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Category: Medical

Agilex Biolabs Client Shasqi Announces Click Chemistry Breakthrough with First-Ever Human Application in Launch of Clinical Program

Agilex Biolabs, Australia’s most advanced FDA-inspected specialist bioanalytical laboratory for clinical trials, congratulates client company Shasqi on the announcement of the first-ever application of click chemistry in humans, with the launch of the Company’s lead clinical candidate, SQ3370. Shasqi is the first Y Combinator-backed biotech company to reach clinical development.

San Francisco-based Shasqi said in the announcement:

First Patients Dosed in Phase 1 Clinical Study of SQ3370 for Advanced Solid Tumor Malignancies

Shasqi is First Y-Combinator Biotech Company to Reach First-in-Human Clinical Studies

Shasqi, a clinical-stage biotechnology company developing precision activated oncology therapeutics with its proprietary Click Activated Protodrugs Against Cancer (CAPACtm) Platform, announced today the first-ever application of click chemistry in humans, with the launch of the Company’s lead clinical candidate, SQ3370. Shasqi is the first Y Combinator-backed biotech company to reach clinical development.

The first two patients have been dosed in Shasqi’s Phase 1 clinical study of SQ3370 for the treatment of advanced solid tumors. SQ3370 is a novel investigational product that activates a non-toxic protodrug into a powerful chemotherapy agent, doxorubicin, precisely at a pre-injected tumor. SQ3370 is designed to allow substantially higher drug doses to be given to the patient, increasing tumor destruction while minimizing toxicity in the rest of the body.

“Shasqi is founded on the belief that one day we will be able to beat cancer without poisoning our bodies. We are excited to reach this milestone with our CAPAC Platform and the launch of Shasqi’s first clinical program,” said Jose M. Mejia Oneto, M.D., Ph.D., Founder and CEO of Shasqi.

The CAPAC Platform is a new therapeutic modality based on click chemistry, which leverages biocompatible chemical reactions, to activate protodrugs at a selected tumor that has been pre-injected with a biopolymer. The CAPAC platform is agnostic to tumor characteristics that can vary from patient to patient, such as biomarker expression and enzymatic activity, rendering it applicable to a broad array of tumor types. Additionally, the CAPAC Platform is highly modular and can be applied to a wide variety of cancer therapeutics in addition to doxorubicin.

“Doxorubicin has been proven effective for dozens of cancers, but severe side effects limit its use. Guiding it directly to the tumor while avoiding damage to the rest of the body may allow us to use doxorubicin and potentially many other drugs in a completely new and effective way for patients,” commented Wayne Saville, M.D., Chief Medical Officer of Shasqi. “Shasqi has taken a novel concept through a rigorous preclinical regulatory path all the way to treating patients in near-record time.”

“Shasqi was Y Combinator’s first therapeutic biotechnology investment and now the first of our life sciences companies to reach clinical development,” said Jared Friedman, Partner, Y Combinator. “We are extremely impressed by the team’s rapid advancement and capital-efficient execution. SQ3370 and CAPAC are not just a standard new small molecule, but rather a broad and powerful new platform leveraging state of the art science and materials to transform the treatment of cancer.”

SQ3370-001 (NCT04106492) is a multicenter, first-in-human, dose-escalation, Phase 1 clinical trial evaluating the safety and tolerability, pharmacokinetics, immune effects, and preliminary anti-tumor efficacy of SQ3370 in patients with locally advanced or metastatic solid tumor malignancies ineligible for standard-of-care therapy. The study is being conducted in the United States and Australia at multiple cancer centers, including MD Anderson Cancer Center and Stanford University. The study is expected to be completed in 2021. More information about the trial is available at: https://clinicaltrials.gov/ct2/show/NCT04106492.

See the announcement here. https://tinyurl.com/y2splohj

Agilex Biolabs is known internationally for its continued investment in the latest technology, and for attracting some of the leading scientists from Australia and around the world.

Agilex Biolabs, the only FDA-inspected lab of its type in the region, also features a rebate of up to 43.5% on clinical trial bioanalytical services spend as part of the Australian Government clinical trial attraction program.

Agilex Biolabs’ world-class bioanalytical facilities have OECD GLP Recognition with NATA (Australian Government OECD GLP Compliance monitoring authority) and ISO 17025 Accreditation for global recognition.

