Perrigo To Present At Upcoming Investor Conferences

On August 22, 2019 Perrigo Company plc (NYSE; TASE: PRGO), reported that CEO and President, Murray S. Kessler and CFO, Ray Silcock, will host one-on-one meetings at the Barclay’s Global Consumer Staples Conference on September 5, 2019 in Boston (Press release, Perrigo Company, AUG 22, 2019, View Source [SID1234538952]).

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!

Mr. Kessler will also present at the 17th Annual Morgan Stanley Global Healthcare Conference at 9:10 am EST on Tuesday, September 10, 2019 in New York City. Interested parties can access the presentation webcasts at View Source

High Sensitivity of Biocept’s Target Selector™ Platform Using CEE-Sure™ Blood Collection Tubes to Be Featured in Poster Presentation at the 2019 IASLC World Conference on Lung Cancer

On August 22, 2019 Biocept, Inc. (NASDAQ: BIOC), a leading commercial provider of liquid biopsy tests designed to provide physicians with clinically actionable information to improve the outcomes of patients diagnosed with cancer, reported that clinical data highlighting real-world performance of the Company’s Target Selector platform for detecting actionable biomarkers in lung cancer patients will be presented at the 2019 IASLC World Conference on Lung Cancer being held September 7-10, 2019 at the Fira Gran Via Exhibition and Conference Center in Barcelona, Spain (Press release, Biocept, AUG 22, 2019, View Source [SID1234538951]). The poster features clinical experience data from over 1,400 blood samples drawn from patients diagnosed with non-small cell lung cancer (NSCLC) and collected and shipped using Biocept’s CEE-Sure specimen collection tubes, specifically designed for liquid biopsy testing. Abstracts for posters to be presented at this conference can be found at library.iaslc.org.

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!

Poster presentation details are as follows:

Title: The Dynamic Range of Mutant Allele Fraction Detected in Patients with NSCLC: Clinical Experience Data and Clinical Implications
Session Category/Title: P1.14/Targeted Therapy Session
Session Date and Time: Sunday September 8, 2019, 09:45am-18:00pm (CEST)
Location: Fira Gran Via Conference Center, Exhibit Hall, Poster Session P1.14

"To date, our clinical experience has demonstrated consistent performance for detecting actionable mutations in the ctDNA of patients with NSCLC as low as 0.01% mutant allele frequency," said Biocept’s Senior Vice President and Senior Medical Director Veena Singh, MD. "The ability to detect mutations at such low levels can serve to expand the cohort of patients that could potentially benefit from the use of targeted therapies and to monitor their progression or therapeutic response, as these patients might be missed with less sensitive technologies. We are also pleased to demonstrate the robust performance of our CEE-Sure blood collection tubes which are designed to stabilize cells in a given blood sample to minimize the presence of non-tumor DNA in the plasma fraction. We believe that our collection tube technology can contribute to a higher level of sensitivity in liquid biopsy testing."

"We are very pleased to highlight the robust real-world performance of our Target Selector ctDNA assays for lung cancer, as well as the utility of our CEE-Sure blood collection tubes at this year’s World Conference on Lung Cancer," said Biocept’s President and CEO Michael Nall. "We believe that these results add to the body of evidence supporting the clinical benefits of our proprietary molecular diagnostic technologies and services, and further distinguish our novel platform in the growing liquid biopsy segment."

Portola Pharmaceuticals to Participate in Two Upcoming Investor Conferences

On August 22, 2019 Portola Pharmaceuticals, Inc. (Nasdaq: PTLA) reported that the Company will participate in the following conferences in September (Press release, Portola Pharmaceuticals, AUG 22, 2019, View Source [SID1234538950]).

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!

Citi’s 14th Annual Biotech Conference on Wednesday, September 4, 2019, in Boston, MA. The Company will conduct one-on-one meetings with institutional investors at this conference.

Morgan Stanley’s 17th Annual Global Healthcare Conference on Tuesday, September 10, 2019, at 11:45 a.m. Eastern Time in New York, NY. The Company will participate in a fireside chat presentation at the conference, which will be webcast live and available for replay in the Investor Relations section of the Portola website (www.portola.com).

