On May 14, 2020 AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, reported that it will participate in the UBS Virtual Healthcare Conference on Wednesday, May 20, 2020 (Press release, AbbVie, MAY 14, 2020, View Source [SID1234557978]). Michael Severino, M.D., vice chairman and president and Robert A. Michael, executive vice president and chief financial officer, will present at 9:50 a.m. Central time.

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A live audio webcast of the presentation will be accessible through AbbVie’s Investor Relations website at investors.abbvie.com. An archived edition of the session will be available later that day.

On May 14, 2020 Hutchison China MediTech Limited ("Chi-Med") (Nasdaq/AIM: HCM) reported that new and updated analyses on the ongoing studies of savolitinib, surufatinib, and fruquintinib will be presented at the upcoming ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program, taking place on May 29-31, 2020 (Press release, Hutchison China MediTech, MAY 14, 2020, View Source [SID1234558002]).

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Chi-Med plans to hold a conference call on the following Monday, June 1, to discuss the results.

SAVOLITINIB

Title:

Phase II study of savolitinib in patients (pts) with pulmonary sarcomatoid carcinoma (PSC) and other types of non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping

Lead Author:

Shun Lu, MD, PhD., Shanghai Chest Hospital, Shanghai Jiao Tong University

Session:

Lung Cancer—Non-Small Cell Metastatic

Abstract Number:

9519

Title:

SAVOIR: A phase III study of savolitinib versus sunitinib in pts with MET-driven papillary renal cell carcinoma (PRCC)

Lead Author:

Toni K. Choueiri, MD, Dana-Farber Cancer Institute and Harvard Medical School

Session:

Genitourinary Cancer—Kidney and Bladder

Abstract Number:

5002

SURUFATINIB

Title:

Efficacy and safety of surufatinib in United States (US) patients (pts) with neuroendocrine tumors (NETs)

Lead Author:

Arvind Dasari, MD, MS, MD Anderson Cancer Center

Session:

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Abstract Number:

4610

Title:

Health-related quality-of-life results from SANET-ep: A phase III study of surufatinib versus placebo for advanced extrapancreatic neuroendocrine tumors

Lead Author:

Chunmei Bai, MD, Peking Union Medical College Hospital

Session:

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Abstract Number:

4613

FRUQUINTINIB (Publication only)

Title:

Early carcinoembryonic antigen (CEA) dynamics to predict fruquintinib efficacy in FRESCO, a 3+ line metastatic colorectal carcinoma (mCRC) phase III trial

Lead Author:

Yuxian Bai, Harbin Medical University Cancer Hospital

Abstract Number:

e16001

Title:

Efficacy and safety of fruquintinib in the treatment of poor patients with metastatic gastrointestinal cancer

Lead Author:

Yanzhi Cui, MD, Tumour Institute, Fourth Hospital of Hebei Medical University

Number:

e16028

About Savolitinib

Savolitinib is an inhibitor of MET, an enzyme which has been shown to function abnormally in many types of solid tumors. Chi-Med designed savolitinib to be a potent and highly selective oral inhibitor, which, through chemical structure modification, addresses human metabolite-related renal toxicity, the primary issue that halted development of several other selective MET inhibitors. In clinical studies to date, involving over 1,000 patients, savolitinib has shown promising signs of clinical efficacy in patients with MET gene alterations in multiple tumor types with an acceptable safety profile.

About Surufatinib

Surufatinib 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.

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) and granted Priority Review status in December 2019. A second NDA for surufatinib for the treatment of patients with advanced pancreatic NET is being prepared for submission. We are preparing for regulatory interactions in the U.S., Europe and Japan to confirm clinical development and path to registration. In the U.S., surufatinib was granted Fast Track Designations for development in pancreatic and non-pancreatic (extra-pancreatic) NET, and Orphan Drug Designation for pancreatic NET. Additionally, surufatinib is in several late-stage and proof-of-concept trials in China, including in combination with immunotherapies, and proof-of-concept clinical trials in the U.S.

Chi-Med currently retains all rights to surufatinib worldwide.

