Chris Garabedian (Forge Biologics)

Chris Garabe­di­an's first Xon­toge­ny com­pa­ny, Lan­dos Bio­phar­ma, preps a nine-fig­ure IPO as lead pro­gram heads to PhI­II

Lan­dos Bio­phar­ma, the lead com­pa­ny in the port­fo­lio of Chris Garabe­di­an’s fund with Per­cep­tive, is prepar­ing to go pub­lic about a year and a half since its last raise. But the com­pa­ny’s last da­ta dump missed on all its pri­ma­ry end­points in IBD de­spite “pos­i­tive” signs it mea­sured up with stan­dard of care — will in­vestors be im­pressed?

The for­mer Vir­ginia Tech spin­out filed for a $100 mil­lion IPO late Wednes­day, aim­ing to take its AI-based pre­ci­sion med­i­cine plat­form and lead pro­gram to Nas­daq. Once the biotech prices, it will trade on the tick­er $LABP.

Though 2020 and its record IPO fundrais­ing to­tals have come to a close, 2021 is main­tain­ing some of that mo­men­tum — at least through the first two cal­en­dar weeks. Last Fri­day, Cul­li­nan On­col­o­gy net­ted an up­sized $249.9 mil­lion raise, while Gra­cell Biotech­nolo­gies hauled an im­pres­sive $209 mil­lion raise.

Al­so on Wednes­day, Sana Biotech­nol­o­gy pen­ciled in an es­ti­mat­ed $150 mil­lion raise, though the back­ers at Flag­ship and ARCH Ven­tures are like­ly shoot­ing for some­thing much high­er.

So what’s got Lan­dos ex­cit­ed to join the par­ty? The biotech was tight-lipped in its S-1 fil­ing, de­clin­ing to de­tail how it would use funds from the raise. But ear­li­er this month, the com­pa­ny re­vealed da­ta they de­scribed as pos­i­tive from a Phase II proof-of-con­cept tri­al in its lead com­pound, BT-11, even though none of the p-val­ues hit the mag­ic 0.05 fig­ure for sta­tis­ti­cal sig­nif­i­cance.

The idea be­hind the pro­gram is a path­way that Vir­ginia Tech pro­fes­sor Josep Bas­saganya-Ri­era has stud­ied for more than a decade known as Lan­thio­n­ine Syn­thetase C-Like 2 (LAN­CL2), a mem­brane re­cep­tor shown to mod­u­late im­muno­log­i­cal mech­a­nisms as­so­ci­at­ed with au­toim­mune dis­eases. BT-11 is one of three Lan­dos com­pounds aim­ing to take ad­van­tage of the path­way, with lead in­di­ca­tions in ul­cer­a­tive col­i­tis and Crohn’s dis­ease.

Lan­dos aimed to com­pare BT-11 to place­bo in 198 pa­tients with mild to mod­er­ate UC in a ran­dom­ized, dou­ble-blind tri­al. Pa­tients were ran­dom­ized even­ly be­tween two dos­ing co­horts and the con­trol arm, and clin­i­cal re­mis­sion was an­a­lyzed over a 12-week in­duc­tion pe­ri­od.

Re­searchers said they saw a “pos­i­tive trend” in ab­solute clin­i­cal re­mis­sion rates for the 1,000 and 500 mg dos­es com­pared to place­bo, not­ing rates of 31.8%, 30.3% and 22.7%, re­spec­tive­ly. Those amount­ed to dis­ap­point­ing p-val­ues of p=0.340 and p=0.235. Lan­dos not­ed, how­ev­er, that the re­sult­ing place­bo-ad­just­ed clin­i­cal re­mis­sion rates of 9.1% and 7.6% were con­sis­tent with stan­dard of care treat­ments in both mild to mod­er­ate and mod­er­ate to se­vere UC.

That has prompt­ed the com­pa­ny to pre­pare a Phase III tri­al for this year, aim­ing to eval­u­ate main­te­nance of clin­i­cal re­mis­sion af­ter a year fol­low­ing the 12-week in­duc­tion pe­ri­od. There are al­so plans to launch a Phase II tri­al of BT-11 in mod­er­ate to se­vere Crohn’s dis­ease in the first half of 2021.

Lan­dos al­so has plans for BT-11 in eosinophilic esophagi­tis, pso­ri­a­sis and atopic der­mati­tis. The com­pa­ny has ad­vanced a sec­ond pro­gram in­to the clin­ic in IBD as well, launch­ing a Phase I study of NX-13 last Ju­ly.

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

Onno van de Stolpe, Galapagos CEO (Thierry Roge/Belga Mag/AFP via Getty Images)

Gala­pa­gos chops in­to their pipeline, drop­ping core fields and re­or­ga­niz­ing R&D as the BD team hunts for some­thing 'trans­for­ma­tive'

Just 5 months after Gilead gutted its rich partnership with Galapagos following a bitter setback at the FDA, the Belgian biotech is hunkering down and chopping the pipeline in an effort to conserve cash while their BD team pursues a mission to find a “transformative” deal for the company.

