COVID-19 drug development

Applied BioMath, LLC Presents Mechanistic PK/PD Modeling of a Bispecific Antibody at PepTalk 2023

Retrieved on: 
Tuesday, January 10, 2023
Quantitative biology, Pharmacology, RO, COVID-19 drug development, Doctor of Philosophy, Applied information economics, R, Monoclonal antibody, Neoplasm, Pharmaceutical industry

Kas Subramanian, PhD, Executive Director of Modeling at Applied BioMath will present, "A semi-mechanistic pharmacology model of ATG-101, a PD-L1/4-1BB bispecific antibody for treatment of solid tumors" during the Developability of Bispecific Antibodies track on Wednesday, January 18th at 12:05 p.m.

Key Points: 
  • Kas Subramanian, PhD, Executive Director of Modeling at Applied BioMath will present, "A semi-mechanistic pharmacology model of ATG-101, a PD-L1/4-1BB bispecific antibody for treatment of solid tumors" during the Developability of Bispecific Antibodies track on Wednesday, January 18th at 12:05 p.m.
  • "When developing bispecific antibodies, various factors might impact dose and some of these factors can be difficult to measure directly.
  • Modeling and simulation approaches are often able to predict these difficult to measure factors, thereby enabling more accurate dose predictions," said John Burke, PhD, Co-founder, President and CEO of Applied BioMath.
  • "In our collaboration with Antengene, trimer formation was key to the pharmacology of their bispecific, ATG-101.

SARM1 Inhibitors Market by Target Indications, Type of Molecules, Drug Developers, Drug Candidates and Key Geographies : Industry Trends and Global Forecasts, 2022-2040

Retrieved on: 
Monday, December 12, 2022
Molecule, United Nations, Therapy, NIH, Peripheral neuropathy, Neurological disorder, COVID-19 drug development, Amyotrophic lateral sclerosis, Patient, Multiple sclerosis, Glaucoma, Research, Neurodegeneration, Death, Element, CPC, Alzheimer's disease, Geography, Investment, Parkinson's disease, Sterile alpha motif, Vance DeGeneres, Growth, UN, First Nations in Ontario, SARM1, Patent, Organization, Pharmaceutical industry, Fine chemical, Medical device

View original content:https://www.prnewswire.com/news-releases/sarm1-inhibitors-market-by-targ...

Key Points: 
  • In fact, the annual expenditure associated with neurological disorder care in 2020 was more than USD 655 billion, in the US alone.
  • Additionally, several patents related to SARM1 targeting therapies have been recently filed / granted, demonstrating the continued innovation in this domain.
  • Information on recent developments (partnerships and collaborations, and funding and investments) reported by several players engaged in the SARM1 targeting therapeutics domain.
  • This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments.

SOTIO Doses First Patient in AURELIO-04 Phase 2 Trial of SOT101 in Combination with KEYTRUDA® (pembrolizumab)

Retrieved on: 
Tuesday, July 26, 2022
MSD, COVID-19 drug development, GLOBE, Pembrolizumab, Interleukin 2, Merck & Co., Safety, Czech Republic, Technology, Cell, ADCC, Immunotherapy, Merck, Merck Sharp & Dohme Federal Credit Union, Trial of the century, Patient, NK, PPF (company), Survival, Drug development, Pharmaceutical industry

The initiation of this Phase 2 study is a significant milestone for the clinical development of SOT101, said Richard Sachse, M.D., Ph.D., Chief Medical Officer of SOTIO and Managing Director of SOTIO Biotech in Switzerland.

Key Points: 
  • The initiation of this Phase 2 study is a significant milestone for the clinical development of SOT101, said Richard Sachse, M.D., Ph.D., Chief Medical Officer of SOTIO and Managing Director of SOTIO Biotech in Switzerland.
  • The Phase 2 trial ( NCT05256381 ) is an open-label, single-arm, multicenter study of SOT101 in combination with pembrolizumab to evaluate efficacy and safety in patients with selected advanced/refractory solid tumors.
  • The Phase 2 trial will enroll up to 320 patients targeting multiple solid tumor indications across 55 trial sites in Europe and the US.
  • Validated by promising Phase 1/1b AURELIO-03 data, AURELIO-04 will aim to confirm safety and demonstrate efficacy of SOT101 in combination with pembrolizumab in additional indications.

