Shang­hai-based can­cer drug­mak­er Ab­bisko lines up $42M B round as it makes a leap for the clin­ic

Qim­ing Ven­tures is lead­ing a B round for Ab­bisko Ther­a­peu­tics, more than dou­bling the Shang­hai-based biotech’s pre­vi­ous haul as it hus­tles a pair of home­grown can­cer drugs to­ward an IND.

Yaochang Xu

Ab­bisko Ther­a­peu­tics re­cent­ly moved in­to Glax­o­SmithK­line’s old fa­cil­i­ties at Zhangjiang High Tech Park, where founder Yaochang Xu set foot 16 years ago while set­ting up a con­tract re­search ven­ture for Eli Lil­ly. Xu — a sea­soned ear­ly de­vel­op­ment ex­ec who helped breath life in­to the mi­graine drug las­mid­i­tan — was lat­er poached by No­var­tis to launch and run its R&D cen­ter in Chi­na. There, he met Hong­ping Yu and Zhui Chen, over­seas re­turnees 10 and 20 years his ju­nior re­spec­tive­ly. Xu and Yu would lat­er move to Han­soh, but the rig­or­ous aca­d­e­m­ic and project dis­cus­sions among them had plant­ed a seed for the of­fi­cial found­ing of Ab­bisko in 2016.

With Chen well versed in cut­ting-edge med­ical re­search, Xu ex­pe­ri­enced in ear­ly-stage de­vel­op­ment and Yu adept in lat­er-stage clin­i­cal work, the trio re­solved from the be­gin­ning to cre­ate small mol­e­cule on­col­o­gy drugs from scratch. The fo­cus is on can­cers preva­lent among Asian pop­u­la­tions — and of­fer­ing ei­ther first- or best-in-class prod­ucts.

Hong­ping Yu

Two of the com­pa­ny’s drugs will en­ter clin­i­cal tri­als in the com­ing months, with a slate of pro­grams to fol­low af­ter lead op­ti­miza­tion.

“Be­gin­ning in 2019, we will have at least one to two pro­grams en­ter­ing the clin­i­cal de­vel­op­ment stage,” Xu told Pharm­Cube last Oc­to­ber, adding that Ab­bisko is start­ing with more val­i­dat­ed tar­gets like FGFR4 and CSF-1R be­fore mov­ing in­to fresh­er and riski­er ones.

Zhui Chen

Ab­bisko is com­ing of age at a time Chi­na’s bio­phar­ma in­dus­try is un­der­go­ing a trans­for­ma­tion on a Cam­bri­an scale as de­scribed by McK­in­sey’s Franck Le Deu days ago, with on­col­o­gy mak­ing up the bulk of the col­lec­tive pipeline. And it could very well pro­vide some of the mo­men­tum for the burst of true, break­through in­no­va­tion that Le Deu has pre­dict­ed.

CI­CC Cap­i­tal, Loy­al Val­ley Cap­i­tal and an un­named in­ter­na­tion­al sov­er­eign wealth fund joined the Se­ries B, which al­so fea­tured ex­ist­ing in­vestors Lil­ly Asia Ven­tures and TF Cap­i­tal In­vest­ments.

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

CDC’s Robert Redford, NIAID’s Anthony Fauci, Admiral Brett Giroir at HHS, and FDA’s Stephen Hahn prepare to testify at a House hearing on June 23 (Getty)

'Ex­treme­ly po­lit­i­cal' — Trump neuters FDA's at­tempt to strength­en vac­cine EUA, ques­tions need to length­en process

Stephen Hahn went before a Senate committee Wednesday and declared he’s fighting. “Every one of the decisions we have reached has been made by career FDA scientists based on science and data, not politics,” he exclaimed, adding that “FDA will not permit any pressure from anyone to change that. I will fight for science.”

A few hours later, he was undermined by President Donald Trump when a reporter asked if he was okay with stricter vaccine guidelines that the FDA was said to be cooking up. “That has to be approved by the White House. We may or may not approve it. That sounds like a political move,” he decided.

David Berry (Flagship)

Flag­ship's next big tech­no­log­i­cal bet? The cloud

Earlier this month, Flagship announced their big bet on the software half the industry is talking about, launching the AI and machine learning startup. Now, they and a couple other investors are gambling $100 million on a software that much of the public generally thinks of as a cool, IT afterthought: cloud computing.

The idea, says founder and Flagship partner David Berry, is one of scale: The sheer magnitude of biological data that you can store on cloud technology is unprecedented. And that size, when leveraged properly, can allow you to ask questions and form insights that are similarly unprecedented.

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CEO Markus Warmuth (Monte Rosa)

Monte Rosa rakes in $96M Se­ries B as it pre­pares 'mol­e­c­u­lar glue' plat­form for IND-en­abling stud­ies

About four months after completing an extension to its Series A, Monte Rosa Therapeutics is putting its next foot forward with another heap of cash.

The Boston-based biotech is back with $96 million in Series B financing with a goal to get its lead program ready for IND-enabling studies by the end of the year. Though Monte Rosa is keeping its specific target a secret for now, the company has been researching how to utilize its protein degradation technology in breast cancer and non-small cell lung cancer, among other areas.

Chair of FDA's vac­cine ad­comm — who's al­so a lead in­ves­ti­ga­tor of Mod­er­na's vac­cine — re­cus­es her­self from Covid-19 talks

When the FDA’s Vaccines and Related Biological Products Advisory Committee meets next month to discuss the development and authorization of Covid-19 vaccines, the chairwoman won’t be there.

Hana El Sahly has recused herself from the expert panel’s review of the topic, citing her role as a lead investigator in Moderna’s Phase III trial, Reuters reported. An associate professor of virology and microbiology at Baylor College of Medicine in Houston, El Sahly was appointed the chairwoman last year.

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.

Jim Roberts and Brian Finrow (Lumen Bioscience)

With a $4M fed­er­al grant, Lu­men jumps in­to the Covid-19 treat­ment race

It’s been less than a month since Lumen Bioscience announced a $16 million Series B to engineer spirulina — a nutrient-packed super food — for diseases like traveler’s diarrhea, norovirus and C. difficile colitis. And now, the biotech has pulled in another $4 million to do the same for Covid-19.

The approach is quite similar to other gastrointestinal targets the company is pursuing, co-founders and Brian Finrow and Jim Roberts said. The Seattle-based company is working on a camelid antibody cocktail to combat GI infection common among Covid-19 patients. In a study published in the American Journal of Gastroenterology, a majority of Covid-19 patients showed GI and respiratory symptoms, and 25% had only GI symptoms.

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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