AdAPT-001 is an oncolytic virus that is injected directly into the tumor or via intraarterial administration. The purpose of this study is to find out if AdAPT-001 is safe and tolerable. The next step is to find out if AdAPT-001 if efficacious with or without a checkpoint inhibitor.

开始日期2021-03-29

申办/合作机构

EpicentRx, Inc.

100 项与 AIM-001 相关的临床结果

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100 项与 AIM-001 相关的转化医学

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100 项与 AIM-001 相关的专利（医药）

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项与 AIM-001 相关的文献（医药）

2023-09-01·Clinical and translational science

Data Management 101 for drug developers: A peek behind the curtain.

Review

作者: Oronsky, Bryan ; Williams, Jeannie ; Caroen, Scott ; Abrouk, Nacer ; Stirn, Meaghan ; Coyle, Angelique ; Burbano, Erica ; Cabrales, Pedro ; Brechlin, Joanne ; Reid, Tony R

In drug development a frequently used phrase is "data-driven". Just as high-test gas fuels a car, so drug development "runs on" high-quality data; hence, good data management practices, which involve case report form design, data entry, data capture, data validation, medical coding, database closure, and database locking, are critically important. This review covers the essentials of clinical data management (CDM) for the United States. It is intended to demystify CDM, which means nothing more esoteric than the collection, organization, maintenance, and analysis of data for clinical trials. The review is written with those who are new to drug development in mind and assumes only a passing familiarity with the terms and concepts that are introduced. However, its relevance may also extend to experienced professionals that feel the need to brush up on the basics. For added color and context, the review includes real-world examples with RRx-001, a new molecular entity in phase III 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 I/II 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 review is also included for easy reference.

2022-09-01·Future oncology (London, England)

BETA PRIME: Phase I study of AdAPT-001 as monotherapy and combined with a checkpoint inhibitor in superficially accessible, treatment-refractory solid tumors

Article

作者: Kesari, Santosh ; Caroen, Scott ; Madere, DeLisa ; Nabell, Lisle M ; Gastman, Brian R ; Oronsky, Bryan ; Villaflor, Victoria M ; Li, Li ; Barve, Minal A ; Stirn, Meaghan ; Bessudo, Alberto ; Conley, Anthony P ; Reid, Tony ; Williams, Jeannie ; Spencer, Christina ; Larson, Christopher ; Chacon, Emma

AdAPT-001 is an investigational therapy consisting of a replicative type 5 adenovirus armed with a TGF-β receptor-immunoglobulin Fc fusion trap, designed to neutralize isoforms 1 and 3 of the profibrotic and immunosuppressive cytokine, TGF-β. In preclinical studies with an immunocompetent mouse model, AdAPT-001 eradicated directly treated ‘cold’ tumors as well as distant untreated tumors, and, from its induction of systemic CD8+ T cell-mediated antitumor immunity, protected the mice from rechallenge with tumor cells. 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.

2022-01-01·American journal of cancer research

AdAPT-001, an oncolytic adenovirus armed with a TGF-β trap, overcomes in vivo resistance to PD-L1-immunotherapy.

Article

作者: Oronsky, Bryan ; Larson, Christopher ; Reid, Tony

Monoclonal antibodies targeting the programmed cell death protein-1/programmed cell death-ligand 1 (PD-1/PD-L1) and cytotoxic T lymphocyte-associated protein-4 (CTLA-4) axes have permanently changed the therapeutic landscape for multiple tumor types previously associated with a dismal prognosis such as melanoma, non-small cell lung cancer, renal cell carcinoma, bladder cancer, head and neck squamous cell carcinoma, MSI-high colorectal carcinoma, Merkel cell carcinoma, and Hodgkin lymphoma. However, only a subset of patients initially benefits from these inhibitors, and increasing clinical experience indicates that in a substantial proportion of initial responders, lethal secondary resistance ultimately develops months or years later. 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.

项与 AIM-001 相关的新闻（医药）

2024-05-23

·PRNewswire

EpicentRx Announces Oral Presentation for the Most Clinically Advanced TGF-β Ligand Trap, AdAPT-001, at the Upcoming 2024 ASCO Annual Meeting

