On May 19, 2016 Incyte Corporation (Nasdaq: INCY) reported that more than 20 abstracts featuring its clinical development candidates will be presented at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and European Hematology Association (EHA) (Free EHA Whitepaper) annual meetings (Press release, Incyte, MAY 19, 2016, View Source;p=RssLanding&cat=news&id=2169771 [SID:1234512564]). These conferences will take place from June 3–7, 2016 (ASCO) (Free ASCO Whitepaper) in Chicago, Illinois and June 9–12, 2016 (EHA) (Free EHA Whitepaper) in Copenhagen, Denmark.

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"The abstracts to be presented at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) illustrate both the diversity and the potential of our rich portfolio," stated Steven Stein, M.D., Incyte’s Chief Medical Officer. "We are especially pleased to present long-term data from the COMFORT-I Phase 3 study, which further advances the understanding of Jakafi in the treatment of patients with myelofibrosis. These five-year data, along with additional new data from capmatinib, our potent and highly selective c-MET inhibitor licensed to Novartis, underscore Incyte’s commitment to researching and progressing innovative therapies that have the potential to transform the lives of patients living with cancer."

Select ASCO (Free ASCO Whitepaper) Abstracts

Myelofibrosis
Long-term Outcomes of Ruxolitinib Therapy in Patients with Myelofibrosis: 5-Year Update from COMFORT-I (Abstract #7012)
June 6, 2016, 8:00–11:30 a.m., E354b Hall A
ReTHINK: A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study of Ruxolitinib in Early Myelofibrosis patients with High Molecular Risk Mutations (Abstract #TPS7080)
June 6, 2016, 8:00–11:30 a.m., Hall A, Poster Board #67b

