Flag­ship Pi­o­neer­ing has a fresh com­pa­ny out this week, one that aims to lay the ground­work for a whole new dis­ci­pline.

Sen­da Bio­sciences launched Wednes­day with $88 mil­lion in Flag­ship cash. The goal? Gain in­sights in­to the mol­e­c­u­lar con­nec­tions be­tween peo­ple and co­e­volved non­hu­man species like plants and bac­te­ria, paving the way for “In­ter­sys­tems Bi­ol­o­gy.”

Guil­laume Pfe­fer

Guil­laume Pfe­fer has been tapped to run the show, a 25-year biotech vet­er­an who comes from GSK af­ter lead­ing the de­vel­op­ment of the com­pa­ny’s shin­gles vac­cine.

“For Sen­da, we are zoom­ing in­to what’s go­ing on at hu­man lev­els, and we rec­og­nize that these in­ter­ac­tions are the prod­uct of evo­lu­tion since the dawn of time,” Pfe­fer told End­points News. “We know which species are in­volved in our bod­ies and where.”

A cen­ter­piece of Sen­da’s pro­pri­etary tech in­volves ma­chine learn­ing to cre­ate what the com­pa­ny hopes is an en­tire­ly new class of drugs. By fo­cus­ing in part on the bac­te­ria that re­side in hu­mans, Sen­da is look­ing at po­ten­tial­ly de­vel­op­ing large mol­e­cule med­i­cines like pep­tides and nu­cle­ic acids us­ing oral ad­min­is­tra­tion, which the com­pa­ny says is a first.

In­ter­sys­tems Bi­ol­o­gy has been in the works at Flag­ship for some time. The firm says the dis­ci­pline is based on a decade of re­search in oth­er ar­eas, in­clud­ing mi­cro­bio­me sci­ence and com­pu­ta­tion­al bi­ol­o­gy, and the cel­lu­lar in­ter­ac­tions Sen­da is an­a­lyz­ing can be found in sev­er­al dif­fer­ent places with­in the body.

“Through the ex­plo­rations con­duct­ed by Flag­ship Labs over the last sev­er­al years we have dis­cov­ered that these in­ter­con­nec­tions have pro­found im­pli­ca­tions on hu­man health,” Flag­ship founder Noubar Afe­fan told End­points News in an email.

One prime ex­am­ple is the neu­ro­trans­mit­ter sero­tonin, most of which is not found in the cen­tral ner­vous sys­tem but the gut. As much as 90% of sero­tonin is pro­duced in re­sponse to bac­te­ria break­ing down com­pounds with­in the di­ges­tive tract, Sen­da says, and if this reg­u­la­tion falls out of whack, it can lead to health prob­lems with both low and high blood sug­ar.

“With this ap­proach, you re­al­ize that we have a phar­ma­cy with­in us,” Pfe­fer said. “The key point is we have evolved with the bac­te­ria, and now with Sen­da are able to look with high res­o­lu­tion in­to how the species with­in us com­mu­ni­cate and par­tic­i­pate in dis­ease and health.”

David Berry

Sen­da cur­rent­ly has six on­go­ing pre­clin­i­cal pro­grams un­der its belt across mul­ti­ple ar­eas, with INDs ex­pect­ed for each by the end of 2022. In neu­rol­o­gy, Sen­da has can­di­dates in mul­ti­ple scle­ro­sis and Parkin­son’s dis­ease. For on­col­o­gy, they’re look­ing at im­muno-on­col­o­gy and col­orec­tal can­cer. And in chron­ic and meta­bol­ic dis­ease, the first tar­gets are chron­ic kid­ney dis­ease and obe­si­ty.

Specif­i­cal­ly, Pfe­fer men­tioned that Sen­da is look­ing at a bac­te­ria that in­ter­feres with L-dopa in the treat­ment of Parkin­son’s and at­tempt­ing to dis­rupt that process, thus mak­ing ther­a­pies more ef­fec­tive.

As Sen­da moves its six pre­clin­i­cal pro­grams for­ward, Pfe­fer’s goal is to con­tin­ue to de­ploy its dis­cov­ery en­gine in­to fur­ther in­di­ca­tions, set­ting up the com­pa­ny for more pro­grams once the proof of mech­a­nism has been es­tab­lished at the end of 2022.

“We are touch­ing on some­thing very fun­da­men­tal here and very pro­found,” Pfe­fer said.

The com­pa­ny was co-found­ed by sev­er­al mem­bers of Flag­ship’s team, in­clud­ing part­ners David Berry and Igna­cio Mar­tinez. Sen­da’s board will be chaired by Flag­ship’s ex­ec­u­tive part­ner John Mendlein.

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.