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.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

The End­points 11: They've got mad mon­ey and huge am­bi­tions. It's time to go big or go home

These days, selecting a group of private biotechs for the Endpoints 11 spotlight begins with a sprint to get ahead of IPOs and the M&A teams at Big Pharma. I’ve had a couple of faceplants earlier this year, watching some of the biotechs on my short list choose a quick leap onto Nasdaq or into the arms of a buyer.

Vividion, you would have been a great pick for the Endpoints 11. I’m sorry I missed you.

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Dave Lennon, former president of Novartis Gene Therapies

So what hap­pened with No­var­tis Gene Ther­a­pies? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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Maureen Hillenmeyer, Hexagon Bio CEO

Hexa­gon Bio rais­es $61M to con­tin­ue ef­forts to turn fun­gi in­to drugs

A year after raising a $47 million launch round, the fungi-loving drug hunters at Hexagon Bio have more than doubled their coffers.

Hexagon announced today that it raised another $61 million for its efforts to design cancer and infectious disease drugs based on insights mined from the DNA in millions of species of fungi. The new financing brings Hexagon’s committed funding to over $108 million.

Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

FDA+ roundup: Bs­U­FA III ready for show­time, court tells FDA to re-work com­pound­ing plan, new guid­ance up­dates and more

The FDA has now spelled out what exactly will be included in the third iteration of Biosimilar User Fee Act (BsUFA) from 2023 through 2027, which similarly to the prescription drug deal, sets fees that industry has to pay for submitting applications, in exchange for firm timelines that the agency must meet.

This latest deal includes several sweeteners for the biosimilar industry, which has yet to make great strides in the US market, with shorter review timelines for safety labeling updates and updates to add or remove an indication that does not contain efficacy data.

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Jean Bennett (Brent N. Clarke/Invision/AP Images)

Lux­tur­na in­ven­tor Jean Ben­nett starts a new gene ther­a­py com­pa­ny to tack­le rare dis­eases left be­hind by phar­ma, VCs

A few years ago Jean Bennett found herself in a surprising place for a woman who invented the first gene therapy ever approved in the United States: No one, it seemed, wanted her work.

Bennett, who designed and co-developed Luxturna, approved in 2018 for a rare form of blindness, had kept building new gene therapies for eye diseases at her University of Pennsylvania lab. But although the results in animals looked promising, pharma companies and investors kept turning down the pedigreed ophthalmology professor.

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Blue­bird sends blood dis­or­der drug to FDA for ap­proval; CG On­col­o­gy en­ters col­lab­o­ra­tion with Roche for Tecen­triq

Bluebird bio announced it completed the rolling submission of its BLA to the FDA for betibeglogene autotemcel gene therapy.

The therapy, designed for patients with beta-thalassemia who require regular red blood cell transfusions, was previously granted breakthrough therapy designation for treating transfusion-dependent beta-thalassemia (TDT). If approved, beti-cel will be the first hematopoietic stem cell ex-vivo gene therapy for patients in the US.