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Details:
UTD1 (utidelone) is the only approved innovative microtubule inhibitor developed using synthetic biology technology. It is being evaluated for the treatment of breast cancer brain metastasis.
Lead Product(s): Utidelone,Bevacizumab,Etoposide
Therapeutic Area: Oncology Product Name: UTD1
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 March 29, 2024
Details:
BPI 2358 (Plinabulin) is a potent dendritic cell maturation agent, which is being evaluated in combination with pembrolizumab plus etoposide/platinum for the treatment of small cell lung cancer extensive stage.
Lead Product(s): Plinabulin,Pembrolizumab,Etoposide
Therapeutic Area: Oncology Product Name: BPI 2358
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 March 25, 2024
Details:
APL-106 (uproleselan) is an investigational, first-in-class E-selectin antagonist, which is under phase 3 clinical development for the treatment of of adults with relapsed or refractory acute myeloid leukemia (relapsed/refractory AML).
Lead Product(s): Uproleselan,Mitoxantrone,Etoposide
Therapeutic Area: Oncology Product Name: APL-106
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 03, 2024
Details:
Hansizhuang (serplulimab) is a novel humanized monoclonal anti-PD-1 antibody, which is approved for the first-line treatment of extensive stage small cell lung cancer in combination with fluorouracil and etoposide.
Lead Product(s): Serplulimab,Cisplatin,Etoposide
Therapeutic Area: Oncology Product Name: Hansizhuang
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 25, 2023
Details:
Henlius will utilize OncoHost's PROphet® platform to identify exploratory, correlative biomarkers for Phase III trial evaluating the efficacy and safety of serplulimab, a novel anti-PD-1 antibody, in patients with Extensive-Stage Small Cell Lung Cancer.
Lead Product(s): Serplulimab,Carboplatin,Etoposide
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Hengenix Biotech
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement October 03, 2023
Details:
GMI-1271 (uproleselan) is designed to bind to E-selection and block the normal processes controlled by E-selectin. E-selectin is expressed on the surface of blood vessels, and its binding to myeloid cells confers a pro-survival effect via NF-kB signaling.
Lead Product(s): Uproleselan,Mitoxantrone,Etoposide
Therapeutic Area: Oncology Product Name: GMI-1271
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 15, 2023
Details:
Debio 0123 is a brain-penetrant, highly selective WEE1 kinase inhibitor combines with standard-of-care therapy to short-circuit DNA damage repair (DDR) in adults with recurrent or progressive small cell lung cancer (SCLC).
Lead Product(s): Debio 0123,Etoposide,Carboplatin
Therapeutic Area: Oncology Product Name: Debio 0123
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 May 30, 2023
Details:
Hansizhuang (serplulimab) is a novel humanized monoclonal anti-PD-1 antibody, which is approved for the first-line treatment of extensive stage small cell lung cancer in combination with carboplatin and etoposide.
Lead Product(s): Serplulimab,Carboplatin,Etoposide
Therapeutic Area: Oncology Product Name: Hansizhuang
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 17, 2023
Details:
Ivonescimab (also known as AK112) is an anti-programmed death 1 (PD-1) and anti-vascular endothelial growth factor (VEGF) bispecific antibody. Ivonescimab blocks PD-1 binding to PD-L1 and PD-L2, and blocks VEGF binding to VEGF receptors.
Lead Product(s): Ivonescimab,Etoposide,Carboplatin
Therapeutic Area: Oncology Product Name: AK112
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 October 31, 2022
Details:
ZKAB001 (Socazolimab) (anti-PD-L1 monoclonal antibody) was discovered by Sorrento from its fully human antibody G-MABTM library and licensed by China Oncology Focus Limited (“COF”), a Lee’s Pharm subsidiary, for the Great China Territories.
Lead Product(s): Socazolimab,Carboplatin,Etoposide
Therapeutic Area: Oncology Product Name: ZKAB001
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Sorrento Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 17, 2022
Details:
Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function).
