Vaccine Info

NEO-PV-01 Cancer Vaccine

Description

NEO-PV-01  Cancer vaccine candidate is a personal neoantigen vaccine which is custom designed and manufactured for each individual patient.

NEO-PV-01 combines up to 20 individually designed and manufactured peptides with a proprietary formulation to construct a unique vaccine for each patient.

Indication

NEO-PV-01 is indicated to generate an anti-tumor immune response that directs patients’ T cells to target their individual tumor’s particular neoantigens and kill the cancer cells.

Dosage

NEO-PV-001 vaccine candidate, plus an adjuvant will be administered subcutaneously (one vial of pooled peptides per injection site) in up to four distinct sites (each extremity or flanks).

The schedule and dosage of NEO-PV-001 will differ among the clinical trials.

Update

July 15, 2019: 

  • Neon Therapeutics, Inc. a clinical-stage immuno-oncology company developing neoantigen-based therapeutics, today announced top-line results, with at least 12-month median follow-up, from the ongoing, multicenter Phase 1b clinical trial evaluating NEO-PV-01, Neon’s personal neoantigen vaccine candidate, in combination with OPDIVO in patients with advanced or metastatic melanoma, smoking-associated non-small cell lung cancer (NSCLC) and bladder cancer.
  • Across all three distinct tumor types, results demonstrated prolonged and consistent improvements in progression-free survival (PFS) that compare favorably to that observed with checkpoint inhibitor monotherapy, based on historical benchmark data.
  • At 13.4-month median follow-up in 34 patients with metastatic melanoma, median PFS had not yet been reached. In 27 patients with metastatic NSCLC, median PFS was 5.6 months; and in 21 patients with metastatic bladder cancer, median PFS was 5.6 months.
  • These top-line data, which come from 82 patients who received at least one dose of OPDIVO in the Phase 1b NT-001 trial (Intention-to-Treat analysis, or ITT), support further development of NEO-PV-01, including randomized Phase 2 trials of NEO-PV-01 in metastatic disease settings. 
  • The NT-001 trial was initiated in November 2016 and completed enrollment in July 2018.

Clinical Trials

NEO-PV-001 is active in two clinical trials and is recruiting currently for a third trial.

Clinical Trial NCT02897765: A Personal Cancer Vaccine (NEO-PV-01) w/ Nivolumab for Patients With Melanoma, Lung Cancer or Bladder Cancer 

  • This active clinical trial will enroll patients with metastatic or advanced melanoma, lung, or bladder cancer. The three agents being used in this study are:
    • A new, investigational, personal cancer vaccine called "NEO-PV-01"
    • Poly-ICLC (Hiltonol), an investigational adjuvant that is used to help stimulate the immune system
    • A cancer drug called nivolumab (Opdivo®)
  • These agents are considered immunotherapy and work by stimulating the immune system to fight cancer.
  • NEO-PV-01 is a truly personal vaccine therapy in that it is custom designed and manufactured to include targets for the immune system that are present uniquely on an individual's cancer.
  • Poly-ICLC is an adjuvant that helps stimulate the immune system and make the vaccine, NEO-PV-01 more effective.
  • Nivolumab (Opdivo) helps T-cells, a certain type of immune cell, that recognize these targets to reach and attack the tumor. Nivolumab is in clinical development for treatment of bladder cancer and is approved by the FDA for the treatment of some lung, skin, kidney, and blood cancers.
  • The purpose of this study is to find out if treatment with NEO-PV-01 + adjuvant in combination with nivolumab is safe and effective for patients with melanoma, lung, or bladder cancer.
  • The study also will see if NEO-PV-01 vaccine + adjuvant with nivolumab can improve responses compared to available therapies such as nivolumab monotherapy The side effects of NEO-PV-01 + adjuvant and nivolumab will be monitored and additional research tests will be done to assess the immune response against each individual's cancer.

Clinical Trial NCT03380871: A Personal Cancer Vaccine (NEO-PV-01) With Pembrolizumab and Chemotherapy for Patients With Lung Cancer

  • This active clinical trial will enroll patients with advanced or metastatic nonsquamous non-small cell lung carcinoma not having received treatment for metastatic disease. The five agents being used in this study are:
    • A new, investigational, personalized cancer vaccine called "NEO-PV-01"
    • Poly-ICLC (Hiltonol), an investigational adjuvant that is used to help stimulate the immune system
    • A cancer drug called pembrolizumab (KEYTRUDA®)
    • A chemotherapy called pemetrexed (ALIMPTA®)
    • A chemotherapy called carboplatin
  • Both NEO-PV-01 and pembrolizumab are considered immunotherapies and work using the immune system to fight cancer.
  • NEO-PV-01 is a custom made vaccine for you that is based on the specific targets on your cancer.
  • Poly-ICLC is an adjuvant that helps stimulate the immune system and make the vaccine, NEO-PV-01, more effective.
  • Pembrolizumab (Keytruda) helps T-cells, a certain type of immune cell, that recognize these targets to reach and attack your cancer. Pembrolizumab, which is approved in the USA and some other countries, is available by prescription to treat several different cancers 
  • The purpose of this study is to find out if treatment with NEO-PV-01 in combination with pembrolizumab and chemotherapy is safe and useful for patients with lung cancer.
  • The study also will assess if the NEO-PV-01 vaccine, when given together with pembrolizumab and chemotherapy, can improve the immune response compared with pembrolizumab and chemotherapy treatment alone.
  • The side effects of NEO-PV-01, pembrolizumab, and chemotherapy will be monitored and additional research tests will be done to assess the immune response to the cancers.

Clinical Trial NCT03597282: A Personal Cancer Vaccine (NEO-PV-01) and APX005M or Ipilimumab With Nivolumab in Patients With Advanced Melanoma

  • This recruiting clinical trial will enroll patients with advanced or metastatic melanoma not having received treatment for metastatic disease. The 5 agents being used in this study are:
    • A new, investigational, personal cancer vaccine called "NEO-PV-01".
    • Poly-ICLC (Hiltonol), an investigational adjuvant that is used to help stimulate the immune system.
    • A cancer drug called APX005M, a drug that stimulates specific types of immune cells that help the immune system to recognize specific targets.
    • A cancer drug called ipilimumab
    • A cancer drug called nivolumab (Opdivo®)
  • NEO-PV-01, APX005M, ipilimumab, and nivolumab are considered immunotherapies and work using the immune system to fight cancer.
  • NEO-PV-01 is a personal vaccine therapy in that it is manufactured specifically to include targets for the immune system that are present uniquely on your cancer.
  • Poly-ICLC is an adjuvant that helps stimulate the immune system and make the vaccine, NEO-PV-01, more effective.
  • The purpose of this study is to find out if treatment with NEO-PV-01 + Poly-ICLC (the NEO-PV-01 vaccine) in combination with either APX005M or ipilimumab and nivolumab is safe and useful for patients with melanoma.
  • The study also will assess if the NEO-PV-01 vaccine, when given at different intervals, can improve your response compared with the standard schedule.
  • This study will also assess the effects of poly-ICLC in combination with nivolumab. 
  • The FDA has not yet approved the NEO-PV-01 vaccine for use alone or in combination with other cancer drugs such as APX005M, ipilimumab, and nivolumab. 
Updated
August 20th, 2019