Safety and Efficacy of IMCnyeso in Advanced NY-ESO-1 and/or LAGE-1A Positive Cancers

This is a multi-center, open label, dose finding Phase 1/2 study of single agent IMCnyeso
administered in patients with NY-ESO-1 and/or LAGE-A1 positive tumors. The study consists of
2 Arms. In the first Arm (the dose escalation phase), IMCnyeso will be evaluated in 4
diseases (advanced non-small cell cancer (NSCLC), melanoma, urothelial carcinoma, and
synovial sarcoma). The primary objective of this Arm is to determine the maximum tolerated
dose (MTD) and/or recommended Phase II dose (RP2D) of IMCnyeso. The second Arm is an
expansion phase in which the dose determined in Arm 1 will be tested in 3 diseases (advanced
NSCLC, urothelial carcinoma and synovial sarcoma) to further evaluate the safety and assess
the anti-tumor activity of IMCnyeso

Inclusion Criteria:

1. Male or female patients age ≥ 18 years of age at the time of informed consent

2. HLA-A*0201 positive, confirmed by central laboratory

3. NY-ESO-1 and/or LAGE-1A positive tumor confirmed by the central laboratory

4. Arm 1: Patients must be refractory to or intolerant to all existing therapies known to
provide clinical benefit for their condition.

5. Arm 2: Subjects will have received the following previous therapies:

1. NSCLC — PD-1/PD-L1 inhibitor

2. Patients with NSCLC and an EGFR or ALK genomic tumor aberration must have disease
progression after treatment with Health Authority-approved agents for these
aberrations

3. Urothelial cancer — PD-1/PD-L1 inhibitor

4. Synovial sarcoma — at least one prior chemotherapy regimen

6. Arm 1 only: Histologically confirmed diagnosis of advanced NSCLC, melanoma, urothelial
carcinoma, or synovial sarcoma

7. Arm 2 only: Histologically confirmed diagnosis of advanced NSCLC, urothelial
carcinoma, or synovial sarcoma

8. Arm 2 only: Disease amenable to biopsy

9. Arm 2 only: Measurable disease to RECIST v.1.1 criteria

Exclusion Criteria:

Impaired baseline organ function as evaluated by out-of-range laboratory values 2. History
of severe hypersensitivity reactions (eg, anaphylaxis) to other biologic drugs or
monoclonal antibodies 3. Clinically significant cardiac disease or impaired cardiac
function 4. Presence of symptomatic or untreated central nervous system (CNS) metastases 5.
Active infection requiring systemic antibiotic therapy 6. Known history of human
immunodeficiency virus infection (HIV) 7. Active hepatitis B virus (HBV) or hepatitis C
virus (HCV) infection 8. Malignant disease, other than that being treated in this study 9.
Patients receiving systemic steroid therapy or any other systemic immunosuppressive
medication. Local steroid therapies are acceptable 10. Systemic anti-cancer therapy within
2 weeks of the first dose of study drug.

11. Major surgery within 2 weeks of the first dose of study drug 12. Radiotherapy within 2
weeks of the first dose of study drug, with the exception of palliative radiotherapy to a
limited field 13. Use of hematopoietic colony-stimulating growth factors (eg, G-CSF,
GM-CSF, M-CSF) ≤ 2 weeks prior to start of study drug 14. Pregnant, likely to become
pregnant, or lactating women