Amgen And Allergan Announce Positive Top-Line Results From Comparative Clinical Study Of ABP 798, Biosimilar Candidate To Rituxan® (Rituximab)

On August 22, 2019 Amgen (NASDAQ:AMGN) and Allergan plc. (NYSE:AGN) reported positive top-line results from a comparative clinical study evaluating the efficacy and safety of ABP 798, a biosimilar candidate to Rituxan (rituximab), compared to Rituxan in patients with CD20-positive B-cell non-Hodgkin’s lymphoma (Press release, Amgen, AUG 22, 2019, View Source [SID1234538949]). The primary endpoint, an assessment of overall response rate (ORR) by week 28, was within the prespecified margin for ABP 798 compared to Rituxan, showing clinical equivalence. Safety and immunogenicity of ABP 798 were comparable to Rituxan.

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!

This is the second of two studies intended to support regulatory submissions for ABP 798. The first study was conducted in patients with moderate-to-severe rheumatoid arthritis (RA) and met the primary endpoint of pharmacokinetic similarity. This RA study demonstrated clinical equivalence within the prespecified efficacy margin, and a similar safety and immunogenicity profile.

"Today’s results with ABP 798 demonstrate another positive development from Amgen’s robust pipeline of biosimilar medicines and we look forward to working with regulatory agencies to bring this treatment to patients," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "We continue to leverage our deep expertise and heritage in biologics across innovative and biosimilar medicines as part of our commitment to providing a range of treatment options for patients with the most serious diseases, including cancer."

ABP 798 is being developed as a biosimilar candidate to Rituxan, an anti-CD20 monoclonal antibody that is approved in many regions for the treatment of adult patients with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, moderate-to-severe rheumatoid arthritis, pemphigus vulgaris, granulomatosis with polyangiitis and microscopic polyangiitis.

Amgen has a total of 10 biosimilars in its portfolio, including three that are approved in the United States (US).

About the JASMINE Study
The JASMINE study was a randomized, double-blind comparative clinical study (study number NCT02747043) that evaluated the efficacy, safety and immunogenicity of ABP 798 compared to rituximab in patients with non-Hodgkin’s lymphoma. There were 256 adult patients enrolled and randomized to receive either ABP 798 or rituximab at a dose of 375 mg/m2 administered as an intravenous (IV) infusion once weekly for four weeks followed by dosing at weeks 12 and 20. The primary endpoint of the study was risk difference of overall response rate.

About Non-Hodgkin’s Lymphoma
Non-Hodgkin’s lymphoma is a type of cancer that originates in the lymph system, part of the body’s immune system, and occurs when the body produces too many abnormal lymphocytes, a type of white blood cell.1,2 Non-Hodgkin’s lymphoma is one of the most common cancers in the U.S., and about 85 percent of cases originate in B cells.3,4 There are several subtypes, and follicular lymphoma is one of the most common.2

About ABP 798
ABP 798 is being developed as a biosimilar candidate to Rituxan (rituximab), an anti-CD20- monoclonal antibody that is approved in many regions for the treatment of adult patients with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, moderate-to-severe rheumatoid arthritis, pemphigus vulgaris, granulomatosis with polyangiitis and microscopic polyangiitis. The active ingredient of ABP 798 is a monoclonal antibody that has the same amino acid sequence as Rituxan.

About the Amgen and Allergan Collaboration
In December 2011, Amgen and Allergan plc. (then Watson Pharmaceuticals, Inc.) formed a collaboration to develop and commercialize, on a worldwide basis, four oncology antibody biosimilar medicines. This collaboration reflects the shared belief that the development and commercialization of biosimilar products will not follow a pure brand or generic model and will require significant expertise, infrastructure, and investment to ensure safe, reliably supplied therapies for patients. Under the terms of the agreement, Amgen assumes primary responsibility for developing, manufacturing and initially commercializing the oncology antibody products.

