On September 14, 2020 Immunomic Therapeutics, Inc. (ITI) reported that it will participate at the World Vaccine Congress Washington being held virtually September 28-October 1, 2020 (Press release, Immunomic Therapeutics, SEP 14, 2020, View Source [SID1234565112]). Andrew Eisen, MD, Ph.D., Immunomic’s Vice President of Clinical Development, will present a talk titled, "Pharmacodynamic Imaging in a CMV Vaccine Trial for Glioblastoma."

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In addition, Immunomic Therapeutics, lead founder and supporter of Why We Vax, a non-profit whose mission is to help educate communities with research backed facts on vaccines, will be leading a Q&A panel titled, "What If They Gave a COVID-19 Vaccine and Nobody Came," at 3:50pm EST on October 1, 2020.

"Vaccines are one of the safest, most widely-adopted health care practices in the world. Why We Vax will spread the message that vaccines are rigorously tested and provide the best defense against diseases. One example is Measles, which can have a lasting impact on a child’s immune system," said Dr. William Hearl, Why We Vax Chairman, Immunomic Therapeutics CEO, and experienced vaccinologist.

The World Vaccine Congress Washington is a multi-faceted conference experience with over 300 industry leading speakers, exclusive interviews, world leading presentations, live panel debates, and virtual face to face meetings.

Presentation details are as follows:

Dr. Andrew Eisen Presentation
Title: Pharmacodynamic Imaging In A CMV Vaccine Trial For GBM
Panel Category: Cancer and Immunotherapy Track
Panel Date and Time: Wednesday, September 30, 2020 2:30PM

Why We Vax Q&A Panel
Title: What If They Gave a COVID-19 Vaccine and Nobody Came
Category: Vaccine Safety track: Risk Assessment & Communication of Safety
Date and Time: Thursday, October 1, 2020 3:50PM

About UNITE

ITI’s investigational UNITE platform, or UNiversal Intracellular Targeted Expression, is thought to work by encoding the Lysosomal Associated Membrane Protein, an endogenous protein in humans. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release and critical immunological memory. This approach could put UNITE technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. UNITE is currently being employed in Phase II clinical trials as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of UNITE in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for UNITE therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.

About ITI-1000 and the Phase 2 (ATTAC-II) Study

ITI-1000 is an investigational dendritic cell vaccine therapy currently in a Phase 2 clinical trial (ATTAC-II) for the treatment of GBM. ITI-1000 was developed using Immunomic’s proprietary investigational lysosomal targeting technology, UNITE, in the context of cell therapy. In May 2017, Immunomic exclusively licensed a patent portfolio from Annias Immunotherapeutics for use in combination with UNITE and ITI-1000, allowing Immunomic to combine UNITE with a patented and proprietary CMV immunotherapy platform. The ATTAC-II study (NCT02465268) is a Phase II randomized, placebo-controlled clinical trial enrolling patients with newly diagnosed GBM that will explore whether dendritic cell (DC) vaccines, including ITI-1000, targeting the CMV antigen pp65 improves survival. This study is enrolling up to 120 subjects at 3 clinical sites in the United States. For more information on the ATTAC-II study, please visit www.clinicaltrials.gov.

On September 14, 2020 Tyme Technologies, Inc. (NASDAQ:TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs), reportedd that its leadership team will present at the BioNJ 10th Annual BioPartnering Conference on Tuesday, October 6, 2020 (Press release, TYME, SEP 14, 2020, View Source [SID1234565111]). The Company will present its corporate overview for fiscal year 2021 with a special focus on multiple growth opportunities driven by advances in the science of cell metabolism, SM-88 (racemetyrosine) pivotal and late-stage trials in pancreatic cancer, SM-88 HopES trial in ultra-rare metastatic sarcoma, proof-of-concept RESPOnD trial evaluating TYME-19 in COVID-19, and expanding clinical plans for its cancer-metabolism pipeline candidate SM-88 in pancreatic, prostate, breast and hematological cancers.

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Co-sponsored by J.P. Morgan and Johnson & Johnson Innovation, the conference brings together biopharmaceutical companies, investors, and academic collaborators across the Northeast to Mid-Atlantic states.

Event: BioNJ’s 10th Annual BioPartnering Conference
Place: The Palace at Somerset Park in Somerset, NJ
Presentation Time: October 6th, 2020, 1:30 – 3:00 PM ET

The presentation will be accessible on the events page under the Investor Relations section of Tyme Technologies’ website at www.tymeinc.com. There is no webcast for this event.

