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.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA have vowed not to let politics get in the way of science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped health agencies under his purview — including the FDA — of their rulemaking ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Dan Skovronsky, Eli Lilly CSO

UP­DAT­ED: An­a­lysts are quick to pan Eli Lil­ly's puz­zling first cut of pos­i­tive clin­i­cal da­ta for its Covid-19 an­ti­body

Eli Lilly spotlighted a success for one of 3 doses of their closely-watched Covid-19 antibody drug Wednesday morning. But analysts quickly highlighted some obvious anomalies that could come back to haunt the pharma giant as it looks for an emergency use authorization to launch marketing efforts.

The pharma giant reported that LY-CoV555, developed in collaboration with AbCellera, significantly reduced the rate of hospitalization among patients who were treated with the antibody. The drug arm of the study had a 1.7% hospitalization rate, compared to 6% in the control group, marking a 72% drop in risk.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,300+ biopharma pros reading Endpoints daily — and it's free.

Eli Lilly CSO Dan Skovronsky (file photo)

#ES­MO20: Eli Lil­ly shows off the da­ta for its Verzenio suc­cess. Was it worth $18 bil­lion?

The press release alone, devoid of any number except for the size of the trial, added nearly $20 billion to Eli Lilly’s market cap back in June. Now investors and oncologists will get to see if the data live up to the hype.

On Sunday at ESMO, Eli Lilly announced the full results for its Phase III MonarchE trial of Verzenio, showing that across over 5,000 women who had had HR+, HER2- breast cancer, the drug reduced the odds of recurrence by 25%. That meant 7.8% of the patients on the drug arm saw their cancers return within 2 years, compared with 11.3% on the placebo arm.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,300+ biopharma pros reading Endpoints daily — and it's free.

Greg Friberg (File photo)

#ES­MO20: Am­gen team nails down sol­id ear­ly ev­i­dence of AMG 510’s po­ten­tial for NSCLC, un­lock­ing the door to a wave of KRAS pro­grams

The first time I sat down with Amgen’s Greg Friberg to talk about the pharma giant’s KRAS G12C program for sotorasib (AMG 510) at ASCO a little more than a year ago, there was high excitement about the first glimpse of efficacy from their Phase I study, with 5 of 10 evaluable non-small cell lung cancer patients demonstrating a response to the drug.

After decades of failure targeting KRAS, sotorasib offered the first positive look at a new approach that promised to open a door to a whole new approach by targeting a particular mutation to a big target that had remained “undruggable” for decades.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,300+ biopharma pros reading Endpoints daily — and it's free.

#ES­MO20: Out to beat Tagris­so, J&J touts 100% ORR for EGFR bis­pe­cif­ic/TKI com­bo — fu­el­ing a quick leap to PhI­II

J&J’s one-two punch on EGFR-mutant non-small cell lung cancer has turned up some promising — although decidedly early — results, fueling the idea that there’s yet room to one up on third-generation tyrosine kinase inhibitors.

Twenty out of 20 advanced NSCLC patients had a response after taking a combination of an in-house TKI dubbed lazertinib and amivantamab, a bispecific antibody targeting both EGFR and cMET engineered on partner Genmab’s platform, J&J reported at ESMO. All were treatment-naïve, and none has seen their cancer progress at a median follow-up of seven months.

#ES­MO20: As­traZeneca aims to spur PRO­found shift in prostate can­cer treat­ment with Lyn­parza OS da­ta

AstraZeneca has unveiled the final, mature overall survival data that cemented Lynparza’s first approval in prostate cancer approval — touting its lead against rivals with the only PARP inhibitor to have demonstrated such benefit.

But getting the Merck-partnered drug to the right patients remains a challenge, something the companies are hoping to change with the new data cut.

The OS numbers on the subgroup with BRCA1/2 or ATM-mutated metastatic castration-resistant prostate cancer are similar to the first look on offer when the FDA expanded the label in May: Lynparza reduced the risk of death by 31% versus Xtandi and Zytiga. Patients on Lynparza lived a median of 19.1 months, compared to 14.7 months for the anti-androgen therapies (p = 0.0175).

#ES­MO20: It’s not just Keytru­da any­more — Mer­ck spot­lights 3 top ear­ly-stage can­cer drugs

Any $12 billion megablockbuster in the portfolio tends to overshadow everything else in the pipeline. Which is something Merck can tell you a little bit about.

Keytruda not only dominates the PD-(L)1 field, it looms over everything Merck does, to the point some analysts wonder if Merck is a one-trick pony.

There’s no shortage of Keytruda data on display at ESMO this weekend, but now the focus is shifting to the future role of new drugs and combos in maintaining that lead position for years to come. And the pharma giant has a special focus for 3 early-stage efforts where Roger Perlmutter’s oncology team is placing some big bets.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,300+ biopharma pros reading Endpoints daily — and it's free.

Exelixis CEO Michael Morrissey (file photo)

#ES­MO20: Look out Mer­ck. Bris­tol My­ers and Ex­elix­is stake out their com­bo’s claim to best-in-class sta­tus for front­line kid­ney can­cer

Now that the PD-(L)1 checkpoints are deeply entrenched in the oncology market, it’s time to welcome a wave of combination therapies — beyond chemo — looking to extend their benefit to larger numbers of patients. Bristol Myers Squibb ($BMY} and Exelixis {EXEL} are close to the front of that line.

Today at ESMO the collaborators pulled the curtain back on some stellar data for their combination of Opdivo (the PD-1) and Cabometyx (the TKI), marking a significant advance for the blockbuster Bristol Myers franchise while offering a big leg up for the team at Exelixis.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,300+ biopharma pros reading Endpoints daily — and it's free.

#ES­MO20: Trodelvy da­ta show that Gilead­'s $21B buy­out may have been worth the big pre­mi­um

Gilead CEO Dan O’Day has been on a shopping spree. And while some analysts gawked at the biotech’s recent $21 billion Immunomedics buyout, new data released at virtual ESMO 2020 suggest the acquisition may have been worth the hefty price.

The deal, announced last weekend, will give California-based Gilead $GILD Trodelvy, which was recently approved for metastatic triple-negative breast cancer (mTNBC).

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,300+ biopharma pros reading Endpoints daily — and it's free.