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Details:
Amcenestrant (SAR439859) is an orally bioavailable SERD that demonstrates pure ER antagonism in vivo. Compared with other SERD agents, amcenestrant provides optimal ER antagonism and degradation.
Lead Product(s): Amcenestrant,Letrozole
Therapeutic Area: Oncology Product Name: SAR439859
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 August 17, 2022
Details:
The net proceeds will be used to advance Avenzo’s ARTS-021 (AVZO-021), a potentially best-in-class CDK2 selective inhibitor being studied in an ongoing U.S.-based Phase 1 clinical study for the treatment of HR+/HER2- metastatic breast cancer and other advanced solid tumors.
Lead Product(s): AVZO-021,Fulvestrant,Letrozole
Therapeutic Area: Oncology Product Name: ARTS-021
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: New Enterprise Associates
Deal Size: $150.0 million Upfront Cash: Undisclosed
Deal Type: Series A Financing March 26, 2024
Details:
ON123300 (narazaciclib) is a multi-kinase inhibitor targeting CDK 4, CDK 6, and other kinases important for cell proliferation and motility. It is being investigated in combination with letrozole in recurrent metastatic low-grade endometrioid endometrial cancer (LGEEC).
Lead Product(s): Narazaciclib,Letrozole
Therapeutic Area: Oncology Product Name: ON 123300
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 May 11, 2023
Details:
ONA-XR (onapristone extended release) is a potent and specific antagonist of the progesterone receptor (PR) that is orally administered. ONA-XR is an investigational drug that has not been approved for marketing by any regulatory authority.
Lead Product(s): Onapristone,Letrozole,Palbociclib
Therapeutic Area: Oncology Product Name: ONA-XR
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: The Menarini Group
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration August 02, 2022
Details:
Latest in HR+/HER2- metastatic breast cancer, including data on CDK recycling with Kisqali® plus endocrine therapy, further MONALEESA-2 quality of life and overall survival analyses, and a new biomarker analysis of Piqray® plus fulvestrant.
Lead Product(s): Ribociclib,Letrozole
Therapeutic Area: Oncology Product Name: Kisqali
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Astex Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 12, 2022
Details:
After balancing for baseline demographic and clinical characteristics, median OS (95% CI) was significantly longer in Ibrance (palbociclib) group versus AI group (49.1 [45.2–57.7] vs 43.2 [37.6–48.0] months; hazard ratio (HR) = 0.76 [95% CI, 0.65–0.87]; P=0.0001).
Lead Product(s): Palbociclib,Letrozole
Therapeutic Area: Oncology Product Name: Ibrance
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 04, 2022
Details:
MONALEESA-2 results show a statistically significant more than one-year increase in survival for women with HR+/HER2- postmenopausal aBC when using Kisqali plus letrozole compared to letrozole alone as first-line therapy.
Lead Product(s): Ribociclib,Letrozole
Therapeutic Area: Oncology Product Name: Kisqali
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Astex Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 09, 2022
Details:
MONALEESA-2 final analysis showed Kisqali, a CDK4/6 inhibitor in combination with letrozole has reported statistically significant overall survival benefit with aromatase inhibitor for postmenopausal women with HR+/HER2- advanced breast cancer in first-line (1L) setting.
Lead Product(s): Ribociclib,Letrozole
Therapeutic Area: Oncology Product Name: Kisqali
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Astex Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 19, 2021
Details:
Abstract, titled “Utility of the 70-gene MammaPrint assay for prediction of benefit from extended letrozole therapy in the NRG Oncology/NSABP B-42 trial” detailed a retrospective evaluation of 1,866 samples representing entire cohort.
Lead Product(s): Letrozole
Therapeutic Area: Oncology Product Name: Undisclosed
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 07, 2021
Details:
Kisqali plus endocrine therapy had a median OS of nearly five years (58.7 months), the longest ever reported for premenopausal women with HR+/HER2- metastatic breast cancer (MBC), after a median of 53.5 months follow-up.
Lead Product(s): Ribociclib,Tamoxifen Citrate,Letrozole
Therapeutic Area: Oncology Product Name: Kisqali
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Astex Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 09, 2020
Details:
PENELOPE-B is a randomized, double-blind, placebo-controlled Phase 3 study comparing one year of palbociclib plus at least five years of standard adjuvant endocrine therapy to placebo plus at least five years of standard adjuvant endocrine therapy.
Lead Product(s): Palbociclib,Trastuzumab,Letrozole
Therapeutic Area: Oncology Product Name: Ibrance
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 09, 2020
Details:
Kisqali is the only CDK4/6 inhibitor, in combination with endocrine therapy, to achieve a perfect 5 out of 5 score, confirming substantial benefit for premenopausal women with HR+/HER2- advanced breast cancer, based on strong overall survival benefit in the MONALEESA-7 trial.
Lead Product(s): Ribociclib,Tamoxifen Citrate,Letrozole
Therapeutic Area: Oncology Product Name: Kisqali
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Astex Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 21, 2020
Details:
AWARE-1combines the appropriate intervention for their breast cancer sub-type, plus pelareorep, with or without atezolizumab (Tecentriq®), followed by surgery in early-stage breast cancer.
Lead Product(s): Pelareorep,Atezolizumab,Letrozole
Therapeutic Area: Oncology Product Name: Undisclosed
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 May 04, 2020
Details:
There has been no impact on the continuity of the manufacturing of pelareorep, and Oncolytics is fully capable of supplying pelareorep to all ongoing clinical studies.
Lead Product(s): Pelareorep,Atezolizumab,Letrozole
Therapeutic Area: Oncology Product Name: Undisclosed
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 April 20, 2020