Richard DiMarchi, MBX Biosciences

Suc­cess­ful sci­en­tist-in­vestor al­lies team up again — this time for a stab at rare meta­bol­ic dis­ease

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.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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Stuart Peltz, former PTC Therapeutics CEO

Stu­art Peltz re­signs as PTC Ther­a­peu­tics CEO af­ter 25 years

Stuart Peltz, the longtime CEO of PTC Therapeutics who’s led the rare disease drug developer since its founding 25 years ago, is stepping down.

Succeeding him in the top job is Matthew Klein, who joined PTC in 2019 and was promoted to chief operating officer in 2022. In a call with analysts, he said the CEO transition has been planned for “quite some time” — in fact, as part of it, he gave the company’s presentation at the JP Morgan healthcare conference earlier this year.

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Bet­ter Ther­a­peu­tics cuts 35% of staff while await­ing dig­i­tal ther­a­peu­tic ap­proval

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.

FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

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.

Steven James, Pionyr Immunotherapeutics CEO

Gilead pass­es on ful­ly ac­quir­ing Pi­o­nyr, as eyes now turn to Tizona, a fel­low sum­mer 2020 buy­out op­tion

Gilead and Pionyr Immunotherapeutics, a biotech trying to follow up on the first generation of checkpoint inhibitors, have “mutually agreed” on a rewrite to their 2020 terms, with Gilead deciding not to buy out the company.

The California biopharma waived its option to acquire the remaining 50.1% of Pionyr, which would have triggered a $315 million upfront payment and up to $1.15 billion down the road. Had Gilead waited to decide, the drugmaker would have had a potential payment to make in the near term under their agreement, a spokesperson said in an email to Endpoints News.

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Zhi Hong, Brii Biosciences CEO

Brii Bio­sciences stops man­u­fac­tur­ing Covid-19 an­ti­body com­bo, plans to with­draw EUA re­quest

Brii Biosciences said it will stop manufacturing its Covid-19 antibody combination, sold in China, and is working to withdraw its emergency use authorization request in the US, which it started in October 2021.

The Beijing and North Carolina biotech commercially launched the treatment in China last July but is now axing the work and reverting resources to other “high-priority programs,” per a Friday update. The focus now is namely hepatitis B viral infection, postpartum depression and major depressive disorders.

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