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.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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ProFound Therapeutics founding team

Flag­ship's lat­est biotech could turn some of the thou­sands of new pro­teins it dis­cov­ered in­to ther­a­pies — and it has $75M to start

Flagship Pioneering, the incubator of Moderna and dozens of other biotechs, says it has landed upon tens of thousands of previously undiscovered human proteins. The VC shop wants to potentially turn them into therapeutics.

Like other drug developers that have turned proteins into therapeutics (think insulin for diabetes), Flagship’s latest creation, ProFound Therapeutics, wants to tap into this new trove of proteins as part of its mission to treat indications ranging from rare diseases to cancer to immunological diseases.

Richard Silverman, Akava Therapeutics founder and Northwestern professor

This time around, Lyri­ca's in­ven­tor is de­vel­op­ing his North­west­ern dis­cov­er­ies at his own biotech

Richard Silverman was left in the dark for the last five years of clinical development of the drug he discovered. The Northwestern University professor found out about the first approval of Lyrica, in the last few days of 2004, like most other people: in the newspaper.

What became one of Pfizer’s top-selling meds, at $5 billion in 2017 global sales before losing patent protection in 2019, started slipping out of his hands when Northwestern licensed it out to Parke-Davis, one of two biotechs that showed interest in developing the drug in the pre-email days, when the university’s two-person tech transfer team had to ship out letters to garner industry appetite.

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David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

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Up­dat­ed: US sees spike in Paxlovid us­age as Mer­ck­'s mol­nupi­ravir and As­traZeneca's Evusheld are slow­er off the shelf

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

Pfiz­er and CD­MOs ramp up Paxlovid man­u­fac­tur­ing with Kala­ma­zoo plant ex­pan­sion lead­ing the way

As the Covid-19 pandemic continues to evolve, pharma companies and manufacturers are exploring how to step up production on antivirals.

Pfizer is planning to expand its Kalamazoo-area facility to increase manufacturing capabilities for the oral Covid-19 antiviral Paxlovid, according to a report from Michigan-based news site MLive. The expansion of the facility, which serves as Pfizer’s largest manufacturing location, is expected to create hundreds of “high-skilled” STEM jobs, MLive reported. No details about the project’s cost and timeline have been released, but according to MLive, Pfizer will announce the details of the expansion at some point in early June.

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FDA spells out the rules and re­stric­tions for states seek­ing to im­port drugs from Cana­da

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

Simba Gill, CEO of Evelo Biosciences

While down 87% YOY, Evelo gets Flag­ship and oth­ers to in­fuse new cap­i­tal for come­back hope

Just four years after Flagship spinout Evelo Biosciences went public in an IPO worth $85 million, the biotech has seen its share price tank from $13 a share this time last year (ultimately reaching a peak of over $17) to now under $1.50. And today, it looks like Flagship still thinks the fledging biotech, in a down market, is still worth something after initial pre-IPO backing from the likes of Google’s GV, Celgene, Mayo Clinic and Alexandria Venture.

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Peter Thompson, Terremoto Biosciences interim CEO

For­mer Prin­cip­ia team looks to shake up co­va­lent small mol­e­cules again, this time at 'earthquake' scale

Terremoto Biosciences goes back a long ways, in a sense, to about a dozen years ago when Principia Biopharma was founded by UCSF professor Jack Taunton. Peter Thompson initially helmed the biotech.

The company helped expand covalent small molecule inhibitors beyond oncology and into autoimmune disease by targeting cystine. But that amino acid is uncommon in a lot of proteins, offering fewer drug targets than, say, lysine, which is present in most proteins of interest. So, over the years, Taunton went back to the drawing board to check out that second amino acid.

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