Ancora Biotech's founders, CMO Ben Buelow (L) and CEO Roland Buelow

Ex­clu­sive: Af­ter Am­gen ex­it, fa­ther-son duo gets Light­speed back­ing to fund re­main­ing Teneo­bio 'ba­bies'

The fa­ther-son duo be­hind Teneo­bio is back with an­oth­er biotech, com­pris­ing three bis­pe­cif­ic an­ti­bod­ies that nei­ther Am­gen want­ed when dish­ing out $900 mil­lion up­front last year, nor Ab­b­Vie want­ed when ac­quir­ing a mul­ti­ple myelo­ma as­set in 2019.

Tech­ni­cal­ly, An­co­ra Biotech is three shell com­pa­nies, one for each of its an­ti­bod­ies or “Teneo ba­bies,” CEO Roland Buelow told End­points News. The “un­con­ven­tion­al” route is meant to give each as­set op­tion­al­i­ty on its path to mar­ket, just like the path set by Teneo­bio, said CMO Ben Buelow, Roland’s son.

“We are in a po­si­tion even­tu­al­ly to take these com­pa­nies ei­ther pub­lic and get them fund­ed for reg­is­tra­tional tri­als and even­tu­al ap­proval, or we have the pos­si­bil­i­ty to sell them off like we have done so far,” the CEO said.

The 10-per­son start­up is get­ting $60 mil­lion in back­ing from Light­speed Ven­ture Part­ners — one of the orig­i­nal Teneo­bio in­vestors — and SR One. Buelow fu­eled An­co­ra with $10 mil­lion when it first kicked in­to gear af­ter last year’s Am­gen ex­it, he said.

“When I tell peo­ple about the sto­ry of Teneo­bio, I al­ways talk about the movie ‘The Blues Broth­ers,’ get­ting the band back to­geth­er, be­cause Roland pulled all of the best peo­ple he’d worked with over his 25-30 years of biotech ex­pe­ri­ence in­to that com­pa­ny,” the younger Buelow said. Oth­er Teneo­bio ex­ecs have gone on to launch biotechs, in­clud­ing Ron­do Ther­a­peu­tics.

The el­der Buelow has a his­to­ry of con­struct­ing biotechs and sell­ing them off. Pri­or to Teneo­bio, he built up hu­man an­ti­body de­vel­op­er Open Mon­o­clon­al Tech­nol­o­gy, which sold to Lig­and Phar­ma­ceu­ti­cals for $178 mil­lion in 2015. It’s now go­ing pub­lic via a SPAC spin­off at an $850 mil­lion val­u­a­tion.

Back to An­co­ra: Two of the biotech’s “ba­bies” are al­ready in the clin­ic. A dose-es­ca­la­tion study is un­der­way for CD19- and CD3-tar­get­ing TNB-486, which is an­tic­i­pat­ed to be a lym­phoma treat­ment, the CEO said. Close to 30 pa­tients have been en­rolled and the first round of da­ta will come out at ASH this year or the an­nu­al AS­CO con­fer­ence next year, the CMO said, not­ing the com­pa­ny is close to choos­ing the rec­om­mend­ed Phase II dose.

Right now, TNB-486 is in the third-line-plus set­ting, but An­co­ra hopes to move in­to ear­li­er lines by com­bin­ing it with oth­er ther­a­pies, the CMO not­ed. About 80 pa­tients are ex­pect­ed to en­roll in the ear­ly-stage study be­ing con­duct­ed in the US and Ko­rea, ac­cord­ing to the clin­i­cal tri­als reg­is­ter.

An­co­ra’s sec­ond clin­i­cal-stage as­set, TNB-738, is a CD38 en­zyme in­hibitor de­signed to tamp down in­flam­ma­tion in fi­bro­sis and treat­ing age-re­lat­ed dis­eases, the CEO said. Ben Buelow said the drug is in a Phase I healthy vol­un­teer study. The Aus­tralia-based tri­al aims to en­roll 64 pa­tients and col­lect the last pri­ma­ry out­come da­ta in De­cem­ber, ac­cord­ing to the clin­i­cal tri­als data­base.

“It’s a re­al­ly nov­el mech­a­nism and of­ten­times, when you have some­thing like that, we be­lieve in that mol­e­cule in a very sub­stan­tial way and un­til oth­er peo­ple see the light on that, we may have to take it for quite a ways our­selves,” the med­ical chief ex­plained.

