On September 4, 2018 Asterias Biotherapeutics, Inc. (NYSE American: AST), a biotechnology company dedicated to developing cellular immunotherapies to treat cancer and cell-based therapeutics to treat neurological conditions associated with demyelination, reported that the Safety Review Committee (SRC) for the first clinical trial of VAC2 has held its second scheduled meeting to review the safety and tolerability data generated in patients two and three enrolled in the study and recommended continuation of the study and moving to open enrollment in the advanced disease cohort (Arm A), as planned per the study’s protocol (Press release, Asterias Biotherapeutics, SEPT 4, 2018, View Source;date=September+04%2C+2018&title=Asterias+Biotherapeutics+Announces+Positive+Outcome+from+Second+Safety+Review+Committee+Meeting+and+Open+Enrollment+for+VAC2+Clinical+Trial+in+Non-Small+Cell+Lung+Cancer+%28NSCLC%29 [SID1234529352]). This initial clinical trial, which is being sponsored, managed and funded by Cancer Research UK, will examine the safety and tolerability of VAC2 in NSCLC as the study’s primary endpoints. Secondary and tertiary endpoints of the study include evaluations of the immunogenicity of VAC2 in NSCLC.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are encouraged that VAC2 was found to be safe and well-tolerated in all three patients and are enthusiastic for Cancer Research UK to begin open enrollment of the advanced disease cohort," commented Dr. Edward Wirth, Chief Medical Officer of Asterias Biotherapeutics. "Cancer Research UK recently opened a second site in Birmingham, England to support enrollment and we are pleased with how the study is progressing."

The Safety Review Committee has now reviewed accumulated safety data generated to date for the first three patients in the advanced disease cohort. Each patient has now received all six weekly doses of 10 million VAC2 cells per protocol.

As specified in the VAC2 clinical trial protocol, the Safety Review Committee meets on a dosing-driven basis to review safety and tolerability data from the ongoing trial. The Committee is comprised of a group of medical and scientific experts and is responsible for reviewing and evaluating patient safety data in order to safeguard the wellbeing of trial participants.

About VAC2

VAC2 is an innovative immunotherapy product that contains mature dendritic cells derived from pluripotent stem cells. These non-patient specific (allogeneic) VAC2 cells are engineered to express a modified form of telomerase, a protein widely expressed in tumor cells, but rarely found in normal cells. The modified form of telomerase invokes enhanced stimulation of immune responses to the protein. Similar to an earlier, Asterias-sponsored, hematological cancer program using an autologous approach, the VAC2 dendritic cells instruct the immune system to generate responses against telomerase and, through this mechanism, target tumor cells. VAC2’s mode of action is complementary to and potentially synergistic with other immune therapies such as checkpoint inhibitors or other immune pathway inhibitors.

About Non-Small Cell Lung Cancer and the VAC2 Trial

Lung cancer (both small cell and non-small cell) is the leading cause of cancer-related death, accounting for about one-quarter of all cancer deaths and more than colorectal, breast, and prostate cancers combined. Non-small cell lung cancer (NSCLC) accounts for about 80% to 85% of lung cancers, according to the American Cancer Society. The three main types of NSCLC are adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. The American Cancer Society’s estimates for lung cancer in the United States for 2017 are: about 222,500 new cases of lung cancer, and about 155,870 deaths from lung cancer. Despite the large number of people afflicted by non-small cell lung cancer, patients remain vastly underserved due to a scarcity of effective treatments. According to statistics published by Cancer Research UK, the five year survival rate for lung cancer patients in England and Wales is less than 10%.

As currently designed, the first VAC2 clinical trial will enroll up to 24 subjects into one of two cohorts, depending on the stage of their non-small cell lung cancer. The first cohort will evaluate VAC2 in up to 12 subjects with advanced non-small cell lung cancer. Subjects in this cohort, who carry the major histocompatibility gene, HLA-A2, will receive six weekly injections of VAC2 and will be followed for safety, immune responses to telomerase and overall clinical survival. These survival results will be compared directly to a control group who meet all of the other inclusion/exclusion criteria but do not possess the HLA-A2 gene. Assuming safety is demonstrated in the first cohort, enrolment will advance to a second cohort. In the second cohort, early stage subjects who have had successful resection of their tumour with no evidence of metastasis will be enrolled. Up to 12 subjects in this second cohort who carry the major histocompatibility allele HLA-A2 will receive six, weekly injections of VAC2 and will be followed for safety, immune responses to telomerase, overall clinical survival and time to relapse. These survival results will again be compared directly to a control group who meet all of the inclusion/exclusion criteria of cohort 2 but are not HLA-A2+. Subjects will be followed for one year for immune response to telomerase and for 2 years for the survival endpoints. The supply of VAC2 to be used in this trial is being manufactured by Cancer Research UK’s Biotherapeutics Development Unit. Asterias and Cancer Research UK are exploring the combination of VAC2 with an immune pathway inhibitor.

