On May 18, 2017 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that a series of abstracts highlighting new study results for its in-house discovered lenvatinib mesylate (selective inhibitor of receptor tyrosine kinases (RTKs) with a novel binding mode, product name: Lenvima / Kisplyx, "lenvatinib") and eribulin mesylate (halichondrin class microtubule dynamics inhibitor, product name: Halaven, "eribulin"), as well as H3B-8800, a splicing modulator discovered by Eisai’s U.S. research subsidiary H3 Biomedicine Inc., will be presented during the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), taking place in Chicago, the United States, from June 2 to 6, 2017 (Press release, Eisai, MAY 18, 2017, View Source [SID1234519265]).

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Detailed data regarding the results of a Phase III clinical trial (Study 304) of lenvatinib compared with sorafenib as a first-line treatment for patients with unresectable hepatocellular carcinoma, which has already achieved its primary endpoint, will be presented orally at the ASCO (Free ASCO Whitepaper) Annual Meeting. This presentation is scheduled to take place on Sunday, June 4, 8:12 AM local time, in Hall D2.

Major poster presentations will include a highlight of the results of a Phase Ib/II clinical trial (Study 111) of lenvatinib in combination with the anti-PD-1 antibody pembrolizumab for the treatment of patients with endometrial carcinoma, and the results of a Phase I clinical trial of H3B-8800 in patients with advanced myeloid malignancies.

Eisai positions oncology as a key therapeutic area, and is aiming to discover revolutionary new medicines with the potential to cure cancer. The company will continue to create innovation in the development of new drugs based on cutting-edge cancer research, as it seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families, and healthcare providers.

Oral Presentations:
Product Abstract title and scheduled presentation date and time (local time)
Lenvatinib

Abstract No: 4001 Phase 3 trial of lenvatinib (LEN) vs sorafenib (SOR) in first-line treatment of patients (pts) with unresectable hepatocellular carcinoma (uHCC)
Oral Presentation | June 4 (Sun), 8:12-8:24 AM
Major Poster Presentations:
Product Abstract title and scheduled presentation date and time (local time)
Lenvatinib

Abstract No: 5598 A Phase Ib/II Trial of Lenvatinib (LEN) Plus Pembrolizumab (Pembro) in Patients (Pts) With Endometrial Carcinoma
Poster Presentation | June 3 (Sat), 1:15-4:45 PM
Lenvatinib

Abstract No: TPS4595 A Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib in Combination with Everolimus or Pembrolizumab vs Sunitinib Alone in First-Line Treatment of Patients with Advanced Renal Cell Carcinoma
Poster Presentation | June 4 (Sun), 8:00-11:30 AM
Lenvatinib

Abstract No: 10544 Single-agent Dose-finding Cohort of a Phase 1/2 Study of Lenvatinib (LEN) in Children and Adolescents with Refractory or Relapsed Solid Tumors
Poster Presentation | June 4 (Sun), 8:00-11:30 AM
Eribulin

Abstract No: 6603 Validity and Reliability of Four Value Frameworks for Cancer Drugs

Poster Presentation | June 5 (Mon), 1:15-4:45 PM
H3B-8800

Abstract No: TPS7075 H3B-8800-G0001-101: A first in human phase I study of a splicing modulator in patients with advanced myeloid malignancies
Poster Presentation | June 5 (Mon), 8:00-11:30 AM

Background: FGFR2b-overexpressing gastric cancer is characterized by poor prognosis. FPA144, a humanized monoclonal IgG1 antibody that specifically binds to and blocks FGFR2b, has been engineered for enhanced antibody-dependent cell-mediated cytotoxicity (ADCC). FPA144-001 is a two-part Phase 1 study of FPA144 monotherapy in patients with advanced solid tumors, including gastric and gastroesophageal cancers (GEJ cancers).
Methods: Part 1A was a 3+3 design to assess safety and PK and to establish a recommended dose (RD) of FPA144. Patients with gastric cancer were enrolled in Part 1B to assess PK in gastric cancer. Part 2 includes 4 cohorts of gastric cancer patients with either high, moderate, low or no FGFR2b overexpression based on a centralized immunohistochemistry (IHC) assay. Here, we describe results of gastric cancer patients that highly overexpress FGFR2b (FGFR2b+ High) enrolled in Parts 1 and 2 of the study.
Results: As of October 28, 2016, 18 FGFR2b+ High (IHC 3+ ³10% tumor membrane staining) patients were enrolled in the study. 12 of these patients received the RD of 15 mg/kg every 2 weeks. Enrolled patients received a median of 3 prior treatment regimens. Fatigue (22.2%, none ³ gr 3) and infusion reaction (16.7%, 5.6% gr 3) were the most common treatment-related AEs. Treatment-related SAEs were reported in 2 patients: Grade 2 ulcerative keratitis and Grade 3 infusion reaction. There were 5 PRs, 4 confirmed and 1 unconfirmed. Disease control (PR+SD) was 55.6%, including a confirmed ORR of 22% with median DOR of 15.4 weeks. ctDNA analysis of a responding patient revealed baseline elevated FGFR2 gene copy (165 copies in the blood, mutation allele burden 66%) that decreased after monotherapy (nadir 75 copies, mutation allele burden 38.5%) corresponding with clinical response, serum tumor markers and near complete response on PET imaging.
Conclusions:
The demonstration of activity and an acceptable safety profile supports further development of FPA144 in patients with FGFR2b+ tumors. FGFR2 gene amplification detected in ctDNA may provide a non-invasive diagnostic test for patient selection. Updated data will be presented. NCT02318329.

