Plinabulin

BeyondSpring Presents Poster Highlighting Preclinical and Clinical POC Immunomodulating Activity of Plinabulin Inducing Dendritic Cell Maturation and Re-sensitization in Immunotherapy Refractory Tumors when Combined with Radiation and PD-1/PD-L1 Inhibitor

Retrieved on: 
Tuesday, November 7, 2023

Based on preclinical models, where plinabulin plus radiation and anti-PD-1 antibody enhances dendritic cell (DC) activation, T-cell proliferation, and abscopal effect, a clinical study was initiated to test these findings.

Key Points: 
  • Based on preclinical models, where plinabulin plus radiation and anti-PD-1 antibody enhances dendritic cell (DC) activation, T-cell proliferation, and abscopal effect, a clinical study was initiated to test these findings.
  • 11 out of 14 patients eligible for efficacy assessment per RECIST criteria and had measurable target lesion responses in the non-irradiated tumor lesion.
  • Please reference conference title: Clinical Significance of Plinabulin SITC Presentation with PI Dr. Steven Lin from MD Anderson.
  • A live webcast will be available on BeyondSpring’s website at www.beyondspringpharma.com under “Events & Presentations” in the Investors section.

BeyondSpring and Leading Cancer Center Present Poster Highlighting Plinabulin’s Ability to Reduce Infectious Neutropenic Fever for Multiple Myeloma Patients Undergoing AHCT

Retrieved on: 
Wednesday, June 7, 2023

BeyondSpring and Memorial Sloan Kettering Cancer Center (MSK) presented the data at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting .

Key Points: 
  • BeyondSpring and Memorial Sloan Kettering Cancer Center (MSK) presented the data at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting .
  • Between January 2022 and February 2023, 15 patients with a median age of 64 received Plinabulin after a high dose of melphalan.
  • The Plinabulin and pegfilgrastim combination appears well tolerated without additional major toxicities post AHCT.
  • “The Plinabulin-pegfilgrastim combination represents a new potential supportive care for MM patients undergoing AHCT.

BeyondSpring Provides Business Update and Reports Year End 2022 Financial Results

Retrieved on: 
Tuesday, April 18, 2023

NEW YORK, April 18, 2023 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI) (“BeyondSpring” or the “Company”), a clinical-stage global biopharmaceutical company focused on using its novel technology platform for drug discovery and development of innovative therapies to improve clinical outcomes for patients with high unmet medical needs, today provided a business update and reported results for the year ended December 31, 2022.

Key Points: 
  • In March 2023, BeyondSpring withdrew its NDA submission for the CIN indication from China’s National Medical Products Administration (NMPA) review.
  • The $17.7 million decrease was primarily due to lower pre-commercialization expenses for Plinabulin and lower personnel costs, as results of the organizational streamlining announced in January 2022.
  • Net loss attributable to the Company was $33.3 million for the year ended December 31, 2022, compared to $64.2 million for the year ended December 31, 2021.
  • As of December 31, 2022, the Company had cash, cash equivalents, and short-term investments of $37.3 million.

BeyondSpring Presents Positive Data with Plinabulin for the Prevention of Docetaxel-Induced Neutropenia in Patients with Non-Small Cell Lung Cancer and Breast Cancer at Three Medical Conferences

Retrieved on: 
Tuesday, December 13, 2022

In addition, data was presented on plinabulin for the prevention of docetaxel-induced neutropenia in breast cancer (BC in the 105 study ) at the 2022 San Antonio Breast Cancer Symposium (SABCS).

Key Points: 
  • In addition, data was presented on plinabulin for the prevention of docetaxel-induced neutropenia in breast cancer (BC in the 105 study ) at the 2022 San Antonio Breast Cancer Symposium (SABCS).
  • “Docetaxel-induced neutropenia can cause life-threatening infections in cancer patients, and the current standard of care, prophylactic treatment with a G-CSF in high-risk patients, has limitations.
  • “The data that we presented at these three conferences demonstrate that plinabulin can provide solutions for some of the challenges seen with G-CSF.
  • The plinabulin and G-CSF combination for the prevention of CIN has demonstrated positive Phase 3 data in the PROTECTIVE-2 study.

BeyondSpring Files 2021 Annual Report on Form 20-F

Retrieved on: 
Thursday, April 14, 2022

The annual report on Form 20-F, which contains the Companys audited consolidated financial statements, can be accessed on the SECs website at www.sec.gov and on the Companys website at www.beyondspringpharma.com under Financials & Filings in the Investors section.

Key Points: 
  • The annual report on Form 20-F, which contains the Companys audited consolidated financial statements, can be accessed on the SECs website at www.sec.gov and on the Companys website at www.beyondspringpharma.com under Financials & Filings in the Investors section.
  • The Company will provide a hard copy of its annual report containing its audited consolidated financial statements, free of charge, to its shareholders upon request.
  • Requests should be directed to Investor Relations, BeyondSpring Inc., 28 Liberty Street, 39th Floor, New York, NY 10005 USA.
  • Headquartered in New York City, BeyondSpring is a clinical stage global biopharmaceutical company focused on developing innovative cancer therapies to improve clinical outcomes for patients who have high unmet medical needs.

BeyondSpring Announces Fourth Quarter and Year End 2021 Financial Results and Provides a Corporate Update

Retrieved on: 
Thursday, April 14, 2022

NEW YORK, April 14, 2022 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (the “Company” or “BeyondSpring”) (NASDAQ: BYSI), a clinical stage global biopharmaceutical company focused on developing innovative cancer therapies to improve clinical outcomes for patients who have high unmet medical needs, today announced its financial results for the fourth quarter and year ended December 31, 2021 and provided a corporate update. At the start of 2022, the Company took steps to streamline its operations and is focused on executing on near-term opportunities for value creation.