On September 4, 2018 Seattle Genetics, Inc. (NASDAQ:SGEN) reported that management will present at the Morgan Stanley Global Healthcare Conference on Thursday, September 13, 2018 at 2:05 p.m. EDT (Press release, Seattle Genetics, SEP 4, 2018, View Source;p=RssLanding&cat=news&id=2365825 [SID1234529344]). The presentation will be webcast live and available for replay from Seattle Genetics’ website at www.seattlegenetics.com in the Investors section.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On September 4, 2018 Medtronic plc (NYSE:MDT), the global leader in medical technology, reported it will participate in the Morgan Stanley 16th Annual Global Healthcare Conference on Friday, September 14, 2018, in New York City (Press release, Medtronic, SEP 4, 2018, View Source;p=RssLanding&cat=news&id=2365882 [SID1234529342]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Karen Parkhill, executive vice president and chief financial officer of Medtronic, will answer questions about the company beginning at 10:30 a.m. EDT (9:30 a.m. CDT).

A live audio webcast of the session will be available on September 14, 2018, by clicking on the Investors Events link at View Source An archived audio file will be available for replay on the same webpage later in the day.

On September 4, 2018 IntegraGen (FR0010908723: ALINT – PEA-SME Eligible), a company specializing in the transformation of data from biological samples into genomic information and diagnostic tools for oncology, reported the publication of the results of a definitive study reporting on the analysis of the expression of miR-31-3p in tumors from 370 RAS wild-type (WT) metastatic colorectal cancer (mCRC) patients enrolled in the FIRE-3 clinical trial (AIO KRK-0306) (Press release, Integragen, SEP 4, 2018, View Source [SID1234529334]). The paper, entitled "Validation of miR-31-3p Expression Level to Predict Cetuximab Efficacy When Used as First-Line Treatment in RAS Wild-Type Metastatic Colorectal Cancer" was published online in Clinical Cancer Research, a leading oncology journal which focuses on innovative clinical and translational cancer research studies that bridge the laboratory and the clinic.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The study found that a low expression of the miR-31-3p biomarker predicts both improved survival and treatment response in patients receiving anti-EGFR therapy. In addition to confirming miR-31-3p is predictive of outcomes for RAS WT mCRC patients treated with anti-EGFR therapy, the study also found that patients with a miR-31-3p expression below a pre-defined threshold have a one year longer median overall survival, a 40% reduction in mortality risk, and a better treatment response when they are treated with FOLFIRI plus cetuximab compared to FOLFIRI plus bevacizumab. Conversely, no difference in outcomes was seen between the two treatment groups in patients with miR-31-3p expression above the pre-defined threshold. These results support the use of miR-31-3p expression testing in primary tumors from RAS WT mCRC patients to assist clinicians to identify the most appropriate first line biologic therapy may be most beneficial.

"The results of our study demonstrate the ability for miR-31-3p to predict which patients with RAS wild-type metastatic colorectal cancer will have improved outcomes when treated in first line with cetuximab compared to bevacizumab when combined with FOLFIRI therapy," explained Prof. Dr. Sebastian Stintzing, an oncologist from University Hospital, LMU Munich in Munich, Germany and lead author on the paper. "These findings are particularly significant since nearly two-thirds of the patients with RAS wild-type tumors in our study had low miR-31-3p expression levels and would therefore benefit from being treated with cetuximab versus bevacizumab as first line therapy for mCRC."

"The results from this study confirm the ability of the miR-31-3p biomarker to predict anti-EGFR therapy response, and in turn, demonstrates the clinical utility of this biomarker for patients with metastatic colorectal cancer," stated Dr. Bernard Courtieu, IntegraGen’s CEO. "This data demonstrates that the use of miR-31-3p expression testing can guide the choice of first line biologic therapy in RAS wild-type patients and enable oncologists to better select a personalized therapeutic approach, resulting in an improved opportunity for positive patient outcomes and decreased cost of care."

