On November 25, 2019 Inovio Pharmaceuticals, Inc. (NASDAQ: INO) reported that Dr. J. Joseph Kim, President and CEO, will present in a fireside discussion at the Piper Jaffray 31st Annual Healthcare Conference on Wednesday, December 4, 2019 at 12:30 p.m. Eastern Time in New York, NY (Press release, Inovio, NOV 25, 2019, View Source [SID1234551641]). Dr. Kim will provide an Inovio overview and business update.

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The fireside discussion will be webcast live and may be accessed by visiting Inovio’s website at View Source Archived versions of the presentations will be made available through the Inovio Investor Relations Events page.

On November 25, 2019 Incyte (Nasdaq:INCY) reported that numerous abstracts, including data from its clinical development programs for ruxolitinib (Jakafi), itacitinib and ponatinib (Iclusig) will be presented at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting 2019 in Orlando, Florida from December 7-10, 2019 (Press release, Incyte, NOV 25, 2019, View Source [SID1234551640]).

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"We look forward to ASH (Free ASH Whitepaper) 2019 and the opportunity to present data for our approved and late stage compounds from our oncology portfolio," said Steven Stein, M.D., Chief Medical Officer, Incyte. "These data strengthen the body of evidence supporting treatments that may deliver meaningful benefit for patients with rare cancers like polycythemia vera and myelofibrosis, leukemias and serious conditions such as graft-versus-host disease."

Select key abstract presentations include:

Oral Presentations

Risk of Hemorrhage in Patients with Polycythemia Vera Exposed to Aspirin in Combination with Anticoagulants: Results of a Prospective, Multicenter, Observational Cohort Study (REVEAL) (Abstract #168)

Saturday, December 7, 2019, 12:00-1:30p.m., Orange County Convention Center, Room W314, Level 3
Poster Sessions

Ruxolitinib (Jakafi): Myeloproliferative Neoplasms

U.S. OPTUM Database Study in Polycythemia Vera Patients: Thromboembolic Events (TEs) with Hydroxyurea (HU) vs Ruxolitinib Switch Therapy and Machine-Learning Model to Predict Incidence of TEs and HU Failure (Abstract #1659)1

Saturday, December 7, 2019, 5:30-7:30 p.m., Orange County Convention Center, Hall B, Level 2
A Retrospective Real-World Study of the Current Treatment Pathways for Myelofibrosis in the UK (The REALISM UK Study) (Abstract #1671)1

Saturday, December 7, 2019, 5:30-7:30 p.m., Orange County Convention Center, Hall B, Level 2
Patient-Reported Outcomes (PRO) Data from Patients (Pts) with Essential Thrombocythemia (ET) Enrolled in the MOST Study (Abstract #1665)

Saturday, December 7, 2019, 5:30-7:30 p.m., Orange County Convention Center, Hall B, Level 2
Ruxolitinib (RUX) Induced Meaningful and Directional Changes in the Bone Marrow Microenvironment of Patients with Myelofibrosis Enrolled in the COMFORT-I Study (Abstract #2948)

Sunday, December 8, 2019, 6:00-8:00 p.m., Orange County Convention Center, Hall B, Level 2
Baseline Mutational Status of Patients with Myelofibrosis and Anemia in the REALISE Trial and Impact on Outcome (Abstract #2952)1

Sunday, December 8, 2019, 6:00-8:00 p.m., Orange County Convention Center, Hall B, Level 2
Ruxolitinib for Patients (Pts) with Polycythemia Vera: Responders vs Non-Responders as Defined in the RESPONSE Trial (Abstract #2947)1

Sunday, December 8, 2019, 6:00-8:00 p.m., Orange County Convention Center, Hall B, Level 2
Disease and Clinical Characteristics of Patients with Myelofibrosis Enrolled in the MOST Study (Abstract #4190)

Monday, December 9, 2019, 6:00-8:00 p.m., Orange County Convention Center, Hall B, Level 2
Real-World Dosing Patterns of Ruxolitinib in Patients with Polycythemia Vera Who Are Resistant to or Intolerant of Hydroxyurea (Abstract #4192)

Monday, December 9, 2019, 6:00-8:00 p.m., Orange County Convention Center, Hall B, Level 2
Adherence to Treatment in Myelofibrosis Patients: Preliminary Results from Italian ROMEI Observational Study (Abstract #4179)1