About Amgen Biosimilars
Amgen is committed to building upon Amgen’s experience in the development and manufacturing of innovative human therapeutics to expand Amgen’s reach to patients with serious illnesses. Biosimilars will help to maintain Amgen’s commitment to connect patients with vital medicines, and Amgen is well positioned to leverage its nearly four decades of experience in biotechnology to create high-quality biosimilars and reliably supply them to patients worldwide.

For more information, visit www.amgenbiosimilars.com and follow us on www.twitter.com/amgenbiosim.

New Jersey’s First National Cancer Institute Community Oncology Research Program (NCORP) Awarded to Atlantic Health Cancer Consortium

On August 22, 2019 The National Cancer Institute (NCI) reported that it has designated Atlantic Health System as a National Community Oncology Research Program (NCORP) site of the Atlantic Health Cancer Consortium (AHCC) (Press release, US NCI, AUG 22, 2019, View Source [SID1234538947]). As the first and only New Jersey-based NCORP, AHCC will help develop and implement NCI cancer prevention, screening, care delivery, and treatment studies with leading healthcare systems across the state. The major health systems and medical centers throughout New Jersey that make up the AHCC NCORP include:

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!

Atlantic Health System (Congressional District NJ-011)
Morristown Medical Center, Overlook Medical Center, Chilton Medical Center, Newton Medical Center and Hackettstown Medical Center and Goryeb Children’s Hospital
CentraState Healthcare System (NJ-004)
Holy Name Medical Center (NJ-005)
Hunterdon Healthcare (NJ-007)
St. Joseph’s Health (NJ-009)
St Joseph’s University Medical Center, St. Joseph’s Wayne Medical Center, St. Joseph’s Children’s Hospital
Saint Peter’s Healthcare System (NJ-006)
Saint Peter’s University Hospital, Saint Peter’s Children’s Hospital
Atlantic Health System will serve as the lead affiliate for NCORP Community Site activities, providing the scientific leadership and central support personnel necessary to accomplish the AHCC NCORP objectives. Atlantic Health System leadership includes experienced cancer investigators in both adult and pediatric cancers with unique expertise that span the cancer continuum.

"As the first National Cancer Institute NCORP site based in New Jersey, we will expand the NCORP network coverage by 6.5 million people," said Missak Haigentz, MD, medical director of Hematology and Oncology for Atlantic Health System and principal investigator for AHCC NCORP. "We are proud to partner with these leading healthcare organizations, each of which has its own unique strengths and patient populations. This will be an exceptional and unprecedented cancer care consortium for New Jersey, which has a diverse population and higher rates of adult and childhood cancer than the nation as a whole."

The incidence of cancer in New Jersey is 477.5 cases per 100,000 versus 441.2 cases per 100,000 nationally. Warren (511.5/100,000) and Monmouth (497.8/100,000) counties have even higher cancer rates, while the pediatric cancer rate for New Jersey is above the national average at 17.1 versus 16.3 cases per 100,000.

The grant will enable all sites in the AHCC NCORP to participate in additional cutting-edge research from the NCI and National Clinical Trials Network (NCTN), and will significantly enhance access to these trials for cancer patients throughout New Jersey. The clinical trials will focus on cancer control, prevention, screening, care delivery, treatment and medical imaging, and many will include a quality-of-life component. These studies will also incorporate the needs of diverse populations and will be integrated with cancer disparities research.

"Ultimately, the AHCC NCORP presents a substantial opportunity to advance scientific understanding in cancer prevention, screening, control, treatment and care delivery research within a large and diverse population," said Dr. Haigentz. "We will also be part of a nationwide integrated network of community-based cancer programs that will collaborate, analyze and share data through the NCORP Research Bases."

Specific goals of the consortium will be to increase adult and pediatric participation in the above-referenced types of NCI and National Clinical Trials Network clinical trials, including members of groups that are currently underrepresented in clinical trials, such as ethnic and racial minorities. The consortium will also collect tissue samples in order to support advances in genomics and molecularly targeted therapies.

Additional goals include enhancing community involvement and the involvement of community-based physicians in cancer control, prevention and care delivery research through a variety of targeted community outreach and engagement efforts, and to support and mentor community oncologists and other medical specialists.

