Chris Garabedian. Perceptive

IBD start­up Lan­dos lands $60M Se­ries B in first test case of Chris Garabe­di­an's lean and mean mod­el at Xon­toge­ny

When Chris Garabe­di­an teamed up with Vir­ginia Tech pro­fes­sor Josep Bas­saganya-Ri­era to launch Lan­dos, their team of 13 was ready to test their lead drug for in­flam­ma­to­ry bow­el dis­ease in the clin­ic. But they al­so set out to prove an­oth­er, al­most ex­is­ten­tial, hy­poth­e­sis: If you find the right part­ners, you can build a prop­er ear­ly-stage biotech with just $10 mil­lion in­stead of fol­low­ing the more splashy mod­el that’s be­come stan­dard in the in­dus­try.

Josep Bas­saganya-Ri­era

So 18 months lat­er, as Lan­dos clos­es a $60 mil­lion Se­ries B and lines up two Phase II stud­ies, it’s al­so serv­ing as an in­ter­im read­out of sorts for the meta ex­per­i­ment at Garabe­di­an’s start­up ac­cel­er­a­tor, Xon­toge­ny. In the process, the ex-Sarep­ta CEO is al­so un­veil­ing a ven­ture fund that Xon­toge­ny has set up with Per­cep­tive Ad­vi­sors as he plots sev­er­al more sim­i­lar plays.

True to its lean and mean mot­to, Lan­dos has grown on­ly slight­ly to 15 staffers while hus­tling through large an­i­mal tox­i­c­i­ty stud­ies and a Phase I in Aus­tralia, which con­firmed both safe­ty and ac­tiv­i­ty in a key bio­mark­er.

“We’ve come a long way,” Bas­saganya-Ri­era told me.

In ad­di­tion to tar­get­ing a path­way he’s stud­ied for more than a decade known as Lan­thio­n­ine Syn­thetase C-Like 2 (LAN­CL2), Lan­dos has come up with a small mol­e­cule drug that over­comes sev­er­al draw­backs of cur­rent ther­a­pies for Crohn’s dis­ease and ul­cer­a­tive col­i­tis. It’s oral­ly avail­able and lim­it­ed to the gut with lit­tle sys­temic ex­po­sure.

In the up­com­ing Phase II stud­ies — first ul­cer­a­tive col­i­tis, then Crohn’s — Lan­dos plans to eval­u­ate two dos­es of BT-11 along­side place­bo, eye­ing clin­i­cal re­mis­sion as the main end­point.

They’ve set it up this way to present the strongest case pos­si­ble for the in­dus­try, Ga­rade­bian said. With crossover in­vestors like RTW, Os­age Uni­ver­si­ty Part­ners and PBM Cap­i­tal on board, he’s al­ready think­ing about an ex­it, whether in the form of an IPO or a buy­out.

“We looked at when Cel­gene ac­quired No­gra Phar­ma for $700 mil­lion, it was based on an open la­bel sin­gle arm study that had some in­ter­est­ing da­ta in Crohn’s that ul­ti­mate­ly failed,” he said. “We ac­tu­al­ly like the idea of fol­low­ing the Re­cep­tos mod­el, which did a well de­signed pow­ered Phase II stud­ies that ul­ti­mate­ly sold to Cel­gene for $7 bil­lion in­stead of $700 mil­lion.”

Bas­saganya-Ri­era, the CEO, added that in prepa­ra­tion for the ex­it he will like­ly beef up the med­ical team and hire a CFO in the man­age­ment of­fice at Ash­burn, Vir­ginia (his lab, as well as the cor­po­rate head­quar­ters, re­mains in Black­burg in the south­ern part of the state). But the hope is to stay ag­ile, con­tin­u­ing to re­ly on a close re­la­tion­ship with Garabe­di­an and his team at Xon­toge­ny, which has helped with every­thing from ad­vis­ing on how to deal with the FDA to re­view­ing term sheets that has saved the com­pa­ny many mis­takes along the way.

That kind of week-to-week in­ter­ac­tion and over­sight was ex­act­ly what Garabe­di­an was look­ing for in a Xon­toge­ny com­pa­ny. With a goal to and a goal to raise as much as $200 mil­lion for the Per­cep­tive Xon­toge­ny Ven­ture Fund, he’s eye­ing a num­ber of oth­er projects span­ning on­col­o­gy, hema­tol­ogy, CNS, car­dio­vas­cu­lar, and more, in which they can write the en­tire Se­ries A check and help bring a com­pa­ny to the clin­ic with­in two years of get­ting in­volved by out­sourc­ing much of the work.

Garabe­di­an calls it the old fash­ioned way of do­ing ven­ture cap­i­tal. And he be­lieves it still works.

“I would ar­gue that many ear­ly-stage biotechs are over-cap­i­tal­ized, they are over-re­sourced,” he said. “It’s not un­com­mon for a Se­ries A round to end up hir­ing a CEO and a chief sci­en­tif­ic of­fi­cer and a chief med­ical of­fi­cer and a head of reg­u­la­to­ry and a head of tech ops and a lot of these peo­ple are mak­ing half a mil­lion dol­lars a year, and I think that is more than what’s need­ed if you know what you’re do­ing. If you fo­cus on the de­sign of the ex­per­i­ments and you know how to iden­ti­fy the right sup­plies to help you do it.”

“Hon­est­ly, the mes­sage that we want to get out ul­ti­mate­ly is to prove that you can do good drug de­vel­op­ment, and you can do it ef­fi­cient­ly with a small, fo­cused team. and I hope that peo­ple will look back and say why are we spend­ing $50 mil­lion, $60 or $80 mil­lion in a Se­ries A,” he added.

