On September 14, 2020 Pfizer Inc. (NYSE: PFE) reported that it will host its virtual Investor Day today and tomorrow: Monday, September 14, 2020 from 1:00 p.m. EDT to 3:45 p.m. EDT and Tuesday, September 15, 2020 from 10:00 a.m. EDT to 1:30 p.m. EDT (Press release, Pfizer, SEP 14, 2020, View Source [SID1234565115]). Pfizer business executives and scientific leadership will provide updates on the company’s progress in advancing its R&D pipeline, specifically on product candidates with blockbuster potential that are expected to launch by 2025.

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The agenda for Pfizer’s Investor Day is as follows:

DAY 1

Monday September 14, 2020 | 1:00 p.m. – 3:45 p.m. ET

DAY 2

Tuesday September 15, 2020 | 10:00 a.m. – 1:30 p.m. ET

1:00 p.m.

Welcome & Introduction to Day 1

Speaker: Chuck Triano

10:00 a.m.

Welcome & Introduction to Day 2

Speaker: Chuck Triano

1:05 p.m.

Executive Leadership Team Plenary Session

Pfizer "Big Picture"
Speaker: Albert Bourla
R&D Turnaround Story
Speaker: Mikael Dolsten
Productivity of Clinical Change
Speaker: Rod MacKenzie
Pfizer Biopharmaceuticals Group Core Therapeutic Area Overview
Speaker: Angela Hwang
10:05 a.m.

Inflammation & Immunology Triad Presentation and Q&A

Speakers: Richard Blackburn, Michael Corbo, Michael Vincent & Tamas Koncz

10:50 a.m.

Rare Disease Triad Presentation and Q&A

Speakers: Suneet Varma, Brenda Cooperstone & Seng Cheng

10 Minute Break

10 Minute Break

2:15 p.m.

Internal Medicine Triad Presentation and Q&A

Speakers: Michael Gladstone, James Rusnak & Morris Birnbaum

11:45 a.m.

Oncology Triad Presentation and Q&A

Speakers: Andy Schmeltz, Chris Boshoff, Jeff Settleman & Nicholas Saccomano

3:00 p.m.

Vaccines Tetrad Presentation and Q&A

Speakers: Nanette Cocero, Luis Jodar, Kathrin Jansen & William Gruber

5 Minute Break

12:35 p.m.

Updates on COVID-19 Programs and Q&A

Speakers: Mikael Dolsten, Kathrin Jansen & Angela Hwang

1:20 p.m.

Closing Remarks

Speaker: Albert Bourla

To access the live webcast, including audio, video and presentation slides, visit our web site at www.pfizer.com/investors. The webcast can also be accessed directly at www.PfizerInvestorDay.virtualeventsite.com. Participants are advised to register in advance.

Investors and analysts will also have an opportunity to ask questions in live Q&A sessions with speakers. Those participants who would like to ask a question can dial either (833) 711-4985 in the United States and Canada or (916) 637-9673 outside of the United States and Canada. The password is "Pfizer2020". Members of the media are invited to monitor the call by dialing (833) 711-4985 in the United States and Canada or (916) 637-9673 outside of the United States and Canada with the password "Pfizer2020". Journalists who wish to ask questions are requested to contact a member of Pfizer’s Media Relations team.

Interested parties unable to watch the live webcast will be able to view and listen to an archived copy of the webcast, which will be available on www.pfizer.com/investors following the conclusion of the event.

On September 14, 2020 Diaceutics PLC, (AIM: DXRX), reported the establishment of a dedicated Advisory Panel of experts to support and inform the development and rollout of its revolutionary DXRX platform – the world’s first diagnostic network for precision medicine (Press release, Diaceutics, SEP 14, 2020, View Source [SID1234565114]).

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The panel consists of key opinion leaders from the areas of oncology, including lung cancer research and colorectal research; pathology, including tissue pathology and uropathology; molecular diagnostics; digital image analysis; telemedicine and informatics; external quality assessment (EQA); and FDA-expertise. They are providing insights and recommendations to help drive the future direction of DXRX, as well as other solutions developed by Diaceutics to better support the treatment of patients across the world and transform the healthcare industry.

Endorsed and shaped by these industry leaders with over 120 years of collective experience, DXRX will help to unlock the power of precision medicine, drive standardization of diagnostic testing and ensure that every eligible patient gets access to the right treatment at the right time. The end-to-end solution will not only enhance Diaceutics’ service offering but also offer a secure platform for pharmaceutical companies, laboratories and diagnostic companies to collaborate more effectively.

Currently, the Diaceutics Advisory Panel consists of Dr Anthony Magliocco of Protean BioDiagnostics Inc. (Founder and CEO, Consultant Pathologist) in the USA, Keith Kerr from Aberdeen University School of Medicine in Scotland (Professor, Consultant Pathologist), US-based Kenneth J. Bloom of Invicro and Ambry Genetics (CMO, MD, FCAP), Markus Eckstein from University Hospital Erlangen in Germany (MD) and Dr Fotios Loupakis from the Institute of Oncology at Veneto in Italy (Medical Oncologist, MD, MS, Ph.D).

