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22, 2020 /PRNewswire/ -- BioNTech is an industry-leading mRNA therapy company that is working with Pfizer and Fosun Pharma to advance the mRNA vaccine against the new coronavirus pneumonia (COVID-19), respectively.
mRNA is a nucleic acid molecule that carries genetic information.
mRNA vaccine to the genetic information into the body, so that the body cells produce the corresponding antigen, thereby inducing the body to produce neutral antibodies and stimulate The T-cell response, through the body fluid immunity and cell immunity of the dual mechanism of anti-virus.
in the face of sudden major outbreaks, compared with traditional vaccines, mRNA vaccine synthesis and production process is relatively convenient, with strong immunogenicity, do not need the traditional vaccine necessary additional adjuve, good safety.
mid-July, Fosun Pharma obtained approval from the National Drug Administration (NMPA) for the launch of Phase 1 clinical trials from BioNTech-licensed new crown mRNA vaccine BNT162b1.
in the United States, Pfizer and BioNTech advanced another new crown mRNA vaccine, BNT162b2, to Phase 23 clinical trials at the end of July.
based on positive results from Phase I/II clinical trials, the two new crownmRNA vaccines were granted fast track eligibility by the U.S. FDA in July.
in addition to developing a new crown mRNA vaccine, BioNTech is also using mRNA technology to develop new cancer immunotherapy.
, the company recently announced a strategic partnership with Regeneron to conduct a clinical trial of a mRNA immunotherapy, BNT111 FixVac, in combination with the anti-PD-1 therapy Libtayo (cemiplimab) to treat melanoma.
the two sides plan to jointly conduct a randomized Phase II study with BNT111 FixVac and Libtayo as a second-line treatment in patients with anti-PD-1 refractability/recurrence, advanced non-resectionable (phase III or IV) skin melanoma.
will release details of the Phase II study in the third quarter of this year, with the goal of starting trials in the fourth quarter.
BNT111 is the fastest advancing in BioNTech's extensive development pipeline of five clinical-phase FixVac candidates, a mRNA cancer immunotherapy for the four commonly expressed antigens (NY-ESO-1, MAGE-A3, tyrosine asse, TPTE) in melanoma patients.
FixVac is a fixed vaccine combination of highly expressed cancer-related antigens in tumors.
in an ongoing Phase 1 clinical trial, BNT111 has been shown to be antitumor-active in patients with advanced melanoma who have previously undergone checkpoint blocking therapy as a monotherapy, in combination with checkpoint inhibitors.
melanoma is the deadliest skin cancer, with an estimated 63,000 deaths worldwide in 2020.
in recent years, while anti-PD-1 therapy has made progress in the treatment of melanoma, most patients have not received lasting clinical benefits.
BNT111 FixVac and Libtayo combine drugs that combine two immunotherapy and complementary action mechanisms to enhance the immune system's ability to effectively identify melanoma in a variety of ways, and is expected to improve immuno-targeted to control cancer.
() Original source: BioNTech Announces Strategic Collaboration with RegeneroN to Advance FixVac and Libtayo ® (cemiplimab) in Combination in Melanoma.