An Open-Label Study of the Effect of Tesetaxel on the QTc Interval and the Effect of Food, Itraconazole, and Rifampin on Tesetaxel Pharmacokinetics in Patients With Advanced Solid Tumors

This is a 3-cohort, multicenter, Phase 1 study of the effect of tesetaxel, an investigational, orally administered taxane, on the corrected QT (QTc) interval and the potential effect of food, a cytochrome P450 (CYP) 3A inhibitor (itraconazole), and a CYP3A inducer (rifampin) on tesetaxel pharmacokinetics (PK) in adult patients with advanced solid tumors.

Start Date06 Mar 2020

Sponsor / Collaborator

Odonate, Inc.

NCT03952325

/ TerminatedPhase 2

A Multicenter, Phase 2 Study of Tesetaxel Plus Three Different PD-(L)1 Inhibitors in Patients With Triple-Negative, Locally Advanced or Metastatic Breast Cancer and Tesetaxel Monotherapy in Elderly and Non-Elderly Adult Patients With HER2-Negative, Locally Advanced or Metastatic Breast Cancer

CONTESSA TRIO is a multi-cohort, multicenter, Phase 2 study of tesetaxel, an investigational, orally administered taxane, in patients with metastatic breast cancer (MBC). In Cohort 1, approximately 200 patients with triple-negative MBC who have not received prior chemotherapy for advanced disease will be randomized 1:1:1 to receive tesetaxel plus either: (1) nivolumab; (2) pembrolizumab; or (3) atezolizumab. The primary efficacy endpoints for Cohort 1 are objective response rate (ORR) and progression free survival (PFS) in patients with programmed death-ligand 1 (PD-L1) positive status. In Cohort 2, approximately 60 elderly patients with human epidermal growth factor receptor 2 (HER2) negative MBC who have not received prior chemotherapy for advanced disease will receive tesetaxel monotherapy. The primary efficacy endpoints for Cohort 2 are ORR and PFS in patients with hormone receptor (HR)-positive, HER2-negative disease. In Cohort 3, approximately 60 non-elderly adult patients with HER2-negative MBC who have not received prior chemotherapy for advanced disease will receive tesetaxel monotherapy. The primary efficacy endpoints for Cohort 3 are ORR and PFS in patients with HR positive, HER2-negative disease.

Start Date09 Jul 2019

Sponsor / Collaborator

Odonate, Inc.

NCT03858972

/ TerminatedPhase 2

Multinational, Multicenter, Phase 2 Study of Tesetaxel Plus a Reduced Dose of Capecitabine in Patients With HER2 Negative, Hormone Receptor Positive, Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Received a Taxane

CONTESSA 2 is a multinational, multicenter, Phase 2 study of tesetaxel in patients with HER2 negative, HR positive, locally advanced or metastatic breast cancer (LA/MBC) not previously treated with a taxane. The primary objective of the study is to establish the efficacy of tesetaxel plus a reduced dose of capecitabine based on objective response rate (ORR) as assessed by an Independent Radiologic Review Committee (IRC). 152 patients were enrolled.

Start Date05 Feb 2019

Sponsor / Collaborator

Odonate, Inc.

100 Clinical Results associated with Tesetaxel

100 Translational Medicine associated with Tesetaxel

100 Patents (Medical) associated with Tesetaxel

Literatures (Medical) associated with Tesetaxel

01 Apr 2013·Clinical investigation

Novel oral taxane therapies: recent Phase I results

Article

Author: Flores, John Paul ; Saif, M Wasif

The oral taxanes are analogues of existing taxanes with a possible broad range of antitumor activity. They also have the potential advantages of ease of administration, better efficacy and lesser toxicity than currently available taxanes. These drugs have been used in several Phase I clinical trials, the methodology and results of which will be reviewed here.

