Nan Fung Life Sci­ences antes up $32M to fu­el a neu­ro play as the Hong Kong con­glom­er­ate burns through $1.5B man­date

Hav­ing re­lied heav­i­ly on its Piv­otal bioVen­tures Part­ners arm to make di­rect in­vest­ments in biotech, Nan Fung Life Sci­ences is tak­ing an in­creas­ing­ly promi­nent seat at the ta­ble, putting up $32 mil­lion as the sole in­vestor in a neu­ro­science start­up’s launch round.

With the Se­ries A En­grail Ther­a­peu­tics is al­so tak­ing the cov­ers off its busi­ness mod­el, which in­volves find­ing, buy­ing and then de­vel­op­ing drugs for brain dis­or­ders.

Vikram Su­darsan

It’s a tough field, but neu­ro­science is mak­ing “mas­sive strides,” CEO Vikram Su­darsan said in a state­ment.

“As the brain’s com­plex­i­ties and mol­e­c­u­lar mech­a­nisms have be­come clear­er, we are bet­ter able to iden­ti­fy dis­ease tar­gets, which has al­so sup­port­ed a resur­gence in fund­ing neu­ro­science drug de­vel­op­ment,” he said.

The as­sets they want would have val­i­dat­ed mech­a­nisms, hit­ting well-known tar­gets tied to bur­den­some symp­toms. ENX-101, a sub­type se­lec­tive GA­BA A mod­u­la­tor, is the first ex­am­ple; the pre­clin­i­cal mol­e­cule promis­es to cir­cum­vent the side ef­fects and risk of drug de­pen­dence that plague the ben­zo­di­azepine class.

“Our goal is to build a pipeline of at least five com­pounds over the next few years,” Su­darsan told End­points News. “Our flex­i­ble trans­ac­tion mod­el in­cludes li­cens­ing, co-de­vel­op­ing, eq­ui­ty in­fu­sion with op­tion to li­cense and com­pa­ny ac­qui­si­tions. This flex­i­bil­i­ty al­lows us to ac­quire the most promis­ing prod­ucts. We will con­tin­ue to eval­u­ate if, how, when and with whom we part­ner our as­sets.”

But per­haps as im­por­tant as the com­pounds is the ex­per­tise its team takes to clin­i­cal de­vel­op­ment, reg­u­la­to­ry con­sid­er­a­tions, IP build­ing and even com­mer­cial po­si­tion­ing. While Su­darsan brings an eye to good deals from six years lead­ing Cipla New Ven­tures — which over­lapped with a short stint as CEO of the In­di­an phar­ma’s US arm — co-founder Stephen Cun­ning­ham cut his teeth at Zeneca both be­fore and af­ter it merged with As­tra. Then for 13 years, Cun­ning­ham spear­head­ed med­ical af­fairs for No­var­tis.

Anil Vootkur, an alum of Take­da and Al­ler­gan, is VP of cor­po­rate de­vel­op­ment while biotech Eve Tay­lor is VP of clin­i­cal de­vel­op­ment.

With $1.5 bil­lion to spend on life sci­ence com­pa­nies, Nan Fung Life Sci­ences has bet on neu­ro­sciences be­fore, when Piv­otal bioVen­tures Part­ners backed Karuna’s Se­ries B. Pe­ter Bis­gaard, who’s man­ag­ing both sides of the in­vest­ing busi­ness, is chair­ing En­grail’s board.

“En­grail’s dy­nam­ic mod­el for ad­vanc­ing drugs aimed at treat­ing life-lim­it­ing dis­eases of the ner­vous sys­tem is ex­act­ly the in­no­va­tion this com­plex field re­quires,” he said in a state­ment.

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 €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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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.

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.

Anthony Coyle (Repertoire)

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.