On March 29, 2019 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it filed an application with the Ministry of Health, Labour and Welfare (MHLW) for expanded use of "FoundationOne CDx Cancer Genomic Profile," a next-generation sequencing based program currently under preparation for launch, to include as a companion diagnostic using tumor tissue specimens for PARP inhibitor "Lynparza" (generic name: olaparib) (Press release, Chugai, MAR 29, 2019, View Source [SID1234534748]).

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The filing aims to expand the program for use as a companion diagnostic to identify people that could potentially benefit from Lynparza for the maintenance treatment of adult patients with advanced ovarian cancer in complete or partial response to first-line platinum-based chemotherapy who have tumor mutations in BRCA1/2 based on the SOLO-1 Phase 3 randomized trial results.

FoundationOne CDx Cancer Genomic Profile is a next-generation sequencing based in vitro diagnostic device for the detection of substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. The program was approved by the MHLW in December 2018 as the first cancer genomic test in Japan with the two functions of cancer genomic profiling and companion diagnostics for molecular-targeted drugs.

As a leading company in the field of oncology, Chugai is committed to realize advanced personalized oncology care and contribute to patients and healthcare professionals through improving access to comprehensive genomic profiling.

[Notes]
A press release issued on December 27, 2018: Chugai Obtains Approval for Genomic Mutation Analysis Program "FoundationOne CDx Cancer Genomic Profile"
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On March 29, 2019 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported that the company will present at the following conferences in April (Press release, Iovance Biotherapeutics, MAR 29, 2019, View Source;p=RssLanding&cat=news&id=2392771 [SID1234534740]):

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American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Atlanta, March 29-April 3
Title: Persistence of cryopreserved tumor-infiltrating lymphocyte product lifileucel (LN-144) in C-144-01 study of advanced metastatic melanoma
Authors: Viktoria Gontcharova et al.
Session Title: Late-Breaking Research: Immunology 1
Session Type: Late-Breaking Poster Session
Section: 41
Abstract Number: LB-069

Location: Georgia World Congress Center
Date/Time: Monday, April 1, from 8:00 a.m. – 12:00 p.m. EDT
Jefferies 6th Annual IO Cell Therapy Summit in Boston, April 5
Location: Boston Harbor Hotel
Date/Time: Friday, April 5, at 10:35 a.m. EDT

HC Wainwright Global Life Science Conference in London, April 7-9
Location: JW Marriott Grosvenor House London
Date/Time: Tuesday, April 9, at 9:50 a.m. BST
A live and archived webcast of the presentation will be available by visiting the Investors section of the Iovance Biotherapeutics website at View Source

2019 Cell & Gene Meeting on the Mediterranean in Barcelona, April 23-25
Location: Hotel Arts Barcelona
Date/Time: Wednesday, April 24, at 12:00 p.m. CEST

15th European Association of Dermato-Oncology (EADO) Congress in Paris, April 24-27
Title: Safety and efficacy of cryopreserved autologous tumor infiltrating lymphocytes (LN-144, lifileucel) in previously treated metastatic melanoma patients (Encore presentation)
Location: Maison de la Chimie Conference Center
Date/Time: Thursday, April 25 at 2:07 p.m. CEST

On March 28, 2019 Biokin Pharmaceutical Co. Ltd., ("Biokin Pharma") a leading pharmaceutical company with operations in China and U.S., and Cryoport, Inc. (NASDAQ: CYRX) (NASDAQ: CYRXW) ("Cryoport"), the world’s leading temperature-controlled logistics company dedicated to the life sciences industry, reported Cryoport’s full suite of temperature-controlled solutions will support Biokin Pharma’s pending Phase I and II clinical trials in immuno-oncology in both the U.S. and China (Press release, Biokin Pharma, MAR 28, 2019, View Source [SID1234554051]).