01 Dec 2011·Cancer chemotherapy and pharmacologyQ4 · MEDICINE

Tesetaxel, a new oral taxane, in combination with capecitabine: a phase I, dose-escalation study in patients with advanced solid tumors

Q4 · MEDICINE

Article

Author: Patnaik, Amita ; Tolcher, Anthony W. ; Takimoto, Chris ; Saif, Muhammad Wasif ; Sarantopoulos, John ; Beeram, Murali

PURPOSE:

This phase I study was conducted primarily to determine the maximum tolerated dose (MTD) of tesetaxel, a novel, orally active, semisynthetic microtubule inhibitor of the taxane class, administered with oral capecitabine to patients with advanced solid tumors.

METHODS:

During each 21-day cycle, patients were to receive tesetaxel on Day 1 and capecitabine twice daily on Days 1 through 14. The starting dose was tesetaxel 18 mg/m(2) and capecitabine 1,250 mg/m(2)/day. These doses were increased based on tolerability during the first cycle according to the protocol-specified dose-escalation scheme. Response was evaluated every other treatment cycle according to RECIST. Serial blood samples were collected during the first and second cycles to explore possible pharmacokinetic drug interactions.

RESULTS:

Twenty-seven patients were enrolled and treated. The most frequently reported dose-limiting toxicities were neutropenia and febrile neutropenia, with individual patients experiencing dose-limiting stomatitis and diarrhea. The MTD for the treatment regimen was defined as tesetaxel 27 mg/m(2) and capecitabine 2,500 mg/m(2)/day. The most common ≥ Grade 3 treatment-related adverse events included leukopenia (44% of patients) and neutropenia (41%). Of 22 evaluable patients, the best overall response was stable disease in 82% and progressive disease in 18%. No meaningful pharmacokinetic drug interactions were apparent.

CONCLUSIONS:

The results of this study demonstrate that these two orally active agents can be combined at the individual MTD of each drug with acceptable toxicity. These data further support the continued clinical development of tesetaxel both as a single agent and in combination with other active cancer therapeutics.

01 Jul 2008·Journal of thoracic oncology : official publication of the International Association for the Study of Lung CancerQ1 · MEDICINE

Phase I/II Study of a 3 Weekly Oral Taxane (DJ-927) in Patients with Recurrent, Advanced Non-small Cell Lung Cancer

Q1 · MEDICINE

Article

Author: E Juhász ; I Albert ; R Oyama ; Z Sztancsik ; J von Pawel ; J Milanowski ; A Szczęsna ; Paul Baas ; S Burgers

INTRODUCTION:

A phase I/II study was performed to assess the efficacy and toxicity of a new oral taxane in patients with recurrent, advanced Non-small Cell Lung Cancer.

PATIENTS AND METHODS:

Patients who were treated with one prior, taxane free chemotherapy regimen, were eligible for this study. A single oral dose of DJ-927 (27 mg/m) was given every 3 weeks. In case of good tolerance, one dose escalation to 35 mg/m was allowed. Response and toxicity were measured and plasma pharmacokinetic analysis was performed during the first course.

RESULTS:

From October 2004 to September 2005, 36 patients gave informed consent and 34 received medication. The mean age was 58 years (range, 33-75 years). The majority of patients were pretreated with a combination of cisplatin and gemcitabine. Median interval between end of first treatment and the registration of this study was 7 months (range, 0.8-22 months). Twelve patients died on study of which eight due to disease progression. In four patients with preexisting cardiac disease, toxicity led to cardiac worsening and subsequent death. Grade 3 and 4 toxicities according to the National Cancer Institute Common Toxicity Criteria were neutropenia in 18 patients (53%), anemia in six patients (18%), nausea and fatigue in two patients (6%), febrile neutropenia and neurotoxicity in one patient (3%). The overall response rate for all patients was 5.6% (Confidence Interval [CI] 0.7-18.7%). The percentage of patients with stabilization for >6 weeks was 47%. The median time to progression was 97 days (CI: 47-167 days) and the median survival time was 120 days (CI: 68-222 days) for the ITT group. Since only a minority of patients (3) tolerated the higher drug dose we omitted this dose level because of hematological toxicity. Pharmacokinetic analysis showed that the median area under the curve (t = 0-168 hours) was 1752 +/- 1355 ngr/ml/h and the half-life was 167 +/- 77 hours.

