On November 30, 2021 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported its participation in investor conferences in December 2021 (Press release, Ideaya Biosciences, NOV 30, 2021, View Source [SID1234596303]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Evercore ISI HealthConX Conference
Thursday, December 2, 2021 at 10:30 am ET

Fireside Chat with Yujiro Hata, Chief Executive Officer, hosted by Josh Schimmer, M.D., M.B.A, Fundamental Research Analyst
A live audio webcast of the event will be available, as permitted by conference host, at the "Investors/News and Events/Investor Calendar" section of the IDEAYA website at View Source A replay of available webcasts will be accessible for 30 days following the live event.

On November 30th 2021 Defence Therapeutics, is a publicly-traded biotechnology company working on engineering the next generation vaccines, Antibody Drug Conjugates, ADC products, and cancer therapeutics using its proprietary AccumTM platform (Press release, Defence Therapeutics, NOV 30, 2021, View Source [SID1234626241]). The core of Defence Therapeutics platform is its AccumTM technology, which enables precision delivery of proteins of pharmacological interest to target cells and increases the intracellular accumulation to these targeted cells. As a result, increased efficacy and potency can be reached against catastrophic illness such as cancer and infectious diseases. With four new patents filed over the last year, Defence is providing increased company IP with its technologies. Defence’s research activities conducted over the last year along with future clinical plans to prove validation is ongoing.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Development of the core Technology
The Company’s core technological research is based around addressing a major and common challenge in both the vaccine and antibody drug conjugates ("ADCs") fields limiting their efficacy. When the target cell binds and internalizes an antigen or an ADC, the complex is entrapped inside intracellular small vesicles named endosomes. Ultimately, these endosomes undergo maturation consequently leading to their degradation prior to eliciting their respective role/function. The Company’s goal is to use the AccumTM enhancer formulation to improve intracellular delivery of biological therapeutic agents by inducing their escape to the cytosol consequently improving their therapeutic efficacy.

Effective Cellular Vaccine Design
The AccumTM technology is highly suitable to the vaccination field. More specifically, antigens that are normally captured by dendritic cells ("DCs") – the best antigen-presenting cells present in our body- are first entrapped in endosomes. While maturation of these endosomal organelles occurs, the pH decreases (becomes acidic ⁓4-5) in order to trigger the activation of specific enzymes as a means to initiate non-specific antigen degradation. As a result, the generated fragments can then pass-through endosomal pores to reach the cytoplasm where specific antigen degradation takes place by the proteasomal machinery. Although this process occurs naturally, the generated antigen fragments are often damaged, which renders them unsuitable for optimal immune stimulation. By using the AccumTM technology, captured antigens are preserved in their natural conformation while being delivered to the cytoplasm. As such, proteasomal degradation ends-up leading to a higher number of immunogenic and stable peptides presented at the surface of DCs and capable of eliciting potent T-cell activation.

Research conducted by the Company has found that the addition of Accum-linked antigens to allogeneic DCs (AccuVAC-D001) enhances the therapeutic efficacy of the vaccine leading to a survival rate of 70-80% in contrast to 0-20% obtained with current experimental DC-based vaccines. With the completion of such study, Defence has signed an agreement with a Canadianbased clean room to initiate dry runs of its DC vaccine. The objective is to complete all needed GLP studies by Q1 2022 and initiate a Phase I trial against melanoma in the UK by mid 2022.

The development of protein-based vaccines for infectious diseases (COVID and HPV)
In parallel, the Company has already completed all pre-clinical work related to its COVID-19 vaccines. The first vaccine (DTC-PT001) is an injectable formulation delivered with an FDAapproved adjuvant. Generated data demonstrated potent and sustainable production of IgG titers (over 16 weeks), which was also highly reactive against all tested variants. In addition, the immunogenicity of the vaccine was highly comparable between rodent (mice) and non-rodent (rabbit) models. Furthermore, vaccination of hamsters (third model-GLP study) followed by viral challenge showed potent protection with no noted side effects.

The second vaccine formulation (DTC-IN003) is a transmission-blocking vaccine designed to halt infection as opposed to lowering the pathophysiology of the virus. In this case, the vaccine is delivered intranasally with a special adjuvant (designed for intranasal vaccination). This vaccine not only triggered the production of IgAs at mucosal sites (entry site of the virus), but systemic immunity was also observed and generated antibodies cross-reacted with all tested variants. A GLP challenge study is currently ongoing with final data to be obtained by the end of December 2021.

Another infectious disease vaccine in development at Defence Therapeutics is AccuVAC-PT009 targeting HPV. This vaccine is using a mixture of L1 proteins (derived from different HPV strains) linked to AccumTM and tested for their ability to confer protective antibodies against the HPV virus. The potency of the AccuVAC-PT009 vaccine will be compared to the commercially available Gardasil-9 vaccine in terms of its immunogenicity (prophylactic vaccine). In addition, Defence is working on a second HPV-related vaccine but targeting cervical cancer (AccuVACPT0067). The objective of this vaccine is to modify both E6 and E7 proteins to covalently link AccumTM then test the vaccine for its ability to treat pre-established cervical cancer. Results of the pre-clinical studies will be available by early 2022.

Effective Design of ADCs
One challenge posed by ADCs is insufficient intracellular accumulation of the delivered chemotherapeutic necessary for potent tumor killing. Defence has demonstrated that the AccumTM technology enhances the ability of ADC Kadcyla (T-DM1) to specifically kill breast cancer cells. AccumTM improved the escape of ADC Kadcyla from endosomes while targeting the nucleus. Defence believes that the AccumTM technology will be able to increase T-DM1 effectiveness enabling the treatment to overcome resistance mechanisms such as reducing the number of cell surface receptors, therefore limiting the potency and delivery of T-DM1 inside the cell. The Company has formed a strategic collaboration with two European institutions to further develop its Accum-ADCs platform.

