Fund­ed for PhII, biotech en­tre­pre­neurs achieve a 15-year-old R&D dream

Niels Riede­mann and Ren­feng Guo fol­lowed en­tire­ly dif­fer­ent paths, but 15 years ago both wound up work­ing to­geth­er in the lab of Pe­ter Ward at the Uni­ver­si­ty of Michi­gan, a promi­nent in­ves­ti­ga­tor known for his land­mark re­search on the C5 path­way. That ear­ly team­work cre­at­ed a bond over their in­sights in­to a par­tic­u­lar av­enue of the path­way that they hope will lead to a first-in-class an­ti-in­flam­ma­to­ry drug. And they have now raised their first big chunk of cash — $34 mil­lion — to put it to its first big Phase II proof-of-con­cept chal­lenge.

The biotech they co-found­ed is In­flaRx and their drug is IFX-1. It’s an an­ti­body de­signed specif­i­cal­ly to tack­le C5a while leav­ing the mem­brane at­tack com­plex (C5b-9) alone. And by do­ing that, they’ve gath­ered some ear­ly-stage clin­i­cal ev­i­dence that they can block an in­flam­ma­to­ry path­way that can cause hav­oc.

In­flaRx may be small — there’s a staff of 13 now which is ex­pect­ed to grow to 20 or 25 peo­ple — but it has a glob­al struc­ture.

The biotech is based in Je­na, Ger­many, where Riede­mann is vice di­rec­tor of in­ten­sive care med­i­cine at the Uni­ver­si­ty of Je­na. Ren­feng Guo still spends part of the year in Ann Ar­bor, when he’s not in Ger­many or Chi­na, where his con­nec­tions among im­munol­o­gy re­searchers has pro­vid­ed some of the im­por­tant foun­da­tion work done on their pipeline drugs.

Riede­mann tells me those Asian con­nec­tions al­so put the com­pa­ny in touch with new, un­tra­di­tion­al in­vestors, which in turn led Staid­son Hongkong In­vest­ment Com­pa­ny (STS) to jump in­to the syn­di­cate.

“It’s a very tricky tar­get,” says the CEO, with­out much di­rect com­pe­ti­tion in the clin­ic. But if the drug works the way they be­lieve it does, they ex­pect to in­ter­rupt a process in which white blood cells get ac­ti­vat­ed, at­tract­ing neu­trophils and spurring the re­lease of gran­u­lar en­zymes that dam­age tis­sue.

Just a few weeks ago, the biotech launched a Phase II for pa­tients un­der­go­ing com­plex car­diac surgery. Pul­monary ab­dom­i­nal in­fec­tions is one fo­cus, and there’s some ad­di­tion­al work be­ing done on or­phan in­di­ca­tions as In­flaRx brings along two more pre­clin­i­cal drugs in the pipeline.

Gen­er­al­ly, when you hear about a C5 drug, your at­ten­tion im­me­di­ate­ly goes to Alex­ion’s Soliris, the most ex­pen­sive drug in the U.S. A va­ri­ety of biotechs — Like Ra Phar­ma­ceu­ti­cals and Akari — have tack­led fol­lowup pro­grams that look to go deep­er along the path­way in search of bet­ter ri­vals to Soliris, which is used to treat rare cas­es of PNH. But In­flaRx is steer­ing clear of that field.

Alex­ion, though, is bank­ing on its own ex­per­tise in the field to push along ALXN1007, an an­ti­body now in Phase II for graft-ver­sus-host dis­ease.

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Aduhelm OK 'bit­ter­sweet' for ALS ad­vo­cates; Con­trast­ing Covid-19 vac­cine read­outs; GSK joins TIG­IT bat­tle; 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.

With the busiest days of June now behind us, we’re starting to think seriously about the second half of the year. In August, we have scheduled a special report where Endpoints will compile a list of the 20 most influential R&D executives in biopharma. Know a luminary who should definitely be included? Nominate them now.

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Who are the lu­mi­nar­ies dri­ving the biggest ad­vances in bio­phar­ma R&D? End­points News is ask­ing for your nom­i­na­tions for a spe­cial re­port

In biopharma, driving a drug to market is the ultimate goal — but none of that happens without a strong research and development program. At the most successful companies, those R&D efforts are spearheaded by true innovators in the field who are always looking for that next novel mechanism of action or breakthrough safety profile.