Monday, December 9, 2019, 6:00-8:00 p.m., Orange County Convention Center, Hall B, Level 2
Impact of Disease Burden in Myelofibrosis Patients: A Sub Analysis from Italian ROMEI Observational Study (Abstract #4188)1

Monday, December 9, 2019, 6:00-8:00 p.m., Orange County Convention Center, Hall B, Level 2
Ruxolitinib (Jakafi): Graft-Versus-Host Disease

Disease Progression, Hospital Readmissions, and Clinical Outcomes of Patients with Steroid-Refractory Acute Graft-Versus-Host Disease: A Multicenter Chart Review (Abstract #1994)

Saturday, December 7, 2019, 5:30-7:30 p.m., Orange County Convention Center, Hall B, Level 2
Population Pharmacokinetics of Ruxolitinib in Patients with aGVHD Who Had an Inadequate Response to Corticosteroids (Abstract #4534)

Monday, December 9, 2019, 6:00-8:00 p.m., Orange County Convention Center, Hall B, Level 2
Stratification of Responders and Non-Responders in the REACH-1 Trial Based on Serum Proteomic Analysis (Abstract #4531)

Monday, December 9, 2019, 6:00-8:00 p.m., Orange County Convention Center, Hall B, Level 2
Itacitinib

Prophylactic Itacitinib (INCB039110) for the Prevention of Cytokine Release Syndrome Induced by Chimeric Antigen Receptor T-Cells (CAR-T-cells) Therapy (Abstract #1934)

Saturday, December 7, 2019, 5:30-7:30 p.m., Orange County Convention Center, Hall B, Level 2
A Biomarker Signature to Predict Complete Response to Itacitinib and Corticosteroids in Acute Graft Versus Host Disease (Abstract #3279)

Sunday, December 8, 2019, 6:00-8:00 p.m., Orange County Convention Center, Hall B, Level 2
Ponatinib (Iclusig)

Multicenter, Prospective and Retrospective Observational Cohort Study of Ponatinib in Patients with CML in Italy: Interim Analysis of the OITI Trial (Abstract #1652)

Saturday, December 7, 2019, 5:30-7:30 p.m., Orange County Convention Center, Hall B, Level 2
Real-World Treatment Patterns, Health-Care Costs and Predictors for TKI Changes in CML: Results from a Population Representative German Claims Data Analysis (Abstract #1645)

Saturday, December 7, 2019, 5:30-7:30 p.m., Orange County Convention Center, Hall B, Level 2
Interim Analysis of a Prospective Multicentre Study Using Next Generation Sequencing for Kinase Domain Mutational Analysis in CML Patients on First or Subsequent TKI Therapy (Abstract #2935)

Sunday, December 8, 2019, 6:00-8:00 p.m., Orange County Convention Center, Hall B, Level 2
Sequence of Second Generation Tyrosine Kinase Inhibitors (TKIs) in the Treatment of Patients with Chronic Phase Philadelphia Chromosome-Positive Chronic Myeloid Leukaemia – Real World Experience in the UK (Abstract #3434)

Sunday, December 8, 2019, 6:00-8:00 p.m., Orange County Convention Center, Hall B, Level 2
Ultra-Accurate Assessment of Pretreatment ABL1 Kinase Domain (KD) Mutations in Patients (Pts) with Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL) Using Duplex Sequencing (DS)2

Sunday, December 8, 2019, 6:00-8:00 p.m., Orange County Convention Center, Hall B, Level 2
Real-Life Outcomes of Ponatinib Treatment in Patients with Chronic Myeloid Leukemia (CML) and Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL): Data from a Nationwide Belgian Registry (Abstract #4161)

Monday, December 9, 2019, 6:00-8:00 p.m., Orange County Convention Center, Hall B, Level 2
Major Adverse Cardiac, Arterial Occlusive, and Venous Occlusive Events Among Chronic Myeloid Leukemia Patients Prescribed Ponatinib vs Bosutinib (Abstract #4751)

Monday, December 9, 2019, 6:00-8:00 p.m., Orange County Convention Center, Hall B, Level 2
Full session details and data presentation listings for ASH (Free ASH Whitepaper) 2019 can be found at View Source

About Jakafi (ruxolitinib)

Jakafi is a first-in-class JAK1/JAK2 inhibitor approved by the U.S. FDA for treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older.

Jakafi is also indicated for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea as well as adults 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. Jakafi is a registered trademark of Incyte Corporation. Jakavi is a registered trademark of Novartis AG in countries outside the United States.

