On April 1, 2019 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported that it will release its financial results for the first quarter of 2019 before the market opens on Wednesday, April 24, 2019, and will hold a conference call on the same day at 8:30 a.m. EDT (Press release, Thermo Fisher Scientific, APR 1, 2019, View Source [SID1234534825]).

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During the call, the company will discuss its financial performance, as well as future expectations. To listen, call (877) 273-7122 within the U.S. or (647) 689-5496 outside the U.S. You may also listen to the call live on the "Investors" section of our website, www.thermofisher.com. The earnings press release and related information can be found in that section of our website under "Financial Results." A replay of the call will be available under "Webcasts and Presentations" through Friday, May 10, 2019.

On April 1, 2019 Oncorus, Inc., an oncolytic virus therapeutics company focused on driving innovation to transform outcomes for cancer patients, reported preclinical data yesterday supporting the clinical advancement of its lead oncolytic virus candidate, ONCR-177, during an oral presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019 (Press release, Oncorus, APR 1, 2019, View Source [SID1234534841]). The data demonstrated that intra-tumoral administration of ONCR-177 resulted in high partial and complete response rates on both injected and non-injected tumors in preclinical models of several tumor types, including immune-inert, or cold, tumors. Responses were durable, resulting in an extension of survival and the establishment of protective immunity against tumor re-challenge.

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ONCR-177, a locally administered oncolytic virus therapy for the treatment of multiple solid tumor indications, is built on Oncorus’ proprietary, next-generation oncolytic herpes simplex virus (HSV) platform. ONCR-177 is armed with five transgenes, IL-12, CCL4, FLT3L, and CTLA-4 and PD-1 antagonists – representing the largest payload in the oncolytic virus therapy class – for potent stimulation of anti-tumor immunity. The therapy also employs an innovative microRNA (or miR)-attenuation strategy to enable selective viral replication in tumor cells, while preventing replication in healthy tissues.

"We are excited to share these important data driving the clinical advancement of ONCR-177," said Theodore (Ted) Ashburn, M.D., Ph.D., President and Chief Executive Officer of Oncorus. "We are highly encouraged by the responses we’ve seen to treatment with ONCR-177 in multiple preclinical models as a result of the proprietary potency and safety innovations we have engineered. Our team continues to make remarkable progress on several fronts as we advance our best-in-class portfolio of oncolytic virus therapies for both local and systemic administration toward the clinic, with the goal of transforming outcomes for cancer patients."

Oncorus plans to file an investigational new drug application (IND) for ONCR-177 in 2019. In addition to its oncolytic HSV platform, Oncorus is also developing a novel synthetic oncolytic virus platform to enable the development of oncolytic virus therapies for repeated, systemic administration for uninjectable tumors, such as those of the lung.

About the Preclinical Findings

Intra-tumoral administration of the mouse surrogate of ONCR-177 in the oncolytic HSV-sensitive A20 BALB/c lymphoma bilateral tumor model resulted in response rates (partial and complete tumor regressions) of 100% and 80%, respectively, on the injected and uninjected tumor. mONCR-177 was also highly efficacious in the B16F10-nectin 1 melanoma model, an oncolytic HSV-resistant C57BL/6 based tumor model engineered to be permissive to oncolytic HSV by introduction of nectin-1, and in two colon carcinoma models CT26 and MC38.

mONCR-177 treatment resulted in increased numbers of activated NK cells, CD8+ and CD4+ effector T cells, and classical dendritic cells. The proportion of regulatory T cells, or Tregs, decreased, resulting in large increases CD8/Treg ratios. These changes in immune contexture occurred in both injected and uninjected tumors. They were more pronounced with mONCR-177 treatment compared to the base vector without payloads, indicating that the observed abscopal effects were due to mONCR-177’s elicitation of systemic anti-tumor immunity mediated in part by its payload of multiple transgenes.

"Due to their ability to kill cancer cells while eliciting a potent systemic antitumor immune response, ONCR-177 represents a potentially transformational treatment modality for cancer, as a monotherapy and in combination with checkpoint inhibitors," said Christophe Quéva, Ph.D., Oncorus’ Chief Scientific Officer. "At Oncorus, we have made important strides to overcome the ‘potency versus safety’ tradeoff that has historically held back this class of therapeutics, and we look forward to moving ONCR-177 into the clinic."

