WideTrial to Support Cost Recovery for Personalized Cancer Vaccine Trial and Expanded Access Program
Michimich.com/10190886

SAN FRANCISCO - Michimich -- WideTrial, Inc. will provide key regulatory support to a personalized cancer treatment program run by the Jaime Leandro Foundation for Therapeutic Cancer Vaccines (JLF) in association with Washington University School of Medicine in St. Louis.

In a basket trial for neoantigen synthetic long peptide vaccines, patients with advanced malignancies will be given a customized mix of neoantigen peptides based on their individual tumor mutation profiles.  Cancer patients who do not meet the trial's eligibility criteria or who are geographically remote from the trial centers may still gain the personalized treatment through an Expanded Access Program (an "EAP").

WideTrial will conduct the planning and regulatory filings required for FDA-authorized Cost Recovery for both the research trial and the EAP.

"The recent draft Guidance on Charging for Investigational Treatment under an IND was a great step by FDA to clarify Cost Recovery rules, but it's still a complicated matter," said Jess Rabourn, CEO of WideTrial.  "Our company was created to make this space easier to navigate, ensuring that non-traditional clinical trials, including Expanded Access Programs, are feasible for more clinics to offer to more patients as a care option."

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In the United States, all Expanded Access Programs and some research trials are eligible for Cost Recovery. This permits a sponsor to pass through some of its costs to interested parties.  It is intended for cases in which the cost burden on the sponsor would otherwise severely restrict the feasibility or scope of the program.

"We reached out to WideTrial because of Jess's long-standing leadership in Expanded Access but also for his reputation for helping companies understand and utilize Cost Recovery in their clinical development," said William Hoos, President of JLF.  "It's been a successful partnership so far."

WideTrial Inc. is a Silicon Valley based health-tech corporation.  Its mission is to make investigational treatment options accessible to all patients with serious and life-threatening health conditions.  To learn more, visit widetrial.com

The Jaime Leandro Foundation for Therapeutic Cancer Vaccines (JLF) is a 501(c)3 nonprofit organization that organizes the complex process necessary to give patients and doctors access to personalized neoantigen vaccines.