Phase 1/2 Study of Combination Immunotherapy and mRNA Vaccine in Subjects With NSCLC

Inclusion Criteria

1. Histologic confirmation of metastatic NSCLC. For subjects with known EGFR or ALK/ROS-1
mutations, prior therapy must have included an EGFR tyrosine kinase inhibitor or
ALK/ROS-1 inhibitor, respectively. Subjects may have had 1 prior line of
anti-PD-1/PD-L1 therapy. Subjects who received prior anti-PD-1/PD-L1 therapy must have
progressed during or after treatment, but not prior to Week 12 of treatment.

2. Availability of archival (diagnostic) specimens or willing to undergo a pre-treatment
biopsy.

3. Subjects with treated brain metastases must have been treated with surgery and/or
radiation therapy ≥ 21 days pre-study and must be clinically stable with no
requirement for steroids.

4. Laboratory parameters for vital functions should be in the normal range.

5. ECOG Performance Status ≤ 2.

Exclusion Criteria

Subjects may not enter the study if they fulfill any of the following criteria:

1. Treatment with an investigational agent within 4 weeks of starting treatment or prior
treatment with anti-CTLA-4 therapy.

2. Active, suspected or prior documented autoimmune disease, clinically significant
cardiovascular disease, or clinically uncontrolled hypertension.

3. History of pneumonitis or interstitial lung disease, or any unresolved immune-related
adverse events following prior therapy.

4. Major surgery within 4 weeks of starting treatment (or scheduled for surgery during
the projected course of the study) or prior cancer vaccine treatment or allogeneic
bone marrow transplantation.

5. Subjects who are immunosuppressed, including those with known immunodeficiency or have
active infection including tuberculosis or other serious illnesses.

6. Skin disease (e.g., psoriasis) that may prevent intradermal administration of the
vaccine into the target areas.