Lead Product(s): Toripalimab,Etoposide
Therapeutic Area: Oncology Product Name: JS001
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Shanghai Junshi Biosciences
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 14, 2022
Details:
Sulanda (Surufatinib), a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptors and fibroblast growth factor receptor.
Lead Product(s): Surufatinib,Toripalimab,Etoposide
Therapeutic Area: Oncology Product Name: Sulanda
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 10, 2021
Details:
HLX10 (Serplulimab) in combination with chemotherapy showed a significant improvement in OS against chemotherapy, which met the pre-defined efficacy criteria, with good safety and no detection of a new safety signal.
Lead Product(s): Serplulimab,Carboplatin,Etoposide
Therapeutic Area: Oncology Product Name: HLX10
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 07, 2021
Details:
The primary endpoint of APL-106 is overall survival and Secondary outcome measures the rate and duration of remission, and whether APL-106 can reduce the rate of oral mucositis, a chemotherapy-related side effect.
Lead Product(s): Uproleselan,Mitoxantrone,Etoposide
Therapeutic Area: Oncology Product Name: APL-106
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 22, 2021
Details:
The initiation of this Phase 3 trial is based on the very encouraging results from an earlier Phase Ib trial in which Socazolimab combined with carboplatin and etoposide showed a promising efficacy and safety profile in patients with extensive-stage small-cell lung cancer.
Lead Product(s): Socazolimab,Carboplatin,Etoposide
Therapeutic Area: Oncology Product Name: ZKAB001
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Sorrento Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 23, 2021
Details:
Phase 1b/2 clinical trial utilizes LB-100 as a single agent in the treatment of patients with low and intermediate-1 risk MDS, including patients with del(5q) myelodysplastic syndrome (del5qMDS) failing first line therapy.
Lead Product(s): LB-100,Carboplatin,Etoposide
Therapeutic Area: Oncology Product Name: LB-100
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: City of Hope
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 07, 2021
Details:
In the Phase 1b trial of LB-100 for the treatment of ED-SCLC, Lixte’s lead compound will be given in combination with carboplatin, etoposide and atezolizumab, an FDA approved but marginally effective regimen, in previously untreated ED-SCLC.
Lead Product(s): LB-100,Carboplatin,Etoposide
Therapeutic Area: Oncology Product Name: LB-100
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: City of Hope
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 02, 2021
Details:
APL-106 (uproleselan) has been granted Breakthrough Therapy Designation (BTD) from the China National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) for the treatment of relapsed/refractory acute myeloid leukemia (AML).
Lead Product(s): Uproleselan,Mitoxantrone,Etoposide
Therapeutic Area: Oncology Product Name: APL-106
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 07, 2021
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:
This approval enables the initiation of a Phase 1 pharmacokinetic (PK) and tolerability study and includes acceptance of a Phase 3 bridging study of APL-106 in combination with chemotherapy in relapsed/refractory acute myeloid leukemia (AML).
Lead Product(s): Uproleselan,Mitoxantrone,Etoposide
Therapeutic Area: Oncology Product Name: APL-106
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: GlycoMimetics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 27, 2020
Details:
The combination of the three agents, iadademstat and carboplatin-etoposide, produced encouraging signs of clinical efficacy, with an objective response rate (ORR) of 40% (4 partial remissions in 10 patients) and a mean duration of response of 4.5 months.
Lead Product(s): Iadademstat,Carboplatin,Etoposide
Therapeutic Area: Oncology Product Name: ORY-1001
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 17, 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:
The ten year SIOPEN High-Risk Neuroblastoma Clinical Trial 2 (HR-NBL2) is a Phase III clinical trial designed to evaluate potential treatment pathways for children identified with the disease.
Lead Product(s): Vincristine Sulfate,Carboplatin,Etoposide
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: $0.7 million Upfront Cash: Undisclosed
Deal Type: Funding May 21, 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:
High-level results from the final analysis of the Phase III CASPIAN trial showed Imfinzi in combination with a choice of standard-of-care chemotherapies confirmed a sustained overall survival benefit.
Lead Product(s): Durvalumab,Tremelimumab,Etoposide
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 17, 2020