Expanded Access

Heat Biologics' Position on Offering Expanded Access and Compassionate Use to Investigational Medicines

At Heat Biologics, we are committed to developing safe and effective immunotherapies for a wide range of cancers, and believes that participation in clinical trials is the most appropriate way to access our investigational therapies.

We conduct clinical trials to assess the safety and efficacy of investigational medicines, so we can obtain the necessary approvals from regulatory authorities, and provide those therapies to the broadest group of patients as quickly as possible.

In some instances, it may not be possible for patients with serious or life-threatening diseases to be eligible for a clinical trial, or have other options for treatment. These situations are known as expanded access or compassionate use.

Expanded access refers to the use of an investigational therapy outside a clinical trial when the primary purpose is to treat a serious condition in patients. We understand the need for these programs and recognize the importance of having an appropriate policy.

Aligning with guidelines from the FDA and other regulatory bodies, an expanded access program, or a single request for use of an investigational medicine, can only be considered if all of the following conditions are met:

  • The illness must be serious or life-threatening with no other satisfactory treatment options (such as approved products or enrolling clinical trials)
  • There is sufficient evidence that the potential benefit to the patient would likely outweigh potential risks, based on available safety and efficacy information
  • Ability to provide a product in a fair and equitable manner, so that there is adequate manufacturing capacity for ongoing programs
  • Whether granting expanded access would potentially compromise the scientific validity of broader development programs, or interfere with or delay current clinical trials or regulatory filings designed to make the therapy available to many more patients

Requests for access to experimental therapies must be made by a qualified and licensed physician through our Contact page.

In line with the 21st Century Cures Act, Heat Biologics may revise this policy at any time. This website and policy will be updated with a hyperlink or other reference to an expanded access record at ClinicalTrials.gov after such record becomes active.

FDA Expanded Access
https://www.fda.gov/ForPatients/Other/ExpandedAccess/ucm20041768.htm

Clinical Trial Information
https://www.ciscrp.org/education-center/important-information/
https://www.nhlbi.nih.gov/studies/clinicaltrials

21st Century Cures Act
https://energycommerce.house.gov/news-center/fact-sheets/hr-6-21st-century-cures-act-frequently-asked-questions