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.

Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

FDA side­lines Paul Hud­son's $3.7B MS drug af­ter es­tab­lish­ing link to liv­er dam­age

One of Sanofi CEO Paul Hudson’s top picks in the pipeline — picked up in a $3.7 billion buyout 2 years ago — has just been sidelined in the US by a safety issue.

The pharma giant put out word early Thursday that the FDA has put their Phase III studies of tolebrutinib in multiple sclerosis and myasthenia gravis on partial clinical hold, halting enrollment and suspending dosing for patients who have been on the drug for less than 60 days. Patients who have completed at least 60 days of treatment can continue therapy as researchers explore a “limited” — but unspecified in Sanofi’s statement — number of cases of liver injury.

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Phar­ma re­acts to post-Roe; Drug­mak­ers beef up cy­ber de­fense; Boehringer, Roche qui­et­ly axe 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.

As a reminder, we are off on Monday for the Fourth of July. I hope this recap will kick off your (long) weekend well and that the rest of it will be just what you need. See you next week for a shortened edition!

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Eric Hughes, incoming Teva EVP of global R&D and CMO

Te­va chief raids Ver­tex for his new glob­al head of re­search and de­vel­op­ment

Teva CEO Kåre Schultz has found his new R&D chief and CMO in Vertex’s ranks.

The global generics giant, which has some 3,500 staffers in the R&D group, has named Eric Hughes to the top research spot in the company. He’ll be replacing Hafrun Fridriksdottir, who held the role for close to five years, on Aug. 1.

Hughes hasn’t been at Vertex for long, though. He jumped from Novartis less than a year ago, after heading the immunology, hepatology & dermatology global development unit. Before that, he completed a five-year stint as head of early clinical research for the specialty discovery medicine department in the exploratory clinical & translational research group at Bristol Myers Squibb, according to his LinkedIn profile.

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#BIO22: Man­ag­ing a biotech in tur­bu­lent times. 'There's a per­fect shit­show out there'

On Tuesday, June 14, Endpoints News EIC John Carroll sat down with a group of biotech execs to discuss the bear market for industry stocks and how they were dealing with it. Here’s the conversation, which has been lightly edited for brevity.

Martin Meeson, sponsor opening:

Thank you, John. Hello everyone. My name’s Martin Meeson, I’m the CEO of Fujifilm Diosynth. For those of you who don’t know Fujifilm Diosynth, we operate in the development of clinical and commercial product scale up, we have facilities in Europe and the US, and around about 4,000 employees. We run on average about 150 programs, so when it comes to managing in turbulent times over the last two years, we’ve had quite a lot of experience of that. Not just keeping the clinical pipelines and the commercial pipelines open, but also our response to the pandemic and the molecules that we’ve had within there. One of the phrases that I coined probably about a year ago when we were talking at JP Morgan, was I talked about managing through turbulent times. Well, it’s become the fact that we are not managing and leading through these times, we are managing in them, which is why that’s really the purpose of and the topic that we’ve got today.

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On Friday, Lonza announced plans to construct a large-scale commercial drug product fill and finish facility in the town of Stein, Switzerland.

Lon­za to in­vest $500M+ on fill-fin­ish fa­cil­i­ty on its home turf

Lonza has been expanding its reach across the globe, bringing sites in China and the US online this year, but now they are looking closer to home for their next major investment.

The Swiss manufacturer on Friday announced plans to construct a large-scale commercial drug fill and finish facility in the town of Stein, Switzerland. The new facility will be delivered through an investment of approximately CHF 500 million, or $519 million, and is expected to be completed in 2026. The facility will also be constructed on the same campus as Lonza’s current clinical drug product facility.

Kate Haviland, Blueprint Medicines CEO

What bear mar­ket? Blue­print lines up $1.25B to ex­pand la­bels, maybe tack on more drugs

As it works to pad the case for expanding its Ayvakit and Gavreto labels, Blueprint Medicines has lined up $1.25 billion in funding, with some of that money seemingly earmarked for acquisitions or pipeline expansion projects.

Following the likes of BioCryst, Cytokinetics and MorphoSys, Blueprint is aiming to monetize the royalties of its RET+ non-small cell lung cancer and thyroid cancer drug Gavreto with Royalty Pharma. The investment group will dole out $175 million upfront and might tack on another $165 million in biobucks as part of Blueprint’s royalties receivable from net sales of the drug by Roche outside the US, sans China.

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Fu­ji­film in­vests an­oth­er $1.6B in­to its CD­MO arm to up­grade facil­lites in the US and Eu­rope

Fujifilm’s spending spree into its CDMO arm is not slowing down.

The multinational announced on Wednesday that it will invest $1.6 billion to enhance and expand the cell culture manufacturing services of the CDMO arm of the Japanese conglomerate Fujifilm Diosynth.

The investment will enhance Fujifilm Diosynth Biotechnologies’ sites in Hillerød, Denmark, and College Station, TX. The investment is expected to create approximately 450 jobs across both facilities.

Anand Parikh, Faeth Therapeutics CEO

Sid Mukher­jee, Lew Cant­ley be­hind new can­cer biotech with food+drug com­bo treat­ment am­bi­tions 

Famed oncologist Sid Mukherjee and repeat biotech co-founder Lew Cantley have teamed up to form Faeth Therapeutics, a startup aiming to treat cancer the way other conditions are addressed: pairing nutrition with therapeutics.

The goal is to transform cancer treatment with nutrition and make it the fourth “pillar” in the oncology regimen, which to date has centered on radiotherapy, surgery and drugs, Faeth CEO Anand Parikh told Endpoints News. Other conditions have already been addressed with a side of nutrients or diet, he said, pointing to diabetes, irritable bowel syndrome and other diseases.

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Amgen's taking social media followers around the globe as it introduces the many different

From Tam­pa to Mu­nich, Am­gen’s ‘Places’ cam­paign in­tro­duces its lo­ca­tions around the world

Amgen is taking social media followers around the world with its latest corporate campaign. Called “Places of Amgen,” the twice monthly posts highlight the biopharma’s different offices and sites – and the people who work there.

Each post runs on LinkedIn, Facebook and Instagram with details about the work Amgen does in that location, when it was established, comments from people who work there and other interesting facts. The most recent one about Paris, France, for example, notes that Amgen France last year signed a French association charter committed to the inclusion of LBGT+ people in the workplace.

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