Jean-Jacques Ga­raud

When Jean-Jacques Ga­raud left the top role in re­search and ear­ly de­vel­op­ment at Roche to build and ad­vise ear­ly-stage biotechs in his na­tive Paris, one fledg­ling quick­ly drew close to his heart.

The start­up, In­otrem, was de­vel­op­ing an im­munother­a­py to treat sep­tic shock. Hav­ing trained as a crit­i­cal care physi­cian be­fore mov­ing to Scher­ing-Plough and then No­var­tis, Ga­raud was all too fa­mil­iar with the dearth of treat­ments for sep­sis, which is dead­ly even in de­vel­oped coun­tries, claim­ing more than a quar­ter-mil­lion deaths in the US each year.

To­geth­er with co-founders Sébastien Gi­bot and Marc De­rive (De­rive did his PhD at Gi­bot’s lab and is now In­otrem’s CSO), he swift­ly gath­ered €18 mil­lion from French VCs An­dera Part­ners and Sofinno­va Part­ners, as well as the trans­fer seed fund known as In­serm and Swiss play­er Bio­Med­In­vest. But for the next round of fund­ing, Ga­raud told Phar­ma Board­room ear­li­er this year, he’d be look­ing to bring in in­ter­na­tion­al in­vestors out­side of France and Eu­rope.

Marc De­rive

And bring in in­ter­na­tion­al in­vestors he did. Morn­ing­side Ven­tures, which traces its roots to Hong Kong, is lead­ing In­otrem’s €39 mil­lion Se­ries B. New York-based In­vus al­so joined the syn­di­cate.

“This fi­nanc­ing val­i­dates the po­ten­tial of our tech­nol­o­gy plat­form cen­tered on the TREM-1 path­way and of our lead drug can­di­date for sep­tic shock, nan­gi­botide, which will be en­ter­ing a large Phase IIb clin­i­cal tri­al lat­er this year,” Ga­raud said in a state­ment.

Char­ac­ter­ized by dan­ger­ous­ly low blood pres­sure, sep­tic shock is the most se­vere com­pli­ca­tion of sep­sis, which oc­curs when the body mounts an over­whelm­ing re­sponse to an in­fec­tion, lead­ing to or­gan fail­ures. While an­tibi­otics can help tamp down the in­fec­tion, nei­ther it nor sup­port­ive care ad­dress­es the un­der­ly­ing shock.

In­otrem’s hy­poth­e­sis is that by in­hibit­ing TREM-1 — a re­cep­tor ex­pressed on myeloid cells — its pep­tide drug can mod­u­late the im­mune at­tack with­out com­plete­ly stop­ping the in­flam­ma­to­ry re­sponse from clear­ing harm­ful bac­te­ria.

The field is not packed, but the biotech is not alone ei­ther. Berlin-based Adrenomed is tack­ling a tar­get called adrenomedullin, while Medicxi-backed UK start­up Crit­i­cal Pres­sure reck­ons hit­ting DDAH1 is the way to go.

With the new fund­ing, In­otrem plans to launch a glob­al Phase IIb tri­al to test that the­o­ry, re­cruit­ing 450 pa­tients and test­ing two dos­es of nan­gi­botide against stan­dard of care and place­bo.

Keep­ing his phar­ma con­nec­tions close, Ga­raud has al­so se­cured a part­ner­ship with Roche on a com­pan­ion di­ag­nos­tic tool based con­cen­tra­tion of TREM-1 in pa­tients.

In ad­di­tion to sep­tic shock, In­otrem is al­so de­vel­op­ing its TREM-1 drugs in car­dio­vas­cu­lar dis­eases and chron­ic in­flam­ma­to­ry con­di­tions.

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.