CONCLUSION:

When administered once every 3 weeks, this oral taxane formulation of DJ-927 was well-absorbed with a long terminal half-life of 167 +/- 77 hour. DJ-927 has antitumor activity against Non-small Cell Lung Cancer when given as second-line monotherapy (overall response rate in 5.6%; CI 0.7-18.7%). Ten patients experienced SD for more than 8 weeks. Different types of dose administration (metronomic dosing) or combination with other cytotoxic agents should be considered in future studies.

News (Medical) associated with Tesetaxel

21 Mar 2024

·www.biospace.com

100% CBR! FDA Granted ODD to Biostar Pharma's Utidelone Capsule (UTD2) for the Treatment of Gastric Cancer

SAN FRANCISCO, March 21, 2024 /PRNewswire/ -- Biostar Pharma, Inc., the U.S. subsidiary of Beijing Biostar Pharmaceuticals Co., Ltd. which is a synthetic biology driven biopharma company focusing on the development and commercialization of innovative oncology drugs, announced today that their key pipeline product UTD2 (utidelone capsule) had been granted an Orphan Drug Designation (ODD) by the FDA for the treatment of gastric cancer. An orphan drug is used to treat a rare disease that affects fewer than 200,000 patients in the US. Orphan drug development presents several major challenges including difficulties in patient recruitment, small market size and low return for the pharmaceutical companies. To encourage drug development for the benefit of rare disease patients, an ODD granted by the FDA provides many incentives such as tax relief on clinical trial costs, opportunity to apply for grants to support clinical trials, waiver of new drug application fee, acceleration for regulatory pathway, and the potential to receive 7 years of marketing exclusivity in the US market upon product approval. Utidelone is the only approved innovative microtubule inhibitor developed using synthetic biology technology. It has similar mechanism of action with that of taxanes while demonstrating multiple advantages, including better anti-tumor activity, broader anti-tumor spectrum, high oral bioavailability, better safety pro very low hematologic toxicity, not susceptible to P-glycoprotein and effective against multidrug-resistant tumors, and capability of crossing the blood-brain barrier for brain tumor treatment. In addition, its environmental-friendly fermentation production process also contrasts with paclitaxel. Development of oral formulation of microtubule inhibitors has been challenging due to susceptibility to P-glycoprotein-mediated efflux and low bioavailability. Oral taxanes such as Tesetaxel® and Oraxol® all failed in clinical trials because of safety problems, suggesting a huge unmet medical need. So far there is no approved oral microtubule inhibitors in the US and Europe. Biostar successfully developed utidelone capsule leveraging on its proprietary technology platform. Utidelone capsule has many advantages including improved administration convenience, enhanced patient compliance, reduced treatment cost, facilitation of long-term therapy and promotion of combination therapy. Gastric cancer, despite its low prevalence in the US, is an extremely serious global health problem due to its highly invasive and heterogeneous nature. In 2022, about 810,000 gastric cancer patients died worldwide, ranking fourth in the global mortality rate of malignant tumors [1]. In the U.S., according to the American Cancer Center, 26,890 new cases and 10,880 deaths of gastric cancer are expected in 2024. In addition, the five-year survival rate of gastric cancer in the U.S. is only 31.1%, indicating poor prognosis. Chemotherapy is the cornerstone therapy for gastric cancer and is widely used for major subtypes and various treatment lines. Chemotherapy combined with PD-1 has gradually become the first choice for the first-line treatment of advanced gastric cancer. The FDA granted ODD to UTD2 based on the promising data of a two-stage, multi-center phase 2 clinical study. For the first stage which has been completed, 15 advanced gastric cancer patients who received utidelone capsule monotherapy were evaluated for efficacy with an outcome of 3 PR (partial response) and 5 SD (stable disease). For the second stage, 11 patients with metastatic and/or unresectable HER2 negative gastric cancer who received the first-line treatment of utidelone plus sintilimab and oxaliplatin completed tumor assessment with an outcome of 8 PR and 3 SD, showing 100% clinical benefit rate (CBR)! Currently utidelone capsule's clinical studies are underway both in the U.S. and China. The preliminary data showed high bioavailability of 57% with low effective dose, wide therapeutic window, and a good safety profile. Biostar Pharma believes that utidelone capsule will show huge application potential and market space with its promising clinical performance and other advantages. [1] Source: Frost & Sullivan Analysis About Beijing Biostar Pharmaceuticals Co., Ltd. Beijing Biostar Pharmaceuticals Co., Ltd. is an integrated biopharma company focusing on the development of first- and best-in-class innovative anti-cancer drugs with independent intellectual property through state-of-the-art technology platforms of combinatorial biosynthesis, microbial fermentation production and microbial drug formulation development. With an insight-driven strategy, experienced R&D teams, cGMP-compliant manufacturing facility and domestic commercialization capability, the company have built a balanced product pipeline, covering both lead product life-cycle expansion and early-stage projects development. Further information can be found on the company's website or by contacting our business development team at bd@biostar-pharma.com on partnering with us.

