Focus on the JPM | Wanchun's new ascending white drug Punabrin PHASE III clinical end point

Punabrin - The multi-acting bird nucleotide exchange factor (GEF-H1) exciter Punablin is an asset purchased by Avant-chun Pharmaceuticals from Nereus Pharmaceuticals, a compound molecule synthesized on the structure of the marine caramel extract diketone pyridoxine, which has the effect of deconstructing the cell microtome network.
long-term study, it has been found that Punablin activates GEF-H1 by affecting the structure of the microchan tube, thereby activating the signal path downstream of GEF-H1.
And the activation of the downstream signaling path of GEF-H1 can trigger a series of biological effects, including promoting the maturation of degenerative cells, promoting the activation of T cells, promoting the maturation of neutral granulocytes, etc., and has a wide range of regulatory effects on inherent and adaptive immunity.
PROTECTIVE-2 study background Neutral granulocytosis is the most serious hematological toxicity disease caused by chemotherapy drugs.
recombinant human granulocyte cluster stimulation factor (G-CSF) is the only drug approved since 1991 to prevent severe CIN.
studies have shown that even with G-CSF, more than 80% of patients in some chemotherapy programs still have level 4 CINs, and that the lowest point of the neutral granulocyte count (ANC) usually occurs on the 6th to 8th days, with clinical adverse consequences such as severe infection, fever, mycobacteremia and death still occurring from time to time.
, for patients with the possibility of severe CIN chemotherapy, severe CIN must be prevented at the source to minimize the adverse clinical consequences associated with CIN.
Punabrin, with its unique mechanism of action, is able to quickly protect neutral granulocytes in the first 8 days, complementing G-CSF co-use time and significantly reducing the full-cycle severe CIN rate caused by chemotherapy in patients with non-myelin cancer.
ProteCTIVE-2 of the International Multi-Center Phase III Study of Proteative-2, a joint treatment between Punablin and Pfeisting, achieved the main study endpoint, and all key secondary endpoints were also statistically significant.
PROROTECTIVE-2 Research Design PROTECTIVE-2 is a phase III global multi-center, double-blind, positive-controlled clinical study comparing 40 mg of Punabrin combined with 6mg of Pnablin combined with 6 mg of Pyphedrine monodynaminosis in breast cancer patients receiving TAC (dostatin, amycin, and cyclophosphamide).
Final data analysis included data on 221 patients (111 in the combined treatment group and 110 in the single-drug treatment group in the Pfeisting single-drug treatment group), and compared with the single-drug treatment group in the Pyega-Gestin single-drug treatment group, the combined treatment group showed significant statistically significant improvements in the following areas, with important data Summary: The main study endpoint: The percentage of patients who did not have level 4 neutral granulocyte reduction in the first chemotherapy cycle reached p.lt;0.01, which was of significant statistical significance, and confirmed that the combined treatment group of Punabrin was significantly better than the single drug treatment of Pyphedrine.
Key Secondary Efficacy Endpoints: (1) The number of days of severe neutral granulocyte reduction (DSN) in the first 8 days of the first chemotherapy cycle is statistically significant (p<0.05), confirming that the Punabrin group can play a neutral granulocyte protection role in the first 8 days; (2) The DSN in the first chemotherapy cycle is statistically significant (p.lt;0.05), which proves that combination therapy is superior to Pyega-Gestin single-drug therapy and provides comprehensive protective effect.
current clinical trials around CIN, Punablin also include Study 101, Study 105 and Study 106.
data from the Study 105 clinical trial, published in the journal JAMA Oncology.
the study was conducted in 19 cancer facilities in China, the United States, Russia and Ukraine in four treatment groups in a randomized, open-label Phase II clinical trial.
study group were adult patients with non-small cell lung cancer who developed the disease after chemotherapy for platinum drugs.
data collection was completed between April 2017 and March 2018 and completed between August 2019 and February 2020.
All subjects received dossytatin (75 mg/m2) and one dose of Punabrin (5, 10 or 20 mg/m2) on random day 1 or Pfeisting (6 mg) on day 2.
receive a total of 4 cycles of chemotherapy every 21 days.
data analysis showed that the 20 mg/m2 dose of Punabrin was no less effective in reducing the efficacy of CIN than the standard dose of 6 mg of Pyegesting.
same time, the 20 mg/m2 dose of Punablin was significantly better than the standard dose of pyrethrin in terms of overall quality of life, bone pain control, and maintenance of platelets.
this clinical trial is the first head-to-head comparison between Punabrin and the classic long-acting white drug, which is of great significance to the development of Punablin.
based on the above research, Wanchun Pharmaceuticals plans to submit the NDA of Punablin for CIN adaptation certificate in China and the United States in the first quarter of 2021.
in the field of lung cancer, Wanchun Medicine is also exploring the therapeutic effects of Punabrin in the field of non-small cell lung cancer (NSCLC).
Currently, Wanchun Pharmaceuticals is conducting a Phase III clinical trial called DUBLIN-3 (103 Studies) in EGFR wild NSCLC patients, the main endpoint of which is total survival, with secondary endpoints including 4 levels of neutral granulocyte reduction, objective remission rate (ORR), progress-free survival (PFS), and medium remission time (DoR).
final top-line cancer data are expected to be released in the first half of 2021.
Punabrin is a non-G-CSF drug that reduces the occurrence of early CNs by reversing the blocking of neutrophils in the bone marrow induced by chemotherapy drugs, maintaining neutrophil levels within the normal range, and achieving early protection of white blood cells in the bone marrow.
studies have shown that Punabrin prevents multiple severe CINs caused by chemotherapy drugs with different anti-tumor mechanisms.
is expected to accelerate its launch as the first breakthrough treatment in 30 years to meet the standards and clinical benefits of severe CIN accreditation.
, Wanchun Medicine will also explore the therapeutic potential of Punablin in solid tumors.
hope that the new drug can be approved as soon as possible, as soon as possible for clinical use, for the benefit of more cancer patients.
source: 1.2021 JPM Conference. 2.JAMA Oncol. Published online September 24, 2020. doi:10.1001/jamaoncol.2020.4429; 3.Neulasta (pegfilgrastim): a once-per-cycle option for the management of chemotherapy-induced neutropenia. 4.Once-per-cycle pegfilgrastim (Neulasta) for the management of chemotherapy-induced neutropenia.