Agilex Biolabs and Gyros Protein Technologies Partner for BioAnalysis Zone Webinar on Singlicate Analysis

ADELAIDE, AUS, May 31, 2021 – (ACN Newswire) – Agilex Biolabs, Australia's largest and most technologically advanced specialist bioanalytical laboratory for clinical trials is partnering with Gyros Protein Technologies and BioAnalysis Zone to share the latest on singlicate analysis on the Gyrolab platform.





Register Here https://tinyurl.com/puwwj9zp
Singlicate analysis on the Gyrolab platform
Wednesday 2 June 2021
18:00 [EDT] 23:00 [BST] | Thursday 3 June 06:00 [CST] 08:00 [AEST]

Agilex Biolabs' Principal Method Development Scientist, Morgan Evans will present with Gyros Protein Technologies' Application & Service Director EMEA and Asia Pacific, John Chappell for a comprehensive webinar titled Singlicate analysis on the Gyrolab platform.

The webinar topic was inspired by the Agilex Biolabs poster presentation Development and Validation of a PK Method for Tocilizumab in Both Singlicate and Duplicate on the Gyrolab Platform presented at the 13th EBF open symposium.

Over the last several years singlet analysis has become a hot topic within the world of LBA non-regulated and regulated bioanalysis. A number of studies have demonstrated positive outcomes on both replicate precision assessment and PK/TK parameters.

Due to the highly automated and robust nature of the instrument, Gyrolab has become a front runner in LBA technologies for singlicate analysis.

This webinar will look at the overall landscape of singlet analysis and through Agilex Biolabs case studies discuss the use of the Gyrolab technology. It will also look at how lessons learned can inform prospects of singlicate analysis on other technological platforms keeping in mind 'speed to patient' to ensure efficiency in bioanalytical laboratories.

Agilex Biolabs' world-class laboratories feature state-of-the-art equipment including Gyrolab Xplore, MSD Quickplex 120, Luminex Magpix, BD FACSymphony A3 flow cytometer and soon to be released, digital droplet quantitative real-time RT-PCR.

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.

Australian clinical trials have remained open for business and Agilex Biolabs is a designated essential service so clients can be assured of study continuity.

Agilex Biolabs has more than 120 staff which includes 85 dedicated laboratory staff, and supports client pharma and biotech companies from US, Europe and APAC.

Book a confidential briefing with our scientists 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 24 years' experience in performing regulated bioanalysis, including quality method development, method validation and sample analysis services. It has successfully supported hundreds of preclinical and clinical trials from 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. Agilex Biolabs also offers toxicology services through its company TetraQ, an established GLP rodent toxicology facility in Australia.

Agilex Biolabs has the leading certifications including 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 main labs by more than 30% to accommodate biotech demand from APAC and the USA. Watch the new lab video walkthrough at 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, Gyrolab, Luminex) and flow cytometry (BD FACSymphony A3, 20 colour cell analyser).

Agilex 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

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

Copyright 2021 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Avance Clinical Releases Industry Survey Results at BIO Korea 2021

ADELAIDE, AUS, May 27, 2021 – (ACN Newswire) – The leading Australian CRO for biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient Avance Clinical shared results of a recent industry survey conducted by the company that found data quality to be the most important criteria for selecting a CRO for Phase ll studies in Australia.

Results from the survey found 63.64% of respondents selected data quality as the Key operational consideration when planning Phase II, followed by access to patients, then CRO therapeutic area expertise, cost, and access to KOLs.

Avance Clinical is attending BIO Korea 2021 virtually and is available via the Partnering platform to discuss the benefits of conducting trials in Australia. Avance Clinical has extensive experience in conducting trials in oncology, CNS, cardiovascular, infectious diseases and dermatology.

Avance Clinical CEO, Yvonne Lungershausen, said South Korea is recognised globally for its thriving biotech sector and the CRO is keen to connect with companies wanting regional alternatives for their clinical development. "As Australia's CRO for biotechs, we are seeing an increasing number of South Korean biotechs selecting Australia to accelerate their Phase I and II trials," she said. "The high-quality of our data for FDA and other regulatory authority approvals is a key factor in the decision-making process."

The clinical trial environment in Australia supports rapid startup and a rebate of more than 40% on clinical costs as part of the Australian Government's clinical trial attraction incentive program.