Now, Endpoints News is asking you to tell us who those guiding lights are.

Leen Kawas, Athira CEO

Biotech founder placed on leave as $400M Alzheimer's start­up idea comes un­der scruti­ny

Athira Pharma, the Alzheimer’s biotech that emerged out of obscurity last year and raised nearly $400 million for a dark-horse approach to treating neurodegeneration, has found itself in sudden turmoil.

On Tuesday evening, the company released a terse statement announcing that CEO and founder Leen Kawas had been placed on administrative leave while an independent review board investigated “actions stemming” from her doctoral research at Washington State University. Mark Litton, who joined the company as COO two years ago, will take over day-to-day operations, they said.

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Bris­tol My­ers breaks the bank on Ei­sai's fo­late re­cep­tor ADC drug, lay­ing out more than $3B+ for rights

For years, innovation in oncology has been a crapshoot with Big Pharma — the whales at the table — dropping the big bucks for the key to the next generation of tumor fighters. Bristol Myers Squibb hasn’t exactly made a name for being an innovator in the space, but that doesn’t mean it won’t splash in when it sees a potential winner.

Now, with a massive check in hand, the drugmaker is willing to put its intuition to the test.

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Michael Chambers (L) and John Ballantyne

Dana­her strikes deal to buy boom­ing next-gen man­u­fac­tur­er Alde­vron for $9.6B

Life sciences conglomerate Danaher Corp. $DHR has struck a deal to buy the fast-growing Aldevron, one of the world’s top manufacturers of hotly sought-after plasmid DNA, mRNA and recombinant proteins for the burgeoning world of vaccine and drugmakers pushing some game-changing technologies.

Buyout talks set the stage for Danaher to settle on a $9.6 billion cash pact to acquire the private Fargo, ND-based company — a key supplier for a disruptive new Covid vaccine as well as a host of gene and cell therapy and CRISPR gene editing players — founded by Michael Chambers and CSO John Ballantyne as a crew of 2 back in 1998.

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Jeff Albers, Blueprint CEO

Blue­print Med­i­cines nabs 4th ap­proval in bid to­ward prof­itabil­i­ty

Blueprint Medicines’ push to profitability continues.

On Wednesday, the Cambridge biotech announced the FDA approved its longtime lead drug, Ayvakit, for advanced systemic mastocytosis, a group of debilitating rare diseases where one type of immune cell — mast cells — builds up uncontrollably in a particular organ. The decision came on the heels of Phase III trials showing that more than half of late-stage patients who received the drug responded to it and did so for just over three years.

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Franz-Werner Haas, CureVac CEO (Christoph Schmidt/picture-alliance/dpa/AP Images)

UP­DAT­ED: Cure­Vac blames vari­ants as a close­ly-watched Covid vac­cine goes down in flames, fail­ing piv­otal study with woe­ful da­ta

CureVac was widely expected to come in with a late but likely late-stage winner in the race to develop new vaccines for the Covid-19 pandemic. Instead, late Wednesday, the German biotech said their mRNA candidate CVnCoV flat failed a pivotal trial — quashing any hopes for a quick entry in the blockbuster field and gutting their share price.

CVnCoV demonstrated an interim vaccine efficacy of 47% against COVID-19 disease of any severity and did not meet prespecified statistical success criteria. Initial analyses suggest age and strain dependent efficacy.

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Al Sandrock, Biogen R&D chief (Biogen via YouTube)

Days af­ter con­tro­ver­sy greet­ed Bio­gen's block­buster Alzheimer's OK, the big biotech con­cedes a set­back on the tau front

Just days after triggering a maelstrom of controversy with their decision to launch an unproven Alzheimer’s drug with a $56,000 price, Biogen $BIIB is back with the latest data on its mid-stage tau drug.

And it’s not good.

The big biotech says that gosuranemab — targeted at tau, the second leading drug target in Alzheimer’s — flat failed its Phase II and will now be taken out and dumped in the mass grave for all but one other Alzheimer’s drug in the past generation.

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