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Details:
The acquisition adds AnHeart’s lead asset, AB-106 (taletrectinib), a next-generation, potentially best-in-class ROS1 inhibitor with Breakthrough Therapy Designations currently completing two pivotal studies for patients with ROS1-positive non-small cell lung cancer.
Lead Product(s): Taletrectinib
Therapeutic Area: Oncology Product Name: AB-106
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Nuvation Bio
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition April 10, 2024
Details:
The acquisition adds AnHeart’s lead asset, AB-106 (taletrectinib), a next-generation, potentially best-in-class ROS1 inhibitor with Breakthrough Therapy Designations currently completing two pivotal studies for patients with ROS1-positive non-small cell lung cancer.
Lead Product(s): Taletrectinib
Therapeutic Area: Oncology Product Name: AB-106
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Nuvation Bio
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition March 25, 2024
Details:
AB-106 (taletrectinib) is a next-generation ROS1 tyrosine kinase inhibitor (TKI), which is being evaluated for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).
Lead Product(s): Taletrectinib
Therapeutic Area: Oncology Product Name: AB-106
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Innovent Biologics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 04, 2024
Details:
AB-106 (taletrectinib) is a next-generation ROS1 tyrosine kinase inhibitor (TKI), which is under phase 2 clinical development for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).
Lead Product(s): Taletrectinib
Therapeutic Area: Oncology Product Name: AB-106
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Innovent Biologics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 18, 2023
Details:
The collaboration aims for the development and regulatory approval of Foundation Medicine’s FoundationOne®CDx and FoundationOne®Liquid CDx, as companion diagnostics for AnHeart’s investigational next-generation ROS1 inhibitor, taletrectinib, in the United States.
Lead Product(s): Taletrectinib
Therapeutic Area: Oncology Product Name: AB-106
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Foundation Medicine
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration December 14, 2023
Details:
Under the terms of the agreement, Nippon Kayaku will be responsible for regulatory approvals and commercialization of AB-106 (taletrectinib) for ROS1-positive NSCLC in Japan, and will have rights to further develop taletrectinib for new indications in the region.
Lead Product(s): Taletrectinib
Therapeutic Area: Oncology Product Name: AB-106
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Nippon Kayaku
Deal Size: Undisclosed Upfront Cash: $40.0 million
Deal Type: Licensing Agreement October 30, 2023
Details:
AB-106 (taletrectinib) is an oral, potent, brain penetrant, selective, next-generation potential best-in-class ROS1 inhibitor being evaluated for the treatment of ROS1-positive NSCLC.
Lead Product(s): Taletrectinib
Therapeutic Area: Oncology Product Name: AB-106
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 October 21, 2023
Details:
Under the terms of the collaboration, Guardant Health and AnHeart Therapeutics will develop Guardant360® CDx and Guardant360 TissueNext™ assays as companion diagnostics for AB-106 (taletrectinib) in Advanced or Metastatic ROS1-Positive NSCLC.
Lead Product(s): Taletrectinib
Therapeutic Area: Oncology Product Name: AB-106
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: AnHeart Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration February 02, 2023
Details:
AB-106 (taletrectinib) is a novel, potential best-in-class, next-generation ROS1 inhibitor designed to effectively target ROS1 fusions with potential to treat both TKI-naïve and pre-treated patients.
Lead Product(s): Taletrectinib
Therapeutic Area: Oncology Product Name: AB-106
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: NewG Lab Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 12, 2022
Details:
Taletrectinib (AB-106) received FDA granted Breakthrough Therapy Designation for the treatment of adult patients with advanced or metastatic ROS1-positive non-small cell lung cancer who are ROS1 tyrosine kinase inhibitor treatment naïve or previously treated with crizotinib.
Lead Product(s): Taletrectinib
Therapeutic Area: Oncology Product Name: AB-106
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 August 04, 2022
Details:
In five patients with ROS1 G2032R resistant mutation, 4/5 achieved confirmed partial response (cPR), and 1/5 achieved stable disease (SD) ET140203 (taletrectinib) was generally well tolerated.
