Af­ter decades in the big leagues, Mar­tin Mack­ay is go­ing small — and he's de­light­ed

Mar­tin Mack­ay has spent more than three decades in drug dis­cov­ery and de­vel­op­ment, reach­ing top R&D po­si­tions at Pfiz­er, As­traZeneca and Alex­ion, where he en­joyed big bud­gets in pur­suit of block­buster drugs and styl­ish­ly sur­vived a se­ries of big cor­po­rate shake­ups.

Stephen Uden

Now, the Scot­tish re­search ex­ec and some of his ex-Alex­ion col­leagues are go­ing small, in a big way. Mack­ay, for­mer Alex­ion SVP Stephen Uden and for­mer Alex­ion tax chief Jef­frey Fry­er band­ed to­geth­er af­ter the big Lud­wig Hantson purge in 2017 to start Rally­bio at the be­gin­ning of this year. And some mar­quee ven­ture groups are bankrolling their ef­fort with a $37 mil­lion A round.

“I just feel we have some meds left in us,” says Mack­ay. 

Jef­frey Fry­er

The cash will go to build­ing out a small team at Rally­bio, where Mack­ay and his co-founders have been scout­ing rare dis­ease drugs in acad­e­mia and phar­ma, plan­ning to start build­ing a pipeline of drugs with an eye to ex­e­cut­ing a quick piv­ot to reg­u­la­tors.

5AM Ven­tures, Canaan Part­ners, and New Leaf Ven­ture Part­ners led the fi­nanc­ing, with Con­necti­cut In­no­va­tions lend­ing some state sup­port for the Farm­ing­ton, CT-based com­pa­ny.

“It would be eas­i­er to say what we’re not go­ing to do,” Mack­ay tells me. He ticks off the don’t-go-there list: On­col­o­gy, in­fec­tious dis­eases, oph­thal­mol­o­gy and vac­cines. They’re stick­ing with what they know: an­ti­bod­ies, small mol­e­cules and en­gi­neered pro­teins.

There are no ge­o­graph­ic bound­aries to their search. Uden has worked a lengthy stint in Japan. They all have ex­ten­sive Eu­ro­pean ex­pe­ri­ence, Mack­ay’s old stomp­ing grounds be­fore in­vestors drove a purge at As­traZeneca that brought Pas­cal So­ri­ot to the helm. The US is home, but they’re not lim­it­ing them­selves to the big hubs in Boston/Cam­bridge and the Bay Area.

Right now, they have the mon­ey to get to work and some lines on some ear­ly-stage as­sets.

“We’d be look­ing for ear­ly proof-of-con­cept to piv­ot to a reg­u­la­to­ry OK,” says Mack­ay, who’s tak­ing the CEO post at the new com­pa­ny.

Now with a staff of about 8, Mack­ay plans to build a group of 15 sci­en­tists and one busi­ness per­son to keep an eye on the num­bers. He plans to keep it sim­ple — there’s no ad­min­is­tra­tive as­sis­tant to book trav­el — with a bare­bones bud­get.

Mack­ay knows what it’s like to man­age glob­al re­search groups. Now he wants to see just how nim­ble a lit­tle biotech can be.


Im­age: Mar­tin Mack­ay. NO­VO NORDISK

Tar­get­ing a Po­ten­tial Vul­ner­a­bil­i­ty of Cer­tain Can­cers with DNA Dam­age Re­sponse

Every individual’s DNA is unique, and because of this, every patient responds differently to disease and treatment. It is astonishing how four tiny building blocks of our DNA – A, T, C, G – dictate our health, disease, and how we age.

The tricky thing about DNA is that it is constantly exposed to damage by sources such as ultraviolet light, certain chemicals, toxins, and even natural biochemical processes inside our cells.¹ If ignored, DNA damage will accumulate in replicating cells, giving rise to mutations that can lead to premature aging, cancer, and other diseases.

Roivant par­lays a $450M chunk of eq­ui­ty in biotech buy­out, grab­bing a com­pu­ta­tion­al group to dri­ve dis­cov­ery work

New Roivant CEO Matt Gline has crafted an all-equity upfront deal to buy out a Boston-based biotech that has been toiling for several years now at building a supercomputing-based computational platform to design new drugs. And he’s adding it to the Erector set of science operations that are being built up to support their network of biotech subsidiaries with an eye to growing the pipeline in a play to create a new kind of pharma company.

