A Phase I, Open-label, Dose-finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TRX-920 Oral Gel (10 mg and 30 mg) in Patients With Advanced Solid Tumors

The study drug TRX-920 Oral Gel contains SN38, an active metabolite of Irinotecan (CPT-11), which is a widely prescribed anti-cancer drug that has been approved in many countries for the treatment of colorectal and pancreatic cancer. TRX-920 is the oral gel formulation that directly contains SN38 instead of Irinotecan. A series of biology and animal studies have demonstrated that the TRX-920 Oral Gel could inhibit tumor growth with fewer side effects compared to Irinotecan.

Start Date31 Oct 2023

Sponsor / Collaborator

TaiRx, Inc.

NCT05257590 / RecruitingPhase 2

A Phase 2, Open-Label Study of CVM-1118 in Combination With Nivolumab in Subjects With Unresectable Advanced Hepatocellular Carcinoma

CVM-1118 is a new small molecule chemical entity being developed as a potential anti-cancer therapeutic by TaiRx, Inc. CVM-1118 is a potent anti-cancer agent in numerous human cancer cell lines. The safety of administrating CVM-1118 on human has been evaluated from the phase 1 study. The objective of the phase 2 study is to further investigate the efficacy of CVM-1118 with nivolumab for subjects with unresectable advanced hepatoma.

Start Date23 May 2022

Sponsor / Collaborator

TaiRx, Inc.

NCT04336124 / CompletedPhase 1

A Phase I Safety and Pharmacokinetic Study of CVM-1118 Extended-Release Capsules Administered Orally to Patients With Advanced Cancers

CVM-1118 Immediate-release (IR) Capsule and CVM-1118 Extended-release (ER) Capsule are proprietary oncology products developed by TaiRx, Inc. for the treatment of patients suffering from advanced cancer. Due to the short elimination half-life of CVM-1118 IR capsules, the extended release (ER) formulation, containing mini-tablets in hard capsule, has been developed to prolong the drug absorption and longer exposure after oral administration. The designed dose of CVM-1118 ER was 200 mg per capsule to provide a more patient-compliant and safe dosage of CVM-1118. The clinical study CVMEX-001 is therefore designed to evaluate the safety and pharmacokinetics of CVM-1118 extend release (ER) Capsule (200 mg/capsule) in patients with advanced cancer.

Start Date25 May 2020

Sponsor / Collaborator

TaiRx, Inc.

100 Clinical Results associated with TaiRx, Inc.

0 Patents (Medical) associated with TaiRx, Inc.

Literatures (Medical) associated with TaiRx, Inc.

10 Aug 2024·Journal of Clinical Oncology

CVM-1118: An oral anti-vasculogenic mimicry (VM) agent in combination with nivolumab in patients with unresectable advanced hepatocellular carcinoma (HCC)—A phase IIa study.

Author: Chen, Yen-Ling ; Melink, Teresa J. ; Yen, Chia Jui ; Chen, Chun-Man ; Gutheil, John ; Yeh, Kun-Yun ; Chu, Yi-Wen ; Chao, Ting-Yu (Tiffany) ; Chien, Du-Shieng ; Lu, Sheng-Nan ; Huang, Yi-Hsiang ; Chen, Pei-Jer