The company has recently expanded its labs by more than 30% to accommodate biotech demand from APAC and the USA. Watch the New Labs Walkthrough Video Here https://www.agilexbiolabs.com/new-labs-video

Agilex Biolabs specialises in bioanalysis of small molecules and biologics for PK, immunogenicity, biomarkers and immunological pharmacodynamics assessments utilising LC-MS/MS, immunoassay (Mesoscale, Gurolab, Luminex) and flow cytometry (BD FACSymphony A3, 20 colour cell analyser).

Agilex also offers pharmacodynamics services that include immunobiology services using the latest state-of-the-art technology to support immunology, cell biology and mode of action assays, including:
– Immunophenotyping
– Receptor occupancy
– Cytokine release assays (whole blood or PBMC stimulation assays) and cytokine/biomarker profiling
– PBMC assays and cellular mechanism of action assays (eg: ADCC)

Agilex Biolabs has more than 90 staff including 65 dedicated laboratory staff, and annually support more than 80 clinical trials. This year they will analyse more than 60,000 samples for pharma/biotechs companies from US, Europe and APAC.

Please Book a Briefing with us before you start your next clinical trial. https://calendly.com/agilexbiolabs/15min

About Agilex Biolabs https://www.agilexbiolabs.com/

Agilex Biolabs, Australia’s leading bioanalytical laboratory, has more than 20 years’ experience in performing regulated bioanalysis, including quality method development, method validation and sample analysis services. We have successfully supported hundreds of preclinical and clinical trials around the world where customers choose Australia for the streamlined regulatory process and access to the world’s most attractive R&D rebate of more than 40% on clinical trial work conducted in Australia.

We offer services for both small molecules and biologics for PK, immunogenicity (PD) and biomarker bioanalysis utilising the two platforms of LC-MS/MS and Immunoassay.

Agilex Biolabs Media Contact:
Media@AgilexBiolabs.com
Kate Newton

Shasqi media contact:
David Rosen, Argot Partners
media@shasqi.com
+1 (212) 600-1902

October 30, 2020
Biotechs get scalable early to late phase clinical offering from Avance Clinical and Cromos Pharma – announced at Bio-Europe 2020

Two dominant regional contract research organizations (CRO), Avance Clinical and Cromos Pharma, with operations in Australia and Central/Eastern Europe, respectively, are successfully collaborating on a scalable clinical solution for biotechs.

The collaboration allows biotechs to quickly start their pre-IND early phase studies in Australia, then expand to Central/Eastern Europe to access the large patient populations for their Phase 2 and 3 studies.

Importantly, the AU/EU model allows biotechs to keep their data and trial management in Australia, and take advantage of the Australian cash rebate of up to 43.5% on clinical trial costs, throughout all study phases, across both regions.

“We are very excited about this model that seamlessly incorporates two of the most compelling and complementary international clinical research hubs for our biotech clients from early to late phase studies,” said Yvonne Lungershausen, CEO of Avance Clinical.

“Our eClinical and early phase expertise is well augmented by Cromos Pharma’s track record in late stage trials and rapid enrollment capabilities,” she continued.

“We have been collaborating with Avance Clinical and referring clients to each other for years,” remarked Vlad Bogin, CEO of Cromos Pharma.

“But it was a true Eureka moment when we realized that combining Australia’s 43.5% tax rebate with Central/Eastern Europe’s unbeatable recruitment rates is a paradigm shift in how clinical trials should be conducted,” he concluded.

Cromos Pharma can access hundreds of millions of patients via more than 2,500 sites in Central/Eastern Europe.

