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Foundation Medicine Expands Molecular Information Decision Support Offerings with GeneKit™, a Genomic Solutions Portal for Pathologists

On September 15, 2015 Foundation Medicine, Inc. (NASDAQ:FMI) reported the expansion of its suite of molecular information-based products with GeneKitTM, a genomics solutions portal for pathologists (Press release, Foundation Medicine, SEP 15, 2015, View Source [SID:1234507470]). Uniquely differentiated by the power of FoundationCORETM, Foundation Medicine’s ever-growing comprehensive cancer genomics knowledgebase of more than 50,000 genomic profiles, GeneKit facilitates the interpretation of genomic data generated by pathologists from targeted next generation sequencing (NGS) and "hot spot" assays. This integration will help pathologists to more effectively support clinical diagnosis and treatment strategies via the rapid interpretation and efficient reporting of genomic information to oncology care teams.

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"To ensure that molecular information is used to inform therapeutic decisions and improve patient care, we are offering pathologists a sophisticated clinical interpretation system. GeneKit will allow pathologists to assess a patient’s specific tumor alterations against a knowledgebase of curated genomic variants, relevant scientific research, targeted therapy and clinical trial information, enabling the creation of actionable reports in a timely fashion for care teams," said David J. Daly, chief commercial officer of Foundation Medicine. "Today, a large number of institutions use manual interpretation procedures that can be incredibly arduous, technical and time-consuming. GeneKit overcomes these challenges of manual reporting and furnishes pathologists with highly relevant clinical and scientific data for the betterment of patient care."

Since hotspot panels are most widely used in pathology laboratories, GeneKit has been designed to seamlessly integrate into a pathologist’s standard workflow. GeneKit differs from other pathology reporting tools because of the following key features:

Integrates with any NGS assay that interrogates the variant status of up to 50 cancer-related genes that are known to be involved in the development, progression and/or treatment of cancers;

Relies upon FoundationCORE, Foundation Medicine’s knowledgebase of comprehensive genomic cancer information;
Efficiently and rapidly organizes and reports information on up to 50 genes using data from FoundationCORE, as well the customer’s proprietary data;

Easily integrates with other IT systems;

Offers a user-friendly interface that gives pathologists customized reporting options; and,

Provides a reflex option to Foundation Medicine’s comprehensive genomic profiling assays, FoundationOne and FoundationOne Heme.

GeneKit is a cloud-based software solution and is a component of Foundation Medicine’s molecular information-based suite of decision support solutions. GeneKit complements Interactive Cancer Explorer (ICE 2) with PatientMatchTM, the company’s innovative physician-facing decision support portal. Together, GeneKit and ICE 2 provide an unparalleled offering of molecular information-based solutions that empower cancer care teams to make informed diagnostic and therapeutic care choices based on the unique genomic drivers of each person’s cancer.

Cancer Research UK launches three new funding schemes for cancer doctors

On September 15, 2015 Cancer Research UK reported it is launching three new funding schemes to support the careers of cancer doctors researching new ways to prevent, diagnose and treat the disease (Press release, Cancer Research UK, SEP 15, 2015, View Source [SID:1234507469]).

Over the next few years, the charity’s Clinical Careers Committee hopes to fund twice as many fellowships as were previously available. And three schemes will be available for clinicians at different stages of their careers.

The Postdoctoral Research Bursary is available to clinicians to carry out research while completing speciality medical training. This bursary covers research costs for up to two years but does not cover salary.

The Clinician Scientist Fellowship is available to researchers with no previous post-doctoral fellowship experience. It provides the successful candidate’s salary and research costs for up to five years.

And the Advanced Clinician Scientist Fellowship is available to researchers with more than three years post-doctoral research experience. This fellowship provides up to five years funding for the successful candidate’s salary, the salary of another post-doctoral researcher and an assistant or technician in addition to equipment and running costs.

Dr Karen Noble, head of research training and fellowships at Cancer Research UK, said: "We’ve listened to the needs of the community and we’re tailoring our funding accordingly. These new schemes will allow us to support talented clinicians and help to advance research into new cancer treatments.

"Clinical research is the key to finding out if a new approach to cancer treatment works well – and is safe – in patients. It also helps us discover which treatments or strategies work best for certain types of cancer or groups of patients."

Professor Peter Johnson, Cancer Research UK’s chief clinician, said: "Finding the next generation of clinical research leaders is one of our highest priorities at Cancer Research UK. People who can turn our amazing discoveries into things that will help patients in the clinic are vital to our future. We’re excited to further invest in the best clinical research taking place in the UK."

ARIAD Announces Full Enrollment in Phase 2 ALTA Trial of Brigatinib

On September 15, 2015 ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) reported that it has achieved full enrollment in the pivotal Phase 2 ALTA trial of its investigational anaplastic lymphoma kinase (ALK) inhibitor, brigatinib (Press release, Ariad, SEP 15, 2015, View Source [SID:1234507472]). This registration study enrolled approximately 220 patients at approximately 75 sites in North America, Europe and Asia.

