Josep Bassaganya-Riera, Landos Biopharma CEO (Landos)

Per­cep­tive's Chi­na up­start Lian­Bio con­tin­ues swing­ing deals, team­ing up with lead Xon­toge­ny biotech Lan­dos in IBD

One of Chi­na’s biggest up-and-com­ers has a brand new part­ner, and it’s one whose back­ers are like­ly fa­mil­iar with the oth­er’s.

Per­cep­tive’s Lian­Bio has se­cured a col­lab­o­ra­tion with Lan­dos Bio­phar­ma, the lead com­pa­ny in Chris Garabe­di­an’s Xon­toge­ny fund, to de­vel­op and mar­ket two pro­grams in Greater Chi­na and oth­er coun­tries in the re­gion, the biotechs an­nounced Mon­day morn­ing. In ex­change, Lan­dos is get­ting an up­front pay­ment of $18 mil­lion, up to $200 mil­lion in mile­stones and roy­al­ties on sales in the li­censed ter­ri­to­ries.

In ad­di­tion to Chi­na, Macau, Hong Kong and Tai­wan, Lian­Bio will be able to ex­clu­sive­ly mar­ket these two can­di­dates in South Ko­rea, Sin­ga­pore, Thai­land, Viet­nam, Myan­mar, Cam­bo­dia, In­done­sia and the Philip­pines.

Found­ed just nine months ago, Lian­Bio has been busy ever since it was birthed by Per­cep­tive in or­der for the VC firm to gain a foothold in a grow­ing area. The biotech has gone full steam ahead with its in-li­cens­ing busi­ness mod­el, part­ner­ing with sev­er­al biotechs to po­ten­tial­ly bring promis­ing late-stage as­sets to the Chi­nese and Asian mar­ket­places.

Lan­dos is the sixth biotech with which Lian­Bio has part­nered so far, join­ing a sta­ble of Per­cep­tive com­pa­nies that have al­ready part­nered with the Chi­na play­er, in­clud­ing found­ing col­lab­o­ra­tors MyoKar­dia and Bridge­Bio. The two pro­grams in ques­tion will be the sev­enth and eighth in Lian­Bio’s pipeline. These can­di­dates, known as omi­lan­cor (for­mer­ly BT-11) and NX-13, would al­so mark Lian­Bio’s first for­ay in­to the IBD area.

Lian­Bio al­so saw sig­nif­i­cant in­vest­ment from Pfiz­er, which was the on­ly Big Phar­ma to join its $310 mil­lion Se­ries A last Au­gust. Pfiz­er fur­ther chipped in an­oth­er $70 mil­lion last No­vem­ber to in-li­cense pro­grams that they can then co-de­vel­op, putting them first in line to ne­go­ti­ate for stand­alone com­mer­cial deals.

Their busi­ness mod­el is one that has im­pressed Lan­dos CEO Josep Bas­saganya-Ri­era thus far, he told End­points News. Ever since Chi­na adopt­ed the ICH guide­lines in 2017, al­low­ing the coun­try to ex­pand its list of ap­proved drugs from main­ly gener­ics, more and more com­pa­nies have been clam­or­ing to break in­to the world’s biggest mar­ket. As Lan­dos ap­proach­es the lat­er stages of its two lead pro­grams, the part­ner­ship proved a nat­ur­al fit, Bas­saganya-Ri­era said.

“By us­ing this mod­el, there’s an op­por­tu­ni­ty for Lian­Bio to be­come a plat­form that brings the next wave of in­no­va­tion in­to Chi­na,” he told End­points. “Lian­Bio can be a true chan­nel, bring­ing in­no­va­tion from the US and oth­er parts of the world to those pa­tients that need those drugs in Asia and Chi­na in par­tic­u­lar.”

Omi­lan­cor is a LAN­CL2 ag­o­nist be­ing de­vel­oped to treat ul­cer­a­tive col­i­tis, Crohn’s dis­ease and eosinophilic esophagi­tis, and Lan­dos is ex­pect­ing to meet with the FDA by the end of June to fi­nal­ize its glob­al Phase III tri­al pro­to­col, Bas­saganya-Ri­era said. The cur­rent plan is to have Lian­Bio han­dle re­cruit­ment and have the nec­es­sary “boots on the ground” when ap­proach­ing reg­u­la­to­ry au­thor­i­ties in the li­censed coun­tries, he added.

It’s a pro­gram that no­tably missed sta­tis­ti­cal sig­nif­i­cance in its Phase II tri­al for mild to mod­er­ate UC, though re­searchers said they saw a “pos­i­tive trend” at the time. The ab­solute clin­i­cal re­mis­sion end­point for two dos­es com­pared to place­bo post­ed rates of 31.8%, 30.3% and 22.7%, re­spec­tive­ly, amount­ing to dis­ap­point­ing p-val­ues of p=0.340 and p=0.235.

But the re­sult­ing place­bo-ad­just­ed clin­i­cal re­mis­sion rates of 9.1% and 7.6% were con­sis­tent with stan­dard of care treat­ments for even se­vere UC, prompt­ing the com­pa­ny to go ahead with its Phase III. Lan­dos al­so dosed its first pa­tient for a Phase II Crohn’s dis­ease tri­al ear­li­er this month.

The oth­er can­di­date in the deal, NX-13, is an NL­RX1 tar­get­ing com­pound in de­vel­op­ment for the treat­ment of UC and Crohn’s. It’s cur­rent­ly in Phase Ib de­vel­op­ment where three dos­es are be­ing test­ed in 40 UC pa­tients, Bas­saganya-Ri­era said. The plan is to start a Phase II po­ten­tial­ly as soon as next year.

