On March 21, 2019 Epic Sciences, Inc. reported that new data will be presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019, in Atlanta, Georgia, March 29 to April 4, 2019 (Press release, Epic Sciences, MAR 21, 2019, View Source [SID1234534564]). The data from multiple studies and indications demonstrate the feasibility of Epic’s Functional Cell Profiling (FCP) technology to predict patients’ response to cancer immunotherapies and drugs that target DNA damage repair pathways.

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Epic’s FCP technology platform identifies and characterizes all circulating tumor cells in a blood sample to link their response or resistance to several drug classes. Following the highly successful development of Epic’s proprietary AR-V7 test for patients with metastatic castration-resistant prostate cancer, currently marketed as the Oncotype DX AR-V7 Nucleus Detect test, the company and its research partners are utilizing the FCP platform to analyze biomarkers to guide treatment decisions in breast cancer and small-cell lung cancer, expanding into new areas of unmet need.

"For years, Epic Sciences has been transforming late-stage prostate cancer treatment with our powerfully predictive Functional Cell Profiling technology by providing a comprehensive view of how populations of cancer cells change under selective pressure of different drug classes," said Katherine Atkinson, Chief Commercial Officer at Epic Sciences. "At AACR (Free AACR Whitepaper), we are presenting new data that demonstrates our technology’s significant value can be applied to new indications and drug classes in development, in addition to late stage prostate cancer, potentially improving the lives of many more patients."

Following are the AACR (Free AACR Whitepaper) 2019 posters and presentations:

Oral Presentation:

Title: Liquid Biopsies: From Validation to Clinical Utility
Session Description: Discussion of the development and clinical application of validated circulating tumor cell (CTC) and cell-free DNA assays to determine prognosis, predict response to treatment, identify mechanisms of resistance to guide future treatment, and assess drug effects.
Chairperson & Presentation: Howard I. Scher, Memorial Sloan Kettering Cancer Center; Predictive biomarkers in circulating tumor cells to direct management of metastatic castration-resistant prostate cancer (mCRPC)
Session Date and Time: April 1, 2019, 2:05 pm – 2:30 pm ET

Poster Presentations:

Title: HER2, AR protein expression and chromosomal instability in circulating tumor cells (CTCs) of metastatic breast cancer (MBC) patients (pts)
Session Category and Title: Clinical Research: Current Developments in Non-invasive Biomarkers for Assessment of Cancer 1
Session Date and Time: Sunday, March 31, 2019 1:00 pm – 5:00 pm ET

Title: Genomic instability as a marker of poor prognosis in advanced prostate cancer: Subclonal insights from whole-genome sequencing of single circulating tumor cells
Session Category and Title: Clinical Research: Current Developments in Non-invasive Biomarkers for Assessment of Cancer 1
Session Date and Time: Sunday, March 31, 2019, 1:00 pm – 5:00 pm ET

Title: Characterization of SLFN11 protein expression in circulating tumor cells (CTCs) of patients with metastatic castration-resistant prostate cancer (mCRPC) prior to platinum based chemotherapy
Session Category and Title: Clinical Research: Circulating and Cell-free Biomarkers for Diagnosis and Monitoring of Cancer 2
Session Date and Time: Monday, April 1, 2019, 8:00 am – 12:00 pm ET

Title: Comparison of the Epic CTC HRD assay vs. tumor DDR mutations in metastatic castration-resistant prostate cancer (mCRPC) patients (pts)
Session Category and Title: Clinical Research: Circulating and Cell-free Biomarkers for Diagnosis and Monitoring of Cancer 3
Session Date and Time: Monday, April 1, 2019, 1:00 pm – 5:00 pm ET

Title: Single-cell analyses reveal increasing intratumoral heterogeneity as an essential component of treatment resistance in small-cell lung cancer
Session Category and Title: Tumor Biology: Tumor Evolution and Heterogeneity 1
Session Date and Time: Tuesday, April 2, 2019 8:00 am – 12:00 pm ET

Title: Evaluation of pharmacokinetics of proxalutamide, a novel androgen receptor antagonist, in treatment for mCRPC patients via CTC enumeration and AR biomarker analysis
Session Category and Title: Experimental and Molecular Therapeutics: Pharmacokinetics and Pharmacodynamics/Preclinical Toxicology
Session Date and Time: Tuesday, April 2, 2019, 1:00 pm – 5:00 pm ET

Title: Simultaneous quantification of activated immune cells and PD-L1 expressing circulating tumor cells (CTCs) in peripheral blood of cancer patients receiving checkpoint inhibitor therapy
Session Category and Title: Immunology: Biomarkers and Immune Monitoring
Session Date and Time: Tuesday, April 2, 2019, 1:00 pm – 5:00 pm ET

On March 21, 2019 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology, reported it will release its audited annual financial results for the year ended December 31, 2018 on Thursday, March 28, 2019, before the US markets open (Press release, BioLineRx, MAR 21, 2019, View Source;p=irol-newsArticle&ID=2391959 [SID1234534528]).

