Ro­mesh Sub­ra­man­ian births a new biotech with $50M and a plan to steer to­ward the clin­ic with drugs for rare mus­cle dis­eases

The At­las Ven­ture crew has nev­er liked be­ing splashy with mon­ey when it comes to star­tups. They like to get a good, lean team to­geth­er with some seed mon­ey, find an ex­pe­ri­enced helms­man on the bench, gath­er a string of ex­perts to lend ad­vice and of­fer enough cash in the A round — usu­al­ly with syn­di­cate part­ners — to see if they’re re­al­ly on­to some­thing with their lead drug. 

Maybe, the At­las team could even score a pre­clin­i­cal deal, like the one they did with Delinia. Be­cause they are al­ways on the look­out for a great X fac­tor re­turn for an in­vest­ment. The high­er the bet­ter. 10X will get a rous­ing cheer go­ing in this group. A fast 10X-plus works even bet­ter. And if it looks like too long a path to piv­otal da­ta, they’ve been known to bow out as well.

So along those lines, it’s not too sur­pris­ing to see the start­up mod­el Ro­mesh Sub­ra­man­ian is rolling in­to the biotech lane to­day.

Ja­son Rhodes

At­las, For­bion and MPM got to­geth­er to pro­vide the $50 mil­lion launch round, which will al­low the CEO to build up the crew as they build on the pre­clin­i­cal work they’ve been at for the past year or so — cour­tesy of At­las Ven­ture’s in­cu­ba­tion funds.

At­las’ Ja­son Rhodes will be play­ing a key role as ex­ec­u­tive chair­man, help­ing steer a com­pa­ny he co-found­ed.

The biotech is called Dyne Ther­a­peu­tics and they’ve been work­ing on us­ing oligonu­cleotides to de­grade RNA re­spon­si­ble for dis­ease — with a spe­cial fo­cus on mus­cle ail­ments.

Dyne has been de­vel­op­ing its own in-house con­ju­gate tech­nol­o­gy so they can take this ap­proach and care­ful­ly tar­get it to mus­cles. Ze­ro in close enough and you can amp up your dosage and avoid off-tar­get is­sues. 

Their first dis­ease is my­oton­ic dy­s­tro­phy type 1 — or DM1 — a rare, in­her­it­ed ail­ment that caus­es mus­cle weak­ness. The plan is to build a pipeline of ther­a­pies that can kick down gene ex­pres­sion for rare, mono­genic neu­ro­mus­cu­lar dis­eases, start­ing with skele­tal, car­diac and smooth mus­cle. And they want to stay fo­cused on break­through ther­a­pies.

“Fifty mil­lion takes us to the clin­ic,” says Sub­ra­man­ian. He’s not shar­ing any time­lines with me — not un­usu­al in a start­up’s ear­ly days. But with these back­ers, clear, track­able progress is baked in­to every­thing they do.

This is all fa­mil­iar ter­ri­to­ry for Sub­ra­man­ian, a well-known fig­ure in biotech, who did a stint as a se­nior sci­en­tist at Pfiz­er with Art Krieg be­fore mov­ing on to co-found RaNA and then set up trans­la­tion­al re­search groups for rare dis­eases at Alex­ion — up un­til Lud­wig Hantson’s big purge in the fall of 2017.

With­in months, he was build­ing the new com­pa­ny at At­las. These days, you see one door close, you po­ten­tial­ly get to have your pick of doors. 


Left to right: Sud­hir Agraw­al, Charles Thorn­ton, Louis Kunkel, Nan­cy An­drews.

Here’s their im­pres­sive list of sci­en­tif­ic ad­vis­ers help­ing Dyne stay on track:

— Nan­cy An­drews, for­mer dean of the School of Med­i­cine at Duke Uni­ver­si­ty and No­var­tis board mem­ber.

— Louis Kunkel, mem­ber of the Di­vi­sion of Ge­net­ics and Ge­nomics at Boston Chil­dren’s Hos­pi­tal and pro­fes­sor of pe­di­atrics and ge­net­ics at Har­vard Med­ical School.

— Charles Thorn­ton, Saun­ders Dis­tin­guished Pro­fes­sor of Neu­ro­mus­cu­lar Re­search at the Uni­ver­si­ty of Rochester.

— Sud­hir Agraw­al, vis­it­ing pro­fes­sor in the De­part­ment of Med­i­cine at The Uni­ver­si­ty of Mass­a­chu­setts Med­ical School and founder of Idera Phar­ma­ceu­ti­cals.

