The goal of this interventional study is to evaluate the efficacy of APG-157 in combination with Bevacizumab in subjects with recurrent high-grade glioma. The main questions the study aims to answer are:
* Progression-free and overall survival of patients receiving this combination;
* Quality of Life (QOL); and
* Tumor response on imaging
The participants will take APG-157 daily by dissolving two pastilles in their mouth at around breakfast, lunch and dinner time (total of six pastilles per day). The pastilles dissolve in the mouth.
The participants will continue to receive Bevacizumab as standard of care.

开始日期2023-12-13

申办/合作机构

Aveta Biomics, Inc.初创企业

NCT05865028 / Recruiting临床2期IIT

Phase II A Proof of Concept Trial Investigating Safety and Efficacy of APG-157 in Oral Dysplasia

The purpose of this study is to assess whether APG-157 can reduce the tumor size in participants with the study disease. Another purpose is to find out about the effects of APG-157 on certain tumor markers and oral rinses in participants with the study disease.

开始日期2023-05-24

申办/合作机构

University of Miami

[+1]

NCT05312710 / Recruiting临床2期

Phase 2 Study to Evaluate the Safety and Efficacy of APG-157 as Neoadjuvant/Induction Therapy for Patients With Head and Neck Squamous Cell Cancer (HNSCC) of the Oral Cavity and/or Oropharynx

The purpose of this clinical research study is to study safety and efficacy of orally administered APG-157 as the neoadjuvant/induction therapy in newly diagnosed, locally advanced patients with Head & Neck Cancer of oral cavity and/or oropharynx.
The study hypothesis is that neoadjuvant use of APG-157 will reduce the tumor burden prior to any definitive therapy to improve the outcomes over current standard of care.

开始日期2022-04-22

申办/合作机构

Aveta Biomics, Inc.初创企业

100 项与 APG-157 相关的临床结果

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100 项与 APG-157 相关的转化医学

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100 项与 APG-157 相关的专利（医药）

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项与 APG-157 相关的文献（医药）

2020-04-15·Cancer1区 · 医学

A randomized, phase 1, placebo‐controlled trial of APG‐157 in oral cancer demonstrates systemic absorption and an inhibitory effect on cytokines and tumor‐associated microbes

1区 · 医学

Article

作者: Mudgal, Sharmila ; Basak, Saroj K. ; Yoon, Alexander J. ; Wang, Marilene B. ; Bera, Alakesh ; Shin, Daniel Sanghoon ; Mehta, Parag ; Nasser, Hassan ; Lagishetty, Venu ; Faull, Kym ; Morselli, Marco ; Tosevska, Anela ; Srivastava, Meera ; Guo, Rong ; Sajed, Dipti ; Pellegrini, Matteo ; Jeong, Chan ; Dong, Tien S. ; Eklund, Michael ; Jacobs, Jonathan ; Avila, Luis ; Srivatsan, Eri S. ; Russ, Eric

Background:

Although curcumin's effect on head and neck cancer has been studied in vitro and in vivo, to the authors' knowledge its efficacy is limited by poor systemic absorption from oral administration. APG‐157 is a botanical drug containing multiple polyphenols, including curcumin, developed under the US Food and Drug Administration's Botanical Drug Development, that delivers the active components to oromucosal tissues near the tumor target.

Methods:

A double‐blind, randomized, placebo‐controlled, phase 1 clinical trial was conducted with APG‐157 in 13 normal subjects and 12 patients with oral cancer. Two doses, 100 mg or 200 mg, were delivered transorally every hour for 3 hours. Blood and saliva were collected before and 1 hour, 2 hours, 3 hours, and 24 hours after treatment. Electrocardiograms and blood tests did not demonstrate any toxicity.

Results:

Treatment with APG‐157 resulted in circulating concentrations of curcumin and analogs peaking at 3 hours with reduced IL‐1β, IL‐6, and IL‐8 concentrations in the salivary supernatant fluid of patients with cancer. Salivary microbial flora analysis showed a reduction in Bacteroidetes species in cancer subjects. RNA and immunofluorescence analyses of tumor tissues of a subject demonstrated increased expression of genes associated with differentiation and T‐cell recruitment to the tumor microenvironment.

Conclusions:

The results of the current study suggested that APG‐157 could serve as a therapeutic drug in combination with immunotherapy.

Lay Summary:

Curcumin has been shown to suppress tumor cells because of its antioxidant and anti‐inflammatory properties. However, its effectiveness has been limited by poor absorption when delivered orally.Subjects with oral cancer were given oral APG‐157, a botanical drug containing multiple polyphenols, including curcumin. Curcumin was found in the blood and in tumor tissues. Inflammatory markers and Bacteroides species were found to be decreased in the saliva, and immune T cells were increased in the tumor tissue.APG‐157 is absorbed well, reduces inflammation, and attracts T cells to the tumor, suggesting its potential use in combination with immunotherapy drugs.