In addition, Avance Clinical is accredited by the Office of the Gene Technology Regulator (OGTR) so it can manage gene technology trials in Australia.

This accreditation recognizes that Avance Clinical has the CRO resources and internal processes in place to effectively manage pre-clinical and clinical trials for products involving genetically modified organisms (GMOs).

Take the Quiz: Test your Knowledge about Australian Clinical Trials here. https://www.surveymonkey.com/r/Australian-Clinical-Trials

About Avance Clinical

Avance Clinical, Australia's CRO for biotechs, has more than 20-years of experience providing excellence in clinical research services for biotech companies from around the globe. Avance Clinical facilitates quality drug development by aligning people, skills, and expertise in the pursuit of drug development for a healthier world. 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 specific patient groups. Visit http://www.avancecro.com for more information.

Recent Awards:
Excellence in Business Award 2021
Frost & Sullivan Asia-Pacific CRO Market Leadership Award 2020

Other benefits of working with Avance Clinical include:
1. The Government R&D grant offers up to 43.5% rebate on clinical trial spend
2. COVID-19 clinical 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. Access to sites/Phase I facilities with established healthy subject databases and specific patient populations
8. Major hospitals with world-class infrastructures and dedicated Clinical Trial Units with a long track-record in FDA compliant research
9. Seasonal studies: Northern hemisphere sponsors can conduct their studies year-round by taking advantage of Australia's counter-flu and allergy seasons

Media Contact:
media@avancecro.com

Copyright 2021 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Agilex Biolabs Partners with Endpoints News on Deconvoluting Inflammation and Immunology for Clinical Trials

ADELAIDE, AUS, May 21, 2021 – (ACN Newswire) – Agilex Biolabs, Australia's largest and most technologically advanced specialist bioanalytical laboratory for clinical trials is partnering with Endpoints News to share the latest on deconvoluting inflammation and immunology for clinical trials, in a webinar hosted by Endpoints News Editor Arsalan Arif.





Agilex Biolabs' Director, Immunoassay, Kurt J. Sales (B.Sc; B.Sc (MED) Hons; M.Sc, Ph.D, PGCM) said:

"Inflammation is a complex biological process involving a host of resident and recruited immune cells which are mobilized to infiltrate tissues in response to invading pathogens. These immune cells boast elevated numbers and heightened activation as they churn out inflammatory mediators, which act in unison to coordinate and modulate the immune response. Choosing the right bioanalytical platform for your immunology clinical trial is critical to data collection. But navigating the intricate inflammation process can be difficult."

In this webinar Dr Sales will examine what these platforms look like in use, and how should you go about selecting the right one. It will also identify the most common bioanalytical platforms used during clinical trials to measure levels of inflammatory mediators in biological fluids.

Using SARS-COV-2 samples, the webinar will cover a custom 10 analyte inflammatory panel and identify how the levels observed for these mediators in Covid patients compare with an uninfected patient's matrix.

It will also discuss how these platforms measure specific immunological markers in clinical trial subjects by flow cytometry.

Register Here
May 25, 2:00 pm – 3:00 pm EDT
https://webinars.endpts.com/deconvoluting-inflammation-and-immunology-for-clinical-trials/

Agilex Biolabs' world-class laboratories feature state-of-the-art equipment including Gyrolab Xplore, MSD Quickplex 120, Luminex Magpix, BD FACSymphony A3 flow cytometer and soon to be released, digital droplet quantitative real-time RT-PCR.

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.

Australian clinical trials have remained open for business and Agilex Biolabs is a designated essential service so clients can be assured of study continuity.

Agilex Biolabs has more than 120 staff which includes 85 dedicated laboratory staff, and supports client pharma and biotech companies from US, Europe and APAC.

Book a confidential briefing with our scientists 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 24 years' experience in performing regulated bioanalysis, including quality method development, method validation and sample analysis services. It has successfully supported hundreds of preclinical and clinical trials from 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. Agilex Biolabs also offers toxicology services through its company TetraQ, an established GLP rodent toxicology facility in Australia.

Agilex Biolabs has the leading certifications including 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 main labs by more than 30% to accommodate biotech demand from APAC and the USA. Watch the new lab video walkthrough at 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, Gyrolab, Luminex) and flow cytometry (BD FACSymphony A3, 20 colour cell analyser).