About Cromos Pharma, www.cromospharma.com

Cromos Pharma provides tailored and effective clinical trial solutions to support the development of drugs that transform healthcare. An international CRO with over 15 years’ experience, we offer fully integrated services performing all aspects of clinical trials in all clinical phases and in a wide range of therapeutic areas. Cromos Pharma delivers rapid recruitment and excellent patient retention as well as expert study design and management. Cromos Pharma has strong regional experience in Central and Eastern Europe with global coverage provided by its US bases in Portland, Oregon and Miami, Florida. Cromos Pharma’s European HQ is in Dublin, Ireland. At Cromos Pharma, we know how important your product is. When the stakes are this high, you need a high-performance partner.
Key benefits:
– International expertise combined with in-depth regional knowledge in Central and Eastern Europe (300+ clinical trials conducted in 70+ indications).
– Extensive PI/site and patient network (40,000+ patients enrolled from nearly 2,500 trial sites).
– Unparalleled patient recruitment – our team met or shortened project timelines in 95% of conducted trials.
– Responsible recruitment is supported by Cromos Pharma’s “No Patients-No Payments” initiative – a unique risk-sharing program.
– Extremely short startup timelines (e.g. Georgia where we assure a study launch in less than 2 months).
– Expertise in innovative, generics and biosimilar global studies (NDAs, ANDAs, BLAs, 505b2).
– Regulatory inspections and audits that attest to the highest quality of data: EMA in 2019 (1-week oncology site inspection); FDA in 2017 (2-week oncology site inspection).
– Clinical Development Strategy – we provide expert guidance on study design, favorable venues, local and global landscape to improve study outcomes.

About Avance Clinical, www.avancecro.com

Australia’s Avance Clinical has more than 20-years of experience and is now one of Australia’s leading Contract Research Organizations for biotechs. Avance Clinical is committed to providing high-quality clinical research services with its highly-experienced team.
The collective pool of knowledge and experience at Avance Clinical continually grows through the careful selection of experts who also demonstrate passion in their chosen field.
Avance Clinical offers high-quality services in an established clinical trial ecosystem, that includes world-class Investigators and Sites able to access specialized patient groups.
Other benefits include:
1. The Government R&D grant means up to 43.5% rebate on clinical trial spend
2. eClinical solutions capabilities – speed and continuity
3. Site Initiation Visit (SIV) and Study Start achieved in 5 – 6 weeks
4. No IND required for clinical trials
5. Full GMP material is not mandated for Phase I clinical trials
6. Established clinical trial environment with world-class Investigators and sites
7. Established healthy subject databases and specialized patient populations
8. Five independent Phase 1 facilities across Australia including hospital-based units for critical care
9. Major hospitals with world-class infrastructures and dedicated Clinical Trial Units with a long track-record in FDA compliant research
10. Seasonal studies: Northern hemisphere Sponsors can conduct their studies year-round by taking advantage of Australia’s counter-flu and allergy seasons

Media Contacts:
Avance Clinical
Chris Thompson: media@avancecro.com

Cromos Pharma
Nicola Donnelly: media@cromospharma.com

October 28, 2020
Endpoints News Presents “Why Australia and Agilex Biolabs for your Next Clinical Trial” for Bio Europe 2020

Agilex Biolabs, Australia’s most advanced FDA-inspected specialist bioanalytical laboratory for clinical trials, has partnered with Endpoints News to produce an exceptional step-by-step webinar on how to run your trial in Australia, and why Agilex Biolabs is the leading biolabs partner.

Watch here (no charge) https://tinyurl.com/yyzf6o44

Agilex Biolabs is known internationally for its continued investment in the latest technology, and for attracting some of the leading scientists from Australia and around the world.

The webinar was launched as part of Agilex Biolabs’ presence at Bio Europe. Click here to meet Agilex Biolabs at Bio Europe via the partneringone tool. https://informaconnect.com/bio-europe-virtual/

Dr Kurt J. Sales, Agilex Biolabs Director, Immunoassay B.Sc (Med)(Hons), M.Sc, PhD, PGCM led with a presentation detailing the rapid trials process in Australia.

He stressed the importance of talking to Agilex Biolabs early, even before selecting a CRO and other partners, due to the depth of advice the scientific team can offer Sponsors, and the time it can take to develop some assays.

The webinar also featured leading clinical research specialist Jane Kelly who has 27 years in the industry. She is CEO of CMAX Clinical Research, a major Phase 1 Unit located near Agilex Biolabs.

Kelly pointed to the significant advantages of having the biolabs close to the Phase 1 Unit in terms of sample transfer and data turnaround, and offering a seamless clinical experience for Sponsors.

Agilex Biolabs, the only FDA-inspected lab of its type in the region, also features a rebate of up to 43.5% on clinical trial bioanalytical services spend as part of the Australian Government clinical trial attraction program.

Agilex Biolabs’ world-class bioanalytical facilities have OECD GLP Recognition with NATA (Australian Government OECD GLP Compliance monitoring authority) and ISO 17025 Accreditation for global recognition.

