Then-Prince Felipe of Spain (R) toasts with Victor Grifols Roura (Photo by Kevork Djansezian/Getty Images)

Gri­fols makes a $146M bet on a Stan­ford play in a con­tro­ver­sial an­ti-ag­ing field

For the last cou­ple of years, when it came to the vague­ly vam­pir­ic field of young blood plas­ma trans­fu­sions, there was Alka­h­est and there was every­one else.

Since the field was briefly mocked on Sil­i­con Val­ley in 2017, one start­up charged $8,000 to $12,000 to pump the el­der­ly with the plas­ma of young donors and one doc­tor pitched his clin­i­cal tri­al in a glitzy West Palm Beach gala where he re­mind­ed re­tirees they were like­ly to die soon, prompt­ing FDA’s chief Scott Got­tlieb to warn such treat­ments were “un­proven” and that “some pa­tients are be­ing preyed up­on by un­scrupu­lous ac­tors.” But Alka­h­est, found­ed by a Genen­tech al­umn and a Stan­ford neu­ro­sci­en­tist, has promised to take a more mea­sured, sci­en­tif­ic ap­proach to the still-fringe sci­ence, run­ning phased clin­i­cal tri­als for their plas­ma-de­rived prod­ucts and couch­ing their press re­leas­es ac­cord­ing­ly.

Now, the plas­ma gi­ant Gri­fols is go­ing all-in on their work. On La­bor Day, the Span­ish com­pa­ny an­nounced they would buy out the re­main­ing shares of the start­up they didn’t al­ready own, spend­ing $146 mil­lion for just over 50% of Alka­h­est’s stock.

Gri­fols is a rough­ly $15 bil­lion com­pa­ny, so the buy­out is not ex­act­ly a huge out­lay for them. Nor is the near­ly $300 mil­lion mar­ket val­ue this deal places on Alka­h­est near­ly enough to rank them among the in­dus­try’s most valu­able play­ers. Still, the ac­qui­si­tion rep­re­sents a ma­jor val­i­da­tion for a com­pa­ny and a young-blood field that has grown up large­ly on the fringes of the bio­med­ical main­stream. And it amounts to a step for­ward for the an­ti-ag­ing field more broad­ly, which has strug­gled to make gains de­spite sig­nif­i­cant big-name in­vest­ment over the last few years.

The new deal is about four times what Gri­fols paid for the first 45% of Alka­h­est’s stock in 2015. The start­up has re­lied on Gri­fols to col­lect plas­ma for its prod­ucts.

“We saw the promise of Alka­h­est’s un­der­stand­ing of ag­ing when we made our first in­vest­ment and en­tered in­to a col­lab­o­ra­tion agree­ment with them five years ago,” Gri­fols CEO Víc­tor Grí­fols said in a state­ment. “Now we see a wealth of plas­ma-de­rived and non-plas­ma ther­a­peu­tic can­di­dates iden­ti­fied by Alka­h­est that can sig­nif­i­cant­ly sup­port the un­met needs of many dis­eases as­so­ci­at­ed with ag­ing.”

Un­like, say, Am­brosia (the afore­men­tioned $8,000 in­fu­sion com­pa­ny), Alka­h­est doesn’t give plas­ma di­rect­ly from young donors to the el­der­ly. In­stead, it has worked since 2014 on map­ping the pro­teins in plas­ma and dis­till­ing a cock­tail of rough­ly 400 dif­fer­ent types of pro­teins it be­lieves can make a dif­fer­ence in treat­ing Alzheimer’s and oth­er CNS dis­or­ders. That’s a ton of pro­teins com­pared to most bi­o­log­ics, which are made of 1, but it amounts to just 3% of what’s in plas­ma. The Long Is­land Ice Tea of a lead drug is known as GRF-6019. The sci­ence is based on work from Stan­ford neu­ro­sci­en­tist Tony Wyss-Coray, which was spun out by for­mer Genen­tech sci­en­tist Karoly Nikolich.

Tony Wyss-Coray

So far, ev­i­dence for ef­fec­tive­ness re­mains scant. Last year, the com­pa­ny said that, in a 47-per­son Phase II study, pa­tients with mild to mod­er­ate Alzheimer’s main­tained their lev­el of cog­ni­tion for 6 months. But they still have yet to re­lease da­ta from that study and while this is cer­tain­ly a new ap­proach to the eva­sive dis­ease, many oth­er ther­a­pies have failed af­ter show­ing promise in ear­ly tri­als. Their Phase I study, pub­lished in JA­MA, showed lit­tle change in cog­ni­tive per­for­mance tests among 18 Alzheimer’s pa­tients, al­though it was on­ly pow­ered for safe­ty.