Lead Product(s): Taletrectinib
Therapeutic Area: Oncology Product Name: AB-106
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 August 03, 2022
Details:
The updated ORR and DCR data of AB-106 (taletrectinib) demonstrated its potential superior benefits in terms of both efficacy and safety for Chinese patients with ROS1-positive NSCLC.
Lead Product(s): Taletrectinib
Therapeutic Area: Oncology Product Name: AB-106
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Innovent Biologics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 06, 2022
Details:
AB-106 (taletrectinib) is a novel best-in-class next-generation ROS1 inhibitor designed to effectively target ROS1 fusions with potential to treat both TKI-naïve and pre-treated patients.
Lead Product(s): Taletrectinib
Therapeutic Area: Oncology Product Name: AB-106
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 March 21, 2022
Details:
The NMPA Breakthrough Therapy Designation was based on results from the Phase 2 TRUST trial of ROS1 fusion-positive NSCLC patients treated with AB-106 (taletrectinib), a new generation of potent ROS1 inhibitors.
Lead Product(s): Taletrectinib
Therapeutic Area: Oncology Product Name: AB-106
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: AnHeart Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 01, 2022
Details:
AB-106 (taletrectinib) is an investigational next-generation TKI designed to effectively target ROS1 and NTRK with potential to treat TKI-naïve or pretreated patients.
Lead Product(s): Taletrectinib
Therapeutic Area: Oncology Product Name: AB-106
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 June 18, 2021
Details:
Innovent will obtain exclusive rights to co-develop and commercialize taletrectinib in Greater China. AnHeart will retain rights to develop taletrectinib up to regulatory approval in mainland China and for supplying taletrectinib for in Greater China.
Lead Product(s): Taletrectinib
Therapeutic Area: Oncology Product Name: AB-106
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Innovent Biologics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration May 31, 2021
Details:
In the two Phase 1 studies, taletrectinib demonstrated meaningful clinical activity in advanced ROS1+ NSCLC patients who are ROS1 TKI-naïve or crizotinib-refractory and had a manageable safety profile.
Lead Product(s): Taletrectinib
Therapeutic Area: Oncology Product Name: AB-106
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 October 29, 2020
Details:
Proceeds from the financing will be used to advance the global Phase 2 trials of taletrectinib, a potent and highly selective next generation ROS1/NTRK inhibitor as well as to further expand AnHeart’s oncology portfolio.
Lead Product(s): Taletrectinib
Therapeutic Area: Oncology Product Name: AB-106
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: $20.0 million Upfront Cash: Undisclosed
Deal Type: Series A Financing August 10, 2020
Details:
This Phase 2 trial will enroll approximately 106 NSCLC patients with ROS1 fusion and is designed as an open-label, single-arm, multi-center study in China.
Lead Product(s): Taletrectinib
Therapeutic Area: Oncology Product Name: AB-106
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 21, 2020
Details:
NewG Lab will be responsible for development, market authorization and commercialization activities for taletrectinib in Korea. AnHeart will allow NewG Lab to join its Phase 2 multi-regional clinical trial (MRCT) for non-small cell lung cancer (NSCLC) with ROS1/NTRK mutations.
Lead Product(s): Taletrectinib
Therapeutic Area: Oncology Product Name: AB-106
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: NewG Lab
Deal Size: $7.0 million Upfront Cash: Undisclosed
Deal Type: Licensing Agreement July 15, 2020
Details:
The lead clinical candidate taletrectinib is a next-generation novel, potent, highly selective ROS1 and NTRK inhibitor that can cross the blood-brain barrier.
Lead Product(s): Taletrectinib
Therapeutic Area: Oncology Product Name: AB-106
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 June 26, 2020
Details:
The first Phase 2 trial will enroll first-and second-line Non-Small Cell Lung Cancer (NSCLC) patients with ROS1 mutations and is designed as an open-label, single-arm, multi-center study.
Lead Product(s): Taletrectinib
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 24, 2020
Details:
The first Phase 2 trial will enroll first-and second-line Non-Small Cell Lung Cancer (NSCLC) patients with ROS1 mutations and is designed as an open-label, single-arm, multi-center study.
Lead Product(s): Taletrectinib
Therapeutic Area: Oncology Product Name: Undisclosed
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 March 23, 2020
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