Solid Tumors
GEOMETRY duo-1: A Phase Ib/II, Multicenter Trial of Oral cMET inhibitor Capmatinib (INC280) ± Erlotinib vs. Platinum/Pemetrexed in Adult Patients with Epidermal Growth Factor Receptor (EGFR)-mutated, cMET-amplified, Locally Advanced/Metastatic Non-small Cell Lung Cancer (NSCLC) with Acquired Resistance to Prior EGFR Tyrosine Kinase Inhibitor (TKI) Therapy (Abstract #TPS9109)
June 4, 8:00–11:30 a.m., Hall A, Poster Board #427a
Phase I Study of the Safety and Efficacy of the c-MET Inhibitor Capmatinib (INC280) in Patients with Advanced c-MET+ NSCLC (Abstract #9067)
June 4, 8:00–11:30 a.m., Hall A, Poster Board #390
Phase II Study of the Efficacy and Safety of the c-MET Inhibitor Capmatinib (INC280) in Patients with Advanced Hepatocellular Carcinoma (Abstract #4074)
June 4, 8:00–11:30 a.m., Hall A, Poster Board #66
Phase II Safety and Efficacy Results of a Single-arm Phase Ib/II Study of Capmatinib (INC280) + Gefitinib in Patients with EGFR-mutated, c-MET-positive Non-small Cell Lung Cancer (NSCLC) (Abstract #9020)
June 4, 3:00–4:15 p.m., E354b Hall A
Select EHA (Free EHA Whitepaper) Abstracts
Myelofibrosis
Long-Term Outcomes of Ruxolitinib Therapy in Patients with Myelofibrosis: 5-Year Final Efficacy and Safety Analysis from COMFORT-I (Abstract #S452)
June 11, 11:30–11:45 a.m., Hall A3
Safety and Efficacy of Ruxolitinib in Patients with Dipss Intermediate-1–Risk Myelofibrosis from JUMP: An Open-Label, Multicenter, Single-Arm Expanded-Access Study (Abstract # P296)
June 10, 5:15–6:45 p.m., Hall H
Polycythemia Vera
Ruxolitinib Reduces JAK2V617F Allele Burden in Patients with Polycythemia Vera enrolled in the RESPONSE Study (Abstract #S454)
June 11, 12:00–12:15 p.m., Hall A3
Ruxolitinib Proves Superior to Best Available Therapy in Patients with Polycythemia Vera Resistant to or Intolerant of Hydroxyurea and a Nonpalpable Spleen; Results from RESPONSE-2 (Abstract #S112)
June 10, 12:00–12:15 p.m., Auditorium 1
Essential Thrombocythaemia
Ruxolitinib Compared with Best Available Therapy for Essential Thrombocythaemia Patients Resistant or Intolerant to Hydroxycarbamide in MAJIC – An Investigator Lead Randomized Trial (Abstract #LB304)
June 10, 5:15–6:45 p.m., Hall H
Full session details and data presentations at the 2016 ASCO (Free ASCO Whitepaper) Annual Meeting can be found at: View Source Full session details and data presentations at the 21st Congress of the EHA (Free EHA Whitepaper) can be found at: http://www.ehaweb.org/congress-and-events/21st-congress/program/program-by-day/.
About Jakafi (ruxolitinib)
Ruxolitinib is a first-in-class JAK1/JAK2 inhibitor approved by the U.S. Food and Drug Administration, as Jakafi (ruxolitinib), for treatment of people with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea.
Jakafi is also indicated for treatment of people with intermediate or high-risk myelofibrosis (MF), including primary MF, post–polycythemia vera MF, and post–essential thrombocythemia MF.
Jakafi is marketed by Incyte in the United States and by Novartis as Jakavi (ruxolitinib) outside the United States.
Important Safety Information
Jakafi can cause serious side effects, including:
Low blood counts: Jakafi (ruxolitinib) may cause your platelet, red blood cell, or white blood cell counts to be lowered. If you develop bleeding, stop taking Jakafi and call your healthcare provider. Your healthcare provider will perform blood tests to check your blood counts before you start Jakafi and regularly during your treatment. Your healthcare provider may change your dose of Jakafi or stop your treatment based on the results of your blood tests. Tell your healthcare provider right away if you develop or have worsening symptoms such as unusual bleeding, bruising, tiredness, shortness of breath, or a fever.
Infection: You may be at risk for developing a serious infection during treatment with Jakafi. Tell your healthcare provider if you develop any of the following symptoms of infection: chills, nausea, vomiting, aches, weakness, fever, painful skin rash or blisters.
Skin cancers: Some people who take Jakafi have developed certain types of non-melanoma skin cancers. Tell your healthcare provider if you develop any new or changing skin lesions.
Increases in Cholesterol: You may have changes in your blood cholesterol levels. Your healthcare provider will do blood tests to check your cholesterol levels during your treatment with Jakafi.
The most common side effects of Jakafi include: low platelet count, low red blood cell counts, bruising, dizziness, headache.
These are not all the possible side effects of Jakafi. Ask your pharmacist or healthcare provider for more information. Tell your healthcare provider about any side effect that bothers you or that does not go away.
Before taking Jakafi, tell your healthcare provider about: all the medications, vitamins, and herbal supplements you are taking and all your medical conditions, including if you have an infection, have or had tuberculosis (TB), or have been in close contact with someone who has TB, have or had hepatitis B, have or had liver or kidney problems, are on dialysis, had skin cancer or have any other medical condition. Take Jakafi exactly as your healthcare provider tells you. Do not change or stop taking Jakafi without first talking to your healthcare provider. Do not drink grapefruit juice while on Jakafi.
Women should not take Jakafi while pregnant or planning to become pregnant, or if breast-feeding.
Full Prescribing Information, which includes a more complete discussion of the risks associated with Jakafi, is available at www.jakafi.com.

On May 19, 2016 AstraZeneca and its global biologics research and development arm, MedImmune, reported that they will provide an update on their extensive oncology pipeline at the annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago, USA, on 3-7 June 2016 (Press release, AstraZeneca, MAY 19, 2016, View Source [SID:1234512562]).