About Iclusig (ponatinib)

Iclusig targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved TKIs.

In the EU, Iclusig is approved for the treatment of adult patients with chronic phase, accelerated phase or blast phase chronic myeloid leukemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation, or the treatment of adult patients with Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.

Incyte has an exclusive license from ARIAD Pharmaceuticals, Inc., since acquired by Takeda Pharmaceutical Company Limited, to develop and commercialize Iclusig in the European Union and 22 other countries, including Switzerland, Norway, Turkey, Israel and Russia.

On November 25, 2019 Bio-Techne Corporation (NASDAQ: TECH) reported that Chuck Kummeth, President and Chief Executive Officer, will present at the Evercore ISI 2nd Annual HealthCONx Conference on Wednesday, December 4, 2019 at 11:45 a.m. EST (Press release, Bio-Techne, NOV 25, 2019, View Sourcenews/detail/167/bio-techne-to-present-at-the-evercore-isi-2nd-annual-healthconx-conference [SID1234551639]). The conference will be held at the Four Seasons hotel in Boston, MA. A live webcast of the presentation can be accessed via Bio-Techne’s Investor Relations website at View Source or through the following link View Source

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On November 25, 2019 Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) reported that the U.S. Food and Drug Administration ("FDA") has granted Orphan Drug designation to surufatinib for the treatment of pancreatic neuroendocrine tumors ("NET") (Press release, Hutchison China MediTech, NOV 25, 2019, View Source [SID1234551638]).

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"NET is an area of significant unmet medical need. The current treatment options are very limited," said Christian Hogg, CEO of Chi-Med. "The FDA granting Orphan designation is a positive step and continues to reinforce the importance of our research and development in bringing surufatinib to more patients in need."

If approved by the FDA as an orphan treatment, surufatinib will be entitled to seven years of market exclusivity for the approved indication. Orphan Drug designation also affords certain development cost benefits in the U.S.

Surufatinib is under investigation in multiple solid tumors in China and the U.S., both as a monotherapy and in combination with immunotherapies.

Surufatinib is the second novel oncology drug discovered by Chi-Med to successfully complete a Phase III trial in China. A New Drug Application ("NDA") for surufatinib for the treatment of patients with advanced non-pancreatic NET was accepted for review by the China National Medical Products Administration (NMPA) on November 11, 2019.

About FDA Orphan Drug Designation

The FDA Orphan Drug Designation Program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rarer diseases/disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug.

About Surufatinib

Surufatinib (previously known as HMPL-012 or sulfatinib) is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptor ("VEGFR") and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Its unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies. Surufatinib is in several late-stage and proof-of-concept clinical trials in China and proof-of-concept clinical trials in the U.S.

According to Frost & Sullivan, the market for anti-angiogenesis VEGF/VEGFR inhibitors in China has grown from US$500 million in 2015 to over US$1.5 billion in 2019 and is expected to reach US$5 billion by 2026.

Chi-Med currently retains all rights to surufatinib worldwide.

Non-Pancreatic neuroendocrine tumors in China: In 2015, we initiated the SANET-ep study, a Phase III study of surufatinib in advanced neuroendocrine tumors – extra-pancreatic patients in China for whom there is no effective therapy. In June 2019, a 198 patient interim analysis was conducted, leading the independent data monitoring committee to determine that the study met the pre-defined primary endpoint of progression-free survival ("PFS") and should be stopped early.

Pancreatic neuroendocrine tumors in China: In 2016, we initiated the SANET-p study, which is a pivotal Phase III study in patients with low- or intermediate-grade, advanced pancreatic neuroendocrine tumors in China. The primary endpoint is PFS. We expect an interim analysis in the first half of 2020 and enrollment to complete in 2020 (clinicaltrials.gov identifier: NCT02589821).

Neuroendocrine tumors in the U.S. and Europe: We are planning a U.S. registration study in neuroendocrine tumors patients based on the encouraging data from the Phase II and Phase III studies of surufatinib in neuroendocrine tumors in China (clinicaltrials.gov identifier: NCT02267967), and the ongoing Phase Ib study in the U.S. (clinicaltrials.gov identifier: NCT02549937).

Biliary tract cancer in China: In March 2019, we initiated a Phase IIb/III study comparing surufatinib with capecitabine in patients with advanced biliary tract cancer whose disease progressed on first-line chemotherapy. The primary endpoint is overall survival (OS) (clinicaltrials.gov identifier NCT03873532).