About SM-88
SM-88 is an oral investigational modified proprietary tyrosine derivative that is believed to interrupt the metabolic processes of cancer cells by breaking down the cells’ key defenses and leading to cell death through oxidative stress and exposure to the body’s natural immune system. Clinical trial data have shown that SM-88 has demonstrated encouraging tumor responses across 15 different cancers, including pancreatic, lung, breast, prostate and sarcoma cancers with minimal serious grade 3 or higher adverse events. Learn more.

About TYME-18
TYME-18 is composed of a proprietary surfactant delivery agent with a specific sulfonic acid component. It is designed for intra-tumoral administration of difficult to treat tumors and leverages the acidic tumor microenvironment and signaling pathways to kill cancer cells. TYME-18 is distinct in composition, but like SM-88, aims to leverage susceptibilities of a cancer that are related to its altered metabolism. Initial preclinical data for TYME-18 in animal tumor models demonstrate rapid and complete tumor regression, with no reported local or systemic toxicities. TYME-18 continues to be studied as a potential therapy for difficult to treat tumors that may not be eligible for surgical or other interventions. Learn more.

About TYME-19
TYME-19 is a potent, well characterized synthetic antiviral bile acid that is being evaluated as a potential oral therapy for COVID-19. In preclinical testing, TYME-19 repeatedly prevented COVID-19 viral replication without attributable cytotoxicity in treated cells. COVID-19 hijacks a cell’s ability to make proteins and lipids and divert these processes to make viral proteins and lipids in order to reproduce. COVID-19 accomplishes this by inducing stress in the endoplasmic reticulum (ER), where cells process proteins, which enables the virus to remodel protein and lipid synthesis. In preclinical testing, TYME-19 has been shown to counteract these effects, preventing viral replication, by reducing ER stress. TYME-19 is believed to physically degrade viruses by solubilizing the protective lipid layer and other structural components, which prevent a virus from binding to and infecting a cell.

About TYME-88-Panc Pivotal Trial
The TYME-88-Panc pivotal trial applies the latest advances in the field of cancer metabolism by evaluating the efficacy and safety of an oral investigational compound that targets the metabolic mechanisms of the disease at its source. A prospective, open label pivotal trial in metastatic pancreatic cancer for patients who have failed two lines of any prior systemic therapy. The trial is designed to evaluate the safety and efficacy of SM-88 used with MPS (methoxsalen, phenytoin and sirolimus) in advanced pancreatic cancer and will measure multiple endpoints, including overall survival, progression free survival, relevant biomarkers, quality of life, safety, and overall response rate. Learn more.

On September 14, 2020 TScan Therapeutics, a biopharmaceutical company focused on the development of T-cell receptor (TCR)-engineered T cell therapies in oncology, reported that management will present virtually at the following upcoming industry conferences (Press release, TScan Therapeutics, SEP 14, 2020, View Source [SID1234565110]):

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H.C. Wainwright 22nd Annual Global Investment Conference
David Southwell, Chief Executive Officer, will present a company overview on September 14, 2020, at 12:30 p.m. Eastern Time
CAR-TCR Digital Week
Gavin MacBeath, Ph.D., Chief Scientific Officer, will present "TScan, a Whole Genome, Unbiased Approach to Cancer Target Discovery" on September 14, 2020, at 1:45 p.m. Eastern Time
American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) COVID-19 Symposium
Dr. MacBeath will present the poster "Unbiased Genome-Wide Discovery Using TScan Reveals Shared Immunodominant CD8+ T Cell Epitopes in SARS-COV-2" in an oral session on September 16, 2020, at 5:00 p.m. Eastern Time
TCR-based Therapies Summit
Dr. MacBeath will lead the seminar "Expanding TCR Therapy by Identifying New Targets and TCRs from Patient TILs" on October 28, 2020, at 9:00 a.m. Eastern Time

On September 14, 2020 NanoString Technologies, Inc. (NASDAQ:NSTG), a leading provider of life science tools for discovery and translational research, reported the establishment of the GeoMx Premier Access Sites, a global service network that will provide access to the GeoMx Cancer Transcriptome Atlas and future GeoMx commercial assays (Press release, NanoString Technologies, SEP 14, 2020, View Source [SID1234565109]). The company also announced the availability of the new GeoMx Whole Transcriptome Atlas through the Technology Access Program (TAP) for the GeoMx Digital Spatial Profiler (DSP). Together these initiatives provide expanded access to next generation sequencing readout on GeoMx DSP.

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The GeoMx Premier Access Site (GPAS) partners will enable a broader user base to try the Cancer Transcriptome Atlas (CTA) and evaluate the applicability of GeoMx DSP in their research. Eight global sites have been selected and include Cedars-Sinai Medical Center, Los Angeles, University of Minnesota, University of Pittsburgh, University Medical Center Utrecht, University of York, FynnBio and Griffith University. Each site will receive advanced training on the GeoMx RNA with NGS readout protocol to offer access to the CTA and other GeoMx assays in their regions.

