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.
MedinCell | December 01, 2022
MedinCell has received an additional US$ 4 million payment from the Bill & Melinda Gates Foundation
This amount is intended to finance the next steps of MedinCell’s program mdc-WWM in readiness to initiate the first clinical trial end of 2023
It follows US$ 11,8 million already received as part of the two successive grants for a total of up to US$ 22,5 million from the Bill & Melinda Gates Foundation to finance the development of the program up to phase 1 completion
The Gates Foundation has a non-exclusive license on the product for the purposes of achieving Global Access in the target low-and middle-income countries, whilst MedinCell owns all marketing rights worldwide
MedinCell is a pharmaceutical company at premarketing stage that develops a portfolio of long-acting injectable products in various therapeutic areas by combining its proprietary BEPO® technology with active ingredients already known and marketed. Through the controlled and extended release of the active pharmaceutical ingredient, MedinCell makes medical treatments more efficient, particularly thanks to improved compliance, i.e. compliance with medical prescriptions, and to a significant reduction in the quantity of medication required as part of a one-off or chronic treatment. The BEPO® technology makes it possible to control and guarantee the regular delivery of a drug at the optimal therapeutic dose for several days, weeks or months starting from the subcutaneous or local injection of a simple deposit of a few millimeters, fully bioresorbable. MedinCell collaborate with tier one pharmaceuticals companies and foundations to improve Global Health through new therapeutic options.
TC BioPharm | November 23, 2022
TC Biopharm a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer today announced the dosing of its first three patients within its Phase 2b clinical trial of OmnImmune®, an allogeneic unmodified cell therapy focused on treating Acute Myeloid Leukemia.
The initial 5 patients in the trial are deemed a "safety cohort", spaced two weeks apart with safety review by an oversight board to confirm no drug related toxicity issues, subsequent to 5 patients being dosed the study will advance to open enrollment. This safety cohort is in line with TCBP's step-wise clinical trial advancement, moving from donor matching in the Phase 1b to a universal donor model with no HLA matching of donor to patient.
"The launch of our Phase 2B trial is a key milestone in the development of our lead therapeutic, OmnImmune®, for patients with AML and for TC BioPharm's emerging pipeline of 'off-the-shelf' gamma-delta T cell therapies. This study design includes a 5 patient safety cohort prior to open enrollment, we expect to complete the safety cohort before the end of 2022. The next step in the study is a 19 patient interim review, which will allow TCBP to review dosing and increase dosing to a higher level should our team deem it necessary for efficacy, or we can elect to maintain our current dosing level of 7x10^7 or 700 million cells per dose. We look forward to moving ahead with our Phase 2b trial with a target for open enrollment in January 2023, as well as our efforts to expand our clinical efforts in the US in the first half of 2023."
Bryan Kobel, CEO of TC BioPharm
TC BioPharm's Phase 2B trial, dubbed ACHIEVE, will enroll adults diagnosed with AML who have either relapsed or are refractory to prior treatments as well as a cohort for patients with myelodysplastic syndromes conditions that can occur when the blood-forming cells in the bone marrow become abnormal. The trial is expected to enroll approximately 37 patients.
About TC BioPharm PLC
TC BioPharm is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of gamma-delta T cell therapies for the treatment of cancer with human efficacy data in acute myeloid leukemia. Gamma-delta T cells are naturally occurring immune cells that embody properties of both the innate and adaptive immune systems and can intrinsically differentiate between healthy and diseased tissue. TC BioPharm uses an allogeneic approach in both unmodified and CAR modified gamma-delta T cells to effectively identify, target and eradicate both liquid and solid tumors in cancer.
TC BioPharm is the leader in developing gamma-delta T cell therapies, and the first company to conduct phase II/pivotal clinical studies in oncology. The Company is conducting two investigator-initiated clinical trials for its unmodified gamma-delta T cell product line - Phase 2b/3 pivotal trial for OmnImmune® in treatment of acute myeloid leukemia using the Company's proprietary allogenic CryoTC technology to provide frozen product to clinics worldwide. TC BioPharm also maintains a robust pipeline for future indications in solid tumors as well as a significant IP/patent portfolio in the use of CARs with gamma-delta T cells and owns our manufacturing facility to maintain cost and product quality controls.