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.”

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 has vowed not to let politics overrule 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 the FDA and other health agencies under his purview of their rule making 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.

Can a mag­net­ic cell ther­a­py re­place corneal trans­plan­ta­tion? As eight-year jour­ney leads to the clin­ic, two broth­ers un­veil bold vi­sion

Jeff Goldberg was getting acquainted with a brand new way to do corneal transplants when an even newer, even bolder idea hit him.

It was almost 10 years ago, and Goldberg was in his first faculty position at Bascom Palmer Eye Institute at the University of Miami. Scientists had developed a new way to do cornea transplants where instead of sewing a whole donor cornea — a decades-old practice — they were just engrafting the inner layer of cells.

News brief­ing: Tiny Vac­cinex's drug flops in PhII Hunt­ing­ton's tri­al, stock craters; Siol­ta nabs $30M Se­ries B to de­vel­op mi­cro­bio­me drug

Siolta Therapeutics, a microbiome company targeting allergic diseases, raked in a $30 million Series B to develop its lead candidate, STMC-103H. The drug, which has been FDA fast-tracked, is headed for proof-of-concept trials, according to the company. Its various indications include allergic asthma, food allergies, atopic dermatitis, allergic rhinitis, and allergy prevention.

The news comes just after the California-based biotech added a prominent biopharma veteran as an advisor: 20-year Gilead CEO John Martin. The biotech also gained Richard Shames as CMO, who came by way of Protagonist Therapeutics.

Embattled CDC director Robert Redfield (AP Images)

Covid-19 roundup: CDC ad­vi­so­ry com­mit­tee de­lays pri­or­i­ty dis­tri­b­u­tion vote; EU re­port­ed­ly in­dem­ni­fy­ing vac­cine mak­ers

A federal committee that advises the CDC was expected to hold a vote Tuesday on a plan regarding the distribution for initial doses of approved Covid-19 vaccines. But that vote has been scrapped.

The Advisory Committee on Immunization Practices, or ACIP, won’t be voting until the committee members learn more about which vaccines become available first, the Wall Street Journal reported. The vote could potentially wait until a specific vaccine is authorized before recommending how to dole out the first doses.

Samit Hirawat (Bristol Myers Squibb)

Af­ter bruis­ing re­jec­tion, blue­bird and Bris­tol My­ers Squibb land ide-cel pri­or­i­ty re­view. But will it mat­ter for the CVR?

With the clock all but up, the FDA accepted and handed priority review to Bristol Myers Squibb and bluebird bio’s BCMA CAR-T, keeping a narrow window open for Celgene investors to still cash in on the $9 CVR from the $63 billion Celgene merger.

The acceptance comes five months after the two companies weres slammed with a surprise refuse-to-file that threatened to foreclose the CVR entirely. Today’s acceptance sets the FDA decision date for March 27, 2021 – or precisely 4 days before the CVR deadline of March 31. Given the breakthrough designation and strong pivotal data — 81.5% response rate, 35.2% complete response rate — priority review was largely expected.

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Francesco De Rubertis

Medicx­i's David Grainger and Francesco De Ru­ber­tis pump €200M in­to six com­pa­nies and what they say is a first-of-its kind fund

In what they’re billing as a first for biotech, David Grainger, Francesco De Rubertis and their team at Medicxi have put down a €200 million to sweep up stakes in six companies from their predecessor VC and pump new money into them.

Medicxi didn’t disclose which companies it was investing in but the portfolio draws from Index Ventures Life VI, one of the last funds the Medicxi team launched while they were still part of the multinational, tech-focused VC firm Index Ventures. That team kept advising Index on their life sciences portfolio even after they spun out to form their own firm in the middle of 2016.

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Anthony Coyle (Pfizer via Youtube)

Flag­ship's merged biotech Reper­toire nets ex-Pfiz­er CSO An­tho­ny Coyle as R&D chief

Flagship is building a big-name C-Suite at its new, $220 million merged biotech.

Repertoire Immune Medicines, which already boasts former Bioverativ chief John Cox as its CEO, announced yesterday that Anthony Coyle, the former Pfizer CSO and the founding CEO of Pandion, will join as their head of R&D.

“As we progress clinical trials for our multi-clonal T cell candidates in immuno-oncology, Tony’s deep expertise in cellular immunology and novel therapeutic development will help us achieve our vision of creating a new class of transformative medicines for patients,” Cox said in a statement.

President Donald Trump (via AP Images)

Signs of an 'Oc­to­ber Vac­cine Sur­prise' alarm ca­reer sci­en­tists. HHS con­tin­ues to claim Azar “will de­fer com­plete­ly to the FDA"

President Donald Trump, who seems intent on announcing a Covid-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the FDA and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.

#ES­MO20: Push­ing in­to front­line, Mer­ck and Bris­tol My­ers duke it out with new slate of GI can­cer da­ta

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.