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FP-1305 (bexmarilimab) is a first-in-class, humanized monoclonal antibody, which binds to Clever-1, an immunosuppressive receptor found on macrophages. It is being evaluated for the treatment of higher-risk (HR) myelodysplastic syndrome.
Lead Product(s): Bexmarilimab,Azacitidine,Venetoclax
Therapeutic Area: Oncology Product Name: FP-1305
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 March 18, 2024
Details:
FP-1305 (bexmarilimab) is a monoclonal antibody that binds to Clever-1. It is being evaluated in phase 1/2 clinical trials for the treatment of acute myeloid leukemia, myelodysplastic syndromes & chronic myelomonocytic leukemia.
Lead Product(s): Bexmarilimab,Azacitidine,Venetoclax
Therapeutic Area: Oncology Product Name: FP-1305
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 January 25, 2024
Details:
FP-1305 (bexmarilimab) is a CLEVER-1 binder, which is under phase 1/2 clinical development in combination with azacitidine & venetoclax for the treatment of acute myeloid leukemia, myelodysplastic syndromes & chronic myelomonocytic leukemia.
Lead Product(s): Bexmarilimab,Azacitidine,Venetoclax
Therapeutic Area: Oncology Product Name: FP-1305
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 January 09, 2024
Details:
FP-1305 (bexmarilimab) binds to Clever-1, an immunosuppressive receptor found on macrophages leading to tumor growth and metastases, which is investigated for the treatment of relapsed/refractory AML and HMA-refractory MmDS patients.
Lead Product(s): Bexmarilimab,Azacitidine,Venetoclax
Therapeutic Area: Oncology Product Name: FP-1305
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 November 06, 2023
Details:
FP-1305 (bexmarilimab) binds to Clever-1, an immunosuppressive receptor found on macrophages leading to tumor growth and metastases, which is investigated for the treatment of relapsed/refractory AML and HMA-refractory MmDS patients.
Lead Product(s): Bexmarilimab,Azacitidine
Therapeutic Area: Oncology Product Name: FP-1305
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 October 11, 2023
Details:
U.S. FDA has granted Orphan Drug Designation to Faron Pharmaceuticals' wholly owned asset bexmarilimab, for the treatment of acute myeloid leukemia. ODD will further help bexmarilimab program by offering clinical development and commercialization benefits.
Lead Product(s): Bexmarilimab
Therapeutic Area: Oncology Product Name: FP-1305
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 August 29, 2023
Details:
FP-1305 (bexmarilimab) binds to Clever-1, an immunosuppressive receptor found on macrophages leading to tumor growth and metastases (i.e. helps cancer evade the immune system).
Lead Product(s): Bexmarilimab,Azacitidine
Therapeutic Area: Oncology Product Name: FP-1305
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 July 19, 2023
Details:
FP-1305 (bexmarilimab) is Faron's wholly-owned, investigative precision immunotherapy with the potential to provide permanent immune stimulation for difficult-to-treat cancers through targeting myeloid cell function.
Lead Product(s): Bexmarilimab,Azacitidine
Therapeutic Area: Oncology Product Name: FP-1305
Highest Development Status: IND EnablingProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 16, 2022
Details:
Of 11 patients, 4 experienced clinical benefit - 1 patient had a partial response after two cycles of bexmarilimab (tumor growth reduced by 40% from baseline) but was discontinued before a confirmatory scan was performed. 3 patients had stable disease.
Lead Product(s): Bexmarilimab
Therapeutic Area: Oncology Product Name: FP-1305
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 21, 2022
Details:
The conclusion from analysis is that, when used together, IFNy and TNFa are highly predictive of response to bexmarilimab (P < 0.0001), and patients with low IFNy and TNFa levels experienced significantly higher clinical benefit following treatment with bexmarilimab.
Lead Product(s): Bexmarilimab
Therapeutic Area: Oncology Product Name: FP-1305
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 March 09, 2022
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