Enterome has accomplished affected person enrollment in its part 2 medical trial (ROSALIE) evaluating its lead OncoMimics candidate, EO2401, together with an immune checkpoint inhibitor (nivolumab) +/- an anti-VEGF remedy (bevacizumab) in sufferers with first development/recurrence of glioblastoma, an aggressive type of mind most cancers.

Enterome is a French medical stage firm creating first-in-class immunomodulatory medication based mostly on its intestine bacterial Mimicry drug discovery platform.

The part 2 trial is an open-label, multicenter examine assessing the protection, tolerability, immunogenicity and preliminary efficacy of EO2401. A complete of 100 sufferers have began remedy within the completely different examine cohorts at 10 medical websites in Europe and the U.S. Preliminary and extremely promising immunological and medical outcomes had been obtained in 2022 and offered at medical oncology conferences throughout 2022. 

OncoMimics immunotherapies are designed to activate pre-existing effector reminiscence T cells that concentrate on bacterial (non self) peptides, that are strongly cross-reactive towards chosen tumor-associated antigens (TAAs) expressed on tumoral cells, leading to a fast focused cytotoxic response towards most cancers.

Potential breakthrough

EO2401 combines three OncoMimics peptides mimicking IL13Ra2, BIRC5 and FOXM1, TAAs current in aggressive cancers equivalent to glioblastoma, mixed with the helper peptide UCP2 (common most cancers peptide 2).

“The completion of enrollment in ROSALIE strikes us one step nearer to establishing OncoMimics immunotherapies as potential breakthrough medication for treating aggressive types of most cancers, resisting immediately’s best therapies, in broad affected person populations,” mentioned Pierre Bélichard, co-founder and CEO of Enterome. 

“Because of the eagerness and dedication amongst international investigators, and a powerful effort from our crew, we had been in a position to enroll 100 sufferers throughout the projected timeframe. I think about it a exceptional achievement for the primary immune-oncology examine ever sponsored and carried out by Enterome. We prolong our honest because of the sufferers, caregivers, medical investigators and employees who’re collaborating within the ROSALIE trial, and we look ahead to presenting additional leads to 2023.”

Trial information

Throughout 2022, the corporate mentioned trial information revealed to this point verify that EO2401 together with nivolumab +/- bevacizumab is properly tolerated with a security profile in keeping with the protection profiles of nivolumab and bevacizumab, with the addition of native administration web site reactions.

The corporate additionally mentioned EO2401 together with nivolumab generated robust systemic immune responses via activation of particular effector reminiscence CD8+ T cells, correlating with medical efficacy.

As in comparison with the administration of EO2401 together with nivolumab with out the addition of the anti-edema compound bevacizumab, the symptom-driven addition of low-dose, time-limited, bevacizumab (LDB) resulted in longer remedy durations (median remedy period 3.2 months with LDB in comparison with 1.4 months with out LDB), and a few enchancment of efficacy.

In a subsequent cohort, the addition of steady customary bevacizumab (as labeled within the U.S.) to EO2401 together with nivolumab additional improved median remedy period (to five.5 months), goal response fee (to 55%), and median PFS (to five.5 months).

With a median follow-up of 15.4 months, median survival for EO2401 together with nivolumab and bevacizumab has reached 14.5 months.

CD8+ T cells towards at the least one of many EO2401 peptides was detected in 26 out of 28 sufferers with some sufferers exhibiting as much as 5% of circulating particular CD8+ T cells. Reminiscence-specific CD8+ T cell responses had been noticed as early as two weeks after the primary administration and upkeep of a robust and secure immune response may very well be detected for greater than 10 months.

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