Inovio TRT-001: Telomerase DNA Immunotherapy in Breast, Lung, and Pancreatic Cancers

Inclusion Criteria:

1. Signed and dated written IRB approved informed consent;

2. Males or females aged ≥18 years;

3. Subjects with either breast, lung, pancreatic, head and neck, ovarian, colorectal,
gastric, esophageal, or hepatocellular cancer who are at high risk of relapse post
definitive surgery and standard therapy as described for each tumor type below:

Breast carcinoma:

- Individuals with Stage III or Stage II/axillary node positive disease who are
post definitive surgery and at least 4 and no more than 24 weeks post completion
of definitive chemotherapy and/or radiation adjuvant therapy at the time of
signing informed consent (for ER+ or Her2+ positive subjects, these subjects may
continue on hormonal therapy or anti-Her2 therapy as per standard of care);

- Individuals with Stage IV disease who have no evidence of disease after therapy
which includes a history of surgical resection of some or all tumor sites.

- Individuals with ER/PR/HER2 negative breast cancer (triple negative) of any
stage who are status post definitive surgery but with residual microscopic
breast cancer in surgical specimen following adjuvant chemotherapy; if given;
patient may be at least 4 and no more than 24 weeks from completion of adjuvant
therapy (e.g. radiation) at the time of signing informed consent;

- Individual receiving ongoing adjuvant endocrine (e.g. tamoxifen, anastrazole)
therapy or trastuzumab is allowed.

Squamous non-small cell Lung cancer:

* Individuals with Stage IB, II, or IIIA squamous non-small cell cancer who are
status post definitive surgery; Individuals with Stage IV disease who have no
evidence of disease after therapy which includes a history of surgical resection of
some or all tumor types;

Pancreatic carcinoma:

* Individuals with Stage I-III pancreatic ductal adenocarcinoma who are status post
definitive surgery. Neuroendocrine tumors or tumors not of pancreatic origin are not
allowed). Individuals with Stage IV disease who have no evidence of disease after
therapy which includes a history of surgical resection of some or all tumor sites.

Head and neck squamous cell carcinoma

- Individuals with Stage IV a/b head and neck squamous cell carcinoma who have no
evidence of disease after therapy which includes a history of surgical
resection;

- Individuals with Stage III head and neck squamous cell carcinoma who are status
post definitive therapy;

- Individuals with Stage IV a/b head and neck squamous cell carcinoma who have no
evidence of disease after therapy which includes a history of surgical
resection.

Ovarian cancer

- Individuals with ovarian fallopian tube, primary peritoneal carcinoma. Allowable
histologic types include high grade serous, high grade (grade 3- 3)
endometrioid, carcinosarcoma, clear cell carcinoma, or mixed histology including
aforementioned types;

- Individuals with incompletely resected stage III or with stage IV disease who
have completed at least 6 but no more than 8 cycles of primary platinum-taxane
based chemotherapy and have undergone maximal attempt at cytoreductive surgery,
either prior to chemotherapy or as an interval procedure;

- Individuals with Stage IV disease who have completed a platinum-taxane
chemotherapy must be in complete remission based on no evidence of disease;

- Individuals treated with other agents (such as anti-angiogenic agents) as a
component of primary therapy, either in combination with or following
platinum-taxane chemotherapy, may be eligible as long as other eligibility
criteria have been fulfilled.

Colorectal cancer

- Individuals with Stage III histologically confirmed adenocarcinoma of colon or
rectum who are status post definitive surgery;

- Individuals with Stage IV colorectal cancer (CRC) who have no evidence of
disease after therapy which includes a history of surgical resection of some or
all tumor sites.

Gastric and esophageal cancer

- Individuals with Stage IIB, and III adenocarcinoma of the stomach, gastroesophageal
junction, or esophagus who are status post definitive surgery.

