MATEON THERAPEUTICS, INC. (OTCMKTS:MATN) Files An 8-K Entry into a Material Definitive Agreement
Item 1.01 Entry into a Material Definitive Agreement.
Expanded Access Program (EAP) Master Service Agreement between myTomorrow and Mateon Therapeutics Inc. (“Mateon”).
Mateon’s ongoing phase 2 development of OT-101 (Trabedersen) as an immunotherapy for the treatment of cancer shares commonality with potential covid-19 therapies on the basis of the transforming growth factor beta (TGF-β) inhibition mechanism.
Recognizing this potential and the urgency of the global situation early on, Mateon’s has engaged myTomorrows as a regulatory intelligence asset and pre-approval access expert. With regard to the former, myTomorrows will provide regulatory guidance in support of Mateon’s research objectives and Clinical Trial Application (CTA) in the U.K. In parallel to the Clinical Trial launch, myTomorrows will also develop and run an Expanded Access Program for OT-101 in both the U.K. and U.S.
myTomorrows operates as an integrated end-to-end platform serving patients, healthcare providers, and drug developers. myTomorrows offers direct support as a single point of contact for patients with a life-threatening disease where there are limited or no standard approved therapies. These patients and their physicians are provided a personalized report detailing relevant Clinical Trials and pre-approval treatment options. myTomorrows also serves as a global partner for companies developing drugs to treat patients with unmet medical needs through program management at all phases — from patient identification for Clinical Trials to the distribution of investigational drugs around the world.
myTomorrows directly engages with physicians and patients. Requests for access may come in directly to myTomorrows by phone, email, or through an online portal. Physicians and patients will be directed to a member of our Medical team who will guide them through the access process. The response time for an inquiry is no longer than one business day.
An Expanded Access Program (EAP), also known as Early Access Program or Managed Access Program, facilitate access to pre-approval drugs outside of a Clinical Trial. They are typically an option for patients who have high unmet medical need, no suitable options amongst registered drugs and cannot participate in a Clinical Trial.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.