"We are proud to have completed patient enrollment in the ALTA trial in the timeframe we established at the outset," stated Timothy P. Clackson, president of research and development and chief scientific officer of ARIAD. "We expect data from this trial to form the basis for an NDA filing of brigatinib in patients with refractory non-small cell lung cancer in the third quarter of next year."

The ALTA (ALK in Lung Cancer Trial of AP26113) trial is designed to determine the safety and efficacy of brigatinib (previously known as AP26113) in refractory non-small cell lung cancer (NSCLC) patients who test positive for the ALK oncogene (ALK+) and who have been treated with and progressed on their most recent crizotinib therapy. The primary endpoint of the trial is objective response rate (ORR) as measured by RECIST criteria. Brigatinib received Breakthrough Therapy designation from the U.S. Food and Drug Administration in 2014.

Median time on treatment for patients in the ALTA trial is less than 4 months, and follow-up data are limited at this time. As a result, ARIAD now expects that first data from the trial will be submitted for presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in 2016. Presenting data at ASCO (Free ASCO Whitepaper) will also align more closely with the anticipated filing for marketing approval of brigatinib in the U.S. in the third quarter of 2016.

A randomized front-line clinical trial of brigatinib is expected begin in early 2016. This Phase 3 trial will compare brigatinib to crizotinib in approximately 300 patients with ALK+ NSCLC, who have not received prior ALK inhibitors.

About Brigatinib

Brigatinib (AP26113) is an investigational, targeted cancer medicine discovered internally at ARIAD Pharmaceuticals, Inc. It is in development for the treatment of patients with ALK+ NSCLC that is resistant to crizotinib. Brigatinib received Breakthrough Therapy designation from the FDA in October 2014 on the basis of an ongoing Phase 1/2 trial. Brigatinib is currently being evaluated in the global Phase 2 ALTA trial that is anticipated to form the basis for its initial regulatory review.

10-Q – Quarterly report [Sections 13 or 15(d)]

vTv Therapeutics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, vTv Therapeutics, 2017, SEP 14, 2015, View Source [SID1234521330]).

Release of CAR-T for Non-Small Cell Lung Cancer Phase I Clinical Trial Data at 2015 European Cancer Congress

On September 14, 2015 Cellular Biomedicine Group Inc. (NASDAQ: CBMG) ("CBMG" or the "Company"), a biomedicine firm engaged in the development of effective stem cell therapies for degenerative diseases and immunotherapies for cancer, reported a scheduled poster presentation during the 2015 European Cancer Congress (ECCO) annual meeting to be held in Vienna, Austria from September 25-29, 2015 (Press release, Cellular Biomedicine Group, SEP 14, 2015, View Source [SID:1234507489]).

The presentation will detail PLAGH/CBMG’s Phase I clinical trial data using Chimeric Antigen Receptor-Modified T-Cells (CAR-T) targeting HER-1 for the treatment of patients with HER-1 expressing advanced relapsed/refractory Non-Small Cell Lung Cancer (NSCLC). The CAR-T trial was designed and conducted by Chinese PLA General Hospital ("PLAGH", Beijing, also known as "301 Hospital"), led by Principal Investigator Wei Dong Han, MD, PhD, head of PLAGH’s cancer immunotherapy department. Dr. Han and his research team have authored several CAR-T publications, including "Tolerance and Efficacy of Autologous or Donor-derived T-Cells Expressing CD19 Chimeric Antigen Receptors in Adult B-ALL with Extramedullary Leukemia" and "Effective Response and Delayed Toxicities of Refractory Advanced Diffused Large B-cell Lymphoma Treated by CD20-directed Chimeric Antigen Receptor-modified T-cells". (OncoImmunology (Impact Factor: 6.28). 03/2015; DOI: 10.1080/2162402X.2015.1027469 and Clin Immunol. 2014 Dec;155(2):160-75. doi: 10.1016/j.clim.2014.10.002) The Company previously announced positive clinical data from its Phase I clinical trials for CD19, CD20 and CD30 constructs targeting late-stage blood cancers.

Title: Chimeric Antigen Receptor-Modified T-Cells for the immunotherapy of Patients with HER-1 Expressing Advanced Relapsed/Refractory Non-Small Cell Lung Cancer
Poster Session: Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), September 26 2015 from 16:45 to 18:45 (CEST)
Abstract Number: 516
Poster Number: P250
Location: Messe Wien Exhibition & Congress Centre, Hall C
Presenter: Wei Dong Han, MD, PhD, Chinese PLA General Hospital

Company management will participate in the meeting and be available for discussions. Full detail of the presented data will be available on the Company website following the presentation.