On September 4, 2018 LifeArc, one of the UK’s leading medical research charities, is delighted to announce the appointment of Melanie Lee, PhD, CBE as its new Chief Executive Officer (CEO), effective 1st November 2018 (Press release, LifeArc, SEP 4, 2018, View Source [SID1234529465]). Dave Tapolczay, the present CEO, will be retiring from his position next month after 11 years’ service.1 Melanie brings to LifeArc a wealth of leadership experience from the biopharmaceutical industry and the medical research charity sector. Her previous role as Chief Scientific Officer of BTG plc followed senior research leadership positions at Glaxo/GlaxoWellcome, Celltech plc / UCB; Non-Executive Director roles at H. Lundbeck A/S and BTG plc and currently at Sanofi, CEO roles at Syntaxin Ltd and NightstaRx Ltd and Chair and Deputy Chair Trustee appointments at Cancer Research Technology and Cancer Research UK respectively.

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!

Explaining her reasons for accepting the CEO role Melanie said: "This is a once in a lifetime opportunity for me to join a unique charity that can create life-changing therapeutics. The innovative scientific research supported by LifeArc encompasses numerous life science sectors and has the potential to deliver great science, innovative medicines and new diagnostics to patients in need; it’s this potential that really motivates me. I am looking forward to the prospect of leading this vibrant research charity through the next phase of its development."

Melanie’s appointment has been made at a time of great opportunity for LifeArc. The charity, which evolved from Medical Research Council Technology (MRCT) in 2017, has benefitted from a significant royalty stream arising from sales of Keytruda.2 The income stream generated by Keytruda and other projects, has transformed LifeArc’s ability to fund and invest in innovative medical research and has already resulted in the creation of a dedicated Seed Fund and of a Philanthropic Fund providing rare disease research grant funding.

Commenting on the announcement, Dr John Stageman, OBE, LifeArc’s Chair, said: "We conducted a detailed and lengthy search for our new CEO and my fellow Trustees and I are delighted that Melanie has decided to join us at this most exciting time in the organisation’s history. I believe that she possesses the ideal blend of business leadership plus strategic and scientific acumen to help us deliver a bright future for LifeArc. With the addition of Melanie’s unique professional experience to our already-established senior executive team, I am confident that LifeArc can continue to evolve by turning great science into greater patient benefit."

On September 4, 2018 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported that Marc N. Casper, president and chief executive officer, will present at the Morgan Stanley Global Healthcare Conference on Wednesday, September 12, 2018, at 2:15 p.m. (ET) at the Grand Hyatt New York, New York (Press release, Thermo Fisher Scientific, SEP 4, 2018, View Source [SID1234529458]).

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!

You can access the live webcast of the presentation via the Investors section of our website, www.thermofisher.com.

On September 4, 2018 Eagle Pharmaceuticals, Inc. ("Eagle" or "the Company") (NASDAQ: EGRX) reported that Scott Tarriff, Chief Executive Officer, and Pete Meyers, Chief Financial Officer, will present at the Morgan Stanley 16th Annual Global Healthcare Conference as follows (Press release, Eagle Pharmaceuticals, SEP 4, 2018, View Source [SID1234529441]):

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!

Date: Thursday, September 13, 2018
Time: 4:05 p.m. Eastern Daylight Time
Location: Grand Hyatt New York, NYC
Webcast:

https://cc.talkpoint.com/morg007/091218a_as/?entity=53_0XGPDH2

The presentation will be webcast live at the aforementioned time, and archived for 30 days thereafter, via the Company’s website at www.eagleus.com, under the Investors + News Section.

On September 4, 2018 Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for cancer, respiratory and other diseases, reported that it has dosed the first patient in the Company’s Phase 1 combination clinical trial of PRS-343, its lead proprietary immuno-oncology drug candidate targeting HER2 and 4-1BB, plus atezolizumab (Tecentriq), an approved PD-L1 inhibitor (Press release, Pieris Pharmaceuticals, SEP 4, 2018, View Source [SID1234529394]).

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 trial, a multicenter, open-label, Phase 1 dose escalation study, is designed to determine the safety, tolerability, and potential synergistic anti-tumor effects of PRS-343 plus anti-PD-L1 immunotherapy in patients with advanced or metastatic HER2-positive solid tumors. Elevated HER2 expression is associated with multiple cancers, including gastroesophageal, bladder, breast, and a range of other tumor types. The trial is fully funded and sponsored by Pieris, while Roche is supplying atezolizumab.

"The initiation of the combination trial of PRS-343 with an anti-PD-L1 immunotherapy marks the beginning of Pieris’ investigation into the potential synergistic effects of its 4-1BB-targeted therapy with PD-1/L1 blockade," said Louis Matis, M.D., Senior Vice President and Chief Development Officer of Pieris. "Given evidence from multiple preclinical studies demonstrating synergistic anti-tumor activity from concurrent 4-1BB activation and PD-(L)1 pathway blockade, we believe that combination therapy with PRS-343 and atezolizumab has the potential to provide significant clinical benefit for patients. We are enthusiastic to be initiating this trial and look forward to reporting our findings from this combination study next year."

About PRS-343

PRS-343 is a bispecific monoclonal antibody-Anticalin fusion protein comprised of a HER2 tumor-targeting antibody genetically linked to a potent Anticalin specific for the immune costimulatory TNF family receptor 4-1BB (CD137). PRS-343 is being developed as the first 4-1BB based bispecific therapeutic to mediate the activation of tumor-specific T lymphocytes selectively within the tumor microenvironment (TME). 4-1BB is a potent costimulatory immunoreceptor and an established marker for tumor-specific infiltrating T lymphocytes, and is, therefore, an attractive target for cancer immunotherapy. In in vivo preclinical tumor models, PRS-343 has demonstrated potent T lymphocyte activation localized to the TME of established HER2-positive tumors, indicating the potential for both enhanced safety and efficacy.

About HER2-Positive Malignancies

HER2 is a tyrosine kinase receptor growth-promoting protein found on the surface of some cancer cells and is associated with aggressive disease progression. Multiple tumor types can express HER2 including breast, gastroesophageal, bladder, biliary (cholangiocarcinoma), colorectal, endometrial, ovarian, non-small cell lung, pancreatic, head and neck, and other cancers.

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.