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Glenmark will be responsible for further developing, registering, and commercializing KN035 (envafolimab), approved in China for the treatment of adult patients with previously treated MSI-H or dMMR advanced solid tumor, in multiple geographies around the World.
Lead Product(s): Envafolimab
Therapeutic Area: Oncology Product Name: KN035
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Glenmark Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement January 25, 2024
Details:
KN035 (envafolimab) is a single-domain antibody against PD-L1 invented by Alphamab Oncology and licensed by TRACON, is the first approved subcutaneously injected PD-(L)1 inhibitor, which is investigated for MSI-H/dMMR advanced solid tumors.
Lead Product(s): Envafolimab,Ipilimumab
Therapeutic Area: Oncology Product Name: KN035
Highest Development Status: Phase IIProduct Type: Large molecule
Recipient: TRACON Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 20, 2023
Details:
Result demonstrated highly tolerable safety profile and significantly higher objective response rate observed in lower weight patients in ENVASARC, to increase dose of envafolimab to 600 mg every three weeks, which is double the original envafolimab dose of 300 mg Q3W.
Lead Product(s): Envafolimab,Ipilimumab
Therapeutic Area: Oncology Product Name: KN035
Highest Development Status: Phase IIProduct Type: Large molecule
Recipient: TRACON Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 19, 2022
Details:
KN046-204 is a phase II clinical study in China to evaluate the efficacy and safety of KN046 monotherapy or plus chemotherapy for unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma.
Lead Product(s): KN046
Therapeutic Area: Oncology Product Name: KN046
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 07, 2021
Details:
KN046-203 is a phase Ib/II, open label, multi-center clinical study, evaluating the efficacy, safety, and tolerability of KN046 in combination with nab-paclitaxel in patients with TNBC.
Lead Product(s): KN046,Paclitaxel
Therapeutic Area: Oncology Product Name: KN046
Highest Development Status: Phase I/ Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 13, 2021
Details:
KN046 is a bispecific antibody targeting PD-L1 and CTLA-4 immune checkpoints. Alphamab will conduct a open label, multi-center phase II pivotal clinical study in the U.S to evaluate the efficacy, safety and tolerability of KN046 for the treatment of thymic carcinoma.
Lead Product(s): KN046
Therapeutic Area: Oncology Product Name: KN046
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Jiangsu Alphamab Biopharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 09, 2021
Details:
The recombinant humanized PD-L1/ CTLA-4 bispecific antibody KN046 was granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of thymic epithelial tumors.
Lead Product(s): KN046
Therapeutic Area: Oncology Product Name: KN046
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 03, 2020
Details:
According to the agreement, Alphamab Oncology and Institut Pasteur Shanghai will form a joint project team. Alphamab Oncology is responsible for providing its proprietary Mixed Antibodies Platform, constructing humanized antibodies and recombinant engineered cell lines,
Lead Product(s): COVID-19 neutralizing antibody
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: UndisclosedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Institut Pasteur Shanghai
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership June 10, 2020
Details:
According to the terms of the agreement, after reaching certain clinical milestones, Sanofi will have the right to negotiate the exclusive right to introduce KN026 during the exclusive period.
Lead Product(s): KN026,Docetaxel
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Sanofi
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration June 09, 2020
Details:
KN046's Phase I clinical trials in Australia and China, along with multiple Phase II trials in China have shown a good safety profile and promising efficacy.
Lead Product(s): KN046
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 16, 2020
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