Yao-Chang Xu, Abbisko Therapeutics founder and CEO

Qim­ing-backed Ab­bisko makes $200M+ Hong Kong de­but, as a SPAC and Agenus spin­out al­so price on Nas­daq

Three new en­ti­ties priced their pub­lic de­buts late Thurs­day and ear­ly Fri­day, in­clud­ing a SPAC, a tra­di­tion­al Nas­daq IPO and a Chi­nese biotech join­ing the Hong Kong In­dex.

Shang­hai-based Ab­bisko Ther­a­peu­tics raised the most mon­ey of the tri­umvi­rate, gar­ner­ing $226 mil­lion in its Hong Kong de­but and pric­ing at HK$12.46, or rough­ly $1.60 in US dol­lars. The blank check com­pa­ny fol­lowed up with a $150 mil­lion raise, while MiNK Ther­a­peu­tics priced on Nas­daq at $12 per share and a $40 mil­lion raise.

As the IPO mar­ket con­tin­ues to heat back up af­ter a sum­mer lull, the biotech sec­tor re­cent­ly passed the $14 bil­lion mark in com­bined funds raised, per the End­points News tal­ly. That has al­lowed the in­dus­try to re­main on pace to sur­pass last year’s record sum of $16.5 bil­lion across 91 Nas­daq de­buts, ac­cord­ing to fig­ures from the stock ex­change.

Here’s a look at each of the en­ti­ties:

Ab­bisko makes a Hong Kong de­but

Ab­bisko was found­ed in 2016 and saw sig­nif­i­cant in­vest­ment a few years lat­er from promi­nent Chi­na VC firm Qim­ing Ven­ture Part­ners.

Back in 2019, Qim­ing led the biotech’s $42 mil­lion Se­ries B round, get­ting Ab­bisko primed and ready to sub­mit its can­cer drugs for INDs. The fundraise came short­ly af­ter the biotech moved in­to Glax­o­SmithK­line’s old digs where founder Yao-Chang Xu aimed to set up a con­tract re­search ven­ture for Eli Lil­ly.

The biotech has part­nered with As­traZeneca for its lead pro­gram, a pan-FGFR in­hibitor be­ing stud­ied as a monother­a­py and in com­bi­na­tion ther­a­pies to treat urothe­lial car­ci­no­ma. Ab­bisko’s last up­date for the pro­gram came in April, when it said it would “soon” be launch­ing Phase Ib/II tri­als for the pro­gram in Chi­na.

Ab­bisko has sev­er­al oth­er FGFR-re­lat­ed pro­grams in its pipeline, in­clud­ing ones look­ing at FGFR19-pos­i­tive he­pa­to­cel­lu­lar car­ci­no­ma and oth­er sol­id tu­mors. Re­searchers are al­so work­ing on a slate of im­muno-on­col­o­gy pro­grams for things like tenosyn­ovial gi­ant cell tu­mors, graft ver­sus host dis­ease and triple neg­a­tive breast can­cer.

Fri­day’s de­but on the Hong Kong In­dex comes about nine months af­ter Ab­bisko raised $123 mil­lion in a Se­ries D round last Jan­u­ary. That round, in ad­di­tion to par­tic­i­pa­tion from Qim­ing, was led by The Car­lyle Group. Qim­ing said in a re­lease the biotech is de­but­ing with a mar­ket cap of more than $1.1 bil­lion.

An­oth­er SPAC lands on Nas­daq

The newest health­care SPAC to hit Nas­daq comes from a pair of in­vestors that raised $150 mil­lion for the en­ter­prise.

The SPAC, known as San­a­by Health Ac­qui­si­tion Corp. I, is run by San­dra Sh­pil­berg and Tim­o­thy Zan­ni. Sh­pil­berg is the founder of Seek­er Health, a dig­i­tal health­care en­roll­ment plat­form that was ac­quired by pa­tient sup­port ser­vice Ever­sana in 2018. Zan­ni, mean­while, spent 30 years at the Dutch pro­fes­sion­al ser­vices net­work KP­MG and re­tired in Sep­tem­ber 2020.

San­a­by’s S-1 con­tained much of the same boil­er­plate text used by near­ly every life sci­ences SPAC dur­ing the cur­rent boom. Its ac­qui­si­tion strat­e­gy will cen­ter around buzzy phras­es like “re­spon­si­ble in­no­va­tion” and “proven trac­tion,” with the caveat that it can still choose to re­verse-merge with a com­pa­ny from any sec­tor.

Like any SPAC, San­a­by will have two years to find a part­ner be­fore it’s re­quired to re­turn the funds to in­vestors.

Agenus spin­out set to start trad­ing

MiNK Ther­a­peu­tics comes to Nas­daq with a mod­est raise of $40 mil­lion and a lead al­lo­gene­ic nat­ur­al killer T cell ther­a­py ex­pect­ing a read­out be­fore the end of the year.

Re­searchers are study­ing the pro­gram, known as AGENT-797, in sol­id tu­mors, re­lapsed or re­frac­to­ry mul­ti­ple myelo­ma, GvHD and ARDS re­lat­ed to Covid-19. The mul­ti­ple myelo­ma por­tion of the tri­als will like­ly read out be­fore 2021 is out, MiNK said in the S-1, while the oth­er parts come lat­er.

The GvHD study will launch some­time this quar­ter, and MiNK plans to study the pro­gram in sol­id tu­mors both as a monother­a­py and in com­bi­na­tion with check­point in­hibitors — with da­ta for both com­ing in the first half of 2022. MiNK was spun out of Agenus back in 2017, and Agenus owns an 83% stake in the com­pa­ny. MiNK will trade un­der the tick­er $INKT.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

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Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Radek Spisek, Sotio CEO (Cellestia)

A qui­et Czech biotech bags $315M to dri­ve its blos­som­ing can­cer pipeline through the clin­ic

In the rather insular world of biotech, most innovation inevitably comes from a cluster of R&D hubs — Cambridge, San Francisco, etc. But sometimes success stories sprout from rocky soil, which is most certainly the case with Prague-based Sotio Biotech and its suddenly jam-packed pipeline of cancer drugs.

After years in quiet development, Sotio now has $315 million in new funds to play with from parent company PPF Group, an investment group founded in the Czech Republic, as the biotech looks to advance its growing pipeline through early- and mid-stage trials.

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In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

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Biospec­i­men M&A: Dis­cov­ery ac­quires Al­bert Li's he­pa­to­cyte project; PhI­II tri­al on Bay­er's Nube­qa reached pri­ma­ry end­point

Discovery Life Sciences has acquired what claims to be the Maryland-based host of the world’s largest hepatocyte inventory, known as IVAL, to help researchers select more effective and safer drug candidates in the future.

The combined companies will now serve a wider range of drug research and development scientists, according to Albert Li, who founded IVAL in 2004 and is set to join the Discovery leadership team as the CSO of pharmacology and toxicology.

Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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