IMNN-101 Vaccine for COVID-19

Recruiting at 1 trial location

Overseen By Khursheed Anwer, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Imunon

Must not be taking: Immunotherapy, Immunosuppressants

Disqualifiers: SARS-CoV-2 infection, Severe allergies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

74 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are receiving immunotherapy or immunosuppressants, you may need to stop as these are not allowed within certain timeframes before and during the study.

What data supports the effectiveness of the IMNN-101 treatment for COVID-19?

Research on similar treatments, like the IDO/PD-L1 vaccine combined with nivolumab, shows promising results in treating metastatic melanoma by enhancing immune responses and achieving high response rates. This suggests that targeting immune pathways can be effective, which may be relevant for the IMNN-101 vaccine for COVID-19. ^{1 2 3 4 5}

How is the IMNN-101 treatment for COVID-19 different from other treatments?

The IMNN-101 vaccine is unique because it is administered intranasally (through the nose), which can induce strong mucosal immunity (protection at the site where the virus enters the body) and potentially prevent infection and transmission, unlike most current COVID-19 vaccines that are given by injection and primarily reduce disease severity. ^{6 7 8 9 10}

What is the purpose of this trial?

This is an open-label phase 1/2, dose-escalation study. Participants will receive a single intramuscular (IM) dose of IMNN-101 on Day 0 in the deltoid muscle and will be followed through 12 months post-vaccination (through Study Day 365).

Research Team

Douglas Faller, MD

Principal Investigator

Imunon

Eligibility Criteria

This trial is for healthy adults aged 18-65 who have previously been vaccinated against COVID-19. Participants must be in good health, with a BMI of 18-35 kg/m2, and agree to not receive other vaccines or join another study during the trial period. They should understand the study procedures and commit to follow-up visits.

Inclusion Criteria

For a volunteer capable of becoming pregnant: Agree to use an acceptable method of contraception

Willing to disclose prior SARS-CoV-2 infection and/or prior vaccination

Agrees not to enroll in another study of an investigational agent during participation in the trial

Exclusion Criteria

I have been diagnosed with an immune deficiency or an autoimmune disease.

History of severe allergic reactions or allergy to any pertinent components of IMNN-101

History of alcohol or drug abuse within 3 years before first vaccination

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intramuscular (IM) dose of IMNN-101 on Day 0 in the deltoid muscle

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and immunogenicity through 12 months post-vaccination

12 months

Multiple visits at 0.5, 1, 3, 6, 9, and 12 months

Treatment Details

Interventions

• IMNN-101

Trial Overview The safety and immune response generated by IMNN-101 are being tested in this phase 1/2 trial. Volunteers will get one intramuscular shot of the vaccine candidate and will be monitored for a year to see how well it works.

Participant Groups

Group I: IMNN-101 Experimental Treatment 1 Intervention

Participants will receive a single intramuscular (IM) dose of IMNN-101 on Day 0 in the deltoid muscle. IMNN-101 is for intramuscular injection only.

Who Is Running the Clinical Trial?

Imunon

Lead Sponsor

Trials

16

Recruited

1,600+

Findings from Research

In a phase 1/2 study involving 30 patients with metastatic melanoma, the combination of the immune-modulatory vaccine (IO102/IO103) with nivolumab showed a high objective response rate of 80%, with 43% of patients achieving complete responses.

The safety profile of the combination therapy was comparable to nivolumab alone, and after a median follow-up of nearly 23 months, the median progression-free survival was 26 months, indicating promising efficacy and tolerability for further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase 1/2 trial of an immune-modulatory vaccine against IDO/PD-L1 in combination with nivolumab in metastatic melanoma. Kjeldsen, JW., Lorentzen, CL., Martinenaite, E., et al.[2023]

The phase IIb KEYNOTE-942 trial suggests that the investigational mRNA-4157/V940 vaccine combined with pembrolizumab may significantly reduce the risk of disease recurrence in high-risk melanoma patients after surgery.

