Norbert Bischofberger, Kronos CEO

Three more biotechs look to jump on­to Nas­daq amid IPO boom, in­clud­ing Nor­bert Bischof­berg­er's Kro­nos

Three drug de­vel­op­ers an­nounced plans to go pub­lic on Fri­day, a sign that the IPO win­dow for bio­phar­ma is wide open.

First up is Daly City, CA-based Spruce Bio­sciences. They filed for an $86 mil­lion IPO to de­vel­op their pipeline for clas­sic con­gen­i­tal adren­al hy­per­pla­sia (CAH). Cur­rent­ly, on­ly steroids are avail­able to treat the con­di­tion, which af­fects the adren­al glands above the kid­neys. Spruce’s tildac­er­font, a non-steroidal op­tion, is in a Phase IIb tri­al in adults with clas­sic CAH and poor dis­ease con­trol. The com­pa­ny ex­pects a topline read­out here in the next 12 to 15 months. The small mol­e­cule is al­so in a Phase IIb study in adults with clas­sic CAH and good dis­ease con­trol. Spruce ex­pects topline da­ta here in the first half of 2022.

The com­pa­ny says IPO mon­ey will help fund op­er­a­tions for at “least the next 12 months.” And they plan fur­ther R&D work to po­ten­tial­ly treat chil­dren with clas­sic CAH and oth­er rare en­docrine dis­or­ders.

Spruce raked in an $88 mil­lion Se­ries B round in Feb­ru­ary, led by Omega Funds and Abing­worth. So far, the com­pa­ny has blown through $42.9 mil­lion, ac­cord­ing to its S-1 fil­ing. Oth­er in­di­ca­tions could al­so be in tildac­er­font’s fu­ture. “In ad­di­tion to ad­dress­ing these un­met needs in CAH, tildac­er­font’s mech­a­nism of ac­tion could al­so be rel­e­vant in pa­tients suf­fer­ing oth­er ab­nor­mal­i­ties of the hy­po­thal­a­m­ic-pi­tu­itary adren­al ax­is, in­clud­ing non-clas­sic CAH, Cush­ing’s Dis­ease, and poly­cys­tic ovary syn­drome,” Wiebke Arlt, di­rec­tor of the In­sti­tute of Me­tab­o­lism and Sys­tems Re­search at the Uni­ver­si­ty of Birm­ing­ham, said in Feb­ru­ary.

Next up we have Shat­tuck and Kro­nos, who both filed for $100 mil­lion IPOs to fo­cus on can­cer treat­ments.

Austin, TX-based Shat­tuck says it’s de­vel­op­ing a new class of ag­o­nist redi­rect­ed check­points, or ARCs. Its lead can­di­date, SL-172154, is de­signed to in­hib­it CD47 and stim­u­late CD40, and is cur­rent­ly in a Phase I tri­al for ovar­i­an can­cer. Ini­tial da­ta are ex­pect­ed in the sec­ond half of next year.

The com­pa­ny al­so plans to be­gin a sec­ond Phase I tri­al in pa­tients with cu­ta­neous squa­mous cell car­ci­no­ma or head and neck squa­mous cell car­ci­no­ma, from which dose-es­ca­la­tion da­ta would be avail­able in the sec­ond half of 2022. Their Take­da-part­nered can­di­date, SL-279252, is in a Phase I tri­al for ad­vanced sol­id tu­mors and lym­phoma. Dose-es­ca­la­tion da­ta is com­ing in the sec­ond half of next year, Shat­tuck an­nounced.

Back in June, Shat­tuck reeled in a $118 mil­lion Se­ries B from Red­mile Group and over 10 oth­er in­vestors. It in­tends to use the IPO funds to push SL-172154 from Phase I to Phase II, and de­vel­op ad­di­tion­al can­di­dates. So far, the com­pa­ny has burned through $48.3 mil­lion.

“Longer-term, we are pur­su­ing ad­di­tion­al dis­ease ar­eas, in­clud­ing au­toim­mune dis­eases, where our dual-sided fu­sion pro­tein plat­forms may pro­vide ad­van­tages over cur­rent treat­ment modal­i­ties,” the biotech said in its S-1.

Then there’s Nor­bert Bischof­berg­er’s Kro­nos. The 30-year Gilead vet joined Kro­nos in 2018, pitch­ing in to an $18 mil­lion seed round to launch the biotech. Af­ter an­nounc­ing $155 mil­lion in pri­vate fi­nanc­ing in Au­gust, Kro­nos hit the $278 mil­lion mark.

In Ju­ly, Kro­nos picked up en­tosple­tinib — a drug that was shelved when Bischof­berg­er was head of R&D at Gilead. Kro­nos forked over a “few mil­lion” in cash and a slice of eq­ui­ty to get it and an­oth­er SYK in­hibitor, lan­raplenib, the CEO told End­points News fol­low­ing the deal. And now, the biotech plans on us­ing IPO pro­ceeds to fund a reg­is­tra­tional Phase II/III study of en­tosple­tinib in com­bi­na­tion with in­duc­tion chemother­a­py (IC) in acute myeloid leukemia (AML) pa­tients with NPM1 mu­ta­tions. That would in­clude a $29 mil­lion mile­stone pay­ment to Gilead.

The com­pa­ny is al­so look­ing to con­duct a Phase I/II tri­al of its can­di­date KB-0742 for the treat­ment of ad­vanced sol­id tu­mors, and to fur­ther de­vel­op its SYK and CDK9 pro­grams. Its ac­cu­mu­lat­ed deficit is $39 mil­lion.

“Sub­ject to clear­ance of an In­ves­ti­ga­tion­al New Drug ap­pli­ca­tion (IND) for KB-0742, which we plan to sub­mit in the fourth quar­ter of 2020, we plan to ini­ti­ate a Phase I/II clin­i­cal tri­al in pa­tients with ad­vanced sol­id tu­mors in 2021,” the S-1 states.

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

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

The slate of products we’re offering here at Endpoints is continuing to grow, and it’s not just limited to editorial. If you haven’t, do visit your reader profile to see if there are any other weekly newsletters you’re interested in — as each comes with its own exclusive content. And don’t miss the publisher’s note from Arsalan Arif on Endpoints Studio, our latest avenue for advertising on Endpoints.

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Lisa Deschamps, AviadoBio CEO

Ex-No­var­tis busi­ness head hops over to a gene ther­a­py start­up — and she's reeled in $80M for a dash to the clin­ic

Neurologist and King’s College London professor Christopher Shaw has been researching neurodegenerative diseases like ALS and collaborating with drugmakers for the last 25 years in the hopes of pushing new therapies forward. But unfortunately, none of those efforts have come anywhere close to fruition.

“So, you know, after 20 years in the game, I said, ‘Let’s try and do it ourselves,’” he told Endpoints News. 

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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