Humanigen Inc (HGENQ)

[bobshmob]

very helpful paper, agmcsf. Thanks for the link.

Two things in particular stood out, and I'll talk about them in two parts. First is a brief rundown of the anti-GMCSF's mentioned.

I didn't realize there were so many groups working on anti GM-CSF(r) for SARS-CoV2. Here's a brief summary:

Frontrunners
lenzilumab (Humanigen)
2 trials: 1) pneumonia but no ARDS, 238 patients at 8 sites, began enrollment approx May 1; 2) NIH-sponsored combo therapy trials with remdesivir, 100 patients, begin August(?) 2020. EINDs looked good; seal of approval from NIH is a big boost of confidence.

otilimab (GlaxoSmithKline): treatment for RA, not yet approved anywhere; P2 trials for severe covid-19 cases to enroll 800 patients at around 40 sites in US (9), France, Japan, Netherlands, Poland, Spain, UK beginning (roughly) at the start of June. Primary endpoint is mortality + respiratory failure (high flow O2 or ventilator) at day 28. Inclusion criteria: severe cv19 w/ pneumonia and respiratory failure.

mavrilimumab (Kiniksa): developed for RA and trials have been going on for many years but abandoned; now working on GCA and CAR-T CRS. 4 trials for covid-19 were initiated this summer in US: 573 patients P2/3 (July), 60 patients P2 (August), 60 patients P2 (July), 60 patients P2 (June). Maybe not enough sites lined up to enroll 753 patients before the year 2022? [3, 1, 1, 2 sites for the 4 trials, resp.]. Primary endpoint for each is similar: mortality + O2 support at day 14. Big trial is divided into two cohorts: 1) severe but not intubated, 2) intubated. Inclusion for the other trials: severe (hospitalized). Company has several products and recently got BTA and orphan drug designation for rilonacept for pericarditis. Company has struggled for many but seems to be breaking through with revenue soon, several plausible INDs moving through the pipeline; good cash on hand and no debt, but still doing dilutions. Encouraging results from preliminary study in Italy.

gimsilumab (Roivant): One P2 trial for severe cases; to enroll 270 patients, beginning in April; been recruiting approx. 2/day. Primary endpoint is mortality at day 43. Inclusion: ARDS.

Hmm...
namilumab (Izana): no trial in US; no data yet from trial in UK (began in April)

TJ003234 (I-Mab Biopharma Co. Ltd)
One P1/P2 trial with 144 patients, starting in April. Chinese company that focuses almost exclusively on China.