Expanded Access of Vigil in Solid Tumors

Approximately 40 subjects who had tissue procured and Vigil manufactured but fail
manufacturing release criteria under a previous Gradalis protocol are considered for this
study.

Participants will be managed in an outpatient setting. Hematologic function, liver enzymes,
renal function and electrolytes will be monitored. Blood for immune function analyses in
response to autologous tumor antigens will be collected at screening, Day 1 (prior to Vigil
administration) at Cycles 2, 4, and 6, end of treatment (EOT); 3 months after EOT, and every
6 months thereafter for those in response follow up. For subjects with Ewing's sarcoma, blood
for ctDNA analysis will be collected at screening, on Day 1 prior to Vigil administration at
Cycles 2, 3, 4, and 6, and EOT.

Study Enrollment Inclusion Criteria:

1. Histologically confirmed advanced or metastatic non-curable solid tumor.

2. Completed manufacture of at least 1 vial of Vigil, but failure of one or more
manufacturing release criteria.

3. ECOG performance status (PS) 0-1 or Karnofsky performance status (KPS) / Lansky
performance status (LS)≥ 70%.

4. Normal organ and marrow function as defined below:

Absolute granulocyte count ≥1,000/mm3, Absolute lymphocyte count ≥400/mm3, Platelets
≥75,000/mm3, Hemoglobin ≥ 8.0 mg/dL, Total bilirubin ≤ institutional upper limit of
normal*, AST(SGOT)/ALT(SGPT) ≤2x institutional upper limit of normal, Creatinine <1.5
mg/dL

*documented Gilbert's syndrome may be considered after medical monitor review

5. No systemic therapy, immunologic therapy or investigational therapy within 2 weeks and
no radiation therapy within 1 week prior to enrollment.

6. Subject has recovered to CTCAE Grade 1 (except for parameters noted in Item 4, above)
or better from all adverse events associated with prior therapy or surgery.
Pre-existing motor, sensory neurologic pathology or symptoms, or dermatologic
toxicities must be recovered to CTCAE Grade 2 or better.

7. If female of childbearing potential, has a negative urine or serum pregnancy test. If
the urine test is positive or cannot be confirmed as negative, a negative serum test
will be required for study entry.

8. Ability to understand and the willingness to sign a written informed protocol specific
consent or a parental/guardian informed consent and pediatric assent when appropriate.

Study Enrollment Exclusion Criteria:

1. Medical condition requiring any form of chronic systemic immunosuppressive therapy
(steroid or other) except physiologic replacement doses of hydrocortisone or
equivalent (no more than 30 mg hydrocortisone or 10 mg prednisone equivalent daily)
for < 30 days duration.

2. Known history of other malignancy unless having undergone curative intent therapy
without evidence of that disease for ≥ 3 years except cutaneous squamous cell and
basal cell skin cancer, superficial bladder cancer, in situ cervical cancer or other
in situ cancers are allowed if definitively resected.

3. Receipt of greater than 2 lines of systemic treatment between Vigil manufacture and
screening for this protocol.

4. Live vaccine used for the prevention of infectious disease administered < 30 days
prior to the start of study therapy.

5. Post-surgery complication that in the opinion of the treating investigator would
interfere with the subject's study participation or make it not in the best interest
of the patient to participate.

6. Brain metastases unless treated with curative intent (gamma knife or surgical
resection) and without evidence of progression for ≥ 2 months.

7. Any documented history of autoimmune disease with exception of Type 1 diabetes on
stable insulin regimen, hypothyroidism on stable dose of replacement thyroid
medication, vitiligo, or asthma not requiring systemic steroids.

8. Known HIV or chronic Hepatitis B or C infection.

9. Known history of allergies or sensitivities to gentamicin.

10. History of or current evidence of any condition (including medical, psychiatric or
substance abuse disorder), therapy, or laboratory abnormality that might confound the
results of the study, interfere with the patient's participation for the full duration
of the study, or is not in the best interest of the patient to participate, in the
opinion of the treating Investigator.