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; 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.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Am­gen lays off about 300 work­ers, cit­ing 'in­dus­try head­wind­s'

Amgen has laid off about 300 employees, a company spokesperson confirmed to Endpoints News via email Sunday night.

Employees posted to LinkedIn in recent days about layoffs hitting Amgen last week. The Thousand Oaks, CA-based biopharma, which employs about 24,000 people, said the reduction “mainly” impacted US-based workers on its commercial team.

Drug developers of all sizes, including small upstarts and pharma giants, have let employees go in recent months as the biopharma market drags through a quarters-long winter doldrum.

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Boehringer In­gel­heim touts pre­ven­tion re­sults in rarest form of pso­ri­a­sis

Boehringer Ingelheim uncorked some positive results suggesting that Spevigo can help prevent flare-ups in patients with a severe form of psoriasis, months after the drug was approved to treat existing flares.

Spevigo, an IL-36R antibody also known as spesolimab, met its primary and a key secondary endpoint in the Phase IIb EFFISAYIL 2 trial in patients with generalized pustular psoriasis (GPP), Boehringer announced on Monday. While the company is keeping the hard numbers under wraps until later this year, it said in a news release that it anticipates sharing the results with regulators.

As­traZeneca, No­vo Nordisk and Sanofi score 340B-re­lat­ed ap­peals court win over HHS

AstraZeneca, Novo Nordisk, and Sanofi won an appeals court win on Monday, as the US Court of Appeals for the Third Circuit found that the companies cannot be forced to provide 340B-discounted drugs purchased by hospitals from an unlimited number of community and specialty pharmacies.

“Legal duties do not spring from silence,” the decision says as the court makes clear that the federal government’s interpretation of the “supposed requirement” that the 340B program compels drugmakers to supply their discounted drugs to an unlimited number of contract pharmacies is not correct, noting:

Ap­peals court toss­es J&J's con­tro­ver­sial 'Texas two-step' bank­rupt­cy case

A US appeals court has ruled against Johnson & Johnson’s use of bankruptcy to deal with mounting talc lawsuits, deciding that doing so would “create a legal blind spot.”

The Third Circuit Court of Appeals reversed a previous bankruptcy court decision on Monday, calling for the dismissal of a Chapter 11 filing by J&J’s subsidiary LTL Management.

Faced with more than 38,000 lawsuits alleging its talc-based products caused cancer, J&J spun its talc liabilities into a separate company called LTL Management back in October 2021 and filed for bankruptcy, a controversial move colloquially referred to as a “Texas two-step” bankruptcy. Claimants argued that the strategy is a misuse of the US bankruptcy code — and on Monday, a panel of judges agreed.

Charles Riv­er se­cures $50M ac­qui­si­tion of drug dis­cov­ery tech com­pa­ny

Over the past several years, Massachusetts-based contractor Charles River Laboratories has been busy on the M&A front, with the latest, $50 million buyout coming Monday for a provider of high-throughput screening solutions for discovery research.

Chicago-based SAMDI Tech will now be folded into Charles River’s discovery and safety assessment division, Charles River announced.

The $50 million in cash is for the 80% of SAMDI that Charles River didn’t previously own. Other financial details on the deal were not disclosed.

Chad Mirkin, Flashpoint co-founder

‘The field is at a flash­point’: New Chad Mirkin-found­ed biotech hopes to make more ef­fec­tive can­cer vac­cines

Following the success of the mRNA Covid vaccines, cancer vaccines are seeing renewed interest after years of middling results. But a group of researchers suggests that more attention needs to be paid not to what goes into those vaccines, but how the parts are put together.

In a recent paper published in Nature Biomedical Engineering, researchers led by Northwestern University’s Chad Mirkin describe how the placement of different antigens in a cancer vaccine impacts its efficacy. The paper builds on past work done by Mirkin’s lab that suggests the structure, or how the parts of a vaccine are arranged, impact a vaccine’s efficacy, not just its components.

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#JPM23: Reg­u­la­to­ry un­cer­tain­ty? What about M&A? Da­ta rule? Alessan­dro Masel­li and John Car­roll take out their crys­tal balls

Endpoints editor and founder John Carroll sat down the Catalent CEO Alessandro Maselli to talk about what’s ahead in 2023. Right or wrong, this covers all the big issues faced by biopharma. This transcript has been edited for brevity and clarity.

John Carroll:

I think 2022 had to be one of the worst years ever for crystal balls. You went into 2022 thinking all sorts of nice things about what was ahead, not thinking about a European land war, maybe not thinking that the Federal Reserve was going to be jacking up interest rates as fast as they could to get ahead of inflation. Just a tremendous number of macroeconomic issues that were out there. The sudden and complete collapse of support on the markets in Nasdaq for biotech. A lot of darlings in the industry that had been out there for a while suddenly found themselves moving from a really hot market to a really cold market all of a sudden and had to make a lot of different changes in terms of strategizing.

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Richard Gonzalez, AbbVie CEO (Chris Kleponis/picture-alliance/dpa/AP Images)

Up­dat­ed: $100B+ in sav­ings? Why the in­com­ing Hu­mi­ra biosim­i­lars will take time to catch on

The 20-year reign of AbbVie’s best-selling biologic of all time — the autoimmune disease biologic Humira (adalimumab) that has brought in upwards of $200 billion during its monopoly — is coming to an end tomorrow with the launch of Amgen’s biosimilar Amjevita.

The launch comes more than four years after Europe saw the exact same competition, leading to steep discounts in price, higher uptake, and big cost savings across the board.

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