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t epotinib c-Met kinase inhibitor Non-small cell lung cancer tepotinib c-Met kinase inhibitor Hepatocellular cancer avelumab anti-PD-L1 mAb Merk el cell cancer 1L 1 sprifermin fibroblast growth factor 18 O steoarthritis atacicept anti-Blys /anti-APRIL fusion protein Systemic lupus erythematosus atacicept anti-Blys /anti-APRIL fusion protein IgA nephropathy abituzumab anti-CD 51 mAb Systemic sclerosis with interstitial lung dis. evobrutinib BTK inhibitor R heumatoid arthritis evobrutinib BTK inhibitor Systemic lupus erythematosus evobrutinib BTK inhibitor Multiple sclerosis 1 Merck pipeline M2698 p70S6K & Akt inhibitor Solid tumors M3814 DNA-PK inhibitor Solid tumors M9831 (VX-984) DNA-PK inhibitor Solid tumors M6620 (VX-970) ATR inhibitor Solid tumors M4344 (VX-803) ATR inhibitor Solid tumors M7583 BTK inhibitor Hem atological malignancies avelumab anti-PD-L1 mAb Solid tumors avelumab anti-PD-L1 mAb Hem atological malignancies M9241 (NHS-IL12) 8 Cancer immunotherapy Solid tumors M7824 anti-PD-L1/ TGFbeta trap Solid tumors M1095 (ALX-0761) 10 anti-IL-17 A/F nanobody Psoriasis Registration Phase III Phase II Phase I cladribine 4 tablets lymphocyte targeting agent Relapsing-remitting multiple sclerosis avelumab 6 anti-PD-L1 mAb Merk el cell cancer (EU) avelumab-anti-PD-L1 mAb Non-small cell lung cancer 1L 1 avelumab-anti-PD-L1 mAb Non-small ce ll lung cancer 2L 2 avelumab-anti-PD-L1 mAb Gastric cancer 1L-M 1M avelumab-anti-PD-L1 mAb Gastric cancer 3L 3 avelumab-anti-PD-L1 mAb O varian cancer platinum resistant/refractory avelumab-anti-PD-L1 mAb O varian cancer 1L 1 avelumab-anti-PD-L1 mAb Urothelial cancer 1L-M 1M avelumab-anti-PD-L1 mAb Renal cell cancer 1L 1 avelumab-anti-PD-L1 mAb Locally advanced head and neck cancer MSB 11022 9 proposed biosimilar of adalimumab Chronic plaque psoriasis 1 First Line treatment; 1M First Line maintenance treatment; 2 Second Line treatment; 3 Third Line treatment; 4 As announced on July 18, 2016, the EMA has accepted for review the Marketing Authorization Application (MAA) of Cladribine Ta ble ts for the treatment of relapsing-remitting multiple sclerosis. 5 As announced on March 23, 2017, the US FDA has granted accelerated approved of avelumab for the treatment of adults and pedia tri c patients 12 years and older with metastatic Merkel cell carcinoma (MCC). This indication was approved under accelerated approval based on tumor response and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Avelumab has not yet been approved for metastatic MCC outside of the US. 6 As announced on October 31, 2016, the EMA has validated for review Merck’s MAA for avelumab, for the proposed indication of m eta static Merkel cell cancer. 7 As announced on May 9, 2017 the US FDA granted accelerated approval of avelumab for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) who have disease progression during or following platinum-containing chemotherapy therapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This indication was approved under accelerated approval based on tumor response and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Avelumab has not yet been approved f or metastatic UC outside of the US. 8 Sponsored by the National Cancer Institute (USA). 9 On April 24, 2017 the divestment of Merck’s Biosimilars business to Fresenius was announced. Closing is expected in H2, 2017, s ubject to regulatory approvals and other conditions. 10 As announced on March 30, 2017 in an agreement with Avillion, anti-IL-17 A/F nanobody will be developed by Avillion for plaque psoriasis and commercialized by Merck. May 18, 2017 Recently Registered avelumab 5-anti-PD-L1 mAb Merk el cell cancer (US) avelumab 7-anti-PD-L1 mAb Urothelial cancer (US) Neurology Oncology Immunology Immuno-Oncology B iosimilars P ipeline products are under clinical investigation and have not been proven to be s afe and effective. T here is no guarantee any product will be approved in the s ought-after indication.