Agilex 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

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

Copyright 2021 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Agilex Biolabs Partners with Endpoints News on Deconvoluting Inflammation and Immunology for Clinical Trials

ADELAIDE, AUS, May 21, 2021 – (ACN Newswire) – Agilex Biolabs, Australia's largest and most technologically advanced specialist bioanalytical laboratory for clinical trials is partnering with Endpoints News to share the latest on deconvoluting inflammation and immunology for clinical trials, in a webinar hosted by Endpoints News Editor Arsalan Arif.





Agilex Biolabs' Director, Immunoassay, Kurt J. Sales (B.Sc; B.Sc (MED) Hons; M.Sc, Ph.D, PGCM) said:

"Inflammation is a complex biological process involving a host of resident and recruited immune cells which are mobilized to infiltrate tissues in response to invading pathogens. These immune cells boast elevated numbers and heightened activation as they churn out inflammatory mediators, which act in unison to coordinate and modulate the immune response. Choosing the right bioanalytical platform for your immunology clinical trial is critical to data collection. But navigating the intricate inflammation process can be difficult."

In this webinar Dr Sales will examine what these platforms look like in use, and how should you go about selecting the right one. It will also identify the most common bioanalytical platforms used during clinical trials to measure levels of inflammatory mediators in biological fluids.

Using SARS-COV-2 samples, the webinar will cover a custom 10 analyte inflammatory panel and identify how the levels observed for these mediators in Covid patients compare with an uninfected patient's matrix.

It will also discuss how these platforms measure specific immunological markers in clinical trial subjects by flow cytometry.

Register Here
May 25, 2:00 pm – 3:00 pm EDT
https://webinars.endpts.com/deconvoluting-inflammation-and-immunology-for-clinical-trials/

Agilex Biolabs' world-class laboratories feature state-of-the-art equipment including Gyrolab Xplore, MSD Quickplex 120, Luminex Magpix, BD FACSymphony A3 flow cytometer and soon to be released, digital droplet quantitative real-time RT-PCR.

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.

Australian clinical trials have remained open for business and Agilex Biolabs is a designated essential service so clients can be assured of study continuity.

Agilex Biolabs has more than 120 staff which includes 85 dedicated laboratory staff, and supports client pharma and biotech companies from US, Europe and APAC.

Book a confidential briefing with our scientists 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 24 years' experience in performing regulated bioanalysis, including quality method development, method validation and sample analysis services. It has successfully supported hundreds of preclinical and clinical trials from 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. Agilex Biolabs also offers toxicology services through its company TetraQ, an established GLP rodent toxicology facility in Australia.

Agilex Biolabs has the leading certifications including 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 main labs by more than 30% to accommodate biotech demand from APAC and the USA. Watch the new lab video walkthrough at 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, Gyrolab, Luminex) and flow cytometry (BD FACSymphony A3, 20 colour cell analyser).

Agilex 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

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

Copyright 2021 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Agilex Biolabs’ Toxicology Tapped for SARS-CoV-2 Vaccine Research

ADELAIDE, AUS, May 17, 2021 – (ACN Newswire) – Agilex Biolabs, Australia's largest and most technologically advanced specialist bioanalytical laboratory for clinical trials, said biotechs with first-in-human studies can leverage significant quality, speed and cost advantages working with their company TetraQ toxicology for pre-clinical research in Australia.





TetraQ is a NATA-accredited, GLP-recognised rodent toxicology facility.

The TetraQ toxicology team, whose recent COVID-19 vaccine work is featured in PubMed, is one of the most experienced in the region with more than 15 years of success with biotechs and university researchers. In addition, research costs can be offset by 43.5% with the attractive Australian Government clinical research incentive rebate for USA, Asia and European companies.

Agilex Biolabs works closely with Australia's leading biotech R&D tax rebate specialist, Bentleys R&D Services, to ensure clients are aware of the R&D benefits.

Bentleys' Managing Director Mike Burfield said the attractive 43.5% R&D rebate on clinical research spend can be applicable for the entire toxicology program.

"The rebate covers rodent toxicology services at TetraQ, while second species toxicology research conducted overseas can also be potentially eligible depending on the company, saving considerable costs in the pre-clinical stage.

Each year we have hundreds of biotech companies from around the world benefiting from this significant refund system operated by The Australian Government to attract clinical research.

However, it is vital that biotechs take advice prior to starting research, and that company documentation is prepared correctly from the start to take full advantage of these savings during the toxicology program, through to phase I and beyond."

