Inclusion Criteria:
1. Men and non-pregnant women, ages 16 to 55 years inclusive.
2. Subjects with physician-diagnosed peanut allergy or documented history of peanut
allergy. Note: If subject does not have documented history in their medical record but
is reasonably suspected of having peanut allergy and is deemed to otherwise be a good
candidate for this trial, the screen testing (peanut specific IgE, SPT, etc.) may be
used to establish the peanut allergy and the PI may subsequently document the peanut
allergy to fulfill this inclusion criterion.
3. Subjects with weight ≥ 31.25 kg at Screening. Subjects who fall outside of this range
may be included at the discretion of the investigator.
4. Subjects with a documented history of non-severe anaphylaxis (Grade ≤ 3) to peanuts,
including mild wheezing or dyspnea without hypoxia.
5. Subjects with peanut specific IgE > 5 kU/L as measured by ImmunoCAP at Screening.
Subjects who have previously been on OIT for peanut allergy and who do not have peanut
specific IgE ≥ 5 kU/L as measured by ImmunoCAP at Screening may be included at the
discretion of the investigator, OR Subjects with a positive skin prick test (SPT) to
peanut with a change in wheal diameter ≥ 3 mm as compared to a negative control (50%
glycerin) at Screening. Subjects who have previously been on OIT for peanut allergy
and who do not have a positive skin prick test (SPT) to peanut with a change in wheal
diameter ≥ 3 mm at Screening may be included at the discretion of the investigator.
6. Subjects who are self-reported to be on a peanut free diet with no suspected peanut
exposure, including any peanut food challenge, for at least 14 days prior to Screening
and agreement to continue restriction to peanut exposure during the study.
7. Female subjects and male subjects and their female spouse/partners who are willing to
practice a highly effective method of contraception that may include, but is not
limited to, abstinence, sex only with persons of the same sex, monogamous relationship
with vasectomized partner, vasectomy, hysterectomy, bilateral tubal ligation, licensed
hormonal methods, intrauterine device (IUD), or use of spermicide combined with a
barrier method (e.g., condom, diaphragm) starting at Screening and continuing to Day
60.
8. Female subjects who agree to not breastfeed starting at initial Screening and
continuing to Day 60.
9. Female subjects who agree to not donate ova starting at initial Screening and
continuing to Day 60.
10. Subjects who are willing and able to provide Institutional Review Board (IRB) approved
written informed consent.
11. Subjects who are willing to perform and comply with all study procedures.
12. Male subjects who agree to not donate sperm starting at Screening and continuing to
Day 60.
Exclusion Criteria:
1. Subjects with history of severe anaphylaxis to peanuts defined as neurological
compromise or requiring intubation.
2. Subjects with peanut specific IgE ≥ 100 kU/L as measured by ImmunoCAP at Screening.
3. Subjects who have received administration of vaccinations in the following timeframe:
- - Any live vaccine (other than intranasal Influenza) within 28 days prior to
Screening.
- - Any subunit vaccine within 14 days prior to Screening.
4. Any COVID-19 vaccine within 14 days prior to Screening. Subjects who have received the
first dose of any COVID-19 vaccine may not screen for the study until 14 days
following their last dose of the vaccine if applicable.
5. Any planned vaccination prior to Day 15.
6. Subjects in build-up phase of immunotherapy for aeroallergens or venom. Individuals
tolerating maintenance aeroallergen or venom immunotherapy at Screening can be
enrolled.
7. Subjects with relative contraindication or inability to use epinephrine auto-injector.
8. Subjects who have used the following drug(s) within 2 months prior to Screening: Th2
cytokine inhibitors, thromboxane A2 synthesis inhibitors, thromboxane A2 receptor
antagonists, β-blockers, angiotensin-converting enzyme inhibitors, and/or
angiotensin-receptor blockers unless, in the investigator's opinion, the underlying
condition being treated by the drug is well controlled and the drug dose and frequency
is not expected to interfere with the mechanism of action of CNP-201 as determined in
consultation with the sponsor.