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The Company will host a conference call on Thursday, March 28, 2019 at 10:00 a.m. EDT featuring remarks by Philip Serlin, Chief Executive Officer. The conference call will be available via webcast and can be accessed through the Investor Relations page of BioLineRx’s website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast.

To dial into the conference call, please dial +1-866-229-7198 from the U.S. or +972-3-918-0664 internationally. A replay of the conference call will be available approximately two hours after completion of the live conference call on the Investor Relations page of BioLineRx’s website. A dial-in replay of the call will be available until March 30, 2019; please dial +1-888-295-2634 from the U.S. or +972-3-925-5938 internationally

On March 21, 2019 Provectus (OTCQB: PVCT) reported that updates on the Company’s metastatic uveal melanoma drug development program for its lead investigational cancer agent PV-10 (Press release, Provectus Biopharmaceuticals, MAR 21, 2019, View Source [SID1234534529]). Intratumoral injection of small molecule oncolytic immunotherapy PV-10 can yield immunogenic cell death in solid tumor cancers and stimulate tumor-specific reactivity in circulating T cells1-4, which may lead to a functional recruitment of the immune system.

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Update #1. Presentations about PV-10 treatment of metastatic uveal melanoma will be given by Sapna Patel, MD, Associate Professor, Department of Melanoma Medical Oncology, Division of Cancer Medicine of The University of Texas MD Anderson Cancer Center at:

The International Society of Ocular Oncology (ISOO) Biennial Conference in Los Angeles, California from March 22-26, entitled "Percutaneous oncolytic rose bengal disodium for metastatic uveal melanoma patients with hepatic metastasis." ISOO is a non-profit corporation with the specific and primary purpose to advance and promote the practice of ocular oncology, and

The spring meeting of the Ophthalmic Oncology Group (OOG) in London, England from April 11-13, entitled "A Phase 1 Study of Percutaneous Oncolytic Rose Bengal Disodium (PV10) for Metastatic Uveal Melanoma to the Liver." OOG is an independent scientific group devoted to clinical ophthalmic oncology and related basic-science research.
Update #2. The Company will host a round table involving metastatic uveal melanoma patients at CURE OM’s Eyes on a Cure: Patient & Caregiver Symposium in Raleigh, North Carolina from April 5-7. The Community United for Research and Education of Ocular Melanoma (CURE OM) is the Melanoma Research Foundation’s initiative to increase awareness, education, and research funding for ocular melanoma, while improving the lives of people affected by this disease.

Ocular melanoma is a general category of melanoma disease affecting the eye and orbit. Its most common form, uveal melanoma, is an intraocular affliction originating in melanocytes in the iris, ciliary body, or choroid. Together with melanomas that form in the conjunctiva, cornea, retina, and orbit, these melanomas constitute ocular melanoma. Approximately half of ocular melanoma patients develop metastatic disease despite successful treatment of their primary tumors. Metastatic disease has historically been, and remains, generally fatal.

About Metastatic Uveal Melanoma

Uveal melanoma is a rare disease that is biologically and clinically distinct from cutaneous melanoma.5,6 Nearly 50% of uveal melanoma patients develop metastatic disease, with 80-90% of them presenting with liver as the first site of disease involvement.5,6,7 Outcomes of metastatic uveal melanoma are poor, with a median overall survival of 12 months.8

About PV-10

Provectus’ lead investigational oncology drug, PV-10, the first small molecule oncolytic immunotherapy, can induce immunogenic cell death. PV-10 is undergoing clinical study for adult solid tumor cancers, like melanoma and cancers of the liver, and preclinical study for pediatric cancers. In February 2019, orphan drug designation status was granted to PV-10 by the U.S. Food and Drug Administration for the treatment of ocular melanoma.

On March 21, 2019 Exscientia, a world-leading Artificial Intelligence (AI)-driven drug discovery company, reported that it has entered a three-year AI drug discovery partnership with leading biopharma company Celgene, including an initial $25 million upfront payment and eligibility to receive substantial milestones based on the clinical, regulatory and commercial success of the program (Press release, Exscientia, MAR 21, 2019, View Source [SID1234553912]). In addition, Exscientia is due to receive tiered royalties on net sales on any product resulting from the collaboration. Exscientia will apply its full-stack AI drug discovery capabilities to the execution of the entire project – from gene to the drug candidate.

