Diketopiperazines

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
Organic chemistry, Chemistry, Carbonyl compounds, Carbamates, Taxanes, Diketopiperazines, Imidazoles, Plinabulin, Docetaxel

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
Diketopiperazines, Imidazoles, Chemistry, Plinabulin, Cancer

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 to Announce Fourth Quarter and Year End 2020 Financial Results and Host a Conference Call on Friday, April 30, 2021

Retrieved on: 
Tuesday, April 27, 2021
Diketopiperazines, Imidazoles, Plinabulin, Cancer immunotherapy, Oncology, PD-L1, Medical specialties, Clinical medicine, Medicine

b'Headquartered in New York City, BeyondSpring is a global biopharmaceutical company focused on developing innovative immuno-oncology cancer therapies to improve clinical outcomes for patients who have high unmet medical needs.

Key Points: 
  • b'Headquartered in New York City, BeyondSpring is a global biopharmaceutical company focused on developing innovative immuno-oncology cancer therapies to improve clinical outcomes for patients who have high unmet medical needs.
  • BeyondSpring\xe2\x80\x99s first-in-class lead asset plinabulin, a Selective Immunomodulating Microtubule Binding Agent (SIMBA), is a \xe2\x80\x9cpipeline in a drug.\xe2\x80\x9d It has filed for NDA approval in the US and China for the prevention of chemotherapy-induced neutropenia (CIN) and has a fully enrolled pivotal study to test the anti-cancer benefit, with an overall survival primary endpoint, in non-small cell lung cancer (NSCLC).
  • Additionally, it is being broadly studied in combination with various immuno-oncology agents that could boost the effects of PD-1 / PD-L1 antibodies.
  • In addition to plinabulin, BeyondSpring\xe2\x80\x99s extensive pipeline includes three pre-clinical immuno-oncology assets and a subsidiary, SEED Therapeutics, which is leveraging a proprietary targeted protein degradation (TPD) drug discovery platform, which recently announced an R&D collaboration with Eli Lilly.\n'

BeyondSpring Hosting Key Opinion Leader Webinar on Plinabulin for the Prevention of Chemotherapy-Induced Neutropenia

Retrieved on: 
Thursday, March 11, 2021
Clinical medicine, Medicine, Cancer, Diketopiperazines, Imidazoles, Cancer treatments, Plinabulin, Chemotherapy, Neutropenia

BeyondSpring's management team will also provide an update on its pipeline, including Plinabulin as a pipeline drug in multiple indications.

Key Points: 
  • BeyondSpring's management team will also provide an update on its pipeline, including Plinabulin as a pipeline drug in multiple indications.
  • This follows the recent announcement of positive topline data from the pivotal PROTECTIVE-2 Phase 3 trial of Plinabulin in combination with Pegfilgrastim for the prevention of CIN.
  • If this trial confirms Plinabulins anti-cancer effect, this will be an agent with a unique profile of having both anti-cancer and CIN-preventive activity.
  • The U.S. FDA granted Breakthrough Therapy designation to plinabulin for concurrent administration with myelosuppressive chemotherapeutic regimens in patients with non-myeloid malignancies for the prevention of chemotherapy-induced neutropenia (CIN).

Advisory - Male sexual enhancement product "Harmony" may pose serious health risks

Retrieved on: 
Friday, March 5, 2021
PDE5 inhibitors, Lactams, Chemical compounds, Penis, Organic compounds, Psychiatric diagnosis, Diketopiperazines, Tadalafil, Erectile dysfunction, Sildenafil

Issue:The product contains high levels of a prescription erectile dysfunction drug, tadalafil, which may pose serious health risks.

Key Points: 
  • Issue:The product contains high levels of a prescription erectile dysfunction drug, tadalafil, which may pose serious health risks.
  • Health Canada is warning consumers to not use Harmony, a male sexual enhancement capsule, because it may pose serious health risks.
  • It was authorized as a natural health product, but Health Canada testing found it contains high levels of a prescription erectile dysfunction drug, tadalafil.
  • The product was not authorized to contain tadalafil, it was not authorized as a sexual enhancement product, and it did not list tadalafil on the product label.

BeyondSpring Forms Partnership Advisory Committee Comprised of Industry Veterans

Retrieved on: 
Monday, October 12, 2020
Diketopiperazines, Imidazoles, Plinabulin, Chemistry

NEW YORK, Oct. 12, 2020 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (the Company or BeyondSpring) (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative immuno-oncology and chemotherapy-induced neutropenia therapies, announced today that it has formed a Partnership Advisory Committee comprised of former multi-national pharmaceutical veterans and industry leaders.

Key Points: 
  • NEW YORK, Oct. 12, 2020 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (the Company or BeyondSpring) (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative immuno-oncology and chemotherapy-induced neutropenia therapies, announced today that it has formed a Partnership Advisory Committee comprised of former multi-national pharmaceutical veterans and industry leaders.
  • The committee is tasked with supporting BeyondSprings business development activities related to its lead asset, Plinabulin, and other pipeline assets.
  • As BeyondSpring nears submission of Plinabulins New Drug Application (NDA) and commercialization, having access to industry veterans who bring to bear track records of striking successful partnerships is of the utmost importance, said Dr. Huang.
  • We are especially grateful to have Mr. Agarwal join our committee, as he was instrumental in Gileads acquisition of Forty Seven.