TetraQ toxicology, which was acquired by Agilex Biolabs earlier this year, started in 2005 based out of the University of Queensland and has since earned a strong global reputation for excellence in GLP rodent pre-clinical safety studies.

Agilex Biolabs CEO, Jason Valentine said:

"Biotech clients are discovering the considerable speed and cost advantages of using an Australian-based toxicology facility like TetraQ.

The 43.5% rebate on toxicology costs is a major benefit, but clients are also keen to then leverage the easy and rapid transition to first-in-human trials available in Australia. Australia is known as the ideal early-phase destination because of the many regulatory and cost advantages – and most importantly that clinical data is accepted by the FDA and other major authorities.

TetraQ's NATA-accredited, GLP-recognised rodent toxicology facility is highly regarded for its personalised service, rapid response, and innovative solutions for biotechs planning their first-in-human studies."

TetraQ non-GLP toxicology study results can be used to support the design of both key efficacy studies and formal GLP toxicology studies in rodents. Formal GLP toxicity studies can in turn support first-in-human studies. GLP studies employ a test item manufactured under Good Manufacturing Practice (GMP) and a study design informed by non-GLP exploratory toxicity studies as well as the intended clinical use. GLP studies are subject to Quality Assurance (QA) audit, as their results are intended to facilitate the safe design of clinical studies.

The study management and data collection processes are supported by an FDA 21 CFR Part 11-compliant Provantis software system. Furthermore interim and final report preparation is also facilitated by this centralized data collection system to allow rapid delivery of written reports to clients.

Agilex Biolabs has more than 120 staff which includes 85 dedicated laboratory staff, and supports client pharma and biotech companies from US, Europe and APAC.

Agilex Biolabs' world-class laboratories feature state-of-the-art equipment including Gyrolab Xplore, MSD Quickplex 120, Luminex Magpix, BD FACSymphony A3 flow cytometer and soon to be released, digital droplet quantitative real-time RT-PCR.

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.

Australian clinical trials have remained open for business and Agilex Biolabs is a designated essential service so clients can be assured of study continuity.

Book a confidential briefing with our scientists 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 and toxicology laboratory, has more than 24 years' experience in performing regulated bioanalysis, including quality method development, method validation and sample analysis services. It has successfully supported hundreds of preclinical and clinical trials from 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.

Agilex Biolabs has the leading certifications including OECD GLP Recognition with NATA (Australian Government OECD GLP Compliance monitoring authority) and ISO 17025 Accreditation for global recognition. The company has recently acquired TetraQ biolabs and toxicology, and also expanded its main labs by more than 30% to accommodate biotech demand from APAC and the USA. Watch the new lab video walkthrough 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, Gyrolab, Luminex) and flow cytometry (BD FACSymphony A3, 20 colour cell analyser).

Agilex 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

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

Copyright 2021 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Avance Clinical Expands Gene Technology Clinical Trial Services to Meet $17.4 billion Market Demand

ADELAIDE, AUS, May 7, 2021 – (ACN Newswire) – The leading Australian CRO for biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award winner, Avance Clinical, has expanded its gene technology clinical trial services to meet the increasing global demand predicted to reach $17.4 billion by 2023.





Avance Clinical is accredited as a gene technology CRO under the Office of the Gene Technology Regulator (OGTR).

This accreditation recognizes that Avance Clinical has the CRO resources and internal processes in place to effectively manage pre-clinical and clinical trials for products involving genetically modified organisms (GMOs).

In Australia, dealings with GMOs in clinical research requires authorisation under the Gene Technology Act 2000. The OGTR administers the Gene Technology Act 2000, and has specific responsibility to protect the health and safety of people, and to protect the environment, by identifying risks posed by or as a result of gene technology, and by managing those risks through regulating dealings with GMOs.

The global market for genetic modification therapies is expected to grow from $2.3 billion in 2018 to reach $17.4 billion by 2023, growing at a compound annual growth rate of 49.9% (BCC Research, 2018). The utilization of gene modification technologies used in COVID-19 vaccine products is likely to translate in further growth in this field of therapeutics.

Avance Clinical CEO Yvonne Lungershausen said OGTR accreditation is important for our international clients. "Our clients need to know that their CRO has all the necessary credentials and is capable of delivering the highest of clinical research standards in this exciting and rapidly evolving sector," she said.

