Flag­ship un­veils gut-fo­cused up­start Kin­tai, with for­mer GSK ex­ec as chief

Pro­lif­ic ven­ture group Flag­ship Pi­o­neer­ing has spawned a fresh bio­phar­ma play­er with a for­mer big phar­ma ex­ec at the helm: Kin­tai Ther­a­peu­tics. The Cam­bridge, Mass­a­chu­setts-based com­pa­ny is fo­cus­ing on the gut — but it is not lim­it­ing it­self to mi­cro­bio­ta and look­ing in­stead at the in­ter­play be­tween mi­crobes, im­mune cells, and neu­rons in the re­gion, to har­ness a new class of ther­a­peu­tics.

David Berry

“The gut—which is home to tril­lions of bac­te­ria, 70% of our im­mune cells, and 500 mil­lion neu­rons—is tru­ly a com­mand cen­ter, trans­mit­ting con­stant mes­sages and sig­nals through­out the body that af­fect our propen­si­ty for dis­ease,” said David Berry, gen­er­al part­ner at Flag­ship Pi­o­neer­ing and co-founder of Kin­tai Ther­a­peu­tics in a state­ment.

The gut im­mune sys­tem, the en­teric ner­vous sys­tem and the mi­cro­bio­me can be looked at in iso­la­tion, but it makes sense to ap­proach them in an in­te­grat­ed way us­ing com­pu­ta­tion­al bi­ol­o­gy and deep learn­ing al­go­rithms to un­der­stand what’s re­al­ly go­ing on at the in­ter­face be­tween the ex­ter­nal world (the gut mi­cro­bio­me) and im­mune cells, said Kin­tai chief Paul-Pe­ter Tak in an in­ter­view with End­points News.

Us­ing map­ping tech­nol­o­gy, since its found­ing in 2016, Kin­tai has iden­ti­fied 44,000 new genes and hun­dreds of new metabo­lites, and de­vel­oped a fe­cund pipeline of at least 10 ex­per­i­men­tal drugs for dif­fer­ent con­di­tions, Tak said.

The ner­vous sys­tem of the gas­troin­testi­nal tract (the en­teric ner­vous sys­tem) has five times as many nerve cells as the hu­man spinal cord, and 80% of our im­mune cells spend time in our gut, ac­cord­ing to Kin­tai.

By tar­get­ing the gut, “we are able to tar­get these (im­mune) cells and there­by have a dis­tant, re­mote an­ti-in­flam­ma­to­ry ef­fect…there­by hav­ing an ef­fect on neu­ro­log­i­cal dis­eases in the brain with­out even hav­ing to de­vel­op mol­e­cules that pen­e­trate the blood-brain bar­ri­er. We are able repli­cate the ef­fects of the gut mi­cro­bio­me with dis­crete mol­e­cules and that has led to a new class of mol­e­cules — pre­ci­sion en­teric med­i­cines — which al­low us to ac­ti­vate a cer­tain path­way in spe­cif­ic parts of the gut,” the for­mer GSK chief im­munol­o­gy of­fi­cer said. 

Tak ex­pects to be­gin hu­man stud­ies with its two lead pro­grams — meta­bol­ic syn­drome and ul­cer­a­tive col­i­tis — next year, and an­tic­i­pates start­ing clin­i­cal stud­ies with five pro­grams with­in two years. In the com­ing years, the com­pa­ny in­tends to pri­or­i­tize the fields of on­col­o­gy and neu­rol­o­gy, Tak added.

For some of the com­pa­ny’s pro­grams such as meta­bol­ic syn­drome or in­flam­ma­to­ry bow­el dis­ease, it’s quite like­ly that Kin­tai will even­tu­al­ly seek a big phar­ma­ceu­ti­cal part­ner to has­ten the pace of drug de­vel­op­ment, he said.

Kin­tai — which gets its name from a his­tor­i­cal wood­en arch bridge, in the city of Iwaku­ni, Japan — cur­rent­ly has about 60 em­ploy­ees.

Im­age Source: Paul-Pe­ter Tak. GSK

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.

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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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.

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.

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.

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.

Zai Lab hauls in $761M from Hong Kong IPO to push Ze­ju­la, more bud­ding can­di­dates in Chi­na — re­port

Zai Lab is set to net more than $761 million from its secondary listing in Hong Kong after pricing the IPO at $72.51 (HKD$562) — just a hair below its Nasdaq closing price on Monday, Bloomberg and Nikkei Asian Review reported.

A pioneer in bringing Western drugs to China, co-founder and CEO Samantha Du has more than tripled Zai Lab’s market cap in the three years it’s been public in the US. The HKEX listing is designed to fund R&D and commercialization for the current portfolio while fueling new in-licensing pacts, the biotech wrote in a filing.