Philipp Spycher, Araris CEO

Promis­ing bet­ter link­er tech to ADC field, Araris has 'very, very am­bi­tious' plans for the clin­ic

A cou­ple months af­ter rais­ing CHF 2.5 mil­lion ($2.76 mil­lion) in ini­tial seed fund­ing, one-year-old Araris Biotech is top­ping off the round with an­oth­er CHF 12.7 mil­lion ($14 mil­lion).

The Paul Scher­rer In­sti­tute and ETH Zurich spin­out now has CHF 15.2 mil­lion to work with, and CEO Philipp Spy­cher has big plans. He hopes to bring one of the com­pa­ny’s an­ti­body-drug con­ju­gates (ADC) to the clin­ic by late 2022 or ear­ly 2023. “It’s very, very am­bi­tious, but we are very op­ti­mistic that we ac­tu­al­ly can make it,” he said.

AD­Cs have been around for “quite some time,” Spy­cher said. They con­sist of three parts: a drug pay­load, an an­ti­body and a link­er mol­e­cule that bridges the two to­geth­er. They’re de­signed to de­liv­er po­tent drugs to a de­sired tis­sue — for ex­am­ple, a chemother­a­py agent to a tu­mor. How­ev­er, the link­er can be un­sta­ble, or even “fall off,” Spy­cher said.

“And this is where we come in,” he added. Araris is work­ing on a sta­ble, uni­ver­sal link­er that can at­tach any off-the-shelf an­ti­body with any pay­load, with­out the need for mod­i­fi­ca­tion.

“Com­pa­nies, they spend mil­lions on iden­ti­fy­ing the prop­er an­ti­bod­ies. And then when you… need to mod­i­fy this an­ti­body in or­der to at­tach to the pay­load, this is what com­pa­nies re­al­ly don’t want to do,” Spy­cher said. The “beau­ty of the tech­nol­o­gy,” he added lat­er, is that the AD­Cs can be gen­er­at­ed “very eas­i­ly,” cut­ting de­vel­op­ment costs and time.

As for the tar­gets? “Stay tuned,” Spy­cher said. He ex­pects more in­for­ma­tion re­gard­ing the com­pa­ny’s can­di­dates to be re­leased lat­er this year.

The ADC field has seen a resur­gence of play­ers over the last few years, who join some long­time res­i­dents like Seagen (you may still re­mem­ber it as Seat­tle Ge­net­ics) and — you guessed it — ADC Ther­a­peu­tics.

Last year, the FDA grant­ed ac­cel­er­at­ed ap­proval for Pad­cev, an ADC de­vel­oped by Astel­las and Seagen for adults with lo­cal­ly ad­vanced or metasta­t­ic urothe­lial can­cer who pre­vi­ous­ly re­ceived a PD-1/L1 in­hibitor and a plat­inum-con­tain­ing chemo. And back in Sep­tem­ber, Mer­ck struck a $1.6 bil­lion deal to de­vel­op Seagen’s oth­er ADC, ladi­ratuzum­ab ve­dotin. In May, ADC Ther­a­peu­tics hit Nas­daq with a $233 mil­lion pub­lic de­but.

“To­day, there are nine an­ti­body-drug con­ju­gates ap­proved by the FDA but many of them can­not be dosed high enough to elic­it ef­fi­ca­cy due to sys­temic tox­i­c­i­ty of­ten caused by link­er in­sta­bil­i­ty or het­eroge­nous dis­tri­b­u­tions of the pay­load. The Araris tech­nol­o­gy ad­dress­es these lim­i­ta­tions and of­fers a nov­el and in­no­v­a­tive ap­proach to bring bet­ter ther­a­pies to pa­tients in need,” Do­minik Es­ch­er, a man­ag­ing part­ner at Pure­os Bioven­tures and new mem­ber of Araris’ board of di­rec­tors, said in a state­ment.

The most re­cent seed fund­ing was led by Pure­os, with a hand from 4BIO Cap­i­tal, btov Part­ners, Redalpine, VI Part­ners and Schroder Ad­veq.

“It’s a very young com­pa­ny and I think we are pro­gress­ing very well and can at­tract in­ter­est from large phar­ma­ceu­ti­cal com­pa­nies, and al­so from in­vestors,” Spy­cher said.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Who’s spend­ing and who’s cut­ting from Big Phar­ma’s $127B R&D bud­get? Here are the top 15 play­ers

A couple of the Big 15 biopharma companies in R&D hit the gas on research spending last year. Merck and Sanofi still have lots to prove in the pipeline, and they’re willing to gamble large sums to make a better future for themselves.

Doing nothing would be infinitely worse.

