On May 16, 2018 Oncology Venture AB (OV:ST) ("OV" or the "Company") reported that three abstracts detailing clinical trials of its product candidates have been accepted by the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) for the 2018 ASCO (Free ASCO Whitepaper) Clinical Meeting (Press release, 2X Oncology, MAY 16, 2018, View Source [SID1234526692]).

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Notably, Ruth Plummer, MD, PhD, FRCP, will present an abstract describing the first-in-human Phase 1 study of 2X-121, an investigational PARP 1/2 and tankyrase 1/2 inhibitor, as monotherapy in patients with advanced solid tumors.

Abstract Title: First-in-human phase 1 study of the PARP/tankyrase inhibitor 2X-121 (E7449) as monotherapy in patients with advanced solid tumors and validation of a novel drug response predictor (DRP) mRNA biomarker.

Abstract No.: 2505

Date: June 1, 2018

Time: 4:09pm CDT

Location: S406

In addition to evaluating the safety, maximum tolerated dose, and anti-tumor efficacy of 2X-121, the study also assessed the ability of a novel tumor agnostic molecular biomarker to identify responders and non-responders to 2X-121. This companion diagnostic, called the 2X-121 DRP, is based on expression of 414 genes predictive of response to 2X-121.

Following completion of the study, the 2X-121 DRP was applied in a blinded manner following a pre-specified analysis plan. The 2X-121 DRP successfully predicted the responders to treatment with 2X-121, irrespective of BRCA mutation status.

OV in-licensed this anti-cancer agent (formerly E7449) from Eisai Inc. in July 2017. Oncology Venture will initiate a Phase 2, open-label clinical study to investigate the anti-tumor effect and tolerability of 2X-121 in patients with metastatic breast cancer (mBC) selected by the 2X-121 DRP.

Dr. Plummer is director of the Sir Bobby Robson Cancer trials Research Centre at the Northern Centre for Cancer Care, Freeman Hospital, Newcastle upon Tyne, UK, and was the primary investigator of this study. She is a member of the Cancer Research UK (CRUK) Science Funding committee and chair of the CRUK New Agents Committee.

Two additional abstracts on OV pipeline products were accepted by ASCO (Free ASCO Whitepaper) as electronic abstracts as follows:

LiPlaCis

Abstract Title: Liposomal cisplatin response prediction in heavily pretreated breast cancer patients: A multigene biomarker in a prospective phase 2 study.

Abstract No.: e13077

LiPlaCis is a lipid formulation of cisplatin, one of the most widely used drugs in the treatment of cancer. This improved formulation enables a more selective up-take of cisplatin at the tumour site. Once it has accumulated in the cancer tissue, the LiPlaCis is broken down by secretory phospholipase A2 (sPLA2), an enzyme present on tumors. The lipid composition of LiPlaCis is tailored to be specifically sensitive to degradation by the sPLA2 enzyme and thereby for release of the encapsulated cisplatin.

APO010

Abstract Title: Characterization of resistance to APO010, a recombinant hexameric FAS ligand, in human myeloma cell lines.

Abstract No.: e20025

APO010 is a recombinant, soluble, hexameric fusion protein consisting of three human Fas ligand (FasL) extracellular domains fused to the dimer-forming collagen domain of human adiponectin with potential pro-apoptotic and antineoplastic activities. Assembled into a soluble hexameric structure mimicking the ligand clustering of endogenous active FasL, APO010 activates the Fas receptor, resulting in caspase-dependent apoptosis in susceptible tumor cell populations. FasL is a transmembrane protein of the tumor necrosis factor (TNF) superfamily and a pro-apoptotic ligand for the death receptor Fas.

For further information, please contact

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Mobile: +45 2170 1049

E-mail: [email protected]

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Peter Buhl Jensen, CEO

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E-mail: [email protected]

On May 16, 2018 MEI Pharma, Inc. (NASDAQ: MEIP), a pharmaceutical company focused on leveraging its extensive development and oncology expertise to identify and advance new therapies for cancer, reported the publication of two data abstracts related to MEI Pharma’s clinical stage drug development programs to be presented at the 2018 ASCO (Free ASCO Whitepaper) Annual Meeting to be held June 1-5, 2018 in Chicago (Press release, MEI Pharma, MAY 16, 2018, View Source [SID1234526708]). Study investigators will present updated results from the Phase 1b study evaluating ME-401 in relapsed/refractory indolent B-cell malignancies and from an investigator-initiated study of ME-344 in patients with HER2-negative breast cancer.

