Back to the be­gin­ning: Pfiz­er seeds dis­cov­ery-stage neu­ro start­up Mag­no­lia (af­ter ax­ing its own brain R&D)

Af­ter yank­ing its own neu­ro­science ef­forts —  and re­treat­ing from the fail­ure-strewn bat­tle­ground of brain sci­ence — Pfiz­er is ped­al­ing back to the be­gin­ning in this field. The phar­ma gi­ant is fund­ing a brand-new MD An­der­son spin­out that’s ques­tion­ing the very ba­sics of neu­rode­gen­er­a­tion.

The start­up, called Mag­no­lia Neu­ro­sciences (“Mag­no­lia” as a nod to its Texas roots), is be­ing rather tightlipped about what it’s work­ing on. But CEO Thong Le tells me the com­pa­ny is steer­ing away from tra­di­tion­al ef­forts in the field.

In short, the start­up is tap­ping a body of lit­er­a­ture around a bi­o­log­i­cal process that oc­curs in the womb dur­ing the ear­li­est stages of life. When an em­bryo is form­ing, the body trash­es ex­cess neu­rons in a process called “pro­grammed cell death.” Re­search shows that this same process is re­ac­ti­vat­ed in the brain through­out the course of Alzheimer’s dis­ease, among oth­er neu­ro con­di­tions. Mag­no­lia is hy­poth­e­siz­ing that block­ing spe­cif­ic com­po­nents of this process will pre­serve brain tis­sue in hu­mans and — hope­ful­ly — pre­vent mem­o­ry loss. That’s what they’ve seen in mouse mod­els, any­way.

“Not on­ly can you pre­serve brain tis­sue and en­hance mem­o­ry, but — from a more bi­o­log­i­cal point of view — you could dra­mat­i­cal­ly change the course and de­vel­op­ment of neu­ro­log­i­cal dis­ease,” Le said.

To get to work on the idea, Mag­no­lia has round­ed up $31 mil­lion in a Se­ries A packed with high pro­file cor­po­rate VCs. The stel­lar syn­di­cate was put to­geth­er by Ac­cel­er­a­tor Life Sci­ence Part­ners, a start­up fac­to­ry that churns out these ven­tures by shop­ping aca­d­e­m­ic labs and oth­er hubs of in­no­va­tion around the globe. Once they find some­thing promis­ing, they put to­geth­er a team and spin the tech out in­to a start­up of its own.

It should be not­ed that Le is the CEO at Ac­cel­er­a­tor, which is why he’s head­ing up Mag­no­lia for the time be­ing.

Ac­cel­er­a­tor has satel­lites in New York, Seat­tle, and San Diego, and has launched sev­en star­tups since its in­cep­tion. One of their ven­tures is Lo­do Ther­a­peu­tics, the New York-based com­pa­ny that scored a $969 mil­lion (biobucks) deal with Genen­tech in metage­nomics ear­li­er this year.

Mag­no­lia man­aged to at­tract a slew of cor­po­rate VCs, in­clud­ing the afore­men­tioned Pfiz­er, Eli Lil­ly, Ab­b­Vie Ven­tures, and John­son & John­son In­no­va­tion, among oth­ers. You can see the full list on the com­pa­ny’s press re­lease.

Af­ter scrap­ping its own neu­ro­science work ear­li­er this year, some might see Pfiz­er’s in­vest­ment in star­tups as putting a bandaid over a gap­ing hole. But the phar­ma gi­ant is mak­ing an ef­fort to seed in­no­va­tion out­side of its own labs. In June, the com­pa­ny com­mit­ted an ad­di­tion­al $150 mil­lion to its VC group to in­vest in neu­ro­science star­tups. This in­vest­ment in Mag­no­lia is one of the first bets, it seems.

Le said it ac­tu­al­ly makes a lot of sense for large phar­ma­ceu­ti­cal com­pa­nies to leave the ear­ly dis­cov­ery work to small­er biotechs.

“When it comes to de­vel­op­ing drugs for com­plex dis­eases like Alzheimer’s, to some ex­tent we’re muck­ing with bi­ol­o­gy that we don’t re­al­ly have a per­fect un­der­stand­ing of, which re­quires tak­ing cal­cu­lat­ed risk from a de­vel­op­ment per­spec­tive,” he said. “Large phar­ma com­pa­nies that are pub­licly trad­ed don’t have as much flex­i­bil­i­ty as they’d like to have in terms of be­ing ag­ile and tak­ing the leaps of faith need­ed to push an ear­ly stage pro­gram ag­gres­sive­ly for­ward.”

Le said this lat­est round of fund­ing should move Mag­no­lia to­ward clin­i­cal de­vel­op­ment, al­though he’s not shar­ing time­lines just yet.


Im­age: Ac­cel­er­a­tor and Mag­no­lia CEO Thong Le. Mag­no­lia

In a stun­ning set­back, Amarin los­es big patent fight over Vas­cepa IP. And its high-fly­ing stock crash­es to earth

Amarin’s shares $AMRN were blitzed Monday evening, losing billions in value as reports spread that the company had lost its high-profile effort to keep its Vascepa patents protected from generic drugmakers.

