Vaccine developments in China include IND acceptance for Fosun, Phase II start for Chongqing Zhifei

Two days after FDA granted Fast Track designation to two of BioNTech’s partnered COVID-19 vaccine candidates, one of the products advanced closer to human testing in China.

Shanghai Fosun Pharmaceutical Group Co. Ltd. (Shanghai:600196; HKSE:2196) announced Tuesday that China’s National Medical Products Administration (NMPA) accepted an IND for BNT162b1, one of four COVID-19 vaccine candidates in the BNT162 program.

Shanghai Fosun is the BNT162 development partner for BioNTech SE (NASDAQ:BNTX) in China, outside of which the German company’s partner is Pfizer Inc. (NYSE:PFE).

BNT162b1 and BNT162b2, which have Fast Track designation, are among the most advanced COVID-19 vaccines in development; and BNT162b1 has induced some of the highest neutralizing antibody titers in a human trial to date. Pfizer and BioNTech plan to move one of its four candidates into a 30,000-participant Phase IIb/III trial this month (see “BioNTech, Pfizer Vaccine Yields High Titers”).

Separately, Chongqing Zhifei Biological Products Co. Ltd. (SZSE:300122) launched a Chinese Phase II trial of its COVID-19 vaccine, a recombinant spike protein receptor binding domain (RBD) dimer.

T cell, interferon responses

A study reported Wednesday in Nature revealed that T cell immunity against human coronaviruses, including SARS-CoV, can last well over a decade. A team led by Duke-NUS Medical School scientists had found, in blood samples from individuals who recovered from the 2003 SARS outbreak, memory T cells recognizing SARS-CoV N that cross-reacted to SARS-CoV-2 N.

They also detected CD4⁺ and CD8⁺ T cells that recognize SARS-CoV-2 N in plasma from 36 COVID-19 patients who had recovered; and anti-SARS-CoV-2 T cells in individuals with no known history of SARS or COVID-19. T cell response profiles differed based on donor history: cells from those who recovered form SARS or COVID-19 reacted preferentially to SARS-CoV-2 nucleocapsid peptides; cells from unexposed donors tended to respond to peptides from non-structural proteins.
A separate publication, released Monday in Science, pointed to a subset type of interferon responses as a potential target for treating severe COVID-19.

Assistance Publique - Hopitaux de Paris and INSERM researchers showed that impaired type I interferon responses -- characterized by no IFNβ and low IFNα production and activity -- were associated with severe and critical COVID-19. They linked the altered immune response to persistent viremia and exacerbated inflammation driven in part by NF-kB and marked by increased TNFα and IL-6 signaling.

Moleculin in manufacturing deal
Moleculin Biotech Inc. (NASDAQ:MBRX) has announced a deal with CDMO Sterling Pharma Solutions covering U.S. production of WP1122 for clinical COVID-19 trials. WP1122 is a prodrug of 2-deoxy-D-glucose; and in a May publication in Nature, University of Frankfurt researchers showed 2-deoxy-D-glucose prevented SARS-CoV-2 replication in a cell-based assay.

Targets

IL-6 - Interleukin-6

NF-kB (NFKB1) (p105) (p50) - Nuclear factor of kappa light polypeptide gene enhancer in B cells 1

SARS-CoV N - SARS-CoV nucleocapsid protein

SARS-CoV-2 N - SARS-CoV-2 nucleocapsid protein

TNFα - Tumor necrosis factor α