On March 28, 2019 Innovation Pharmaceuticals (OTCQB:IPIX) ("the Company"), a clinical stage pharmaceutical company, reported that the European Medicines Agency (EMA) has granted a meeting with the Company’s European subsidiary, IPIX Pharma Ltd., to discuss a briefing package submitted for Scientific Advice regarding the clinical development program of Brilacidin oral rinse to decrease the incidence of Severe Oral Mucositis (SOM) in Head and Neck Cancer (HNC) patients receiving chemoradiation (Press release, Innovation Pharmaceuticals, MAR 28, 2019, View Source [SID1234534715]).

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The purpose of such meetings is for the EMA to provide guidance on the appropriate tests and studies in the development program for a medicine. Receiving formal scientific advice helps ensure health authority alignment regarding appropriate testing to support an eventual marketing-authorization application in Europe.

The meeting with IPIX Pharma has been scheduled by EMA for mid-April 2019 and will serve to complement the regulatory feedback and advice obtained by the Company from the already completed End-of-Phase 2 Meeting held with the U.S. Food and Drug Administration (FDA). At this meeting, an acceptable Phase 3 development pathway was agreed upon by the FDA and the Company to advance Brilacidin for the prevention of SOM in HNC.

"We are extremely pleased to have been granted this scientific meeting with the EMA, particularly in such rapid fashion," commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. "New and effective treatments that not only help mitigate, but actually prevent the occurrence of oral mucositis, have been long sought-after. Currently there is no approved drug to decrease the incidence of Severe Oral Mucositis in Head and Neck Cancer. We look forward to advancing Brilacidin toward potential regulatory approval, both in Europe and the United States, as we refine key aspects of our planned Phase 3 program in oral mucositis."

About Brilacidin Phase 2 Results in Treating Severe Oral Mucositis

The Company’s Brilacidin oral rinse demonstrated a strong therapeutic benefit in patients receiving an aggressive chemotherapy regimen (cisplatin administered 80-100 mg/m2, every 21 days), which currently is the standard of care. In this patient population, the incidence of SOM was reduced to 25.0% in the modified Intent-to-Treat (mITT) population, versus 71.4% of patients on placebo. In the Per Protocol (PP) patient group, incidence of SOM dropped to 14.3% for patients receiving Brilacidin-OM, compared to 72.7% among those receiving placebo.

The completed Phase 2 study met its primary endpoint, showing a reduction of SOM incidence versus placebo, as well as beneficial treatment effects in reducing the duration of SOM and in delaying the onset of SOM.

Linked below is information, published in a blog on the Company’s website, elaborating on how Brilacidin is positioned compared to other investigational Oral Mucositis drugs currently in clinical development.

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About Brilacidin and Severe Oral Mucositis

There currently are no FDA-approved drugs to decrease the incidence of Severe OM (SOM) (WHO Grade ≥ 3) in Head and Neck Cancer (HNC) patients receiving chemoradiation. The additional expenses incurred by patients suffering from SOM are estimated to be as high as $18,000 to $25,000 per case in the U.S. when hospitalization is required. These factors contribute to SOM qualifying as an area of significant unmet medical need. According to published statistics, the number of new annual HNC cases in the U.S. is estimated to be 65,000, and on a worldwide basis, ~750,000 cases. Between 60 and 70 percent of these HNC patients typically will develop SOM, with the overall incidence of HNC patients developing some grade of OM (WHO Grades 1 to 4) approaching 100 percent. Because it cannot be predicted which patients will develop SOM, a preventative treatment, such as Brilacidin oral rinse, would begin in all patients as soon as starting chemoradiation and continue until its completion (typically a seven-week course). Given Brilacidin is administered as a convenient oral rinse, with plans to package it in an easily transportable sachet form, the Company believes it would be attractive both to doctors and patients—likely translating to widespread and rapid market adoption should Brilacidin oral rinse gain regulatory approval.

On March 28, 2019 Coherus BioSciences, Inc. (Nasdaq: CHRS), reported that senior management will present at the H.C. Wainwright & Co.Global Life Sciences Conference in London on Tuesday, April 9, 2019 at 12:10 p.m. GMT (Press release, Coherus Biosciences, MAR 28, 2019, http://investors.coherus.com/news-releases/news-release-details/coherus-biosciences-management-present-hc-wainwright-co-global [SID1234534734]).

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The audio portion of the presentation will be available on the investors page of the Coherus BioSciences website at View Source

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 Xcovery Holdings, Inc., an oncology-focused biopharmaceutical company, reported the appointment of Li Mao, M.D., as Chief Executive Officer (CEO) and Giovanni Selvaggi, M.D., as Chief Medical Officer (CMO) (Press release, Xcovery, MAR 28, 2019, View Source [SID1234534716]). With more than 50 years of clinical experience in oncology between them, Dr. Mao and Dr. Selvaggi will oversee the clinical development of ensartinib and vorolanib, Xcovery’s two leading drug candidates currently in a global Phase 3 trial for ALK positive non-small cell lung cancer (NSCLC) and in a Phase 1/2 trial in combination with immune-oncology (IO) agents for thoracic cancer, respectively.