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Highlights will include new data demonstrating the strength and versatility of AstraZeneca’s industry-leading line of DNA damage response (DDR) medicines in multiple types of cancer. New data will highlight the continued momentum behind AstraZeneca’s numerous immuno-oncology (IO) programmes, and showcase small-molecule developments including Tagrisso (osimertinib) in leptomeningeal (brain) disease and the highly-selective Bruton’s tyrosine kinase (BTK) inhibitor, acalabrutinib, in chronic lymphocytic leukaemia (CLL).

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: "Oncology is a strategic priority for AstraZeneca because of the potential of our broad pipeline to offer transformational therapies in cancer care. At ASCO (Free ASCO Whitepaper), we will update on our next-generation portfolio focusing on DNA damage response as a breakthrough paradigm in cancer treatment, including new long-term overall survival data for Lynparza. Our increased commitment to DDR therapies complements developments in our exciting immuno-oncology pipeline, from which we are expecting clinical results over the coming year."

DDR: A promising scientific platform, a leading position for AstraZeneca

DDR is a term describing the network of cellular pathways that minimise the daily impact of DNA damage. Currently, many cancers are known to have defects in DDR pathways, which makes them dependent on and therefore, highly sensitive to inhibition of the remaining DDR pathways. Targeting DDR deficiencies to preferentially kill cancer cells, while minimising the impact on normal cells, has potential for more selective, better tolerated therapies to improve survival in multiple cancers.

AstraZeneca is developing a comprehensive pipeline of compounds that target molecular pathways across the DDR system. These include the PARP inhibitor Lynparza (olaparib); Wee1 inhibitor AZD1775, ATM inhibitor AZD0156; ATR inhibitor AZD6738, and Aurora B Kinase inhibitor AZD2811. These compounds act on different cell-cycle points to prevent tumour cells from reproducing.

At the ASCO (Free ASCO Whitepaper) congress, DDR presentations will highlight:

The potential for maintenance of DDR therapies as shown by Lynparza overall survival data from Study 19 in ovarian cancer (Abstract # 5501). This abstract has been selected as a "Best of ASCO (Free ASCO Whitepaper)" abstract.
Opportunities for combination approaches with DDR and immuno-oncology therapies as shown in a Phase I study of the PD-L1 inhibitor, durvalumab, in combination with Lynparza or a VEGFR inhibitor, cediranib, in women’s cancers (Abstract # 3015)
The importance of selecting patients with a DDR pathway defect using the right diagnostic tool (abstract #4041)
The potential of DDR therapies against multiple biological DDR targets in different tumour types, with studies of the highly-selective WEE1 inhibitor, AZD1775, in advanced high-grade serous ovarian cancer (Abstract # TPS5610), squamous cell carcinoma of the head and neck (SCCHN) (Abstract # TPS6106), advanced solid tumours (Abstract # TPS2608) and glioblastoma (GBM) (Abstract # 2008)
Immuno-Oncology: Robust development momentum on track for read-outs in H1 2017

AstraZeneca is leading in a number of first-line studies with its IO strategy, where combined PD-L1 and CTLA-4 blockade – through the combination of durvalumab and tremelimumab – may address a significant unmet medical need for cancer patients who may not benefit from PD-1 pathway drugs in monotherapy.

Key updates include presentations covering pre-clinical data, late-stage trials and biomarker research:

Early study results of durvalumab monotherapy in urothelial bladder cancer from Phase Ib Study 1108 (Abstract # 4502)
Final results from a Phase III study of tremelimumab in mesothelioma (Abstract # 8502)
New study results on safety and clinical activity of durvalumab as first-line treatment in non-small cell lung cancer (NSCLC) (Abstract # 9029)
Ongoing investigation of the potential synergistic effects of durvalumab and the CTLA-4 inhibitor, tremelimumab, in bladder cancer (DANUBE trial – Abstract # TPS4574) and SCCHN (KESTREL trial – Abstract # TPS6101)
Enhanced understanding of PD-L1 biomarker expression in relation to primary versus metastatic tumours and sample age (Abstract # 3025)
Tagrisso in brain metastasis; acalabrutinib in CLL

AstraZeneca’s strong heritage in developing innovative targeted small molecules was underscored by the recent approval of Tagrisso as the first indicated treatment for EGFR T790M mutation-positive metastatic NSCLC in the US, EU and Japan. At ASCO (Free ASCO Whitepaper), new data will highlight the importance of Tagrisso activity in leptomeningeal disease through its ability to penetrate the blood-brain barrier. Further presentations will show the growing role of circulating tumour DNA (ctDNA) testing for diagnosis and treatment monitoring.