Interim Data from the Phase 1/1b AURELIO-03 Trial of SOT101 Presented at the AACR 2022 Annual Meeting

Retrieved on: 
Tuesday, April 12, 2022
GPC3, Vivo, Lead, Cancer, Mesothelioma, Association, Immunotherapy, PPF (company), Calendar, SITC, COVID-19 drug development, Patient, Pembrolizumab, CAR, ADCC, Drug development, American Association for Cancer Research, Neoplasm, Safety, American Association, Prevalence, AACR, Survival, Pharmaceutical industry, Vaccine

The data were presented by Dr. Stephane Champiat from Gustave Roussy Cancer Center in an oral presentation at the American Association for Cancer Research (AACR) Annual Meeting 2022.

Key Points: 
  • The data were presented by Dr. Stephane Champiat from Gustave Roussy Cancer Center in an oral presentation at the American Association for Cancer Research (AACR) Annual Meeting 2022.
  • The AURELIO-03 study is an open-label, single-arm, multicenter dose escalation study of the IL-15 superagonist, SOT101, in combination with pembrolizumab.
  • Establishing the Phase 2 dosing and interim safety and efficacy for SOT101 in combination with pembrolizumab in the AURELIO-03 trial has been a key milestone for us.
  • SOT101 hasdemonstrated strong preclinical in vivo efficacy invarious tumor models showing increased long-term survival andtumor regression, aswell asafavorable toxicology profile.

ScienceMedia's Protocol Compliance Management Solution To Accelerate Clinical Trial Timelines Up To 20% In 2022

Retrieved on: 
Thursday, March 31, 2022
Clinical trial, CSO, Adaptive clinical trial, Safety, Technology, COVID-19 drug development, Solution, Blog, SAN, SMI, Patient, Pharmaceutical industry, Medical imaging

SAN DIEGO, March 31, 2022 /PRNewswire/ --Upon finishing a record-breaking 2021, SMi Trial , ScienceMedia's protocol compliance management solution, sets forth to shatter records in 2022 by shortening recruitment timelines, significantly reducing deviations, and accelerating trial timelines by up to 20%.

Key Points: 
  • SAN DIEGO, March 31, 2022 /PRNewswire/ --Upon finishing a record-breaking 2021, SMi Trial , ScienceMedia's protocol compliance management solution, sets forth to shatter records in 2022 by shortening recruitment timelines, significantly reducing deviations, and accelerating trial timelines by up to 20%.
  • SMiTrialprovides mobile clinical trial management tools that are integrated into study workflows and accessed, monitored, and deployed throughout the lifecycle of a clinical trial.
  • "The technology in SMi Trial's protocol compliance management closes the circuit using analytics and metrics so that trials can collapse or fold timelines, thus enabling adaptive clinical trial design.
  • SMi Trial , for site-based trials, and SMi TrialD , for decentralized or hybrid trials, are protocol compliance management solutions that mitigate clinical risk and decrease trial cost.

FDA Expands Authorized Use of REGEN-COV™ (casirivimab and imdevimab)

Retrieved on: 
Friday, July 30, 2021
Health sciences, Articles, Health, Antiviral drugs, COVID-19 drug development, Monoclonal antibodies, Casirivimab/imdevimab, Roche, COVID-19, Regeneron Pharmaceuticals

REGEN-COV is not a substitute for vaccination against COVID-19, and is not authorized for pre-exposure prophylaxis to prevent COVID-19.

Key Points: 
  • REGEN-COV is not a substitute for vaccination against COVID-19, and is not authorized for pre-exposure prophylaxis to prevent COVID-19.
  • This authorization enables these groups to use REGEN-COV to prevent infection in post-exposure and certain institutional settings.
  • REGEN-COV has not been approved by the FDA, but is currently authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use under section 564(b)(1) of the Act, 21 U.S.C.
  • Consequently, REGEN-COV remains available for use across the U.S., and Regeneron will continue actively monitoring the potency of REGEN-COV against emerging variants.

DARE-19 Phase III Collaboration between AstraZeneca, Saint Luke’s Mid America Heart Institute and George Clinical Shows Treatment’s Well-Established Safety Profile Was Consistent in Patients with COVID-19

Retrieved on: 
Thursday, July 29, 2021
Health sciences, Life sciences, Health, Clinical research, Pharmaceutical industry, Clinical trials, Adenoviridae, COVID-19 vaccines, Oxford–AstraZeneca COVID-19 vaccine, AstraZeneca, Contract research organization, COVID-19 drug development

The study was a collaboration of George Clinical, a global scientifically-backed clinical research organization and Saint Lukes Mid America Heart Institute and was funded by AstraZeneca.

