Expanded Access To Neoantigen Synthetic Long Peptide Vaccines in Patients With Local Or Metastatic Solid Tumors

Patients must satisfy the following criteria to be enrolled in the protocol:

Main Inclusion Criterion:

1. Patient who qualifies for treatment under 21 CFR 312.305 based on treating physician
judgment, inability to enroll in study JLF-200, must have received or be ineligible for
FDA-approved therapies for their specific cancer type, and an estimated 5-year survival
of less than 50%.

Other Inclusion Criteria:

1. >= 12 years of age.

2. ECOG performance status ≤ 2 or Karnofsky score of >=70.

3. Adequate organ function allowing favorable benefit to risk ratio per the treating
physician

4. Systemic corticosteroid therapy is permitted provided dosing is no greater than 4 mg
per day (dexamethasone or equivalent) on the day of vaccine administration.

5. Ability to understand and willingness to sign an IRB approved written informed
consent document.

Exclusion Criteria:

1. History of serious adverse reaction to vaccines such as anaphylaxis, hives, or
respiratory difficulty or known allergy to a component of the neoantigen synthetic
long peptide vaccine.

2. Intercurrent illness requiring chronic use of medications that may interfere with
rescue medications for treatment of vaccine-related anaphylaxis or attenuate immune
response to vaccine treatment (immunosuppressive therapies).

3. Psychiatric illness or social situations that would limit compliance with study
requirements.

4. History of pre-existing immunodeficiency disorder or autoimmune condition requiring
immunosuppressive therapy that would preclude response to vaccine. 5. Females of
childbearing potential may participate provided they agree to practice abstinence;
and, if heterosexually active, agree to use at least 2 highly effective
contraceptive methods throughout the study and for 3 months following the last dose
of study drug; and have a negative serum pregnancy test.

6. Females of non-childbearing potential must be post-menopausal or have been surgically
sterilized.

7. Male subjects with a female partner of childbearing potential must agree to practice
abstinence or to use a physician-approved contraceptive method throughout the study and
for 3 months following the last dose of study drug.