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Details:

TUKYSA (tucatinib) is an oral medicine that is a tyrosine kinase inhibitor of the HER2 protein and in combination with ado-trastuzumab emtansine is being developed in patients with HER2-positive metastatic or unresectable breast cancer.


Lead Product(s): Tucatinib,Trastuzumab emtansine

Therapeutic Area: Oncology Product Name: Tukysa

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 06, 2023

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TUKYSA (tucatinib) is an oral medicine that is a tyrosine kinase inhibitor of the HER2 protein and in combination with ado-trastuzumab emtansine is being developed in patients with HER2-positive metastatic or unresectable breast cancer.


Lead Product(s): Tucatinib,Kadcyla

Therapeutic Area: Oncology Product Name: Tukysa

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 August 16, 2023

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Tukysa (tucatinib) is a TKI of HER2, inhibiting phosphorylation of HER2 and HER3, resulting in inhibition of downstream MAPK and AKT signaling and cell proliferation, and showed antitumor activity in HER2 expressing tumor cells in combination with trastuzumab.


Lead Product(s): Tucatinib,Trastuzumab

Therapeutic Area: Oncology Product Name: Tukysa

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 19, 2023

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In vivo (in living organisms), TUKYSA (tucatinib) inhibited the growth of HER2-expressing tumors. The combination of TUKYSA and the anti-HER2 antibody trastuzumab showed increased anti-tumor activity in vitro and in vivo compared to either medicine alone.


Lead Product(s): Tucatinib,Trastuzumab,Oxaliplatin

Therapeutic Area: Oncology Product Name: Tuksya

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 19, 2022

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At a median duration of follow-up of 20.7 months, results of MOUNTAINEER trial showed a 38.1% cORR per blinded independent central review in HER2-positive patients who were assigned to receive Tuksya (tucatinib) in combination with trastuzumab.


Lead Product(s): Tucatinib,Trastuzumab,Oxaliplatin

Therapeutic Area: Oncology Product Name: Tuksya

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Merck & Co

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 02, 2022

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Pivotal HER2CLIMB trial showed that TUKYSA resulted in a robust and durable prolongation of overall survival that was consistent with results from the primary analysis for HER2-positive metastatic breast cancer patients with brain metastases.


Lead Product(s): Tucatinib,Capecitabine,Trastuzumab

Therapeutic Area: Oncology Product Name: Tukysa

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 November 19, 2021

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Zanidatamab is a bispecific antibody, based on Zymeworks’ Azymetric™ platform. Zymeworks is developing zanidatamab in multiple Phase 1, Phase 2, and pivotal clinical trials globally as a targeted treatment option for patients with solid tumors that express HER2.


Lead Product(s): Zanidatamab,Tucatinib,Capecitabine

Therapeutic Area: Oncology Product Name: ZW25

Highest Development Status: Phase IProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 19, 2021

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Zanidatamab binds to HER2 across a range of expression levels and has demonstrated multiple mechanisms of action including the formation of receptor clusters, resulting in receptor internalization and downregulation that affect signal transduction .


Lead Product(s): Zanidatamab,Tucatinib,Capecitabine

Therapeutic Area: Oncology Product Name: ZW25

Highest Development Status: Phase IProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 28, 2021

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Pieris' option to co-develop and co-commercialize the second of 3 programs in the collaboration has been amended to provide it with a co-promotion option in the U.S, with Seagen solely responsible for the development and overall commercialization of that program.


Lead Product(s): Cinrebafusp alfa,Tucatinib

Therapeutic Area: Oncology Product Name: PRS-343

Highest Development Status: PreclinicalProduct Type: Large molecule

Partner/Sponsor/Collaborator: Pieris Pharmaceuticals

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Collaboration March 25, 2021

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Patients who received TUKYSA in combination with trastuzumab and capecitabine in the pivotal trial had a 46 percent reduction in the risk of cancer progression or death compared to patients who received trastuzumab and capecitabine alone.


Lead Product(s): Tucatinib

Therapeutic Area: Oncology Product Name: Tukysa

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 12, 2021

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Outcomes for TUKYSA® (tucatinib) in combination with trastuzumab and capecitabine in patients with HER2-positive metastatic breast cancer from the pivotal HER2CLIMB trial by hormone receptor (HR) status will be featured in a spotlight poster.


Lead Product(s): Tucatinib,Trastuzumab

Therapeutic Area: Oncology Product Name: Tukysa

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 08, 2020

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Australian regulatory authorities have approved TUKYSA® (tucatinib) in combination with trastuzumab and capecitabine for the treatment of patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases.


Lead Product(s): Tucatinib,Trastuzumab,Capecitabine

Therapeutic Area: Oncology Product Name: Tukysa

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 12, 2020

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UKYSA combination reduced risk of cancer progression in the brain or death by two-thirds, doubled response rate and reduced risk of death by nearly half compared to standard therapy alone.


Lead Product(s): Tucatinib,Trastuzumab,Capecitabine

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 29, 2020

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Highlights from 12 presentations showcasing its research and development portfolio of novel targeted therapies and antibody-drug conjugate technology advances and innovation will be presented at the American Association for Cancer Research (AACR) Virtual Annual Meeting II.


Lead Product(s): Tucatinib

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: PreclinicalProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 18, 2020

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The approval is based on results from the pivotal trial HER2CLIMB in patients with HER2+ unresectable metastatic breast cancer who had previously received trastuzumab, pertuzumab, and ado-T-DM1.


Lead Product(s): Tucatinib,Trastuzumab,Capecitabine

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 12, 2020

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First investigational therapy in a pivotal trial to include patients with metastatic HER2-positive breast cancer with active brain metastases.


Lead Product(s): Tucatinib,Trastuzumab,Capecitabine

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 January 31, 2020

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