The AccuTOX Program
The AccumTM technology platform is very efficient at enhancing intracellular delivery of proteins of pharmacological interests such as vaccine antigens or ADCs. However, a novel anti-cancer function was recently discovered for "free" AccumTM. More specifically, when directly delivered without direct linking onto protein, the AccumTM moiety behaves as a toxic "silver bullet" to cancer cells. So far, the Defence team has engineered and tested a large library of AccumTM variants and identified a lead molecule capable of killing breast, colon, melanoma and lymphoma cancers. A GLP study is currently ongoing with final results expected by the end of 2021 with plan to initiate a Phase I trial against breast cancer in Q2 of 2022.

On November 30, 2021 THERADIAG (Paris:ALTER) (ISIN: FR0004197747, Ticker: ALTER), a company specializing in in vitro diagnostics and Theranostics, reported that it has received yesterday a letter from BIOSYNEX informing it of its acquisition of a stake in its capital and the crossing of statutory thresholds, in accordance with article 12.3 of THERADIAG’s articles of association (Press release, Theradiag, NOV 30, 2021, View Source [SID1234596230]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Following acquisitions on the market and its participation in the Rights Issue, BIOSYNEX held 2,468,932 shares, i.e. 18.82% of THERADIAG’s share capital and 18.89% of its voting rights, as at 29 November 2021 at 8:00 a.m.

On November 30, 2021 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported its agenda and distinguished speaker list for a comprehensive Investor Update Meeting taking place Thursday, December 2nd , from 10:00am ET – 1:30pm EST (Press release, Delcath Systems, NOV 30, 2021, View Source [SID1234596248]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The event will focus on the company’s US product candidate, HEPZATO KIT (melphalan hydrochloride for injection/hepatic delivery system), a percutaneous hepatic perfusion (PHP) system. In the United States HEPZATO is an investigational drug/device combination product. In Europe, the product is a stand-alone medical device approved for sale under the trade name CHEMOSAT Hepatic Delivery System for Melphalan, or CHEMOSAT, where it has been used at major medical centers to treat a wide range of cancers of the liver.

A distinguished panel of physicians will discuss their experience with HEPZATO in the FOCUS trial, commercial experience with CHEMOSAT and the unmet need in the treatment of liver metastases. The participating physicians will present on the following topics:

Current unmet need and treatment options for liver metastases
The longest single institution experience with PHP – The University Hospital Southampton experience
PHP quality of life and combination with immuno-oncologic therapy – The Leiden University experience
Current unmet needs in ocular melanoma
Focus Trial – efficacy and safety results
Future clinical development plans
In addition to the Delcath management team, planned speakers and panelists will include:

John Bridgewater, MRCP, PhD, FRCP
Professor and Consultant Medical Oncologist, UCL Cancer Institute, University College London, London, UK

Mark Burgmans, MD, PhD
Head of Interventional Radiology, Department of Radiology, Leiden University Medical Center, Leiden, The Netherlands

Aslam Ejaz MD, MPH
Assistant Professor of Surgery, The Ohio State University, Columbus, OH

Francesco Pier Ferrucci, MD
Director, Tumor Biotherapy Unit, Istituto Europeo di Oncologia, Milan, Italy

Evan S. Glazer, MD, PhD, FACS
Assistant Professor of Surgery, College of Medicine and Principal Investigator, Center for Cancer Research, The University of Tennessee Health Science Center, Memphis, TN

Sachin Modi, BSc (Hons), MBBS, FRCR, FRCR (IR)
Consultant Interventional Radiologist, Department of Interventional Radiology, University Hospital Southampton, Southampton, UK

Siddharth A. Padia, MD
HS Clinical Professor, Division of Interventional Radiology, David Geffen School of Medicine, University of California, Los Angeles, CA

Sapna Patel, MD
Associate Professor, Department of Melanoma Medical Oncology, MD Anderson Cancer Center, Houston, TX

Sunil A. Reddy, MD
Clinical Assistant Professor, Division of Oncology, Department of Medicine, Stanford University School of Medicine, Stanford, California

Brian Stedman, BSc, MBBS, FRCS, FRCR
Consultant Interventional Oncologist, Department of Interventional Radiology, University Hospital Southampton, Southampton, UK

Juan Valle, MD
Professor and Consultant Medical Oncologist, The Christie NHS Foundation Trust, Manchester, UK

Jonathan Zager, MD, FACS (Global Lead Investigator)
Chief Academic Officer, Director of Regional Therapies, and Senior Member, Departments of Cutaneous Oncology and Sarcoma, Moffitt Cancer Center; Chair, Department of Oncological Sciences and Professor of Surgery, USF, Morsani School of Medicine, Tampa, FL

Event Details:
Event: Delcath Systems Virtual Investor Update Meeting
Date: Thursday, December 2, 2021
Time: 10:00am – 1:30 p.m. EST

On November 30, 2021 Avid Bioservices, Inc. (NASDAQ:CDMO), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality services to biotechnology and pharmaceutical companies, reported that it will report financial results for the second quarter of fiscal year 2022 on December 7, 2021 after market close and will host a conference call and webcast at 1:30 PM Pacific Time (4:30 PM Eastern Time) (Press release, Avid Bioservices, NOV 30, 2021, View Source [SID1234596267]). Members of Avid’s senior management will discuss financial results for the first quarter and review recent corporate developments.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

To listen to the live webcast, or access the archived webcast, please visit: View Source

To listen to the conference call, please dial (877) 312-5443 or (253) 237-1126 and request the Avid Bioservices call.