The company has recently expanded its labs by more than 30% to accommodate biotech demand from APAC and the USA. Watch the New Labs Walkthrough Video Here https://www.agilexbiolabs.com/new-labs-video

Agilex Biolabs specialises in bioanalysis of small molecules and biologics for PK, immunogenicity, biomarkers and immunological pharmacodynamics assessments utilising LC-MS/MS, immunoassay (Mesoscale, Gurolab, Luminex) and flow cytometry (BD FACSymphony A3, 20 colour cell analyser).

Agilex also offers pharmacodynamics services that include immunobiology services using the latest state-of-the-art technology to support immunology, cell biology and mode of action assays, including:
– Immunophenotyping
– Receptor occupancy
– Cytokine release assays (whole blood or PBMC stimulation assays) and cytokine/biomarker profiling
– PBMC assays and cellular mechanism of action assays (eg: ADCC)

Agilex Biolabs has more than 90 staff including 65 dedicated laboratory staff, and annually support more than 80 clinical trials. This year they will analyse more than 60,000 samples for pharma/biotechs companies from US, Europe and APAC.

Please Book a Briefing with us before you start your next clinical trial. https://calendly.com/agilexbiolabs/15min

Australia: +61 8 8302 8777 | China: +86 21 8036 9483 | South Korea: +82 80 812 1255 | USA: +1 800 247 1909

About Agilex Biolabs https://www.agilexbiolabs.com/

Agilex Biolabs, Australia’s leading bioanalytical laboratory, has more than 20 years’ experience in performing regulated bioanalysis, including quality method development, method validation and sample analysis services.

Agilex Biolabs has successfully supported hundreds of preclinical and clinical trials around the world where customers choose Australia for the streamlined regulatory process and access to the world’s most attractive R&D rebate of more than 40% on clinical trial work conducted in Australia.

The company offers services for both small molecules and biologics for PK, immunogenicity (PD) and biomarker bioanalysis utilising the two platforms of LC-MS/MS and Immunoassay.

Agilex Biolabs operates a fully quality-assured laboratory ensuring that, within the principles of GLP, assays are validated to the latest FDA/EMA guidance and study samples are assayed and reported to the sponsor’s desired format using WATSON LIMS. Laboratory certifications include OECD GLP and ISO/IEC17025.

Media Contact:
Media@AgilexBiolabs.com
Kate Newton

October 27, 2020
Epazz DeskFlex Room Booking System Sees Demand Coming From Asia Pacific Region; Advances COVID-Compliant Software Suite For Specific Functionality

Epazz DeskFlex desk booking software has COVID-compliant software features that secure the workplace for the flexible work set up amidst the Coronavirus pandemic.

Epazz Inc. DeskFlex (OTC: EPAZ), a mission critical provider of cloud-based workspace management software solutions and blockchain business solutions, announced today that the DeskFlex desk booking software is receiving demands coming from the Asia Pacific Region.

DeskFlex room booking system adds more software customers from local U.S. firms and companies in Europe and Latin America weekly. The rising demand for workspace management software is bringing more inquiries from global companies, including businesses in the Asia Pacific Region. DeskFlex is also considering extending its reach in Asia when demands continue to grow by hiring local account managers.

Asia Pacific employers were the first to manage the COVID-19 pandemic since the start of the year, longer than many of their global counterparts. Recent survey findings showed that enhancing health safety and well-being is top of the employers’ priority list to restore their employees’ and businesses’ stability. Furthermore, 3 in 5 employers in the Asia Pacific region developed strategies following the lifting of social distancing restrictions in many markets. Two-thirds of the companies expected their employees to return to the workplace through alternating shifts, reviewed their workplace safety protocols, and managed workspaces to maintain social distancing.

In another study in the workspace management software market, the survey reveals that due to the current global market scenario, the office space management market will grow by $1.11 billion starting from 2020 to 2024, progressing at a compound annual growth rate of thirteen percent (13%) during the same forecast period. The expected market growth results from the rising need for optimized space planning, integrating the Internet of Things (IoT) technology, and increasing coworking startups following the Coronavirus pandemic.