Orphan DrugPhase 2Drug Approval

12 Jun 2023

·www.prnewswire.com

Biostar Pharma Announces First Patient Enrolled for Phase 1 Study of Utidelone Capsule (UTD2)--The World's First Oral Epothilone Anti-Cancer Drug

SAN FRANCISCO, June 12, 2023 /PRNewswire/ -- Biostar Pharma, Inc., the US subsidiary of Beijing Biostar Pharmaceuticals Co., Ltd. which is a synthetic biology driven biopharma company focusing on the discovery, development and commercialization of innovative oncology drugs, is pleased to announce that the first patient has been enrolled today for a Phase 1 clinical study (BG02-2201; NCT05681000) of its proprietary oral formulation product of utidelone, UTD2 (utidelone capsule) in advanced solid tumor patients in the US. This study will be conducted at multiple clinical research centers including Sarah Cannon Research Institute (Florida Cancer Specialists & Research Institute), University of Southern California, Washington University School of Medicine in St. Louis, et al. Unmet Medical Need With the improvement of treatment regimen, the overall survival of cancer patients has increased significantly in the past years. Therefore, good patient compliance is an important factor for clinical efficacy in the long-term care of cancer patients. Chemotherapy, represented by microtubule inhibitors, remains the most common systemic treatment for cancer, However, most microtubule inhibitors are through I.V. administration, which may potentially cause allergic reactions and inconvenience. So far there have been barely oral dosage forms of microtubule inhibitors successfully developed due to low solubility and being a substrate of drug-resistant P-glycoprotein. Liporaxel is an oral taxane that has only been approved for marketing in South Korea, and its oral bioavailability was still quite low. Other oral dosage forms such as Tesetaxel and Oraxol have failed in clinical trials due to safety and other problems, suggesting a huge unmet medical need. Advantage for Oral Administration UTD2 is the world's first oral epothilone microtubule inhibitor. Utidelone has the advantage for oral formulation since it's not the substrate of P-glycoprotein. Pre-clinical studies of UTD2 demonstrated good PK and safety profiles and relatively high bioavailability. Compared with injections, utidelone capsules do not require the addition of organic solvents and surfactants. Thus, they may reduce the adverse events caused by intravenous administration, shorten the hospital stay of patients, improve administration convenience, enhance patient compliance and broaden the potential for combination therapy with other anti-cancer drugs. Dr. Li Tang, Chairman of Biostar Pharma said: "The first patient enrollment of UTD2 in the US clinical trial is an important step for our international development strategy. We are honored to have a number of well-known research institutions and investigators in the US to carry out the study. We are confident that this breakthrough product will provide more benefits for numerous cancer patients and bring about a substantial change to microtubule inhibitors administration. The company is fully committed to advancing this study in order to meet substantial clinical needs around the world." About UTD2 and Utidelone UTD2 is the oral formulation of utidelone (utidelone capsule), which is developed through the proprietary microbial drug formulation platform of Beijing Biostar Pharmaceuticals Co., Ltd. Utidelone is a genetically engineered microtubule inhibitor and its injectable dosage has been launched in China in 2021 for the treatment of metastatic breast cancer (MBC). It is the only approved new molecular of microtubule inhibitor in the past 10 years around the world. Among all single agent or combination regimen of non-taxane chemotherapies, utidelone injectable is the only one to achieve both PFS and OS benefits for heavily pretreated MBC patients. It demonstrated several advantageous features, such as overcoming taxane-resistant, low hematological toxicity suitable for longer term exposure, ability to cross the blood-brain barrier that is able to prevent and treat tumor brain metastasis. The phase 3 study results of utidelone injectable were twice selected for oral presentations at ASCO annual meetings and invited to publish in Lancet Oncology and Annals of Oncology. It is also recommended by "2023 CSCO Guidelines for Diagnosis and Treatment of Breast Cancer" as Class I (category IA). Clinical studies for multiple indication expansion are in progress, including phase 3 trials for non-small-cell lung cancer and breast cancer neoadjuvant, respectively, as well as phase 2 trial for the first line treatment of advanced esophageal cancer and gastric cancer. About BG02-2201 Study BG02-2201 represents the "Phase I Clinical Study on the Tolerability of Utidelone Capsule in Patients with Advanced Solid Tumors" (NCT05681000), which is an open-label phase I dose escalation study and will be conducted at several clinical research centers in the United States. 16-28 patients with advanced solid tumors are expected to be enrolled. The primary objective is to evaluate the safety and tolerability of UTD2 to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT). The secondary objectives are to evaluate the pharmacokinetic profile of UTD2 and to preliminarily assess the anti-tumor efficacy of UTD2 in advanced solid tumor patients. About Beijing Biostar Pharmaceuticals Co., Ltd. Beijing Biostar Pharmaceuticals Co., Ltd. is an integrated biopharma company focusing on the developing of first- and best-in-class innovative anti-cancer drugs with independent intellectual property through state-of-the-art technology platforms of combinatorial biosynthesis, microbial fermentation production and microbial drug formulation development. With an insight-driven strategy, experienced R&D teams, cGMP-compliant manufacturing facility and domestic commercialization capability, the company have built a balanced product pipeline, covering both lead product life-cycle expansion and early-stage projects development. Further information can be found on the company's website or by contacting our business development team at [email protected] on partnering with us. SOURCE Biostar Pharma, Inc.

