Medical Food for the Dietary Management of Advanced/Metastatic Pancreatic Cancer

Key Inclusion Criteria:

1. Signed informed consent form (ICF) by subject.

2. Histologically or cytologically confirmed pancreatic adenocarcinoma.

3. Locally advanced and unresectable or metastatic pancreatic adenocarcinoma.

4. Eligible for standard of care treatment with the gem+nabP regimen.

5. 18 years of age or older.

6. Measurable disease as determined by RECIST 1.1 (at least one measurable lesion mustnot have been irradiated in the past).

7. ECOG Performance Status of ≤ 1.

8. Adequate organ function during screening evaluation

9. Available pancreatic adenocarcinoma tissue samples from a primary or metastatic sitethat has been biopsied within the last 12 months and provide consent for them to beobtained and analyzed by the study sponsor to assist in determining finaleligibility. A minimum of five (ten preferred) formalin fixed paraffin embedded (FFPE) archival or fresh tumor tissue slides are required.

Key Exclusion Criteria:

1. Any prior neoadjuvant or adjuvant therapy for pancreatic cancer within 6 months ofscreening.

2. Any prior therapy for metastatic pancreatic cancer or locally advanced andunresectable pancreatic cancer (except for neoadjuvant or adjuvant therapy as notedabove in exclusion criteria 1)

3. Known cerebral metastasis.

4. Diagnosis of another malignancy within the past 2 years (excluding a history ofcarcinoma in situ of the cervix, superficial non-melanoma skin cancer, orsuperficial bladder cancer that has been adequately treated, or stage 1 prostatecancer that does not require treatment or requires only treatment with luteinizinghormone-releasing hormone agonists or antagonists if initiated at least 30 daysprior to beginning the NEAAR medical food).

5. Body mass index (BMI) <18.5 kg/m2 or >40 kg/m2 or serious or refractive cachexia oranorexia that, in the investigator's judgment, prohibits subjects from having energyor appetite sufficient to reliably engage in a strict medical food regimen for anextended time.

6. Presence of any significant comorbidity including clinically significant cardiacdisease (e.g., congestive heart failure, symptomatic coronary artery disease andcardiac arrhythmias not well controlled with medication), myocardial infarction orunstable angina within the 12 months prior to screening, or any major organ failure.

7. Known hypersensitivity, allergy, or religious restrictions regarding pork orpork-derived products; or known allergy to any of the major food allergens asdefined by U.S. law (milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts,wheat, soybeans and sesame); or known allergy or hypersensitivity to , gemcitabineor nab-paclitaxel, PERT products (e.g., Pancreaze), or formulary excipients in theseproducts (refer to the FDA-approved package insert).

8. Major surgery or significant traumatic injury within 14 days of planned start ofNEAAR medical food or the anticipation of the need for a major surgical procedureduring the study.

9. Unwillingness to consume small quantities of meat products and byproducts (e.g.,fish sauce, bone marrow, chicken broth).

10. Diagnosed with an eating disorder, irritable bowel syndrome (IBS), Crohn's disease,ulcerative colitis, or gluten-sensitive enteropathy.