Focus on the JPM | Wanchun new whitening drug Punabrin III clinical up to the main...

San Francisco local time January 11-14 (January 12-15, Beijing time), the 39th J.P. Morgan Healthcare Conference (JPM Health Conference) opened.
affected by the new coronary pneumonia (COVID-19) outbreak, the meeting was held online.
as one of the largest industry events in the field of biomedical health worldwide, JPM has brought the movement of large pharmaceutical companies.
Among other notable developments, BeyondSpring presented the latest developments in its core product, Punablin, at this session: the company plans not only to simultaneously submit Plinabulin's new drug listing application (NDA) for neutral granulocytosis (CIN) in China and the United States in the first quarter, but also to unveil Punablin's cancer trial Phase III data in the first half of 2021.
let's take a look at Punablin's breakthrough.
Punabrin - The multi-acting bird nucleotide exchange factor (GEF-H1) excitant Punabrin is an asset purchased by Avant-chun Pharmaceuticals from Nereus Pharmaceuticals, a compound molecule that is synthesized on the structure of the marine coromatobacteria extract diketone pyridoxine and has the effect of deconstructing the cell microsububular 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 collection 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 day, 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, in which Pampering and Pfeisting combined the treatment of Pfeisting single-drug therapy, reached the main study endpoint, and all the key secondary endpoints were also statistically significant.
PROCYCTIVE-2 Study Design PROTECTIVE-2 is a phase III global multi-center, double-blind, positive-controlled clinical study that compared 40 mg of punablin with 6 mg of Pyphedrine combined with 6 mg of pirestin monodrug efficacy in breast cancer patients receiving TAC (dosytaxin, amycin, and cyclophosphamide).
The final data analysis included data on 221 patients (111 in the combined treatment group and 110 in the single-drug treatment group in Pyega-Gestin), 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 Summarized as follows: The main study endpoint: The percentage of patients who did not experience stage 4 neutral granulocyte reduction in the first chemotherapy cycle reached p.lt;0.01, which was of significant statistical significance and proved 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 the Punabrin combination The group was able to play a neutral granulocyte protection role within the first 8 days, and (2) DSN during the first chemotherapy cycle was statistically significant (p.lt;0.05), confirming that the combination therapy was superior to the single-drug treatment of Pfeisting, providing a comprehensive protective effect.
clinical trials currently under way 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 a dose of Punabrin (5, 10 or 20 mg/m2) or pyraeps (6 mg) on day 2 at random.
treatment cycle every 21 days and receives a total of 4 cycles of chemotherapy.
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 Pyegatin.
same time, the 20 mg/m2 dose of Punablin was significantly better than the standard dose of Pyfygstin in terms of overall quality of life, control of bone pain, and maintenance of platelet numbers.
the clinical trial is the first head-to-head comparison between Punabrin and the classic long-acting whitening drug, which is of great significance to the development of Punabrin.
based on the above research, Wanchun Pharmaceuticals plans to submit the NDA of Punablin's CIN adaptation certificate in China and the United States in the first quarter of 2021.
in addition to CIN treatment, Wanchun Pharmaceuticals 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.
Punablin is a non-G-CSF drug that reduces the occurrence of early CINs 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 a severe CIN accreditation certificate.
, Wanchun Medicine will also explore the therapeutic potential of Punabrin 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.