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"The ASCO (Free ASCO Whitepaper) Annual Meeting is an important event for MEI Pharma this year and we are excited to present promising updated data from both our ME-401 and ME-344 programs at the meeting next month," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "Specifically with regard to the ME-401 program, the Phase 1b data demonstrating high efficacy rates across all patient groups with an adverse event profile consistent with other PI3K delta inhibitors, along with our recently announced financing, make us well positioned to pursue our plan to initiate a ME-401 registration study before year end."

Poster Presentations at ASCO (Free ASCO Whitepaper) 2018

Title: Initial results of a dose escalation study of a selective and structurally differentiated PI3Kδ inhibitor, ME-401, in relapsed/refractory (R/R) follicular lymphoma (FL) and chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).
Date & Time: 6/4/2018, 1:15 PM-2:30 PM
Poster Discussion Session: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Abstract: 7519
Author: Jacob Drobnyk Soumerai, M.D., Massachusetts General Hospital

Title: Abrogation of resistance against bevacizumab (Bev) by mitochondrial inhibition: A phase 0 randomized trial of Bev plus ME-344 or placebo in early HER2-negative breast cancer (HERNEBC).
Date & Time: 6/4/2018, 8:00 AM-11:30 AM
Poster Session: Developmental Therapeutics—Clinical Pharmacology and Experimental Therapeutics
Abstract: 2552
Author: Miguel Quintela-Fandino, M.D., Ph.D., Director of the Clinical Research Program, Centro Nacional De Investigaciones Oncologicas, Madrid, Spain.

Abstracts featured as part of the ASCO (Free ASCO Whitepaper) 2018 program may be found at: View Source

On May 16, 2018 Pfizer Inc. reported that new data from its diversified portfolio of marketed and investigational oncology medicines will be presented at the 54th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago from June 1-5, 2018 (Press release, Pfizer, MAY 16, 2018, View Source [SID1234526724]). Data from programs in small molecules, immunotherapies, biomarker-driven medicines, as well as biosimilars, will be featured in more than 40 abstracts, including company-sponsored and collaborative research studies.

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"The breadth and depth of our data at ASCO (Free ASCO Whitepaper) this year are indicative of our focus on understanding the full potential of our medicines, including IBRANCE and XTANDI, which are already making a difference in patient lives. We are also exploring new and exciting pathways designed to transform treatment outcomes"

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"The breadth and depth of our data at ASCO (Free ASCO Whitepaper) this year are indicative of our focus on understanding the full potential of our medicines, including IBRANCE and XTANDI, which are already making a difference in patient lives. We are also exploring new and exciting pathways designed to transform treatment outcomes," said Charles Hugh-Jones, MD, FRCP, chief medical officer, Pfizer Oncology. "Our comprehensive research is resulting in near-term potential benefits for patients, as well as multiple new therapies that we hope to introduce this year."

The research to be presented includes new insights on Pfizer’s late-phase investigational compounds dacomitinib, lorlatinib, talazoparib and glasdegib, as well as Pfizer’s marketed therapy XTANDI (enzalutamide). These compounds represent the next five potential Pfizer Oncology advancements in lung, breast, hematologic and prostate cancers.

"At this year’s ASCO (Free ASCO Whitepaper), we’re particularly excited to present overall survival data for dacomitinib that builds upon our precision medicine focus and legacy in lung cancer," said Mace Rothenberg, MD, chief development officer, Oncology, Pfizer Global Product Development. "Further, we’ll be sharing new insights on our medicines across 16 disease areas and 13 mechanisms of action, including early-phase through post-approval analyses. Our extensive presence reinforces our commitment to speeding accessible breakthrough medicines to patients."

