Baeuer­le-backed Cul­li­nan grows its pipeline of port­fo­lio plays, adopts a new can­cer drug with eye to clin­i­cal de­vel­op­ment

About 15 months af­ter Cul­li­nan On­col­o­gy de­buted with $150 mil­lion and in­tro­duced its part-fund/part-op­er­at­ing com­pa­ny mod­el for piec­ing to­geth­er a pipeline full of can­cer drugs un­der in­di­vid­ual in­vest­ment ve­hi­cles, the biotech is pub­licly spot­light­ing an ear­ly-stage on­col­o­gy drug that is be­ing adopt­ed af­ter mak­ing the cut.

The biotech struck a deal with Tai­ho Phar­ma­ceu­ti­cals to take the drug and put it in a ve­hi­cle dubbed Cul­li­nan Pearl, which will op­er­ate un­der the um­brel­la or­ga­ni­za­tion now manned by a lean-and-mean team of 15. Tai­ho in turn gets a chunk of eq­ui­ty and its ven­ture arm is in­vest­ing along­side Cul­li­nan in a launch round for Pearl.

The drug here is TAS6417, an EGFR ty­ro­sine ki­nase in­hibitor, which “spares wild type EGFR.” The think­ing is that fea­ture will help the team amp up the po­ten­cy of the drug to dis­tin­guish it from the rest of the drugs in the same field.

Owen Hugh­es

“We are a means to an end,” says Owen Hugh­es, the CEO at Cul­li­nan. Tai­ho had this one nes­tled in among its ear­ly-stage pipeline projects and is li­cens­ing it out for Cul­li­nan to see if it can beat a fast path through the clin­ic — ei­ther un­veil­ing some re­al val­ue or killing it as a los­er.

Back when I talked to Hugh­es in the fall of 2017 dur­ing the for­mal launch of Cul­li­nan, he out­lined a plan to build a pipeline en­tire­ly out of deals with oth­er com­pa­nies, turn­ing to ven­dors to do a lot of the heavy R&D lift­ing for the sub­sidiaries un­der di­rec­tion from the team. 

Since then, he’s had a first-hand les­son on just how com­pet­i­tive that mar­ket is. He’s al­so killed 2 op­tion deals where they had a shot at some promis­ing pro­grams but couldn’t repli­cate the pre­clin­i­cal re­search work that snagged their at­ten­tion.

Hugh­es, though, has an ace in the hole. Patrick Baeuer­le at MPM is the co-founder, fi­nan­cial backer and CSO of the com­pa­ny. He di­rect­ed the Mi­cromet BiTE plat­form, ac­quired by Am­gen, which com­plet­ed the de­vel­op­ment on the first BiTE. And af­ter help­ing launch a se­ries of biotechs in the can­cer space, he’s al­so been help­ing Cul­li­nan come up with a slate of home-grown drugs to add to the pipeline.

Cul­li­nan now has 8 pro­grams un­der the um­brel­la, in­clud­ing VK-2019, an Ep­stein-Barr Nu­clear Anti­gen 1 in­hibitor dis­cov­ered at The Wis­tar In­sti­tute. Hugh­es and the team set up Cul­li­nan Apol­lo for that drug. You can look for 1 or 2 new deals this year, he adds, as the biotech reach­es the high end of the 6 to 10 projects orig­i­nal­ly planned.

The CEO isn’t get­ting spe­cif­ic on the up­fronts and mile­stones for these ear­ly-stage drugs, which wouldn’t like­ly as­tound any­one in this free-flow­ing en­vi­ron­ment. But he did note that the key to cap­tur­ing these pro­grams has less to do with cash than eq­ui­ty. The part­ners get a com­pa­ny com­mit­ted to hus­tling ahead, and a chunk of eq­ui­ty — gen­er­al­ly 20% or less — that can pay off if they score pay dirt da­ta.

So how is the mon­ey hold­ing out? Hugh­es says they re­cent­ly banked their sec­ond $50 mil­lion tranche to push ahead with deal­mak­ing. The third tranche is wait­ing for them as they con­tin­ue to make progress.

Vac­cine doc­u­ments, young lead­ers and mar­ket tur­moil: End­points' 10 biggest sto­ries of 2022

It’s been a volatile year in the world of biopharma. Market declines reset M&A valuations, and may be beginning to tempt bigger buyers back into dealmaking. Russia’s war in Ukraine disrupted drug sales and clinical trials. A new generation of young biotech leaders emerged in the Endpoints 20(+1) Under 40. And as capital runs dry in a tough environment for raising new funds, companies big and small are taking a look at their headcounts and operations for ways to make it through lean times.

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Tom Riga, Spectrum Pharmaceuticals CEO

Spec­trum im­plodes af­ter a harsh pub­lic slap­down and now a CRL from Richard Paz­dur

The FDA has gone out of its way several times to flatten any expectations for Spectrum’s lung cancer drug poziotinib, including slamming the regulatory door in the biotech’s face four years ago when the their executive crew came calling for a breakthrough drug designation and encouragement from the oncology wing of the FDA.