Avance Clinical currently has a number of GMO studies underway and is expanding its services further to accommodate increasing global demand.

Take the Quiz: Test your Knowledge about Australian Clinical Trials here. https://www.surveymonkey.com/r/Australian-Clinical-Trials

About Avance Clinical

Australia's Avance Clinical has more than 20-years of experience and is now one of Australia's leading Contract Research Organizations. Avance Clinical facilitates quality drug development by aligning people, skills, and expertise in the pursuit of drug development for a healthier world.

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. Visit http://www.avancecro.com for more information.

Other benefits include:
1. The Government R&D grant means up to 43.5% rebate on clinical trial spend
2. Telehealth pivot during COVID-19 pandemic – 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 Contact:
media@avancecro.com

Copyright 2021 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Agilex Biolabs Congratulates Bionomics Limited on BNC210 PK Results

ADELAIDE, AUS, Apr 30, 2021 – (ACN Newswire) – Agilex Biolabs, Australia's largest and most technologically advanced specialist bioanalytical laboratory for clinical trials, today congratulated client Bionomics Limited (Bionomics) on its positive pharmacokinetic (PK) results from a 7-day dosing study in healthy volunteers using the newly developed solid dose oral tablet formulation of BNC210.

Liz Doolin, Bionomics' Vice President Clinical Development commented that "We greatly value our long-standing partnership with Agilex Biolabs who continue to be a partner of choice for Bionomics and have supported the development of BNC210 from the beginning. We look forward to continuing this partnership into the future."

Bionomics (ASX: BNO, OTCQB: BNOEF, Germany: AU000000BNO5), is a global, clinical stage biopharmaceutical company. Bionomics said in their announcement:

"BNC210 is a novel, negative allosteric modulator of the alpha 7 nicotinic acetylcholine receptor in development for the treatment of anxiety and stressor-related disorders, and in November 2019 was granted Fast Track designation by the US Food and Drug Administration (FDA) for the treatment of Post-Traumatic Stress Disorder (PTSD).

The 7-day dosing PK study in ten healthy volunteers (females and males) demonstrated that at a dose of 900 mg given twice daily, the tablet formulation of BNC210 had steady-state 12-hourly exposure levels ranging from 33-57 mg.h/L which exceed the 12-hourly blood exposure of ~25 mg.h/L predicted as necessary to meet the primary endpoints for effectiveness for treating PTSD patients in future clinical trials.

Dr. Errol De Souza, Executive Chairman of Bionomics said, "We are extremely pleased with the results of the 7-day PK study which demonstrate that we reach steady-state levels on the second day following the start of twice daily dosing and that we not only meet but exceed the blood exposure predicted from the pharmacometric analysis as necessary for future trials.

"With the dose now selected, we can initiate manufacturing of the tablets, clinical site selection and regulatory filings in preparation for a Phase 2b trial with BNC210 in PTSD patients projected for mid-2021."

Dr Kurt J. Sales Agilex Biolabs' Director Immunoassay said: "Anxiety and stress-related disorders have a major impact on the health and wellbeing of hundreds of thousands of Australians with more than 1 in 4 people reported to be impacted by these disorders. The effects of stress and anxiety not only impact a person's psychological well-being but also their physical well-being and productivity which in turn has a tremendous impact on the economy.

"Novel treatments such as BNC210 are essential weapons in the fight against anxiety and stress-related disorders. Agilex Biolabs has been working closely with Bionomics for several years, supporting the PK regulated Bioanalysis of BNC210 and is privileged to be a part of this potential new treatment for anxiety and stressor-related disorders."

Agilex Biolabs' world-class laboratories feature state-of-the-art equipment including Gyrolab Xplore, MSD Quickplex 120, Luminex Magpix, BD FACSymphony A3 flow cytometer and soon to be released, digital droplet quantitative real-time RT-PCR. 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.

Clients can also access a rebate of up to 43.5% on clinical trial bioanalytical services spend as part of the Australian Government clinical trial attraction program. Australian clinical trials have remained open for business and Agilex Biolabs is a designated essential service so clients can be assured of study continuity. Agilex Biolabs has more than 100 staff which includes 75 dedicated laboratory staff, and supports client pharma and biotech companies from US, Europe and APAC.

Book a confidential briefing with our scientists 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 24 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.