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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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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Covid-19 roundup: J&J, BAR­DA set ear­ly 2021 fin­ish line for $1B vac­cine race; FDA al­lows emer­gency drug use, ahead of piv­otal da­ta

J&J has zeroed in on a Covid-19 vaccine candidate that it hopes to begin testing in humans by September this year — with the extraordinary goal of getting it ready for emergency use in early 2021. And together with BARDA, it’s committing $1 billion to make it happen.

That kind of accelerated timeline would fall on the fast side of NIAID director Anthony Fauci’s well-publicized prediction that it would be another 12 to 18 months before a vaccine can be available for public use. A Phase I trial of Moderna’s mRNA vaccine began two weeks ago, and both the biotech and fellow mRNA player CureVac have discussed similar, if not even faster, timelines for emergency use among healthcare workers.

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As­traZeneca says its block­buster Farx­i­ga proved to be a game-chang­er in CKD — wrap­ping PhI­II ear­ly

If the FDA can still hold up its end of the bargain, AstraZeneca is already on a short path to scooping up a cutting-edge win with a likely approval for their SGLT2 drug Farxiga in cutting the risk of heart failure. Now the pharma giant says it can point to solid evidence that the drug — initially restricted to diabetes — also works for chronic kidney disease, potentially adding a blockbuster indication for the franchise.

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It is 'kind of a proven tech­nol­o­gy': Hep B vac­cine mak­er joins glob­al hunt for coro­n­avirus vac­cine

Using lab-grown proteins that are engineered to mimic the architecture of viruses to induce an immune response, VBI Vaccines is joining the hunt for a coronavirus vaccine — harnessing technology that has initially been proved safe in early trials as a prophylactic for cytomegalovirus (CMV) infection.

Unlike the raft of the companies in the Covid-19 vaccine race — including Moderna, CureVac and J&J — VBI is taking a pan-coronavirus approach, by developing a vaccine that will encompass Covid-19, severe acute respiratory syndrome (SARS), and Middle East respiratory syndrome (MERS).

Can a pair of top AveX­is alum­ni steer a new gene ther­a­py up­start to R&D glo­ry? 3 VCs bet $60M on it

VCs love few things more than a proven executive team when it comes to launching a new company. And now a group of A-listers has turned to a pair of top execs out of AveXis to steer the latest gene therapy player into the clinic.

The biotech is Waltham, MA-based Affinia and the two execs are Sean Nolan and Rick Modi — the former CEO and CBO respectively of AveXis, the gene therapy pioneer that fetched $8.7 billion in a sale to Novartis. Nolan has now taken the chairman’s role at Affinia while Modi moves up to the CEO post at the company.

Un­de­terred by a pan­dem­ic, Gilde Health­care rais­es their largest fund yet

When Pieter van der Meer started raising the capital for Gilde Healthcare’s fifth fund in the waning months of 2019, he had his eyes on a different chain of events that could change the healthcare system and perhaps even play to his firm’s advantage: The US presidential election.

Since raising their third fund in 2011, the 34-year-old Dutch firm had focused on value-based care. They chose late-stage biotechs that came up with new devices and delivery systems for de-risked established compounds, and when they chose preclinical biotechs, they spoke with potential pharma partners, payers and regulators to ask where and at what prices the drug made sense. As the Democratic primary became a contest over how to lower healthcare costs, it looked like a strategy that could pay off.

Daniel O'Day (AP Images)

Gilead CEO Dan O'­Day of­fers a de­tailed ex­pla­na­tion on remde­sivir ac­cess — re­as­sur­ing an­a­lysts that Covid-19 da­ta are com­ing fast

After coming under heavy fire from consumer groups ready to pummel them for grabbing the FDA’s orphan status for remdesivir — reserved to encourage the development of rare disease therapies — Gilead CEO Daniel O’Day had some explaining to do about the company’s approach to providing access to this drug to patients suffering from Covid-19. And he set aside time over the weekend to patiently explain how they are making their potential pandemic drug available in a new program — one he feels can better be used to address a growing pack of infected patients desperately seeking remdesivir under compassionate use provisions.

In addition to trying to reassure patients that they will once again have an avenue to pursue access, O’Day also reassured some analysts who had been fretting that China’s quick comeback from the coronavirus outbreak could derail its ultra-fast schedule for testing the drug in patients. The data are still expected in a few weeks, he says in the letter, putting the readout in April.

O’Day emphasizes that Gilead intends to pursue a pricing approach that will make this drug widely available — if it proves effective and safe. But no one is quite sure just what the longterm value would be, given the work being done on a variety of vaccines that may be rolled out as early as this fall — at least to the most heavily threatened groups.

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