9. Subjects who have used biologics and/or immune modulators (including but not limited
to anti-TNFα antibody and anti-IgE monoclonal antibody) within three months prior to
Screening.
10. Subjects with a history of allergic reactions such as anaphylactic shock, angioedema
with airway constriction, or hypotension caused by food other than peanut and/or
medical products.
11. Subjects with positive test results for hepatitis B surface antigen (HBsAg), hepatitis
C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen/ antibody as
determined at Screening.
12. Subjects who are immunocompromised, including those receiving immunosuppressive doses
of corticosteroids (more than 20 mg of prednisone given daily or on alternate days for
2 weeks or more within 6 months prior to Screening, any dose of corticosteroids within
30 days of Screening, or high dose inhaled corticosteroids [> 960 μg/day of
beclomethasone dipropionate or equivalent]) or other immunosuppressive agents.
13. Subjects with a history of unstable angina pectoris, cardiac disease or dysrhythmias,
severe chronic lung disease, or any other chronic medical condition that which in the
opinion of the investigator, would pose a significant health threat in the event of
anaphylaxis/treatment of anaphylaxis.
14. Subjects with active eosinophilic esophagitis (EoE) or other eosinophilic
gastrointestinal disease.
15. Subjects with clinically significant abnormality on electrocardiogram (ECG) at
Screening that, in the investigator's opinion, makes the subject unsuitable for study
participation.
16. Subjects with active malignancy, or history of malignancy or chemotherapy within the
past 5 years other than history of localized or surgical removal of focal skin cancer,
or cervical cancer in situ treated successfully in the past by local treatment
(including but not limited to cryotherapy or laser therapy) or by hysterectomy.
17. Subjects with a mental condition such as schizophrenia, bipolar disorder, major
depressive disorder, generalized anxiety disorder, panic disorder/attacks, or subjects
who have received drug(s) for the treatment of dementia.
18. Subjects with severe or poorly controlled (resistant to appropriate medical
intervention) atopic disease including atopic dermatitis, generalized eczema, allergic
rhinitis and/or urticaria.
19. Subjects with tryptase values outside of the normal reference range.
20. Subjects with severe or uncontrolled/difficult to control asthma/wheezing, defined by
at least one of the following criteria:
- - Global Initiative for Asthma (GINA) 2020: Personalized management to control
symptoms and minimize future risk requiring treatment Steps 4 or 5 (Appendix 3)
OR;
- Forced expiratory volume in 1 second (FEV1) < 80% of predicted, or ratio of FEV1
to forced vital capacity (FEV1/FVC) < 75% of predicted, with or without
controller medications (only those able to reliable perform spirometry.
If unable
to do spirometry, PEF of > 80% is acceptable OR;
- - One overnight admission to a hospital in the past year for asthma OR;
- Emergency room visit for asthma within 6 months prior to Screening OR;
- History of two or more systemic corticosteroid courses within 6 months of
Screening or one course of systemic corticosteroids within 3 months of Screening
to treat asthma/wheezing OR;
- Prior intubation/mechanical ventilation for asthma/wheezing.
21. Subjects who have received an investigational therapy within 28 days or 5 half-lives,
whichever is longer, prior to Screening.
22. Subjects with any condition which, in the investigator's opinion, makes the subject
unsuitable for study participation: Past or current medical problems, history of other
chronic diseases requiring therapy, findings from physical assessment, or
abnormalities in clinical laboratory testing that are not listed above, which in the
opinion of the investigator, may pose additional risks from participation in the
study, may interfere with the participant's ability to comply with study requirements,
or that may impact the quality or interpretation of the data obtained from the study.
23. Subjects with a known sensitivity to any components of CNP-201 (PLGA, sucrose,
mannitol, or sodium citrate).
