Expanded Access to Mifomelatide for Cachexia in Adults With Advanced PDAC

Inclusion Criteria:

1. Must be at least 18 years of age
2. Documented histologic or cytologic diagnosis of advanced, unresectable PDAC
3. Current cachexia (documented in medical records) as defined by Fearon criteria based on at least one of the following three weight loss conditions in the 6 months prior to enrollment:

   1. Weight loss of at least 5%
   2. Weight loss of at least 2% together with a BMI \<20 kg/m2 and/or
   3. Weight loss of at least 2% together with sarcopenia
4. Eastern Cooperative Oncology Group (ECOG) status of ≤ 3 and life expectancy ≥ 4 months
5. Lack of satisfactory therapeutic alternatives for their cancer cachexia
6. Willing and able to safely self-inject or be injected by a caregiver daily
7. Not eligible to participate in ongoing clinical trials of the investigational drug
8. Willing and able to sign informed consent

Exclusion Criteria:

1. Patients with BMI \> 35
2. Known hypersensitivity to mifomelatide or its formulation
3. Significant medical conditions or illnesses that might increase the risk-benefit ratio of participating in this EAP as determined by the

   Treating Physician, which may include:
   * Patients with swallowing abnormalities, malabsorption syndromes, severe short or inflammatory bowel syndromes, or other conditions that in the Treating Physician's opinion could impair food consumption or metabolism
   * Receiving exclusive tube feeding or parenteral nutrition at the time of enrollment
   * History of weight loss surgery including gastric stapling, or bypass
   * ANC \< 1.5 x 109/L
   * AST and/or ALT \> 3 x ULN (\> 5 x ULN in the presence of documented liver metastases)
   * Total bilirubin \> 1.5 x ULN (\> 3 x ULN in the presence of documented Gilbert's Syndrome)
   * Creatinine clearance calculated by Cockcroft and Gault equation \< 50 mL/min Uncontrolled diabetes defined as HbA1c \>7%
4. Currently pregnant, breastfeeding or planning to become pregnant