Frontiers in oncology

Cell-Free RNA as a Novel Biomarker for Response to Therapy in Head & Neck Cancer

Article

作者: Srivatsan, Eri S ; Pellegrini, Matteo ; Wang, Marilene B ; Basak, Saroj K ; Mehta, Parag ; Avila, Luis ; Tosevska, Anela ; Morselli, Marco

Liquid biopsies are gaining more traction as non-invasive tools for the diagnosis and monitoring of cancer. In a new paradigm of cancer treatment, a synergistic botanical drug combination (APG-157) consisting of multiple molecules, is emerging as a new class of cancer therapeutics, targeting multiple pathways and providing a durable clinical response, wide therapeutic window and high level of safety. Monitoring the efficacy of such drugs involves assessing multiple molecules and cellular events simultaneously. We report, for the first time, a methodology that uses circulating plasma cell-free RNA (cfRNA) as a sensitive indicator of patient response upon drug treatment. Plasma was collected from six patients with head and neck cancer (HNC) and four healthy controls receiving three doses of 100 or 200 mg APG-157 or placebo through an oral mucosal route, before treatment and on multiple points post-dosing. Circulating cfRNA was extracted from plasma at 0-, 3- and 24-hours post-treatment, followed by RNA sequencing. We performed comparative analyses of the circulating transcriptome and were able to detect significant perturbation following APG-157 treatment. Transcripts associated with inflammatory response, leukocyte activation and cytokine were upregulated upon treatment with APG-157 in cancer patients, but not in healthy or placebo-treated patients. A platelet-related transcriptional signature could be detected in cancer patients but not in healthy individuals, indicating a platelet-centric pathway involved in the development of HNC. These results from a Phase 1 study are a proof of principle of the utility of cfRNAs as non-invasive circulating biomarkers for monitoring the efficacy of APG-157 in HNC.

项与 APG-157 相关的新闻（医药）

2024-08-22

·avetabiomics.com

FDA Grants Fast Track Designation to Aveta Biomics’ Drug APG-157 for Neoadjuvant Treatment of Head and Neck Cancer

BOSTON, MASSACHUSETTS, UNITED STATES, August 22, 2024 /EINPresswire.com/ — – Aveta Biomics, a pioneering oncology company developing first-in-class oral immuno-oncology drugs, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to APG-157, its next-generation immuno-oncology drug, for the neoadjuvant treatment of Head and Neck Cancer (HNC). This designation underscores the potential of APG- 157 to address a significant unmet medical need in treating a highly challenging form of cancer. The FDA’s Fast Track Designation is intended to facilitate the development and to expedite the review of drugs aimed at treating serious conditions with unmet medical needs. This designation allows for more frequent interactions with the FDA, eligibility for rolling submissions for a marketing application, and potential Accelerated Approval, ultimately aiming to bring promising new treatments to patients more rapidly. “There is an urgent need for new treatments for head and neck cancer patients, many of whom face poor survival odds and considerable morbidities following current standard-of-care treatments, including surgery, radiotherapy, and chemotherapy/targeted treatments. The rare grant of Fast Track Designation for neoadjuvant treatment in Head and Neck Cancer underscores the FDA’s recognition of the potential role of APG-157 in providing meaningful treatment benefits to these patients,” said Parag Mehta, PhD, Chief Executive Officer of Aveta Biomics. Head and Neck Cancer affects approximately 900,000 people globally, with an overall five-year mortality rate of around 50%, a figure that has remained largely unchanged for decades. The molecular complexity of these tumors presents significant challenges for existing treatments, including targeted therapies. APG-157 is a first-in-class drug that acts through a dual mechanism: inducing selective apoptosis of cancer cells while also reprogramming the immune environment. “This Fast Track Designation, based on our comprehensive Phase 1 and Phase 2 data, accelerates our ability to bring our promising first-line therapy to all newly diagnosed, locally advanced Head and Neck Cancer patients in a frontline setting,” added Karim Malek, MD, MTh, MBA, Chief Medical Officer of Aveta Biomics. About Aveta Biomics: Aveta Biomics is an oncology company committed to developing next-generation of safer and highly effective cancer drugs based on mimicking the functions of body’s endogenous metabolites and processes. Aveta’s drugs stimulate the immune system to destroy cancer cells while sparing healthy cells. Aveta is conducting multiple clinical trials for head and neck cancer, high-grade adult glioma including Glioblastoma, and pre-clinical studies for pediatric glioma. For more information visit https://avetabiomics.com/ Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements, including those regarding the impact of the Fast Track Designation, the progress of our clinical trials, potential regulatory approvals, the development and commercial success of our drug candidates, and our strategic goals, reflect our current expectations and involve risks and uncertainties. Actual results may differ materially due to factors such as our ability to advance drug candidates through development and regulatory approval, clinical trial outcomes, competition, and economic conditions. Words like “may,” “will,” “could,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” and similar expressions are intended to identify forward-looking statements. These statements are based on current expectations and are subject to risks and uncertainties that could cause actual results to differ materially. We caution you not to place undue reliance on these statements, which speak only as of the date they are made. As a private company, we are under no obligation to publicly update or revise any forward-looking statements to reflect new information or future events, except as required by applicable law. Hema Gandhi Aveta Biomics, Inc betterhealth@avetabiomics.com

快速通道免疫疗法临床2期临床1期

100 项与 APG-157 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
多形性胶质母细胞瘤	临床2期	美国	Aveta Biomics, Inc.初创企业	2023-12-13
复发性恶性胶质瘤	临床2期	美国	Aveta Biomics, Inc.初创企业	2023-12-13
头颈部鳞状细胞癌	临床2期	美国	Aveta Biomics, Inc.初创企业	2022-04-22
口腔鳞状细胞癌	临床2期	美国	Aveta Biomics, Inc.初创企业	2022-04-22
口咽部鳞状细胞癌	临床2期	美国	Aveta Biomics, Inc.初创企业	2022-04-22
鳞状细胞癌	临床1期	-	University of California, Los Angeles	-

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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


ASCO2019 人工标引	临床1期	口腔鳞状细胞癌	15	APG-157 3x100 mg	壓願鬱網膚壓範蓋築衊(蓋鹽鹹遞範積鑰糧範鹹) = None 醖夢構憲範襯糧憲簾衊 (窪艱廠觸鬱鏇觸繭醖淵 )	积极	2019-05-26
				APG-157 3x200 mg