Con­nect Bio­phar­ma snags $115 mil­lion in Se­ries C to de­vel­op ar­se­nal of im­mune mod­u­la­tors

Zheng Wei and William Pan met in a mol­e­c­u­lar bi­ol­o­gy study group in col­lege in Guangzhou, Chi­na.

Zheng Wei

In the fol­low­ing decades, the duo trans­formed from col­lege note-tak­ers to co-founders of Taicang, Chi­na-based Con­nect Bio­phar­ma­ceu­ti­cals. And on Mon­day, they com­plet­ed a $115 mil­lion Se­ries C to pro­pel their pipeline of im­mune mod­u­la­tors.

“The amount and the type of in­vestors that we have in this round — it re­al­ly is a big boost for the com­pa­ny,” said Wei, who most re­cent­ly served as di­rec­tor of im­munol­o­gy at San Diego-based Are­na Phar­ma­ceu­ti­cals.

“We have come a long way” since Con­nect was found­ed in 2012, he added lat­er. The com­pa­ny has ad­di­tion­al op­er­a­tions in Shang­hai, Mel­bourne, Aus­tralia, and San Diego.

The Se­ries C was led by RA Cap­i­tal Man­age­ment, and in­clud­ed fel­low new in­vestors Lil­ly Asia Ven­tures, Box­er Cap­i­tal and HBM Health­care In­vest­ments. In ear­ly 2019, Con­nect snagged $55 mil­lion in Se­ries B fund­ing, which it used to fund a mul­ti­ple as­cend­ing dose tri­al of its drug CBP-201 for atopic der­mati­tis.

The most re­cent round will sup­port fur­ther de­vel­op­ment of CBP-201, as well as CBP-307 — the com­pa­ny’s two lead can­di­dates, both in Phase II test­ing. CBP-307, a mol­e­cule mod­u­la­tor of S1P1, is slight­ly ahead of the pack, with two on­go­ing Phase II tri­als for ul­cer­a­tive col­i­tis and Crohn’s dis­ease. It was the com­pa­ny’s first drug to en­ter clin­i­cal tri­al, Wei said.

CBP-201 isn’t far be­hind, with one on­go­ing Phase II tri­al for atopic der­mati­tis. Wei ex­pects CBP-201 will “even­tu­al­ly catch up” to CBP-307 in de­vel­op­ment.

For now, Con­nect is fo­cused on com­plet­ing Phase II tri­als for both drugs in the sec­ond half of next year. If all goes well, the com­pa­ny will use top line da­ta to pitch a Phase III tri­al to the FDA as soon as pos­si­ble, Wei said.

“I have been in the in­dus­try for quite a while now. And there are two things I have ob­served: One is that just as we be­gin to think that this is about as much as we can do to help pa­tients, new break­throughs come along, and they re­al­ly move the treat­ment ef­fi­ca­cy and safe­ty, every­thing up to a new lev­el. I have seen that hap­pen all the time,” Wei said. “The Num­ber 2 is that de­spite all these in­no­va­tions and break­throughs, the need to man­age some of the se­vere dis­eases, au­toim­mune dis­eases, (and) in­flam­ma­tion is still very large.”

CBP-201 is a mon­o­clon­al an­ti­body de­signed to in­hib­it IL-4Rα sig­nal­ing. Phase 1b re­sults showed that a four-week treat­ment im­proved skin le­sion and pru­ri­tus in mod­er­ate-to-se­vere atopic der­mati­tis pa­tients. If ap­proved, the drug would ri­val Sanofi and Re­gen­eron’s Dupix­ent, which was ap­proved by the FDA to treat atopic der­mati­tis in 2017, and has a list price of $3,110.09 per car­ton.

“Even with Dupix­ent, there’s still a lot of space to be im­proved,” Wei said, adding that Con­nect hopes to beat the al­ready-ap­proved drug in ef­fi­ca­cy mea­sures.

CBP-201 is al­so in pre­clin­i­cal tri­als for asth­ma and chron­ic rhi­nos­i­nusi­tis with nasal polyps. Some of the Se­ries C will be used to ad­vance oth­er pre­clin­i­cal pro­grams, in­clud­ing CBP-174 for the treat­ment of pru­ri­tus.

“We want to be a com­pa­ny that re­al­ly can de­vel­op and in­no­vate and bring new drugs in­to clin­i­cal de­vel­op­ment, rather than in-li­cens­ing oth­er peo­ple’s drugs … We be­lieve that some­one needs to start from the first step,” Wei said.

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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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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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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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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