Eyeing emergency use of COVID-19 drug, Humanigen partners with Lonza to make it

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Humanigen is hoping for emergency use authorisation in the US for an antibody to treat severe COVID-19 before the end of 2020, and has teamed up with Swiss contract manufacturer Lonza to make sure it can meet demand.

The antibody – called lenzilumab – targets colony stimulating factor 2 (CSF2) and granulocyte-macrophage colony stimulating factor (GM-CSF), two cytokines that are linked to the runaway immune response that can result in serious lung damage in COVID-19.

It started phase 3 testing in May to treat the so-called ‘cytokine storm’ that leaves some people with coronavirus infections fighting for their lives with acute respiratory distress syndrome (ARDS), and Humanigen is hopeful for data that could support an emergency okay.

Cytokine storm – also known as cytokine release syndrome (CRS) – is also a complication of some cell-based therapies for cancer such as CAR-Ts, and Humanigen is also developing lenzilumab for that indication with Gilead’s Kite subsidiary.

The new deal gives the US biotech access to Lonza’s expertise in manufacturing biologic drugs, as well as ushering them along the regulatory pathway and onto the market, and will boost the manufacturing capacity for lenzilumab.

Humanigen said in July it had also partnered with Catalent to make the drug, which was developed using Catalent’s cell line development platform.

In June, Mayo Clinic researchers announced data on the first clinical use of lenzilumab in 12 patients with severe and critical COVID-19 pneumonia, saying that the majority showed rapid recovery and discharge from hospital.

An update a few days later from Humanigen – involving 19 patients – showed that the median time to recovery with lenzilumab was five days, which Humanigen said compared favourably to the 10 days to recovery seen in a similar patient group treated with Gilead’s antiviral therapy remdesivir.

Last week, the independent data safety monitoring board (DSMB) for Humanigen’s phase 3 trial recommended that the trial continue as planned after an initial look at the results. They looked at safety as well as carrying out a futility analysis to gauge whether the drug was working as expected.

Humanigen now expects to complete enrolment of the 300 subjects this month with topline results due in the fourth quarter.

Other attempts to tackle the cytokine storm that afflicts some people infected with SARS-CoV-2 have ended mainly in disappointment, although a UK study found that an immune-dampening corticosteroid drug – dexamethasone – was able to improve survival in severely-ill COVID-19 patients.

Two IL-6 inhibitors – Sanofi/Regeneron’s Kevzara (sarilumab) and Roche’s Actemra/RoActemra (tocilizumab) – have failed to show a significant benefit in clinical trials to date, and Sanofi confirmed recently it had abandoned any further studies of the drug in COVID-19 patients. Roche meanwhile is continuing to trial its drug in combination with remdesivir.

Other anti-inflammatory drugs in testing for COVID-19 include Eli Lilly’s Olumiant (baricitinib) and Novartis/Incyte’s Jakafi (ruxolitinib), both JAK inhibitors, and Atriva Therapeutics’ experimental MEK inhibitor ATR-002, which promises to combine anti-inflammatory and antiviral properties.

AstraZeneca meanwhile is testing its BTK inhibitor Calquence (acalabrutinib), which is currently used to treat various types of blood cancer, as a coronavirus therapy in the CALAVI trial, reporting encouraging preliminary results in June. Lilly also has studies on the go for LY3127804, an investigational antibody targeting angiopoietin 2 (Ang2).