Key Pfizer abstracts include:

The first presentation of final overall survival results from the pivotal ARCHER 1050 study of dacomitinib vs. gefitinib in locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutation
Phase 2 results from a clinical research collaboration evaluating IBRANCE (palbociclib) in combination with cetuximab in platinum-resistant HPV unrelated recurrent/metastatic head and neck squamous cell carcinoma
An analysis of resistance to therapy based on genetic mutations from the pivotal PALOMA-3 trial of CDK 4/6 inhibitor IBRANCE in combination with fulvestrant in ER+/HER2- metastatic breast cancer
Longer-term efficacy and safety results from two registrational trials: the JAVELIN Merkel 200 study of PD-L1 inhibitor BAVENCIO (avelumab) in a rare skin cancer, being developed in collaboration with Merck KGaA, Darmstadt, Germany and the BFORE trial of BOSULIF (bosutinib) vs. imatinib in patients with newly diagnosed chronic myeloid leukemia
A comparative clinical study of PF-06439535, a candidate bevacizumab biosimilar, and reference bevacizumab, in patients with advanced non-squamous non-small cell lung cancer
Details for the Pfizer-sponsored oral presentations are below:

Title/Abstract Number Date/Time (CDT) Location
(Abstract 9008) Friday, June 1 Hall D1
Avelumab (anti-PD-L1) in Combination with Crizotinib or Lorlatinib in Patients with Previously Treated Advanced NSCLC: Phase 1b Results from JAVELIN Lung 101 4:30 PM – 6:00 PM

Shaw A
(Abstract 7002) Saturday, June 2 E450
Bosutinib vs Imatinib for Newly Diagnosed Chronic Myeloid Leukemia in the BFORE Trial: 24-Month Follow-Up 3:00 PM – 6:00 PM

Cortes J
(Abstract 1001) Sunday, June 3 Hall D2
Genetic Landscape of Resistance to CDK4/6 Inhibition in Circulating Tumor DNA (ctDNA) Analysis of the PALOMA3 Trial of Palbociclib and Fulvestrant Versus Placebo and Fulvestrant 8:00 AM – 11:00 AM

Turner N
(Abstract 6008) Sunday, June 3 E451
Multicenter Phase 2 Trial of Palbociclib, a Selective Cyclin Dependent Kinase (CDK) 4/6 Inhibitor, and Cetuximab in Platinum-Resistant HPV Unrelated (-) Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (RM HNSCC)

8:00 AM – 11:00 AM

Adkins D
(Abstract 9507) Monday, June 4
Arie Crown Theater

Two-Year Efficacy and Safety Update from JAVELIN Merkel 200 Part A: A Registrational Study of Avelumab in Metastatic Merkel Cell Carcinoma Progressed on Chemotherapy 8:00 AM – 11:00 AM

Nghiem P
(Abstract 109) Monday, June 4 Hall D1
A Comparative Clinical Study of PF-06439535, a Candidate Bevacizumab Biosimilar, and Reference Bevacizumab, in Patients with Advanced Non-Squamous Non-Small Cell Lung Cancer 9:45 AM – 11:15 AM

Socinski M
(Abstract 9004) Monday, June 4 Hall B1
Dacomitinib (daco) Versus Gefitinib (gef) for First-Line Treatment of Advanced NSCLC (ARCHER 1050): Final Overall Survival (OS) Analysis 3:00 PM – 6:00 PM

Mok T

Please see a complete list of Pfizer-sponsored abstracts featuring data on our broad pipeline of biologics and small molecules at View Source

Learn more about how developing new medicines and supporting people with cancer is personal for Pfizer Oncology at View Source

Dacomitinib, lorlatinib, talazoparib and glasdegib are investigational agents and have not been approved by any regulatory agencies.

On May 16, 2018 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH) last night reported preliminary data from an ongoing Phase I dose escalation and expansion study evaluating the safety and efficacy of the combination of monalizumab, a first-in-class monoclonal antibody targeting NK- and T cell checkpoint receptor NKG2A, with durvalumab (Press release, Innate Pharma, MAY 16, 2018, View Source [SID1234526741]).

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Data show preliminary anti-tumor activity in patients with recurrent, metastatic colorectal cancer, with 3 partial responses and 11 stable disease responses among 37 patients evaluable for efficacy, with a disease control rate of 24% at 16 weeks (data cut as of February 8, 2018). The data also showed a manageable toxicity profile.