The consortium will also help develop and implement clinically significant studies that incorporate the unique research needs of New Jersey’s diverse population. A special emphasis will be placed on involving non-English speaking individuals.

"Clinical advancements in prevention and treatment approaches must benefit all cancer patients. The best way to make that a reality is to ensure clinical research is conducted in diverse populations—both ethnic and geographic diversity," said NCI Acting Director Douglas R. Lowy, MD. "Communities of color and rural communities face disadvantages in access to cutting-edge cancer care. We believe that clinical trials provide access to high quality cancer care. NCORP enables us to make this available to more communities."

NCI grants went to 32 Community Sites and 14 Minority/Underserved (M/U) Community Sites, who have assembled more than 1,000 affiliates across the country to carry out cancer research. The NCORP network now covers 44 states, the District of Columbia, and the territories of Puerto Rico and Guam, the largest geographic coverage in the program’s history.

Clinical trial enrollment in the AHCC NCORP began August 1, 2019.

About AHCC NCORP
The Atlantic Health Cancer Consortium Community Oncology Research Program (AHCC CORP) is the first and only New Jersey-based National Cancer Institute (NCI) Community Oncology Research Program (NCORP). Combining the collective strengths of world-class healthcare systems with community oncology care delivery, the consortium includes Atlantic Health System, CentraState Healthcare System, Holy Name Medical Center, Hunterdon Healthcare, St. Joseph’s Health and Saint Peter’s Healthcare System. Atlantic Health System will serve as the lead affiliate for NCORP Community Site activities, providing the scientific leadership and central support personnel necessary to accomplish the AHCC NCORP objectives. Atlantic Health System leadership includes experienced cancer investigators in both adult and pediatric cancers with unique expertise that span the cancer continuum. The overall goals of the consortium are to improve and extend the lives of New Jerseyans with cancer and reduce disparities by providing access to leading edge clinical trials in community settings. The consortium covers nearly three-quarters of the state and 6.5 million people.

NCORP is a community-based cancer research network of the National Cancer Institute with sites throughout the country. The network designs and conducts clinical trials and other cancer studies involving adults and children. These studies focus on cancer control, prevention, screening and care delivery, as well as quality-of-life research embedded within the treatment clinical trials. NCORP and its sites incorporate the needs of diverse populations such as children, adolescents and young adults; the elderly; racial and ethnic minorities; sexual and gender minorities; and rural residents into studies and take steps to enhance participation of these groups. NCORP also enhances patient and provider access to treatment and imaging trials conducted under NCI’s National Clinical Trials Network. In addition, NCORP integrates cancer disparities research within the community research network.

About Atlantic Health System Cancer Care
Atlantic Health System Cancer Care offers an unparalleled network of cancer specialists and resources for more than 6000 newly diagnosed cancer patients annually through its flagship Carol G. Simon Cancer Center at Morristown and Overlook medical centers, as well as its comprehensive oncology programs at Chilton, Hackettstown and Newton medical centers. With more than 250 cancer specialists, all five hospitals and Atlantic Medical Group are designated Blue Cross Blue Shield ‘Blue Distinction Centers,’ and participate in The Centers for Medicare & Medicaid Services Oncology Care Model that supports and encourages higher quality care. Morristown and Newton medical centers earned the coveted American College of Surgeons Commission on Cancer Outstanding Achievement Award and, along with Overlook and Chilton, earned Three-Year Approval with Commendation. U.S. News & World Report has ranked Atlantic Health System hospitals as high performing in colon cancer surgery, lung cancer surgery, neurology and neurosurgery, and pulmonology. In 2019, Morristown Medical Center (#28) and Overlook Medical Center (#98) were rated as some of the best hospitals in the entire United States by Newsweek in its inaugural hospital rankings.

Atlantic Health System Cancer Care is affiliated with the Translational Genomics Research Institute (TGen) of Phoenix, Arizona, and together they have created the Breakthrough Oncology Accelerator, a pioneering research and clinical collaboration designed to improve patient access to the most innovative and sophisticated therapies for cancer.