DeskFlex’s collection of COVID-compliant room booking software is continuously onboarding new clients since June and improves to meet different organizational needs. The developers have further refined the functionalities to address actual issues occurring in the workplace. Among the enhanced DeskFlex meeting room scheduling software include Dynamic Scheduling, Capacity Limit, and Social Distancing Policy. Using these advanced software features, you can choose specific parameters to add to your desk reservation process. For example, you can add your own company’s social distancing policy in the survey.

In development, push-button software functions include importing multiple desks, event notification/broadcast buttons, invitation email, activity log, and DeskFlex printable screen. Continually improving DeskFlex’s room booking system can resolve real-time user concerns and system issues.

DeskFlex’s COVID-compliant software suite helps local and global companies secure their workplaces while organizing their teams as they return to the office amid the Coronavirus pandemic.

Epazz, Inc. CEO and Chairman, Dr. Shaun Passley said in an interview: “We are reaching more clients globally as the workplace transition happens worldwide. Different organizations need customized desk booking software. We are always improving our software solutions to provide our users with a more specialized, easy to navigate, and multifaceted software interface to meet their various organizational needs inside the workplace.”

About DeskFlex.com
DeskFlex is a desk booking solution and workspace management software useful in booking conference rooms, meeting rooms, workspaces, desks, car parking spaces, and office equipment. DeskFlex meeting room scheduling system helps office managers accommodate remote workers’ time in the office, reducing rent and facility costs. DeskFlex lets employees reserve desks in advance or claim desks right away. It adjusts the telephone switch (PBX), so calls ring at the “desk du jour.” DeskFlex includes check-in, point-and-click floor maps, a web browser, a local kiosk, Outlook integration, and conference room scheduling.

About Epazz, Inc. (www.epazz.com)
Epazz, Inc., is a leading cloud-based software company that specializes in providing customized cloud applications to the corporate world, higher-education institutions, and the public sector. Epazz BoxesOS(TM) v3.0 is a complete web-based software package for small- to mid-size businesses, Fortune 500 enterprises, government agencies, and higher education institutions. BoxesOS provides many of the web-based applications organizations would otherwise need to purchase separately. Epazz’s other products are K9Sky.com kennel software and the Provitrac applicant tracking system.

SAFE HARBOR
This is the “Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995: certain statements contained in this press release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by the use of forward-looking words such as “may,” “expect,” “intend,” “estimate,” “anticipate,” “believe,” and “continue” (or the negation thereof) or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors that could cause actual results to differ materially from future results or those implied by such forward-looking statements. Investors are cautioned that no forward-looking statement is a guarantee of future performance and that actual results may differ materially from those contemplated by such forward-looking statements. Epazz, Inc. assumes no obligation and has no intention of updating these forward-looking statements. It has no obligation to update or correct information prepared by third parties that are not paid for by Epazz, Inc. Investors are encouraged to review Epazz, Inc.’s public filings on SEC.gov and otcmarkets.com, including its unaudited and audited financial statements and its OTC market filings, which contain general business information about the company’s operations, results of operations, and risks associated with the company and its operations.

CONTACT:
For more information, please contact
Investor Relations:
https://www.twitter.com/epazz
investors@epazz.net
(312) 955-8161
www.epazz.com

October 22, 2020
Olympus to Support Endoscopic AI Diagnosis Education for Doctors in India and to Launch AI Diagnostic Support Application

Participating in Ministry of Internal Affairs and Communications project: “Survey Study for International Expansion of AI Diagnosis Support System Using Ultra-High Magnifying Endoscopes in India”

Olympus Corporation took part in a ground-breaking project as a business promoter, in cooperation with the Ministry of Internal Affairs and Communications (MIC), entitled, “Survey Study for International Expansion of AI Diagnosis Support System Using Ultra-High Magnifying Endoscopes in India.” The project aims to develop advanced endoscopy diagnostics in India, where there are relatively few endoscopists.

In collaboration with CYBERNET SYSTEMS CO,. LTD., Olympus has established an AI diagnostic support system at a major medical institution, the Asian Institute of Gastroenterology (AIG) based in Hyderabad, India. Specialist lecturers and physicians from Showa University Northern Yokohama Hospital provided expert guidance to AIG doctors. In addition to training AIG doctors in techniques for detecting diseases and differential diagnosis by colonoscope, they also trained the doctors on how to instruct the next generation of endoscopists.

