A Phase 1 Trial of Intralesional Immunotherapy with IFx-Hu2.0 Vaccine in Patients with Advanced Non Melanoma

In this clinical phase I, non-randomized, open-label, uncontrolled, interventional,
multi-center trial, 20 adult subjects (≥ 18 years of age) with advanced non-melanoma skin
cancers will receive a fixed dose of 0.1 mg of IFx-Hu2.0 intralesionally as monotherapy in up
to three lesions at up to three time points. Subjects will be observed for any acute adverse
events (AEs) post injection and for any delayed AEs at Day 28, 35 and/or 42 ± 7 days,
depending on the cohort (exposure escalation and expansion design).

Inclusion Criteria:

- Life expectancy ≥ 3 months at recruitment

- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 at the time of study
treatment initiation.

- Males or females with histologically confirmed diagnosis of advanced non-melanoma skin
cancers.

- Patients must have progressed despite standard therapy(ies) or are intolerant to or
refused standard therapy(ies).

- Clinically measurable disease with at least 1 injectable lesion ≥ 3 mm in longest
diameter; an injectable lesion is defined as an easily palpable superficial lesion
(cutaneous, subcutaneous or lymph nodal metastasis) that can be accurately localized,
stabilized by palpation, and is superficial enough to enable intralesional injection.

- No known bleeding diathesis or coagulopathy that would make intratumoral injection or
biopsy unsafe

- The entry laboratory criteria for subject eligibility must be less than or equal to
Grade 1 adverse event levels for the parameters tested as defined by CTCAE v5.0:

- Bone Marrow Function:

- Hemoglobin (Hb) > LLN 10 g/dL

- White Blood Cell Count (WBC) > LLN 3,000 cells/mcL

- Platelet count (PLT) > LLN - 75,000 /mcL

- Blood Coagulation Parameters

- PT, INR < 1.5 x institutional ULN unless patient is therapeutically
anticoagulated. If on anticoagulation PT/INR need to be within appropriate
anticoagulation limits for the clinical indication. Patients who are
receiving anticoagulants may participate in the trial if their
anticoagulation can be stopped safely for several days at the time of
biopsy.

- Renal Function

- Serum Creatinine (SCr) < 1 - 1.5 x baseline; < 1 1.5 x ULN

- Hepatic Function:

- Blood bilirubin < 1 - 1.5 x ULN if baseline was normal; < 1 1.5 x baseline
if baseline was abnormal

- Serum Alanine Aminotransferase (ALT) < 1 - 3 x ULN if baseline was normal;
1.5 3 x baseline if baseline was abnormal

- Serum Aspartate Aminotransferase (AST) < 1 - 3 x ULN if baseline was normal;
1.5 3 x baseline if baseline was abnormal

- Alkaline Phosphatase (ALP) < 1 - 2.5 x ULN if baseline was normal; 2 2.5 x
baseline if baseline was abnormal

- Gamma Glutylamyltransferase (GGT) < 1 - 2.5 x ULN, if baseline was normal; 2
2.5 x baseline if baseline was abnormal

- Males and females of reproductive potential must agree to continuously use adequate
contraception prior to study entry and for up to 6 months thereafter. A female is of
childbearing potential unless she has had a surgical procedure that would accomplish
sterility such a bilateral tubal ligation, hysterectomy or has not had menses for the
past 12 months.

- Females of childbearing potential must have a negative urine or serum pregnancy test
within one week prior to start of treatment

- Patient or legal representative must understand and sign a written informed consent
form.

Exclusion Criteria:

- Concurrent use of any other investigational product or participation in another trial
within 28 days before start of study treatment.

- Have received oncologic therapy within 2 weeks of planned IFx-Hu2.0 injection

- Presence or history of central nervous system metastasis [treated/stable brain
metastasis are allowable when patients have received prior therapy for their brain
metastases and their central nervous system (CNS) disease is radiographically stable
(> 4 weeks)]

- Pregnant or breastfeeding females and females desiring to become pregnant or
breastfeed within the timeframe of this study

- Concurrent steroid therapy (> 10 mg of daily prednisone equivalent) or other
immunosuppressive therapies such as those needed for solid organ transplants and
rheumatoid arthritis. Topical or inhaled steroids are allowable.

- History of organ allograft transplantation

- History of hemolytic anemia

- History of significant tumor bleeding, or coagulation or bleeding disorders.

- Patients with autoimmune disorder, with exception of patients with vitiligo or
endocrine-related autoimmune conditions receiving appropriate hormonal supplementation
who are eligible; systemic use of immunosuppressant drugs such as steroids (except as
hormone replacement therapy or short-course supportive medication such as chemotherapy
or drug allergy, etc.), azathioprine, tacrolimus, cyclosporine, etc. within 4 weeks
before recruitment. Prior autoimmune toxicity resolved to Grade 1 or less no longer
requiring immunosuppressive therapy is not an exclusion under this criterion.

- Major surgery within 14 days prior to starting study drug or has not recovered from
major side effects (tumor biopsy is not considered major surgery) resulting from a
prior surgery

- Leptomeningeal involvement regardless of treatment status

- Active, clinically serious uncontrolled medical conditions such as HIV, HBV, HCV, and
EBV infection

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
protocol requirements

- Unwilling or unable to follow protocol requirements