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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new personalized cancer vaccine, YE-NEO-001, designed for individuals with various solid cancers, such as breast, lung, or colorectal cancer. The primary goal is to determine the vaccine's safety and potential effectiveness after patients have completed their regular cancer treatments and are under surveillance for disease recurrence. Individuals who show no signs of cancer following initial treatments and are willing to provide a tissue sample for vaccine development may be suitable candidates for this trial. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

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.

Is there any evidence suggesting that YE-NEO-001 is likely to be safe for humans?

Research has shown that early tests of the YE-NEO-001 vaccine in patients with advanced solid tumors have been safe, with participants generally not experiencing serious side effects. These studies also found that the vaccine activated specific immune responses, which is encouraging.

This is a phase 1 trial, focusing primarily on safety and determining the best dose for future research. While YE-NEO-001 has shown promise in terms of safety in early tests, participants in this study will help gather more detailed safety information. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for solid cancers, like chemotherapy and radiation, YE-NEO-001 is a cancer vaccine that harnesses the body's immune system to target cancer cells. This vaccine is designed to stimulate the immune system by using neoepitopes, which are unique markers found on cancer cells but not on normal cells. Researchers are excited about YE-NEO-001 because it offers a more personalized approach, potentially leading to fewer side effects and targeting cancer cells more precisely. This innovative method could pave the way for more effective and safer cancer treatments.

What evidence suggests that YE-NEO-001 might be an effective treatment for solid cancers?

Research has shown that yeast-based cancer vaccines, such as YE-NEO-001, which participants in this trial will receive, hold promise because they activate the body's natural defenses to recognize and fight cancer cells. The vaccine targets specific markers on a person's cancer cells, potentially helping to prevent the cancer from returning. Early studies suggest that this approach effectively strengthens the immune system against cancer. Although still in the early stages, this method shows potential in creating personalized treatments for cancer patients. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03552718

NCT03552718 | QUILT-2.025 NANT Neoepitope Yeast ... This is a phase 1 trial to evaluate the safety, the RP2D, and preliminary efficacy of a personalized neoepitope yeast-based vaccine, YE-NEO-001, in subjects who ...

2. mycancergenome.org mycancergenome.org/content/clinical_trials/NCT03552718/

Clinical Trial: NCT03552718 This is a phase 1 trial to evaluate the safety, the RP2D, and preliminary efficacy of a personalized neoepitope yeast-based vaccine, YE-NEO-001, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11934169/

Harnessing live vectors for cancer vaccines - PubMed Central Yeast-based cancer vaccines represent a cost effective, versatile and promising approach leveraging innate and adaptive immune responses. Yeast is an effective ...

4. immunitybio.com immunitybio.com/immunitybio-and-nantomics-announce-clinical-validation-of-a-proprietary-method-to-identify-unique-targets-for-immunotherapy-in-individual-breast-cancer-patients/

ImmunityBio and NantOmics Announce Clinical Validation ... The “neoepitope” identification pipeline facilitates discovery of immunotherapy targets unique to individual cancer patients as a ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2950247025000878

An overview of current immunotherapy approaches for ... For hepatocellular carcinoma (HCC), immunotherapy combinations are regarded as a first-line treatment due to its efficacy over traditional chemotherapy.

6. synapse.patsnap.com synapse.patsnap.com/drug/76a0af6bf3b04bd0befd7a5868e74b87

Neoepitope yeast vaccine(Nantbioscience, Inc.) Promising clinical results in melanoma and other solid tumor types are emerging. As with all cancer therapy modalities, neoepitope vaccine ... data packages ...

7. adisinsight.springer.com adisinsight.springer.com/drugs/800052281

YE NEO 001 - AdisInsight - Springer YE NEO 001, a neoepitope yeast vaccine, is being developed by NantBioScience for the treatment of solid tumours including colorectal cancer, ...