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."

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 VBL Therapeutics (Nasdaq: VBLT) reported financial results for the year ended December 31, 2018, and provided a corporate update (Press release, VBL Therapeutics, MAR 28, 2019, View Source [SID1234534697]).

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"We continue to advance our clinical program for VB-111 in ovarian cancer and are also exploring additional oncology indications," said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. "The ongoing Phase 3 OVAL trial in platinum resistant ovarian cancer continues to enroll patients and we expect an interim efficacy readout by year end 2019.

"Recently, at the Society of Gynecologic Oncology (SGO) conference, we presented data showing that in 3 out of 3 ovarian cancer patients from whom we obtained tumor biopsies, including a Phase 3 patient who was enrolled in the early unblinded stage of the Phase 3 OVAL study, VB-111 resulted in recruitment of infiltrating T-cells into the tumor, turning it from `cold` to `hot`. This important finding suggests that VB-111 may be applied to other `cold` tumors, in which checkpoint inhibitors show limited or no efficacy. Furthermore, although limited, we are encouraged that in the open label part of the Phase 3 study, data seem to recapitulate the activity of VB-111 in our prior Phase 2 trial for ovarian cancer.

"Based on these data on the potential ability for VB-111 to turn immunologically `cold` tumors `hot`, we expect the launch of a Phase 2 clinical trial with the National Cancer Institute (NCI), exploring VB-111 in colon cancer in combination with a checkpoint inhibitor, in the second half of 2019.

"We are also seeing renewed interest from the medical oncology community in the potential of VB-111 to treat recurrent Glioblastoma (rGBM) based on MRI analyses performed by UCLA. Accordingly, recruitment in an investigator-sponsored study for VB-111 in rGBM is expected to commence in Q2 2019. This study will be conducted at top neuro-oncology centers in the US. Therefore, toward late 2019 we expect there will be three ongoing clinical trials of VB-111, in ovarian cancer, colon cancer and rGBM.

"We also have valuable pipeline assets, including our MOSPD2 antibody programs in inflammation and oncology, as well as VB-201, for which we have recently signed a strategic exclusive option license agreement for veterinary use, with potential payments to VBL that may exceed €50 million during the license term."

"We had more than $50 million in cash and cash equivalents at December 31, 2018. This is expected to provide us with sufficient resources to continue to develop VB-111 and other product candidates and to fund our operating expenses and capital expenditure requirements through 2021," said Amos Ron, Chief Financial Officer of VBL Therapeutics.

Fourth Quarter and Recent Corporate Highlights:

Executed a strategic exclusive option license agreement with one of the world-leading European animal health companies, for the development of VBL’s proprietary anti-inflammatory molecule, VB-201, for veterinary use. VBL is receiving an undisclosed up-front payment and upon exercising the option to license, VBL will receive additional milestones and royalties, which may exceed €50 million. VBL retains worldwide rights for the use of VB-201 for the treatment of humans.
Presented new data at the Society of Gynecologic Oncology (SGO) 50th Annual Meeting on Women’s Cancer demonstrating the potential of VB-111 to stimulate the immune system and drive immune cells to infiltrate the tumor microenvironment, switching tumors from immunologically `cold` to `hot`.
Presented new analysis from the Phase 3 GLOBE study of VB-111 in patients with rGBM at the 2018 Society for Neuro-Oncology (SNO) annual meeting. New data provided insight into how the VB-111 treatment regimen may influence its anti-tumor activity, and thus why use of Avastin without prior priming with VB-111 monotherapy can block VB-111 activity. This likely explains why the positive Phase 2 data in rGBM were not replicated in the GLOBE Phase 3 study.
Presented new data on the potential of VB-600 platform of antibodies targeting MOSPD2 for treatment of various inflammatory indications, including multiple sclerosis (MS), nonalcoholic steatohepatitis (NASH) and rheumatoid arthritis (RA) at the Keystone Symposia on Myeloid Cells. An Investigational New Drug (IND) application for MOSPD2 mAb for treatment of inflammatory indications is planned for submission in 2020.
Published a manuscript demonstrating MOSPD2 as a key player in breast cancer metastasis and a potential target for treatment of solid tumors. Earlier in 2018, VBL presented a late-breaking study at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2018 Annual Meeting, demonstrating a novel bi-specific antibody that induces immune-cell mediated killing of cancer cells through binding MOSPD2. An IND application for bi-specific antibody for treatment of solid tumor indications is planned for 2H2020.
Awarded a non-dilutive grant of over 10 million New Israeli Shekels (approximately $2.9 million) by the Israel Innovation Authority (IIA), to support continued development of VB-111 for 2019.
Fiscal Year Ended December 31, 2018 Financial Results:

