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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:
BPI-2358 (plinabulin) triggers the release of the immune defense protein, GEF-H1, which leads to a durable anticancer benefit due to the maturation of dendritic cells resulting in the activation of tumor antigen-specific T-cells to target cancer cells.
Lead Product(s): Plinabulin,Docetaxel,Pembrolizumab
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 01, 2023
Details:
BPI-2358 (Plinabulin), BeyondSpring’s lead asset, is a selective immunomodulating microtubule-binding agent, which is a potent antigen presenting cell (APC) inducer that is being developed as an anticancer agent.
Lead Product(s): Plinabulin,Docetaxel
Therapeutic Area: Hematology Product Name: BPI-2358
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 13, 2022
Details:
Plinabulin (BPI-2358) exerts early-onset of action in the prevention of chemotherapy-induced neutropenia (CIN) by boosting the number of hematopoietic stem/progenitor cells (HSPCs).
Lead Product(s): Plinabulin,Pegfilgrastim
Therapeutic Area: Hematology Product Name: BPI-2358
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 13, 2022
Details:
Plinabulin triggers the release of the immune defense protein, GEF-H1, which leads to two distinct effects: first is a durable anticancer benefit due to the maturation of dendritic cells resulting in the activation of tumor antigen-specific T-cells to target cancer cells.
Lead Product(s): Plinabulin,Pegfilgrastim
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 August 29, 2022
Details:
Plinabulin (BPI-2358) in combination with docetaxel (DP) showed statistically significant overall survival improvements compared to docetaxel alone (D) for the ITT population (DP: n=278; D: n=281).
Lead Product(s): Plinabulin,Pegfilgrastim
Therapeutic Area: Hematology Product Name: BPI-2358
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 May 27, 2022
Details:
Plinabulin is a first-in-class selective immunomodulating microtubule-binding agent (SIMBA) with potential chemotherapy-induced neutropenia (CIN) prevention and anticancer benefits.
Lead Product(s): Plinabulin,Pegfilgrastim
Therapeutic Area: Oncology Product Name: BPI-2358
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 April 28, 2022
Details:
Plinabulin is a selective immunomodulating microtubule-binding agent (SIMBA), which triggers the release of the immune defense protein, GEF-H1. The plinabulin and G-CSF combination for the prevention of CIN has demonstrated positive Phase 3 data.
Lead Product(s): Plinabulin,Pegfilgrastim,Docetaxel
Therapeutic Area: Oncology Product Name: BPI-2358
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 01, 2021
Details:
DUBLIN-3 Phase 3 registrational trial of its first-in-class lead asset, plinabulin, in combination with docetaxel used for the treatment of 2nd/3rd line NSCLC patients with EGFR wild type. Plinabulin is a selective immunomodulating microtubule-binding agent.
Lead Product(s): Plinabulin,Docetaxel
Therapeutic Area: Oncology Product Name: BPI-2358
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, 2021
Details:
Plinabulin, a selective immunomodulating microtubule-binding agent (SIMBA), being developed with docetaxel as combination in patients with NSCLC.
Lead Product(s): Plinabulin,Docetaxel
Therapeutic Area: Oncology Product Name: BPI-2358
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 17, 2021
Details:
Applications are supported by positive PROTECTIVE-2 Phase 3 data demonstrating that plinabulin in combination with G-CSF offers greater protection against CIN than the standard of care, G-CSF alone.
Lead Product(s): Plinabulin,Pegfilgrastim,Docetaxel
Therapeutic Area: Oncology Product Name: BPI-2358
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 31, 2021
Details:
Plinabulinin combination with pegfilgrastim met the primary endpoint with statisticallysignificant improvement in the rate of prevention of Grade 4 neutropenia in Cycle1, as well as achieving statistical significancein all key secondary endpoints.
Lead Product(s): Plinabulin,Pegfilgrastim
Therapeutic Area: Oncology Product Name: BPI-2358
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 16, 2020
Details:
The manuscript analyzed BeyondSpring’s Phase 2 portion of its PROTECTIVE-1 randomized clinical trial, which consisted of four treatment arms and was conducted in 19 treatment centers in the U.S., China, Russia and Ukraine from April 2017 through March 2018.
Lead Product(s): Plinabulin
Therapeutic Area: Oncology Product Name: BPI-2358
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 29, 2020
Details:
In the protocol-specified interim analysis, Plinabulin, in combination with Neulasta, was significantly better than Neulasta alone in achieving the primary endpoint, along with a well-tolerated safety profile and fewer Grade 4 adverse events, compared to Neulasta alone.
Lead Product(s): Plinabulin,Pegfilgrastim
Therapeutic Area: Oncology Product Name: BPI-2358
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 08, 2020
Details:
Company presented clinical data on BeyondSpring’s first-in-class, late-stage asset, Plinabulin, showing potent CD34+ progenitor cell mobilization from bone marrow, which has broad applications for stem cell-based therapies, gene therapy and regenerative medicine.
Lead Product(s): Plinabulin,Pegfilgrastim
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 30, 2020
Details:
PROTECTIVE-2 Phase 2 superiority trial for chemotherapy-induced neutropenia shows that the Company’s lead asset, Plinabulin, in combination with Neulasta, enables more cancer patients to receive the optimal chemotherapy dose and regimen.
Lead Product(s): Plinabulin,Pegfilgrastim
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 09, 2020
Details:
Upon reviewing the safety and efficacy data of over 500 patients and approximately 300 pre-specified death events, the Data & Safety Monitoring Board (DSMB) has advised BeyondSpring to continue the study without any modifications.
Lead Product(s): Plinabulin,Docetaxel
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 03, 2020
Details:
BeyondSpring’s e-poster presentations are mainly focused on company's lead drug Plinabulin and the 1st poster presents a comparison between Plinabulin vs Neulasta as a monotherapy for CIN prevention.
Lead Product(s): Plinabulin,Pegfilgrastim
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 02, 2020
Details:
The patent covers methods of treating severe chemotherapy-induced neutropenia (CIN) from Taxane in cancer patients by administering its lead asset Plinabulin.
Lead Product(s): Plinabulin
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 May 13, 2020
Details:
If approved, Plinabulin in combination with G-CSFs can potentially be the first superior therapy to the standard of care (G-CSF alone) for chemotherapy-induced neutropenia.
Lead Product(s): Plinabulin
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 March 30, 2020
Details:
Presentation at the 2020 ASCO-SITC provides strong validation for Plinabulin as a potent activator of the innate immune system.
Lead Product(s): Plinabulin
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 February 10, 2020
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