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CD38-SADA is the program within its Self-Assembly DisAssembly Pre-targeted Radioimmunotherapy Theranostic Platform (SADA Y-PRIT), and is being investigated for the treatment of Relapsed or Refractory non-Hodgkin Lymphoma.
Lead Product(s): CD38-SADA,177Lu-DOTA
Therapeutic Area: Oncology Product Name: CD38-SADA
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 October 17, 2023
Details:
Danyelza® (naxitamab-gqgk) binds to the glycolipid GD2, indicated in combination with GMCSF, for the treatment of relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response to prior therapy.
Lead Product(s): Naxitamab-gqgk,GM-CSF
Therapeutic Area: Oncology Product Name: Danyelza
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 23, 2023
Details:
The GD2-SADA construct was created using the Company’s SADA platform. SADA utilizes a pre-targeted payload delivery method where antibody constructs assemble in tetramers and bind to the tumor target.
Lead Product(s): GD2-SADA,177Lu-DOTA
Therapeutic Area: Oncology Product Name: GD2-SADA
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 05, 2023
Details:
Danyelza® (naxitamab-gqgk) binds to the glycolipid GD2, indicated in combination with GMCSF, for the treatment of relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response to prior therapy.
Lead Product(s): Naxitamab-gqgk,GM-CSF
Therapeutic Area: Oncology Product Name: Danyelza
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 02, 2023
Details:
Danyelza (naxitamab-gqgk) is a humanized, monoclonal antibody that binds to the glycolipid GD2. GD2 is a disialoganglioside that is overexpressed on neuroblastoma cells and other cells of neuroectodermal origin, including the central nervous system and peripheral nerves.
Lead Product(s): Naxitamab-gqgk,GM-CSF
Therapeutic Area: Oncology Product Name: Danyelza
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: WEP Clinical
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership December 21, 2022
Details:
CHMP considered that it was not possible to conclude on the effectiveness of omburtamab as the main study did not have a randomized comparator.
Lead Product(s): 131I-omburtamab
Therapeutic Area: Oncology Product Name: Omblastys
Highest Development Status: Phase II/ Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 16, 2022
Details:
DANYELZA (naxitamab) is a humanized, monoclonal antibody that targets the ganglioside GD2, which is highly expressed in various neuroectoderm-derived tumors and sarcomas. DANYELZA is administered three times in a week in an outpatient setting and is repeated every four weeks.
Lead Product(s): Naxitamab,GM-CSF
Therapeutic Area: Oncology Product Name: Danyelza
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 08, 2022
Details:
Omblastys® (131I-omburtamab) is being developed for the treatment of CNS/LM metastases in pediatric patients with neuroblastoma. 131I-omburtamab is an iodine-131 radiolabeled murine monoclonal antibody that recognizes and binds selectively to the B7-H3 antigen.
Lead Product(s): 131I-omburtamab
Therapeutic Area: Oncology Product Name: Omblastys
Highest Development Status: Phase II/ Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 01, 2022
Details:
Omblastys (omburtamab), a radiolabeled monoclonal antibody 8H9, is being developed to target B7-H3–expressing cells in human solid tumors, including embryonal tumors, carcinomas, sarcomas, and brain tumors.
Lead Product(s): 131I-omburtamab
Therapeutic Area: Oncology Product Name: Omblastys
Highest Development Status: Phase II/ Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 28, 2022
Details:
OMBLASTYS® (131I-omburtamab),targets tumors that express B7-H3 for the treatment of CNS/leptomeningeal metastasis from neuroblastoma, interim results for 32 patients enrolled showed twelve-month overall survival (“OS”) of 73.5%, with a median follow-up of 25 months.
Lead Product(s): 131I-omburtamab
Therapeutic Area: Oncology Product Name: Omblastys
Highest Development Status: Phase II/ Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 03, 2022
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