Clover becomes latest COVID-19 vaccine developer to gain CEPI funding as Moderna, Jenner continue to advance

Pneumagen reports antiviral activity, Sarepta enters ring with antisense oligos

Amid a flurry of COVID-19 vaccine updates, CEPI has announced an investment in Clover that will support its advancement into the clinic. On the treatment front, Pneumagen reported preclinical antiviral activity for its lead program, and Sarepta has entered the field with its antisense platform.

The Australian subsidiary of Sichuan Clover Biopharmaceuticals Inc. will receive $3.5 million from the Coalition for Epidemic Preparedness Innovations (CEPI) to prepare for and begin Phase I testing of its COVID-19 S-Trimer vaccine. The candidate, a trimeric SARS-CoV-2 spike protein subunit vaccine, is based on Clover’s Trimer-Tag platform (see “Clover: Trimerizing Fusion Proteins”).

This marks CEPI’s ninth COVID-19 deal and brings its total COVID-19 vaccine R&D investments to $39.6 million. Other recipients of CEPI’s COVID-19 vaccine funding include CureVac AG, Inovio Pharmaceuticals Inc. (NASDAQ:INO) and Moderna Inc. (NASDAQ:MRNA), which on Monday said it has submitted an IND to FDA to run a Phase II and later stage trials of mRNA-1273, pending supportive safety data from the NIH-led Phase I trial of the candidate.

Moderna has already received initial feedback from FDA on the design of the Phase II trial, which is expected to start this quarter. The placebo-controlled study will enroll about 600 healthy adults ages 18-55 and about 300 individuals ages 55 and older. It will test two immunizations, 28 days apart, and evaluate safety, reactogenicity and immunogenicity.

On April 16, the company secured a commitment of up to $473 million from the Biomedical Advanced Research and Development Authority (BARDA) for clinical development and manufacturing scale-up of mRNA-1273. The company said Phase III testing could begin in autumn, when the vaccine might also become available for emergency use (see “BARDA’s $483M Commitment to Moderna”).

Another COVID-19 vaccine that could become available on an emergency basis as early as September is ChAdOx1 nCoV-19 from the University of Oxford’s Jenner Institute.

Oxford confirmed for BioCentury that NIH’s Rocky Mountain Labs had generated preclinical data showing that six monkeys given the vaccine were still healthy 28 days after challenge by SARS-CoV-2.

With the promising data in hand, the institute plans ramp up clinical evaluation of ChAdOx1 nCoV-19. The original Phase I design was a blinded comparison of ChAdOx1 nCoV-19 with an approved meningococcus vaccine in up to 1,112 adults. Testing will now be done in over 6000 individuals.

Inovio’s hints from MERS

Inovio and GeneOne Life Science Inc. (KSE:011000) unveiled data from its Middle East respiratory syndrome coronavirus (MERS-CoV) vaccine on Monday that suggest Inovio’s Phase I COVID-19 vaccine, INO-4800, will also be immunogenic.

Interim Phase I/II data showed that among individuals who received two doses of INO-4700, a DNA vaccine targeting the MERS-CoV spike protein, 84% developed anti-spike antibodies, 92% had a neutralizing response and 60% had a robust T cell response. Among individuals who received three vaccine doses, 100% formed anti-spike antibodies, 92% developed a neutralizing response and 84% developed a T cell response. INO-4700 did not lead to vaccine-related serious adverse events.

Similar to the MERS candidate, INO-4800 is a DNA vaccine that targets the SARS-CoV-2 spike protein and is delivered with Inovio’s intradermal CELLECTRA device.

In vitro data for Pneumagen

Pneumagen Ltd. said it plans to begin clinical testing of its multivalent carbohydrate binding molecules (mCBMs) after three studies showed the molecules reduced SARS-CoV-2 plaques in vitro.

In the plaque reduction assays, the biotech tested whether its mCBMs, including lead product Neumifil, could both prevent and treat infection. The glycan-binding proteins block the virus by physically preventing the pathogen from binding host cells (see “Out-Competing Viral Sugar Binding to Prevent Infection”).

Neumifil, which comprises six CBM40 units, is in preclinical development for influenza and RSV.

Sarepta, USAMRIID explore ASO therapies

Sarepta Therapeutics Inc. (NASDAQ:SRPT) partnered with the U.S. Army Medical Research Institute of Infectious Diseases to identify antisense oligonucleotides to treat COVID-19.

Under a CRADA, Sarepta will design and manufacture multiple peptide-conjugated phosphorodiamidate morpholino oligomer constructs based on genetic sequencing of SARS-CoV-2. The pair will then evaluate the constructs for activity against the virus and consider collaborative funding proposals to advance development of a therapy.

The company said clinical and preclinical studies have shown antiviral activity of its RNA technology in coronaviruses.

Further analysis of the coronavirus crisis can be found at https://www.biocentury.com/coronavirus.

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