Immunotherapy combinations: In November 2018 and September 2019, we entered into collaboration agreements to evaluate the safety, tolerability and efficacy of surufatinib in combination with anti-programmed cell death protein 1 (PD-1) monoclonal antibodies. This included global collaborations to evaluate the combination of surufatinib with Tuoyi, approved in China by Shanghai Junshi Biosciences Co. Ltd, and with Tyvyt, approved in China by Innovent Biologics, Inc.

About Neuroendocrine Tumors (NET)

Neuroendocrine tumors form in cells that interact with the nervous system or in glands that produce hormones. They can originate in various parts of the body, most often in the gut or the lungs and can be benign or malignant. Neuroendocrine tumors are typically classified as pancreatic neuroendocrine tumors or non-pancreatic neuroendocrine tumors. Approved targeted therapies include Sutent and Afinitor for pancreatic neuroendocrine tumors, or well-differentiated, non-functional gastrointestinal or lung neuroendocrine tumors.

According to Frost and Sullivan, there were 19,000 newly diagnosed cases of neuroendocrine tumors in the U.S. in 2018. Importantly, neuroendocrine tumors are associated with a relatively long duration of survival compared to other tumors. As a result, there were approximately 141,000 estimated patients living with neuroendocrine tumors in the U.S. in 2018 of which over 90%, or approximately 132,000, were non-pancreatic neuroendocrine tumor patients.

In China, there were approximately 67,600 newly diagnosed neuroendocrine tumor patients in 2018 and, considering the current incidence to prevalence ratio in China, potentially as many as 300,000 patients living with the disease in the country1. It is estimated that approximately 80% of the patients living with neuroendocrine tumors in China are non-pancreatic neuroendocrine tumor patients.

1 According to Frost & Sullivan, in 2018, there were 19,000 newly diagnosed cases of NETs in the U.S and an estimated 141,000 patients living with NETs. The current incidence to prevalence ratio in China is estimated at 4.4, lower than the 7.4 ratio in the U.S. due to lower access to treatment options.

On November 25, 2019 ArQule, Inc. (Nasdaq: ARQL) reported that final clinical data from the company-sponsored phase 1 study of ARQ 531 will be presented on December 9, 2019 at the 61stAmerican Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition in Orlando, Florida (Press release, Arqule, NOV 25, 2019, View Source [SID1234551637]). The poster presentation will highlight the final data set with respect to ARQ 531’s safety profile, clinical activity and durability across multiple refractory B-cell malignancies, including C481-mutant chronic lymphocytic leukemia (CLL).

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Presentation Details
Title: Final Results of Phase 1, Dose Escalation Study Evaluating ARQ 531 in Patients with Relapsed or Refractory B-cell Lymphoid Malignancies
Abstract #: 4298
Session Name: CLL: Therapy, excluding Transplantation: Poster III
Date: Monday, December 9, 2019
Presentation Time: 6:00- 8:00 p.m. EST
Location: Orange County Convention Center, Hall B

ArQule will host a conference call and webcast for investors on Monday, December 9, 2019 at 8:15 a.m. EST to discuss the ARQ 531 clinical data. The live webcast can be accessed in the "Investors and Media" section of our website, www.arqule.com, under "Events & Presentations" or by visiting link here. You may also listen to the call by dialing (877) 868-1831 within the U.S. or (914) 495-8595 outside the U.S. and providing conference ID 4573858. A replay will be available two hours after the completion of the call and can be accessed in the "Investors & Media" section of our website, www.arqule.com, under "Events and Presentations."

ArQule management will also be hosting an Investor Event to answer questions and discuss these data in Orlando on Monday, December 9, 2019 from 8:00–10:00 p.m. EST. Investors, sell side analysts, and industry representatives are welcome to attend. For event details and to RSVP, please email [email protected].

About BTK and ARQ 531

Bruton’s tyrosine kinase, BTK, is a therapeutic target that has been clinically proven to inhibit B-cell receptor signaling in blood cancers. ARQ 531 is an orally bioavailable, potent and reversible dual inhibitor of both wild type and C481S-mutant BTK. The C481S-mutation is a known resistance mechanism for first generation irreversible BTK inhibitors. ARQ 531 has demonstrated a manageable safety profile, predictable PK, profound pharmacodynamic effects and signs of clinical activity.