92 Background: CVM-1118 is a potent anti-tumor new chemical entity with multiple mechanisms of action including induction of apoptosis, cell cycle arrest, and inhibition of VM network formation. This study evaluated the anti-tumor effect and safety profile of CVM-1118 plus nivolumab in patients with progressive unresectable advanced HCC following the first-line therapy with TKIs. Methods: Eligible pts had unresectable advanced HCC and were refractory to prior systemic therapy (e.g., sorafenib, lenvatinib, regorafenib, and/or ramucirumab), with the exception of prior immunotherapy. Patients received oral CVM-1118 at 200 mg BID (400 mg daily) in combination with intravenous nivolumab at 240 mg Q2W in 28-day cycles. The primary endpoint of objective response rate was evaluated using mRECIST. The secondary endpoints were overall response rate (ORR) (per RECIST 1.1), progression free survival (PFS), disease control rate (DCR), and duration of overall response (DoR). Results: A total of 31 evaluable pts were enrolled (25 M/6 F; median age 65 y, range 44–80 y). All patients were Child Pugh A, BCLC stage B (13%, n=4) or C (87%, n=27) at the start of treatment. The median number of prior lines of therapy was 1 (range 1–2). The duration of CVM-1118 and nivolumab treatment ranged from 1.5–17.7 mos (median 3.1 mos) with 5/31 (16%) pts remaining on treatment for ≥ 5.2 mos (range 5.2–17.7 mos). The best ORR was 19.4% (mRECIST) (2 CR (6%), 4 PR (13%)), with remaining responses including 11 SD (36%) and 14 PD (45%). The DCR was 54.8% (95% CI 37.3–72.3%), the median PFS was 3.53 mos (95% CI 1.9–5.4 mos) and the median DoR was 12.1 mos (95% CI 5.2–16.1 mos). The most common treatment-related AEs ³ grade 3 included AST increased (12.9%), neutrophil count decreased (9.7%), anemia (6.5%), and WBC decreased (6.5%). As opposed to therapy with atezolizumab plus bevacizumab, gastrointestinal hemorrhage and hypertension were not observed in this study. Pharmacokinetics data demonstrated that CVM-1118 was rapidly metabolized to CVM-1125 in all pts following administration. On Day 1, the mean drug exposure of CVM-1125 was Cmax 564 ng/mL and the AUC0-24 was 2154 ng·hr/mL. Intersubject variability of drug exposure appeared to be high; the T1/2 of CVM-1125 was ~1.7 hr. Conclusions: CVM-1118 combined with nivolumab demonstrated clinical activity in advanced HCC pts with a safety profile that appears favorable compared to atezolizumab plus bevacizumab. These data support further development of the combination of CVM-1118 and nivolumab in pts with unresectable advanced HCC. Clinical trial information: NCT05257590 .

01 Jun 2023·Journal of Clinical Oncology

CVM-1118: A potent oral anti-vasculogenic mimicry (VM) agent in patients with advanced neuroendocrine tumors (NETs)—A phase IIa study.

Author: Chen, Ming Huang ; Gutheil, John ; Melink, Teresa J. ; Chen, Chun-Man ; Bai, Li-Yuan ; Chien, Du-Shieng ; Shih, Yu-Hsuan ; Chu, Yi-Wen ; Chen, Yen-Ling ; Su, Wu-Chou ; Wu, I-Chen ; Chen, Yen-Yang ; Chen, Jen-Shi

e16235 Background: CVM-1118 is a potent anti-tumor new chemical entity with multiple mechanisms of action including induction of apoptosis, cell cycle arrest, and inhibition of VM network formation. The Phase I trial in Asia determined an MTD of 600 mg daily (300 mg BID) with a favorable safety profile. The best response was stable disease with measurable tumor reduction in one patient with NET. We present preliminary results for this ongoing Phase IIa study. Methods: Eligible patients had advanced NETs (low/intermediate grade lung or WHO grade 1 or 2 gastrointestinal or pancreatic origin) which were refractory to standard of care therapy and progressed within 6 months prior to screening. Patients received oral CVM-1118 at 200 to 300 mg BID (400 to 600 mg daily) in 28-day cycles. Pharmacokinetics (PK) was assessed. The primary endpoint was progression-free survival (PFS) and secondary endpoints were objective response rate (ORR), disease control rate (DCR), duration of overall response (DoR), time-to-progression (TTP), and overall survival (OS). Planned enrollment is 33 evaluable patients. Results: As of February 10, 2023, 30 patients were enrolled, of which 21 evaluable patients (12 M/9 F; median age 61 y, range 37–82 y) were predominately grade 2 pNET (12/21, 57%) or GI NET (8/21, 38%). The majority (14/21, 67%) had disease progression after prior treatment with chemotherapy or small molecule inhibitor (median of 1 prior therapy). The duration of CVM-1118 treatment ranged from 1.4–34.6 mos (median 3.8 mos) with 4/21 (19%) patients remaining on treatment for more than 20 mos (range 22–34 mos). The median PFS was 6.9 mos (95% CI 3.3–10.3 mos), which exceeded the historical estimate for PFS of 4–6 mos (Raymond et al., 2011; Yao et al., 2016). The 8-mo and 12-mo PFS rates were 42% (95% CI 25–64%) and 29% (95% CI 14–50%), respectively. The DCR was 66.7% (95% CI 45–83%) with an ORR of 4.8% (1 PR with ongoing tumor reduction of 46% in pNET group). The most common treatment-related AEs ≥ grade 3 included ALT/AST increased (3.3%), diarrhea (3.3%), anemia (3.3%), neutrophil count decreased (3.3%), and tumor lysis syndrome (3.3%). No CVM-1118-related SAEs were reported. PK results showed CVM-1118 was rapidly metabolized to the active metabolite CVM-1125 in all patients following oral dosing. On Day 1, the mean drug exposure of CVM-1125 was Cmax 418 ng/mL and AUC0-24 2170 ng·hr/mL. Intersubject variability of drug exposure appeared to be high; the T1/2 of CVM-1125 was ~2.2 hr. No clear correlation between drug exposure and adverse effects or tumor reduction was observed. Conclusions: CVM-1118 has demonstrated a durable DCR with acceptable safety and tolerability. PK results showed good drug exposure with T1/2 of CVM-1125 ~2.2 hr. These data support future studies in patients with advanced NETs. Raymond E et al., 2011. N Eng J Med 364(6): 501-513. Yao JC et al., 2016. Lancet 387(10022): 968-977. Clinical trial information: NCT03600233 .