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The fu­ture of mR­NA, J&J's vac­cine ad­comm, Mer­ck­'s $1.85B au­toim­mune bet and more

Welcome to the third installment of Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

If this report was helpful in recapping it all for you, please do share it with your colleagues.

Get ready for FDA’s third Covid-19 vaccine

On the heels of a ringing endorsement from FDA reviewers earlier in the week, J&J‘s single-dose vaccine — which proved 66% effective at preventing symptomatic Covid-19, and 85% effective at stopping severe disease 28 days after administration — the advisory committee convened by the agency voted unanimously to recommend its emergency use authorization. It was “a relatively easy call,” according to one of the committee members — although that doesn’t mean they didn’t have questions. Jason Mast has the highlights from the discussion, including new information from the company, on this live blog.

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With dust set­tled on ac­tivist at­tack, Lau­rence Coop­er leaves Zio­pharm to a new board

Laurence Cooper has done his part.

In the five years since he left a tenured position at Houston’s MD Anderson Cancer Center to become CEO of Boston-based Ziopharm, he’s steered the small-cap immunotherapy player through patient deaths in trials, clinical holds, short attacks and, most recently, an activist attack on the board.

So when the company has “fantastic news” like an IND clearance for a TCR T cell therapy program, he’s ready to pass on the baton.

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Per­cep­tive's fourth — yes, fourth — SPAC jumps to Nas­daq as the blank check tree con­tin­ues to ripen

The biotech SPAC boom has gone almost hand-in-hand with the industry’s IPO gold rush, and this week saw more blank check companies hop aboard the train.

Leading the way is Perceptive Advisors’ fourth SPAC, appropriately named Arya Sciences Acquisition IV, which priced Friday morning after raising $130 million. And on top of that, new Ziopharm executive chair James Huang is launching his own SPAC with MSD Partners and Panacea Venture, filing S-1 paperwork Thursday with plans to raise $200 million.

Fol­low biotechs go­ing pub­lic with the End­points News IPO Track­er

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

Steve Cutler, Icon CEO (Icon)

In the biggest CRO takeover in years, Icon doles out $12B for PRA Health Sci­ences to fo­cus on de­cen­tral­ized clin­i­cal work

Contract research M&A had a healthy run in recent years before recently petering out. But with the market ripe for a big buyout and the Covid-19 pandemic emphasizing the importance of decentralized trials, Wednesday saw a tectonic shift in the CRO world.

Icon, the Dublin-based CRO, will acquire PRA Health Sciences for $12 billion in a move that will shake up the highest rungs of a fragmented market. The merger would combine the 5th- and 6th-largest CROs by 2020 revenue, according to Icon, and the merger will set the newco up to be the second-largest global CRO behind only IQVIA.

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CEO Fred Aslan (Artiva)

NK cell ther­a­py play­er Arti­va makes some more noise, pulling in $120M Se­ries B less than a month af­ter Mer­ck deal

Not even one month after Big Pharma took notice of Artiva when Merck signed a collaboration worth nearly $2 billion in milestones, the off-the-shelf NK cell biotech already has its next big fundraise.

Artiva returns from the venture well Friday with a $120 million Series B round, money they will use to get their first program into the clinic and to file INDs for another two candidates. The raise marks the latest development in a rapidly expanding footprint for Artiva, which, in addition to the Merck deal last month, has now raised almost $200 million since its Series A last June.

Doug Ingram (file photo)

Why not? Sarep­ta’s third Duchenne MD drug sails to ac­cel­er­at­ed ap­proval

Sarepta may be running into some trouble with its next-gen gene therapy approach to Duchenne muscular dystrophy. But when it comes to antisense oligonucleotides, the well-trodden regulatory path is still leading straight to an accelerated approval for casimersen, now christened Amondys 45.

We just have to wait until 2024 to find out if it works.

Amondys 45’s approval was unceremonious, compared to its two older siblings. There was no controversy within the FDA over approving a drug based on a biomarker rather than clinical benefit, setting up a powerful precedent that still haunts acting FDA commissioner Janet Woodcock as biotech insiders weighed her potential permanent appointment; no drama like the FDA issuing a stunning rejection only to reverse its decision and hand out an OK four months later, which got more complicated after the scathing complete response letter was published; no anxious tea leaf reading or heated arguments from drug developers and patient advocates who were tired of having corticosteroids as their loved ones’ only (sometimes expensive) option.

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