University of Queensland COVID-19 vaccine becomes seventh with CEPI funding to enter the clinic

Plus Altimmune vaccine heads towards the clinic, and Fast Track for Pfizer, BioNTech candidates

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As Moderna readies for Phase III testing of its COVID-19 vaccine after reporting more positive data, multiple other vaccines continue to show progress as countermeasures against the virus. A CEPI-funded candidate from the University of Queensland has entered human testing, while a program from Altimmune is expected to enter the clinic next quarter. Meanwhile, a vaccine candidates from Pfizer and BioNTech, which are neck and neck with Moderna’s program, have gained Fast Track status.

The Coalition for Epidemic Preparedness Innovations announced that the first volunteers in a Phase I trial of Queensland’s COVID-19 vaccine were enrolled on Monday. The Australian study will enroll about 120 participants.

The vaccine, which uses synthetic proteins developed with the university’s “molecular clamp” technology, is the seventh of nine CEPI-funded candidates to have entered human studies.

In June, CEPI, Queensland and CSL Ltd. (ASX:CSL) entered a manufacturing deal to share clinical development and manufacturing costs. If the vaccine candidate is safe and effective, all of CEPI’s allocation will be distributed via the COVID-19 Vaccine Global Access Facility (COVAX) (see “Queensland Aboard Vaccine Train”).

COVAX was established by the Access to COVID-19 Tools (ACT) Accelerator, a collaboration created in April by global health and private sector organizations. Its central idea is to negotiate advanced purchase commitments for vaccines -- guaranteeing manufacturers that they’ll be able to sell specific quantities at predetermined prices -- and couple these with agreements for how countries of different income levels should pay in and receive back once a vaccine becomes available (see “COVAX to Avoid Bidding Frenzy for COVID-19 Vaccines”).

Other vaccine news

Moving closer to human testing is intranasal vaccine AdCOVID from Altimmune Inc. (NASDAQ:ALT). On Monday, the company said AdCOVID in mice induced serum antiviral neutralizing antibody titers of 320 by day 28, and that a separate study conducted by University of Alabama at Birmingham scientists showed AdCOVID stimulated a 29-fold induction of mucosal IgA in vaccinated mice’s respiratory tracts.

The vaccine, which expresses the receptor-binding domain (RBD) of the SARS-CoV-2 spike, is slated to enter Phase I testing next quarter.

Separately, Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) has gained an option to exclusively license a bovine parainfluenza virus-based COVID-19 vaccine via a research collaboration with Kansas State University. The live attenuated replicating viral vector vaccine, dubbed TNX-2300, expresses CD40L and targets the SARS-CoV-2 spike. The platform, developed by Kansas State Assistant Professor Waithaka Mwangi, is suitable for nasal and parenteral delivery.

TNX-2300 is Tonix’s second live viral vector COVID-19 vaccine. The first, TNX-1800, is based on horsepox virus; the company expects to have IND-enabling animal data next quarter.

On the other end of the development spectrum are BNT162b1 and BNT162b2, the two most advanced mRNA COVID-19 vaccine candidates from Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX), which received Fast Track designation from FDA. Pfizer and BioNTech have four vaccines in the BNT162 program, all of which are in Phase I/II testing.

BNT162b1 is a nucleoside-modified RNA subunit vaccine encoding trimerized spike RBD; BNT162b2 is a nucleoside-modified RNA subunit vaccine encoding a mutated full-length spike.

Two weeks ago, BioNTech and Pfizer released Phase I/II data for BNT162b1 showing that prime-boost administration of the low and medium doses induced mean neutralizing antibody titers of 168 and 267 -- the highest reported in humans to date (see “BioNTech, Pfizer Vaccine Yields Highest Titers to Date”).

That was until Tuesday, when Moderna revealed that prime-boost administration of low and medium doses of its COVID-19 vaccine induced the highest neutralization titers reported to date (see “Moderna, NIH Pick Phase III COVID-19 Vaccine Dose”).

BioNTech and Pfizer plan to select a candidate and start a 30,000 Phase IIb/III trial this month.

The companies are jointly developing and commercializing BNT162 globally, with the exception of China, where BioNTech is partnered with Fosun Pharmaceutical Group Co. Ltd. (Shanghai:600196; HKEX:2196).

Targets

CD40L (CD40LG; CD154) - CD40 ligand

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