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On May 18, 2017 Bellicum Pharmaceuticals, Inc. (Nasdaq:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers and orphan inherited blood disorders, reported that three abstracts have been accepted for presentation at the 22nd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) being held in Madrid, Spain on June 22-25, 2017 (Press release, Bellicum Pharmaceuticals, MAY 18, 2017, View Source;p=RssLanding&cat=news&id=2273891 [SID1234519217]).

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Latest on Bellicum Pharmaceuticals’ Cancer Pipeline, book your free 1stOncology demo here.

Bellicum’s presentation of the overall cohort of children with malignant and non-malignant diseases treated with BPX-501 was selected as one of the Congress’ five best abstracts, and will be reviewed during the Presidential Symposium.

Additional oral and poster presentations selected include clinical data on BPX-501 for the treatment of pediatric leukemias, hemoglobinopathies and erythroid disorders. The abstracts are now available online at the EHA (Free EHA Whitepaper) conference website.

EHA Presentation Details

Oral Presentation – Presidential Symposium
Title: BPX-501 Donor T-Cell Infusion (with Inducible Caspase 9 Suicide Gene) Facilitates HLA Haploidentical Stem Cell Transplant in Children with Both Hematological Malignancies and Non-Malignant Conditions
Session Title: Presidential Symposium
Date: Friday, June 23
Time: 3:45 – 4:00 PM CEST
Location: Hall A
Abstract Code: S146

Oral Presentation
Title: Impact of Post-Transplant Infusion of Donor T-Cells Genetically Modified with Inducible Caspase 9 Suicide Gene (BPX-501 Cells) on Children with Leukemia Given Alpha-Beta T-Cell Depleted Haplo-HSCT
Session Title: Stem cell transplantation – Clinical 1
Date: Saturday, June 24
Time: 5:00 – 5:15 PM CEST
Location: Room N103
Abstract Code: S495

Poster Presentation
Title: The Use of BPX-501 Donor T-Cell Infusion (with Inducible Caspase 9 Suicide Gene) Together with HLA-Haploidentical Stem Cell Transplant to Treat Children with Hemoglobinopathies and Erythroid Disorders
Session Title: Stem cell transplantation – Clinical 1
Date: Friday, June 23
Time: 5:15 – 6:45 PM CEST
Location: Poster Area (Hall 7)
Abstract Code: P381

On May 17, 2017 Redx (AIM: REDX) reported its interim results for the six months ended 31 March 2017 (Press release, Redx Pharma, MAY 17, 2017, View Source [SID1234524750]):

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Clinical trial application filed for Porcupine inhibitor RXC004
Development candidate chosen for reversible BTK inhibitor RXC005 for drug resistant chronic lymphocytic leukaemia
Strategic restructuring completed post period; estimated £4.2 million annual cost saving
Iain Ross appointed as Non-Executive Chairman of the Board from 1 May 2017
£12 million gross raised in March 2017, including a subscription with a related sharing agreement
Pipeline highlights
RXC004 — our "best-in-class" Porcupine inhibitor
Clinical trial application (CTA) filed post period in April
Scheduled to enter first-in-human studies upon CTA approval
Shown to have the potential to be used in combination with immune checkpoint inhibitors (anti-PD-1)
RXC005 — our "best-in-class" reversible BTK inhibitor
In vivo proof of concept achieved for the reversible BTK program
Development candidate nominated for drug resistant chronic lymphocytic leukaemia (CLL)
Pre-clinical profile presented at ASH (Free ASH Whitepaper) meeting in December 2016 and iwCLL in May 2017
Investigational new drug (IND) application and CTA to be filed around the end of 2017
Other highlights
Fibrotic disease selected as core immunology research area
Redx acquired the locally acting Rho kinase (ROCK) inhibitor AMA0825 from Amakem NV in March 2017 for an undisclosed amount. ROCK is a promising anti-fibrotic target and AMA0825 is at late lead optimisation stage
Redx was awarded US$1 million competitive grant by CARB-X to enable the Company to advance its Gram-negative anti-infective program with a prospective partner
Key Financials
Net cash at 31 March 2017: £5.1m (2016: £4.4m)
Comprehensive loss: £10.7m (2016: £7.1m)
Strategic refocus expected to deliver annual cost savings of £4.2 million
Dr Neil Murray, Chief Executive Officer of Redx Pharma, commented, "Redx Pharma is now optimally positioned to capitalise on the potential of its world class discovery engine with the transition to clinical development of our two best-in-class assets RXC004 and RXC005 in oncology. I am also excited by the potential of our pipeline in fibrosis, bringing novel medicines to areas of severe unmet need. We look forward to announcing the start of our first clinical trial with RXC004 and to building greater value for our shareholders as a clinical stage business."

Iain Ross, Chairman of Redx Pharma, added,"I have been impressed by the potential of Redx Pharma’s science, approach to drug discovery and the speed with which the Company has created a world class pipeline of best-in-class products. Following the recent re-structuring of the organisation we are now focused on implementing an aggressive strategy to accelerate the "realisation of value" by progressing the clinical and commercial development of our lead programs and maximising the long term potential of the pipeline. I am delighted to be working with the Redx team."