The project started on October 12. At the kick-off meeting, Satoshi Hemmi, Deputy Director-General of the Information and Communications Bureau, the Ministry of Internal Affairs and Communications commented, “We hope to contribute to the spread of AI endoscopy systems and the development of medical care in India through training future leaders in AI endoscopy systems in India. We also hope that the cooperation between India and Japan in the field of healthcare ICT will continue to develop.”

In addition to the ultra-magnifying scope Endocyto(*1) released last year, Olympus will release endoscopic diagnostic support software equipped with AI in India from December. The endoscopic diagnostic support software EndoBRAIN(*2) and EndoBRAIN-EYE(*3) will be utilized for physician training in India. Olympus intends to assist in the development of physicians and promote the use of endoscopic diagnostics.

(*1) An endoscope that enables observation at the cellular level in real time with up to 520 times optical magnification.
(*2) AI real-time in-vivo analysis of colon lesions taken with ultra-high magnifying endoscopes, numerically indicating the possibility of neoplastic and non-neoplastic polyps to assist physicians in the differentiation and detection of polyps through figures.
(*3) AI endoscopic diagnostic imaging support software that assists physicians in diagnosing lesions by alerting if a polyp or other lesion is detected using regular colonoscope images.

Background of Olympus’ Participation

In India, the rate of cancer morbidity is expected to increase as the economy grows. On the other hand, there is a severe shortage of doctors who can conduct precision diagnostics with endoscopes, which are essential for early detection and treatment of cancer. Olympus participated in this project to support trained AIG specialists to train doctors in India and neighboring countries and to contribute to the popularization and development of endoscope diagnostics using the latest AI technology.

Ministry of Internal Affairs and Communications Project

– Purpose:
The MIC aims to realize the sustainable development goal and SDG pledges to ensure “no one will be left behind.” To this end, the MIC aims to realize a model that contributes to SDG through digitization and to disseminate and promote an SDG + ICT model domestically and overseas between both public and private sectors. This project aims to contribute to the introduction and dissemination of Japan’s endoscopic AI diagnostic support system to India and neighboring countries in response to the social issue of increasing cancer prevalence in India.

– Projects:
1) Survey on the Current Status of Policies in the Medical Health Sector in India and the Current Status of the Introduction of Medical ICT in India:
Collecting information from major medical institutions and external research institutions and investigating the spread of medical systems, including endoscopic systems.

2) Verification through proof-of-concept tests in India:
Physicians from the Showa University Northern Yokohama Hospital will train AIG physicians, from the detection of disease utilizing a colonoscope to discriminatory diagnosis, and train them as lecturers to train instructors. MIC provided equipment and training courses.

For questions or additional information, please contact:
Yuka Horimoto
+81-90-2490-1071
yuka.horimoto@olympus.com

October 20, 2020
Impact BioMedical to Begin Efficacy Testing of Pan-Coronavirus Vaccine Under New Wholly Owned Subsidiary Innate Immune, Inc.

Document Security Systems, Inc. (“DSS” or the “Company”) (NYSE American: DSS), a multinational company operating businesses focusing on brand protection technology, blockchain security, direct marketing, healthcare, real estate, and securitized digital assets, today announced its wholly owned subsidiary Impact BioMedical, Inc. (“Impact BioMedical”) has formed a new wholly owned subsidiary, Innate Immune, Inc. (“Innate Immune”), to initiate efficacy testing of a pancoronavirus vaccine, a special type of vaccine designed to protect against multiple coronaviruses.

“Highly pathogenic human coronaviruses are continuously emerging and remain a major threat to human health,” stated Daryl Thompson, Impact BioLife’s Director of Scientific Initiatives and founder of advanced research company GRDG Sciences, LLC (“GRDG”). Impact BioLife is a wholly owned subsidiary of Impact BioMedical. “Our pan-coronavirus vaccine is designed to allow us to not only protect against COVID-19, which is likely here to stay, but also allow for us to quickly respond to any outbreaks of a virus of this type in the future.”

Coronaviruses are a large family of viruses and are common throughout the world. There are currently seven known human coronaviruses that can make people sick. Common human coronaviruses, including types 229E, NL63, OC43, and HKU1, usually cause mild to moderate upper-respiratory tract illnesses, while MERS-CoV, SARS-CoV, and now SARS-CoV2 can cause more severe pulmonary diseases.