At Lan­dos, the $10 mil­lion didn’t even just cov­er BT-11. While the lead as­set has tak­en up the ma­jor­i­ty of their ef­forts, Bas­saganya-Ri­era said they have an “ex­pan­si­ble pipeline” fea­tur­ing as­sets that tar­get LAN­CL2 in dif­fer­ent ways for oth­er au­toim­mune dis­eases like type 1 di­a­betes and rheuma­toid arthri­tis. As­sets tar­get­ing a nov­el path­way dubbed NL­RX1 are al­so in the works.

“We have the po­ten­tial to ad­vance oth­er as­sets over next few months,” he said. “We are not a one-trick pony.”

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Justin Klee (L) and Joshua Cohen, Amylyx co-CEOs (Cody O'Loughlin/The New York Times; courtesy Amylyx)

Ad­vo­cates, ex­perts cry foul over Amy­lyx's new ALS drug, cit­ing is­sues with price, PhI­II com­mit­ment

Not 24 hours after earning the first ALS drug approval in five years, Amylyx Pharmaceuticals’ Relyvrio is already drawing scrutiny. And it’s coming from multiple fronts.

In an investor call Friday morning, Amylyx revealed that it would charge about $158,000 per year, a price point that immediately drew backlash from ALS advocates and some outside observers. The cost reveal had been highly anticipated in the immediate hours after Thursday evening’s approval, though Amylyx only teased Relyvrio would cost less than previously approved drugs.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 151,400+ biopharma pros reading Endpoints daily — and it's free.

Land­mark Amy­lyx OK spurs de­bate; Some... pos­i­tive? Alzheimer's da­ta; Can­cer tri­al bot­tle­neck; Sanofi's CRISPR bet; and more

Welcome back to 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.

After brief stops in Paris and Boston, John Carroll and the Endpoints crew are staying on the road in October with their return for a live/streaming EUBIO22 in London. The hybrid event fireside chats and panels on mRNA, oncology and the crazy public market. We hope you can join him there.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 151,400+ biopharma pros reading Endpoints daily — and it's free.

Joshua Cohen (L) and Justin Klee, Amylyx co-CEOs

Up­dat­ed: Af­ter long and wind­ing road, FDA ap­proves Amy­lyx's ALS drug in vic­to­ry for pa­tients and ad­vo­ca­cy groups

For just the third time in its 116-year history, the FDA has approved a new treatment for Lou Gehrig’s disease, or ALS.

US regulators gave the thumbs-up to the drug, known as Relyvrio, in a massive win for patients and their families. The approval, given to Boston-area biotech Amylyx Pharmaceuticals, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists, following the readout of a mid-stage clinical trial in September 2020.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 151,400+ biopharma pros reading Endpoints daily — and it's free.

Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

#AAO22: J&J’s first look at com­mon eye dis­ease port­fo­lio pads the case for PhII of gene ther­a­py

CHICAGO — While the later-stage drug developers in the geographic atrophy field are near the finish line, Johnson & Johnson’s Janssen is taking a more deliberate route, with a treatment that it hopes to be a one-time fix.

The Big Pharma will take its Hemera Biosciences-acquired gene therapy into a Phase II study later this year in patients with GA, a common form of age-related macular degeneration that impacts about five million people worldwide. To get there, Janssen touted early-stage safety data at the American Academy of Ophthalmology annual conference Saturday morning, half a day after competitors Apellis and Iveric Bio revealed their own more-detailed Phase III analyses.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 151,400+ biopharma pros reading Endpoints daily — and it's free.

George Church (courtesy EnPlusOne BioSciences)

George Church, Wyss sci­en­tists and North­pond chal­lenge con­ven­tion­al RNA man­u­fac­tur­ing with new biotech

RNA medicine has been at the forefront for the past few years, with the first RNA silencing therapy approved in 2018, and mRNA Covid vaccines following after. But flying under the radar has been the process of actually making RNA for these treatments.

That’s what Daniel Wiegand and Jonathan Rittichier have been working on in George Church’s lab for the past six years.

Friday morning, they unveiled EnPlusOne Biosciences, a biotech built on their RNA synthesis platform. Wiegand will serve as the Watertown, MA-based biotech’s CEO, and Rittichier will be CSO. And no different from his other startups, Church will be acting as scientific advisor. Its fourth co-founder, Dan Ahlstedt, joined through a Harvard Business School program, and will be COO.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 151,400+ biopharma pros reading Endpoints daily — and it's free.

Up­dat­ed: Al­ny­lam re­in­forces APOL­LO-B patisir­an da­ta be­fore head­ing to the FDA

Weeks after uncorking some mostly positive data for patisiran in transthyretin-mediated (ATTR) amyloidosis with cardiomyopathy, Alnylam is bolstering its package with new exploratory and subgroup data before shipping it off to regulators.

The RNAi drug maintained “generally consistent” benefits in efficacy and quality of life across several prespecified subgroups at month 12, Alnylam announced on Friday afternoon, including age, baseline tafamidis use, ATTR amyloidosis type, baseline six-minute walk test score and others.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 151,400+ biopharma pros reading Endpoints daily — and it's free.

Jerome Durso, Intercept Pharmaceuticals CEO

In­ter­cep­t's OCA fails a PhI­II NASH tri­al, rais­ing fresh doubts about its years­long quest for an OK

Intercept Pharmaceuticals has run into another big setback in its yearslong quest to win an approval for OCA in NASH. The biotech put out word Friday morning that its Phase III REVERSE study failed the primary endpoint for the liver disease, sending its share price into a tailspin.

There was no significant improvement in fibrosis among the patients suffering from cirrhosis who were treated with obeticholic acid, with investigators hunting for a minimum 1-stage histological improvement in the disease after 18 months of therapy.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 151,400+ biopharma pros reading Endpoints daily — and it's free.