Agilex Biolabs has the leading certifications including 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 lab video walkthrough here: https://youtu.be/WNdPGkdr9FA

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

Agilex 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 media contact:
Kate Newton
Media@AgilexBiolabs.com

Copyright 2021 ACN Newswire. All rights reserved. http://www.acnnewswire.com

Agilex Biolabs and B2S Life Sciences on Immunoassay Bioanalysis for Clinical Trials

ADELAIDE, AUS, Apr 29, 2021 – (ACN Newswire) – Agilex Biolabs, Australia's largest and most technologically advanced specialist bioanalytical laboratory for clinical trials, and B2S Life Sciences, a biotherapeutic enablement company advancing improved analytical methods and outcomes for developers of biotherapeutic drugs and diagnostics, shared key ways to navigate the immunogenicity and biomarker requirements for clinical trials via webinar.

Watch the webinar here (no registration required): https://bit.ly/3sZp8IA / https://youtu.be/x0H9a8oCb98

"Hot Topics in Immunoassay Bioanalysis – Key points in navigating the immunogenicity and biomarker requirements for clinical trials" was presented by Endpoints Webinars on April 6. Hosted by Endpoints Editor Arsalan Arif, the webinar featured Dr Kurt J. Sales, Agilex Biolabs' Director of Immunoassay, Ronald R. Bowsher PhD, Partner and Chief Scientific Officer at B2S Life Sciences, and Amy Rosen, Associate Director of Statistics at B2S.

The panel shared insights from many years working in immunoassay bioanalysis for clinical trials. Ronald R. Bowsher said B2S has been working with Agilex Biolabs for more than four years, "Our relationship has evolved very well, and we understand each other's needs. And despite the geographic differences, I think we've had a very productive collaboration serving Agilex Biolabs' customers," he said.

Dr Kurt J. Sales said, "Our world-class laboratories feature state-of-the-art equipment including Gyrolab Xplore, MSD Quickplex 120, Luminex Magpix, BD FACSymphony A3 flow cytometer and soon to be released, digital droplet quantitative real-time RT-PCR, while our scientists have experience in solving the most complex immunogenicity and drug tolerance issues, often encountered in immuno-oncology studies in both an early phase and later phase setting."

Agilex Biolabs specialises in bioanalysis of small molecules and biologics for PK, immunogenicity, biomarkers and immunological pharmacodynamics assessments utilising LC-MS/MS, immunoassay (Mesoscale, Gyrolab, Luminex) and flow cytometry (BD FACSymphony A3, 20 colour cell analyser), and has leading certifications including OECD GLP Recognition with NATA (Australian Government OECD GLP Compliance monitoring authority) and ISO 17025 Accreditation for global recognition.

Australian clinical trials have remained open for business. Agilex Biolabs, a designated essential service so clients can be assured of study continuity, can assist international clients with a rebate of up to 43.5% on clinical trial bioanalytical services spend as part of the Australian Government clinical trial attraction program. The company has recently expanded its labs by more than 30% to accommodate biotech demand from APAC and the USA. Watch the new lab video walkthrough here: https://youtu.be/WNdPGkdr9FA.

Book a briefing with Agilex Biolabs before starting 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:
Kate Newton
Media@AgilexBiolabs.com

Copyright 2021 ACN Newswire. All rights reserved. http://www.acnnewswire.com

TrialWire launches StudyBoost, the Clinical Trial Insurance Plan

SYDNEY & SAN FRANCISCO, Mar 24, 2021 – (ACN Newswire) – TrialWire(TM), the most secure digital Patient Recruitment Platform, announces the launch of StudyBoost, the monthly insurance plan that provides an instant patient recruitment boost at any time, across one or all sites, depending on recruitment needs.



TrialWire, the algorithm powered recruitment platform, launches StudyBoost, a Clinical Trial insurance plan. (3/2021)



With more than 80% of clinical trials failing to recruit patients on time, 30% of research sites not able to meet enrollment goals, and 10% of sites not enrolling any patients, StudyBoost offers peace of mind to Clinical Directors and their CROs.

StudyBoost was designed so that sponsors can avoid trial rescue crisis, saving valuable time and money. If a study needs extra patients, StudyBoost can start delivering instantly and at a significantly reduced cost to normal recruitment. There are no project fees and there is a 50% fee reduction for enrolled patient success.

