publication date: Oct. 18, 2019

Drugs & Targets

Xenikos receives Fast Track designation for T-Guard for steroid-refractory SR-aGVHD

The Dutch company Xenikos B.V. said FDA has granted Fast Track designation to T-Guard, Xenikos’s product designed to treat steroid-refractory acute graft-versus-host disease in patients following allogeneic stem cell transplantation.

T-Guard is designed to reset the body’s immune system in life-threatening T cell-mediated conditions, including transplant-related rejection, acute solid-organ rejection, and severe autoimmune disease. T Guard consists of a combination of toxin-conjugated monoclonal antibodies that target CD3 and CD7 molecules on T cells and NK cells.

Preclinical and early clinical testing have shown that T-Guard can specifically identify and eliminate mature T cells and NK cells with minimal treatment-related side effects, the company said. T-Guard’s action is short-lived, thereby significantly reducing the patient’s vulnerability to opportunistic infections, compared to currently available therapies. Xenikos  has completed a phase I/II study for the second-line treatment of SR-aGVHD in patients following hematopoietic stem cell transplantation.

The results of the study showed that one week of T-Guard treatment triggered a strong clinical response and doubled the 6-month overall survival rate, the company said. These results were published in Biology of Blood and Marrow Transplantation.

A U.S. phase III registration trial involving patients with SR-aGVHD following allogeneic stem cell transplantation will begin soon, and T-Guard has been granted Fast Track designation by the FDA, as well as Orphan Drug Designation status in both the EU and the U.S.


Flatiron announces clinical decision support application through Epic’s App Orchard

Flatiron Health announced the availability of its clinical decision support and pathways application, Flatiron Assist, in the App Orchard.

Flatiron Assist supports oncologists in selecting therapies in line with best clinical practices, including the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology, and in identifying potentially relevant clinical trials.

The integrated regimen selection workflow allows clinicians to quickly confirm the clinical data needed to determine adherence to guidelines. Health system administrators can use the clinical data collected by this tool to streamline the prior authorization process, measure variation in care across a practice or health system, and report pathways compliance to payers.

“The rapidly evolving treatment landscape and increasing payer reporting requirements make it challenging for busy oncologists to efficiently get the best treatments to their patients,” James Hamrick, senior medical director, Flatiron Health, said in a statement. “Flatiron Assist is an EHR-integrated tool that puts the doctor and the patient at the forefront, enabling evidence-based treatment selection, efficient payer authorization, and insight into care patterns across practices and health systems.”

Available now in the App Orchard, Flatiron Assist is a SMART on FHIR application that will launch from the patient’s chart in Epic, eliminating the need for duplicate data entry outside the electronic medical record. Flatiron Assist pulls available demographics, diagnosis, and cancer-specific data, such as staging, from Epic and, based on those inputs, surfaces evidence-based therapy options and clinical trials for each patient. Once the oncologist chooses a treatment regimen in Flatiron Assist™, the selected regimen is automatically opened in Epic.

“Integrating NCCN’s recommendations into point-of-care apps like Flatiron Assist puts the latest evidence and multidisciplinary expert knowledge at the fingertips of oncologists everywhere,” Robert W. Carlson, CEO of NCCN, said in a statement. “NCCN Guidelines are the most frequently updated medical guidelines in any discipline; they should also be the most accessible. The convenience of Flatiron Assist can give doctors more time to engage in shared decision making in order to determine which guideline-concordant treatment plan offers the most benefit.”

Additional information is available here, and here.

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