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Details:
Oral paclitaxel, relative to intravenous paclitaxel, was associated with less neuropathy and was not associated with an increase in febrile neutropenia.
Lead Product(s): Paclitaxel,Encequidar,Dostarlimab
Therapeutic Area: Oncology Product Name: Taxol
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Athenex
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 20, 2022
Details:
The publication of phase 3 data, which show that oral Taxol (paclitaxel) plus encequidar significantly improves tumor response in patients with metastatic breast cancer, compared to IV administration.
Lead Product(s): Paclitaxel,Encequidar,Dostarlimab
Therapeutic Area: Oncology Product Name: Taxol
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 25, 2022
Details:
The agreement will support the expansion phase of the trial to further investigate the preliminary encouraging results of the KX-ORAX-011 Phase 1 clinical trial evaluating Oraxol (encequidar plus oral paclitaxel) in combination with pembrolizumab for certain NSCLC patients.
Lead Product(s): Paclitaxel,Encequidar,Pembrolizumab
Therapeutic Area: Oncology Product Name: Oraxol
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Merck & Co
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration May 16, 2022
Details:
Post hoc analysis of this subgroup of patients with hepatic impairment was conducted and showed a median survival rate of 18.9 months in patients treated with Oral Paclitaxel.
Lead Product(s): Paclitaxel,Encequidar
Therapeutic Area: Oncology Product Name: Oraxol
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 22, 2021
Details:
The primary objective for dose escalation phase of the study was to determine the maximum tolerated dose (MTD) and identify the recommended Phase 2 dose (RP2D) of Oraxol (Oral Paclitaxel + Encequidar) in combination with pembrolizumab in patients with advanced solid tumors.
Lead Product(s): Paclitaxel,Encequidar,Pembrolizumab
Therapeutic Area: Oncology Product Name: Oraxol
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 16, 2021
Details:
In the CRL, the FDA indicated its concern of safety risk to patients in terms of an increase in neutropenia-related sequelae on the Oral Paclitaxel arm compared with the IV paclitaxel arm.
Lead Product(s): Paclitaxel,Encequidar
Therapeutic Area: Oncology Product Name: Oraxol
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 01, 2021
Details:
Data presented at SABCS indicates benefits of oral paclitaxel and encequidar (oral paclitaxel) versus IV paclitaxel (IVP) on Progression-Free Survival (PFS) and on Overall Survival (OS), which supports superiority on the primary endpoint Overall Response Rate (ORR).
Lead Product(s): Paclitaxel,Encequidar
Therapeutic Area: Oncology Product Name: Oraxol
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 09, 2020
Details:
Presentations will include data from the pivotal Phase 3 clinical trial of oral paclitaxel in metastatic breast cancer, a spotlight poster on progression-free survival and overall survival, and posters on neuropathy (CIPN), and management of gastrointestinal side effects.
Lead Product(s): Paclitaxel,Encequidar
Therapeutic Area: Oncology Product Name: Oraxol
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 17, 2020
Details:
The Oral Paclitaxel NDA submission is supported by data from a single pivotal Phase III study of Oral Paclitaxel for the treatment of metastatic breast cancer.
Lead Product(s): Paclitaxel,Encequidar
Therapeutic Area: Oncology Product Name: Oraxol
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 01, 2020
Details:
The Company expects the proceeds from the financing will be used to fund the commercial launch of oral paclitaxel and encequidar (Oral Paclitaxel), ongoing pipeline development, manufacturing infrastructure, and working capital and general corporate purposes.
Lead Product(s): Paclitaxel,Encequidar
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Sagard Healthcare Royalty Partners
Deal Size: $50.0 million Upfront Cash: Undisclosed
Deal Type: Financing August 06, 2020
Details:
Athenex presented interim data from an ongoing Phase II clinical trial in which oral paclitaxel and encequidar monotherapy showed encouraging efficacy and tolerability in elderly patients with unresectable cutaneous angiosarcoma, an aggressive malignancy with poor prognosis.
Lead Product(s): Paclitaxel,Encequidar
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 29, 2020
Details:
This Phase II study is an ongoing, single arm study evaluating the activity, safety and tolerability of oral paclitaxel (205 mg/m2) with encequidar.
Lead Product(s): Paclitaxel,Encequidar
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 29, 2020
Details:
Athenex participated in a meeting with the U.S FDA to discuss the clinical section of the New Drug Application for oral paclitaxel and encequidar for the treatment of metastatic breast cancer.
Lead Product(s): Paclitaxel,Encequidar
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 09, 2020
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