About Fruquintinib

Fruquintinib is a highly selective and potent oral inhibitor of VEGFR 1/2/3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed to improve kinase selectivity to minimize off-target toxicities, improve tolerability and provide more consistent target coverage. The generally good tolerability in patients to date, along with fruquintinib’s low potential for drug-drug interaction based on preclinical assessment, suggests that it may be highly suitable for combinations with other anti-cancer therapies.

Fruquintinib was approved for marketing in China by the NMPA in September 2018 and commercially launched by Eli Lilly and Company ("Lilly") in late November 2018 under the brand name Elunate, for the treatment of patients with metastatic colorectal cancer ("CRC"). We also intend to initiate a Phase III registration study for CRC in the U.S., Europe and Japan. A Phase III registration study is also ongoing in China for the treatment of patients with gastric cancer, in combination with paclitaxel. Additionally, fruquintinib is in several other proof-of-concept trials in China and the U.S., including in combination with immunotherapies.

Chi-Med retains all rights to fruquintinib outside of China and is partnered with Lilly in China.

On May 14, 2020 Incyte (Nasdaq: INCY) reported that multiple abstracts highlighting data from clinical trials of medicines that are being developed in-house and through partnerships with Novartis, MorphoSys and Takeda will be presented at the upcoming 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Meeting (ASCO20; May 29 – May 31); and at the virtual 25thCongress of the European Hematology Association (EHA) (Free EHA Whitepaper) (EHA25; June 11 – 14) (Press release, Incyte, MAY 14, 2020, View Source [SID1234558031]).

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"We are pleased to have virtual platforms such as ASCO (Free ASCO Whitepaper)20 and EHA (Free EHA Whitepaper)25 to continue sharing important data with the scientific community in a timely manner," said Steven Stein, M.D., Chief Medical Officer, Incyte. "These data demonstrate the strength of our broad oncology portfolio and our partnerships; and reinforce our commitment to finding solutions that can help meet patients’ needs."

Key abstracts accepted by ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) include:

ASCO Abstracts

Oral, poster discussion and poster sessions, as well as track-based clinical science symposia, accepted for presentation at ASCO (Free ASCO Whitepaper) will be available on demand beginning Friday, May 29, 2020, 8:00 AM ET.

Oral Presentations

Capmatinib in Patients with High-Level MET-Amplified Advanced Non-Small Cell Lung Cancer (NSCLC): Results from the Phase 2 GEOMETRY mono-1 Study(Abstract #9509, Session: MET Mutations: The Meat of the Matter)1

Interim Analysis (IA) of OPTIC: A Dose-Ranging Study of Three Ponatinib (PON) Starting Doses (Abstract #7502, Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant)2

E-Poster Presentations

An Independent Review of Arterial Occlusive Events (AOEs) in the Ponatinib (PON) Phase 2 PACE Trial (NCT01207440) in Patients (pts) with Ph+ Leukemia (Abstract #7550, Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant)2

Re-MIND Study: A Propensity Score-Based 1:1 Matched Comparison of Tafasitamab + Lenalidomide (L-MIND) Versus Lenalidomide Monotherapy (Real-World Data) in Transplant-Ineligible Patients with Relapsed/Refractory (r/r) Diffuse Large B-cell Lymphoma (DLBCL) (Abstract #8020, Session: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia)3

Safety and Efficacy of Pemigatinib Plus Pembrolizumab Combination Therapy in Patients (pts) with Advanced Malignancies: Results from FIGHT-101, an Open-Label Phase 1/2 study (Abstract #3606, Session: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology)

Capmatinib in Patients with METex14-Mutated or High-Level MET-Amplified Advanced Non-Small-Cell Lung Cancer (NSCLC): Results from Cohort 6 of the Phase 2 GEOMETRY mono-1 study (Abstract #9520, Session: Lung Cancer—Non-Small Cell Metastatic)1

Pan-Cancer Analysis of FGFR1-3 Genomic Alterations to Reveal a Complex Molecular Landscape (Abstract #3620, Session: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology)

EHA Abstracts

Oral abstract presentations and e-posters accepted for presentation at EHA (Free EHA Whitepaper) will be available on the on-demand Virtual Congress platform beginning Friday, June 12, 2020, at 8:30 AM CEST.

