Henrik Stage, ADCendo CEO

The biotech craze hits the Nordics, dri­ving a record-high $62M Se­ries A for a Copen­hagen-based ADC play­er

With the biotech boom in the US in full swing, more mon­ey than ever is flow­ing in­to the in­dus­try — but that gush­er hasn’t ful­ly trans­lat­ed across the pond. Now, a Dan­ish biotech with some big-name back­ers has scored a record-high ear­ly fundrais­ing round. Is it a one-off or a sign of things to come?

Copen­hagen-based AD­Cen­do has bagged a $62 mil­lion Se­ries A round — the largest ever of its kind for a Dan­ish biotech — to ad­vance its pipeline of an­ti­body-drug con­ju­gates tar­get­ing uP­ARAP, a col­la­gen scav­enger re­cep­tor on some tu­mor cells, the com­pa­ny said Thurs­day.

The round was co-led by No­vo Seeds, No­vo Hold­ings’ ear­ly stage in­vest­ment arm, and Ys­ios Cap­i­tal with par­tic­i­pa­tion from RA Cap­i­tal Man­age­ment, Health­Cap and Gilde Health­care.

The biotech is look­ing to build a pipeline of AD­CS around uP­ARAP, which plays a role in tu­mor in­fil­tra­tion and could of­fer a nov­el path­way to tar­get hard-to-crack tu­mors. AD­Cen­do thinks AD­Cs could be used to tar­get uP­ARAP and dri­ve a “drug in­ter­nal­iza­tion pump” to pull the con­ju­gat­ed ther­a­pies in­to the tu­mor’s mi­croen­vi­ron­ment.

The pro­tein is high­ly ex­pressed in a range of tu­mor types, some with high un­met need, in­clud­ing soft tis­sue sar­co­ma, glioblas­toma mul­ti­forme, triple-neg­a­tive breast can­cers, leukemia and os­teosar­co­ma. It could al­so play a mean­ing­ful role in tar­get­ing stro­mal cells in sev­er­al high-preva­lence can­cers with sub­stan­tial stro­mal tis­sue con­tent, such as prostate, breast and pan­cre­at­ic can­cer.

Joël Jean-Mairet

“Ad­cen­do is tak­ing the ADC ap­proach to the next lev­el by fo­cus­ing on tar­gets that are pro­fes­sion­al in­ter­nal­iz­ers and have ex­quis­ite tu­mor se­lec­tiv­i­ty,” Joël Jean-Mairet, Ys­ios Cap­i­tal man­ag­ing part­ner, said in a state­ment.

No­vo Seeds has been an ear­ly backer for AD­Cen­do since 2017, and the com­pa­ny was in­cu­bat­ed in 2018 at the BioIn­no­va­tion In­sti­tute in Copen­hagen. As part of the fi­nanc­ing, No­vo Seeds prin­ci­pal Jeroen Bakker will join the com­pa­ny’s board.

“One of our am­bi­tions at No­vo Seeds is to lever­age and nur­ture the un­tapped in­no­va­tion in the Nordic re­gion,” Bakker said in a state­ment. “We are proud to have been in­volved with AD­Cen­do since its ear­ly days and are very im­pressed with the progress achieved to date.”

The Nordics are, of course, not a stranger to phar­ma­ceu­ti­cal in­dus­try, pro­vid­ing the fer­tile ground for both No­vo Nordisk and As­traZeneca. But as the biotech boom rolls at a fren­zied pace in the US, AD­Cen­do’s in­ter­na­tion­al syn­di­cate of in­vestors may in­di­cate that ven­ture funds are tak­ing a more glob­al ap­proach to find­ing the next big thing in ther­a­peu­tics.

Time will tell whether AD­Cen­do was worth that bet.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

UP­DAT­ED: Boehringer nabs FDA's first in­ter­change­abil­i­ty des­ig­na­tion for its Hu­mi­ra com­peti­tor — but will it mat­ter?

The FDA late Friday awarded Boehringer Ingelheim the first interchangeability designation for its Humira biosimilar Cyltezo, meaning that when it launches in July 2023, pharmacists will be able to automatically substitute the Boehringer’s version for AbbVie’s mega-blockbuster without a doctor’s input.

The designation will likely give Boehringer, which first won approval for Cyltezo in 2017, the leg up on a crowded field of Humira competitors.

Bio­gen hit by ALS set­back with PhI­II fail­ure for tofersen — but fol­lows a fa­mil­iar strat­e­gy high­light­ing the pos­i­tive

Patients and analysts waiting to hear Sunday how Biogen’s SOD1-ALS drug tofersen fared in Phase III didn’t have to wait long for the top-line result they were all waiting for. The drug failed the primary endpoint on significantly improving the functional and neurologic decline of patients over 28 weeks as well as the extension period for continued observation.

In fact, there was very little difference in response.

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Scott Struthers, Crinetics CEO

Cri­net­ics spins out ra­dio­phar­ma ef­forts in­to a new com­pa­ny, high­light­ing the grow­ing field­'s al­lure

Largely known for its nonpeptide small molecule research, Crinetics has been keeping its radiopharma work comparatively under wraps. But that changed Monday afternoon as the California biotech spun out a new company focused solely on the burgeoning field.

Crinetics launched Radionetics after the closing bell Monday, the company announced, seeding the new entity with $30 million raised from 5AM Ventures and Frazier Healthcare Partners. Radionetics will start with its own radiopharma-centric platform and a pipeline of 10 programs aimed at solid tumors.

Two drug­mak­ers hit with PDU­FA date de­lays from FDA amid back­log of in­spec­tions

As the FDA is weighed down with more and more pandemic responsibilities, the agency is beginning to miss PDUFA dates with more frequency too. Two different companies on Monday said they received notices that the FDA has not completed their drug reviews on time.

The review of an NDA for Avadel Pharmaceuticals’ candidate treatment for narcolepsy is not coming this month, the company said, and the review of UCB’s BLA for bimekizumab, used to treat moderate to severe plaque psoriasis, will miss its target date as well.

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Reshma Kewalramani, Vertex CEO (YouTube)

Ver­tex gets much-need­ed win with ‘ex­tra­or­di­nary’ first pa­tient re­sults on po­ten­tial di­a­betes cure

Vertex said Monday that the first patient dosed with its cell therapy for type 1 diabetes saw their need for insulin injections vanish almost entirely, a key early step in the decades-long effort to develop a curative treatment for the chronic disease.

The patient, who had suffered five potentially life-threatening hypoglycemic — or low blood sugar — episodes in the year before the therapy, was injected with synthetic insulin-producing cells. After 90 days, the patient’s new cells produced insulin steadily and ramped up their insulin production after a meal like normal cells do, as measured by a standard biomarker for insulin production.

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Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; 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.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.