That stinging early rebuke pointed straight down the path to a corrosive in-house agency review of Spectrum’s attempt to land an accelerated approval for the oral EGFR TKI and a public whipping that included a classic takedown by none other than Richard Pazdur, who slammed the company for “poor drug development” that led to confusion over the dose needed for a slice of NSCLC patients harboring HER2 exon 20 insertion mutations.

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Big Phar­ma's Twit­ter ex­o­dus; Mer­ck wa­gers $1.35B on buy­out; $3.5M gene ther­a­py; 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.

As you start planning for #JPM23, we hope you will consider joining Endpoints News for our live and virtual events. For those who are celebrating Thanksgiving, we hope you are enjoying the long weekend with loved ones. And if you’re not — we’ll see you next week!

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Albert Bourla, Pfizer CEO (John Thys/POOL/AFP via Getty Images)

Pfiz­er CEO un­der fire from UK watch­dog over vac­cine com­ments — re­port

Pfizer CEO Albert Bourla told the BBC last December that he had “no doubt in my mind that the benefits, completely, are in favor” of vaccinating 5- to 11-year-olds for Covid-19. Almost a year later, those comments have reportedly landed him in trouble with a UK pharma watchdog.

Children’s advocacy group UsForThem filed a complaint with the UK’s Prescription Medicines Code of Practice Authority (PMCPA) last year accusing Bourla of making “disgracefully misleading” statements during the BBC interview, including one that “Covid in schools is thriving.” At the time, UK regulators had not yet cleared the vaccine for the 5 to 11 age group, though the vaccine did have a positive opinion from the EMA’s human medicines committee.

FDA tells Catal­ent to fix is­sues at two man­u­fac­tur­ing sites on its own

The CDMO Catalent will have to fix issues at two manufacturing plants in the US and Europe that were subject to inspections by the FDA this summer, giving the company room to correct the issues without facing further regulatory action.

The FDA gave Catalent a “voluntary action indicated” response to two inspections at the contract manufacturer’s site in Bloomington, IN, and Brussels, Belgium. Fixing the issues on its own is a preferable outcome to facing an “official action indicated” response, meaning that an official warning would be sent out or a sit-down with the FDA would be required.

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Merck targets vaccine-hesitant parents in its latest 'Why Vaccines' campaign. (Image: Shutterstock)

Mer­ck­'s lat­est 'Why Vac­ci­nes' cam­paign seeks to bet­ter in­form vac­cine-hes­i­tant moms

From Hollywood couple endorsements to targeted equity efforts, Merck has been pushing the value of vaccinations, especially since the Covid-19 pandemic disruption. Now the pharma is turning to a new target — vaccine-hesitant parents, and moms in particular.

Merck’s “Why Vaccines” latest social media and digital campaign spotlights real-life new moms who have questions about vaccinating their children.

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Sanofi's new headquarters, La Maison Sanofi, in Paris (Credit: Luc Boegly)

Sanofi wel­comes 500 staffers to new Paris HQ af­ter €30M ren­o­va­tion

When Paul Hudson took the helm at Sanofi back in 2019, he promised to reinvent the pharma giant — including its Paris headquarters. This week, the company set up shop in new “state-of-the-art” digs.

La Maison Sanofi, as the new HQ is called, is officially open for business, Hudson announced on Monday. The 9,000-square-meter (just under 97,000-square-foot) space accommodates 500 employees across the company’s government and global support functions teams, including finance, HR, legal and corporate affairs — and it was built with environmental sustainability and hybrid work in mind.

Sta­da to place $50M+ in­vest­ment in a new fa­cil­i­ty in Ro­ma­nia

While Romania may conjure up images of vast mountain ranges and tales of medieval kings, one generic manufacturer has broken ground on a new facility there.

German pharma company Stada said Monday that it has placed a €50 million ($51.9 million) investment into a 100,000 square-meter (1.08 million square-foot) site in Turda, Romania, a city in the Southeast of the country. According to a Stada spokesperson in an email to Endpoints News, the company has developed only 281,500 square feet of the site so far.

Rachael Rollins (Charles Krupa/AP Images)

US seeks jail time for co-CEO of New Eng­land com­pound­ing cen­ter af­ter dead­ly 2012 fun­gal out­break

The US attorney for the district of Massachusetts late last week called on the state’s district court to sentence the former co-owner of the now-defunct New England Compounding Center to 18 months of jail time for his role in the center’s quality deviations that led to more than 100 people dead from a fungal meningitis outbreak.

Gregory Conigliaro was convicted of conspiring with more than a dozen others at NECC to deceive the FDA and misrepresent the fact that the center was only dispensing drugs pursuant to patient-specific prescriptions.