Oral Presentations

Addition of Parsaclisib, a PI3Kδ inhibitor, in Patients with Suboptimal Response to Ruxolitinib (Rux): A Phase 2 Study in Patients (Pts) with Myelofibrosis (MF) (Abstract #S216, Session: Novel Therapies and Pitfalls in MPN)

Ruxolitinib Versus Best Available Therapy in Patients with Steroid-Refractory Acute Graft-Versus-Host Disease: Overall Response Rate by Baseline Characteristics in the Randomized Phase 3 REACH2 Trial (Abstract #S255, Session: Stem Cell Transplantation – Clinical: Graft-Versus-Host Disease)1

GRAVITAS-301: A Randomized, Double-Blind Phase 3 Study of Itacitinib or Placebo in Combination with Corticosteroids for Initial Treatment of Patients with Acute Graft-Versus-Host Disease (Abstract #S256, Session: Stem Cell Transplantation – Clinical: Graft-Versus-Host Disease)

Interim Analysis from the OPTIC Trial, a Dose-Ranging Study of 3 Starting Doses of Ponatinib (Abstract #S172, Session: Chronic Myeloid Leukemia (CML) Clinical)2

Re-MIND Study: Comparison of Tafasitamab + Lenalidomide (L-Mind) vs Lenalidomide Monotherapy (Real-World Data) in Transplant-Ineligible Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (Abstract #S238, Aggressive Lymphomas: Observational Studies)3

E-Poster Presentations

Real-World Survival in Elderly Patients with Myelofibrosis in the United States: Ruxolitinib Exposed vs Unexposed (Abstract #EP1124, Session: Myeloproliferative Neoplasms – Clinical)

Real-World Survival in Elderly Patients with Myelofibrosis in the United States: Pre- vs Post-Ruxolitinib Approval (Abstract # EP1120, Session: Myeloproliferative Neoplasms – Clinical)

Machine-Learning to Predict Hydroxyurea (HU) Failure and Incidence of Thromboembolic Events (TEs) with HU vs Ruxolitinib Switch Therapy in Polycythemia Vera Patients (Abstract #EP1117, Session: Myeloproliferative Neoplasms – Clinical)1

Patient-Reported Physical, Emotional and Economic Impact of Myeloproliferative Neoplasms in an Expansion of the MPN Landmark Survey(Abstract #EP1112, Session: Myeloproliferative Neoplasms – Clinical)1

Ruxolitinib in PV Patients Resistant and/or Intolerant to Hydroxyurea: Interim Analysis of a European Multi-Centric Observational Study (Abstract #EP1115, Session: Myeloproliferative Neoplasms – Clinical)1

Treatment and Disease Management Practices in Patients with MPNs in 6 Countries: An Expansion of the MPN Landmark Survey(Abstract #EP1123, Session: Myeloproliferative Neoplasms – Clinical)1

Retrospective Independent Review of Arterial Occlusive Events (AOEs) in the Phase 2 PACE Trial of Ponatinib in Philadelphia Chromosome Positive (Ph+) Leukemia (Abstract #EP759, Session: Chronic Myeloid Leukemia (CML) Clinical)2

The Real–Life Study Evaluating the Efficacy and Safety of Ponatinib "Topase" Reveals Induction of Deep Molecular Responses in a Cohort of 75 TKI-Resistant or Intolerant patients with CML (Abstract #EP765, Session: Chronic Myeloid Leukemia (CML) Clinical)

Combination of Tafasitamab (MOR208) and Lenalidomide Enhances Tumor Cell Death of B-cell Lymphoma in Vitro (Abstract #EP1343, Session: Lymphoma Biology & Translational Research)3

Long-Term Outcomes from the Phase II L-MIND Study of Tafasitamab (Mor208) Plus Lenalidomide in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (Abstract #EP1201, Session: Aggressive Non-Hodgkin Lymphoma – Clinical)3

Expression of CD19 Antigen on Chronic Lymphocytic Leukemia Cells After Tafasitamab (Anti-CD19) Treatment: Phase I Trial Data (Abstract #EP671, Chronic Lymphocytic Leukemia and Related Disorders – Biology & Translational Research)3

For full session details and data presentation listings, please see the ASCO (Free ASCO Whitepaper)20 (View Source) and EHA (Free EHA Whitepaper)25 (View Source) online programs.