Key Points: 
  • The study was a collaboration of George Clinical, a global scientifically-backed clinical research organization and Saint Lukes Mid America Heart Institute and was funded by AstraZeneca.
  • DARE-19 was the first large, randomized controlled study of hosptialized patients with COVID-19 to evaluate the safety and efficacy of SGLT2 inhibitors.
  • The trial was conducted in collaboration with Saint Lukes Mid America Heart Institute, the global sponsor, and George Clinical, a global contract research organization.
  • George Clinical is a leading global clinical research organization founded in Asia-Pacific driven by scientific expertise and operational excellence.

Global Academic Research Organization UCL Selects Phlexglobal's Innovative eTMF Solution to Enhance TMF Compliance and Inspection-Readiness Across Entire Study Portfolio

Retrieved on: 
Wednesday, July 28, 2021
Health sciences, Health, Clinical research, Design of experiments, Medical research, Clinical pharmacology, Clinical trial, Pharmaceutical industry

PhlexTMF will support the entire portfolio at UCL's Institute of Clinical Trials and Methodology (ICTM), a pre-eminent center for clinical trials and amongst the largest of its kind in Europe.

Key Points: 
  • PhlexTMF will support the entire portfolio at UCL's Institute of Clinical Trials and Methodology (ICTM), a pre-eminent center for clinical trials and amongst the largest of its kind in Europe.
  • The decision by the UCL team followed a comprehensive tendering process with Phlexglobal appointed as the preferred bidder to help UCL streamline TMF management and oversight while reducing cost and risk.
  • "We're honored that a highly respected research organization like UCL selected Phlexglobal for their eTMF solution," said John McNeill, Chief Executive Officer of Phlexglobal.
  • The Institute of Clinical Trials and Methodology at UCL is a centre of excellence for clinical trials, meta analysis and epidemiological studies.

GSK and Vir Biotechnology Announce Joint Procurement Agreement with European Commission for COVID-19 Treatment, Sotrovimab

Retrieved on: 
Wednesday, July 28, 2021
Life sciences, Health sciences, Biotechnology, Pharmaceutical industry, Antiviral drugs, COVID-19 drug development, Pharmacy, Food and Drug Administration, United States Public Health Service, Biologics license application, Sotrovimab, Biopharmaceutical

The Joint Procurement Agreement enables participating European Union (EU) Member States to quickly purchase sotrovimab, following local emergency authorization or authorization at the EU level, to treat high-risk patients with COVID-19 who may benefit from early treatment with sotrovimab.

Key Points: 
  • The Joint Procurement Agreement enables participating European Union (EU) Member States to quickly purchase sotrovimab, following local emergency authorization or authorization at the EU level, to treat high-risk patients with COVID-19 who may benefit from early treatment with sotrovimab.
  • GSK and Vir have secured supply agreements with multiple governments around the world and will continue those efforts as the pandemic continues to evolve.
  • GSK and Vir have announced plans to submit a Biologics License Application (BLA) to the U.S. FDA in the second half of 2021.
  • GSK and Vir are committed to ongoing evaluation of sotrovimab as the COVID-19 landscape continues to evolve at different rates across the globe and new variants of concern and interest emerge.

Global Gout Clinical Trial Pipeline Market research Report 2021: Phase 3, Phase 2, Phase 1, Preclinical Research, and Discovery Stage - ResearchAndMarkets.com

Retrieved on: 
Wednesday, July 21, 2021
Health, Clinical trials, Health sciences, Health, Life sciences, Drug discovery, Clinical research, Pharmaceutical industry, Design of experiments, Food and Drug Administration, Clinical trial, COVID-19 drug development, Biotie Therapies

The "Global Gout Clinical Trial Pipeline Highlights - 2021" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Gout Clinical Trial Pipeline Highlights - 2021" report has been added to ResearchAndMarkets.com's offering.
  • Gout Pipeline Highlights - 2021, provides the most up-to-date information on key pipeline products in the global Gout market.
  • It covers emerging therapies for Gout in active clinical development stages including early and late stage clinical trials.
  • The report provides Gout pipeline products by clinical trial stages including both early and late stage development - phase 3 clinical trials, phase 2 clinical trials, phase 1 clinical trials, preclinical research, and discovery stage.