RESEARCH, BUSINESS INSIGHTS
Medidata Solutions | March 13, 2023
Medidata, a leading provider of innovative software solutions for clinical trials that streamline the clinical trial process, reduce time and cost, and accelerate the development of new treatments, recently announced that Allucent, a contract research organization (CRO) that brings innovation to biopharma firms, is expanding the global use of Medidata's Clinical Cloud to enhance its clinical trial operations offering.
This agreement extends Allucent's current usage of Medidata's technology, which includes eCOA, Rave EDC, RTSM, and Rave Imaging, supporting crucial development areas such as rare and orphan indications, oncology and cell and gene therapies. As part of the deal, Allucent's team achieved 100% Rave EDC certification, reinforcing their dedication to quality and providing clients with industry-leading technology.
Allucent is a sponsor of Medidata NEXT London and will give a presentation on data analytics for early-phase oncology trials. The presentation will cover how working with Medidata has helped them apply visualization techniques and strategies to extract the total value of information for all stakeholders.
Medidata is a Dassault Systèmes company poised to drive the digital transformation of life sciences in the age of personalized medicine with its 3DEXPERIENCE platform. This platform is the first end-to-end scientific and business solution, from research to commercialization.
Medidata's head of Global Sales, Janet Butler, commented, "Allucent is leveraging the power of the Medidata Clinical Cloud to solidify their position at the forefront of clinical technology." She further emphasized, "Their work with novel therapies requires agile, patient-centric solutions. We are proud to build on our eight-year collaboration to advance the digital transformation of life sciences and deliver clinical innovations to help reach their goals."
(Source – Business Wire)
About Medidata Solutions
Medidata Solutions is a New York-based global provider of cloud-based software solutions for clinical trials. Its platform, the Medidata Clinical Cloud, enables pharmaceutical, biotechnology, medical device companies, and academic research organizations to manage all aspects of clinical trials, including study design, data capture, management, and analysis. Medidata's platform can capture real-time data from multiple sources, including electronic health records and wearable devices, to monitor patients closely, identify potential safety issues earlier, and make informed decisions about trial design and treatment protocols. The platform also features advanced analytics tools like machine learning and artificial intelligence algorithms to help researchers analyze and interpret their data. In 2019, Dassault Systèmes, a global leader in 3D design software and simulation solutions, acquired Medidata, further enhancing its platform.
RESEARCH, PHARMA TECH
Ambrx | February 21, 2023
Ambrx Biopharma Inc., recently released positive preliminary results from its current Phase 1 trial, APEX-01 (NCT04662580), which is examining ARX517, Ambrx's patented anti-PSMA ADC, in patients with prostate cancer.
Patients with advanced prostate cancer who have progressed on at least two prior FDA-approved treatments are enrolled in the Phase 1, first-in-human, open label dose escalation and dose expansion experiment known as APEX-01. In the US, APEX-01 is the only clinical trial that uses an ADC to treat PSMA. The trials revealed
• No grade ≥3 treatment-related adverse events (AEs) or drug-related serious adverse events (SAEs) have been reported in the 22 individuals who were evaluable for safety. ARX517 was well-tolerated otherwise with grade 1 or 2 treatment-related adverse events were observed. It is yet to reach the maximum tolerated dose (MTD) • Starting with the second to lowest dose of 0.64 mg/kg, PSA reductions of > 30% have been seen in Cohorts 2-5 • 3 (100%) patients in Cohort 6 (2.0 mg/kg dosage) had a PSA level reduction of at least 50%. PSA levels were reduced by more than 90% in 2 out of 3 patients. At the initial on-treatment scan, soft tissue measurable disease was found in 1 of the 3 patients, and showed a partial RECIST v1.1 response • In Cohort 7, three patients received doses with no DLTs
Daniel J. O’Connor, CEO of Ambrx, said, “While recent advances have considerably reduced the number of men who die from prostate cancer, it remains the second-most common form of death from cancer in the United States. Approximately 1 man in 41 will die of prostate cancer. Thus, there remains an urgent need for better treatments, in particular for men with advanced prostate cancer.” He further added, “We are very pleased to see a significant reduction of greater than 50% in PSA levels in the first three patients at 2.0 mg/kg, two of which went on to see a greater than 90% PSA level reduction, without any serious drug-related adverse events.”
(Source – Business Wire)
Ambrx Inc., is a clinical-stage biopharmaceutical company. It develops precision biologics using an extended genetic code. Synthetic amino acids are incorporated into proteins using Ambrx technology, which is carried out entirely within a living cell. Precision Biologics, a novel therapeutic class with significant potential uses these synthesized amino acids.
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.