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

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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FDA de­lays de­ci­sion on No­var­tis’ po­ten­tial block­buster MS drug, wip­ing away pri­or­i­ty re­view

So much for a speedy review.

In February, Novartis announced that an application for their much-touted multiple sclerosis drug ofatumumab had been accepted and, with the drug company cashing in on one of their priority review vouchers, the agency was due for a decision by June.

But with June less than 48 hours old, Novartis announced the agency has extended their review, pushing back the timeline for approval or rejection to September. The Swiss pharma filed the application in December, meaning their new schedule will be nearly in line with the standard 10-month window period had they not used the priority voucher.

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Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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David Meline, incoming Moderna CFO

Am­gen vet David Meline finds a new CFO roost at Mod­er­na, tak­ing a ride on the Covid-19 tiger as de­part­ing ex­ec cash­es out with $12M

We found out a few weeks ago that Moderna CFO Lorence Kim isn’t waiting around to see how the biotech wunderkind makes out in its frantic race to field a messenger RNA vaccine that can quell Covid-19. And now we know who’s stepping on board to take his place in the latest move in the executive suite.

David Meline, who forged his rep during a 6-year run at Amgen, slipped out the exit right after his Q2 “retirement” party in California — presumably virtual — and started the next chapter of his career at a biotech company betting big on revolutionizing the vaccine R&D space.

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GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

Covid-19 roundup: Mod­er­na read­ies to en­ter PhI­II in Ju­ly, As­traZeneca not far be­hind; EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund

Moderna may soon add another first to the Covid-19 vaccine race.

In March, the mRNA biotech was the first company to put a Covid-19 vaccine into humans. Next month, they may become the first company to put their vaccine into the large, late-stage trials that are needed to prove whether the vaccine is effective.

In an interview with JAMA editor Howard Bauchner, NIAID chief Anthony Fauci said that a 30,000-person, Phase III trial for Moderna’s vaccine could start in July. The news comes a week after Moderna began a Phase II study that will enroll several hundred people.

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José Basel­ga finds promise in new class of RNA-mod­i­fy­ing can­cer tar­gets, lock­ing in 3 pre­clin­i­cal pro­grams with $55M

Having dived early into some of the RNA breakthroughs of the last decades — betting on Moderna’s mRNA tech and teaming up with Silence on the siRNA front — AstraZeneca is jumping into a new arena: going after proteins that modify RNA.

Their partner of choice is Accent Therapeutics, which is receiving $55 million in upfront payment to steer a selected preclinical program through to the end of Phase I. After AstraZeneca takes over, the Lexington, MA-based startup has the option to co-develop and co-commercialize in the US — and collect up to $1.1 billion in milestones in the long run. The deal also covers two other potential drug candidates.

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