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Lead Product(s): Zandelisib
Therapeutic Area: Oncology Product Name: ME-401
Highest Development Status: Phase II Product Type: Small molecule
Partner/Sponsor/Collaborator: MEI Pharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 02, 2020
Details:
Phase 2, multicenter, open-label, single-arm clinical study is conducted by Kyowa Kirin to evaluate zandelisib as monotherapy for treatment of Japanese patients with relapsed or refractory iNHL with at least two prior systemic therapies.
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Lead Product(s): Patritumab Deruxtecan
Therapeutic Area: Oncology Product Name: U3-1402
Highest Development Status: Phase II Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 14, 2020
Details:
The Phase 2 study will evaluate patritumab deruxtecan, a potential first-in-class HER3 directed antibody drug conjugate, in previously treated patients with HER3 expressing advanced/metastatic colorectal cancer.
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Lead Product(s): Darinaparsin
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase II Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 15, 2020
Details:
The primary endpoint (antitumor effect) was achieved. No new safety concerns were identified in the safety analysis. This study was conducted as the final registration trial for the indication of relapsed or refractory PTCL. Solasia begins preparing for the NDA Filing.
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Lead Product(s): Trastuzumab deruxtecan
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase II Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 22, 2020
Details:
Designation follows recent U.S. Breakthrough Therapy Designations for ENHERTU for HER2 positive metastatic gastric cancer and HER2 mutant metastatic non-small cell lung cancer.
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Lead Product(s): Trastuzumab Deruxtecan
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase II Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 13, 2020
Details:
Research data from the pivotal phase 2 DESTINY-Gastric01 trial of ENHERTU® to be presented along with phase 2 DESTINY-Lung01 and DESTINY-CRC01 research data.
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Lead Product(s): Lenvatinib,Pembrolizumab
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase II Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 13, 2020
Details:
Data highlighted shows continued progress on clinical trials for the KEYTRUDA plus LENVIMA combination across multiple tumor types, including a virtual oral presentation on the Phase 2 results of the metastatic clear cell renal cell carcinoma cohort of a Phase 1b/2 study.
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Lead Product(s): Trastuzumab Deruxtecan
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase II Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 07, 2020
Details:
sNDA based on data from the pivotal phase 2 DESTINY-Gastric01 trial and phase 1 trial where trastuzumab deruxtecan showed a significant and clinically meaningful improvement in HER2+ Gastric Cancer.
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Lead Product(s): Axicabtagene Ciloleucel
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase II Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 30, 2020
Details:
NDA submission based on previous pivotal trial data and a phase 2 study in Japan in patients with certain relapsed/refractory B-cell lymphomas.
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Lead Product(s): Lenvatinib,Everolimus
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase II Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 15, 2020
Details:
The single-arm, multicenter, Phase 2 study of lenvatinib in combination with everolimus enrolled 31 patients with unresectable advanced or metastatic nccRCC.
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Lead Product(s): Polatuzumab Vedotin,Bendamustine,Rituximab
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase II Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 13, 2020
Details:
Polatuzumab vedotin in combination with bendamustine and rituximab achieved complete response rate in patients with relapsed or refractory diffuse large B-cell lymphoma.
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