But collectively, the top players rang up a modest 2.4% increase in spending in 2022, which didn’t cover inflationary pressures. And that set the tone for an extraordinarily cautious year for the industry — even as it laid out about $127 billion to advance new drugs or up the ante on approved therapies.

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Jeff Bluestone (R), Sonoma Biotherapeutics CEO

Jef­frey Blue­stone brings his start­up haul to $400M+, join­ing forces with Re­gen­eron on cell ther­a­pies

These days, when Jeffrey Bluestone gets together with his contemporaries in science, the conversation often turns to retirement plans.

But a little more than three years ago, Bluestone reached a momentous turning point in his career, exiting a prestigious post at UCSF, where he had spent decades in the scientific pursuit of new therapies. And it had nothing to do with retirement anytime in the near future.

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Covant acting CEO Matt Maisak (L) and CSO Iván Cornella

With Boehringer In­gel­heim’s help, Roivant churns out an­oth­er Vant to go up against En­deav­or, Im­pact founders

Roivant Sciences has added another branch to its family tree, unveiling Covant Therapeutics with a $10 million upfront commitment from Boehringer Ingelheim to turn up the heat in cancer.

The Boston-based drug discovery startup will jointly create a new small molecule immunotherapy with the private German pharma giant. The deal, made public Tuesday morning, includes up to $471 million in future payments and tiered royalties, should the product make it to market.

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Richard Murray, Jounce Therapeutics CEO

Jounce nix­es Redx of­fer as I/O biotech in­stead goes with Con­cen­tra Bio­sciences’ takeover bid

A minority shareholder has won out in the Jounce Therapeutics takeover battle, with the once-ambitious immunotherapy biotech now choosing to be acquired by Kevin Tang’s Concentra Biosciences rather than follow through with an already-announced deal that would have brought the UK’s Redx onto Nasdaq.

Via its new merger partner, Jounce is expected to get $1.85 per share from Concentra, which was formed by Tang Capital Partners, the owner of about 10% of Jounce shares. Two weeks ago, Concentra laid out a $1.80 per share proposal plus more for the ability to swoop up 80% of proceeds from licenses of legacy programs out of Jounce’s pipeline.

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Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Van­da wins court case against FDA over dis­clo­sure of CRL de­tails for sleep drug

DC District Court Judge Christopher Cooper today granted Vanda Pharma’s request to require the FDA to disclose more info on the complete response letter for its sleep disorder drug Hetlioz.

The melatonin receptor agonist is approved by the FDA to treat non-24-hour sleep-wake disorder, a circadian rhythm disorder. But in 2018 Vanda filed a supplemental application to market Hetlioz as a treatment for jet lag, which the FDA rejected in August 2019, with few details on what Vanda needed to correct course, according to the company.

Sally Susman, Pfizer EVP and chief corporate affairs officer

Q&A: Pfiz­er cor­po­rate com­mu­ni­ca­tions chief Sal­ly Sus­man dis­cuss­es book craft­ed in pan­dem­ic and per­son­al lessons

From the political arena to the finance and beauty industries to pharmaceuticals, Pfizer’s Sally Susman has broken barriers, stereotypes and conventions. And now the chief communicator is “Breaking Through,” the title of her first book about effective and innovative communications launching today. The full official title is “Breaking Through: Communicating to Open Minds, Move Hearts, and Change the World.”

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Max Colao, OncoVerity CEO

Tiny mul­ti­omics biotech se­cures for­mer J&J drug, new ex­ecs and new fi­nanc­ing

A new spinout from Belgium’s argenx seeks to give new life to a candidate once in-licensed to J&J.

OncoVerity announced Monday afternoon that it had in-licensed cusatuzumab from argenx. The biotech also appointed two new C-suite executives and secured a $30 million Series A round.

CEO Max Colao joins OncoVerity after working as Aurinia’s commercial chief, and stints at Alexion and Amgen. New CMO Clay Smith has been associate chief of the University of Colorado’s hematology division.

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Kevin Lee, Bicycle Therapeutics CEO

No­var­tis rides with Bi­cy­cle for new pact on tar­get­ed ra­dio­ther­a­pies

Novartis has inked a three-year deal with Bicycle Therapeutics to develop new targeted radiotherapies for cancer.

Novartis will pay Bicycle $50 million upfront, with downstream milestones adding up to a potential $1.7 billion. In exchange, Bicycle will use its virus-based platform to discover new bicyclic peptides, which it calls bicycles, that would be used for radiotherapies. Those bicycles would act as a homing beacon for radioactive isotopes, delivering them to cancer cells to kill the cells while limiting radiation to healthy tissue.

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