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Details:
Verzenio (abemaciclib) is a small molecule CDK4/CD6 inhibitor which is under phase 3 clinical development in combination with anastrozole for the treatment of post-menopausal patients with HR+/HER2-, advanced or metastatic breast cancer.
Lead Product(s): Abemaciclib,Anastrozole
Therapeutic Area: Oncology Product Name: Verzenio
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 December 05, 2023
Details:
eFT226 (zotatifin) is a potent and sequence-selective small molecule inhibitor of the RNA helicase eIF4A. It is being evaluated in combination with fulvestrant and abemaciclib for treatment of ER+/HER2- advanced metastatic breast cancer.
Lead Product(s): Zotatifin,Fulvestrant,Abemaciclib
Therapeutic Area: Oncology Product Name: eFT226
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 28, 2023
Details:
VERU-024 (enobosarm), a selective androgen receptor modulator, into a Phase 2b clinical trial in combination with semaglutide to evaluate the efficacy and the safety of enobosarm to further increase fat loss.
Lead Product(s): Enobosarm,Abemaciclib,Tirzepatide
Therapeutic Area: Nutrition and Weight Loss Product Name: VERU-024
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 October 04, 2023
Details:
Under the collaboration, Eli Lilly will supply CDK4/6 inhibitor Verzenio (abemaciclib) for use in combination with BBI-355, an oral, selective small molecule inhibitor of CHK1, in a clinical trial for locally advanced or metastatic solid tumors with oncogene amplifications.
Lead Product(s): BBI-355,Abemaciclib
Therapeutic Area: Oncology Product Name: BBI-355
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Eli Lilly
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration September 19, 2023
Details:
VERU-024 (enobosarm), a first-in-class, oral, non-steroidal, selective androgen receptor agonist, which is investigating for the treatment of metastatic setting of AR+ER+HER2- breast cancer.
Lead Product(s): Enobosarm,Abemaciclib
Therapeutic Area: Oncology Product Name: VERU-024
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Eli Lilly
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 11, 2023
Details:
The funding will be used to develop oncology therapeutics for indications of high unmet need, including VERU-024 (enobosarm), a first-in-class, oral, non-steroidal, selective androgen receptor agonist.
Lead Product(s): Enobosarm,Abemaciclib
Therapeutic Area: Oncology Product Name: VERU-024
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: U.S. Department of Defense
Deal Size: $3.9 million Upfront Cash: Undisclosed
Deal Type: Funding June 21, 2023
Details:
Verzenio (abemaciclib) is an inhibitor of CDK4 and CDK6. In estrogen receptor-positive (ER+) breast cancer cell lines, cyclin D1 and CDK4/6 promote phosphorylation of the retinoblastoma protein, cell cycle progression, and cell proliferation.
Lead Product(s): Abemaciclib
Therapeutic Area: Oncology Product Name: Verzenio
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 03, 2023
Details:
Imlunestrant (LY3484356) is an investigational, oral selective estrogen receptor degrader (SERD) with pure antagonistic properties. The estrogen receptor (ER) is the key therapeutic target for patients with ER+/HER2- breast cancer.
Lead Product(s): Imlunestrant,Abemaciclib,Trastuzumab
Therapeutic Area: Oncology Product Name: LY3484356
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 November 21, 2022
Details:
Lasofoxifene is an investigational, nonsteroidal selective estrogen receptor modulator (SERM), which has been studied in previous comprehensive Phase 1-3 non-oncology clinical trials in more than 15,000 postmenopausal women worldwide.
Lead Product(s): Lasofoxifene,Abemaciclib
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Ligand Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 14, 2022
Details:
Verzenio® (abemaciclib) is a targeted treatment known as a CDK4/6 inhibitor. Verzenio is a nonchemotherapy oral tablet.Verzenio works inside the cell to block CDK4/6 activity and help stop growth of cancer cells so that they may eventually die (based on preclinical studies).
Lead Product(s): Abemaciclib
Therapeutic Area: Oncology Product Name: Verzenio
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 07, 2022
Details:
Verzenio® (abemaciclib), is a targeted treatment known as CDK4/6 inhibitor. Verzenio is a non-chemotherapy oral tablet. Verzenio works inside the cell to block CDK4/6 activity and help stop the growth of cancer cells, so they may eventually die (based on preclinical studies).
Lead Product(s): Abemaciclib,Enobosarm
Therapeutic Area: Oncology Product Name: Verzenio
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Eli Lilly
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 31, 2022
Details:
Verzenio® (abemaciclib) is a targeted treatment known as a CDK4/6 inhibitor. Verzenio is a non-chemotherapy oral tablet. Verzenio works inside the cell to block CDK4/6 activity and help stop the growth of cancer cells, so they may eventually die (based on preclinical studies).
Lead Product(s): Abemaciclib
Therapeutic Area: Oncology Product Name: Verzenio
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 27, 2022
Details:
The objective of the collaboration is to evaluate the efficacy and safety of enobosarm, Veru’s, selective androgen receptor targeting agonist, in combination with Lilly’s Verzenio (abemaciclib), a CDK4/6 inhibitor, as a treatment of AR+ER+HER2- metastatic breast cancer.