Hepatocellular carcinoma

- Individuals with any stage of histologically proven hepatocellular carcinoma who
are status post definitive surgery;

- Individuals should not be suitable for liver transplant therapy or post liver
transplantation;

- Individuals with no higher than Class A Child-Pugh;

4. ECOG (Eastern Cooperative Oncology Group) performance status of 0-1;

5. Normal electrocardiogram (ECG) or ECG without clinically significant findings that
require clinical action;

6. Adequate organ function. At screening,

- Absolute neutrophil count (ANC) ≥ 1.5x103 cell/ml;

- Platelets ≥75,000 /ml (for HCC platelets ≥ 50,000/ml);

- Hemoglobin ≥ 9.0 g/dL;

- Serum creatinine < 2.0 mg/dL; For other blood and urine tests including blood
chemistry, hepatic and renal functions, test results should not be worse than
Grade 1 levels of abnormalities defined by CTCAE v4.03. For subjects who are at
advanced stages of disease (Stage III and above, in general), by the
investigator's discretion and after consultation with medical monitor, test
results may not be worse than Grade 2 levels of abnormalities defined by CTCAE
v4.03.

7. Subjects must agree that during the study, men cannot father children, and women
cannot be or become pregnant if they are of child-bearing potential [(i.e., ≥ 12
months of non-therapy-induced amenorrhea, confirmed by follicle stimulating hormone
(FSH), if not on hormone replacement) or surgically sterile (vasectomy in males or
absence of ovaries and/or uterus in females)], agree to remain abstinent or use one
highly effective or combined contraceptive methods that result in a failure rate of <
1% per year during the treatment period and at least through 12 weeks after the last
Study Treatment dose. Abstinence is only acceptable if it is in line with the
preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar,
ovulation, symptothermal, or post-ovulation methods) and withdrawal are not
acceptable methods of contraception. Examples of contraceptive methods with an
expected failure rate of < 1% per year include male sterilization and hormonal
implants. Alternatively, proper use of combined oral or injected hormonal
contraceptives and certain intrauterine devices (IUDs) or two methods (e.g., two
barrier methods such as a condom and a cervical cap) may be combined to achieve a
failure rate of < 1% per year (barrier methods must always be supplemented with the
use of a spermicide);

8. Able and willing to comply with all study procedures.

Exclusion Criteria:

1. Previous treatment with any TERT or IL-12 containing therapy, or any immunotherapy;

2. Metastasis in brain or central nervous system;

3. Pregnant or breast-feeding subjects;

4. Allergic to any component of the investigational agents;

5. Recipient of an investigational therapy from another interventional clinical trial
within 4 weeks of Study Treatment. Subjects can be enrolled if they are in an
observational study or within a long term follow up phase without any investigational
therapy for at least 4 weeks prior to Study Treatment;

6. History of any clinically significant autoimmune disease or a transplant recipient
who is receiving chronic immunosuppression;

7. History of HIV infection or positive serological test for human immunodeficiency
virus (HIV) at screening;

8. Any cardiac pre-excitation syndromes, e.g., Wolff-Parkinson-White syndrome;

9. Prior major surgery or radiation therapy within 4 weeks of Study Treatment;

10. Concurrent, long-term systemic corticosteroids (equivalent to prednisone > 10 mg/day
for more than 2 weeks) or other systemic immunosuppressive therapy. Non-systemic,
inhaled, topical skin, corticosteroid-containing eye drops and low dose methotrexate
are allowed. Short-term use of corticosteroids in a chemotherapy regimen is allowed.
All other systemic corticosteroids must be discontinued at least 4 weeks prior to
Study Treatment;

11. Recipient of any blood product within 2 weeks of Study Treatment;

12. Recipient of any vaccine within 4 weeks of Study Treatment;

13. Less than two acceptable sites exist for IM injection and EP between the use of both
deltoids and lateral quadriceps muscles. A site for injection/EP is not acceptable if
there are tattoos, keloids or hypertrophic scars within 2 cm of the injection/EP
site, or if there is implanted metal within the same limb. Any device implanted in
the chest (e.g., cardiac pacemaker, defibrillator or retained leads following device
removal) excludes the use of the deltoid muscle on the same side of the body;

14. Active use or dependence on illegal drug or alcohol that, in the opinion of the
investigator, would interfere with adherence to study requirements and affect
subject's safety;

15. Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for
treatment of either a psychiatric or physical (i.e., infectious disease) illness;

16. Any medical and non-medical condition that, in the opinion of the investigator may
affect the safety of the subject or the evaluation of study results.