Key updates will also include presentation on the potential of our potent, highly-selective BTK inhibitor, acalabrutinib, in chronic lymphocytic leukaemia (CLL):

Data from the BLOOM study of Tagrisso in patients with leptomeningeal disease as a complication of EGFRm-metastatic NSCLC (Abstract # 9002)
Intensive plasma ctDNA profiling in experimental trials to identify markers of acquired drug resistance (Abstract # 11530)
Acalabrutinib – preliminary results from a first-line study as first-line therapy in CLL (Abstract # 7521) and in a Phase II study in combination with pembrolizumab in metastatic pancreatic cancer (Abstract # 4130)

On April 16, 2018 Abpro, an integrated life science company at the forefront of synthetic biology, reported co-development agreements with Massachusetts General Hospital (MGH) and Brigham and Women’s Hospital (BWH), two of the country’s leading academic medical centers (Press release, abpro therapeutics, MAY 19, 2016, View Source [SID1234525613]). By leveraging Abpro’s DiversImmune platform, Abpro will co-develop multiple monoclonal antibodies with MGH for use in its oncology and inflammation and autoimmunity research programs and with BWH for its fibrosis research, according to these independent and separate agreements.

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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

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With MGH, Abpro will collaborate with John H. Stone, MD, MPH, Director of Clinical Rheumatology and Professor of Medicine, Harvard Medical School, and Shiv Pillai, MD, PhD, Associate Geneticist, Center for Cancer Research and Professor of Medicine, Harvard Medical School, for both fibrosis and oncology. Dr. Stone’s work focuses on vasculitis, a group of inflammatory diseases that target blood vessels. His team has identified a novel T lymphocyte that may drive the intractable condition of fibrosis across an array of human diseases. At the Pillai Lab, one of the pathways being studied suggests new approaches for the treatment of autoimmune disorders. Dr. Pillai and his colleagues have discovered novel ways to strengthen immune responses and enhance helper T cell memory that provides hope for developing more effective personalized immune-system based treatments for cancer.

"I look forward to leveraging Abpro’s platform to develop antibodies for targets that traditionally, have been difficult to target," said Dr. Shiv Pillai, who also is a member of Abpro’s Scientific Advisory Board. "I have been familiar with Abpro’s unique approach, and we are looking forward to working with it in our lab."

With BWH, Abpro will work with Michael B. Brenner, MD, Theodore B. Bayles Professor of Medicine Chief, Division of Rheumatology, Immunology and Allergy, Brigham and Women’s Hospital, in the areas of inflammation and autoimmunity. In addition to the full development of basic research in areas relevant to rheumatic and allergic diseases, translational research and clinical research at the population level and patient therapeutics, the division has also organized and integrated much of its research to provide interdisciplinary progress in several key human diseases.

According to these co-development agreements, MGH and BWH will work with Abpro towards the development of new therapeutic antibodies using Abpro’s Diversimmune platform, which is designed to generate antibodies with high sensitivity and specificity for advancing human health.

Abpro’s products and discovery services are used by leading academic labs and companies around the world for life science research purposes, such as therapeutics, diagnostics and research products. Abpro has formed multiple partnerships around novel biomolecules with leading biotechnology and international pharmaceutical companies including Amgen, Eli Lilly, Genzyme, MedImmune, Merck, Novartis, Pfizer, and others. In addition, Abpro has collaborated with several academic research centers, including Harvard University, Massachusetts Institute of Technology and Stanford University.