Phase 1Drug ApprovalPhase 3Clinical ResultPhase 2

17 Nov 2021

·www.biospace.com

Odonate Therapeutics Announces Planned Return of Capital to Stockholders through Share Repurchase Plan

Nov. 17, 2021 12:45 UTC NEW YORK--(BUSINESS WIRE)-- Odonate Therapeutics, Inc. (NASDAQ: ODT) today announced that it will commence a share repurchase plan for up to 20 million shares in order to return capital to stockholders. This action is in connection with the Company’s previously announced decision to discontinue the development of tesetaxel. Repurchases may be made from time to time at the Company’s discretion. The plan has no time limit and can be discontinued at any time. There can be no assurance as to the timing or number of shares of any repurchases. As of September 30, 2021, as reported in its recently filed Form 10-Q, the Company had total stockholders’ equity of $71.4 million, or $1.85 per share, based on 38.5 million shares outstanding.

100 Deals associated with Tesetaxel

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KEGG	Wiki	ATC	Drug Bank
-	Tesetaxel	-	DB12019

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
HR positive solid tumors	Phase 3	United States	Odonate, Inc.	21 Dec 2017
HR positive solid tumors	Phase 3	Australia	Odonate, Inc.	21 Dec 2017
HR positive solid tumors	Phase 3	Austria	Odonate, Inc.	21 Dec 2017
HR positive solid tumors	Phase 3	Belgium	Odonate, Inc.	21 Dec 2017
HR positive solid tumors	Phase 3	Canada	Odonate, Inc.	21 Dec 2017
HR positive solid tumors	Phase 3	Czechia	Odonate, Inc.	21 Dec 2017
HR positive solid tumors	Phase 3	France	Odonate, Inc.	21 Dec 2017
HR positive solid tumors	Phase 3	Germany	Odonate, Inc.	21 Dec 2017
HR positive solid tumors	Phase 3	Hungary	Odonate, Inc.	21 Dec 2017
HR positive solid tumors	Phase 3	Italy	Odonate, Inc.	21 Dec 2017