IntegraGen will presenting new data reporting positive results from an analysis of miR-31-3p expression in over 1,400 resected stage III colon cancer patients enrolled in the PETACC-8 trial during the upcoming 2018 Annual Meeting of the European Society for Medical Oncology October 19-23 in Munich, Germany.

IntegraGen has commercialized the miRpredX 31-3p kit, a proprietary IVD CE Marked kit and has also licensed its intellectual property associated with miR-31-3p to GoPath Laboratories for the North American market. GoPath Labs recently announced the commercial launch of miR-31now, a laboratory developed test which measures miR-31-3p expression in FFPE specimens.

ABOUT THE FIRE-3 CLINICAL TRIAL

The FIRE-3 (AIO KRK-0306) clinical trial is an independent, randomized, controlled Phase III trial conducted in Europe and led by University Hospital, LMU Munich, Germany. The study compares outcomes of KRAS Exon 2 wild-type (WT) stage IV colorectal cancer patients randomized to receive FOLFIRI therapy (5-FU, folinic acid and irinotecan) in combination with either cetuximab or bevacizumab.

On September 4, 2018 Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, reported that effective February 1, 2019, David Schenkein, M.D., will transition to the role of executive chairman of the board of directors and serve as a member of the board’s Science & Technology Committee, after a successful decade-long tenure as chief executive officer (Press release, Agios Pharmaceuticals, SEP 4, 2018, View Source [SID1234529308]). Jacqualyn ("Jackie") Fouse, Ph.D., a member of the company’s board, has been named as Agios’ next chief executive officer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Prior to joining Agios’ board in December 2017, Dr. Fouse served as president and chief operating officer of Celgene Corporation, a global biopharmaceutical company, until April 2017, and as a member of its board through June 2017. Dr. Fouse joined Celgene in 2010 as chief financial officer and was named president of the company’s global hematology and oncology franchise in 2014. Prior to joining Celgene, Dr. Fouse served as chief financial officer of Bunge Limited, a leading agribusiness and food company. Earlier in her career, she held senior roles at Alcon Laboratories and various international companies.

Dr. Schenkein has served as Agios’ chief executive officer since 2009. During this time, he has overseen the evolution of Agios from a pure research organization to a fully integrated biopharmaceutical company with two approved medicines from its discovery engine, three additional molecules in clinical development and a robust research pipeline.

"With the recent approval and launch of our second internally discovered medicine, Agios has demonstrated that it is capable of discovering, developing and commercializing precision medicines. After leading the company for nearly 10 years, the board and I believe now is the right time to begin this transition. Having worked closely with Jackie for several years and as a member of our board, I am confident that she is the right person to build on the strong foundation we’ve established," said Dr. Schenkein. "It has been a privilege to lead Agios from a blank piece of paper to a thriving biopharmaceutical company with a science-focused culture that puts patients at the center of everything we do. I look forward to continuing my engagement with the company as executive chair and working with Jackie and the leadership team over the next several months to ensure a smooth transition."

John Maraganore, Ph.D., chairman of the Agios board of directors, said, "Jackie’s appointment as CEO is the result of a thoughtful succession planning process jointly undertaken by David and the board. Jackie brings extensive global leadership experience, a proven track record and tremendous knowledge of our industry. Throughout her career, Jackie has demonstrated the ability to effectively plan for and successfully execute on clinical and commercialization strategies, which will be essential as the company works to further its transition to a sustainable multi-product company. On behalf of the entire board of directors, I want to thank David for his extraordinary leadership and his unwavering commitment to patients during his tenure. Under David’s leadership, Agios has become a recognized leader in cellular metabolism with demonstrated ability to rapidly translate novel biology into precision medicines in areas of high unmet need. Agios will continue to benefit from David’s scientific and clinical expertise as part of his new role as executive chairman of the board."

"Agios is well positioned to become one of the next great science-focused companies in our industry, and I am honored to succeed David as the company’s next CEO," said Dr. Fouse. "I greatly admire David’s leadership in addition to the high-performance track record and enviable culture that he and the Agios team have built. Together with the leadership team and all of Agios’ employees, I look forward to building on this strong foundation and continuing our pace of innovation and execution. Importantly, I bring a shared commitment to culture, science and patients."

With Dr. Schenkein transitioning to the role of executive chairman effective February 1, 2019, Dr. Maraganore will transition to a director of the Agios board at that time, and Dr. Fouse will remain a member of the board.