“COVID-19 has already cost more than one million lives and continues to disrupt the $133 trillion global economy,” commented Jason Grady, COO of DSS. “A successful pan-coronavirus vaccine could save countless lives while lessening or even preventing the types of disruptions we have seen this year that have impacted nearly everyone on the planet.”

Innate Immune’s orally delivered pan-coronavirus vaccine has a well demonstrated safety profile and is designed to quickly be scaled for global distribution, ease of manufacturing, and high degree of stability. Innate Immune has gathered a globally recognized team of virologists to complete the research necessary to bring this vaccine to market.

“The need for a solution to COVID-19 and potential future human coronaviruses is clear. We believe this vaccine can provide that solution while remaining economically affordable, ensuring availability across the globe” stated Chan Heng Fai, Chairman of DSS.

GRDG’s Chief Scientific Advisor Dr. Roscoe M. Moore, Jr., the former United States Assistant Surgeon General and former Epidemic Intelligence Service Officer at Centers for Disease Control and Prevention or CDC commented, “This pan-coronavirus vaccine is designed to boost a human’s innate ability to fight viruses such as SARS-CoV2 by activating all phases of the human immune system. If successful, it could allow us to prevent further deaths and global economic disruptions from coronaviruses.”

GRDG is a specialized research team that focuses on developing solutions for biodefense under the guidelines of the Project BioShield Act, Event 201, and Potomac Institute for Policy Studies.

GRDG performs rapid analysis and research by using advanced algorithms and the most complete databases in the world. The team operates in a lean and efficient manner and when necessary utilizes the top contract research organizations to deliver solid results that are robust and accurate.

About Impact BioMedical, Inc.
Impact BioMedical, Inc. (“Impact BioMedical”) is a wholly owned subsidiary of DSS. Impact BioMedical strives to leverage its scientific know-how and intellectual property rights to provide solutions that have been plaguing the biomedical field for decades. By tapping into the scientific expertise of GRDG Sciences, LLC, Impact BioMedical pledges to undertake a concerted effort in the R&D, drug discovery and development for the prevention, inhibition, and treatment of neurological, oncological and immuno related diseases. For more information on Impact BioMedical visit http://impbio.com/.

About Document Security Systems, Inc.
DSS is a multinational company operating businesses focused on brand protection technology, blockchain security, direct marketing, healthcare, real estate, and securitized digital assets. Its business model is based on a distribution sharing system in which shareholders will receive shares in its subsidiaries as DSS strategically spins them out into IPOs. Its historic business revolves around counterfeit deterrent and authentication technologies, smart packaging, and consumer product engagement. DSS is led by its Chairman and largest shareholder, Mr. Fai Chan, a highly successful global business veteran of more than 40 years specializing in corporate transformation while managing risk. He has successfully restructured more than 35 corporations with a combined value of $25 billion. For more information on DSS visit http://www.dsssecure.com.

Investor Contact:
Dave Gentry, CEO
RedChip Companies Inc.
407-491-4498
Dave@redchip.com

October 2, 2020
Agilex Biolabs Develops World’s Most Accurate Cannabinoid Assay

Award-winning Agilex Biolabs, the Asia-Pacific region’s leading bioanalytical laboratory for clinical trials, based in Australia, has developed the world’s most accurate cannabinoid assay.

The announcement was made at BioPharm America (September 21-24, 2020).

The assay is already being used by 4 sponsors in drug development.

Agilex Biolabs CEO Jason Valentine said the company was now very much at the forefront of assay development for cannabis clinical trials, with more assays in the pipeline.

“We have developed a high sensitivity, quantitative assay for the detection of CBN, CBD and THC and metabolites in human plasma.

The Agilex Biolabs cannabinoids assay achieves >98% of ISR (Incurred Sample Reanalysis) samples within the acceptance criteria, which demonstrates that it is robust and reproducible.

The FDA and EMA criteria is 67% of samples within 20%.

This is the best-in-class because we have resolved interferences that over-state THC concentrations that can potentially skew reported data. The improved accuracy and sensitivity means we now have a precise low level assay for our clients.

This competes with anything in the world for accuracy, and cuts the risk of flawed results.

Due to high client demand a CBD and metabolites assay is in development and will be ready before end of the year.”

