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.

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

Vas Narasimhan (AP Images)

UP­DAT­ED: Still held down by clin­i­cal hold, No­var­tis' Zol­gens­ma falls fur­ther be­hind Bio­gen and Roche as FDA asks for a new piv­otal study

Last October, the FDA slowed down Novartis’ quest to extend its gene therapy to older spinal muscular atrophy patients by slapping a partial hold on intrathecal administration. Almost a year later, the hold is still there, and regulators are adding another hurdle required for regulatory submission: a new pivotal confirmatory study.

The new requirement — which departs significantly from Novartis’ prior expectations — will likely stretch the path to registration beyond 2021, when analysts were expecting a BLA submission. That could mean more time for Biogen to reap Spinraza revenues and Roche to ramp up sales of Evrysdi in the absence of a rival.

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FDA commissioner Stephen Hahn at the White House (AP Images)

Un­der fire, FDA to is­sue stricter guid­ance for Covid-19 vac­cine EUA this week — re­port

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.

Patrick Enright, Longitude co-founder (Longitude)

As its biotechs hit the pan­dem­ic ex­it, Lon­gi­tude rais­es $585M for new neu­ro, can­cer, ag­ing and or­phan-fo­cused fund

The years have been kind to Longitude Capital. This year, too.

A 2006 spinout of Pequot Capital, its founders started their new firm just four years before the parent company would go under amid insider trading allegations. Their first life sciences fund raised $325 million amid the financial crisis, they added a second for $385 million and then in, 2016, a third for $525 million. In the last few months, the pandemic biotech IPO boom netted several high-value exits from those funds, as Checkmate, Vaxcyte, Inozyme and Poseida all went public.

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PhII Alzheimer's fail­ure deals new blow to Roche, AC Im­mune — but the tau hy­poth­e­sis is far from dead

The leading anti-tau antibody has failed its first Phase II testing, casting a shadow on a popular target (just trailing amyloid beta) for Alzheimer’s disease.

Roche and AC Immune are quick to acknowledge disappointment in the topline readout, which suggested that semorinemab did not reduce cognitive decline among patients with early Alzheimer’s disease, who are either just starting to have symptoms or have mild manifestations.

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Covid-19 roundup: J&J be­gins piv­otal Phase III tri­al for vac­cine; Con­tro­ver­sial hu­man chal­lenge tri­als to be­gin in Lon­don — re­port

Johnson & Johnson announced it’s beginning a pivotal Phase III trial for its Covid-19 candidate, JNJ-78436735 — the first single-dose vaccine in this stage.

The Phase III trial, dubbed ENSEMBLE, will enroll 60,000 patients worldwide, making it the largest Phase III study of a Covid-19 vaccine to date. J&J said the candidate achieved positive interim results in a Phase I/IIa study, which will be published “imminently.” There’s a possibility that the first batches will be ready for potential emergency use in early 2021, according to the company.

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Isaac Veinbergs, Libra CEO

With $29M in Se­ries A, Boehringer-backed Li­bra looks to tack­le neu­rode­gen­er­a­tion through cel­lu­lar clean­ing

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.

Gene Wang, Immetas co-founder and CEO (file photo)

Im­metas Ther­a­peu­tics nabs $11M Se­ries A to nar­row their bis­pe­cif­ic work tar­get­ing in­flam­ma­tion in age-re­lat­ed dis­eases

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.

Scoop: ARCH’s Bob Nelsen is back­ing an mR­NA up­start that promis­es to up­end the en­tire man­u­fac­tur­ing side of the glob­al busi­ness

For the past 2 years, serial entrepreneur Igor Khandros relied on a small network of friends and close insiders to supply the first millions he needed to fund a secretive project to master a new approach to manufacturing mRNA therapies.

Right now, he says, he has a working “GMP-in-a-box” prototype for a new company he’s building — after launching 3 public companies — which plans to spread this contained, precise manufacturing tech around the world with a set of partners. He’s raised $60 million, recruited some prominent experts. And not coincidentally, he’s going semi-public with this just as a small group of pioneers appears to be on the threshold of ushering in the world’s first mRNA vaccines to fight a worldwide pandemic.

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