Revenues: Revenues related to the VBL’s collaboration in Japan amounted to $0.6 million in the year ended December 31, 2018.
Cash Position: At December 31, 2018, VBL had cash, cash equivalents and short-term bank deposits of $50.5 million and working capital of $47.0 million. VBL expects that its cash and cash equivalents and short-term bank deposits will be sufficient to fund operating expenses and capital expenditure requirements through 2021.
R&D Expenses: Research and development expenses, net, after government grants, for the year ended December 31, 2018, were approximately $15.9 million, compared to approximately $17.8 million in the same period in 2017.
G&A Expenses: General and administrative expenses for the year ended December 31, 2018 were $5.2 million, compared to $5.8 million for the same period in 2017.
Comprehensive Loss: VBL reported a net loss for year ended December 31, 2018, of $20.4 million, or ($0.62) per share, compared to a net loss of $10.2 million, or ($0.37) per share, in the year ended December 31, 2017.
For further details on VBL’s financials, please refer to Form 20-F filed with the SEC.

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On March 28, 2019 Adaptive Biotechnologies and its collaborators reported that it will present 11 studies, including an oral presentation and 10 poster presentations, at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Atlanta, GA, March 29 – April 3 (Press release, Adaptive Biotechnologies, MAR 28, 2019, View Source [SID1234534717]).

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New data will demonstrate how immunosequencing at scale and with precision using Adaptive’s immunoSEQ Assay may be used in clinical trials to predict overall survival and response to novel immunotherapies, such as checkpoint inhibitors and cancer vaccines, in solid tumors. Other data will examine the ability of immunoSEQ to quantify and characterize the individual T cell receptors (TCR) of tumor infiltrating lymphocytes (TILs), a type of white blood cell that attacks cancer cells and controls tumor proliferation, to assist in identifying subtypes of colorectal cancer. This information may be used to help determine response to immunotherapy and patient outcomes among subtypes. Collectively the studies also demonstrate a growing use of immunoSEQ by academia and the pharmaceutical industry to help guide clinical research.

"Adaptive’s immune medicine platform is essential to helping our academic and pharmaceutical industry partners decode the information stored in our immune systems to answer translational research questions and discover new prognostic and diagnostic signals in oncology clinical trials," said Chad Robins, CEO and co-founder of Adaptive Biotechnologies. "Making this tool widely available to research partners helps us drive toward our goal of transforming medicine to improve patient lives."

Abstracts are available on AACR (Free AACR Whitepaper) website: View Source!/6812. immunoSEQ presentations of interest include:

Exploratory analysis of T cell repertoire dynamics upon systemic treatment with the oncolytic virus pelareorep in combination with pembrolizumab and chemotherapy in patients with advanced pancreatic adenocarcinoma (abstract #2272/1), poster presentation, April 1, 1:00 – 5:00 pm ET, Exhibit Hall B, Section 20
Tumor infiltrating lymphocytes, immunoSEQ, and CMS classification in the molecular epidemiology of colorectal cancer study, (abstract #2332/1), poster presentation, April 1, 1:00 – 5:00 pm ET, Exhibit Hall B, Section 23
Detection of tumor T-cell clones in mediastinal lymph nodes is associated with lower risk of tumor progression (abstract #3175/28), poster presentation, April 2, 8:00 am – 12:00 pm ET, Exhibit Hall B, Section 21
Spatially resolved immunogenomic analyses reveal diverse sub tumoral microenvironments in the context of melanoma immunotherapy (abstract #3776/9), April 2, 1:00 – 5:00 pm ET, Exhibit Hall B, Section 7
About immunoSEQ Assays

Adaptive’s immunoSEQ Assay helps researchers make discoveries in areas such as oncology, autoimmune disorders, infectious diseases and basic immunology. The immunoSEQ Assay can identify millions of T- and B-cell receptors from a single sample in exquisite detail. Offered as a Service or Kit, the immunoSEQ Assay is used to ask and answer translational research questions and discover new prognostic and diagnostic signals in clinical trials. immunoSEQ Assay provides quantitative, reproducible sequencing results along with access to powerful, easy-to-use analysis tools. The immunoSEQ Assay is for research use only and is not for use in diagnostic procedures