Neuro-Oncology Program and Professor, Ronald Reagan UCLA Medical Center
Courtney DiNardo, M.D., MSCE, Assistant Professor, Department of Leukemia, Division of Cancer Medicine, University of Texas MD Anderson Cancer Center
Agios invites the public and media to listen to the presentations via a live webcast that can be accessed under "Events & Presentations" in the Investors and Media section of the company’s website at agios.com. The presentations are scheduled to begin at approximately 9:00 a.m. ET. A replay of the webcast will be archived on the Agios website for approximately 30 days following the presentation.

Delcath Announces National Reimbursement Coverage For CHEMOSAT Procedures In Germany

On October 8, 2015 Delcath Systems, Inc. (NASDAQ: DCTH), a specialty pharmaceutical and medical device company focused on oncology with an emphasis on the treatment of primary and metastatic liver cancers, reported the establishment of a national reimbursement code for procedures performed with the Delcath Hepatic CHEMOSAT Delivery System (CHEMOSAT) in Germany (Press release, Delcath Systems, OCT 8, 2015, View Source;p=RssLanding&cat=news&id=2095411 [SID:1234507669]). The German Institute for the Hospital Remuneration System (InEK) issued a ZE diagnostic-related group (DRG) code, which permits hospitals in Germany to obtain reimbursement for CHEMOSAT procedures beginning in 2016. This new nationwide code replaces the previous Neue Untersuchungs und Behandlungsmethoden (NUB) procedure that required patients in Germany to apply individually for reimbursement of their CHEMOSAT treatment. The decision represents the first national reimbursement mechanism for CHEMOSAT procedures in Europe.

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"The receipt of ZE reimbursement represents an important step towards increased commercialization of CHEMOSAT and highlights the role our therapy has been playing in Germany for the treatment of patients with cancers in the liver," said Jennifer K. Simpson, Ph.D., MSN, CRNP, CEO & President of Delcath Systems, Inc. "The application for coverage under the ZE scheme was made by the German Radiology Society and has been widely supported by major German cancer hospitals, which also speaks to the confidence the German clinical community has in the therapy. With a ZE DRG code established, an application under the annual NUB process is no longer required. We look forward to supporting participating hospitals in their negotiations with insurers in the coming year and are pleased that this new reimbursement will make CHEMOSAT treatment more easily accessible to patients in Germany suffering with cancers in the liver."

ZE is a national reimbursement code that augments existing DRG codes until a specific new DRG code can be created. With the establishment of a ZE code for CHEMOSAT, the procedure is now permanently represented in the DRG catalog in Germany. The establishment of ZE coverage by InEK was made in response to an application made by the German Radiology Society for CHEMOSAT in March 2015.

Myriad Genetics to Highlight New Clinical Outcomes Data on myPath(R) Melanoma at the American Society of Dermatopathology Annual Meeting

On October 8, 2015 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported that new clinical outcomes and clinical utility data for myPath Melanoma will be featured at the American Society of Dermatopathology (ASDP) 52nd meeting being held Oct. 8 to 11, 2015 in San Francisco, Calif (Press release, Myriad Genetics, OCT 8, 2015, View Source [SID:1234507671]). The findings add to the growing body of knowledge for myPath Melanoma and will support the Company’s clinical reimbursement dossier for the product.

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"The accurate diagnosis of melanoma can be challenging based on histologic findings alone and there are potentially severe consequences of a misdiagnosis, including the under-treatment or overtreatment of patients," said Loren Clarke, M.D., vice president, Medical Affairs for Dermatology, Myriad Genetic Laboratories. "Our studies show that myPath Melanoma accurately differentiates malignant melanoma from benign skin lesions and helps physicians deliver a more objective and confident diagnosis for their patients."

A list of the myPath Melanoma presentations at ASDP (#ASDP2015) follows.

Podium Presentation

Title: Correlation of myPath Melanoma gene expression score with clinical outcome on a series of melanocytic lesions.

Date: Saturday, Oct. 10, 2015: 3:00 p.m. PT.

Location: Hilton Union Square, Continental 4-6.

Eugen Minca, M.D., department of Pathology, Cleveland Clinic, will present a study that correlates myPath Melanoma test results with clinical outcomes data (e.g., recurrence, sentinel lymph node metastases and distant metastases) from 127 patients with melanocytic lesions. Of these cases, 65 lesions were melanomas and 62 were benign lesions, according to the pathology diagnosis. The myPath Melanoma test scores were reviewed in conjunction with the diagnosis and clinical outcome. Of the 65 melanomas, 14 developed metastases and 51 had no adverse events after 47 months of follow up and myPath Melanoma diagnosed malignancy in all 14 cases with adverse outcomes, which represents a 100 percent sensitivity rate in these metastatic cases. There were no adverse events associated with the 62 benign lesions after an average follow up of 30 months. Of these, the myPath Melanoma test produced a benign score in 48 cases, an indeterminate score in seven cases and a malignant score in seven cases. Importantly, after myPath testing and upon expert histologic review, three of the seven cases with a malignant score were reclassified as melanomas. This is the first study with clinical outcome data and supports previous validation studies demonstrating that the myPath Melanoma test provides additional insight into difficult-to-diagnose lesions, supporting its use as an ancillary diagnostic test.

Poster Presentation

Title: A retrospective study of the influence of a gene expression signature on the treatment of melanocytic tumors.

Date: Thursday, Oct. 8 from 1:00 p.m. PT to Oct. 11 at 11:00 a.m. PT.

Location: Golden Gate, Ballroom.

In this study, 632 difficult-to-diagnose melanocytic lesions were analyzed using the myPath Melanoma diagnostic test. Retrospective chart reviews were conducted for 315 of the cases to document the actual treatment carried out for each patient. Of these, 214 patients received a benign myPath Melanoma test result, 92 received a malignant result and nine received an indeterminate result. The percentage change was measured from the treatment recommendations of the expert dermatopathologists to the actual treatment provided by dermatologists. The results show that excisions were reduced by 33.1 percent in patients who received a benign myPath Melanoma test result. Conversely, the use of additional treatment, such as surgery, increased by 36.2 percent in patients who received a malignant myPath Melanoma test result. These data support the integration of the myPath Melanoma test into medical practice to improve patient care by allowing more definitive diagnoses by dermatopathologists and optimized treatment decisions by dermatologists.

About myPath Melanoma

myPath Melanoma is a clinically validated gene expression test designed to differentiate malignant melanoma from benign nevi across all major melanoma subtypes. Myriad myPath Melanoma is a unique test of 23 genes that provides valuable, additive diagnostic information unavailable from any other method – information that can help physicians deliver a more confident diagnosis.

Melanoma is the most serious type of skin cancer. According to the American Cancer Society, about 76,000 new melanomas are diagnosed each year and more than 9,000 people die from the disease annually. Each year in the United States, there are approximately 1.5 million skin biopsies performed specifically for the diagnosis of melanoma, and approximately 14 percent or 210,000 biopsies are classified as indeterminate, meaning that the dermatopathologist cannot confidently determine whether the cells are benign or malignant. For more information visit: www.mypath.myriad.com and www.mypathmelanoma.com.