BUSINESS INSIGHTS, PHARMA TECH
Avacta | January 23, 2023
Avacta Group plc, a leading life sciences company focused on developing innovative, targeted oncology medicines and powerful diagnostics, recently announced that AVA6000 has maintained a very favorable safety profile in the fourth dose cohort of the ALS-6000-101 dose escalation phase 1 clinical trial. Furthermore, analysis of tumor samples acquired from six patients across multiple cohorts shows that doxorubicin is being released within the tumor tissue, supporting the pre|CISIONTM technology's tumor-targeting capability.
Patients in cohort 4 continue to tolerate AVA6000 well, with a significant decrease in the occurrence and severity of the commonly associated toxicities with the administration of traditional doxorubicin treatment. Nausea, vomiting, Alopecia, mucositis, myelosuppression, and cardiotoxicity are all among the typical toxicities. Notably, the typical drug-related cardiotoxicity of doxorubicin was not found even at the highest dosage levels in group 4, equivalent to more than double the standard dose of doxorubicin.
In order to confirm the release of the active chemotherapy, doxorubicin, in tumor tissue, several tumor biopsies acquired from patients in different cohorts have been analyzed. This analysis demonstrates that AVA6000 targets the release of doxorubicin to tumor tissue at therapeutic levels that are significantly higher than those detected in the bloodstream at the same time point.
To date, AVA6000 has been administered to 19 patients with advanced and/or metastatic solid tumors who were enrolled across four groups. Based on the very favorable safety profile of AVA6000 in the study thus far, the Safety Data Monitoring Committee (SDMC) has recommended that the study be extended to higher dose cohorts in order to identify a maximum tolerated dose (MTD) required to inform dosing levels for the phase 1b and future studies. The Company anticipates completing these additional cohorts within the first half of 2023.
Avacta is a healthcare group that promotes human health and well-being by creating new cancer treatments and powerful in vitro diagnostics. Its mission is to create the future of medicine by producing safe and effective medications as well as high-performance diagnostics using its unique Affimer® and pre|CISIONᵀᴹ platforms. By merging these two platforms, the Company is constructing a pipeline of innovative cancer therapeutics to fulfil its goal of developing successful treatments for all cancer patients, including those who do not react to current immunotherapies.
BUSINESS INSIGHTS, PHARMA TECH
Elligo Health Research | January 25, 2023
On January 24, 2023, Elligo Health Research®, the leading healthcare-enabling research organization, presented the DataAI Connect, a new data and technology platform that will facilitate data-driven, rapid clinical research. DataAI Connect, a scalable, end-to-end data platform, optimizes the clinical research workflow by decreasing human error and rapidly digesting patient data to speed up clinical studies.
Elligo has created an industry-first AI-driven platform that sources, processes, analyses, and distributes patient real-world data (RWD) by bringing together data, processes, and clinical expertise. That means an end-to-end solution that solves clinical trial issues directly rather than being an add-on technology. The platform is adaptable and reusable, and it includes the following
An RWD repository of electronic health records (EHRs) and clinical data storage that incorporates EHR, clinical trial, and patient data for analytics, artificial intelligence (AI), and research
A comprehensive medical records retrieval and analytics solution that transforms data into searchable, actionable insights and personalized patient journey information within minutes using NLP, ML, and clinical experience.
A data-driven protocol development service that puts designs to the test in the real world.
Elligo's Chief Data Officer, Michael Ibara, commented, "The application of AI approaches to healthcare and clinical study data is moving from the moon-shot approach to more practical applications." He added, "An example of this approach is the process of getting patients' medical records, which involves manual, non-scalable activities such as getting accurate information on patients' providers, asking sites to track down records, and having humans triage hundreds of pages of medical records. The judicious and intelligent application of natural language processing (NLP), machine learning (ML), and other AI approaches increases speed, accuracy and quality, while removing the burden from the sites and patients."
(Source – Business Wire)
About Elligo Health Research
Founded in 2016, Elligo Health Research® is a leading healthcare-enabling clinical research organization. With access to known patients and their HIPAA-compliant healthcare data, its IntElligo® Research Stack technology and eSolutions Research Accelerator PatientSelect approach expedite clinical trials through healthcare. Elligo's Site Solutions, combined with the largest Known Patient Access Network, enable healthcare practices and research sites to engage in clinical studies. Its services expedite the development of novel pharmaceutical, biotechnology, medical device, and diagnostic products through the adaptive involvement of known patients and clinicians.
BUSINESS INSIGHTS, PHARMACY MARKET
Cellworks Group | January 13, 2023
Cellworks Group Inc., a pioneer in personalized therapy biosimulation, announced the introduction of its precision drug development business units.
These units will use predictive biosimulation to shorten drug development time-to-market and revive previously researched but disapproved pharmaceutical assets.
The two new business units will use Cellworks' computational biology model (CBM) and biosimulation platform to predict responses to pharmaceutical interventions in silico, streamlining the clinical trial by identifying suitable patients more quickly, thereby reducing the time and cost of developing successful pharmaceutical agents.
Cellworks precision drug development: Pre-clinical stage
Companion molecule development: The Cellworks platform can augment a drug's usability by finding companion molecules that improve performance when combined with the investigational agent.
Biomarker development: Cellworks utilizes cell lines and historical patient data to uncover novel biomarkers for investigational agents. This may increase drug success rates by proactively identifying individuals who will respond to an agent.
Indication expansion: By utilizing the Cellworks patient database of 100,000+ omics patient profiles and 1,800 oncology cell lines to examine the agent's effectiveness in different indications, the Cellworks platform can identify additional indications where an experimental treatment may be successful.
Cellworks precision drug development: Clinical stage
Drug revival and repurposing: The platform seeks to anticipate whether certain drugs cause a response, which may be used to identify whether shelved assets can be resurrected via suitable patient selection or the discovery of non-obvious reasons.
Clinical trial biosimulation: Through biosimulation clinical trials, the Cellworks platform may anticipate humans' clinical response to pharmaceutical agents in weeks, yielding critical insight years ahead of a traditional clinical practice.
Cellworks Platform and Computational Biology Model (CBM)
The Cellworks platform biosimulates the impact of specific pharmacological molecules on a given patient or class of patients using the patient's genetic profile. To generate a customized or cohort-specific disease model, multi-omic data from a cohort or patient is fed into the Cellworks computational biology model (CBM).
About Cellworks Group
Cellworks is one of the leaders in precision medicine. The organization assists physicians and payers in navigating the most efficacious, cost-effective therapies for patients. Its primary therapeutic areas are oncology, immunology, dermatology, and infectious diseases. Its one-of-a-kind biosimulation platform is a unified representation of biological information gathered from disparate databases and used to find cures. The company has the world's strongest trans-disciplinary team of molecular biologists, cellular pathway modelers, and internet software technologists working towards a common goal, i.e., taking on significant diseases to improve patients' lives.