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"Following a thorough and rigorous process, the Board has unanimously elected Li as the CEO of Xcovery," said Lieming Ding, M.D., Chairman of Xcovery’s Board of Directors. "He will bring deep expertise in oncology, unwavering commitment to patients, and strong track record of building high performing organizations to his new role. I am confident that under Li’s leadership, Xcovery will continue to expand its impact in oncology."

"I am humbled and privileged to be the CEO of Xcovery," said Dr. Mao. "This is an extraordinary company of talented people with incomparable passion and dedication to helping patients. I look forward to working with our talented team to build on what we’ve accomplished, to deliver on the promise of our innovative programs and to make a real difference for our patients."

Prior to joining Xcovery, Dr. Mao was Vice President and Head of the Johnson & Johnson China Lung Cancer Center. Before that, he acted as a Professor and Chair of Department of Oncology and Diagnostic Sciences, and Associate Dean for Research at University of Maryland, Baltimore. Dr. Mao has also served as Leader, Experimental Therapeutics Program in the Marlene and Stewart Greenebaum Cancer Center. Previously, he was a Professor in the Department of Thoracic and Head & Neck Medical Oncology at the University of Texas MD Anderson Cancer Center, where he is currently an Adjunct Professor. Dr. Mao has played a critical role in a number of landmark multi-institution research programs, and has authored and co-authored more than 200 peer-reviewed articles cited more than 24,000 times.

"We are also pleased to welcome Giovanni to the Xcovery team as he brings broad oncology drug development expertise and strong leadership skills," Dr. Ding added. "His recent experience in spearheading the clinical development of ceritinib (Zykadia) at Novartis and leading the immunotherapy program at Bristol-Myers Squibb in thoracic malignancies will be invaluable to us as we work to not only bring ensartinib over the finish line, but also explore synergies in the ever-changing scenario of combination therapies for vorolanib."

"It is a very exciting time to be joining Xcovery as Chief Medical Officer," stated Dr. Selvaggi. "I am very encouraged by the clinical progress to date and look forward to building on this work in the ongoing and future clinical trials. Xcovery is uniquely positioned to make meaningful impact on oncology with ensartinib having the potential to be the best in class in first line therapy for ALK positive NSCLC patients, and vorolanib being tested in various combination trials with anti PD-1 agents. I look forward to working with my colleagues to advance our programs and to help cancer patients to live longer and better lives."

Dr. Selvaggi held positions of increasing responsibility at various global pharmaceutical companies prior to joining Xcovery. He joined the pharmaceutical industry in 2010 as a medical director at GlaxoSmithKline in the MAGE-A3 cancer vaccine lung program. He then played an instrumental role in the successful development and registration of ceritinib (Zykadia) at Novartis in ALK translocated NSCLC. Most recently, Dr. Selvaggi was a part of the immunotherapy team at Bristol-Myers Squibb as Program Lead in different thoracic malignancies with a focus on SCLC. Dr. Selvaggi received his medical degree at the University of Torino Medical School in 1992 and served as staff physician of Thoracic Oncology at the University Hospital in Torino, Italy, participating in several clinical trials in lung cancer and mesothelioma over a span of 16 years.

On March 28, 2019 ArcherDX, Inc., a molecular technology company dedicated to developing breakthrough solutions that advance the application of personalized genomic medicine, reported that it has entered into a research collaboration with the University College London (UCL) and the Francis Crick Institute to use ArcherDX’s proprietary Anchored Multiplex PCR (AMP) technology to detect evidence of disease recurrence in lung cancer patients from cell-free circulating tumor DNA (ctDNA) as part of the Cancer Research UK funded UCL-sponsored TRACERx study (TRAcking lung CancEr evolution through treatment (Rx))[1] (Press release, ArcherDX, MAR 28, 2019, View Source [SID1234534735]).

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"…This collaboration with ArcherDX will help towards achieving our goal of a more personalised approach to developing cancer treatments."
Professor Charles Swanton, M.D., Ph.D., lead researcher for the TRACERx study
Preliminary findings from the TRACERx clinical study were published in Nature and the New England Journal of Medicine in 2017. In the publication, UCL and the TRACERx investigators demonstrated that a patient-specific approach to circulating tumor DNA (ctDNA) profiling could be used to characterize Minimal Residual Disease (MRD) in patients who have undergone potentially curative surgery for lung cancer. Early detection of changes in ctDNA burden after the initiation of curative therapy has been associated in clinical literature with poor disease free survival. In collaboration with ArcherDX, the UCL and TRACERx investigators aim to expand upon these initial findings by developing patient- specific assays based on anchored multiplex-PCR (AMP) technology to detect low-volume MRD at high levels of sensitivity and characterize the phylogenetic and neoantigen landscape of relapsing NSCLC.

"As we expand upon and progress our research, exploring lung cancer in an unprecedented level of detail, this collaboration with ArcherDX will help towards achieving our goal of a more personalised approach to developing cancer treatments," said Professor Charles Swanton, M.D., Ph.D., lead researcher for the TRACERx study.

"We are thrilled to be working with Professor Charles Swanton and UCL," said Josh Stahl, executive vice president and chief scientific officer of ArcherDX. "This collaboration aligns closely with ArcherDX’s mission to expand access and adoption of personalized medicine in oncology. We’ve spent the last five years developing and continually evolving our technology for complex and groundbreaking applications like those being studied in the TRACERx study. We are especially pleased to be a part of this study as it has the potential to fundamentally transform patient care in early stage lung cancer."