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The collaboration will use AI to accelerate the discovery of small molecule therapeutic drug candidates for three therapeutic programmes for Celgene in the areas of oncology and autoimmunity.

Exscientia will use its cutting-edge Centaur Chemist AI drug discovery platform, which has demonstrated its unparalleled capabilities on multiple projects and its ability to reduce the timelines by at least three-quarters to discover pre-clinical drug candidates. Applying AI to improve the speed of delivery of new treatments for patients is a key goal of this collaboration.

This deal extends Exscientia’s list of partnerships with blue chip pharma and biotech companies, with existing collaborations involving Roche, GSK, Sanofi and Evotec, cementing Exscientia’s reputation as the partner of choice in the rapidly developing field of AI-driven drug discovery. At the start of this year, the Oxford based Exscientia secured a $26 million Series B investment to expand its capabilities, develop its platform and build its proprietary drug pipeline.

Professor Andrew Hopkins, CEO of Exscientia, commented: "We’re incredibly proud to collaborate with Celgene and to sign another partnership with a key industry player, reinforcing our place at the forefront of AI drug discovery. Today, patients can wait more than ten years from initial drug discovery to its availability as a treatment. With autoimmune diseases and cancer rates increasing, the pharmaceutical industry’s R&D productivity needs to dramatically improve – and technology is a key part of this. Since our pioneering Nature papers in the field, we have been developing our AI platform on the principle that AI combined with human creativity can significantly accelerate the drug discovery process and thus drastically improve access of new drugs to the market. We’re excited to work with Celgene to drive this transformational change in new therapeutic areas."

On March 21, 2019 Samsung Bioepis Co., Ltd. reported findings of a three-year follow-up study comparing biosimilar ONTRUZANT (trastuzumab) and reference medicine trastuzumab in early or locally advanced HER2-positive breast cancer (Press release, Samsung Bioepis, MAR 21, 2019, View Source [SID1234534530]). The data, which show comparable overall survival and cardiac safety, were presented today at the 16th St. Gallen International Breast Cancer Conference 2019 taking place in Vienna, Austria.

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"With the development of our biosimilar trastuzumab, we aimed to make one of the mainstays of modern cancer therapy more accessible for more people more quickly, and these long-term data underline the importance of that aim," said Chul Kim, Senior Vice President and Head of Clinical Sciences Division, Samsung Bioepis. "We are committed to increasing access to high-quality, life-changing oncology medicines through the development of biosimilars to address some of oncology’s most pressing challenges."

Participants enrolled in an initial Phase III study received eight cycles of the biosimilar trastuzumab or the reference medicine concurrently with chemotherapy in the neoadjuvant setting. Following surgery, they received additional 10 cycles of the biosimilar trastuzumab or the reference medicine. After completion of therapy, 367 of these participants (186 in the biosimilar trastuzumab group and 181 in the reference medicine group) were enrolled in the follow-up study. Median follow-up from initiation of study treatment was 40.8 months in the biosimilar trastuzumab group and 40.5 months in the reference medicine group.

Overall survival was 97% in the biosimilar trastuzumab group and 93.6% in the reference medicine group (HR 0.39, 95% CI, 0.14-1.12). Event-free survival was 92.5% in the biosimilar trastuzumab group and 86.3% in the reference medicine group (HR 0.49, 95% CI, 0.26-0.91). The incidence of cardiac events was rare for both treatment groups throughout the three-year follow-up period. There were three cases of asymptomatic significant left ventricular ejection fraction (LVEF) decrease (biosimilar trastuzumab, n=1; reference medicine, n=2), with all patients recovering with LVEF ≥ 50%. There were no cases of symptomatic congestive heart failure, cardiac death or other significant cardiac conditions reported in either group.

The poster of this study will be exhibited at the 16th St. Gallen International Breast Cancer Conference 2019, as follows:

[P156] 3-YEAR FOLLOW-UP OF A PHASE III STUDY COMPARING SB3 (TRASTUZUMB BIOSIMILAR) AND REFERENCE TRASTUZUMAB IN HER2 POSITIVE EARLY OR LOCALLY ADVANCED BREAST CANCER IN NEOADJUVANT SETTING [POSTER SESSION I, MARCH 21, 2019]
ONTRUZANT (trastuzumab) 150 mg was granted the European Commission (EC) Marketing Authorization in November 2017 and was approved by the U.S. Food and Drug Administration in January 2019. In February 2019, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for a 420 mg vial presentation of ONTRUZANT.iii With the adoption of CHMP’s positive opinion for ONTRUZANT 420 mg vial presentation, ONTRUZANT will be available in two vial sizes in Europe, providing clinics with greater convenience and flexibility than the 150 mg vial presentation alone.