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Details:
L19TNF (onfekafusp alfa) is a homotrimer that forms from engineered peptides for the L19 antibody in scFv format fused to human TNF. It is being evaluated in combination with doxorubicin for the treatment of first-line advanced or metastatic soft tissue sarcoma.
Lead Product(s): Onfekafusp Alfa,Doxorubicin Hydrochloride
Therapeutic Area: Oncology Product Name: L19TNF
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 February 20, 2024
Details:
Nidlegy (bifikafusp alfa & onfekafusp alfa) is designed for the treatment of skin cancer. It consists of two active ingredients, L19IL2 and L19TNF which are manufactured independently, and which are mixed prior to intralesional administration.
Lead Product(s): Bifikafusp Alfa,Onfekafusp Alfa
Therapeutic Area: Oncology Product Name: Nidlegy
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 October 16, 2023
Details:
Under the supply agreement, MSD provides their anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), to be evaluated in combination with Philogen's immunocytokines L19IL2, L19TNF, and Nidlegy (bifikafusp alfa) in a randomized Phase II clinical trial in unresectable melanoma patients.
Lead Product(s): Bifikafusp Alfa,Onfekafusp Alfa,Pembrolizumab
Therapeutic Area: Oncology Product Name: Nidlegy
Highest Development Status: UndisclosedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Merck & Co
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration June 01, 2023
Details:
Under the agreement, Sun Pharma will have exclusive rights to commercialise Nidlegy (bifikafusp alfa), a new anti-cancer biopharmaceutical, being developed by Philogen for melanoma and non-melanoma skin cancers, in the territories of Europe, Australia and New Zealand.
Lead Product(s): Bifikafusp Alfa,Onfekafusp Alfa
Therapeutic Area: Oncology Product Name: Nidlegy
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Sun Pharmaceutical Industries Limited
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement May 30, 2023
Details:
L19TNF is a fully-human immunomodulatory product consisting of the L19 antibody and TNF. The L19 antibody is specific to the EDB domain of fibronectin and mediates selective localization of TNF to the site of disease while sparing healthy organs.
Lead Product(s): Fibromun,Lomustine
Therapeutic Area: Oncology Product Name: L19TNF
Highest Development Status: Phase I/ Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: University Hospital Zürich
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 24, 2023
Details:
Nidlegy (bifikafusp alfa) is combination of the immunocytokines L19IL2 and L19TNF, which is being developed as intralesional treatment for patients with advanced locoregional melanoma and non-melanoma skin cancers.
Lead Product(s): Bifikafusp Alfa,Onfekafusp Alfa
Therapeutic Area: Oncology Product Name: Nidlegy
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 July 25, 2022
Details:
Nidlegy™, the combination of the two active principles bifikafusp alfa (L19IL2) and onfekafusp alfa (L19TNF), has already shown promising results in the intralesional treatment of patients with advanced melanoma and in BCC and cSCC in an ongoing Phase II study.
Lead Product(s): Bifikafusp Alfa,Onfekafusp Alfa
Therapeutic Area: Oncology Product Name: Nidlegy
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 February 17, 2022
Details:
Nidlegy, as a neoadjuvant was found to be well-tolerated and 149 out of the anticipated 214 patients have been safely treated in PIVOTAL phase III trial in melanoma patients with locally advanced, fully resectable metastatic cancer.
Lead Product(s): Bifikafusp Alfa,Onfekafusp Alfa
Therapeutic Area: Oncology Product Name: Nidlegy
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 January 13, 2022
Details:
The findings of the study show how Philogen’s proprietary antibody-cytokine fusions, called immunocytokines, demonstrated striking single-agent anti-cancer activity in immunocompetent preclinical models bearing orthotopic glioblastoma.
Lead Product(s): L19TNF
Therapeutic Area: Oncology Product Name: Fibromun
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 08, 2020
Details:
Swiss national competent authority Swissmedic issued the authorization to run a clinical phase II study in patients with locally-advanced, not metastatic nonmelanoma skin cancer. Patients enrolled in the study will be treated with intralesional injections of NidlegyTM.
Lead Product(s): Bifikafusp alfa,Onfekafusp alfa
Therapeutic Area: Oncology Product Name: Nidlegy
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 June 26, 2020