Data affirm positive immune effects of AdAPT-001 plus a checkpoint inhibitor in sarcomas and triple negative breast cancer with established checkpoint-inhibitor resistance The paucity of immune related adverse events suggests that AdAPT-001 may protect against them. TORREY PINES, Calif., May 23, 2024 /PRNewswire/ -- EpicentRx, a clinical-stage biopharmaceutical company, announced that The American Society of Clinical Oncology (ASCO) has invited Dr. Anthony P. Conley, an MD Anderson Cancer Center (MDACC) Sarcoma Specialist and Lead PI, to give an oral presentation on the unprecedented clinical activity of AdAPT-001 plus an immune checkpoint inhibitor (ICI) in the ongoing Phase 2 open-label BETA PRIME clinical trial that has so far enrolled close to 70 patients. This activity includes complete responses and several durable partial responses in established checkpoint inhibitor-resistant tumor types like sarcoma and triple negative breast cancer, with some patients on treatment for nearly two years. To date, no dose-limiting toxicities or AdAPT-001 related serious adverse events have occurred and only one immune related adverse event (irAE) has been reported. This lack of irAEs suggests that AdAPT-001 may prevent or attenuate ICI-mediated immune attack on normal tissues but not cancerous ones. Lead EpicentRx therapy, AdAPT-001, is the most clinically advanced TGF-β ligand trap that antagonizes the immunosuppressive effects of TGF-β and augments responses to ICIs, even ICIs which patients previously failed. BETA PRIME is a multicenter Phase 2a clinical trial led by Dr. Anthony P. Conley from MDACC and Dr. Lucy B. Kennedy from the Cleveland Clinic. AdAPT-001 is dosed every two weeks in combination with an ICI. "This is incredibly exciting news to have been selected for an oral presentation at ASCO, where the most important trials are presented, discussed, and reviewed," said lead PI, Dr. Anthony P. Conley. "It is a great honor and an indication of the activity, safety, and tolerability of AdAPT-001 in combination with a checkpoint inhibitor. Credit to our clinical trial patients, the EpicentRx team and everyone from MDACC associated with the management of the BETA PRIME clinical trial." The abstract is available on ASCO.org/abstracts. Presentation details: Abstract Number for Publication: 2506 Abstract Title: Phase 1/2 study of the TGF-β-trap-enhanced oncolytic adenovirus, AdAPT-001, plus an immune checkpoint inhibitor for patients with immune refractory cancers. Session Type and Title: Oral Abstract Session – Developmental Therapeutics - Immunotherapy About AdAPT-001 AdAPT-001 is an investigational immunotherapy with a TGF-β receptor-immunoglobulin Fc fusion trap, designed to neutralize isoforms 1 and 3 of the profibrotic, proangiogenic, prohypoxic, and immunosuppressive cytokine, TGF-β, and to sensitize resistant tumors to checkpoint blockade. It is the most clinically advanced TGF-β ligand trap in development. In the ongoing Phase 2 BETA PRIME trial, AdAPT-001 was administered as single-agent and in combination with checkpoint inhibitors to patients with treatment-refractory tumors. Importantly, AdAPT-001 plus checkpoint inhibitors improved toxicity and AE profile over what is typically observed with checkpoint inhibitors. No dose limiting toxicities, AdAPT-001 related serious adverse-events, or dose reductions have been observed to date. About EpicentRx EpicentRx is at the epicenter of innovative drug development with therapies like AdAPT-001 and RRx-001 that target diseases and toxicities of hugely unmet medical need. For more information about the trial and EpicentRx's pipeline, please visit . Business Development Contact: Sa'ar Yaniv EpicentRx [email protected] Media Contact: Ashley Thomaz MCS Healthcare Public Relations [email protected] SOURCE EpicentRx, Inc.

免疫疗法临床2期ASCO会议

2024-04-02

·PRNewswire

EpicentRx to Present Positive Phase 2a Clinical Data with its AdAPT-001 TGF-β Trap Program in Checkpoint Inhibitor Resistant Patients at the 2024 AACR Meeting

Compelling clinical data demonstrate that AdAPT-001, which delivers a TGF-β trap to tumors, reverses established resistance to checkpoint inhibitors and makes checkpoint inhibitors more active SAN DIEGO, April 2, 2024 /PRNewswire/ -- EpicentRx, Inc, a clinical-stage biotechnology drug and device company with two therapeutic platforms that address cancer and inflammatory diseases of unmet clinical need, today announced that an abstract on its lead therapy, AdAPT-001, will be presented at the American Association for Cancer Research (AACR) Annual Meeting to be held in San Diego, CA from April 5-10, 2024. AdAPT-001 constitutes a novel strategy to deliver a transforming growth factor-beta (TGF-β) trap to tumors. Importantly, data from a Phase 1/2 clinical trial demonstrate that administration of AdAPT-001 successfully converted immunologically cold tumors, such as sarcomas and triple negative breast cancer, into immunologically hot tumors. Furthermore, AdAPT-001 administration also demonstrates reversion of established resistance to checkpoint inhibitors. "We're excited to share groundbreaking clinical data with our lead therapy, AdAPT-001, against several treatment- and checkpoint inhibitor resistant solid tumors," said Tony R. Reid, MD, PhD, CEO of EpicentRx. "We're also thrilled to be working with top-notch investigators like Dr. Anthony P. Conley from the MD Anderson Cancer Center and Dr. Lucy B. Kennedy from the Cleveland Clinic." "Immune checkpoint inhibitors are largely ineffective against sarcomas. TGF-β is a soluble protein that suppresses immune responses," said treating study investigator and sarcoma oncologist, Dr. Conley from the MD Anderson Cancer Center. "Based on the several unprecedented responses that I have seen with AdAPT-001, which expresses a TGF-β trap, this TGF-β blockade from AdAPT-001 synergizes with PD-1/PD-L1 inhibition in checkpoint-resistant sarcoma." Poster Presentation: Title: Improved clinical outcomes in patients that received treatment beyond tumor progression with AdAPT-001 +/- a checkpoint inhibitor Presenters: Dr. Anthony P. Conley of MD Anderson Cancer Center and Drs Tony Reid (CEO) and Chris Larson (VP) of EpicentRx. Date and Time: Tuesday, April 9, 2024, 1:30 PM - 5:00 PM PDT Location: Poster Section 48 Poster Number: 23 About AdAPT-001 AdAPT-001 is an investigational immunotherapy with a TGF-β receptor-immunoglobulin Fc fusion trap, designed to neutralize isoforms 1 and 3 of the profibrotic, proangiogenic, prohypoxic, and immunosuppressive cytokine, TGF-β, and to sensitize resistant tumors to checkpoint blockade. In the ongoing Phase 1/2 BETA PRIME trial, AdAPT-001 was administered as single-agent and in combination with checkpoint inhibitors to patients with treatment-refractory tumors. Importantly, AdAPT-001 plus checkpoint inhibitors improved toxicity and AE profile over what is typically observed with checkpoint inhibitors. No dose limiting toxicities, AdAPT-001 related serious adverse events, or dose reductions have been observed to date. About EpicentRx To learn more, visit . Media contact: Jennifer Latchford, [email protected] SOURCE EpicentRx, Inc.

