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Under the collaboration, Greenwich initiated its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent HER2 positive breast cancer recurrences.
Lead Product(s): GLSI-100
Therapeutic Area: Oncology Product Name: GLSI-100
Highest Development Status: Phase IIIProduct Type: Vaccine
Partner/Sponsor/Collaborator: GEICAM
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration March 12, 2024
Details:
GLSI-100 (GP2 + GM-CSF) is a biologic nine amino acid peptide of the HER2/neu protein delivered in combination with GM-CSF that stimulates an immune response targeting HER2/neu expressing cancers. It is being evaluated for HER2/neu positive breast cancer.
Lead Product(s): GP2 Peptide,GM-CSF
Therapeutic Area: Oncology Product Name: GLSI-100
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 27, 2024
Details:
GLSI-100 is an immunotherapeutic agent created for the treatment of HLA-A*02-positive patients with HER2/neu-positive disease at high risk of recurrence following completion of neoadjuvant and adjuvant standard of care therapy.
Lead Product(s): GLSI-100
Therapeutic Area: Oncology Product Name: GLSI-100
Highest Development Status: Phase IIIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 11, 2022
Details:
FLAMINGO-01 is Phase III clinical trial designed to evaluate safety and efficacy of GLSI-100 in HER2/neu breast cancer patients who had disease or high-risk pathologic complete response at surgery and who have completed both postoperative adjuvant trastuzumab based treatment.
Lead Product(s): GLSI-100
Therapeutic Area: Oncology Product Name: GLSI-100
Highest Development Status: Phase IIIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 03, 2022
Details:
GLSI-100 incorporates granulocyte-macrophage colony-stimulating factor and sargramostim, which contribute to the development of white blood cells and cells that become platelets; and GP2, which is a 9 amino acid transmembrane peptide of the HER2/neu protein.
Lead Product(s): GLSI-100
Therapeutic Area: Oncology Product Name: GLSI-100
Highest Development Status: Phase IIIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 12, 2022
Details:
GLSI-100 incorporates granulocyte-macrophage colony-stimulating factor and sargramostim, which contribute to the development of white blood cells and cells that become platelets; and GP2, which is a 9 amino acid transmembrane peptide of the HER2/neu protein.
Lead Product(s): GLSI-100
Therapeutic Area: Oncology Product Name: GLSI-100
Highest Development Status: Phase IIIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 23, 2022
Details:
The study demonstrated that GLSI-100, an immunotherapy safely elicited a potent immune response, as evidenced by injection site reactions that correlate to and may serve as a complement to immune response data such as DTH.
Lead Product(s): GP2 Peptide,GM-CSF
Therapeutic Area: Oncology Product Name: GLSI-100
Highest Development Status: Phase IIIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 19, 2022
Details:
With completion of three clinical lots of GP2 for use in Flamingo-01 trial, and in any additional clinical trials run in parallel, Company intends to file additional patent claims surrounding manufacturing of GP2 and the administration of GLSI-100 immunotherapy.
Lead Product(s): GP2 Peptide,GM-CSF
Therapeutic Area: Oncology Product Name: GLSI-100
Highest Development Status: Phase IIIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 03, 2022
Details:
GLSI-100 (GP2 and GM-CSF), immunotherapy to prevent breast cancer Phase III clinical trial critical steps toward study initiation have been completed, including manufacturing, contracting with clinical trial partners, and setting up infrastructure.
Lead Product(s): GP2 Peptide,GM-CSF
Therapeutic Area: Oncology Product Name: GLSI-100
Highest Development Status: Phase IIIProduct Type: Vaccine
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 01, 2022
Details:
GP2 immunotherapy generated GP2-specific immune responses, leading to no metastatic breast cancer recurrence in the HER2/neu 3+ population in the Phase IIb clinical trial, thus supporting GP2’s mechanism of action.
Lead Product(s): GP2 Peptide,GM CSF
Therapeutic Area: Oncology Product Name: GP2
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 10, 2021
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