Oncorus has three additional poster presentations at the AACR (Free AACR Whitepaper) meeting showcasing the company’s proprietary potency and safety innovations for both its oncolytic HSV and synthetic oncolytic virus platforms, including:

Abstract #: 1455
Title: Design of ONCR-177 base vector, a next generation oncolytic herpes simplex virus type-1, optimized for robust oncolysis, transgene expression and tumor-selective replication
Session: PO.IM02.08 — Cancer Vaccines and Intra-tumoral Immunomodulation
Date and Time: Monday, April 1, 2019 / 8:00 am – 12:00 pm EDT
Location: Poster Section 22
Abstract Link: View Source!/6812/presentation/2749

Abstract #: 1452
Title: Development of ONCR-148, a miR-attenuated oncolytic HSV-1 designed to potently activate antitumor T cell response
Session: PO.IM02.08 — Cancer Vaccines and Intra-tumoral Immunomodulation
Date and Time: Monday, April 1, 2019 / 8:00 am – 12:00 pm EDT
Location: Poster Section 22
Abstract Link: View Source!/6812/presentation/2746

Abstract #: 4773
Title: Development of ONCR-NEP, a lipid nanoparticle delivered oncolytic virus capable of robust in situ amplification resulting in tumor lysis and regression
Session: PO.ET08.01 — Gene- and Vector-based Therapy
Date and Time: Wednesday, April 3, 2019 / 8:00 am – 12:00 pm EDT
Location: Poster Section 12
Abstract Link: View Source!/6812/presentation/1354

On April 1, 2019 Resolution Bioscience, Inc. reported that scientists from Dana-Farber Cancer Institute are presenting the results of a retrospective liquid biopsy comparison study between Resolution’s ctDx-Lung assay and Guardant Health’s Guardant360 test this morning at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (Press release, Resolution Bioscience, APR 1, 2019, View Source [SID1234534857]).

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Liquid biopsy assays have the potential to expand access to personalized care for those whose tissue biopsies are inadequate or unavailable and may present an opportunity for enhanced cancer monitoring and detection of minimal residual disease. The study was conducted to explore the technical differences and test the reliability of cell-free DNA next-generation sequencing (NGS) assays, which are not completely characterized at this time.

The comparison study highlights detection challenges of complex mutations such as gene fusions, as well as the need for platform cross-comparisons to realize the potential of liquid biopsy and increase access to personalized cancer care. A cohort of 169 non-small cell lung cancer (NSCLC) patients with Guardant360 results were screened for gene fusions. The team of scientists at Dana-Farber used a soon-to-be-released ctDx-Lung kit to analyze 16 cases that had a rearrangement in their tumor, along with additional banked plasma. All personnel involved in sample analysis were blinded to tumor genotype and Guardant360 results. The team found that the Resolution ctDx-Lung assay identified more actionable gene fusion mutations with higher allele frequencies than the Guardant360 test. The results further demonstrate the potential of the ctDx-Lung kit for patients with advanced NSCLC.

The ctDx-lung kit detected 13 out 16 fusions (allele frequency range 80-0.3%), while Guardant360 detected only seven (allele frequency range 10-0.3%). Of the 13 cases where an oncogenic fusion was detected in plasma, 89% of patients with productive fusions and 75% of patients with ‘non-productive’ fusions responded to tyrosine kinase inhibitor (TKI) therapies. Additional unblinding is ongoing to better understand false negative cases.

"This study is another strong validation of our targeted NGS-based liquid biopsy platform and its ability to outperform other assays, such as the Guardant360 test," said Mark Li, CEO of Resolution Bioscience. "These results prove our kits can be run at the leading cancer centers around the world, enabling more scientists to detect more of these actionable mutations, which will soon transform the way we diagnose, treat and monitor devastating diseases like NSCLC."

Attendees interested in the presentation, "Building an effective concordance study: Plasma Next Generation Sequencing (NGS) for oncogenic fusion detection in non-small cell lung carcinoma (NSCLC)," by Cloud Paweletz, PhD, of the Belfer Center at Dana-Farber Cancer Institute can reference abstract 1374/13. The study is being presented today between 8 AM-12 PM in Section 19 of the Georgia World Congress Center Exhibit Hall.

The funding for the study was provided by the Expect Miracles Foundation, the Robert and Renee Belfer Foundation, the Damon Runyon Cancer Research Foundation, and the Harold and Gail Kirstein Lung Cancer Research Fund.

To view the scientific poster, please visit www.resolutionbio.com/publications/AACR2019_DFCI_Fusions.pdf.

About Resolution ctDx-Lung

ctDx-Lung is built on Resolution’s patented cell-free DNA NGS analysis platform. The liquid biopsy assay captures and analyzes circulating tumor DNA (ctDNA) for driver mutations in 20 genes associated with NSCLC using Resolution’s proprietary targeted capture NGS chemistry and cloud-based bioinformatics.

On April 1, 2019 Exicure, Inc. (OTCQB: XCUR), the pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) constructs, reported that its CEO, Dr. David Giljohann, will give a company presentation on Monday, April 8, 2019 at 11:50 am GMT at the H.C. Wainwright Global Life Sciences Conference (Press release, Exicure, APR 1, 2019, View Source;p=RssLanding&cat=news&id=2392908 [SID1234534807]). The presentation will be made in the Stratton Suite of the Grosvenor House in London.