Amarin had been fighting to keep key patents under lock and key — and away from generic rivals — for another 10 years, but District Court Judge Miranda Du in Las Vegas ruled against the biotech. She ruled that:
(A)ll the Asserted Claims are invalid as obvious under 35 U.S.C.§ 103. Thus, the Court finds in favor of Defendants on Plaintiff’s remaining infringementclaim, and in their favor on their counterclaims asserting the invalidity of the AssertedClaims under 35 U.S.C. § 103.

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UP­DAT­ED: Have a new drug that promis­es to fight Covid-19? The FDA promis­es fast ac­tion but some de­vel­op­ers aren't hap­py

After providing an emergency approval to use malaria drugs against coronavirus with little actual evidence of their efficacy or safety in that setting, the FDA has already proven that it has set aside the gold standard when it comes to the pandemic. And now regulators have spelled out a new approach to speeding development that promises immediate responses in no uncertain terms — promising a program offering the ultimate high-speed pathway to Covid-19 drug approvals.

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Once fu­ri­ous over No­var­tis’ da­ta ma­nip­u­la­tion scan­dal, the FDA now says it’s noth­ing they need to take ac­tion on

Back in the BP era — Before Pandemic — the FDA ripped Novartis for its decision to keep the agency in the dark about manipulated data used in its application for Zolgensma while its marketing application for the gene therapy was under review.

Civil and criminal sanctions were being discussed, the agency noted in a rare broadside at one of the world’s largest pharma companies. Notable lawmakers cheered the angry regulators on, urging the FDA to make an example of Novartis, which fielded Zolgensma at $2.1 million — the current record for a one-off therapy.

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Covid-19 roundup: GSK, Am­gen tai­lor R&D work to fit the coro­n­avirus age; Doud­na's ge­nomics crew launch­es di­ag­nos­tic lab

You can add Amgen and GSK to the list of deep-pocket drug R&D players who are tailoring their pipeline work to fit a new age of coronavirus.

Following in the footsteps of a lineup of big players like Eli Lilly — which has suspended patient recruitment for drug studies — Amgen and GSK have opted to take a more tailored approach. Amgen is intent on circling the wagons around key studies that are already fully enrolled, and GSK has the red light on new studies while the pandemic plays out.

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The race to de­vel­op Covid-19 drugs and vac­cines is on — here’s what’s hap­pen­ing in the UK

Weeks away from the results of ongoing US and China trials testing its experimental antiviral remdesivir, Gilead is going to trial the failed Ebola drug in a small group of coronavirus patients in England and Scotland. The United Kingdom is also home to a range of other therapeutic efforts, as the pandemic rages on across the globe.

On Tuesday, Southampton, UK-based startup Synairgen kicked off a mid-stage placebo-controlled study testing its experimental drug, SNG001 — an inhaled formulation of interferon-beta-1a — that has previously shown to be safe and effective in improving lung function in asthma patients with a respiratory viral infection in a pair of Phase II trials.

‘There was a grow­ing weari­ness’: Rush­ing against a pan­dem­ic clock, As­pen Neu­ro­sciences se­cures $70M Se­ries A

Just before Christmastime, Howard Federoff got a tip from Washington: There was a new virus in China. And this one could be bad.

News report of the virus had not yet appeared. Federoff, a neuroscientist, was briefed because years before, he was vetted as part of a group — he didn’t give a name for the group — to consult for the US government on emerging scientific issues. His day job, though, was CEO of Aspen Neurosciences, a Parkinson’s cell therapy startup that days before had come out of stealth mode and gave word to investors they were hoping to raise $70 million. That, Federoff realized, would be difficult if a pandemic shut down the global economy.

FDA puts pe­di­atric aGVHD drug on pri­or­i­ty re­view lane — will they go vir­tu­al with the ad­comm?

Despite worries about regulatory delays due to new work arrangements under Covid-19, the FDA appears intent to go full speed ahead with its everyday work, not only granting priority review to a stem cell therapy for acute graft versus host disease but also plotting an advisory committee meeting for it.

With a PDUFA date of September 30, the journey of the drug — remestemcel-L, or Ryoncil — could shed light on the agency’s capacity to facilitate drug development unrelated to Covid-19.

Covid-19 roundup: Trump push­es his new fa­vorite, untest­ed drug; CRISPR out­lines crip­pling im­pact of Covid-19

President Trump has a new favorite Covid-19 drug.

After a conversation with Japanese Prime Minister Shinzo Abe, Politico reports, the president is pressuring the FDA to issue emergency use authorization for favipiravir, a flu drug that showed glimpses of success in China but remains unproven and carries a list of worrying side effects. The push comes after a week-plus in which the White House touted a potentially effective but unproven malaria medication despite the concerns of scientific advisors such as NIAID director Anthony Fauci. And Trump ally Rudy Giuliani has been talking up unproven cell therapy efforts on Twitter.

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ITeos nabs $125M as they prep Keytru­da com­bi­na­tion tri­al — if Covid-19 will let them

For iTeos, it turned out, $75 million could only last so long.

Two years after announcing their eye-catching Series B raise, the Belgian biotech is back with an even larger Series B-2: $125 million.

The now $175 million financing – $25 million of the first B round is considered part of the second – illustrates the vast capital available for those with promising new immuno-oncology compounds, particularly those that might be used in combination with existing therapies. In December, iTeos announced a collaboration with Merck to test its lead compound with Keytruda this year. The proceeds will push forward that trial and help fund the ongoing Phase I/II trials for that compound, EOS-850, and a second one, EOS-448.

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