Study of Personalized Immunotherapy in Adults With Metastatic Colorectal Cancer

This single arm study is designed to evaluate the safety and tolerability of a personalized
treatment in adults with metastatic colorectal cancer by first analyzing the expression of
tumor-associated antigens and then treating the patients with a personalized live,
attenuated, double-deleted Listeria monocytogenes (pLADD)-based immunotherapy. pLADD is based
on the attenuated form of Listeria monocytogenes that has been genetically modified to reduce
its ability to cause disease, while maintaining its ability to stimulate a potent immune
response. pLADD is manufactured using patient-specific antigens and is therefore
individualized to each patient.

Inclusion Criteria:

- metastatic colorectal cancer (mCRC) that is microsatellite stable (MSS)

- able to provide adequate tumor tissue from at least 1 accessible tumor site

- completed or have developed intolerance to a course of oxaliplatin- or
irinotecan-based frontline therapy at Screening

- on maintenance standard-of-care chemotherapies or on treatment holiday

- Eastern Cooperative Oncology Group (ECOG) 0 or 1

- adequate organ function

- progression of disease at the time of Enrollment

Exclusion Criteria:

- BRAF V600E mutation

- known allergy to both penicillin and sulfa drugs

- implanted devices that cannot be easily removed

- immunodeficiency, immune compromised state or receiving immunosuppressive therapy