StudyBoost is ideal for sponsors and CROs wanting to avoid extended recruitment stalls while they find a recruitment firm and process engagement documentation, which can take weeks. StudyBoost means any study has a recruitment booster plan ready to action whenever recruitment slows.

StudyBoost is available via the TrialWire self-serve portal, https://www.trial-wire.com/studyboost/. The package is only available from the start of a study.

About TrialWire(TM) – www.trial-wire.com

The TrialWire(TM) platform is the most secure service, using advanced algorithms to find the right people online that might be suitable for studies listed on the Platform. They are invited to the Platform and taken through the AI-Match screener to determine an exact match to a study-site based or remote/virtual.

No account sign-up is required to find and apply for a study. And unlike all other digital recruitment firms, TrialWire does NOT keep patient details – no databases so no potential privacy breaches. Sponsors are not paying for database building where patients are sent to other studies.

The Platform ingests study data from approved trial registries like ClinicalTrials.gov. It uses advanced algorithms, SEO, search marketing, social media, respected news sites, and wellness blogs and more to find patient/trial matches. The algorithms find people based on detailed demographic and location profiles.

Key to TrialWire success is that it finds motivated people who are online actively trying to find out more about their conditions. These people can be connected to a site in under 2 minutes, and demonstrate the highest retention rates. Learn more about TrialWire at https://www.trial-wire.com.

Contact:
Sydney NSW AUS HQ, +61 2 8218 2145
Singapore APAC HQ, +65 3159 3427
San Francisco USA HQ, +1 415 951 3228
E: team@trial-wire.com, www.trial-wire.com

Copyright 2021 ACN Newswire. All rights reserved. http://www.acnnewswire.com

TrialWire launches StudyBoost, the Clinical Trial Insurance Plan

SYDNEY, Mar 23, 2021 – (ACN Newswire) – TrialWire(TM), the most secure digital Patient Recruitment Platform for trial rescue, announces the launch of StudyBoost, the monthly insurance plan that provides an instant patient recruitment boost at any time, across one or all sites depending on recruitment needs.



TrialWire, the algorithm powered recruitment platform, launches a Clinical Trial recruitment 'Insurance' plan. (3/2021)



With more than 80% of clinical trials failing to recruit patients on time, 30% of research sites not able to meet enrollment goals, and 10% of sites not able to enroll any patients, StudyBoost offers peace of mind for Clinical Directors and their CROs.

StudyBoost was designed so that sponsors avoid a trial rescue crisis, saving valuable time and money. If a study needs extra patients, StudyBoost can start delivering instantly and at a significantly reduced cost to normal recruitment. There are no project fees and there is a 50% fee reduction for enrolled patient success.

StudyBoost is ideal for sponsors and CROs wanting to avoid extended recruitment stalls while they find a recruitment firm and process engagement documentation which can take weeks. Which means a study has a recruitment booster plan ready to action at any time recruitment slows.

The package is only available from the start of a study. StudyBoost is available via the TrialWire(TM) self-serve portal, at https://www.trial-wire.com/studyboost/.

About TrialWire(TM) – www.trial-wire.com

The TrialWire(TM) Platform is the most secure service, using advanced algorithms to find the right people who are online that might be suitable for studies listed on the Platform. They are invited into the Platform and taken through the AI-Match screener to determine an exact match to a study-site based or remote/virtual.

No account sign-up is required to find and apply for a study. And unlike all other digital recruitment firms, TrialWire(TM) does NOT keep patient details – no databases so no potential privacy breaches. Sponsors are not paying for database building where patients are sent to other studies.

The Platform ingests study data from approved trial registries like ClinicalTrials.Gov. It uses advanced algorithms, SEO, search marketing, social media, respected news sites, and wellness blogs and more to find patient/trial matches. The algorithms find people based on detailed demographic and location profiles.

Key to TrialWire(TM) success is that it finds motivated people who are online actively trying to find out more about their conditions. These people can be connected to a site in under 2 minutes, and demonstrate the highest retention rates. Find out more about TrialWire at: https://www.trial-wire.com.

Contact:
Sydney NSW AUS HQ, +61 2 8218 2145
Singapore APAC HQ, +65 3159 3427
San Francisco USA HQ, +1 415 951 3228
E: team@trial-wire.com, www.trial-wire.com

Copyright 2021 ACN Newswire. All rights reserved. http://www.acnnewswire.com