The filgotinib disaster didn’t warrant a mention as Galapagos laid out its Darwinian restructuring plans. Forced to make choices, the company is ditching its IPF molecule ’1205, while moving ahead with a Phase II IPF study for its chitinase inhibitor ’4617.

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Stéphane Bancel, Getty

Mod­er­na CEO brush­es off US sup­port for IP waiv­er, eyes more than $19B in Covid-19 vac­cine sales in 2021

Moderna is definitively more concerned with keeping pace with Pfizer in the race to vaccinate the world against Covid-19 than it is with Wednesday’s decision from the Biden administration to back an intellectual property waiver that aims to increase vaccine supplies worldwide.

In its first quarter earnings call on Thursday, Moderna CEO Stéphane Bancel shrugged off any suggestion that the newly US-backed intellectual property waiver would impact his company’s vaccine or bottom line. Still, the company’s stock price fell by about 9% in early morning trading.

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'Chang­ing the whole game of drug dis­cov­ery': Leg­endary R&D vet Roger Perl­mut­ter leaps back in­to work as a biotech CEO

Roger Perlmutter needs no introduction to anyone remotely involved in biopharma. As the R&D chief first at Amgen and then Merck, he’s built a stellar reputation and a prolific career steering new drugs toward the market for everything from cancer to infectious diseases.

But for years, he’s also held a less known title: science partner at The Column Group, where he’s regularly consulted about the various ideas the VCs had for new startups.

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Ad­comm splits slight­ly in fa­vor of FDA ap­prov­ing Chemo­Cen­tryx’s rare dis­ease drug

The FDA’s Arthritis Advisory Committee on Thursday voted 10 for and 8 against the approval of ChemoCentryx’s $CCXI investigational drug avacopan as a treatment for adults with a rare and serious disease known as anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis.

The vote on whether the FDA should approve the drug was preceded by a split vote of 9 to 9 on whether the efficacy data support approval, and 10 to 8 that the safety profile of avacopan is adequate enough to support approval.

Gold­man Sachs jumps aboard Bain-backed 503(b) com­pound­ing phar­ma­cy with a $275M debt loan to sup­ply hos­pi­tals

Long the bane of the FDA’s existence, compounding pharmacies have seen a minor resurgence in the past year as short-term saviors for hospital drug shortages. Now, a 503(b) company specializing in hospital meds has earned a big backer to keep expanding its 200-drug strong portfolio.

Goldman Sachs and Owl Rock Capital Partners have doled out a $275 million debt loan to QuVa Pharma, a 503(b)-certified outsourcing facility providing compounded drugs to hospitals, the company said Thursday.

Bill Lis, Jasper Therapeutics

Jasper and its stem cell con­di­tion­ing an­ti­body earn a tick­et to Nas­daq in lat­est SPAC re­verse merg­er

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

Another biotech SPAC deal has landed as the glut of blank-check companies continues to make waves in the industry.

Thursday’s winner is Jasper Therapeutics, joining forces with Amplitude Healthcare Acquisition Corp. in a $100 million reverse-merger, Jasper announced. The deal also comes with a PIPE financing of an additional $100 million, setting Jasper up with a $490 million market cap once the merger closes in the third quarter.

Brent Saunders (Richard Drew, AP Images)

OcuWho? Star deal­mak­er turned aes­thet­ics czar Brent Saun­ders flips back in­to biotech. But who’s he team­ing up with now?

Brent Saunders went on a tear of headline-blazing deals building Allergan, merging and rearranging a variety of big companies into one before an M&A pact with Pfizer blew up and sent him on a bout of biotech drug deals. That didn’t work so well, so under pressure, he got his buyout at AbbVie — which needed a big franchise like Botox. And it was no big surprise to see him riding the SPAC wave into a recent $1 billion-plus deal that left him in the executive chairman’s seat at an aesthetics outfit — now redubbed The Beauty Health Company — holding a big chunk of the equity.

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Drug pric­ing watch­dog joins the cho­rus of crit­ics on Bio­gen's ad­u­canum­ab: What about charg­ing $2,560 per year?

As if Biogen’s aducanumab isn’t controversial enough, the researchers at drug pricing watchdog ICER have drawn up the contours of a new debate: If the therapy does get approved for Alzheimer’s by June, what price should it command?

Their answer: At most $8,290 per year — and perhaps as little as $2,560.

Even at the top of the range, the proposed price is a fraction of the $50,000 that Wall Street has reportedly come to expect (although RBC analyst Brian Abrahams puts the consensus figure at $11.5K). With critics, including experts on the FDA’s advisory committee, making their fierce opposition to aducanumab’s approval loud and clear, the pricing pressure adds one extra wrinkle Biogen CEO Michel Vounatsos doesn’t need as he orders full-steam preparation for a launch.