Agilex is also now offering additional pharmacodynamics services that include immunobiology services using the latest state-of-the-art technology to support immunology, cell biology and mode of action assays, including:
– Immunophenotyping
– Receptor occupancy
– Cytokine release assays (whole blood or PBMC stimulation assays) and cytokine/biomarker profiling
– PBMC assays and cellular mechanism of action assays (eg: ADCC)

Agilex Biolabs, the only FDA-inspected lab of its type in the Asia-Pacific, offers bioanalysis for small molecules and biologics for PK, immunogenicity and biomarkers utilising the two platforms of LC-MS/MS and Immunoassay (MesoScale, Gyrolab).

The FDA-inspected facilities have more than 90 dedicated laboratory staff, and annually support more than 80 clinical trials. This year Agilex Biolabs will analyse more than 60,000 samples for pharma/biotechs from US, Europe and APAC.

By combining specialised expertise, technological innovation and a 20-year track record, Agilex Biolabs have supported hundreds of preclinical and clinical trials around the world.

Agilex Biolabs’ world-class bioanalytical facilities have OECD GLP Recognition with NATA (Australian Government OECD GLP Compliance monitoring authority) and ISO 17025 Accreditation for global recognition.

Please Book a Briefing with us before you start your next clinical trial: https://calendly.com/agilexbiolabs/15min

Australia: +61 8 8302 8777 | China: +86 21 8036 9483 | South Korea: +82 80 812 1255 | USA: +1 800 247 1909

About Agilex Biolabs https://www.agilexbiolabs.com/
Agilex Biolabs, Australia’s leading bioanalytical laboratory, has more than 20 years’ experience in performing regulated bioanalysis, including quality method development, method validation and sample analysis services. We have successfully supported hundreds of preclinical and clinical trials around the world where customers choose Australia for the streamlined regulatory process and access to the world’s most attractive R&D rebate of more than 40% on clinical trial work conducted in Australia.

We offer services for both small molecules and biologics for PK, immunogenicity (PD) and biomarker bioanalysis utilising the two platforms of LC-MS/MS and Immunoassay.

Agilex Biolabs operates a fully quality-assured laboratory ensuring that, within the principles of GLP, assays are validated to the latest FDA/EMA guidance and study samples are assayed and reported to the sponsor’s desired format using WATSON LIMS. Laboratory certifications include OECD GLP and ISO/IEC17025.

Our highly experienced team consists of over 65 dedicated laboratory staff with over 15 years average industry experience across senior scientists. Expertise includes development of robust compliant PK and PD assays de novo or by method transfer.

Our laboratory is fitted with 7 SCIEX tandem mass spectrometers, 6 API 4000 and 1 QTRAP 5500 as our standard platform for LC-MS/MS analysis. For immunoassay, we employ the state-of -the-art systems of Meso Scale Discovery (MSD) and Gyrolab xPlore.

Agilex Biolabs owns a suite of validated biosimilar assays that have already supported biosimilar studies executed in the region. These assays include Avastin/Bevacizumab, Lucentis/Ranibizumab, Actemra/Tocilizumab, Xolair/Omalizumab, Herceptin/Trastuzumab and Solaris/Eculizumab. We would like to discuss how we can support companies with biosimilar pipelines looking to conduct trials in the region. Our validated biosimilar assays require less setup saving time and money.

Agilex Biolabs also have a suite of biomarker assays that have been developed to support studies in the areas of endocrinology (estrone, estradiol, progesterone, testosterone and others).

Recently, Agilex Biolabs has added a comprehensive cannabinoid assay to its suite of validated assays to support clinical trials. The fully validated assay includes the five cannabinoids THC, CBD, CBN and the two THC-metabolites OHTHC and COOHTHC.

Our LC-MS/MS experience includes NCEs, sugars, nucleotides, enantiomers, steroids, prodrugs, peptides, immunosuppressants, nanoparticles, neurotransmitters, oligonucleotides and polymeric mixtures.

Our biologics experience entails PK analysis using colorimetric, fluorescence or chemiluminescence detection for recombinant or fusion proteins, monoclonal antibodies, ADCs, immunogenicity testing, biomarker analysis and PBMC blood stimulation assays.

Media Contact:
Media@AgilexBiolabs.com
Kate Newton

September 23, 2020