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.

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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.

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:

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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.

On August 22, 2019 Universal Health Services, Inc. (NYSE: UHS) reported that Steve Filton, Executive Vice President and Chief Financial Officer will present at the following conferences (Press release, Universal Health Services, AUG 22, 2019, View Source [SID1234538946]):

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Wednesday, September 4, 2019 at 10:50 a.m. (ET) at the Baird’s 2019 Global Healthcare Conference in New York, New York.

Thursday, September 5, 2019 at 9:45 a.m. (ET) at the 2019 Wells Fargo Healthcare Conference in Boston, Massachusetts.

Live audio webcasts of the presentations will be available on the Company’s website (www.uhsinc.com). For those unable to listen to the live webcast, replays of the presentations will be available on the Company’s website for 90 days following the conferences.

Headquartered in King of Prussia, PA, UHS has more than 87,000 employees and through its subsidiaries operates 350 inpatient acute care hospitals and behavioral health facilities and 37 outpatient and other facilities located in 37 states, Washington, D.C., Puerto Rico and the United Kingdom. It acts as the advisor to Universal Health Realty Income Trust, a real estate investment trust (NYSE:UHT). For additional information on the Company, visit our web site: View Source

On August 22, 2019 CStone Pharmaceuticals ("CStone" or the "Company", HKEX: 2616) reported that the 22nd Annual Meeting of the Chinese Society of Clinical Oncology (CSCO, 2019 CSCO Annual Meeting) has accepted three abstracts on the clinical trials of CS1001 (Anti-PD-L1 antibody), CS1002 (Anti-CTLA-4 antibody), and CS1003 (Anti-PD-1 antibody), the Company’s three backbone immunotherapy candidates. Meanwhile, three late-breaking abstracts on the CS1001-101 Phase Ib clinical trial have also been submitted for presentation (Press release, CStone Pharmaceauticals, AUG 22, 2019, View Source [SID1234538945]).

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CS1001-101 Trial

The CS1001-101 trial is a Phase Ia/Ib open-label, multiple-dose, dose-escalation, and dose-expansion study assessing the safety, tolerability, pharmacokinetics, and anti-tumor efficacy of CS1001 in Chinese patients with advanced solid tumors or lymphomas. Currently, CS1001 is being investigated in multiple clinical trials in China and the U.S., and over 650 patients have been enrolled in these studies.

The results that will be released in poster presentation at the 2019 CSCO Annual Meeting include:

The safety data from the CS1001-101 Phase Ia/Ib clinical trial, and the efficacy data from the Phase Ib trial in cholangiocarcinoma (Abstract #4763).
Three late-breaking abstracts have also been submitted for oral presentation at the meeting include:

The safety and efficacy data from the CS1001-101 Phase Ib trial in patients with esophageal carcinoma.
The safety and efficacy data from the CS1001-101 Phase Ib trial in patients with gastric cancer.
The safety and efficacy data from the CS1001-101 Phase Ib trial in patients with MSI-H cancers.
CS1002-101 Trial

The CS1002-101 trial is an open-label, multiple-dose, dose-escalation, and dose-expansion study conducted in Australia assessing the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor efficacy of CS1002 in patients with advanced solid tumors. At present, the study has completed the dose-escalation stage of CS1002 monotherapy. The dose-escalation of combination with CS1003 in solid tumors and the dose-expansion of the combination in selected tumor types have been planned.

The data that will be released in oral presentation at the 2019 CSCO Annual Meeting includes:

Preliminary safety, pharmacokinetics and pharmacodynamics results from a Phase Ia study of CS1002 in patients with advanced solid tumors (Abstract #4756).
CS1003-102 Trial

The CS1003-102 trial is a multi-center Phase I study evaluating the safety, tolerability, and preliminary anti-tumor activity of CS1003 in Chinese patients with advanced solid tumors and lymphomas. CS1003 is currently undergoing Phase I clinical studies in China and Australia, and received an Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) in October 2018.

