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).

On September 14, 2020 The Janssen Pharmaceutical Companies of Johnson & Johnson reported multiple data presentations from its oncology portfolio and pipeline, including key data in lung cancer and bladder cancer, will be featured as part of the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020, Science Weekend taking place 19–21 September (Press release, Janssen Pharmaceuticals, SEP 14, 2020, View Source [SID1234565107]).

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Thirteen abstracts featuring Janssen data have been selected for presentation during the virtual congress, including an oral presentation and live Q&A of the latest data from the Phase 1 dose escalation study investigating amivantamab (JNJ-61186372) in combination with lazertinib in patients with advanced EGFR-mutated non-small cell lung cancer (NSCLC); updates on multiple Phase 1/2 studies evaluating erdafitinib in the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC); an update on patient-reported outcomes on health-related quality of life data from the final analysis of the Phase 3 SPARTAN study of apalutamide in patients with non-metastatic castration resistant prostate cancer (nmCRPC) with over four years of follow up. The full final analysis of the SPARTAN study was also recently published in European Urology.1 In addition, Janssen makes its first presentation of in-human data for early-stage investigational protein arginine methyltransferase 5 (PRMT5) inhibitor JNJ-9178 in multiple tumour models (relapsed/refractory B cell non-Hodgkin lymphoma or advanced solid tumours, including patients with lower risk myelodysplastic syndromes). 2,3

"Janssen’s data at this year’s congress demonstrates our continued commitment to advancing our broad oncology portfolio, driven by the critical unmet needs in solid tumours for some of the most prevalent cancers in Europe," said Dr Joaquín Casariego, M.D., Janssen Therapeutic Area Lead, Oncology for Europe, Middle East & Africa, Janssen-Cilag, S.A. "The advancement of new approaches to cancer treatment and interception at earlier stages of the disease is vital to improve clinical outcomes and ultimately enhancing the quality of life for those affected by an oncologic diagnosis."

Company-sponsored abstracts to be presented at the meeting include:

Abstract/Presentation No.

Title

Amivantamab

Proffered Paper 1: NSCLC Metastatic

Sunday 20th September

14:37–14:49 CET

Abstract #1258O

Amivantamab (JNJ-61186372), an EGFR-MET bispecific antibody, in combination with lazertinib, a 3rd-generation tyrosine kinase inhibitor (TKI), in advanced EGFR NSCLC

On-Demand E-Poster Display Session

Thursday 17th September

Abstract #1405P

Survival of patients with Non-Small Lung Cancer and Exon 20 insertion mutation from the Czech Republic

JNJ-9178

On-Demand Mini Oral Session: Development Therapeutics

Friday 18th September

Abstract #537MO

First-in-Human Study of JNJ-64619178, a Protein Arginine Methyltransferase 5 (PRMT5) inhibitor, in Patients with Advanced Cancers

Erdafitinib

On-Demand E-Poster Display Session

Thursday 17th September

Abstract #603TiP

Phase 2, Open-Label Study of Erdafitinib in Adult and Adolescent Patients with Advanced Solid Tumors Harboring Fibroblast Growth Factor Receptor (FGFR) Gene Alterations

Abstract #750P

Erdafitinib in Patients with Locally Advanced or Metastatic Urothelial Carcinoma (mUC): Subgroup Analyses of Long-Term Efficacy Outcomes of a Pivotal Phase 2 Trial (BLC2001)

Abstract #751P

Analysis of Circulating Tumor DNA (ctDNA) From the Phase 2 BLC2001 Trial of Erdafitinib in Locally Advanced or Metastatic Urothelial Carcinoma (mUC) to Identify Markers of Intrinsic Resistance to Fibroblast Growth Factor Receptor (FGFR)-Targeted Therapy

Abstract #752P

Updated Data From the NORSE Trial of Erdafitinib Plus Cetrelimab in Patients with Metastatic or Locally Advanced Urothelial Carcinoma (mUC) and Specific Fibroblast Growth Factor Receptor (FGFR) Alterations

