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.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Lat­est news on Pfiz­er's $3B+ JAK1 win; Pacts over M&A at #JPM22; 2021 by the num­bers; Bio­gen's Aduhelm reck­on­ing; The sto­ry of sotro­vimab; and more

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For those of you who attended #JPM22 in any shape or form, we hope you had a fruitful time. Regardless of how you spent the past hectic week, may your weekend be just what you need it to be.

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A $3B+ peak sales win? Pfiz­er thinks so, as FDA of­fers a tardy green light to its JAK1 drug abroc­i­tinib

Back in the fall of 2020, newly crowned Pfizer chief Albert Bourla confidently put their JAK1 inhibitor abrocitinib at the top of the list of blockbuster drugs in the late-stage pipeline with a $3 billion-plus peak sales estimate.

Since then it’s been subjected to serious criticism for the safety warnings associated with the class, held back by a cautious FDA and questioned when researchers rolled out a top-line boast that their heavyweight contender had beaten the champ in the field of atopic dermatitis — Dupixent — in a head-to-head study.

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Robert Califf, FDA commissioner nominee (Graeme Sloan/Sipa USA/Sipa via AP Images)

Rob Califf ad­vances as Biden's FDA nom­i­nee, with a close com­mit­tee vote

Rob Califf’s second confirmation process as FDA commissioner is already much more difficult than his near unanimous confirmation under the Obama administration.

The Senate Health Committee on Thursday voted 13-8 in favor of advancing Califf’s nomination to a full Senate vote. Several Democrats voted against Califf, including Sen. Bernie Sanders and Sen. Maggie Hassan. Several other Democrats who aren’t on the committee, like West Virginia’s Joe Manchin and Ed Markey of Massachusetts, also said Thursday that they would not vote for Califf. Markey, Hassan and Manchin all previously expressed reservations about the prospect of Janet Woodcock as an FDA commissioner nominee too.

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Michel Vounatsos, Biogen CEO (World Economic Forum/Ciaran McCrickard)

Bio­gen vows to fight CM­S' draft cov­er­age de­ci­sion for Aduhelm be­fore April fi­nal­iza­tion

Biogen executives made clear in an investor call Thursday they are not preparing to run a new CMS-approved clinical trial for their controversial Alzheimer’s drug anytime soon.

As requested in a draft national coverage decision from CMS earlier this week, Biogen and other anti-amyloid drugs will need to show “a meaningful improvement in health outcomes” for Alzheimer’s patients in a randomized, placebo-controlled trial to get paid for their drugs, rather than just the reduction in amyloid plaques that won Aduhelm its accelerated approval in June.

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CRO own­er pleads guilty to ob­struct­ing FDA in­ves­ti­ga­tion in­to fal­si­fied clin­i­cal tri­al da­ta

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

Susan Galbraith, AstraZeneca EVP, Oncology R&D

Can­cer pow­er­house As­traZeneca rolls the dice on a $75M cash bet on a buzzy up­start in the on­col­o­gy field

After establishing itself in the front ranks of cancer drug developers and marketers, AstraZeneca is putting its scientific shoulder — and a significant amount of cash — behind the wheel of a brash new upstart in the biotech world.

The pharma giant trumpeted news this morning that it is handing over $75 million upfront to ally itself with Scorpion Therapeutics, one of those biotechs that was newly birthed by some top scientific, venture and executive talent and bequeathed with a fortune by way of a bankroll to advance an only hazily explained drug platform. And they are still very much in the discovery and preclinical phase.

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‘Skin­ny la­bels’ on gener­ics can save pa­tients mon­ey, re­search shows, but re­cent court de­ci­sions cloud fu­ture

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.

A patient in Alaska receiving an antibody infusion to prevent Covid hospitalizations in September. All but one of these treatments has been rendered useless by Omicron (Rick Bowmer/AP Images)

How a tiny Swiss lab and two old blood sam­ples cre­at­ed one of the on­ly ef­fec­tive drugs against Omi­cron (and why we have so lit­tle of it)

Exactly a decade before a novel coronavirus broke out in Wuhan, Davide Corti — a newly-minted immunologist with frameless glasses and a quick laugh — walked into a cramped lab on the top floor of an office building two hours outside Zurich. He had only enough money for two technicians and the ceiling was so low in parts that short stature was a job requirement, but Corti believed it’d be enough to test an idea he thought could change medicine.

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