01 May 2019·MedicineQ4 · MEDICINE

Epidemiology of sepsis in Taiwan

Q4 · MEDICINE

ArticleOA

Author: Chen, Jin-Hua ; Chen, Fu-Lun ; Chien, Du-Shieng ; Chen, Yen-Ling ; Ko, Yu ; Wu, Man-Tzu Marcie ; Chen, Yen-Jung

AbstractTo investigate the epidemiology trend and characteristics of sepsis-related hospitalizations in Taiwan, and to compare the differences among different severity levels of sepsis.This study is a retrospective national claim database analysis. Hospitalized adult patients with sepsis between 2010 and 2014 were identified from the Two-Million-Sample Longitudinal Health and Welfare Database (LHWD) by the International Classification of Diseases 9th Edition Clinical Modification (ICD-9-CM). The patients were divided into 3 severity groups based on their medical records during hospitalization.The study results showed that in Taiwan, there were 643 new cases of sepsis in 100,000 Taiwanese. The mortality of all septic patients in Taiwan was 287 per 100,000 people, and the case fatality was 29.2%. It was found that the mortality and incidence of sepsis in Taiwan have increased year by year, but there has been no significant change over time. In addition, demographic variation exists in the epidemiology of sepsis. In all the rates investigated, the men's were higher than the women's and the elderly's were higher than the youths’. The analysis results also showed that the respiratory system was the most common site of organ failure in septic patients.The incidence and mortality of any severity level of sepsis were 643, and 287 per 100,000 people in Taiwan, respectively, and the average case fatality was 29.2% during the study period (2010–2014). The respiratory system was the major infected site and site of organ dysfunction, especially in the more severe levels.

News (Medical) associated with TaiRx, Inc.

22 Jun 2023

·www.prnewswire.com

Global Cancer Diagnostics Partnering Deal Terms and and Agreement Analysis Report 2023: Access to Over 900 - Access to Company A-Z, Headline, Upfront, Milestone, Upfront and Royalty Data

