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- FB849 / 1ST Bio
HPK1 inhibitor reinvigorates exhausted tumor-infiltrating CD8 T cells and synergizes with anti-PD-1 blockade in gynecologic malignancies (Section 3) - Mar 5, 2024 - Abstract #AACR2024AACR_6904;
However, there was no synergistic effect of FB849 + anti-PD-1 in terms of proliferative capacity in ovarian cancer. Overall, the results of our present study provide a rationale for clinical trials investigating the anti-tumor efficacy of FB849
- FB849 / 1ST Bio
Integrative analysis of proteomic alterations in human PBMC's treated by HPK1 inhibitor FB849 reveals enriched pathways from various immune cells leading to potential novel biomarker discovery (Section 4) - Mar 5, 2024 - Abstract #AACR2024AACR_5502;
P1/2
Together, this work reveals genome-wide alterations in the proteomic and phosphoproteomic landscape by FB849 in both mouse PBMC's and human PBMC's with clear pathway enrichment potentially from various immune cell lineages. Further exploration of the differential expression of each protein and/or phosphoproteins especially in T cell-, B cell-, and monocyte-enriched biomarkers which link to HPK1-relevant signal transduction is needed to find out their clinical implication and to highlight new understanding of HPK1 signaling network in cancer immunity.
- FB849 / 1ST Bio
A selective HPK1 inhibitor FB849 reprograms intratumoral immune cells and elicits strong anti-cancer immunity (Section 4) - Mar 5, 2024 - Abstract #AACR2024AACR_5500;
These data from patient TIL's together with mouse TIL's pinpoint unprecedented anti-tumor mechanism by FB849 through modulation of exhausted T cells as well as myeloid cells. Altogether, this study supports the planned clinical development of FB849 as a promising immuno-oncology agent as a monotherapy in the selected cancer types and as post-ICI combination with a PD-1 antagonist.
- ||| FB849 / 1ST Bio
Enrollment open, Metastases: KEYNOTE-F25: A Phase I/II, Open-label Study to Investigate the Safety, Tolerability, PK, and Preliminary Efficacy of FB849 (clinicaltrials.gov) - Feb 1, 2024
P1/2, N=121, Recruiting, Sponsor: 1ST Biotherapeutics, Inc.
Altogether, this study supports the planned clinical development of FB849 as a promising immuno-oncology agent as a monotherapy in the selected cancer types and as post-ICI combination with a PD-1 antagonist. Not yet recruiting --> Recruiting
- ||| FB418 / 1ST Bio
New P1 trial: A Phase 1, SAD and MAD Study to Evaluate the Safety and Tolerability of FB418 (clinicaltrials.gov) - Aug 16, 2023
P1, N=64, Not yet recruiting, Sponsor: 1ST Biotherapeutics, Inc.
- || FB849 / 1ST Bio
Trial initiation date, Metastases: KEYNOTE-F25: A Phase I/II, Open-label Study to Investigate the Safety, Tolerability, PK, and Preliminary Efficacy of FB849 (clinicaltrials.gov) - Aug 8, 2023
P1/2, N=121, Not yet recruiting, Sponsor: 1ST Biotherapeutics, Inc.
Not yet recruiting --> Recruiting Initiation date: May 2023 --> Nov 2023
- ||| Trial completion, Trial completion date: DYSCOVER-1: FB101 Intervention in Women Screened to Have Vaginal Dysbiosis (clinicaltrials.gov) - May 3, 2023
P=N/A, N=34, Completed, Sponsor: Freya Biosciences ApS
Initiation date: May 2023 --> Nov 2023 Recruiting --> Completed | Trial completion date: Oct 2022 --> Feb 2023
- |||| FB849 / 1ST Bio
New P1/2 trial, Metastases: KEYNOTE-F25: A Phase I/II, Open-label Study to Investigate the Safety, Tolerability, PK, and Preliminary Efficacy of FB849 (clinicaltrials.gov) - Mar 9, 2023
P1/2, N=121, Not yet recruiting, Sponsor: 1ST Biotherapeutics, Inc.
- || FB-101 / 1ST Bio, D&D Pharmatech
Trial completion: Safety, Tolerability, and Pharmacokinetics of Oral FB-101 in Healthy Subjects (clinicaltrials.gov) - Jan 26, 2023
P1, N=24, Completed, Sponsor: 1ST Biotherapeutics, Inc.
Recruiting --> Completed | Trial completion date: Oct 2022 --> Feb 2023 Active, not recruiting --> Completed
- || FB-101 / 1ST Bio, D&D Pharmatech
wow this is amazing @fb0101 @zane_blanton @CFFILMZ @benskigen @XXXmetaybXXX @skyyfettiNFT @7012io @_tnk @BrumbackLab @monish00 @gonzoffs @thom_6light @prachyaklui (Twitter) - Nov 26, 2022
- FB-101 / 1ST Bio, D&D Pharmatech
Intravenous Administration of FBX-101 (AAVrh10. hGALC) Following Hematopoietic Stem Cell Transplantation, a Potential Treatment for Infantile Krabbe Disease: RESKUE Phase 1/2 Clinical Trial () - Oct 17, 2022 - Abstract #ANA2022ANA_283;
FBX101 was well tolerated with no treatment-related serious adverse events at Day 90... The first patient’s data of the RESKUE clinical trial shows that IV FBX-101following HSCT has been safe and well tolerated through Day 90 with DTI results suggesting adequate GALC to support normal brain development.
- || FB-101 / 1ST Bio, D&D Pharmatech
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date: Safety, Tolerability, and Pharmacokinetics of Oral FB-101 in Healthy Subjects (clinicaltrials.gov) - Jul 25, 2022
P1, N=24, Active, not recruiting, Sponsor: 1ST Biotherapeutics, Inc.
The first patient’s data of the RESKUE clinical trial shows that IV FBX-101following HSCT has been safe and well tolerated through Day 90 with DTI results suggesting adequate GALC to support normal brain development. Unknown status --> Active, not recruiting | N=48 --> 24 | Trial completion date: Jun 2020 --> Aug 2022 | Trial primary completion date: Mar 2020 --> Mar 2022
- | New trial: DYSCOVER-1: FB101 Intervention in Women Screened to Have Vaginal Dysbiosis (clinicaltrials.gov) - Nov 8, 2021
P=N/A, N=40, Recruiting, Sponsor: Freya Biosciences ApS
- FB-101 / 1ST Bio, D&D Pharmatech
[VIRTUAL] Disease Correction by delivery of FBX101, an Intravenous AAV Gene Replacement Therapy, Administered with Unrelated Umbilical Cord Blood Transplantation for the Treatment of Infantile Krabbe Disease () - Oct 2, 2021 - Abstract #ESGCT2021ESGCT_548;
In conclusion, the administration of FBX101 with UCBT is a safe and highly effective approach to address the CNS and PNS symptoms of Krabbe disease. FBX101 is entering the clinical phase in 2021.
- | FB-101 / 1ST Bio, D&D Pharmatech
New P1 trial: Safety, Tolerability, and Pharmacokinetics of Oral FB-101 in Healthy Subjects (clinicaltrials.gov) - Nov 17, 2019
P1, N=48, Recruiting, Sponsor: 1ST Biotherapeutics, Inc.