The Phase I dose escalation and expansion study enrolled a total of 55 patients. In the dose-escalation part, 15 patients with selected solid tumors received durvalumab 1500 mg every 4 weeks in combination with monalizumab at increasing doses. In the expansion phase, 40 patients with microsatellite-stable colorectal cancer (MSS-CRC) were enrolled. 58% of patients in expansion had 3+ lines of prior therapy.

These data were highlighted in an abstract (#3540) published online on May 16 by the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in advance of its annual meeting in Chicago, Illinois, June 1-5, 2018. The abstract is available on the ASCO (Free ASCO Whitepaper) website. A poster (#33) with updated clinical data will be presented at ASCO (Free ASCO Whitepaper) in the Gastrointestinal (Colorectal) Cancer session in Hall A on Sunday, June 3 between 8:00am and 11:30am.

Based on these preliminary results, Innate’s partner AstraZeneca/MedImmune progressed the combination with standard of care therapies

On May 16, 2018 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that Chugai Pharma Taiwan Ltd., a wholly owned subsidiary of Chugai, obtained approval from the Taiwan Food and Drug Administration (TFDA), for "Alecensa," anaplastic lymphoma kinase (ALK) inhibitor, for the treatment of "patients with ALK-positive, advanced non-small cell lung cancer (NSCLC) (Press release, CHUGAI PHARMACEUTICAL CO, MAY 16, 2018, View Source [SID1234526670])."

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"The results of the J-ALEX study conducted by Chugai and the ALEX study conducted overseas showed that Alecensa will greatly contribute to the treatment of patients who receive at an early stage." said Dr. Yasushi Ito, Chugai’s Senior Vice President, Co-Head of Project & Lifecycle Management Unit. "Following approval for first line treatment in the US and the EU in 2017, it is a great pleasure for Chugai that Alecensa has been approved for primary treatment in Taiwan followed by Japan and South Korea in the Asia region."

This approval is based on results from the phase III ALEX study. The ALEX study evaluates the efficacy and safety of Alecensa compared with crizotinib in people with ALK-positive NSCLC who had not received prior systemic therapy (first-line).

In the study, Alecensa significantly reduced the risk of disease worsening or death by 47% (primary endpoint, HR=0.53, 95%CI: 0.38-0.73, stratified log-rank test, p<0.0001) compared to crizotinib as assessed by independent review committee. Median progression-free survival (PFS) was 25.7 months (95%CI: 19.9-not estimable) for people who received Alecensa compared with 10.4 months (95%CI: 7.7-14.6) for people who received crizotinib.

The safety profile of both drugs was consistent with that observed in previous studies, with no new findings.

In addition, Alecensa significantly reduced the risk of the cancer spreading to or growing in the brain or central nervous system (CNS) compared to crizotinib by 84% (HR=0.16, 95%CI: 0.10-0.28, stratified log-rank test, p<0.0001). This was based on a time to CNS progression analysis in which there was a lower risk of progression in the CNS as the first site of disease progression for people who received Alecensa (12%) compared to people who received crizotinib (45%).

About Alecensa
Alecensa is a highly selective oral ALK inhibitor created by Chugai. Outside of Japan, Alecensa is currently approved in the United States, Europe, Kuwait, Israel, Hong Kong, Canada, South Korea, Switzerland, India, Australia, Singapore, Taiwan, Thailand, Liechtenstein, Argentina, United Arab Emirates, Saudi Arabia and Turkey for the treatment of people with metastatic (advanced) ALK-positive NSCLC whose disease has worsened after, or who could not tolerate treatment with, crizotinib and in the US, EU, Australia, Turkey, Switzerland and South Korea for the treatment of first line therapy on ALK-positive metastatic NSCLC.

In Japan, Alecensa is available to patients with "ALK fusion gene positive unresectable, recurrent/advanced NSCLC" and is marketed by Chugai. The approved dosage and administration in Japan is "300mg alectinib administered orally twice daily for adult patient."

Note: The dosage and administration of the ALEX study is "600mg alectinib administered orally twice daily," which is different from the Japanese dosage and administration.

Trademarks used or mentioned in this release are protected by law.