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GO2 Foundation for Lung Cancer Announces Young Innovators Team Award Recipients

On December 3, 2019 GO2 Foundation for Lung Cancer reported the recipients of the 2019 Young Innovators Team Awards (YITA) (Press release, Bonnie J Addario Lung Cancer Foundation, DEC 3, 2019, View Source [SID1234551868]). Two teams of researchers received grants totaling $500,000 for their work developing novel strategies to treat KRAS-mutant non-small cell lung cancer (NSCLC) and examining the impact of age on development, progression, and immunotherapy response in NSCLC.

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"The lack of institutional research funding for lung cancer creates a disincentive for talented young scientists and doctors to pursue research in this area, but we are working to change that through this partnership and joint award," said Bonnie J. Addario, lung cancer survivor, co-founder and chair of GO2 Foundation. "That is why we created the YITA – to support researchers who look beyond current methodologies of treating lung cancer."

Following a rigorous peer-review process by a panel of global lung cancer key opinion leaders, Drs. Yanxiang (Jessie) Guo and Shawn Davidson and Drs. Matthew Bott and Tuomas Tammela came out on top for their proposals titled, Targeting Tumor Metabolism to Improve Immunotherapy in KRAS-mutant NSCLC and Age-related Determinants of Initiation, Progression, and Immunotherapy Response in Non-small Cell Lung Cancer, respectively.

"These exciting proposals by talented young doctors and scientists address ongoing challenges in the field of lung cancer, bringing us closer to finding new treatments for a disease that takes more lives than colon, breast and pancreatic cancers combined," said Laurie Fenton Ambrose, co-founder, president and CEO of GO2.Foundation.

Dr. Yanxiang (Jessie) Guo from Rutgers Cancer Institute of New Jersey and Dr. Shawn Davidson from the Lewis-Sigler Institute for Integrative Genomics at Princeton University submitted the first winning proposal. Targeting Tumor Metabolism to Improve Immunotherapy in KRAS-mutant NSCLC examines the interaction of tumor cells and immune cells for growth of KRAS-driven NSCLC. To date, KRAS-mutant NSCLC has been largely resistant to most treatments. In an effort to improve outcomes and the efficacy of immunotherapy for patients with KRAS mutations, Drs. Guo and Davidson examine the metabolism of different cell types in KRAS-mutant lung tumor microenvironment to determine whether their hypothesis is correct in that cancer cell metabolism deeply affects tumor microenvironment and leads to an impaired anti-tumor immune response. The investigators’ long-term goal is to implement strategies that can overcome resistance to immunotherapy in KRAS-mutant NSCLC.

Drs. Matthew Bott and Tuomas Tammela from Memorial Sloan Kettering Cancer Center and Weill-Cornell Medical College authored the second winning proposal. Age-related Determinants of Initiation, Progression, and Immunotherapy Response in Non-small Cell Lung Cancer explores the intersection of tumor biology, anti-tumor immunity, and aging. Specifically, the investigators’ preliminary data suggest several important differences in the development and progression of lung cancer in young versus older individuals. Further, Drs. Bott and Tammela propose that lung cancer in young and older individuals represents two distinct diseases with different natural histories and susceptibilities to therapy. If true, these findings suggest the two age groups require different approaches to managing lung cancer, particularly with the use of immunotherapies that require a robust immune system.

"While we have seen recent progress in targeting KRAS, more treatment options are desperately needed. The innovative research by these two teams, particularly the proposal examining age determinants in NSCLC, complement our ongoing efforts to understand the genomics of lung cancer in patients under age 40," said Amy Moore, Ph.D., director of science and research of GO2 Foundation.

Five years ago the Bonnie J. Addario Lung Cancer Foundation (which merged with the Lung Cancer Alliance in 2019 to form GO2 Foundation for Lung Cancer) launched the Young Innovators Team Awards in partnership with the Van Auken Private Foundation. Designed to encourage out-of-the-box thinking and foster leadership skills among young innovators by instilling confidence in them to drive breakthrough lung cancer research under a collaborative, cross-institutional paradigm, YITA grants fund research that is:

Out-of-the-box – creative research that has potential for near-term benefits to lung cancer patients; high-risk, high-impact research typically not selected for federal funding
Collaborative – research that fosters collaboration among young researchers who haven’t worked together in the past, preferably across institutions
Translational – research with outcomes that can be quickly moved from the lab to the clinic, or from the bench to bedside
Multi-disciplinary – research projects that involve multiple academic disciplines/specializations in their approach to solve a problem in the field of lung cancer

NS Medical Devices | LineaRx signs agreement with TYME Technologies

On December 3, 2019 Applied DNA Sciences reported that LineaRx, the Company’s majority-owned subsidiary focused on next-generation biotherapeutics and diagnostics, it has signed a definitive agreement with Tyme Technologies, to supply the Company’s Vita-Assay invasive Circulating Tumor Cell (iCTC) capture assay and associated services for use in the pivotal stage of the TYME-88-PANC clinical trial for patients with third-line pancreatic cancer (the "Agreement") (Press release, Applied DNA Sciences, DEC 3, 2019, View Source [SID1234551867]).

Under the terms of the Agreement, TYME has the option to purchase from the Company up to 3,000 Vita-Assay kits and associated iCTC analytical and storage services over the course of treatment of up to 250 patients. The potential value of the Agreement is the largest contract to-date for LineaRx, and the largest in the development history of the iCTC assay.

