Oncoverity

To Whom It Concerns,
OncoVerity, Inc.’s (“OncoVerity” or “we”) mission is to reimagine a world where Cancer never wins. We
understand that success can only be achieved by collaborating closely with the families, patient groups,
clinicians, and regulators who share our mission of initially serving patients with AML.
Our focus is to advance Cusatuzumab toward regulatory approval and make it available to all who can
benefit from this therapy. Clinical research in the form of clinical trials (“Clinical Trials”) are key research
tools for advancing medical knowledge, utilizing innovative strategies to improve patient care. Clinicians
conduct these Clinical Trials in specific patient populations to determine whether an investigational
medicine works and is safe to use in patients. Participation in U.S. Food and Drug Administration (“FDA”)
or other relevant regulatory agency accepted Clinical Trials is the best way to access investigational
therapies. As such, at this time, participation in a Clinical Trial is the only way for patients to gain access
to the investigational therapy, Cusatuzumab, under development by Oncoverity.
We recognize that not all patients will meet the eligibility requirements for participation in a Clinical
Trial and as a result, understand that some may seek pre‐approval access when no other comparable
therapy is available for use, also referred to as expanded access, compassionate use, or named-patient
use (21 CFR part 312, subpart I).
Oncoverity relies on guidelines provided by the FDA and other regulatory agencies along with other
important factors when evaluating our ability to provide pre‐approval access for Cusatuzumab. Key
considerations include:
1) Whether there is sufficient evidence that the potential benefits to the patients outweigh the
potential risks, based on available safety and efficacy data
2) Whether sufficient clinical data is available to identify a recommended dose that might be
effective and is reasonably safe
3) Whether providing pre‐approval access outside of a Clinical Trial setting will compromise, delay,
or otherwise have a negative impact on ongoing Clinical Trials and/or future access by all eligible
patients
4) Whether there is adequate supply of product (Cusatuzumab) for Clinical Trials and any other
usage, such as expanded access
5) Whether it is feasible to provide any necessary follow up outside of the Clinical Trial setting
As we are about to embark on a Phase 2 study of Cusatuzumab, we are collecting additional safety and
efficacy data, which will be evaluated at the end of that study. Once that data is collected, we will reevaluate our policy on expanded access.
Here is the link to our open trial:
https://clinicaltrials.gov/study/NCT04023526?term=cusatuzumab&rank=1
At this time, we are not accepting requests for expanded access. If you have any additional questions
you may contact: helpdesk@oncoverity.com