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Details:
The FDA approved COSELA™ (trilaciclib) as the first and only myeloprotection therapy to decrease the incidence of chemotherapy-induced myelosuppression.
Lead Product(s): Trilaciclib,Irinotecan Hydrochloride,Oxaliplatin
Therapeutic Area: Oncology Product Name: Cosela
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: G1 Therapeutics, Inc
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 12, 2021
Details:
G1T28 (trilaciclib) is an IV-administered transient CDK 4/6 inhibitor, which is being evaluated in combination with gemcitabine & carboplatin for the treatment of metastatic triple negative breast cancer.
Lead Product(s): Trilaciclib,Gemcitabine,Carboplatin
Therapeutic Area: Oncology Product Name: Cosela
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 12, 2024
Details:
Cosela (Trilaciclib hydrochloride), an IV-administered transient CDK4/6 inhibitor, is a first-in-class therapy designed to preserve bone marrow and immune system function during chemotherapy to improve patient outcomes.
Lead Product(s): Trilaciclib,Gemcitabine,Carboplatin
Therapeutic Area: Oncology Product Name: Cosela
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 03, 2023
Details:
The data highlight the potential for G1T28 (trilaciclib) to meaningfully reduce adverse events related to use of sacituzumab. As expected, patients with PD-L1(+) tumors appear to respond earlier than patients with PD-L1(-) tumors.
Lead Product(s): Trilaciclib,Sacituzumab Govitecan
Therapeutic Area: Oncology Product Name: Cosela
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 10, 2023
Details:
Cosela (Trilaciclib) is a CDK4 and CDK6 inhibitor, indicated to reduce the incidence of chemotherapy induced myelosuppression in patients before topotecan-containing or platinum and etoposide-containing chemotherapy for extensive stage small cell lung cancer.
Lead Product(s): Trilaciclib,Bevacizumab,Fluorouracil
Therapeutic Area: Oncology Product Name: Cosela
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 13, 2023
Details:
Cosela (Trilaciclib) is a CDK4 and CDK6 inhibitor, indicated to reduce the incidence of chemotherapy induced myelosuppression in patients before topotecan-containing or platinum and etoposide-containing chemotherapy for extensive stage small cell lung cancer.
Lead Product(s): Trilaciclib,Bevacizumab
Therapeutic Area: Oncology Product Name: Cosela
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 09, 2023
Details:
Cosela (Trilaciclib hydrochloride), an IV-administered transient CDK4/6 inhibitor, is a first-in-class therapy designed to preserve bone marrow and immune system function during chemotherapy to improve patient outcomes.
Lead Product(s): Trilaciclib,Gemcitabine,Cisplatin
Therapeutic Area: Oncology Product Name: Cosela
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 04, 2023
Details:
The results show that trilaciclib monotherapy can improve the ratio of CD8+ T cells to Tregs and thus may enhance the overall antitumor immune response and confirm the trends we observed in preclinical studies and in peripheral blood in our Phase 2 trial in TNBC.
Lead Product(s): Trilaciclib,Doxorubicin Hydrochloride,Cyclophosphamide
Therapeutic Area: Oncology Product Name: Cosela
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 07, 2022
Details:
Company intends to use the net proceeds from this offering for working capital and general corporate purposes, including development of Cosela, having trilaciclib hydrochloride.
Lead Product(s): Trilaciclib
Therapeutic Area: Oncology Product Name: Cosela
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Cowen
Deal Size: $50.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering November 22, 2022
Details:
Company intends to use the net proceeds from this offering for working capital and general corporate purposes, including development of Cosela, having trilaciclib hydrochloride.
Lead Product(s): Trilaciclib
Therapeutic Area: Oncology Product Name: Cosela
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Cowen
Deal Size: $50.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering November 17, 2022
Details:
Trilaciclib (Cosela), is well tolerated when administered prior to sacituzumab. Initial data on the first 18 patients show a effect of trilaciclib to reduce (>50%) the rates of multiple adverse events compared to the sacituzumab govitecan-hziy single agent safety profile.
Lead Product(s): Trilaciclib,Sacituzumab Govitecan
Therapeutic Area: Oncology Product Name: Cosela
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 02, 2022
Details:
Cosela (trilaciclib), an IV-administered transient CDK4/6 inhibitor, is a first-in-class therapy designed to preserve bone marrow and immune system function during chemotherapy to improve patient outcomes.
Lead Product(s): Trilaciclib,Lurbinectedin
Therapeutic Area: Oncology Product Name: Cosela
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 26, 2022
Details:
Trilaciclib, an IV-administered transient CDK4/6 inhibitor, is a first-in-class therapy designed to preserve bone marrow and immune system function during chemotherapy to improve patient outcomes.
Lead Product(s): Trilaciclib,Gemcitabine,Carboplatin
Therapeutic Area: Oncology Product Name: Cosela
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 10, 2022
Details:
COSELA® (trilaciclib) is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer.
