On March 21, 2019 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage immunotherapeutics company, reported that it will announce financial results for the year ended December 31, 2018 before the market open and host a conference call on Tuesday, April 2, 2019 (Press release, Altimmune, MAR 21, 2019, View Source [SID1234534545]).

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Conference Call Details
Date: Tuesday, April 2
Time: 8:30am Eastern Time
Domestic: 877-423-9813
International: 201-689-8573
Conference ID: 13687672
Webcast: View Source

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 20, 2019 PDC*line Pharma reported that grants exclusive license in South Korea and exclusive option in other Asian countries to LG Chem Life Sciences Company, for the development and commercialization of PDC*lung cancer vaccine for lung cancer (Press release, PDC Line Pharma, MAR 20, 2019, View Source [SID1234554037]).

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The total deal value is 108M€ (123M$) plus significant tiered royalties on net sales in Asia.
Under the terms of the agreements, PDC*line Pharma will co-operate with LG Chem, who will have the full rights in South Korea and an exclusive option for other Asian countries, to develop and commercialize the company’s drug candidate, PDC*lung, in lung cancer. PDC*lung is constituted of a PDC*line loaded with HLA-A2 restricted peptides derived from six shared tumor antigens.
Under the terms of the agreement, PDC*line Pharma will continue developing its PDC*lung candidate in the EU, US and global markets outside of Asia, and LG Chem will be responsible for future development and commercialization in its territories.

On March 20, 2019 Genzada Pharmaceuticals USA Inc. (Genzada), a subsidiary of Ionics Life Sciences Limited, reported that the first patient enrolled in its Phase 1 clinical trial for the oral therapeutic GZ17-6.02 received the first dose this week at HonorHealth Research Institute in Scottsdale, Ariz (Press release, Genzada Pharmaceuticals, MAR 20, 2019, View Source [SID1234534510]). Genzada’s GZ17-6.02 will be administered to patients with advanced solid cancers and lymphoma.

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The drug is derived in part from the black calla lily (arum palaestinum), a native plant found in several regions of the Middle East. Traditional Middle Eastern medicine has used the lily for more than 1,000 years as an herbal remedy for multiple maladies, including inflammation, viral infection and cancer.

"We’re excited to have reached the clinical stage of development of GZ17-6.02. Through the rigorous preclinical developmental path, we have discovered a unique mechanism of action via super-enhancer inhibition. We’re confident that this agent will be both safe and effective in cancer patients and are thrilled to bring this into the clinic," said Genzada Chief Operating Officer Cameron West, MD. "Additionally, as GZ17-6.02 is composed of three active pharmaceutical ingredients—originally derived from medicinal plants—we’re hopeful that 6.02 will tackle various malignancies on multiple fronts."

Genzada chose TD2, a contract research organization (CRO), to manage the operational aspects of the trial, including trial design, project management, data management, monitoring, clinical site management, safety and statistics.

"Reaching the clinical stage is a huge milestone for the companies we work with, as it takes a lot of hard work and preparation to get to this point," said Stephen Gately, president and CEO of TD2. "This particular drug is quite interesting in its composition, and we’re honored to be part of this trial that could potentially improve the lives of cancer patients."

With enrollment for the study projected to reach 30-40 patients nationally, Genzada expects continued treatments among trial patients throughout the remainder of 2019. Currently, patients enrolled in this clinical trial will receive the GZ17-6.02 (6.02), an investigational compound, at HonorHealth Research Institute in Scottsdale. In the future, additional trial sites may be included as the study progresses.

"GZ17-6.02 is truly a novel therapy with the potential to transform cancer care. With the support of Genzada and TD2, we are pleased to make this treatment available at HonorHealth Research Institute," said Frank Tsai, MD, medical oncologist, principal investigator at HonorHealth Research Institute.

In November 2018, the project’s Investigational New Drug (IND) application received clearance from the U.S. Food and Drug Administration (FDA) to proceed with the Phase 1 human trial of 6.02 in patients with advanced solid cancers and lymphoma.

The 6.02 compound acts as an inhibitor to super-enhancers, the areas of the genome bound by transcription factors that are uniquely susceptible to repair signal disruption. It previously showed success in many therapeutic settings, including patients with pancreatic cancer and those with head and neck squamous cell carcinoma.

On March 20, 2019 Dynavax Technologies Corporation (NASDAQ: DVAX), a fully-integrated biopharmaceutical company focused on discovering and developing novel vaccines and immuno-oncology therapeutics, reported it will present safety and biomarker data for DV281, its inhaled TLR9 agonist, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019, being held March 29 – April 3, in Atlanta, Georgia (Press release, Dynavax Technologies, MAR 20, 2019, View Source [SID1234534546]).

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Abstract Number and Title: #8304, "Phase Ib/II, open label, multicenter study of inhaled DV281, a Toll-like receptor 9 agonist, in combination with nivolumab in patients with advanced or metastatic non-small cell lung cancer (NSCLC)"

Poster Session Title: Phase I-III Trials in Progress: Part 3

Session Date and Time:Tuesday, April 2, 2019, 1 – 5 p.m. ET

Session Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 17, Poster Board Number: #18

Permanent Abstract Number: CT224

About DV281
DV281 is Dynavax’s proprietary investigational TLR9 agonist designed specifically for focused delivery to primary lung tumors and lung metastases. DV281 is similar in biological activity and mechanism of action to Dynavax’s Phase 2 immunotherapy candidate, SD-101, but has been optimized for administration as an inhaled therapy. Both SD-101 and DV281 activate plasmacytoid dendritic cells which then stimulate T cells specific for antigens released from dying tumor cells. TLR9 agonists such as DV281 and SD-101 have been shown to stimulate potent Type 1 interferon induction along with maturation of dendritic cells to effective antigen-presenting cells; both activities are important for the induction of effective anti-tumor immunity.