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DRUG:

AIM-001

i
Other names: AIM-001, transgene-specific “smart” oncolytic virus therapeutic, transgene-specific smart oncolytic virus therapeutic, AdAPT-001
Associations
Company:
EpicentRx
Drug class:
Immunostimulant, TGF-β1 inhibitor
Related drugs:
Associations
17d
TGF-β trap of AdAPT-001 turns up the heat on tumors and turns down checkpoint blocker resistance. (PubMed, J Immunother Cancer)
AdAPT-001 is an oncolytic adenovirus that expresses a transforming growth factor beta (TGF-β) trap to neutralize active TGF-β. This editorial proposes that the TGF-β trap of AdAPT-001 reverses the immunosuppressive environment of tumor cells, and thus makes these tumors susceptible to CIs like the anti-PD-1 agent, nivolumab, and potentially other therapies as well.
Journal • Checkpoint inhibition • Checkpoint block
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TGFB1 (Transforming Growth Factor Beta 1)
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Opdivo (nivolumab) • AIM-001
5ms
Hypothesis: AdAPT-001 and pseudoprogression - when seeing is not necessarily believing. (PubMed, J Immunother Cancer)
PsP has also been described and documented in the context of oncolytic virotherapy but perhaps to a lesser extent. However, repeated intratumoral injections with these immunostimulatory agents may induce a more intense immune response and release more antigenic epitopes than with ICIs, for example, which are strictly T-cell directed rather than also tumor-directed like AdAPT-001.
Journal
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TGFB1 (Transforming Growth Factor Beta 1)
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AIM-001
8ms
BETA-PRIME: A Study of AdAPT-001 in Subjects With Sarcoma and Refractory Solid Tumors (clinicaltrials.gov)
P2, N=140, Recruiting, EpicentRx, Inc. | Trial completion date: Mar 2025 --> Mar 2027 | Trial primary completion date: Mar 2024 --> Dec 2025
Trial completion date • Trial primary completion date
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TGFB1 (Transforming Growth Factor Beta 1)
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AIM-001
9ms
BETA-PRIME: A Study of AdAPT-001 in Subjects With Sarcoma and Refractory Solid Tumors (clinicaltrials.gov)
P2, N=140, Recruiting, EpicentRx, Inc. | Phase classification: P1/2 --> P2 | N=79 --> 140
Phase classification • Enrollment change
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TGFB1 (Transforming Growth Factor Beta 1)
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AIM-001
1year
Data Management 101 for Drug Developers: A Peek Behind the Curtain. (PubMed, Clin Transl Sci)
For added color and context, the review includes real-world examples with RRx-001, a new molecular entity (NME) in Phase 3 and with fast-track status in head and neck cancer, and AdAPT-001, an oncolytic adenovirus armed with a transforming growth factor-beta (TGF-β) trap in a Phase 1/2 clinical trial with which the authors, as employees of the biopharmaceutical company, EpicentRx, are closely involved. An alphabetized glossary of key terms and acronyms used throughout this manuscript is also included for easy reference (See Table 1).
Journal
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TGFB1 (Transforming Growth Factor Beta 1)
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nibrozetone (RRx-001) • AIM-001
2years
BETA PRIME: Phase I study of AdAPT-001 as monotherapy and combined with a checkpoint inhibitor in superficially accessible, treatment-refractory solid tumors. (PubMed, Future Oncol)
AdAPT-001 also sensitized resistant tumors to checkpoint blockade. This manuscript describes the rationale and design of the first-in-human phase I, dose-escalation and dose-expansion study of AdAPT-001 alone and in combination with a checkpoint inhibitor in adults with treatment-refractory superficially accessible solid tumors.
P1 data • Review • Journal • Checkpoint inhibition
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TGFB1 (Transforming Growth Factor Beta 1)
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AIM-001
2years
Treatment of 4T1 breast cancer with liposome-encapsulated AdAPT-001, a TGF-beta trap encoded oncolytic adenovirus currently in a phase 1/2 anticancer trial (SABCS 2022)
Accordingly, we demonstrate a significant increase (P value= 0.0029) in the expression of green fluorescent protein (GFP) in CAR-negative 4T1 cells infected with the encapsulated AdAPT-001 adenovirus but not the unencapsulated AdAPT-001 adenovirus. Additional in vivo studies using nanoparticle encapsulated adenoviral vectors including AdAPT-001 to treat breast cancer are underway for rapid translation to the clinic.
P1/2 data • Oncolytic virus • IO biomarker
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HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor) • TGFB1 (Transforming Growth Factor Beta 1)
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AIM-001
2years
AdAPT-001, an oncolytic adenovirus armed with a TGF-β trap, overcomes in vivo resistance to PD-L1-immunotherapy. (PubMed, Am J Cancer Res)
In this paper we evaluated combination therapy with a Phase 1 oncolytic adenovirus called AdAPT-001, armed with a TGF-β "trap" that binds to and neutralizes the immunosuppressive cytokine, TGF-β, and a checkpoint inhibitor, anti-PD-L1, in PD-L1 resistant tumors. The study, which was performed in an immunocompetent syngeneic ADS-12 mouse model, demonstrated that the combination of AdAPT-001 with PD-L1 blockade reversed PD-L1 resistance, potentially representing a future paradigm shift for patients that are primarily or secondarily resistant to checkpoint inhibitors.
Preclinical • Journal • Oncolytic virus
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CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • TGFB1 (Transforming Growth Factor Beta 1)
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MSI-H/dMMR
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AIM-001
almost3years
Toxicology and biodistribution of AdAPT-001, a replication-competent type 5 adenovirus with a trap for the immunosuppressive cytokine, TGF-beta. (PubMed, Am J Cancer Res)
At clinically relevant doses, AdAPT-001 was safe and well tolerated. Systemic levels of the TGF-β trap transgene were observed from both local and intravenous dosing.
Journal
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TGFB1 (Transforming Growth Factor Beta 1)
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AIM-001