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03858972 (CONTESSA 2, ASCO 12021 \| ASCO 22021) Manual	Phase 2	Metastatic human epidermal growth factor 2 positive carcinoma of breast HR Positive \| HER2 Negative	150	tesetaxel+capecitabine	djqhhblaba(xmkkrwuwkn) = fkkumvzhhk apcpqfxptf (edgemrsnlw, 42 - 60) View more	Positive	28 May 2021
NCT03326674 (CONTESSA, SABCS2021)	Phase 3	Metastatic human epidermal growth factor 2 positive carcinoma of breast Adjuvant HER2- \| hormone receptor +	685	Tesetaxel plus reduced dose of capecitabine	cbdlzdkzkg(mylqalgxua) = ridoqesjop nsgclxxlem (tmvdbgpdmm ) View more	Positive	15 Feb 2021
NCT03326674 (CONTESSA, SABCS2021)	Phase 3		685	Capecitabine alone	cbdlzdkzkg(mylqalgxua) = ivfcfxgwab nsgclxxlem (tmvdbgpdmm ) View more	Positive	15 Feb 2021
NCT03326674 (CONTESSA, BusinessWire) Manual	Phase 3	Hormone receptor positive HER2 negative breast cancer HR positive \| HER2 negative	685	Capecitabine+Tesetaxel	qxtxbnvvdt(miljgeihqb) = mazqevlmbu iwvuslcojo (trvvbeyfbi ) View more	Positive	24 Aug 2020
NCT03326674 (CONTESSA, BusinessWire) Manual	Phase 3		685	Capecitabine	qxtxbnvvdt(miljgeihqb) = yisetmskat iwvuslcojo (trvvbeyfbi ) View more	Positive	24 Aug 2020
NCT03326674 (CONTESSA, ASCO2019)	Phase 3	Hormone receptor positive HER2 negative breast cancer	600	Tesetaxel plus reduced dose of capecitabine	afxrfiksya(swvpwxompp) = 5.4 mo xhiqlxhllr (cimakotjqo ) View more	-	26 May 2019
NCT01064713 (CTgov)	Phase 2	Metastatic melanoma	17	Tesetaxel (40 mg Tesetaxel, Cohort A)	roappobtcm = ooscsbwucl dojrkvcysy (zecubjlqym, hmliebklud - dqwvsayowy) View more	-	17 Jul 2018
NCT01064713 (CTgov)	Phase 2	Metastatic melanoma	17	Tesetaxel (50 mg Tesetaxel, Cohort B)	roappobtcm = yyruqwehmu dojrkvcysy (zecubjlqym, xfswchwzki - podyvlrjup) View more	-	17 Jul 2018
NCT01221870 (ASCO 12018 \| ASCO 22018) Manual	Phase 2	Hormone receptor positive HER2 negative breast cancer First line	46	Tesetaxel	bmezzvmmto(cvgaaordlg) = ncrfsabwxb ovngtjtkbr (adwgisgozb, 29 - 62) View more	Positive	02 Jun 2018
ASCO2012	Phase 2	Metastatic breast cancer First line	45	Tesetaxel	oavuopepjq(bfungkvphv) = sjtbpqtndt ofrsjngjtf (hjvptnrqwb ) View more	-	20 May 2012
ASCO2012	Phase 2	Malignant neoplasm of gastro-oesophageal junction Second line	24	Tesetaxel	zgehtgeszr(vytvfduoum) = dynaljjtco hwifigznhp (erwptyvpoa )	-	20 May 2012
ASCO2012	Phase 1	Advanced Malignant Solid Neoplasm	26	Tesetaxel	fhexugktck(zbqhiielzp) = okodrhoofu chtcnvrcvu (cadiwpdvnr )	-	20 May 2012
ASCO2012	Phase 1	Advanced Malignant Solid Neoplasm	10	Tesetaxel 27 mg/m2	rvuzblwwnv(ticxiydacs) = ewyonvczdt giucuywpkh (lallgoalyt ) View more	-	20 May 2012

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