On May 14, 2020 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported that data from the Phase 1 study of SRF231, a fully human, high-affinity anti-CD47 antibody, will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Annual Meeting, to be held virtually May 29-31 (Press release, Surface Oncology, MAY 14, 2020, View Source [SID1234558047]).

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A summary is provided below; the full poster will be placed on Surface Oncology’s website following the presentation.

Presentation Type: e-poster (Abstract: 3064 / Poster: 128)
Title: Results of a first-in-human Phase 1 study of SRF231, a fully human, high-affinity anti-CD47 antibody
Lead Author: Amita Patnaik
Session: Developmental Therapeutics – Immunotherapy

In 2018, Surface Oncology deprioritized the SRF231 clinical program and is concluding its Phase 1 study.

On May 14, 2020 CRISPR Therapeutics (Nasdaq: CRSP) and Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) reported that new data from two ongoing Phase 1/2 clinical trials of the CRISPR/Cas9 gene-editing therapy CTX001 in severe hemoglobinopathies have been accepted for an oral presentation at the EHA (Free EHA Whitepaper) Congress, which will take place virtually from June 11-14, 2020 (Press release, CRISPR Therapeutics, MAY 14, 2020, View Source [SID1234558064]).

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An abstract posted online today includes 12 months of follow-up data for the first patient treated in the ongoing Phase 1/2 CLIMB-111 trial in transfusion-dependent beta thalassemia (TDT) and 6 months of follow-up data for the first patient treated in the ongoing Phase 1/2 CLIMB-121 trial in severe sickle cell disease (SCD). Updated data will be presented at EHA (Free EHA Whitepaper), including longer duration follow-up data for the first two patients treated in these trials and initial data for the second patient treated in the CLIMB-111 trial.

The accepted abstract is now available on the EHA (Free EHA Whitepaper) conference website: View Source

Abstract Title: Initial Safety and Efficacy Results With a Single Dose of Autologous CRISPR-Cas9 Modified CD34+ Hematopoietic Stem and Progenitor Cells in Transfusion-Dependent β-Thalassemia and Sickle Cell Disease
Session Title: Immunotherapy – Clinical
Abstract Code: S280

About the Phase 1/2 Study in Transfusion-Dependent Beta Thalassemia
The ongoing Phase 1/2 open-label trial, CLIMB-Thal-111, is designed to assess the safety and efficacy of a single dose of CTX001 in patients ages 18 to 35 with TDT. The study will enroll up to 45 patients and follow patients for approximately two years after infusion. Each patient will be asked to participate in a long-term follow-up study.

About the Phase 1/2 Study in Sickle Cell Disease
The ongoing Phase 1/2 open-label trial, CLIMB-SCD-121, is designed to assess the safety and efficacy of a single dose of CTX001 in patients ages 18 to 35 with severe SCD. The study will enroll up to 45 patients and follow patients for approximately two years after infusion. Each patient will be asked to participate in a long-term follow-up study.

About CTX001
CTX001 is an investigational ex vivo CRISPR gene-edited therapy that is being evaluated for patients suffering from TDT or severe SCD in which a patient’s hematopoietic stem cells are engineered to produce high levels of fetal hemoglobin (HbF; hemoglobin F) in red blood cells. HbF is a form of the oxygen-carrying hemoglobin that is naturally present at birth and is then replaced by the adult form of hemoglobin. The elevation of HbF by CTX001 has the potential to alleviate transfusion requirements for TDT patients and painful and debilitating sickle crises for SCD patients. CTX001 is the most advanced gene-editing approach in development for beta thalassemia and SCD.

CTX001 is being developed under a co-development and co-commercialization agreement between CRISPR Therapeutics and Vertex.

About the CRISPR-Vertex Collaboration
CRISPR Therapeutics and Vertex entered into a strategic research collaboration in 2015 focused on the use of CRISPR/Cas9 to discover and develop potential new treatments aimed at the underlying genetic causes of human disease. CTX001 represents the first treatment to emerge from the joint research program. CRISPR Therapeutics and Vertex will jointly develop and commercialize CTX001 and equally share all research and development costs and profits worldwide.