JAMA Oncology Highlights Plinabulin's Efficacy in Preventing Chemotherapy-Induced Neutropenia as a Monotherapy

Retrieved on: 
Tuesday, September 29, 2020
Branches of biology, Chemistry, Clinical medicine, Diketopiperazines, Imidazoles, Plinabulin, Blood disorders, Lung cancer, Granulocyte colony-stimulating factor, Neutropenia, Non-small-cell lung carcinoma, Eflapegrastim

Participants were adult patients with non-small cell lung cancer (NSCLC) whose cancer had progressed after platinum-based chemotherapy.

Key Points: 
  • Participants were adult patients with non-small cell lung cancer (NSCLC) whose cancer had progressed after platinum-based chemotherapy.
  • The objective was to assess the efficacy and safety of the Companys lead asset, Plinabulin, compared with Pegfilgrastim, a long-lasting G-CSF, which is currently the predominant therapy for chemotherapy-induced neutropenia (CIN) prevention.
  • Plinabulin as a single agent was equally effective as Pegfilgrastim for preventing Grade 4 neutropenia and infections.
  • Plinabulin is currently in late-stage clinical development to increase overall survival in cancer patients, as well as to alleviate chemotherapy-induced neutropenia (CIN).

New Data Highlights BeyondSpring’s Plinabulin as a Highly Effective Agent for Preventing Chemotherapy-Induced Neutropenia, with Potential to Reduce Clinical Resources for COVID-19

Retrieved on: 
Thursday, September 24, 2020
Clinical medicine, Medicine, Cancer, Oncology, Diketopiperazines, Imidazoles, Plinabulin, Cancer treatments, Neutropenia, Chemotherapy

Dr. Douglas Blayney,global principal investigator of BeyondSprings Plinabulin CIN studies and Professor of Medicine at Stanford Medical School, presented the data as a poster at this years ESMO Virtual Congress.

Key Points: 
  • Dr. Douglas Blayney,global principal investigator of BeyondSprings Plinabulin CIN studies and Professor of Medicine at Stanford Medical School, presented the data as a poster at this years ESMO Virtual Congress.
  • Plinabulin is given on the same day as chemotherapy, whereas Peg is given on the day after chemotherapy.
  • In terms of Grade 4 neutropenia and clinical outcomes with severe neutropenia (hospitalizations, infections and sepsis), Plinabulin as a single agent was equally effective as Peg.
  • Plinabulin is currently in late-stage clinical development to increase overall survival in cancer patients, as well as to alleviate chemotherapy-induced neutropenia (CIN).

BeyondSpring Receives Breakthrough Therapy Designations from Both U.S. FDA and China NMPA for Plinabulin in Chemotherapy-Induced Neutropenia Indication

Retrieved on: 
Tuesday, September 8, 2020
Chemistry, Physical sciences, Food and Drug Administration, Health, Diketopiperazines, Imidazoles, Plinabulin, Drug Safety, New Drug Application, Priority review

Products with BTD from the CDE may be considered for conditional approval and priority review when submitting New Drug Applications (NDAs).

Key Points: 
  • Products with BTD from the CDE may be considered for conditional approval and priority review when submitting New Drug Applications (NDAs).
  • We look forward to continuing to work with the FDA as we advance the development of Plinabulin to address this urgent medical need.
  • The Company has submitted an NDA for Plinabulin for the CIN indication to the NMPA on a rolling basis in Q1 2020.
  • Plinabulin is currently in late-stage clinical development to increase overall survival in cancer patients, as well as to alleviate chemotherapy-induced neutropenia (CIN).

BeyondSpring Initiates Expanded Access Program with Plinabulin for Patients Suffering from CIN in the U.S.

Retrieved on: 
Tuesday, August 11, 2020
Clinical medicine, Medicine, Medical specialties, Amgen, Recombinant proteins, Cancer treatments, Diketopiperazines, Plinabulin, Bone marrow suppression, Pegfilgrastim, Chemotherapy, Filgrastim

In light of these NCCN guideline updates, BeyondSpring initiated an Expanded Access Program to enable the use of Plinabulin by oncologists to better protect cancer patients against CIN with the use of myelosuppressive chemotherapies under the current COVID-19 challenges.

Key Points: 
  • In light of these NCCN guideline updates, BeyondSpring initiated an Expanded Access Program to enable the use of Plinabulin by oncologists to better protect cancer patients against CIN with the use of myelosuppressive chemotherapies under the current COVID-19 challenges.
  • When the patient completed Cycle 2 with the Plinabulin and Pegfilgrastim combination, the patient did not develop Grade 4 neutropenia.
  • In our CIN studies, Plinabulin, in combination with Pegfilgrastim, provided superior protection against CIN, compared to the standard of care alone.
  • Plinabulin is currently in late-stage clinical development to increase overall survival in cancer patients, as well as to alleviate chemotherapy-induced neutropenia (CIN).