Abstract #757P

An Observational Study of Outcomes of Patients with Advanced Urothelial Carcinoma (UC) After Anti-programmed Death-(Ligand) 1 (PD-[L]1) Therapy by Fibroblast Growth Factor Receptor Gene Alteration (FGFRa) Status

Abstract #758P

Assessment of Prognostic and Predictive Value of FGFR Alterations (FGFRa) in a Real-World Cohort of Patients with High-Risk pT1 Non-Muscle-Invasive Bladder Cancer (NMIBC)

Apalutamide

On-Demand E-Poster Display Session

Thursday 17th September

Abstract #632P

Health-Related Quality of Life (HRQoL) at Final Analysis of the SPARTAN Study of Apalutamide vs Placebo in Patients with Nonmetastatic Castration-Resistant Prostate Cancer (nmCRPC) Receiving Androgen Deprivation Therapy (ADT)

Abstract #630P

Apalutamide for Non-Metastatic Castration Resistant Prostate Cancer (nmCRPC): A Comparison of Real-Life Experience From an International Named Patient Program vs the Prior Phase 3 Clinical Study

Niraparib

On-Demand E-Poster Display Session

Thursday 17th September

Abstract #689TiP

NRG Oncology’s GU007 (NADIR) TiP: A Randomized Phase II Trial of Niraparib With Standard Combination Androgen Deprivation Therapy (ADT) and Radiotherapy in High-Risk Prostate Cancer (With Initial Phase I)

Big Data and Artificial Intelligence Research

On-Demand E-Poster Display Session

Thursday 17th September

Abstract #695TiP

ORACULUM: A Retrospective Observational Epidemiological Study Using Artificial Intelligence and Natural Language Processing in Electronic Health Records to Characterize the Prostate Cancer pathway, Management and Outcomes in Europe, Middle East and Africa (EMEA region)

# #END# #

About apalutamide
Apalutamide is an orally administered, selective androgen receptor (AR) inhibitor approved in Europe and is indicated in adult men for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease and in adult men for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC), also known as metastatic castration-sensitive prostate cancer (mCSPC), in combination with androgen deprivation therapy (ADT).4 In the U.S. apalutamide is also indicated for the treatment of nmCRPC and mCSPC.5

About erdafitinib
Erdafitinib is a once-daily, oral fibroblast growth factor receptor (FGFR) kinase inhibitor that is being studied in patients with selected FGFR gene alterations in locally advanced or metastatic urothelial cancer, in Bacillus Calmette-Guérin (BCG) experienced, high risk non-muscle-invasive bladder cancer and in advanced solid tumours.6,7,8,9,10,11 In 2019 erdafitinib was approved in the U.S. for the treatment of adults with locally advanced or metastatic urothelial carcinoma (mUC) that has susceptible FGFR3 or FGFR2 genetic alterations and who have progressed during or following at least one line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.12 In 2008, Janssen Pharmaceutica N.V. entered into an exclusive worldwide license and collaboration agreement with Astex Pharmaceuticals to develop and commercialise erdafitinib.13

About amivantamab
Amivantamab (JNJ-6372) is an investigational EGFR-MET bispecific antibody with immune cell-directing activity, which targets activating and resistance EGFR mutations, and MET pathway activation.14,15 The production and development of the antibody followed Janssen Biotech, Inc.’s licensing agreement with Genmab for use of its DuoBody technology platform.16

About lazertinib
Lazertinibi is an oral, third-generation, selective inhibitor of certain forms of the epidermal growth factor receptor (EGFR) with activating mutations, including the resistance mutation T790M, exon 19 deletions (Del19), and the L858R mutation, with potential antineoplastic activity.17 It is currently being explored in combination with amivantamab in patients with advanced non-small cell lung cancer.18

About JNJ-9178
JNJ-64619178 is an oral, selective protein arginine methyltransferase 5 inhibitor which is currently being investigated in a Phase 1 study for the treatment of patients with relapsed/refractory B cell non-Hodgkin lymphoma or advanced solid tumours, including patients with lower risk myelodysplastic syndromes.3,19