Expanded Access Policy
Theratechnologies Inc. (“Theratechnologies”) is a biopharmaceutical company focused on the
development and commercialization of innovative therapies. Our commercialized products and
our research pipeline focus on specialized therapies addressing unmet medical needs in HIV,
oncology and hepatology. Theratechnologies has begun development of the SORT1+
Technology™, a novel and targeted treatment platform in oncology based on new proprietary
peptides targeting sortilin receptor (SORT1). The first peptide-drug conjugate (PDC) generated
from this platform, named TH1902, is under investigational evaluation in a Phase 1 clinical trial
for the treatment of patients with recurrent advanced solid tumors (i.e. triple negative breast
cancer, gynecological cancer, colorectal cancer, and pancreatic cancer) that have relapsed or are
refractory to standard chemotherapy, surgery, radiation therapy, and for which no known
effective therapies exist (ClinicalTrials.gov Identifier: NCT04706962).
Theratechnologies believes that investigational drugs should be primarily studied within clinical
trials designed to obtain data on safety and efficacy about the investigational drug. The data from
these trials may then ultimately be used to support approval of the product by regulatory
agencies such as the FDA in the United States, the European Medicines Agency in Europe and
Health Canada in Canada. The approval by regulatory agencies enables patients to have access to
the medicine. Regulators will only authorize a new medicine if the results obtained from these
clinical trials, together with other research data, demonstrate that a medicine has a favorable
risk/benefit profile when used in a defined and controlled clinical setting. We encourage patients
to speak with their physicians and to participate in clinical trials, when appropriate and if
As a general policy, Theratechnologies will not provide an investigational drug product until
there is sufficient clinical data available from its existing clinical trial(s) to identify an
appropriate dose and to evaluate preliminary safety and efficacy information to make a
risk/benefit analysis consistent with the establishment of an expanded access program. This is
typically not expected to occur earlier than after completion of Phase 2 studies and after
consultation with regulatory agencies. At such a time, Theratechnologies will disclose the criteria
pursuant to which expanded access requests will be assessed. Given the early stage of the clinical
development of TH1902, Theratechnologies’ investigational drug product is currently not
available for expanded access.
If you are a patient who is interested in receiving TH1902, please consult your physician. You
may also learn more about the ongoing clinical trial by visiting www.clinicaltrials.gov and
searching for the clinical trial identified NCT04706962.
If you are a physician who is interested in learning more about our investigational drug, please
submit a request to firstname.lastname@example.org.
In line with the U.S. 21 st Century Cures Act, Theratechnologies Inc. may revise this expanded
access policy at any time and the posting of this policy by Theratechnologies Inc. shall not be
construed as a guarantee to patients of accessing any specific investigational drug.