Imugene marks a new breakthrough, secures FDA IND approvals for HER-Vaxx & VAXINIA

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Imugene marks a new breakthrough, secures FDA IND approvals for HER-Vaxx & VAXINIA

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Imugene progressing with clinical trials
Image source: Company Website

Highlights

  • Imugene Limited (ASX:IMU) has secured the FDA IND approval to start a new Phase 2 clinical trial of HER-Vaxx and Phase 1 clinical trial of VAXINIA.
  • HER-Vaxx can serve as a possibly better tolerated & chemotherapy-free treatment opportunity in metastatic gastric cancer patients.
  • The Company considers the commencement of a VAXINIA OV study as a crucial milestone for clinicians treating patients facing the challenge of solid tumour cancers.

Cancer-fighting player Imugene Limited (ASX:IMU) has achieved a new milestone with regard to its immunotherapy candidate, HER-Vaxx and oncolytic virotherapy candidate, VAXINIA. The Company has secured the US FDA (Food and Drug Administration) Investigational New Drug (IND) approval to commence a new Phase 2 clinical trial of HER-Vaxx and Phase 1 clinical trial of VAXINIA (CF33-hNIS, HOV2).

Titles of HER-Vaxx and VAXINIA clinical trials

Let us quickly discuss the key details of each of these clinical trials below:

Phase 2 trial of HER-Vaxx

The FDA approval of the IND allows the Company to initiate patient recruitment and dosing for the nextHERIZON trial in HER2/neu overexpressing advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction, also called Advanced Gastric Cancer (AGC).

To overcome resistance to immunotherapy within gastrointestinal cancer, one effective strategy is to raise the number of cytotoxic immune cells within the TME (tumour microenvironment) via the use of immunotherapies like HER-Vaxx. Imugene informed that active immunization with HER-Vaxx has induced long-lasting and high antibody levels and expanded lymphocytes’ subpopulations, like interferon gamma (IFN-γ) producing CD4 and CD8 T cells.

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Thus, the introduction of HER-Vaxx post first line treatment in patients that have advanced under trastuzumab could overcome potential resistance. In accordance with the pre-clinical data, HER-Vaxx could also synergize with PD-1 targeting immune checkpoint inhibitor pembrolizumab (marketed and sold as KEYTRUDA®). Thus, HER-Vaxx can serve as a possibly better tolerated & chemotherapy-free treatment opportunity in metastatic gastric cancer patients.

On the latest FDA IND approval for HER-Vaxx, Imugene’s MD and CEO, Mrs Leslie Chong, commented:

Imugene CEO’s view on HER-Vaxx clinical trial

Phase 1 trial of VAXINIA

The FDA approval of the IND allows the Company to commence patient recruitment and dosing in a Phase 1 clinical study for the Metastatic or Advanced Solid Tumors (MAST) trial in multiple solid tumour type patients.

This is an open-label, multi-centre, dose-escalation phase 1 trial assessing the safety of CF33-hNIS administered through two routes of administration, intravenous (IV) or intratumoural (IT), either as a monotherapy or in combination with pembrolizumab administered intravenously in patients with advanced or metastatic solid tumours.

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The Phase 1 clinical trial of VAXINIA will include a dose-escalation, before the trial expands to up to ten patients at the final monotherapy plus combination dose.

Imugene CEO’s view on VAXINIA clinical trial

Imugene shares are trading at A$0.522 as of 2:41 PM AEDT.

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