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Biokin Pharma, is a biopharmaceutical company based in China focused on the treatment of cancer through developing novel therapeutic antibodies and antibody-drug conjugates ("ADC"s). Led by a group of highly experienced immuno-oncology scientists, the company utilizes several technology platforms to develop world class advanced antibody-based drug therapies. Its wholly-owned subsidiary SystImmune Inc. ("SystImmune"), which is funded in part by OrbiMed, was formed to advance its mission in the United States. Partnering with Cryoport will enable Biokin Pharma and SystImmune to utilize Cryoport’s full range of temperature-controlled logistics solutions to support its drug manufacturing processes across the globe. These solutions include the Cryoport Express shippers, the industry-leading Cryoportal Logistics Management Platform, Smartpak II Condition Monitoring System and 24/7/365 logistics support.

"We are pleased to choose the highly reliable condition- and time-sensitive logistics solutions provided by Cryoport to support our upcoming clinical studies using Bispecific and Multi-specific Antibody, ADC, and T-cell Therapy," said Dr. Yi Zhu, Chairman of Biokin Pharma and its U.S. subsidiary, Systimmune of Seattle, WA. "By relying on Cryoport’s excellent solutions, Biokin Pharma and Systimmune will continue to have the best possible viability and recovery of critical cells, vectors, antibodies and other materials, even after time-consuming international or domestic transportation, to ensure the best outcome for our patients."

"As the regenerative medicine market rapidly matures, the demand for our technology-driven solutions to support trials across the globe is growing. We look forward to working alongside Biokin Pharma and its U.S. subsidiary to ensure reliable, secure logistics support for their temperature-sensitive commodities as they advance the development of potentially life-saving therapies," said Mark Sawicki, PhD, Chief Commercial Officer of Cryoport.

On March 28, 2019 Bristol-Myers Squibb and Concerto HealthAI, a market leader in oncology-specific Real-World Data (RWD) and advanced Artificial Intelligence (AI)-enabled insight solutions for Real-World Evidence (RWE) generation, reported a multi-year strategic agreement that will cover a diverse range of cancers, integrate multiple data sources, and apply AI and machine learning to accelerate clinical trials, enable robust protocol design and generate insights for precision treatment and improved patient outcomes (Press release, Bristol-Myers Squibb, MAR 28, 2019, View Source [SID1234554041]).

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Bristol-Myers Squibb will use Concerto HealthAI’s Real-World Data and novel AI insights platform, eurekaHealth, to accelerate insights through novel health economic outcomes and clinical development synthetic control arm studies. With this agreement, the companies will advance the use of RWE for regulatory purposes, validate clinical application of AI solutions and execute clinical studies to advance patient care.

"With the increasing importance of Real-World Data and Real-World Evidence, healthcare providers and regulators need to have confidence in the credibility and accuracy of the data sources and methods of evidence generation," said Jeff Elton, Ph.D. and CEO of Concerto HealthAI. "Our agreement with Bristol-Myers Squibb is a recognition that we have reached a pivot-point for RWE – it is not just a tool for generating insights into the current standard of care, but a field in its own right that can lead to optimization of current treatments and new therapeutic innovations."

"At Bristol-Myers Squibb, we have seen the value of Real-World Data in our efforts to discover, develop and deliver medicines for patients," said Jeff Conklin, Senior Vice President and Head of Business Insights and Analytics at Bristol-Myers Squibb. "This strategic agreement with Concerto HealthAI – a leader in AI solutions for precision oncology – reinforces our commitment to pursue data science to accelerate disease insights, advance novel study concepts and achieve precision in treatment, with the goal of improving patient outcomes."

"Concerto HealthAI’s singular mission," said Dr. Elton "is to partner with leading medical societies, healthcare providers and life science companies to bring together data, technology and talent to enable new RWE insights and improve the use and broaden the beneficial impact of cancer therapies for patients. The strategic agreement between Bristol-Myers Squibb and Concerto HealthAI reflects both how far the field has advanced and its high near-term potential."

