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."

On March 28, 2019 Shuwen Biotech reported that Tasly Pharmaceutical Group has tapped Shuwen Biotech for clinical services and proprietary diagnostics for its oncology drug candidates (Press release, Shuwen Biotech, MAR 28, 2019, View Source [SID1234554004]).

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"With the shifting economic macro-environment globally, the need for cost-saving, innovative and personalized diagnostics is more than ever before. We at Shuwen aim to add value not only to committed innovators in the pharmaceutical space like Tasly, but ultimately to all patients in need of healthcare treatments," commented Jay Z. Zhang, Chairman and CEO of Shuwen Biotech.

The two companies plan to use Shuwen’s established companion diagnostic development team and CAP-accredited reference labs to drive clinical outcomes and ultimately deliver the most innovative and life-saving solutions to patients and healthcare professionals globally.

On March 28, 2019 Nordic Nanovector ASA (OSE: NANO) reported that members of its senior management team will participate and present at the following upcoming investor conferences during April (Press release, Nordic Nanovector, MAR 28, 2019, View Source [SID1234553454]):

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DNB’s 15th Annual Small & Medium Enterprises (SME) Conference in Oslo on 4 April
The 12th Kempen Life Sciences Conference in Amsterdam on 16-17 April
The company presentation will be available on the investors and media page on the first day of the conference.

For further information, please contact:

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On March 28, 2019 ESSA Pharma Inc. (TSX-V: EPI;Nasdaq: EPIX), a pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported the nomination of EPI-7386 as the lead clinical candidate for the treatment of metastatic castration-resistant prostate cancer ("mCRPC") (Press release, ESSA, MAR 28, 2019, View Source [SID1234539332]). EPI-7386 is a novel drug candidate that inhibits the N-terminal domain of the androgen receptor. Through this novel mechanism of action, EPI-7386 displays activity in vitro in numerous prostate cancer models including models where current antiandrogens are inactive. Compared to ESSA’s first generation compound, ralaniten acetate, EPI-7386 is significantly more potent, metabolically stable and more effective in preclinical studies. In addition, EPI-7386 has demonstrated a favorable tolerability profile in all animal studies of the compound conducted to date. IND-enabling studies are currently underway, and ESSA expects to enter clinical studies with EPI-7386 in the first quarter of 2020.

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As recently presented at the 2019 Genitourinary Cancers Symposium, EPI-7386 demonstrates in vitro cellular potency against the androgen receptor in a similar range to the leading antiandrogens, bicalutamide and enzalutamide. Importantly, EPI-7386 shows activity in numerous in vitro models of antiandrogen resistance driven by the AR-V7 splice variant of the androgen receptor while enzalutamide is inactive. In addition, EPI-7386 is metabolically stable in liver microsome and hepatocyte preparations and shows a favorable pharmacokinetic profile in mice, exhibiting significant exposure and a long half-life. Lastly, EPI-7386 (60 mg/kg) displayed comparable activity to enzalutamide (30 mg/kg) in a prostate cancer LNCaP xenograft mouse model in which enzalutamide mouse exposure was estimated to be twice the clinical exposure of enzalutamide in humans.

"We are excited to announce the nomination of EPI-7386 as our lead clinical candidate for the treatment of mCRPC," said David Parkinson, President and Chief Executive Officer of ESSA. "EPI-7386 represents a novel approach to targeting the androgen receptor, one of the most validated targets in oncology. We look forward to bringing this novel drug candidate to patients with mCRPC who have no other treatment options."