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- |||| alintegimod (7HP349) / 7 Hills Pharma
New P1/2 trial, Combination therapy, Monotherapy, Metastases: A Study of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy (clinicaltrials.gov) - Apr 11, 2024
P1/2, N=126, Not yet recruiting, Sponsor: 7 Hills Pharma, LLC
- 7HP349 / 7 Hills Pharma
A randomized, placebo-controlled, first in human phase I single ascending dose (SAD) and multiple ascending dose (MAD) study in healthy male volunteers of the immunostimulant 7HP349 (Hall C) - Oct 6, 2022 - Abstract #SITC2022SITC_930;
7HP349 mean terminal T 1/2 ranged from 20.6-34.6 h, with no accumulation and non-linear PK at the highest doses. Planned studies combining 7HP349 dosed at 100 mg and 300 mg/day x 5 (at a monotherapy safety margin of >10x) have the potential to augment immune checkpoint blockade without additional toxicity.
- | 7HP349 / 7 Hills Pharma
Preclinical, Journal, PD(L)-1 Biomarker, IO biomarker: LFA-1 activation enriches tumor-specific T cells in a cold tumor model and synergizes with CTLA-4 blockade. (Pubmed Central) - Jul 6, 2022
Here, we show that 7HP349, a small-molecule activator of lymphocyte function-associated antigen-1 (LFA-1) and very late activation antigen-4 (VLA-4) integrin cell-adhesion receptors, facilitated the preferential localization of tumor-specific T cells to the tumor and improved antitumor response...We identified baseline CXCL12 gene expression may improve response likelihood to anti-CTLA-4 therapies. Our results provided a proof-of-principle demonstration that LFA-1 activation could convert a T cell-exclusionary TME to a T-cell enriched TME through mechanisms involving cooperation with innate immune cells.
- ||| alintegimod (7HP349) / 7 Hills Pharma
Trial completion, Trial completion date, Trial primary completion date: A Phase 1 SAD and MAD Study of the Safety, Tolerability and PK of 7HP349 in Normal Healthy Male Subjects (clinicaltrials.gov) - Nov 2, 2021
P1, N=60, Completed, Sponsor: 7 Hills Pharma, LLC
Our results provided a proof-of-principle demonstration that LFA-1 activation could convert a T cell-exclusionary TME to a T-cell enriched TME through mechanisms involving cooperation with innate immune cells. Recruiting --> Completed | Trial completion date: Jun 2021 --> Oct 2021 | Trial primary completion date: Jun 2021 --> Oct 2021
- || 7HP349 / 7 Hills Pharma
Clinical, Journal: Use of a small molecule integrin activator as a systemically administered vaccine adjuvant in controlling Chagas disease. (Pubmed Central) - Sep 10, 2021
This demonstrates that 7HP349 can serve as a systemically administered adjuvant to enhance T cell-mediated immune responses to vaccines. This approach could be applied to numerous vaccines with no reformulation of existing stockpiles.
- ||| alintegimod (7HP349) / 7 Hills Pharma
Enrollment open: A Phase 1 SAD and MAD Study of the Safety, Tolerability and PK of 7HP349 in Normal Healthy Male Subjects (clinicaltrials.gov) - Oct 29, 2020
P1, N=68, Recruiting, Sponsor: 7 Hills Pharma, LLC
This approach could be applied to numerous vaccines with no reformulation of existing stockpiles. Not yet recruiting --> Recruiting
- | alintegimod (7HP349) / 7 Hills Pharma
New P1 trial: A Phase 1 SAD and MAD Study of the Safety, Tolerability and PK of 7HP349 in Normal Healthy Male Subjects (clinicaltrials.gov) - Aug 10, 2020
P1, N=68, Not yet recruiting, Sponsor: 7 Hills Pharma, LLC
- 7HP349 / 7 Hills Pharma
[VIRTUAL] 7 Hills Pharma () - Jun 9, 2020 - Abstract #BIO2020BIO_66;
7HP349 improves the effectiveness of immune checkpoint inhibitors for cancer, as well as vaccines for influenza, and COVID-19. 7HP349 is the only systemically safe adjuvant that can activate both cellular and humoral immunity.