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.”

Tesla and SpaceX founder Elon Musk gestures to the audience after being recognized by President Trump following the successful launch of a Falcon 9 rocket at the Kennedy Space Center. (via Getty Images)

Tes­la chief Elon Musk teams up with Covid-19 play­er Cure­Vac to build 'R­NA mi­cro­fac­to­ries'

Elon Musk has joined the global tech crusade now underway to revolutionize vaccine manufacturing — now aimed at delivering billions of doses of a new mRNA vaccine to fight Covid-19. And he’s cutting right to the front.

In a late-night tweet Wednesday, the Tesla chief announced:

Tesla, as a side project, is building RNA microfactories for CureVac & possibly others.

That’s not a lot to go on. But the tweet comes a year after Tesla’s German division in Grohmann and CureVac filed a patent on a “bioreactor for RNA in vitro transcription, a method for RNA in vitro transcription, a module for transcribing DNA into RNA and an automated apparatus for RNA manufacturing.” CureVac, in the meantime, has discussed a variety of plans to build microfactories that can speed up the whole process for a global supply chain.

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George Yancopoulos (Regeneron)

UP­DAT­ED: Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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Douglas Love, Annexon CEO (Annexon)

IPO bound? A Bay Area biotech grabs a mega-round on the road to a piv­otal neu­rode­gen­er­a­tion pro­gram

South San Francisco-based Annexon has added $100 million to its cash reserves, along with a new roster of marquee investors backing their play on the classical complement pathway involved in neurodegeneration. And that may well fit the profile for an IPO — though right now everything seems to be working on that score.

Eighteen months after Bain and their syndicate partners put up $75 million to fuel clinical work, Annexon is back at the trough. And this time they’re adding Redmile Group for the lead role, with supporting investments from these new arrivals: BlackRock, Deerfield Management Company, Eventide Asset Management, Farallon Capital Management, Janus Henderson Investors and Logos Capital.

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Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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Look­ing for 'ex­ter­nal in­no­va­tion,' Boehringer In­gel­heim re­serves $500M+ for new Shang­hai hub

Now that Boehringer Ingelheim’s bet on contract manufacturing in China has paid off, the German drugmaker is anteing up more to get into the research game.

Boehringer has set aside $507.9 million (€451 million) for a new External Innovation Hub to be built in Shanghai over five years. The site will become one of its “strategic pillars” as the team strives to get 71 approvals — either for new products or indications — by 2030, said Felix Gutsche, president and CEO of Boehringer Ingelheim China.

Vas Narasimhan, Novartis CEO (Patrick Straub/​EPA-EFE/​Shutterstock)

No­var­tis pays $678M for kick­back scheme as Vas Narasimhan tries to dis­tance phar­ma gi­ant from shady be­hav­ior

Novartis has reached another large settlement to resolve misconduct allegations, agreeing to pay more than $678 million to settle claims that it had spent hundreds of millions of dollars on lavish dinners, so-called speaking fees and expensive alcohol “that were nothing more than bribes” to get doctors to prescribe Novartis medications.

The top-shelf alcohol and lavish meals included a $3,250 per person night at Nobu in Dallas, a $672-per person dinner at Washington DC’s Smith & Wollensky and a $314 per person meal at Sushi Roku in Pasadena, according to the Justice Department complaint. There were at least 7 trips to Hooters and fishing trips in Alaska and off the Florida coast. Each of these events were supposed to be “speaker programs” where doctors educated other doctors on a drug, but the DOJ alleged many were “bogus” wine-and-dine events where the drug was barely mentioned, if at all.  (“Nobody presented slides on the fishing trips,” the complaint says.)

No­vavax snags Ben Machielse for CMC and pro­motes a trio of staffers; Mar­ty Du­vall lands an­oth­er CEO post at On­copep­tides

Novavax has been making waves recently by securing a $384 million commitment from CEPI to cover R&D and manufacturing for its Covid-19 vaccine while also spending $167 million on a 150,000 square-foot facility. The Maryland biotech continues to shore up its leadership team as well, bringing in Ben Machielse as their EVP of CMC just a couple weeks after nabbing AstraZeneca vet Filip Dubrovsky as their new CMO. Machielse was president and CEO of Vtesse from 2014-17, and before that, he also spent more than 11 years at MedImmune and was EVP of operations for the back half of his tenure.

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Dan Gold, MEI Pharma CEO

De­vel­op­ment part­ners at MEI, Helsinn dump a high-risk PhI­II AML study af­ter con­clud­ing it would fail sur­vival goal

Four years after Switzerland’s Helsinn put $25 million of cash on the table for an upfront and near-term milestone to take MEI Pharma’s drug pracinostat into a long-running Phase III trial for acute myeloid leukemia, the partners are walking away from a clinical pileup.

The drug — an HDAC inhibitor — failed to pass muster during a futility analysis, as researchers concluded that pracinostat combined with azacitidine wasn’t going to outperform the control group in the pivotal.