Patients receiving this combination therapy showed better outcomes compared to those treated with only the PD-1 inhibitor, indicating a promising new approach for adjuvant therapy in melanoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

mRNA Vaccine Slows Melanoma Recurrence. [2023]

In a study involving 99 breast cancer patients, the optimal biologic dose (OBD) of the E75 vaccine combined with GM-CSF was found to be 1000 microg E75 plus 250 microg GM-CSF, administered monthly for 6 months, showing similar toxicity levels compared to lower doses.

Patients receiving the optimal dose exhibited a significantly larger immune response, indicated by a greater delayed type hypersensitivity (DTH) reaction and a trend towards reduced cancer recurrence, suggesting that the E75 vaccine may enhance immunity against HER-2/neu in breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimal dose and schedule of an HER-2/neu (E75) peptide vaccine to prevent breast cancer recurrence: from US Military Cancer Institute Clinical Trials Group Study I-01 and I-02. Holmes, JP., Gates, JD., Benavides, LC., et al.[2008]

In cohort A, which included 30 patients with metastatic melanoma, the combination of an IDO/PD-L1 vaccine and nivolumab resulted in an impressive overall response rate of 80%, with 50% achieving a complete response and a median progression-free survival of 25.5 months.

Cohort B, where the vaccine was added to patients already on anti-PD-1 therapy, showed limited efficacy with only stable disease in 2 out of 10 patients and a median progression-free survival of just 2.4 months, indicating that the combination may not be effective for those with progressive disease during anti-PD-1 treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term follow-up of anti-PD-1 naïve patients with metastatic melanoma treated with IDO/PD-L1 targeting peptide vaccine and nivolumab. Lorentzen, CL., Kjeldsen, JW., Ehrnrooth, E., et al.[2023]

The SA-GM-CSF modified tumor cell vaccine enhances dendritic cell activation and increases tumor-specific CD8+ T-cells, but these T-cells often express PD-1, which contributes to immune resistance.

Combining PD-1/PD-L1 blockade with the GM-CSF vaccine significantly boosts the population of active T-cells and enhances the immune response, leading to effective tumor rejection in prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PD-1/PD-L1 blockade enhances the efficacy of SA-GM-CSF surface-modified tumor vaccine in prostate cancer. Shi, X., Zhang, X., Li, J., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

A phase 1/2 trial of an immune-modulatory vaccine against IDO/PD-L1 in combination with nivolumab in metastatic melanoma. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

mRNA Vaccine Slows Melanoma Recurrence. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Optimal dose and schedule of an HER-2/neu (E75) peptide vaccine to prevent breast cancer recurrence: from US Military Cancer Institute Clinical Trials Group Study I-01 and I-02. [2008]

4. England pubmed.ncbi.nlm.nih.gov

Long-term follow-up of anti-PD-1 naïve patients with metastatic melanoma treated with IDO/PD-L1 targeting peptide vaccine and nivolumab. [2023]

5. Ireland pubmed.ncbi.nlm.nih.gov

PD-1/PD-L1 blockade enhances the efficacy of SA-GM-CSF surface-modified tumor vaccine in prostate cancer. [2018]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Single-Dose Intranasal Immunisation with Novel Chimeric H1N1 Expressing the Receptor-Binding Domain of SARS-CoV-2 Induces Robust Mucosal Immunity, Tissue-Resident Memory T Cells, and Heterologous Protection in Mice. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Intranasal COVID-19 vaccines: From bench to bed. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Intranasal administration of a live-attenuated recombinant newcastle disease virus expressing the SARS-CoV-2 Spike protein induces high neutralizing antibody levels and protects from experimental challenge infection in hamsters. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

An Intranasal OMV-Based Vaccine Induces High Mucosal and Systemic Protecting Immunity Against a SARS-CoV-2 Infection. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

COVID-19 intranasal vaccines: current progress, advantages, prospects, and challenges. [2022]