DUBLIN, June 22, 2023 /PRNewswire/ -- The "Global Cancer Diagnostics Partnering Terms and Agreements 2016-2023" report has been added to ResearchAndMarkets.com's offering. The Global Cancer Diagnostics Partnering Terms and Agreements 2016-2023 report provides an understanding and access to over 900 cancer diagnostics partnering deals and agreements entered into by the worlds leading healthcare companies. This report provides details of the latest cancer diagnostics agreements announced in the life sciences since 2016. The report takes the reader through a comprehensive review cancer diagnostics deal trends, key players, top deal values, as well as deal financials, allowing the understanding of how, why and under what terms, companies are entering cancer diagnostics partnering deals. The report presents financial deal term values for cancer diagnostics deals, listing by headline value, upfront payments, milestone payments and royalties, enabling readers to analyse and benchmark the financial value of deals. The middle section of the report explores the leading dealmakers in the cancer diagnostics partnering field; both the leading deal values and most active cancer diagnostics dealmaker companies are reported allowing the reader to see who is succeeding in this dynamic dealmaking market. One of the key highlights of the report is that over 900 online deal records of actual cancer diagnostics deals, as disclosed by the deal parties, are included towards the end of the report in a directory format - by company A-Z, stage of development, deal type, therapy focus, and technology type - that is easy to reference. Each deal record in the report links via Weblink to an online version of the deal. In addition, where available, records include contract documents as submitted to the Securities Exchange Commission by companies and their partners. Whilst many companies will be seeking details of the payment clauses, the devil is in the detail in terms of how payments are triggered - contract documents provide this insight where press releases and databases do not. The initial chapters of this report provide an orientation of cancer diagnostics dealmaking. Chapter 1 provides an introduction to the report, whilst chapter 2 provides an overview of the trends in cancer diagnostics dealmaking since 2016, including details of headline, upfront, milestone and royalty terms. Chapter 3 provides a review of the leading cancer diagnostics deals since 2016. Deals are listed by headline value. Where the deal has an agreement contract published at the SEC a link provides online access to the contract. Chapter 4 provides a comprehensive listing of the top 25 most active companies in cancer diagnostics dealmaking with a brief summary followed by a comprehensive listing of cancer diagnostics deals announced by that company, as well as contract documents, where available. Chapter 5 provides a comprehensive and detailed review of cancer diagnostics partnering deals signed and announced since Jan 2016, where a contract document is available in the public domain. Each deal title links via Weblink to an online version of the deal record and contract document, providing easy access to each contract document on demand. Chapter 6 provides a comprehensive and detailed review of cancer diagnostics partnering deals signed and announced since Jan 2016. The chapter is organized by specific cancer diagnostics technology type. Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each deal on demand. A comprehensive series of appendices is provided organized by cancer diagnostics partnering company A-Z, stage of development, deal type, and therapy focus. Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each deal on demand. In conclusion, this report provides everything a prospective dealmaker needs to know about partnering in the research, development and commercialization of cancer diagnostics technologies and products. Key benefits Global Cancer Diagnostics Partnering Terms and Agreements 2016-2023 provides the reader with the following key benefits: In-depth understanding of cancer diagnostics deal trends since 2016 Access to headline, upfront, milestone and royalty data Detailed access to actual cancer diagnostics contracts entered into by leading biopharma companies Identify most active cancer diagnostics dealmakers since 2016 Insight into terms included in a cancer diagnostics partnering agreement, with real world examples Understand the key deal terms companies have agreed in previous deals Undertake due diligence to assess suitability of your proposed deal terms for partner companies In Global Cancer Diagnostics Partnering Terms and Agreements 2016-2023, the available deals are listed by: Company A-Z Headline value Stage of development at signing Deal component type Specific therapy target Technology type Analyzing actual contract agreements allows assessment of the following: What are the precise rights granted or optioned? What is actually granted by the agreement to the partner company? What exclusivity is granted? What is the payment structure for the deal? How are sales and payments audited? What is the deal term? How are the key terms of the agreement defined? How are IPRs handled and owned? Who is responsible for commercialization? Who is responsible for development, supply, and manufacture? How is confidentiality and publication managed? How are disputes to be resolved? Under what conditions can the deal be terminated? What happens when there is a change of ownership? What sublicensing and subcontracting provisions have been agreed? Which boilerplate clauses does the company insist upon? Which boilerplate clauses appear to differ from partner to partner or deal type to deal type? Which jurisdiction does the company insist upon for agreement law? Partial list of companies featured Aetna Amgen Angle Axela Bayer BL&H Ceres COTA CSIRO Cypre D-Eye Dako Dell Eigen Falco Fscan GIMDx Glide Grail IBM iCAD IPMD Item KEW Lab21 Mavig Medx MIODx NASA Ochin Orot+ RAW Roche Sebia Seer TaiRx Take2 Telik UPMC ZoBio For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

100 Deals associated with TaiRx, Inc.

100 Translational Medicine associated with TaiRx, Inc.

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