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.

The FDA has been insisting for months that a Covid-19 vaccine had to be at least 50% effective – a measure of transparency meant to shore public trust in the agency and in a vaccine that had been brought forward at record speed and record political pressure. But now, with concerns of a Trump-driven authorization arriving before the election, the agency may be raising the bar.

The FDA is set to release new guidance that would raise safety and efficacy requirements for a vaccine EUA above earlier guidance and above the criteria used for convalescent plasma or hydroxychloroquine, The Washington Post reported. Experts say this significantly lowers the odds of an approval before the election on November 3, which Trump has promised despite vocal concerns from public health officials, and could help shore up public trust in the agency and any eventual vaccine.

Can the natural process by which cells clean out toxic proteins be harnessed to create potential treatments for neurodegenerative disorders?

That’s the question Libra Therapeutics will be trying to answer, as the new biotech officially launched Wednesday morning with $29 million in Series A financing. The company has three preclinical programs at the ready, with its lead candidate targeting ALS and frontotemporal dementia. But CEO Isaac Veinbergs said he hopes to develop therapies for a wide range of diseases, including Parkinson’s, Alzheimer’s and Huntington’s.

How does a biotech celebrate its two-year anniversary? For Immetas Therapeutics, it’s with an $11 million Series A round and a game plan to fight age-related disease.

Co-founders Gene Wang and David Sinclair came together years ago around the idea that inflammation is the ultimate process driving age-related illnesses, including cancer. The duo launched Immetas in 2018 and packed the staff with industry experts. Wang, who says he’s always had an entrepreneurial spirit, has held lead roles at Novartis, GSK, Bristol Myers Squibb and Merck. He’s worked on blockbuster drugs like Humira, Gardasil, Varubi and Zolinza. And now, he’s channeling that spirit as CEO.