Recently, the 21st Century Cures Act accelerated adoption of RWE-based approaches to clinical trials and post-approval studies. In December 2018, the U.S. Food and Drug Administration (FDA) reinforced its commitment to expanding use of RWD in studies, and to preference where RWE would be used for key decisions – by issuing a framework to assess RWE in regulatory decisions and approvals. Concerto HealthAI integrates data from sources including CancerLinQ, a platform that collects and analyzes real-world data from patients at practices nationwide and delivers knowledge back to physicians and researchers. CancerLinQ is developed and operated by CancerLinQ LLC, a nonprofit subsidiary of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper). As an exclusive licensee, Concerto HealthAI works closely with CancerLinQ to broaden the use of RWE for pre- and post-approval studies.

On March 28, 2019 Queen’s University Belfast and Domainex are reported that their joint project team has successfully identified novel first-in-class small molecule inhibitors of the anti-apoptotic protein FLIP (Press release, Queen’s University Belfast, MAR 28, 2019, View Source [SID1234554005]). The team has generated data suggesting multiple therapeutic opportunities for a FLIP inhibitor in both the single agent and combination settings and is now seeking a commercial partner for further development of the novel inhibitors.

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The team is presenting the FLIP inhibitor programme at the AACR (Free AACR Whitepaper) annual meeting in Atlanta on 31 March 2019 (New Molecular Targets poster session, poster 382 /14). The poster showcases the on-target effects of the inhibitors, their drug-like properties, their potency against B Cell Lymphomas, triple negative breast cancer and KRAS and EGFR mutant non-small cell lung cancer, and their potential for combination with chemotherapy, immune oncology agents and EGFR-targeted therapeutics.

The next phase of the programme will comprise selection of a pre-clinical development candidate and completion of pre-clinical activities. Profs Dan Longley (Biology lead) and Tim Harrison (Med Chem lead) are attending the AACR (Free AACR Whitepaper) meeting and will be actively engaging in discussions with potential partners at the meeting.

This FLIP programme has been funded by the Wellcome Trust and has focussed on the identification and optimisation of novel first-in-class small molecule FLIP-FADD protein-protein interaction inhibitors. FLIP is a non-redundant inhibitor of Caspase 8 and functional FLIP allows tumour cells to evade cell death and promotes tumour growth and therapy resistance. The novel FLIP inhibitors activate Caspase 8 and have shown efficacy in a number of pre-clinical models including clinically challenging KRAS and EGFR mutant non-small cell lung cancer.

To arrange to meet the team at AACR (Free AACR Whitepaper) please contact Enda Gribbon: ([email protected])

Trevor Perrior, Chief Executive Officer of Domainex, commented: "Our medicinal chemists have been delighted to work on this exciting target and enable Prof. Dan Longley and his team to identify and optimise the FLIP inhibitors. There were several challenges that we had to solve in order to identify hits and develop a series of potential drug compounds that are potent and selective. We look forward to at least one of these compounds progressing towards the clinic for the benefit of patients. The funding secured from the Wellcome Trust is a clear endorsement of the strength of the integrated drug discovery platform of Domainex to deliver molecules with disease-modifying potential and we remain deeply committed to supporting academic translational research."

Prof. Dan Longley from the Centre for Cancer Research and Cell Biology (CCRCB) at Queen’s University Belfast, added: "Resistance to cancer therapeutics such as chemotherapy is a major clinical problem that limits the effectiveness of many current cancer treatments. Very often, this is caused by the failure of anti-cancer therapies to kill the cancer cells. FLIP is a cellular protein that cancer cells frequently express at high levels, and this increases their resistance to chemotherapy and other types of therapy used to treat cancer, such as radiotherapy. The agents that we are developing target FLIP and prevent it from causing therapy resistance. In addition, some tumour-promoting immune cells also need FLIP, so our FLIP inhibitors may also have beneficial effects in the tumour microenvironment by reactivating immune cells to attack cancer cells."