Cancer Vaccine for Solid Cancers

Overseen By NantBio Clinical Review Team

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: NantBioScience, Inc.

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Autoimmune disease, Organ transplant, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Duration not specified

16 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a phase 1 study to evaluate the safety, the Recommended Phase 2 Dose (RP2D), and preliminary efficacy of a personalized neoepitope yeast-based vaccine, YE-NEO-001, in subjects who have completed potentially curative therapy for their solid cancer and who would otherwise be entering a period of surveillance for recurrent disease.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you are on medications that have adverse reactions with the study treatment, or if you are on chronic daily treatment with systemic corticosteroids. Anti-androgen and anti-estrogen medications are allowed.

What data supports the effectiveness of the treatment YE-NEO-001 for solid cancers?

Research on similar cancer vaccines, like the EGF-based vaccine for lung cancer, shows that these vaccines can be safe and may help improve survival. Additionally, DNA vaccines targeting specific proteins have been shown to inhibit tumor growth, suggesting potential benefits for cancer treatment. ^{1 2 3 4 5}

How does the cancer vaccine treatment differ from other treatments for solid cancers?

This cancer vaccine is unique because it targets specific proteins on cancer cells to stimulate the immune system to attack the tumor, potentially offering long-term immunity and reducing drug resistance. Unlike traditional treatments, it uses a novel approach by delivering tumor-associated antigens to dendritic cells, which are key players in initiating immune responses. ^{3 5 6 7 8}

Eligibility Criteria

This trial is for adults who've had surgery or other curative treatments for certain solid cancers (like colorectal, breast, lung cancer, etc.) and are now in a surveillance period with no evidence of disease. They must be able to provide tissue samples, have an ECOG status of 0-2, and agree to use effective contraception.

Inclusion Criteria

Able to understand and provide a signed informed consent that fulfills the relevant IRB or IEC guidelines

My cancer can be treated with the intention to cure, as per standard care.

I am willing to give a tumor tissue and blood sample for testing.

Exclusion Criteria

My lab results show my organs are not functioning well.

Positive results of screening test for HIV

I am willing and able to follow the study's requirements.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the personalized neoepitope yeast-based vaccine, YE-NEO-001, with dose escalation in part 1 and dose expansion in part 2

Duration not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Long-term follow-up

Participants are monitored for overall survival and disease progression

36 months

Treatment Details

Interventions

• YE-NEO-001

Trial Overview The study tests YE-NEO-001, a personalized neoepitope yeast-based vaccine designed to trigger T-cell responses against cancer. It's given after standard treatment when patients are monitoring for recurrence. The goal is to find the safest dose and see if it helps prevent cancer from coming back.

Participant Groups

Group I: Experimental: NANT Neoepitope Yeast Vaccine (YE-NEO-001) Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

NantBioScience, Inc.

Lead Sponsor

Trials

6

Recruited

280+

Findings from Research

The EGF-based cancer vaccine was found to be safe, with adverse events occurring in less than 25% of patients, and most were mild (grade 1 or 2).

Patients who received the vaccine showed a significant increase in anti-EGF antibody responses and a decrease in serum EGF levels, which correlated with improved survival, particularly in patients younger than 60 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II randomized controlled trial of an epidermal growth factor vaccine in advanced non-small-cell lung cancer. Neninger Vinageras, E., de la Torre, A., Osorio Rodríguez, M., et al.[2018]

The BNT162b2 vaccine demonstrated a high efficacy in solid cancer patients undergoing systemic chemotherapy, with 98.4% of participants showing a positive antibody response three months after the second dose.

The vaccine was found to be safe, as none of the 63 patients required postponement or discontinuation of their chemotherapy due to adverse reactions from the vaccination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Prospective Study Regarding the Efficacy and Safety of the BNT162b2 Vaccine in Patients With Solid Malignancies Undergoing Systemic Chemotherapy. Yamasaki, E., Shimamoto, F., Nishikawa, H., et al.[2022]

In a study of 816 cancer patients, the BNT162b2 vaccine demonstrated a high serologic response rate of 94.2% after the second dose, indicating effective immunization against COVID-19.

The vaccine was well tolerated, with only 3.5% and 1.3% of patients experiencing severe adverse events after the first and second doses, respectively, suggesting it is safe for use in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunogenicity and Safety of COVID-19 Vaccine BNT162b2 for Patients with Solid Cancer: A Large Cohort Prospective Study from a Single Institution. Di Noia, V., Pimpinelli, F., Renna, D., et al.[2021]

The phase 1 trial of CDX-1401, a vaccine targeting dendritic cells with the tumor antigen NY-ESO-1, showed it was safe with no severe toxicities reported, and it successfully induced immune responses in patients with advanced cancers.

Out of 45 patients, 13 experienced disease stabilization for an average of 6.7 months, and two patients had significant tumor shrinkage, suggesting that CDX-1401 could be an effective component in combination with other immunotherapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Induction of antigen-specific immunity with a vaccine targeting NY-ESO-1 to the dendritic cell receptor DEC-205. Dhodapkar, MV., Sznol, M., Zhao, B., et al.[2021]

References

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

Phase II randomized controlled trial of an epidermal growth factor vaccine in advanced non-small-cell lung cancer. [2018]

2. Greece pubmed.ncbi.nlm.nih.gov

A Prospective Study Regarding the Efficacy and Safety of the BNT162b2 Vaccine in Patients With Solid Malignancies Undergoing Systemic Chemotherapy. [2022]

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

Membrane-bound KIT ligand-targeting DNA vaccination inhibits mammary tumor growth. [2021]

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

Immunogenicity and Safety of COVID-19 Vaccine BNT162b2 for Patients with Solid Cancer: A Large Cohort Prospective Study from a Single Institution. [2021]

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

NY-ESO-1 expression is tightly linked to TMPRSS2-ERG fusion in prostate cancer. [2022]

6. England pubmed.ncbi.nlm.nih.gov

A phase I/II trial of a WT1 (Wilms' tumor gene) peptide vaccine in patients with solid malignancy: safety assessment based on the phase I data. [2020]

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

A Whole Cancer Cell-Based Vaccine Boosts Cell Killing and Antitumor Immunity. [2023]

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

Induction of antigen-specific immunity with a vaccine targeting NY-ESO-1 to the dendritic cell receptor DEC-205. [2021]