Lead Product(s): Abemaciclib,Enobosarm
Therapeutic Area: Oncology Product Name: Verzenio
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Eli Lilly
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration February 01, 2022
Details:
Verzenio® abemaciclib is a targeted treatment known as a CDK4/6 inhibitor. Verzenio works inside the cell to block CDK4/6 activity and help stop the growth of cancer cells, so they may eventually die (based on preclinical studies).
Lead Product(s): Abemaciclib,Tamoxifen Citrate
Therapeutic Area: Oncology Product Name: Verzenio
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 28, 2021
Details:
Based on results, Verzenio may require dose modification. Monitor patients for signs and symptoms of thrombosis and pulmonary embolism and treat as medically appropriate. Advise patients of potential risk to a fetus and to use effective contraception.
Lead Product(s): Abemaciclib,Tamoxifen Citrate
Therapeutic Area: Oncology Product Name: Verzenio
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Agilent Technology Inc
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 13, 2021
Details:
Lilly has tapped Care Access in its phase III breast cancer clinical trial, eMonarcHER, designed to evaluate the safety and efficacy of Abemaciclib (LY2835219) in participants with hormone receptor positive and human epidermal receptor 2 positive, early breast cancer.
Lead Product(s): Abemaciclib,Endocrine Therapy
Therapeutic Area: Oncology Product Name: LY2835219
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Eli Lilly
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership September 28, 2021
Details:
Data from monarchE study for Verzenio® (abemaciclib), CDK)4/6 inhibitor used in combination with endocrine therapy used in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2) high risk early breast cancer abemaciclib).
Lead Product(s): Abemaciclib,Tamoxifen Citrate
Therapeutic Area: Oncology Product Name: Verzenio
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 September 27, 2021
Details:
This analysis revealed the addition of Verzenio to ET did not result in a clinically meaningful difference in patients reporting being bothered by treatment side effects.
Lead Product(s): Abemaciclib,Standard adjuvant endocrine therapy
Therapeutic Area: Oncology Product Name: Verzenio
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 March 17, 2021
Details:
In Phase 3 monarchE trial, Verzenio® (abemaciclib) in combination with standard adjuvant endocrine therapy (ET) decreased the risk of breast cancer recurrence by 28.7% compared to standard adjuvant ET alone for people with HR+/HER2- high risk early breast cancer.
Lead Product(s): Abemaciclib,Standard adjuvant endocrine therapy
Therapeutic Area: Oncology Product Name: Verzenio
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 December 09, 2020
Details:
The National Comprehensive Cancer Network® (NCCN®) Oncology Research Program (ORP) announced five projects selected to receive funding for clinical and preclinical evaluation of abemaciclib.
Lead Product(s): Abemaciclib
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: National Comprehensive Cancer Network
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Funding December 03, 2020
Details:
The open-label, multi-center study will evaluate the safety of lasofoxifene in combination with abemaciclib for the treatment of pre- and postmenopausal women with locally advanced metastatic estrogen receptor-positive (ER+)/HER2- breast cancer and an ESR1 mutation.
Lead Product(s): Lasofoxifene,Abemaciclib
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Eli Lilly
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 13, 2020
Details:
With the recent Health Canada agreement to proceed, the open-label, randomized Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE 1, NCT03781063) study will now include Exactis Network sites in Quebec, Ontario, Nova Scotia and New Brunswick.
Lead Product(s): Lasofoxifene,Abemaciclib
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Sermonix
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership September 30, 2020
Details:
Verzenio in combination with endocrine therapy is the only CDK4 & 6 inhibitor to demonstrate a statistically significant improvement in invasive disease-free survival (IDFS) in early breast cancer.
Lead Product(s): Abemaciclib,Adjuvant Endocrine Therapy
Therapeutic Area: Oncology Product Name: Verzenio
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 September 20, 2020
Details:
A final overall survival analysis showed that the addition of tamoxifen to abemaciclib demonstrated a median OS of more than 24 months with progression-free survival consistent to primary study results in patients with HR-positive, HER2-negative metastatic breast cancer.
Lead Product(s): Abemaciclib,Tamoxifen Citrate
Therapeutic Area: Oncology Product Name: Verzenio
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 September 19, 2020
Details:
LY3499446 is an orally available inhibitor of the oncogenic KRAS substitution mutation, G12C, with potential antineoplastic activity.
Lead Product(s): LY3499446,Abemaciclib
Therapeutic Area: Oncology Product Name: LY3499446
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 30, 2020
Details:
Zentalis will evaluate the combination of ZN-c5, the Company’s oral selective estrogen receptor degrader (SERD) product candidate, and Verzenio® (abemaciclib), Lilly’s CDK4 and 6 inhibitor, in patients with ER+/HER2- advanced breast cancer.
Lead Product(s): ZN-c5,Abemaciclib
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Zentalis Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration July 27, 2020
Details:
Results from a pre-planned interim analysis of the Phase 3 monarchE study demonstrate a statistically significant reduction in the risk of cancer recurrence for people with high risk hormone receptor-positive (HR+), HER2- early breast cancer.
Lead Product(s): Abemaciclib,Adjuvant Endocrine Therapy
Therapeutic Area: Oncology Product Name: Verzenio
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 16, 2020