To date, Diaceutics′ Advisory Panel has undertaken extensive research into the inefficiencies in precision medicine testing which are preventing patients from getting the treatment they need, when they need it. For example, this research – which was published in four abstracts and one poster at this year′s American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) conference – revealed the economic burden of not testing for the FLT3 biomarker to treat Acute Myeloid Leukemia (AML), which could cost up to $445 million in the United States alone.

Alongside the establishment of the panel – Diaceutics has invested in building the world’s largest repository of diagnostic testing data consisting of 227 million patient records to power its DXRX platform. The platform has been purpose built to enable access to a global flow of testing data integrating 2500+ laboratories into one secure network. Diaceutics is also building partnerships with industry-leading service providers in areas such as test access and reimbursement, pathology training, health economics, reference standards and EQA including Targos Molecular Pathology and HistoCyte Laboratories earlier this year. The company is currently onboarding laboratory partners to the network with pharmaceutical companies gaining access to the solution in Q4 2020.

Derek Hosty, Head of Innovation, Diaceutics, commented: "It is an honour to have such well-renowned experts joining our ever-expanding network and helping to shape our future service offering. This dynamic group of advisors will enhance the value we deliver to pharmaceutical companies, laboratories and diagnostic companies via our DXRX platform. In turn, this will help to overcome the obstacles currently present in the field of precision medicine and, more importantly, greatly benefit patients by getting them the treatment they deserve.

"DXRX has been designed to give global laboratories a voice, so that they are no longer the forgotten stakeholder in precision medicine, and the very best in the sector are ensuring its success. Together with the industry-leading service providers and partners with whom we are collaborating, the DXRX Advisory Panel will help to transform the broken testing ecosystem and has the potential to transform the entire business model of precision medicine for patients."

Kenneth J. Bloom, CMO, Invicro and Ambry Genetics, said: "I am honored to be part of what is very much an unprecedented approach to bringing stakeholders on to one secure platform to collaborate around diagnostic testing. I see there being a huge appetite for this technology not only with pharma, labs and diagnostic companies but also with clinicians and any service provider involved in the process of getting patients treated."

Keith Kerr, Professor and Consultant Pathologist, Aberdeen University School of Medicine, added: "There is today an unmet need in the testing ecosystem for labs to be much more supported at ground level through in-lab services such as EQA, test standardization and industry training to ensure that more patients get the right treatment at the right time. I am glad to be part of a network which has the potential to deliver on those needs and look forward to what we can achieve together going forward."

On September 14, 2020 LAVA Therapeutics B.V., a biotech company pioneering bispecific gamma-delta T cell engagers for cancer, Amsterdam UMC and the Monash Biomedicine Discovery Institute in Australia, reported that Nature Cancer has published their co-authored paper titled, "A single domain bispecific antibody targeting CD1d and the NKT T cell receptor induces a potent antitumor response," detailing a novel immune-oncology approach for the potential treatment of cancer (Press release, Lava Therapeutics, SEP 14, 2020, View Source [SID1234565113]).

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Findings in the paper highlight the potential for a LAVA-derived antibody fragment, known as a single domain antibody, that acts as a bridge to link together two key immune cell receptors – the CD1d receptor and the T cell receptor of natural killer T (NKT) cells – in order to enhance the body’s immune response to cancer. The CD1d receptor is frequently expressed by tumor cells and NKT cells are positioned at the interface between the innate and adaptive immune system and play an important role in the host-rejection of both tumors and virally infected cells. Preclinical research through the companies’ collaboration demonstrates that a CD1d-NKT cell targeting antibody resulted in significant activation of NKT cells and the subsequent killing of CD1d-expressing tumor cells in multiple tumor samples, including multiple myeloma and acute myeloid leukemia.

"These data underscore the potential of LAVA’s bispecific antibody approach to target and activate NKT cells for the treatment of cancer," said Hans van der Vliet, professor in medical oncology at Amsterdam UMC and chief scientific officer of LAVA Therapeutics. "By targeting and boosting natural immune cells that are inherent in all humans, such as NKT and gamma-delta T cells, for an enhanced therapeutic effect, our approach could translate into a broadly applicable immunotherapeutic strategy for treating a range of cancer indications."

"Using the Australian Synchrotron, the team at Monash University provided detailed atomic insight into how the single domain antibodies exerted their effect on immune cells in a cancer model. Through this, we were able to precisely visualize how the single domain antibody simultaneously recognized CD1d and the NKT T cell receptor, thereby providing a molecular basis for their anti-tumor properties," professor Jamie Rossjohn, Australian Research Council Laureate Fellow at Monash University stated. "The collaboration with LAVA Therapeutics on this ground-breaking approach was very effective."

Instrumental to the study were joint first authors Dr. Roeland Lameris from Amsterdam UMC and Dr. Adam Shahine from Monash University.

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.