"We are excited to be selected to join the GeoMx Premier Access Sites," said Dr. Nic West, Research Manager, Griffith University. "Our customers are enthusiastic about incorporating spatial analysis in their research and the Cancer Transcriptome Atlas has the power to unlock novel biology from both fresh frozen and formalin-fixed paraffin-embedded tissues that are typically analyzed using bulk sequencing."

Expanding on the 1,800+-plex CTA, the GeoMx Whole Transcriptome Atlas (WTA) provides an unbiased view of 18,000+ protein-coding genes. The WTA unlocks new pathways to be explored by researchers and broadens GeoMx RNA profiling from oncology and immunology to include neuroscience, developmental biology, and other diverse fields. WTA utilizes the same workflow and chemistry as CTA, providing robust, sensitive performance on FFPE or Fresh Frozen samples.

"We’re experiencing a groundswell of interest from researchers that would like to leverage the power of next generation sequencing to study spatial biology," said Chad Brown, senior vice president of Sales and Marketing of NanoString Technologies. "We are enthusiastic about the discoveries that can be made through the spatial analysis of the whole transcriptome, which enables a broad range of new applications."

The human WTA is now available through the TAP service. Under the program, a TAP customer can submit tissue samples to NanoString to be analyzed using the GeoMx Whole Transcriptome Atlas and provide the analysis report back to the partner.

Researchers interested in participating in NanoString’s Technology Access Program should contact us at [email protected].

The GeoMx DSP capabilities that are unlocked through use of NGS readout will be featured in an exclusive event, Advancing Science: A Spatial Biology Conference, which will be hosted by NanoString on September 15. This virtual conference brings together research professionals, scientists, and clinicians from around the world to learn about and discuss recent discoveries in spatial biology. Three scientific tracks will highlight the latest data in spatial COVID-19 research, spatial genomics and spatial data analysis applications. Register here: View Source

On September 14, 2020 Seneca Therapeutics, Inc., a clinical-stage biopharmaceutical company dedicated to the development of oncolytic immunotherapeutics for cancer based on Seneca Valley Virus (SVV-001), reported the receipt of positive guidance from the FDA on the reactivation of the SVV-001 IND and Phase I/II protocol (Press release, Seneca Therapeutics, SEP 14, 2020, https://www.businesswire.com/news/home/20200914005006/en/Seneca-Therapeutics-Inc.-Receives-Positive-Feedback-from-FDA-on-Reactivation-of-the-SVV-001-IND-and-Phase-III-Protocol [SID1234565108]). The Phase I/II study will be in combination with a checkpoint inhibitor and include patients with either neuroendocrine tumors (NET) or carcinomas (NEC). The Phase I/II clinical study should begin during 2nd quarter, 2021.

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"We are pleased to receive this guidance from FDA regarding reactivating the SVV-001 IND and starting our Phase I/II protocol in patients with neuroendocrine tumors," stated Dr. Paul Hallenbeck, Founder, President, and Chief Scientific Officer of Seneca Therapeutics.

SVV-001 is a best in class oncolytic immunotherapeutic intended to enable and broaden the number of patients that respond to a checkpoint inhibitor. Seneca’s approach follows a resurgence in the field of oncolytic immunotherapeutics. These agents have demonstrated the ability to synergize with immune checkpoint inhibitors to elicit a robust immune response to the tumor. Further, STI’s trial will also involve enrolling only patients that have key biomarkers, such as the receptor for SVV, which will enhance the probability of obtaining significant patient responses.

Currently, patients with neuroendocrine tumors have limited treatment options. Seneca is seeking to demonstrate an improvement on ORR and OS responses when SVV-001 is utilized in combination with immune checkpoint blockade vs the historical data from several large studies with the immune checkpoint blockade agent alone.

About Neuroendocrine Cancers:

It is estimated that there are over 150,000 patients with neuroendocrine neoplasms in the United States (US) and the incidence is increasing (Dasari et al, 2017). Tumor grade and morphology predicts clinical outcome. Median overall survival is reported to be 16.2 years, 8.3 years, and 10 months in low-grade well NETs, intermediate-grade NETs, and NECs, respectively (Dasari et al, 2017).

Treatment options for NETs are limited. Current options include somatostatin analogues, mTOR inhibitor-everolimus, tyrosine kinase inhibitor-sunitinib, and peptide receptor radionuclide therapy (Pokuri et al, 2017).