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- || RBS2418 / Riboscience
Trial completion date, Trial primary completion date, Monotherapy, Metastases: Evaluation of RBS2418 in Subjects With Advanced, Metastatic Solid Tumors (clinicaltrials.gov) - Jun 13, 2024
P1, N=64, Recruiting, Sponsor: Riboscience, LLC.
Trial completion date: Jul 2025 --> Oct 2025 | Trial primary completion date: Jun 2025 --> Sep 2025
- || RBS2418 / Riboscience
Trial completion date, Trial primary completion date, Monotherapy, Metastases: Evaluation of RBS2418 in Subjects With Advanced, Metastatic Solid Tumors (clinicaltrials.gov) - Jun 5, 2024
P1, N=64, Recruiting, Sponsor: Riboscience, LLC.
Trial completion date: Jul 2025 --> Oct 2025 | Trial primary completion date: Jun 2025 --> Sep 2025 Trial completion date: Mar 2025 --> Jul 2025 | Trial primary completion date: Feb 2025 --> Jun 2025
- RBS2418 / Riboscience, Keytruda (pembrolizumab) / Merck (MSD)
Correlation of baseline ENPP1 and cGAS expression in advanced solid tumors with intratumoral immune activation and clinical outcomes after treatment with the first-in-class oral ENPP1 inhibitor RBS2418, alone or in combination with pembrolizumab. (Hall A; Poster Bd #: 76) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2998;
P1
The robust PK profile shows plasma levels enabling complete ENPP1 inhibition at all time points. Immune activation and observed clinical benefit of treatment in late line treatment of refractory metastatic solid tumors such as CRC and HCC was associated with baseline ENPP1 and cGAS protein expression in tumors.
- RBS2418 / Riboscience
Inhibition of ENPP1 catalyzed ATP and cGAMP hydrolysis and in vivo antitumor efficacy of RBS2418 in the Hepa1-6 and GL261-luc syngeneic liver and glioblastoma mouse models (Section 42) - Mar 5, 2024 - Abstract #AACR2024AACR_3792;
The pharmacology profile was optimized to achieve low serum protein binding and oral bioavailability in humans. RBS2418 treatment was well tolerated in mice under conditions where tumor and plasma levels exceeding ENPP1 serum EC90 levels were achieved.
- || RBS2418 / Riboscience
Trial completion date, Trial primary completion date, Monotherapy, Metastases: Evaluation of RBS2418 in Subjects With Advanced, Metastatic Solid Tumors (clinicaltrials.gov) - Oct 30, 2023
P1, N=64, Recruiting, Sponsor: Riboscience, LLC.
RBS2418 treatment was well tolerated in mice under conditions where tumor and plasma levels exceeding ENPP1 serum EC90 levels were achieved. Trial completion date: Jan 2024 --> Feb 2025 | Trial primary completion date: Jan 2023 --> Jan 2025
- RBS2418 / Riboscience, Keytruda (pembrolizumab) / Merck (MSD)
Preliminary safety, pharmacokinetics and immunomodulatory activity of RBS2418, an oral ENPP1 inhibitor, alone and in combination with pembrolizumab in patients with solid tumors (M) - Jul 27, 2023 - Abstract #ESMO2023ESMO_500;
P1
The PK profile showed plasma levels enabling complete ENPP1 inhibition. Preliminary analyses support the hypothesis that ENPP1 and cGAS co-expression in tumors correlates with RBS2418 treatment associated immune activation and prolonged disease stabilization suggestive of clinical benefit in multiple patients with refractory malignancies including MSS CRC and HCC (NCT05270213).
- |||||| RBS2418 / Riboscience
New trial: Expanded Access RBS2418 Treatment (clinicaltrials.gov) - Jan 13, 2023
P=N/A, N=0, Available, Sponsor: Riboscience, LLC.
- RBS2418 / Riboscience, Keytruda (pembrolizumab) / Merck (MSD)
A First-In-Human, Phase 1 a/b Dose Escalation and Expansion Study to Evaluate RBS2418 as Monotherapy and in Combination with Pembrolizumab in Subjects with Advanced Unresectable, Recurrent or Metastatic Tumors (NCT05270213) (Foyer ABC) - Oct 21, 2022 - Abstract #ESMOIO2022ESMO_IO_348;
P1
Immune biomarkers predictive of anti-tumor responses will be explored as well as translational analyses will be done to explore the depth and breadth of immune activation both in tumor tissue and blood. This study is being funded by Riboscience, Llc.
- RBS2418 / Riboscience, Keytruda (pembrolizumab) / Merck (MSD)
Immunomodulatory effects of RBS2418, an oral ENPP1 inhibitor in combination with pembrolizumab in checkpoint-refractory metastatic adrenal cancer (Foyer ABC) - Oct 21, 2022 - Abstract #ESMOIO2022ESMO_IO_322;
P1
RBS2418 PK data showed excellent oral bioavailability with plasma levels leading to complete ENPP1 inhibition. RBS2418 induced increases in peripheral cDCs, proliferation of CD4 and CD8 T cells and expansion of TCR clonotypes as well as upregulation of T cell cytotoxic granule protein gene expression supporting clinical development of this novel first-in-class immunotherapy agent in an ongoing clinical trial (NCT05270213).
- RBS2418 / Riboscience, Keytruda (pembrolizumab) / Merck (MSD)
First-in-human experience using RBS2418, an oral ENPP1 inhibitor within an expanded access protocol in combination with pembrolizumab in a patient with metastatic adrenal cancer. () - Apr 28, 2022 - Abstract #ASCO2022ASCO_1778;
The pharmacokinetics of RBS2418 showed excellent oral bioavailability, with plasma levels of RBS2418 > 17-fold and > 40-fold above serum EC90 of ENPP1 at the 100 and 200 mg BID dose levels, respectively. Dose levels are further studied in the current Phase 1 trial.
- ||| RBS2418 / Riboscience
Enrollment open, Monotherapy, Metastases: Evaluation of RBS2418 in Subjects With Advanced, Metastatic Solid Tumors (clinicaltrials.gov) - Mar 22, 2022
P1, N=64, Recruiting, Sponsor: Riboscience, LLC.
Dose levels are further studied in the current Phase 1 trial. Not yet recruiting --> Recruiting
- | RBS2418 / Riboscience
New P1 trial, Monotherapy, Metastases: Evaluation of RBS2418 in Subjects With Advanced, Metastatic Solid Tumors (clinicaltrials.gov) - Mar 8, 2022
P1, N=64, Not yet recruiting, Sponsor: Riboscience, LLC.