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 is one of the smartest, best educated industries on the planet. PhDs abound. We’ve had a long enough track record to see a new generation of savvy, experienced execs coming together to run startups.

And in these times, they are being tested as never before.

Biotech is going through quite a rough patch right now. For 2 years, practically anyone with a decent resume and some half-baked ideas on biotech could start a company and get it funded. The pandemic made it easy in many ways to pull off an IPO, with traditional road shows shut down in exchange for a series of quick Zoom meetings. Generalist investors flocked as the numbers raised soared into the stratosphere.

While calls to diversify clinical trials have grown louder in recent years — gaining support from federal agencies such as the FDA and NIH — progress has largely stalled, according to a new report from the National Academies of Sciences, Engineering and Medicine.

Swaths of patients in racial and ethnic minority groups, as well as LGBTQIA+, pregnant and older adult populations continue to be left out of clinical trials. While some advances have been made in the last 30 years — women now account for roughly half of clinical trial participants — growth in other areas remains stagnant, according to the report, which was mandated by Congress and sponsored by the NIH.

It seems that smallpox vaccination production is weighing on the mind of the US government. And manufacturer Bavarian Nordic is the latest company to benefit.

Just a few days after Emergent, a company that has made government contracts its lifeblood, acquired the exclusive rights to Tembexa from Chimerix, with a $225 million cash payment and an expected BARDA contract, the agency has offered a contract for smallpox vaccine production.

The House Energy and Commerce Committee on Wednesday offered a rare show of bipartisan support for a bill that would provide the FDA with user fees for the next five years.

The committee voted 55-0 to advance the quinquennial user fee bill to the full House floor, which if approved, will allow the FDA to use biopharma funds to hire new reviewers, and hit new marks as outlined in the user fee deals that the FDA and biopharma companies forged over the past several years.

The Senate last week voted along party lines, 51-50, with Vice President Kamala Harris casting the tie-breaker, to make President Biden appointee Alvaro Bedoya the deciding vote on a split 2-2 Federal Trade Commission.

The addition of Bedoya to the FTC could not only spell more trouble for biopharma M&A activity, as he may align with his Democrat partners to break the FTC ties, but it may also mean that FTC Chair Lina Khan has what she needs to move forward on a study around the pharma middlemen known as pharmacy benefit managers.

The story of Henrietta Lacks’ immortal cell line and her family’s fight for justice caught the attention of national media outlets and Hollywood years ago. Now, the case faces an uncertain fate as a Baltimore federal judge considers tossing the case.

After a hearing on Tuesday, Judge Deborah Boardman is weighing Thermo Fisher’s motion to dismiss the claims against it on the grounds that the statute of limitations has passed, and the continuing harm doctrine does not apply. Boardman is grappling with the “extraordinarily unique facts” of the case, according to Maryland Matters, which first reported the news.