Clinical Trials

Personal Neoantigen Cancer Vaccine Candidate In Phase 1b Study

Neon Therapeutics Phase 1b NT-001 clinical trial is evaluating a combination of NEO-PV-01 with OPDIVO
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(Precision Vaccinations News)

A clinical-stage, immuno-oncology company developing neoantigen-based therapeutics, said in a press release on May 13, 2019, “The field of cancer immunotherapy has advanced considerably in recent years, but there remains a significant need for new approaches that could extend the benefits of immunotherapy and lead to improved patient outcomes.” 

Hugh O’Dowd, Neon Therapeutics, Inc., Chief Executive Officer, said: “We expect to be the first clinical dataset ever reported with 12-month follow-up for a personal neoantigen vaccine in metastatic melanoma, non-small cell lung (NSCLC) and bladder cancers.” 

Neon’s ongoing Phase 1b open-label clinical trial with 40 participants was last updated on April 24, 2019, and is evaluating a combination of NEO-PV-01 with OPDIVO® (nivolumab) in patients with metastatic melanoma, NSCLC or bladder cancer. 

In the NT-001 study, Nivolumab at a dose of 240 mg will be administered by intravenous infusion every 2 weeks throughout the study. At Week 12, all patients, regardless of their disease status, will receive NEO-PV-01 + adjuvant administered subcutaneously. 

Neon is using 2 distinct neoantigen therapeutic approaches across this platform:

  • personal therapies that target individualized mutations (NEON / ONE), and
  • off-the-shelf precision therapies (NEON / SELECT) that target shared mutations present in sub-populations of cancer patients.

Neon recently presented updated data from NT-001 at the American Association for Cancer Research (AACR) Annual Meeting, describing the immune and pathologic markers associated with study subjects remaining progression-free at nine months. 

The analysis both confirmed the mechanism of action of NEO-PV-01 and highlighted new data on the association between histology and epitope spread in patients who had not progressed at 9 months in the melanoma cohort. 

In addition, multiple molecular markers were determined to correlate with lack of clinical progression, which may prove useful for patient selection in late-stage clinical trials. 

Neon expects to report top-line clinical results, including 12-month follow-up, from NT-001 in July 2019.

 

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