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.

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

German pharma giant Bayer will be looking to make a significant investment into one of its US plants that produces over-the-counter drugs.

Bayer announced that it will spend $43.6 million to expand its facility in Myerstown, PA, a small town east of Harrisburg. Bayer plans to increase the site by 70,000 square feet and will have room for the installation of eight packaging lines and an area to install rooftop solar panels. The project is expected to be completed by 2025 and will add around 50 to 75 jobs.

As the global biologics market is expected to hit nearly the half-trillion-dollar mark this year, new JAMA research points to the importance of timely biosimilar entry, particularly as fewer biosimilars are entering the US than in Europe, and as monthly treatment costs for biosimilars were “substantially higher” in the US compared with Germany and Switzerland.

Among the three countries, biosimilar market share at launch was highest in Germany, but increased at the fastest rate in the US, the authors from the University of Zurich’s Institute of Law wrote in JAMA Network Open today.