Roivant pivots towards ARDS in COVID-19; plus Italian studies of repurposed anti-inflammatories, vaccine updates and more

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Wednesday saw a full slate of clinical updates across the globe for vaccine and therapeutic candidates to address COVID-19, while HHS launched a new public-private partnership to ramp up emergency drug packaging capabilities.

Roivant Sciences GmbH said it has engaged U.S., European and Asian regulators to enable clinical testing of gimsilumab to prevent and treat acute respiratory distress syndrome (ARDS), which is caused by lung tissue damage and inflammation, in COVID-19 patients. To date, the only treatment for ARDS is mechanical ventilation.

The mAb targets pro-inflammatory cytokine GM-CSF, which is upregulated in the serum of COVID-19 patients. Roivant said it will prioritize the COVID-19 trials over a Phase II study it had planned for a different indication. The company completed Phase I dosing of gimsilumab in February.

In response to a request from Italy’s National Institute for Infectious Diseases, Swedish Orphan Biovitrum AB (SSE:SOBI) plans to begin a short-term clinical trial of Kineret anakinra and Gamifant emapalumab to treat hyperinflammatory syndrome associated with severe COVID-19. Kineret is recombinant IL-1RA approved to treat inflammatory diseases including rheumatoid arthritis. Gamifant is a mAb against IFNγ indicated for hemophagocytic lymphohistiocytosis, a systemic inflammatory disorder.

The Papa Giovanni XXIII Hospital has initiated an observational case-control clinical trial, SISCO, of Sylvant siltuximab from EUSA Pharma Ltd. to treat COVID-19 patients who have developed serious respiratory complications. Under a compassionate use protocol, the Italian study is evaluating the mAb against IL-6 in hospitalized patients before or after ICU admission. Primary endpoints are need for invasive ventilation, time spent in the ICU and 30-day mortality. Initial data are expected by the end of March.

CanSino Biologics Inc. (HKEX:6185) said it has gained approval to begin Phase I testing in China for Ad5-nCoV, a COVID-19 vaccine it co-developed with the Academy of Military Medical Sciences. The candidate is an adeno-associated virus serotype 5 (AAV5) vector encoding the SARS-CoV-2 spike protein.

Johnson & Johnson (NYSE:JNJ) Vice Chairman and CSO Paul Stoffels said clinical trials of the company’s COVID-19 vaccine could begin in November. The vaccine program will use the AdVac and PER.C6 technologies the Janssen Pharmaceutical Inc. unit applied to its Ebola vaccine program.

Marianne Stanford, VP of R&D at IMV Inc. (TSX:IMV; NASDAQ:IMV), told BioCentury the Canadian company has generated multiple COVID-19 vaccine candidates from its DPX platform for lipid-based delivery of peptide antigens and is in the process of selecting which one to bring into the clinic. IMV hasn’t yet determined a clinical development timeline.

Synairgen plc (LSE:SNG) has gained expedited approval from the U.K.’s MHRA and Health Research Authority to conduct the double-blind, placebo-controlled Phase II SG016 trial of SNG001 in COVID-19 patients. The company is also exploring ways to adapt its ongoing Phase II study of the inhaled formulation of IFNβ-1a in chronic obstructive pulmonary disease (COPD) to enable patients in the pretreatment pool to be dosed if they become infected by SARS-CoV-2.

According to, Pulmotect Inc. has initiated two Phase II trials of PUL-042 to reduce the severity of COVID-19 in adults positive for SARS-CoV-2 and to prevent COVID-19 in adults exposed to the virus. Both studies’ primary completion dates are in September.

PUL-042 combines two toll-like receptor (TLR) agonists: Pam2CSK4 -- Pam2 linked to a cysteine-serine-lysine-lysine-lysine-lysine motif -- and a 25-nucleotide oligodeoxynucleotide. In January, the company reported that PUL-042 protected mice against lethal SARS and Middle East respiratory syndrome (MERS) coronavirus infections.

HHS launched a public-private partnership, Rapid Aseptic Packaging of Injectable Drugs (RAPID), to enable the Strategic National Stockpile to quickly fill and finish “hundreds of millions of prefilled syringes” for rapid response to widespread health emergencies such as COVID-19. The consortium will be led by public benefit corporation Apiject Systems America, which has received an award of up to $456 million for R&D, rapid prototyping and stability testing of the syringes.

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GM-CSF (CSF2) - Granulocyte macrophage colony-stimulating factor

IL-1RA - Interleukin-1 receptor antagonist

IL-6 - Interleukin-6

IFNγ - Interferon γ

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