Bruce Hironaka, IgGenix CEO

IgGenix emerges from stealth with $10 mil­lion Se­ries A hop­ing to re-en­gi­neer al­ler­gic cas­cade

A lit­tle over six months af­ter the FDA ap­proved the first treat­ment for peanut al­ler­gies, a new biotech has emerged hop­ing to break through in a field that’s seen vir­tu­al­ly no in­no­va­tion.

IgGenix came out of stealth mode Tues­day morn­ing, an­nounc­ing a $10 mil­lion Se­ries A round to get the com­pa­ny start­ed. The Cal­i­for­nia-based biotech aims to fo­cus not just on peanuts, but all types of food al­ler­gies and re­lat­ed se­ri­ous con­di­tions by de­vel­op­ing a plat­form that can in­ter­fere with the al­ler­gic cas­cade. Fi­nanc­ing was led by Khosla Ven­tures and joined by Park­er Ven­tures.

When an al­ler­gic re­ac­tion oc­curs, the body pro­duces an ex­ces­sive amount of al­ler­gen-spe­cif­ic an­ti­bod­ies called im­munoglob­u­lin E, or IgE. This over­re­ac­tion by the im­mune sys­tem leads to the al­ler­gic cas­cade, which can man­i­fest in symp­toms rang­ing from mild itch­ing and swelling to full-blown ana­phy­lac­tic shock.

What IgGenix hopes to do is re-en­gi­neer the IgE an­ti­bod­ies, iso­lat­ing and trans­form­ing them in­to IgG an­ti­bod­ies that are de­signed to al­le­vi­ate and pos­si­bly pre­vent the al­ler­gic cas­cade. While the com­pa­ny is still yet to reach the clin­ic, CEO Bruce Hi­ron­a­ka said, IgGenix hopes to pro­duce a treat­ment that looks like a self-in­jectable project ad­min­is­tered pe­ri­od­i­cal­ly, sim­i­lar to an al­ler­gy shot.

“We don’t know yet how of­ten it would need to be done, but the hope is that the ther­a­py could be some­thing that peo­ple in the al­ler­gy space have ex­pe­ri­ence with be­fore,” Hi­ron­a­ka told End­points News. “Hope­ful­ly we won’t be do­ing our in­jec­tions as of­ten as al­ler­gy shots, but that’s to be de­ter­mined.”

That con­cept dif­fers from Aim­mune’s oral peanut al­ler­gy ther­a­py Pal­forzia, which won FDA ap­proval back in Jan­u­ary and ad­min­is­ters es­ca­lat­ing dos­es of a peanut pro­tein to chil­dren to help build re­sis­tance. Hi­ron­a­ka said he was glad to see some al­ler­gy treat­ment fi­nal­ly re­ceive the green light, but as­sert­ed that IgGenix is one of the few, if not on­ly, com­pa­nies ad­dress­ing the un­der­ly­ing mech­a­nism of al­ler­gies.

Kari Nadeau

The sci­en­tif­ic team at IgGenix is all in­cred­i­bly pas­sion­ate about al­ler­gies as well, Hi­ron­a­ka said, as it’s a per­son­al is­sue for every­one. Sci­en­tif­ic co-founder Stephen Quake, a pro­fes­sor of bio­engi­neer­ing and ap­plied physics at Stan­ford, has a daugh­ter with se­vere al­ler­gies. Chief tech­ni­cal of­fi­cer Derek Croote has a dairy al­ler­gy. And Kari Nadeau, the oth­er sci­en­tif­ic co-founder, is a world-renowned al­ler­gist.

Hi­ron­a­ka’s old­er daugh­ter al­so suf­fers from se­vere peanut al­ler­gies, and he re­count­ed a tale from when they were do­ing col­lege tours and was ac­ci­den­tal­ly served food with traces of the al­ler­gen.

“Watch­ing her grow up, hav­ing to be wor­ried about in­gest­ing a peanut or some oth­er al­ler­gen for her, is not just a ma­jor bur­den on her but ob­vi­ous­ly her par­ents wor­ry quite a bit about that,” Hi­ron­a­ka said. “Un­for­tu­nate­ly the wait staff was not to­tal­ly up to date on the menu … she calm­ly put her­self on the floor of the restau­rant and in­ject­ed her­self with her EpiPen.”

For now, IgGenix will fo­cus on ex­pand­ing and “de-risk­ing” the plat­form tech­nol­o­gy and start to build pre­clin­i­cal can­di­dates for food and non-food al­ler­gies. Hi­ron­a­ka al­so said the com­pa­ny is look­ing for some­one to suc­ceed him as CEO, giv­en that he’s at a stage in his ca­reer where he’s not look­ing for any­thing long-term.

And though Hi­ron­a­ka said it would be “ir­re­spon­si­ble” to say IgGenix can ul­ti­mate­ly de­vel­op a cure for al­ler­gies, the team is en­ticed by the prospect.

“We don’t know yet,” Hi­ron­a­ka said. “We do have dis­cus­sions about our ap­proach be­ing po­ten­tial­ly pro­phy­lac­tic, but I think we need more da­ta to re­al­ly be able to start think­ing we can go as far as be­ing a cure to one or more food al­ler­gy types. Ob­vi­ous­ly, we’d love to be able to get there.”

