Ab­b­Vie backs an Ital­ian start­up fo­cused on au­toim­mune dis­eases; Bio­Th­eryX ad­vances AML drug with $35M D round

Graziano Seghezzi Sofinno­va

Italy’s En­thera Phar­ma­ceu­ti­cals has grabbed a €28 mil­lion launch round to back its work on, lay­ing brag­ging rights to the largest A round ever for an Ital­ian biotech.

The com­pa­ny is us­ing “non­tra­di­tion­al” tech to tar­get au­toim­mune dis­eases, look­ing to re-es­tab­lish stem cell ca­pa­bil­i­ties in type 1 di­a­betes and in­flam­ma­to­ry bow­el dis­ease.

Graziano Seghezzi, man­ag­ing part­ner of Sofinno­va Part­ners, co-seed­ed the com­pa­ny, with Ab­b­Vie step­ping in to help out. This is Ab­b­Vie’s first in­vest­ment in the Ital­ian biotech scene.

CEO Gio­van­ni Am­a­bile said that “the funds raised will en­able us to ac­cel­er­ate our lead pro­gram Ent001 to clin­i­cal proof-of-con­cept. Through this and the de­vel­op­ment of our wider pipeline, we have the op­por­tu­ni­ty to bring re­al hope to pa­tients in need and to pro­vide ef­fec­tive and safe treat­ments.”

Bio­Th­eryX adds a $35M D round as biotech ven­ture pot swells

San Diego-based Bio­Th­eryX has gar­nered $35 mil­lion for its D round. And the CEO isn’t let­ting the oc­ca­sion go past with­out tout­ing the tech.

“We are pleased to have closed this fi­nanc­ing that will en­able us to ac­cel­er­ate ex­pan­sion of our on­go­ing clin­i­cal tri­al of BTX-A51, which I be­lieve may ul­ti­mate­ly be­come one of the most sig­nif­i­cant in­no­va­tions in the past 40 years for AML pa­tients and their fam­i­lies,” said CEO David Stir­ling.

The biotech’s mis­sion is “restor­ing pro­tein home­osta­sis, in­clud­ing pro­tein degra­da­tion and mod­u­la­tion, and mul­ti-ki­nase in­hi­bi­tion to de­vel­op treat­ments in­tend­ed to ex­tend and im­prove the qual­i­ty-of-life of pa­tients with life-threat­en­ing dis­eases.”

MSD Part­ners led the round and their part­ner Robert Platek is join­ing the board.

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.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; and more

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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.

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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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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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 clinicaltrials.gov, 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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89bio to net $275M from stock of­fer­ing; As­sem­bly Bio to pause work on one HBV in­hibitor pro­gram

San Francisco-based biotech 89bio announced on Friday that it expects to rake in $275 million on a stock offering. The raise comes after 89bio announced on Tuesday results of a Phase II study showing that its drug was better than placebo at lessening fibrosis without worsening nonalcoholic steatohepatitis, or NASH.

To run a Phase III study, 89bio CEO Rohan Palekar told Endpoints News that the biotech “would need to raise additional capital.” 89bio offered over 16 million shares of its common stock at $16.25 per share, and expects the offering closes on March 28.