Key Points: 
  • The G-CSF market in China is significant, with $1.2B in sales in 2020 and approximately 30% annual growth since 2017, saidDr.
  • We are also moving forward to target an NDA filing in China by year-end for Plinabulin in the non-small cell lung cancer (NSCLC) indication.
  • Net loss attributable to the Company was $9.5million for the quarter ended December 31, 2021, compared to $17.6 million for the quarter ended December 31, 2020.
  • R&D expenses were $36.9million for the year ended December 31, 2021, compared to $41.8million for the year ended December 31, 2020.

BeyondSpring Announces Positive Topline Results from its DUBLIN-3 Registrational Trial of Plinabulin in Combination with Docetaxel for the Treatment of 2nd/3rd Line Non-Small Cell Lung Cancer (NSCLC) with EGFR Wild Type

Retrieved on: 
Wednesday, August 4, 2021

Plinabulin is a first-in-class, selective immunomodulating microtubule-binding agent (SIMBA), which is a potent antigen presenting cell (APC) inducer.

Key Points: 
  • Plinabulin is a first-in-class, selective immunomodulating microtubule-binding agent (SIMBA), which is a potent antigen presenting cell (APC) inducer.
  • The DUBLIN-3 Phase 3 trial is a randomized, single blind to patients, active controlled, global trial that enrolled 559 patients in 2nd and 3rd line NSCLC, EGFR wild type, with measurable lung lesion.
  • Plinabulin in combination with docetaxel (DP) showed statistically significant improvements compared to docetaxel alone (D) with topline data summarized below for ITT population (DP: n=278; D: n=281).
  • Now that checkpoint inhibitor immunotherapy has moved into first line, there is a vacuum in this indication, where treatment is heavily centered around docetaxel.

BeyondSpring to Host R&D Day to Discuss Novel Immune Agent Plinabulin’s Development Program in Anti-cancer Indications

Retrieved on: 
Thursday, June 17, 2021

NEW YORK, June 17, 2021 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (the Company or BeyondSpring) (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, today announced it will host a Research and Development (R&D) Day to discuss the development program for its novel immune agent, Plinabulin, in anti-cancer indications on Friday, June 25th, at 8:00 a.m.

Key Points: 
  • NEW YORK, June 17, 2021 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (the Company or BeyondSpring) (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, today announced it will host a Research and Development (R&D) Day to discuss the development program for its novel immune agent, Plinabulin, in anti-cancer indications on Friday, June 25th, at 8:00 a.m.
  • (Piedmont Cancer Institute), who will discuss the current treatment landscape and unmet medical need in treating patients with non-small cell lung cancer (NSCLC) and patients who failed checkpoint inhibitors.
  • Also featured will be a management discussion of BeyondSprings pipeline, including lead asset plinabulin, a selective immunomodulating microtubule-binding agent (SIMBA), being developed as a pipeline in a drug.
  • BeyondSprings first-in-class lead asset plinabulin, a Selective Immunomodulating Microtubule-Binding Agent (SIMBA), is being developed a pipeline in a drug.

BeyondSpring Announces Final Positive Data from the PROTECTIVE-1 Phase 3 CIN Program of Plinabulin as a Single Agent Compared to Pegfilgrastim at the American Society of Clinical Oncology (ASCO) Annual Meeting

Retrieved on: 
Thursday, June 10, 2021

The Company has submitted New Drug Applications (NDA) for plinabulin in combination with pegfilgrastim for the prevention of CIN, in both the U.S. and China.

Key Points: 
  • The Company has submitted New Drug Applications (NDA) for plinabulin in combination with pegfilgrastim for the prevention of CIN, in both the U.S. and China.
  • The U.S. FDA accepted the NDA with Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) action date of November 30, 2021.
  • The Plinabulin and G-CSF combination NDA program is comprised of four studies: PROTECTIVE-1 Phase 2 and Phase 3 and PROTECTIVE-2 Phase 2 and Phase 3.
  • PROTECTIVE-1 Phase 2 (4arm randomized study, NSCLC, docetaxel, n=55): Plinabulin single agent (5 mg/m2, 10 mg/m2, or 20 mg/m2, day 1 dose), pegfilgrastim (6 mg, day 2 dose).

BeyondSpring Announces a Late-Breaking Poster Presentation of PROTECTIVE-2 Phase 3 Data Showing Plinabulin, in Combination with Pegfilgrastim, Reverses the Immune-Suppressive Effects of Pegfilgrastim and Offers Superior Prevention of Chemotherapy-Induced

Retrieved on: 
Tuesday, June 8, 2021

Compared to pegfilgrastim alone (n=110), the plinabulin and pegfilgrastim combination (n=111) showed decreased production of immature neutrophil band (p=0.0012), and decreased promyelocytes and myelocyte production (p=0.0488).

Key Points: 
  • Compared to pegfilgrastim alone (n=110), the plinabulin and pegfilgrastim combination (n=111) showed decreased production of immature neutrophil band (p=0.0012), and decreased promyelocytes and myelocyte production (p=0.0488).
  • Immature neutrophil band and promyelocytes and myelocytes are less functional defending against infection and have potentially deleterious immune suppression effects.
  • The Company has submitted New Drug Applications (NDA) for plinabulin in combination with pegfilgrastim as a treatment for the prevention of CIN for review in both the U.S. and China.
  • Treatment or prevention of CIN with G-CSF has been the standard of care since Neupogen was approved in 1991.