The results that will be released in oral presentation at the 2019 CSCO Annual Meeting include:

Preliminary safety, pharmacokinetics and efficacy results from a phase I study of CS1003 in Chinese patients with advanced solid tumors or lymphoma (Abstract #4847).
About CS1001

CS1001 is an investigational monoclonal antibody directed against PD-L1 being developed by CStone. Authorized by the U.S. based Ligand Corporation, CS1001 is developed by the OMT transgenic animal platform, which can generate fully human antibodies in one step. As a fully human, full-length anti-PD-L1 monoclonal antibody, CS1001 mirrors natural G-type immune globulin 4 (IgG4) human antibody, which can reduce the risk of immunogenicity and potential toxicities in patients, potentially representing a unique advantage over similar drugs.

CS1001 has completed a Phase I dose-escalation study in China, in which CS1001 showed good tolerability and produced sustained clinical benefits during the Phase Ia stage of the study.

CS1001 is being investigated in a number of ongoing clinical trials, including one Phase I bridging study in the U.S. In China, its clinical program includes one multi-arm Phase Ib study, two pivotal Phase II studies, and three Phase III studies for several tumor types.

About CS1002 and the CTLA-4 pathway

CS1002 is an investigational anti-CTLA-4 monoclonal antibody being developed by CStone.

Cytotoxic T lymphocyte associated antigen 4 (CTLA-4), also known as CD152, is a transmembrane protein encoded by the CTLA-4 gene that can down-regulate the activity of T cells when binding with its ligand, B7, a pathway also used by tumor cells to avoid T lymphocyte attack. Consequently, blockade of the CTLA-4 pathway can stimulate T cell activation and proliferation to induce or enhance anti-tumor immune responses. CTLA-4 provides a new immuno-therapeutic approach to a number of diseases, including tumors.

Presently, Bristol-Myers Squibb’s Yervoy (ipilimumab) is the only anti-CTLA-4 antibody to gain a market approval worldwide, although Yervoy has not yet been approved in China. Pre-clinical tests have shown that CS1002 has a relatively strong affinity to CTLA-4 and is expected to match Yervoy in terms of efficacy.

About CS1003 and the PD-1/PD-L1 pathway

CS1003 is a humanized anti-PD-1 IgG4 monoclonal antibody developed by CStone using an internationally leading hybridoma platform. CS1003 has shown good tolerability and efficacy profile in preclinical in vivo studies. Unlike other anti-PD-1 mAbs, CS1003 recognizes both human and murine PD-1, providing a unique competitive advantage during efficacy testing in syngeneic mouse tumor models particularly for development of effective combination therapies.

PD-1, or programmed death-1, is an inhibitory checkpoint receptor expressed on T cells. Under normal circumstances, it binds with its ligands, programmed death ligand-1 or ligand 2 (PD-L1/PD-L2), inhibiting T cell and cytokine activation, serving to dampen the immune response in order to prevent damage to healthy tissues. However, studies have shown that PD-L1 can be abundantly expressed on the surface of many solid tumors as well as hematological malignancies. Cancer cells can therefore make use of the PD-1/PD-L1 pathway to successfully avoid immune system recognition. Targeting of the PD-1/PD-L1 checkpoint by anti-tumor drugs can block the "tumor immune evasion mechanism" and restore anti-cancer immune ability in patients.

On August 22, 2019 Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics reported that Aron Knickerbocker, Chief Executive Officer, is scheduled to present at the following healthcare conference (Press release, Five Prime Therapeutics, AUG 22, 2019, View Source [SID1234538944]):

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The 2019 Wells Fargo Healthcare Conference on Thursday, September 5th at 9:10am ET / 6:10am PT.
The presentations will be webcast and may be accessed at the "Events & Presentations" section of the Company’s website at: View Source Five Prime will maintain an archived replay of the webcast on its website for 30 days after the conference.