临床2期AACR会议免疫疗法临床结果

2024-02-13

·FierceBiotech

Japan's Ono Pharma taps Texas startup Shattuck for $227M bifunctional fusion protein deal

Ono will select a pair of targets from Shattuck’s portfolio of bifunctional fusion proteins. Shattuck Labs’ pipeline of bifunctional fusion proteins has caught the attention of Ono Pharmaceutical, with the Japanese drug developer penning a $227 million biobucks deal focused on autoimmune and inflammatory diseases. Under the agreement, Ono will select a pair of targets from Shattuck’s portfolio with an exclusive option to develop and commercialize “multiple products.” In return, Texas-based Shattuck will receive an undisclosed upfront payment and be in line for licensing, regulatory and commercial milestones which could add up to $227 million in total, along with tiered royalties on any approved products. “We have prioritized autoimmune and inflammatory diseases for a select group of preclinical pipeline candidates as we continue to expand into areas of high unmet need,” Shattuck’s CEO Taylor Schreiber, M.D., Ph.D., explained in the release. “This collaboration aligns with our strategy to unlock further value from our bifunctional fusion protein platform and scientific expertise.” Bifunctional proteins have attracted Big Pharma interest in the past, with GSK and Merck KGaA partnering up to work on bintrafusp alfa in 2019. Those efforts, designed to combine a TGF-β trap with the anti-PD-L1 mechanism in one fusion protein, ended in a high-profile failure two years later and the collaboration was dissolved in the wake of a series of clinical setbacks. Still, Ono—which co-developed Bristol Myers Squibb’s blockbuster PD-1 drug Opdivo—appears to see potential in the modality. Toichi Takino, senior executive officer for discovery and research at the company, expressed admiration for Shattuck’s “generation of functional biologics against therapeutic targets that have been difficult through conventional technologies.” “We hope to add bifunctional fusion proteins discovered and developed by Shattuck into our portfolio to bring innovative drugs for patients suffering from autoimmune and inflammatory diseases as soon as possible,” Takino added.

引进/卖出蛋白降解靶向嵌合体

100 项与 AIM-001 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
软骨肉瘤	临床2期	美国	EpicentRx, Inc.	2021-03-29
软组织肉瘤	临床2期	美国	EpicentRx, Inc.	2021-03-29

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04673942 (ASCO2024) 人工标引	临床2期	肿瘤	36	AdAPT-001 monotherapy	廠夢遞觸選鹽範衊遞願(壓顧淵選網襯齋鹹壓築) = 蓋遞淵顧憲淵顧鬱選壓獵簾顧範構膚積餘淵衊 (觸鏇觸網壓艱構鹽觸艱 ) 更多	积极	2024-05-24
NCT04673942 (ASCO2024) 人工标引	临床2期	肿瘤	36	AdAPT-001 + CI combination	廠夢遞觸選鹽範衊遞願(壓顧淵選網襯齋鹹壓築) = 艱遞構築衊糧製獵廠遞獵簾顧範構膚積餘淵衊 (觸鏇觸網壓艱構鹽觸艱 ) 更多	积极	2024-05-24
AACR2024 人工标引	临床2期	肿瘤	36	AdAPT-001 +/- ICI	鹹淵鑰鏇壓構糧觸衊簾(窪淵鑰製願膚窪簾蓋窪) = 衊憲膚構遞膚鹽繭鑰鏇蓋鬱餘齋夢餘艱衊範衊 (窪簾憲範築襯製繭簾淵 ) 更多	积极	2024-04-05
NCT04673942 (BETA-PRIME, ASCO2023) 人工标引	临床1期	实体瘤	19	AdAPT-001	壓製獵顧積淵鏇觸鏇廠(餘襯艱窪衊壓鑰網艱鹽) = 膚鑰鹽鑰淵遞醖衊獵顧膚獵範醖餘獵鹹糧艱鬱 (願觸築襯簾憲獵鑰鏇繭 ) 更多	积极	2023-05-26