Alka­h­est is al­so test­ing GRF-6019 in se­vere Alzheimer’s pa­tients, an oft-over­looked pop­u­la­tion, and said re­cent­ly that it proved safe in a 26-per­son pi­lot study. They have stud­ies on­go­ing in Parkin­son’s, age-re­lat­ed mac­u­lar de­gen­er­a­tion, and pa­tients with end-stage re­nal dis­ease and cog­ni­tive im­pair­ment.

Out­side of plas­ma, the com­pa­ny is al­so de­vel­op­ing an oral drug aimed at an­oth­er an­ti-ag­ing tar­get: Eo­tax­in. It’s an im­munomod­u­la­to­ry pro­tein, they say, that in­creas­es with age. Alka­h­est is in Phase II stud­ies to see if block­ing it can curb Parkin­son’s and AMD.

Bio­mark­er 'roadmap­s' and the fu­ture of can­cer R&D; Cur­tain rais­es on #AS­CO22; Pfiz­er, No­var­tis tack­le drug ac­cess; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

While this was not a week for earth-shattering news, there were certainly a lot of interesting tidbits. If you found this recap helpful, please recommend it to your friends and colleagues. We’ll see you on the other side of the long weekend.

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Keep­ing pres­sure on Am­gen, Mi­rati draws mixed re­views on lat­est cut of KRAS da­ta

As the close runner-up to Amgen’s Lumakras in the KRAS race, any data cut from Mirati’s adagrasib continues to draw scrutiny from analysts. And the latest batch of numbers from ASCO is a decidedly mixed bag.

While a quick comparison suggests that adagrasib spurred slightly more responses and led to a longer overall survival than Lumakras among a group of non-small cell lung cancer patients, its duration of response appears shorter and the safety profile continues to spark concern.

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Tran­si­tion to new Eu­ro­pean clin­i­cal tri­als in­fo sys­tem starts slow­ly

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

Nassim Usman, Catalyst Biosciences CEO

Af­ter $60M Ver­tex deal, group of Cat­a­lyst share­hold­ers claims biotech could’ve sold as­sets three years ago

Catalyst Biosciences was down to five employees in March, and the biotech needed to do something after two rounds of layoffs, a nixed collaboration and a culling of its hemophilia program.

In came Vertex, with $60 million to buy up the South San Francisco biotech’s preclinical complement drugs, which target the system that bridges the body’s innate and adaptive immune response and a class most known for Ultomiris and Soliris. The deal includes CB 2782-PEG, the dry AMD drug that Biogen no longer wanted in March.

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In search of elu­sive NASH break­through, Pfiz­er spot­lights com­bo ap­proach

Pfizer’s second crack at steering a NASH candidate through a battered field seems to be going better than the first.

The pharma giant has scored the FDA’s fast track designation for an experimental combination therapy as a treatment for NASH with liver fibrosis. The combo consists of ervogastat, a diacylglycerol O-acyltransferase 2 inhibitor (DGAT2i), and clesacostat, an acetyl-CoA carboxylase inhibitor (ACCi).

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Ann is one of ViiV Healthcare's newest spokespeople as the retired school administrator speaks up about her HIV status.

GSK's Vi­iV de­buts next evo­lu­tion in HIV med Dova­to cam­paign with new spokes­peo­ple and new mes­sage

When Ann saw the first TV commercials for HIV medicine Dovato, she didn’t see herself represented. So the 74-year-old retired school administrator who’s been living with HIV since 1998, reached out to GSK’s ViiV Healthcare and asked why not?

Now Ann is one of three people starring in ViiV’s latest Dovato campaign called “Detect This.” The next-step evolution in the branded campaign plays on the word “detect” — often used in describing HIV status under control as undetectable — but in this case, uses the word as a directive for people to understand they can use fewer medicines.

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Switzer­land to de­stroy over 600,000 ex­pired dos­es of Mod­er­na Covid vac­cine

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

AS­CO ab­stracts mint some ear­ly win­ners, but Io­vance, Spring­Works get hit by mas­sive loss­es

Before cancer-focused biotechs start their trek to the first in-person American Society of Clinical Oncology (ASCO) annual conference since the pandemic began, investors have taken a good look at the teasers for the data scheduled to be presented — and started placing bets.

With its power to confer overnight fame, ASCO is a stage where impressive or surprise debut performances can go a long way. On the other hand, disappointing details could be punishing.

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Levi Garraway, Roche CMO (Genentech)

Roche's CD20xCD3 does­n't beat Gen­mab at ORR, but sets bar for CR da­ta on lym­phoma drug

On its way to potentially becoming the first to market with a CD20xCD3 bispecific for aggressive lymphoma, Big Pharma’s largest R&D spender has some more data to pad its case with an FDA filing slated for later this year.

Roche dropped some more details from a Phase II expansion study of its fixed-duration glofitamab, to be presented at next week’s ASCO annual meeting, in patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). The patients had received a median of three prior therapies.

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