A sci­en­tist-ex­ec­u­tive team that, over the last decade, sold one di­a­betes biotech to Roche for up-to $537 mil­lion and two oth­ers to No­vo Nordisk for undis­closed sums are back with a new com­pa­ny.

Kent Hawry­luk

Uni­ver­si­ty of In­di­ana bi­ol­o­gist Richard Di­Marchi and se­r­i­al en­tre­pre­neur Kent Hawry­luk have launched MBX Bio­sciences, rais­ing $36.4 mil­lion in a Fra­zier Health­care Part­ners-led round to get it start­ed. For now, the pair are keep­ing their dis­eases and drug tar­gets close to the vest, say­ing on­ly that MBX will de­vel­op the same kind of mol­e­cules they de­vel­oped in pre­vi­ous com­pa­nies — large pep­tide ther­a­peu­tics — but with a fo­cus on rare en­docrine dis­or­ders, as op­posed to di­a­betes.

“There’s just a very rich his­to­ry in the field of pep­tides as mirac­u­lous med­i­cines, start­ing with in­sulin and glucagon and ex­tend­ing through a host of more re­cent reg­is­tra­tions,” Di­Marchi told End­points News. “So it is rare en­docrine dis­eases, it is large mol­e­cules, it is re­lat­ed to things I’ve done his­tor­i­cal­ly.”

The com­pa­ny is based both in the 100,000-per­son city of Carmel, In­di­ana, out­side In­di­anapo­lis, where there are 6 full-time em­ploy­ees, and at Di­Marchi’s lab in Bloom­ing­ton, where sev­er­al full-time sci­en­tists work un­der a spon­sored re­search arrange­ment. “Al­though these days, it feels like we’re based on Zoom,” Hawry­luk told End­points.

Be­fore found­ing his first biotech with Hawry­luk, Di­Marchi led the en­docrine di­vi­sion for two decades at Eli Lil­ly, where he helped de­vel­oped Hu­ma­log, Eli Lil­ly’s best-sell­ing in­sulin. In 2005, he and Hawry­luk found­ed Mar­ca­dia to de­vel­op a sol­u­ble and sta­ble ana­log for the meta­bol­ic hor­mone glucagon, a po­ten­tial treat­ment for di­a­betes and obe­si­ty. Six years lat­er, Roche snapped up the tiny biotech for $287 mil­lion in cash and up-to $250 mil­lion in mile­stones.

Roche end­ed up re­tir­ing the pro­gram short­ly there­after when they left meta­bol­ic dis­ease al­to­geth­er, Di­Marchi said, but he cred­its their work with es­tab­lish­ing the frame­work for oth­ers to en­ter the field. He specif­i­cal­ly named Zealand Phar­ma, which this year filed an NDA for dasiglucagon. He al­so named their work on a hor­mone that can hit both GIP and GLP-1 re­cep­tors, po­ten­tial­ly al­low­ing for a stronger drug for obe­si­ty, di­a­betes and NASH.

“It was our di­rec­tion that I be­lieve led oth­ers,” Di­Marchi said. “There’s prob­a­bly 2 dozen of those clin­i­cal can­di­dates cur­rent­ly be­ing ad­vanced across the globe by more than half a dozen phar­ma­ceu­ti­cal com­pa­nies.”

Lat­er, Di­Marchi and Hawry­luk launched MB2 and Cal­ib­ri­um in 2012 and 2014 to de­vel­op oth­er pro­tein-based di­a­betes drug and sold both to No­vo Nordisk in 2015 for an undis­closed sum. The progress that had been made in di­a­betes, Di­Marchi said, dic­tat­ed that they fo­cus else­where.

That work be­gan last Ju­ly, when Di­Marchi re­turned to a full time role at In­di­ana af­ter a few years work­ing part-time with No­vo Nordisk. He start­ed work­ing on syn­the­siz­ing new mol­e­cules and de­vel­op­ing in vit­ro as­says. He re­cruit­ed back Hawry­luk, who was then CBO of the RNA biotech Avid­i­ty Bio­sciences and who came over in Jan­u­ary af­ter se­cur­ing a $100 mil­lion crossover round.

There’s no time­line yet for the clin­ic or drug tar­gets. For now, Hawry­luk said, they’re look­ing for a CMO and en­joy­ing hav­ing an old band back to­geth­er.

“The jam ses­sions are a lot of fun,” he said.

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.