A “bas­ket-like ap­proach” is an­tic­i­pat­ed for the bis­pe­cif­ic, the CMO said, as mul­ti­ple Phase Ib/II stud­ies will con­sid­er var­i­ous “clin­i­cal in­di­ca­tions of in­ter­est.”

At the bot­tom of the pipeline is a pre­clin­i­cal an­ti-HB­sAg x CD3 an­ti­body be­ing con­sid­ered for chron­ic he­pati­tis B in­fec­tions. Ex­pect a 2024 hu­man tri­al en­try, Light­speed said.

With just 10 em­ploy­ees, half on the clin­i­cal de­vel­op­ment team, An­co­ra is steer­ing the ship with a lean crew. It will stay that way.

“We are plan­ning to con­tin­ue to run these stud­ies as much as pos­si­ble re­mote­ly, vir­tu­al­ly, to keep costs down,” the CMO said, “so cur­rent­ly there is no plan to in­crease our team size.”

An­co­ra de­rives its name from the Ital­ian word for an­chor and again. An an­chor re­sem­bles the shape of an an­ti­body, the CMO said, so the com­pa­ny “thought that was cute” when com­ing up with the brand.

The start­up isn’t to be con­fused with An­co­ra Bio, the fifth biotech to come out of ex-No­var­tis CEO Joe Jimenez’s Adi­tum in­cu­ba­tor, which is test­ing a failed Taisho de­pres­sion drug.

The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer drugs; 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.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

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EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

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Solicitor General Elizabeth Prelogar

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.

Phil Sharp, Nobel Prize laureate (L), and John Carroll, Endpoints News co-CEO (via Michael Last)

The End­points 11: Fire­side chat with No­bel Prize lau­re­ate Phil Sharp

On Thursday evening in Boston I had the great good fortune to talk about the creation of the biotech industry with Nobel Prize-winning scientist Phil Sharp. I learned quite a bit about the early days of Genentech, Biogen and Alnylam, which all helped birth this unusual drug development ecosystem. And that’s why we can do things like the Endpoints 11. Here’s my talk with Phil Sharp, which you can either watch or read below.

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Klick Health gath­ers biotech and phar­ma lu­mi­nar­ies to dis­cuss in­dus­try in­no­va­tions, in­vest­ments and fu­ture

At Klick Health’s first Ideas Exchange conference with biotech and pharma industry insiders since before the pandemic began, it was no surprise many conversations included Covid topics. Yet while vaccines and treatments were discussed, so too were the effects on drug development, federal responses, health inequities — and what to do now and next.

George Yancopoulos, chief scientist and cofounder of Regeneron, opened the conference responding to a question from Acorda CEO Ron Cohen about the spotlight on the industry during Covid and some of the “flak” biopharma has taken in the past.

Neil Desai, Aadi Bioscience CEO (via YouTube)

Pre­ci­sion on­col­o­gy biotech agrees to $72M cash in­fu­sion as it seeks to in­crease rev­enue

Almost a year after the FDA gave the green light to LA-based Aadi Bioscience’s first drug, the biotech is looking to private investors to keep itself going.

The oncology player announced Thursday that it has engaged with both new and existing investors in a PIPE financing — selling 3.3 million shares at $12.50 a share, the biotech’s closing price at Nasdaq on Wednesday. The company is also selling off pre-funded warrants to purchase over 2.4 million more shares at $12.4999 per pre-funded warrant.

FDA's out­side ex­perts vote in fa­vor of Fer­ring's fe­cal trans­plant for C. dif­fi­cile, set­ting the stage for Seres

FDA’s outside advisors voted in favor of Ferring Pharmaceuticals’ RBX2660, an experimental poop-based drug implant that the company says would be the first microbiota-based live biotherapeutic to receive an FDA green light.

That was a point repeatedly discussed during the Vaccines and Related Biological Products Advisory Committee, or VRBPAC, meeting Thursday when evaluating Ferring’s fecal microbiota transplant, or FMT, for reducing the recurrence of Clostridioides difficile infection in adults who have received antibiotics. Multiple members brought up the need for a regulated product amid a landscape of unregulated FMTs already happening in clinical care.

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