The Company and TYME have previously announced a study demonstrating correlation between the number of iCTCs in a patient’s blood and their disease status, as observed in TYME’s SM-88 Phase II trial for recurrent prostate cancer. The study demonstrated that SM-88 had very encouraging efficacy and safety outcomes for prostate cancer patients where sparing testosterone was important. The study also showed that reduction of CTCs, an important prognostic indicator, may prove to be a better surrogate for patient outcomes than PSA, particularly for SM-88 and other non-hormonal agents.

Advaxis Announces Submission of IND Application for ADXS-HOT Drug Candidate for Prostate Cancer

On December 3, 2019 Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, reported it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1 clinical study of ADXS-504, the Company’s ADXS-HOT drug candidate for prostate cancer (Press release, Advaxis, DEC 3, 2019, View Source [SID1234551866]).

"We are pleased to announce continued clinical progress of our ADXS-HOT program," said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. "Results from our ADXS-NEO program provided important proof-of-concept data demonstrating the generation of CD8+ T cells against hotspot mutations. Based on these encouraging results, and the convenient and broadly accessible off-the-shelf approach of our HOT therapies, we are focused on expanding the HOT program to additional cancer-specific trials through various, capital-efficient avenues. In addition, we look forward to reporting immune data from the monotherapy arm of our ongoing Phase 1/2 HOT clinical trial in non-small cell lung cancer (NSCLC) in early 2020."

ADXS-504 is part of the company’s ADXS-HOT off-the-shelf immunotherapy platform which targets hotspot neoantigens, allowing for the development of multiple cancer-type specific clinical candidates. Advaxis has designed over ten ‘HOT’ drug candidates that are in various stages of development, with the company’s Phase 1/2 clinical trial for ADXS-503 in NSCLC currently enrolling patients at five centers. Advaxis anticipates reporting the immune data from the first dose level of ADXS-503, Part A, in monotherapy, and expects to dose the first patient in Part B, which is studying ADXS-503 in combination with the checkpoint inhibitor pembrolizumab, in early 2020.

About ADXS-HOT

ADXS-HOT is a program that leverages the Company’s proprietary Lm technology to target hotspot mutations that commonly occur in specific cancer types. ADXS-HOT drug candidates are designed to target acquired shared or "public" mutations in tumor driver genes along with other cancer-testes and oncofectal tumor-associated antigens that also commonly occur in specific cancer types. ADXS-HOT drug candidates are an off-the-shelf treatment approach designed to potentially treat all patients with a specific cancer type, without the need for pretreatment biomarker testing, biopsy, DNA sequencing or diagnostic testing.

Oncolytics Biotech(R) Presents Clinical Data at the Fifth Annual Oncolytic Virotherapy Conference Highlighting Definitive Evidence of Systemic Delivery and Replication of Pelareorep in Tumor Tissue

On December 3, 2019 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported that Matt Coffey, President & CEO of Oncolytics Biotech, will be presenting on a panel as well as delivering a corporate presentation on systemic delivery tomorrow at the Oncolytic Virotherapy Conference (Press release, Oncolytics Biotech, DEC 3, 2019, View Source [SID1234551864]). The panel presentation, "To IT or IV? Intra-Tumoral vs. Intra-Venous Administration," will discuss what indications require IT versus IV, the risks and challenges associated with IT delivery and the views of physicians. Dr. Coffey’s corporate presentation will focus on a recently announced metanalysis of 13 clinical studies and how this intravenous-related data is driving the clinical programs of Oncolytics. The conference takes place December 4 – 5 at the Westin Waterfront Hotel in Boston, MA.

"Our proven ability to systemically deliver pelareorep through intravenous delivery is a key value driver for Oncolytics," said Dr. Coffey. "I’m excited to see this topic gaining the exposure it deserves and thrilled to be a part of the conversation on this panel at the Oncolytic Virotherapy Conference. I’m also looking forward to presenting data to our peers that outlines pelareorep’s ability to target and infect a majority of tumors, triggering effective immune recruitment following intravenous administration."

Presentations

December 4, 1:40 pm ET

Clinical development of the oncolytic reovirus, pelareorep, for breast cancer

A meta-analysis from 13 different clinical studies on the efficiency of IV delivery
Combination therapy with checkpoint blockade in breast cancer.
Adaptive immune activation following IV delivery and the development of a potential biomarker
December 4, 3:10 pm ET

Panel Presentation: To IT or IV? Intra-Tumoral vs. Intra-Venous Administration

Decide whether OV treatments are most effective when injected directly into the tumour or systemically
Weigh the risks of IT administration with the benefits of a more targeted approach
Consider the views of physicians
About Pelareorep

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

ImmuPharma to present at Biotech Showcase™ 2020 in San Francisco

On December 3, 2019 ImmuPharma PLC (LSE:IMM), a specialist drug discovery and development company, is reported that it will be presenting at the Biotech Showcase 2020, to be held between 13–15 January 2020, at the Hilton, San Francisco Union Square (Press release, ImmuPharma, DEC 3, 2019, View Source [SID1234551863]).

Dr Tim Franklin, Commercial Advisor to ImmuPharma, will be presenting to conference attendees on 14th January 2020 at 10:30am (EST) in room Yosemite C (Ballroom Level). If you are attending the event and would like to meet with Dr Franklin for a one to one meeting, please contact Lisa Baderoon, Head of Investor Relations, who will be able to arrange a meeting: [email protected].