Aeter­na dis­con­tin­ues vac­cine de­vel­op­ment; Idera re­brands as Ac­er­a­gen

As biotechs start to de­tail 2023 plans — M&A, new em­phases in drug R&D and more with in­vestors — oth­ers are start­ing to trim back or us­ing the new year as an op­por­tu­ni­ty to do an about-face and try and start with a clean slate.

Three such biotechs un­veiled next steps for their re­spec­tive com­pa­nies Tues­day morn­ing.

Aeter­na ax­es ear­ly-stage vac­cine pipeline af­ter reac­quir­ing re­gion­al rights to sole prod­uct

Aeter­na Zen­taris is cut­ting its work on a vac­cine plat­form, which the biotech said had po­ten­tial ap­pli­ca­tions against chlamy­dia and Covid-19. How­ev­er, the com­pa­ny said it had not been able to se­lect a clin­i­cal de­vel­op­ment can­di­date for a Covid-19 vac­cine.

The biotech cit­ed “changes in the glob­al sit­u­a­tion” and want­i­ng to be “pru­dent with the use of re­sources” as rea­sons for scrap­ping the vac­cine plat­form. It is al­so ter­mi­nat­ing li­cense agree­ments with the Uni­ver­si­ty of Würzburg for the plat­form tech­nol­o­gy.

Mean­while, the rights to Macrilen, an oral ghre­lin ag­o­nist in­di­cat­ed to di­ag­nose adult growth hor­mone de­fi­cien­cy, will be re­turn­ing back to Aeter­na, the orig­i­nal de­vel­op­er. No­vo Nordisk of­fered $145 mil­lion and a $36 mil­lion eq­ui­ty in­vest­ment in 2018 to Strong­bridge Bio­phar­ma to scoop up re­gion­al rights in US and Cana­da for the ag­o­nist, af­ter Strong­bridge bought the rights from Aeter­na for $24 mil­lion up­front plus mile­stones.

Aeter­na an­nounced last Au­gust that the rights would be re­turn­ing to the com­pa­ny, fol­low­ing a 270-day pe­ri­od.

CFO Giu­liano La Frat­ta added that the de­ci­sion to “stream­line our pipeline” by end­ing the vac­cine de­vel­op­ment pro­gram ex­tends the com­pa­ny’s cash flow in­to 2025.

— Paul Schloess­er

Idera takes on a new name, tick­er af­ter merg­er and stock split

Af­ter merg­ing with a rare dis­ease com­pa­ny, Idera is phas­ing its name out.

Can­cer biotech Idera Phar­ma­ceu­ti­cals put out word Tues­day it will be tak­ing on Ac­er­a­gen’s name and stock tick­er $ACGN, ef­fec­tive Wednes­day af­ter buy­ing the rare dis­ease com­pa­ny in an all-stock deal. Idera had an­nounced last year it would buy Ac­er­a­gen af­ter Idera’s lead drug flopped and a col­lab­o­ra­tion with Ab­b­Vie end­ed.

Shares of the pen­ny stock $IDRA fell 13% af­ter the an­nounce­ment, cur­rent­ly trad­ing be­low 50 cents a share.

Idera flunked a Phase III melanoma tri­al with its Toll-like re­cep­tor 9 ag­o­nist tilso­tolimod back in 2021. While ex­ec­u­tives hoped tri­als in oth­er can­cers would bring about bet­ter re­sults, those failed to pan out, and Idera dis­con­tin­ued en­roll­ment lat­er that year in a Phase II study.

Idera added that with an ap­proved re­verse split of com­mon stock at a ra­tio of 1:17, the com­pa­ny has now got­ten back in com­pli­ance with Nas­daq.

Ac­er­a­gen CEO John Tay­lor said in a state­ment that for 2023, the com­pa­ny has two planned Phase II read­outs for ACG-701, a pro­pri­etary oral dos­ing reg­i­men of sodi­um fusidate for cys­tic fi­bro­sis. Ad­di­tion­al­ly, the biotech is mov­ing for­ward on start­ing a Phase II/II tri­al for ACG-801, an en­zyme re­place­ment can­di­date for Far­ber dis­ease, a dis­ease where a lipid called ce­ramide ac­cu­mu­lates in the body to ex­cess lev­els and can cause pre­ma­ture death.

That tri­al, if every­thing goes to plan, will start some­time in Q1 next year. Cur­rent­ly ACG-801 has or­phan drug, fast track and rare pe­di­atric dis­ease des­ig­na­tions from FDA.

Even with the merg­er and re­gain­ing com­pli­ance with Nas­daq, its avail­able cash is on­ly ex­pect­ed to pro­vide the biotech with run­way in­to Q3 this year. Idera’s lat­est quar­ter­ly fil­ing with the SEC point­ed to the com­pa­ny hav­ing around $30 mil­lion in cash, equiv­a­lents and oth­er cur­rent as­sets.

— Paul Schloess­er

hC Bio­science ac­quires Uni­ver­si­ty of Chica­go spin­out 

Af­ter dis­clos­ing an­oth­er $16 mil­lion in fi­nanc­ing last No­vem­ber, hC Bio­science put out word it has ac­quired a start­up look­ing to make tR­NA-based ther­a­pies.

Take­da-backed hC said it bought 4SR Bio­sciences, found­ed in the labs of the Uni­ver­si­ty of Chica­go’s Christo­pher Katan­s­ki and Tao Pan. Deal terms were not dis­closed. Com­bin­ing the tech, IP and ex­per­tise of the two com­pa­nies will help hC build out ther­a­pies for ge­net­ic dis­ease and can­cer, the biotech said.

The com­pa­ny is at­tempt­ing to go af­ter tR­NA, which peers like Flag­ship Pi­o­neer­ing’s All­tr­na, Shape Ther­a­peu­tics and Tevard Bio­sciences think can open up the drug de­vel­op­ment to treat dis­eases re­gard­less of gene or lo­ca­tion of mu­ta­tion.

“Bring­ing their pow­er­ful re­search tools and ex­per­tise in tR­NA and struc­tur­al bi­ol­o­gy in-house en­ables us to bet­ter un­der­stand fun­da­men­tal mech­a­nisms of tR­NA bi­ol­o­gy and dis­ease path­ways as­so­ci­at­ed with ge­net­ic er­rors and, im­por­tant­ly, how best to in­ter­vene with en­gi­neered tR­NAs,” said hC CEO Leslie Williams.

— Kyle LaHu­cik

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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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.

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.

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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