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; 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.

I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

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Michael Dell (Richard Drew, AP Images)

'Dude, you're get­ting a Del­l' — as a new deep-pock­et biotech in­vestor

What happens when you marry longtime insiders in the global biotech VC game with the family fund of tech billionaire Michael Dell, a synthetic biology legend out of MIT and Harvard and the former director of the NCI?

Today, the answer is a newly financed, $200 million biotech SPAC now cruising the industry for a top player interested in finding a short cut to Nasdaq.

Orion Biotech Opportunities priced their blank check company today, raising $200 million with Dell’s multibillion-dollar MSD group’s commitment on investing another $20 million in a forward-purchase agreement.

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Re­gen­eron's Evkeeza shows promise in curb­ing high triglyc­erides, but will ge­net­ic dis­par­i­ties lim­it use?

When Regeneron scored an early approval for lipid lowering antibody Evkeeza back in February, the drugmaker cracked open a new pathway to lower abnormally high cholesterol levels. Now, Regeneron is chasing high triglycerides as well with some promising mid-stage data — but will genetic restrictions limit the drug’s use?

Regeneron’s Evkeeza (evinacumab) cut median triglyceride levels by more than 800 mg/dL (57%) in patients with a rare disorder causing abnormally high triglyceride levels compared with an overall increase of 50 mg/dL (1.8%) in participants on placebo, according to Phase II data presented Sunday at the virtual American College of Cardiology meeting.

As­traZeneca's Farx­i­ga missed big on Covid-19 study, but it's tak­ing SGLT2 safe­ty da­ta as a sil­ver lin­ing

AstraZeneca hasn’t seen many setbacks in recent months for SGLT2 inhibitor Farxiga, which broke ground in heart failure and kidney disease regardless of diabetes diagnosis. But the British drugmaker had to admit defeat in taking Farxiga into Covid-19, but follow-up results add a bit of a silver lining to that trial’s safety data.

Of hospitalized Covid-19 patients dosed with AstraZeneca’s Farxiga, 11.2% experienced an organ failure or died after 30 days of therapy compared with 13.8% of those given placebo, according to follow-up data from the DARE-19 study revealed Sunday at the virtual American College of Cardiology meeting.

Pfiz­er, Bris­tol My­er­s' Eliquis flops in post-heart surgery pa­tients, spurring an 'un­ex­plained sig­nal' in cer­tain deaths

Pfizer and Bristol Myers Squibb’s non-warfarin blood thinner Eliquis has raced out to become the most prescribed drug of its class on the market — even overtaking warfarin’s long-time lead. But in tricky-to-treat patients after a valve replacement, an investigator-sponsored study couldn’t turn up benefit and raised a troubling safety signal.

Eliquis failed to show benefit over standard of care in preventing serious clinical outcomes after a transaortic valve replacement (TAVR) and was linked to an “unexplained signal” in a subset of populations with a higher rate of non-CV deaths who did not need blood thinners apart from the surgery, according to data presented Saturday at the virtual American College of Cardiology meeting.

Vas Narasimhan (Photographer: Simon Dawson/Bloomberg via Getty Images)

No­var­tis whiffs on En­tresto study af­ter heart at­tacks — but that does­n't mean it's go­ing down qui­et­ly

If Novartis learned one thing from its interaction with the FDA over its latest heart failure approval for Entresto, it was that missing a primary endpoint may not be the nail in the coffin. Now, Entresto has missed again on a late-stage study in high-risk heart patients, and it’s already sowing the seeds for a path forward regardless.

Novartis’ Entresto couldn’t best standard-of-care ramipril in staving off a composite of deaths and heart failure events in patients with left ventricular systolic dysfunction and/or pulmonary congestion who have had a prior heart attack, according to topline data from the Phase III PARADISE-MI study revealed Saturday at the virtual American College of Cardiology meeting.

Abbie Celniker (L) and Rob Sims (Flare)

A Third Rock-backed play­er charts a new course against tran­scrip­tion fac­tors. Do 'switch sites' hold the mag­ic sauce?

Long known for their role in guiding gene expression but considered “undruggable,” DNA binding transcription factors have long been a Holy Grail for drug developers. Now, a new startup from Third Rock Ventures thinks it could have the juice to get after transcription factors once and for all — and it all started with a “flare” of inspiration from an article out of an Oxford lab.

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Gene ther­a­py from Bio­gen's $800M buy­out flops in mid-stage study, deal­ing blow to new am­bi­tions

The #2 candidate from Biogen’s $800 million ocular gene therapy buyout has failed in a mid-stage trial, dealing an early blow to the big biotech’s plans to revitalize its pipeline with new technologies.

Biogen announced that the candidate, an experimental treatment for a rare and progressive form of blindness called X-linked retinitis pigmentosa (XLRP), failed to sufficiently improve vision in patients’ treated eye — patients only received an injection in one eye — after a year, on a standard scale, compared to their untreated eye. The company said they saw “positive trends” on several secondary endpoints, including visual acuity, but declined to say whether the trial actually hit any of those endpoints.

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