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Clinical Trials

Date: 2017-11-13

Type of information: Presentation of results at a congress

phase: preclinical

Announcement: presentation of results at the 32nd Society for Immunotherapy of Cancer (SITC) Annual Meeting

Company: Nouscom (Switzerland) Nektar Therapeutics (USA - CA)

Product: NKTR-214 and great apes adenoviral vaccine encoding neoantigens

Action mechanism:

  • cytokine/proteine/immunotherapy product/vaccine. NKTR-214 is a CD122-biased immune-stimulatory cytokine, which is designed to stimulate the patient's own immune system to eliminate cancer cells. CD122, which is also known as the Interleukin-2 receptor beta subunit, is a key signaling receptor that is known to increase the proliferation of CD8-positive effector T cells, and these CD8-positive T cells comprise a key component of the tumor infiltrating lymphocytes that provide cell-mediated anti-tumor effects.
  • By biasing activation to the CD122 receptor, NKTR-214 enhances CD8-positive T cells (tumor-killing cells) in the tumor. In preclinical studies, a single dose of NKTR-214 resulted in an approximate 400-fold AUC exposure within the tumor compared with an equivalent dose of aldesleukin, an existing IL-2 therapy. This increase potentially enables, for the first time, an antibody-like dosing regimen for a cytokine. In dosing studies in non-human primates, there was no evidence of low blood pressure or vascular leak syndrome with NKTR-214 at predicted clinical therapeutic doses.
  • Nektar and BMS are collaborating to develop NKTR-214 as a potential combination treatment regimen with Opdivo® (nivolumab) in five tumor types and eight potential indications. The Phase 1/2 clinical program will enroll up to 260 patients and will evaluate the potential for the combination of Opdivo (nivolumab) and NKTR-214 to show improved and sustained efficacy and tolerability above the current standard of care in melanoma, kidney, triple-negative breast cancer, bladder and non-small cell lung cancer patients. The initial dose-escalation trial is underway with Opdivo (nivolumab) and NKTR-214 in the indications of first-line melanoma, second-line RCC checkpoint therapy-naïve, and second-line non-small cell lung cancer (NSCLC) checkpoint therapy-naïve.
  • Great Apes Adenovirus (GAd) and Modified Vaccinia Ankara (MVA) are viral vectors encoding  a large set of cancer neoantigens to induce and expand cancer- and patient-specific T cells.

Disease:

Therapeutic area: Cancer - Oncology

Country:

Trial details:

Latest news:

  • • On November 13, 2017, NousCom, an oncology company developing next generation cancer vaccines based on its Exovax platform, announced preclinical data of its neoantigen-based cancer vaccine in combination with Nektar Therapeutics’ NKTR-214, a CD122-biased cytokine agonist which is currently in clinical trials. These results were presented at The Society for Immunotherapy of Cancer (SITC) Annual Meeting. NousCom combined its vectored genetic vaccine encoding multiple cancer neoantigens, capable of inducing potent and broad T cell responses, with NKTR-214, designed to expand the specific population of vaccine induced cancer-killing T cells which infiltrate the tumor. Strong synergy between the two agents was observed, leading to an unprecedented anti-tumor effect in mice. Combination treatment of NousCom vaccine and NKTR-214 resulted in tumor regression in 90% of mice. All animals cured by this combination treatment were resistant to the second tumor challenge. A triple regimen based on NousCom vaccine, NKTR-214 and anti-PD1 resulted in 100% cure of animals with established tumors. Combination treatments induce strong and broad neoantigen specific immune response
  •  The poster is entitled “Great Apes Adenoviral vaccine encoding neoantigens synergizes with immunomodulator (NKTR-214) to cure established tumors in mice" (P434) . Nouscom now look sforward to continuing  the collaboration with the team at Nektar Therapeutics with the goal of further validating its technology platform and developing more effective therapies for the benefit of cancer patients.

Is general: Yes