​The placenta-derived, allogeneic, natural killer NK cell therapy was awarded the FDA orphan drug title for the treatment of glioblastoma​|Yi Mai Meng broke the news

Recent popular reports from Yimaike ★ NK cell therapy has been certified by the FDA for fast-track treatment for the treatment of recurrent glioblastoma multiforme in adultsYimai broke the news ★The first case in China, Guojian presented a "spot type" CAR -The clinical application of NK cell injection for the treatment of solid tumors was accepted by the State Food and Drug AdministrationYiMedMeng broke the news April 15, 2020/YiMike News eMedClub News/--April 13, 2021, Celularity announced its NK cell therapy CYNK -001 was awarded the title of "Orphan Drug" by the U.
S.
Food and Drug Administration (FDA) and is mainly used for the treatment of glioblastoma.

Glioblastoma (GBM) is a fast-growing glioma, a malignant grade 4 tumor, accounting for about 15% of all brain tumors, and there are about 290,000 new patients worldwide each year.

Glioblastoma is highly aggressive, easy to relapse, and has a high rate of lethality and disability.

Currently, there is no effective long-term treatment.

The prognosis of GBM patients is extremely poor, usually less than 15 months after diagnosis.

After most patients undergo treatment, their rapidly growing malignant tumors often recur within 6-8 months.

Due to the lack of standard treatment, limited treatment options and moderate efficacy, the treatment of recurrent GBM is challenging.

At this stage, the 6-month progression-free survival rate was 19%, and the objective response rate was less than 10%.

Therefore, recurrent GBM is a serious disease associated with significant morbidity and disproportionately high mortality.

NK cell therapy for glioblastoma CYNK-001 is placental-derived natural killer (PNK) cells, cryopreservation developed from placental hematopoietic stem cells, allogeneic, "spot" natural killer (NK) cell therapy, As a potential treatment option for a variety of blood system cancers, solid tumors and infectious diseases.

NK cells are a unique type of immune cells that are naturally able to target cancer cells and interact with adaptive immunity.

CYNK-001 is clinically used to treat multiple myeloma (MM), acute myeloid lymphoma (AML), glioblastoma multiforme (GBM), and new coronary pneumonia in a variety of cancer indications.

Pre-clinical studies have shown that CYNK-001 shows killing activity against MM cells, AML cells, GBM cells and SARS-CoV-2 infected cells in vitro.

We are studying CYNK-001 in vivo and hope that it can work by enhancing the body's natural immune response.

CYNK-001 exhibits a series of biological activities expected by NK cells, including the expression of perforin and granzyme B, cytolytic activity against hematological tumors and solid tumor cell lines, and the secretion of immunomodulatory cytokines in the presence of tumor cells Such as IFN-γ).

CYNK-001 cells express NKG2D and CD94, as well as NK activation receptors DNAM1, NKp30, NKp46 and NKp44.

▲ Active clinical pipeline allogeneic placenta-derived cell therapy product candidates (picture source: celularity) At the AACR annual meeting in March 2019, Celularity also announced the results of the research allogeneic natural killer (NK) cell therapy PNK-0071 phase.
PNK-007 has shown long-term safety and effectiveness in patients with multiple myeloma (MM).
A single infusion of PNK-007 is well tolerated.
There are no serious adverse events (AE) related to PNK-007 and no dose.
Limited toxicity, graft versus host disease (GvHD) and cytokine release syndrome (CRS), etc.

The 2021 nucleic acid drug development forum will kick off in Nanjing from May 7th to 8th, 2021, to welcome the "new era of super drugs".