Lead Product(s): Trilaciclib
Therapeutic Area: Oncology Product Name: Cosela
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Jiangsu Simcere Pharmaceutical
Deal Size: $170.0 million Upfront Cash: $14.0 million
Deal Type: Licensing Agreement July 13, 2022
Details:
Cosela (trilaciclib), an IV-administered transient CDK4/6 inhibitor, is a first-in-class therapy designed to preserve bone marrow and immune system function during chemotherapy to improve patient outcomes. It is approved by the U.S. FDA in another indication.
Lead Product(s): Trilaciclib,Bevacizumab,Irinotecan Hydrochloride
Therapeutic Area: Oncology Product Name: Cosela
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 13, 2022
Details:
Results of post-hoc study analysis showing that ES-SCLC patients who received Cosela (trilaciclib) prior to chemotherapy had a lower incidence of single- and multilineage myelosuppressive events compared to patients receiving placebo.
Lead Product(s): Trilaciclib
Therapeutic Area: Hematology Product Name: Cosela
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 02, 2022
Details:
Results showed that the use of trilaciclib prior to chemotherapy was associated with a 50% reduction in the percent of patients with grade ≥ 3 myelosuppressive hematologic adverse events in at least one blood cell lineage and 74% reduction in the percent.
Lead Product(s): Trilaciclib,Irinotecan Hydrochloride,Oxaliplatin
Therapeutic Area: Oncology Product Name: G1T28
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 31, 2022
Details:
The Phase 2 immunologic data analysis suggests that administering trilaciclib prior to chemotherapy may enhance antitumor efficacy by modulating the composition and response of immune cell subsets,” said John Yi, PhD, Director of Translational Medicine at G1 Therapeutics.
Lead Product(s): Trilaciclib,Gemcitabine,Carboplatin
Therapeutic Area: Oncology Product Name: Cosela
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 12, 2021
Details:
COSELA™ (trilaciclib) is first-in-class myelopreservation therapy decrease the incidence of chemotherapy-induced myelosuppression when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer.
Lead Product(s): Trilaciclib
Therapeutic Area: Oncology Product Name: Cosela
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 07, 2021
Details:
PRESERVE 4 will evaluate the survival and myeloprotection benefits of COSELA™ (trilaciclib) in 146 patients with non-small cell lung cancer (NSCLC) previously treated with checkpoint inhibitors.
Lead Product(s): Trilaciclib
Therapeutic Area: Oncology Product Name: Cosela
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 10, 2021
Details:
Trilaciclib significantly improved overall survival (OS) for patients treated with trilaciclib in combination with a chemotherapy regimen of gemcitabine/carboplatin (GC) compared with GC alone.
Lead Product(s): Trilaciclib,Carboplatin,Gemcitabine
Therapeutic Area: Oncology Product Name: G1T28
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 09, 2020
Details:
Trilaciclib is a first-in-class investigational therapy designed to improve outcomes for people with cancer treated with chemotherapy. G1 abstract titles are below; more details are available on the International Association for the Study of Lung Cancer (IASLC).
Lead Product(s): Trilaciclib,Carboplatin,Etoposide
Therapeutic Area: Oncology Product Name: G1T28
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 15, 2020
Details:
FDA has accepted the New Drug Application (NDA) for trilaciclib for small cell lung cancer (SCLC) patients being treated with chemotherapy and granted Priority Review with a Prescription Drug User Fee Act (PDUFA) action date of February 15, 2021.
Lead Product(s): Trilaciclib,Carboplatin,Etoposide
Therapeutic Area: Oncology Product Name: G1T28
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 17, 2020
Details:
Discovered and developed by G1, trilaciclib is a first-in-class investigational therapy designed to improve outcomes for people with cancer treated with chemotherapy.
Lead Product(s): Trilaciclib
Therapeutic Area: Oncology Product Name: G1T28
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Simcere
Deal Size: $170.0 million Upfront Cash: $14.0 million
Deal Type: Licensing Agreement August 03, 2020
Details:
G1 and Boehringer Ingelheim will collaborate on the commercialization of trilaciclib for its first potential indication in small cell lung cancer, with the B.I's oncology commercial team, well-established in lung cancer, leading sales force engagement initiatives.
Lead Product(s): Trilaciclib
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: G1 Therapeutics, Inc
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement June 30, 2020
Details:
Trilaciclib significantly reduced myelosuppression and need for related supportive care interventions for patients with small cell lung cancer (SCLC) receiving chemotherapy.
Lead Product(s): Trilaciclib,Carboplatin,Etoposide
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 13, 2020
Details:
The I-SPY 2 TRIAL is designed to evaluate agents with the goal of accelerating the pace of promising effective and potentially less toxic treatments to patients who are most likely to benefit quickly.
Lead Product(s): Trilaciclib,Paclitaxel
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 14, 2020
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