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.

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

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Peter Greenleaf, Aurinia CEO

Af­ter pass­ing on Ac­celeron, Bris­tol My­ers eyes bolt-on ac­qui­si­tion of au­toim­mune spe­cial­ist — re­port

Bristol Myers Squibb is looking to beef up its autoimmune portfolio by scooping up Aurinia Pharmaceuticals, Bloomberg reported.

The recent overtures to Aurinia, relayed by anonymous insiders, came just as Bristol Myers turned down buyout talks with partners at Acceleron — which Merck ultimately struck a deal to acquire for $11.5 billion. Bristol Myers has reportedly decided to cash out on its minority stake, likely bagging $1.3 billion in the process, while keeping the royalty deals on two of Acceleron’s blood disorder drugs.

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Robert Califf (Pablo Martinez Monsivais, AP Images, File)

As buzz on Califf FDA nom heats up, in­dus­try and agency in­sid­ers of­fer a strong nod for the ‘per­fect’ choice

For once in this long, dramatic road to finding a new FDA commissioner, there’s been some continuity. Both CNN and Politico reported this weekend that Rob Califf met with President Biden to discuss the permanent commish role, following earlier news broken by the Washington Post that all signs point to Califf.

Although there may be a few Democrats who continue to grandstand about the dangers of COI (Califf has worked for Verily, sits on the board of Centessa Pharmaceuticals, and has other ties to industry research), with the pandemic ongoing and the need for some kind of continuity at FDA mounting, Califf is likely to meet the same fate as when he first won Senate confirmation in 2016, by a vote of 89-4 — Bernie Sanders and 6 others didn’t vote.

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AstraZeneca CEO Pascal Soriot (Raphael Lafargue/Abaca/Sipa USA)

A com­bo of As­traZeneca's Imfinzi and chemo wins where oth­ers have failed in piv­otal bil­iary tract test

Looking to run with the big dogs in the PD-(L)1 class, AstraZeneca’s Imfinzi has a tall hill to climb to compete in an increasingly bustling market. An aggressive combo strategy for the drug has paid off so far, and now AstraZeneca is adding another notch to its belt.

A combo of Imfinzi (durvalumab) and chemotherapy significantly extended the lives of first-line patients with advanced biliary tract cancer over chemo alone, according to topline results from the Phase III TOPAZ-1 study revealed Monday.

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Sean Ianchulev, Eyenovia CEO and CMO

Re­cent court de­ci­sion push­es FDA to re­ject and re­clas­si­fy drug-de­vice com­bo, crush­ing shares

Back in April, the FDA lost a crucial court case in which its broad discretion of regulating medical products that might satisfy the legal definitions of either “drug” and/or “medical device” was sharply curtailed.

In addition to the appeals court ruling that Genus Medical Technologies’ contrast agent barium sulfate (aka Vanilla SilQ) should not be considered a drug, as the FDA had initially ruled, but as a medical device, the agency also was forced to spell out which drugs would transition to devices as a result of the ruling.

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So — that pig-to-hu­man trans­plant; Po­ten­tial di­a­betes cure reach­es pa­tient; Ac­cused MIT sci­en­tist lash­es back; 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.

We’re incredibly excited to welcome Beth Bulik, seasoned pharma marketing reporter, to the team. You can find much of her work in our new Marketing channel — and in her weekly newsletter, Endpoints PharmaRx, which will launch in early November. Add it to your subscriptions here.

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NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.

UP­DAT­ED: Agenus calls out FDA for play­ing fa­vorites with Mer­ck, pulls cer­vi­cal can­cer BLA at agen­cy's re­quest

While criticizing the FDA for what may be some favoritism towards Merck, Agenus on Friday officially pulled its accelerated BLA for its anti-PD-1 inhibitor balstilimab as a potential second-line treatment for cervical cancer because of the recent full approval for Merck’s Keytruda in the same indication.

The company said the BLA, which was due for an FDA decision by Dec. 16, was withdrawn “when the window for accelerated approval of balstilimab closed,” thanks to the conversion of Keytruda’s accelerated approval to a full approval four months prior to its PDUFA date.

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