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Details:
The acquisition adds AnHeart’s lead asset, AB-106 (taletrectinib), a next-generation, potentially best-in-class ROS1 inhibitor with Breakthrough Therapy Designations currently completing two pivotal studies for patients with ROS1-positive non-small cell lung cancer.
Lead Product(s): Taletrectinib
Therapeutic Area: Oncology Product Name: AB-106
Highest Development Status: Phase IIProduct Type: Small molecule
Recipient: AnHeart Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition April 10, 2024
Details:
The acquisition adds AnHeart’s lead asset, AB-106 (taletrectinib), a next-generation, potentially best-in-class ROS1 inhibitor with Breakthrough Therapy Designations currently completing two pivotal studies for patients with ROS1-positive non-small cell lung cancer.
Lead Product(s): Taletrectinib
Therapeutic Area: Oncology Product Name: AB-106
Highest Development Status: Phase IIProduct Type: Small molecule
Recipient: AnHeart Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition March 25, 2024
Details:
NUV-1511, the first clinical DDC platform candidate, being evaluated for advanced solid tumors (HER2-negative metastatic breast cancer, metastatic castration-resistant prostate cancer) who previously received and progressed on or after treatment with Enhertu and/or Trodelvy.
Lead Product(s): NUV-1511
Therapeutic Area: Oncology Product Name: NUV-1511
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 March 14, 2024
Details:
NUV-1511 is the first clinical candidate from the company’s novel drug-drug conjugate (DDC) platform. It is being evaluated in preclinical studies for the treatment of advanced solid tumors.
Lead Product(s): NUV-1511
Therapeutic Area: Oncology Product Name: NUV-1511
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 08, 2024
Details:
Patients in the first regimen will be dosed with NUV-868 in combination with olaparib for the treatment of ovarian cancer, pancreatic cancer, metastatic castration-resistant prostate cancer (mCRPC), triple negative breast cancer and other solid tumors.
Lead Product(s): NUV-868,Olaparib
Therapeutic Area: Oncology Product Name: NUV-868
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 December 19, 2022
Details:
Decision to discontinue development of NUV-422 is result of an internal risk-benefit analysis factoring in feedback received from U.S. FDA in partial clinical hold letter for monotherapy Phase 1/2 study and clinical hold letters for its combination Phase 1b/2 studies.
Lead Product(s): NUV-422,Enzalutamide
Therapeutic Area: Oncology Product Name: NUV-422
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 August 01, 2022
Details:
Preclinical studies have shown that NUV-422 has favorable blood-brain barrier penetration. NUV-422 is also designed to limit CDK1 inhibition, a potential cause of toxicity in other second-generation inhibitors.
Lead Product(s): NUV-422
Therapeutic Area: Oncology Product Name: NUV-422
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 June 24, 2022
Details:
NUV-422, a selective small-molecule cyclin-dependent kinase (CDK) 2/4/6 inhibitor, has also received ODD for the treatment of patients with malignant gliomas and FTD for the treatment of high-grade gliomas from USFDA.
Lead Product(s): NUV-422
Therapeutic Area: Oncology Product Name: NUV-422
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 January 10, 2022
Details:
Company announced that the USFDA has granted FTD to NUV-422, a cyclin-dependent kinase (CDK) 2/4/6 inhibitor, for the treatment of patients with high-grade gliomas, including glioblastoma multiforme.
Lead Product(s): NUV-422
Therapeutic Area: Oncology Product Name: NUV-422
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 December 15, 2021
Details:
NUV-422 is a selective small molecule resulting from Nuvation Bio's CDK inhibitor program. Patient enrollment and dosing is ongoing in the Phase 1/2 study of NUV-422 in adult patients with recurrent or refractory high-grade gliomas, including glioblastoma multiforme (GBM).
Lead Product(s): NUV-422
Therapeutic Area: Oncology Product Name: NUV-422
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 March 11, 2021
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