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A live audio webcast will be available on the Investors section of Exicure’s website: www.exicuretx.com. The webcast will be archived for approximately 30 days following the event.

On April 1, 2019 BerGenBio ASA (OSE:BGBIO) reported that on a top-line, preliminary basis, the first efficacy endpoint has been met in a Phase II clinical trial (BGBC003, NCT02488408) evaluating bemcentinib, a first-in-class selective oral AXL inhibitor, in combination with low-dose cytarabine (LDAC) as a potential new treatment regimen for acute myeloid leukaemia (AML) patients unable to tolerate intensive therapy (Press release, BerGenBio, APR 1, 2019, View Source [SID1234534826]). A second cohort evaluating bemcentinib in combination with decitabine is also ongoing and data is further maturing.

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The pre-specified efficacy endpoint in this trial requires at least three patients out of the first 14 patients (21%) to achieve clinical responses* when treated with the novel drug combination.

The cohort evaluating bemcentinib in combination with LDAC, summarised below, has met its primary endpoint; data is further maturing:

In total, 15 patients were enrolled of which 10 are evaluable for response to date. Among these, 4 were newly diagnosed and 6 relapsed or refractory (R/R).
In newly-diagnosed patients, one complete remission (CR) and one CR with incomplete haematologic recovery(CRi) were observed (2 out of 4) and one CR among R/R patients (1 out of 6), yielding a CR/CRi rate of 30% (3 out of 10).
All responders were above the age of 75, at least one had secondary disease, and two had unfavourable cytogenetic profiles. Responses had an early onset (after 1 to 2 cycles), were durable and deepened over time and the combination of bemcentinib with LDAC was well tolerated causing no overlapping or new toxicities compared to each agent given alone.
An extensive translational programme continues to explore potential biomarkers for bemcentinib combination therapy. Further details will be presented at upcoming medical conferences.

Furthermore, the Company is proceeding with preparations for a late-stage bemcentinib monotherapy trial in AML. The study, expected to start in the second half of 2019, will aim to confirm previously reported monotherapy efficacy of bemcentinib in AML patients whose disease has progressed on standard of care therapy. Correlation with relevant biomarkers will be explored with the ambition to pursue an accelerated development path in a selected patient population.

Professor Dr Dr Sonja Loges, attending physician at the University Hospital Hamburg-Eppendorf and lead investigator of the BGBC003 trial, commented: "Data gathered by our group and others have established AXL as a negative prognostic factor in patients with AML and other malignancies. AXL acts both as a driver of leukaemic cell proliferation and as negative regulator of anti-tumour immunity and therefore represents a novel and promising target in AML. Bemcentinib, an oral tablet, targets AXL selectively and I am pleased to see activity in my patients receiving bemcentinib alone or in combination with standard low-intensity therapies while side effects thus far have proven to be limited and manageable. These early results warrant further investigation of bemcentinib in a larger trial addressing AML patients unfit for intensive chemotherapy."

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "Clearing the efficacy threshold for bemcentinib in combination with LDAC is very encouraging, particularly as we have seen responses in a less fit AML patient population who are considered to have unfavourable prognosis after the failure of first-line therapies, or those with high risk cytogenetics. AML patients represent a challenging patient population for clinical trials, but we are keen to pursue AML monotherapy as our first indication based on the high unmet need, strength of clinical proof-of-concept with biomarker correlation, excellent safety and potential for a fast and first route to registration. We look forward to providing more details on the trial design upon initiation and reporting further data with bemcentinib combinations in this indication as it matures." *defined as objective response (OR), as measured by the revised recommendations of the International Working Group (IWG) in AML

END

About AML and the BGBC003 trial
AML is the most common form of acute leukaemia in adults where malignant AML blasts interfere with the normal functioning of the bone marrow leading to a multitude of complications like anaemia, infections and bleeding. AML is diagnosed in over 20,000 patients in the US annually and is rapidly lethal if left untreated. Successful treatment typically requires intensive therapy or bone marrow transplantation, and relapse and resistance are common. Consequently, there is an urgent need for effective novel therapies in relapsed/refractory patients, particularly those that are ineligible for intensive therapy or bone marrow transplant.

The BGBC003 trial is a phase Ib/II multi-centre open label study of bemcentinib in combination with cytarabine (part B2) and decitabine (part B3) in patients with AML who are unsuitable for intensive chemotherapy as a result of advanced age or existing-co-morbidities.

For more information please access trial NCT02488408 at www.clinicaltrials.gov.

About AXL
AXL kinase is a cell membrane receptor and an essential mediator of the biological mechanisms underlying life-threatening diseases. In cancer, AXL suppresses the body’s immune response to tumours and drives cancer treatment failure across many indications. AXL inhibitors, therefore, have potential high value at the centre of cancer combination therapy, addressing significant unmet medical needs and multiple high-value market opportunities. Research has also shown that AXL mediates other aggressive diseases.