Kevin Judice

DiCE gets its 'li­brary' card ready as it speeds de­vel­op­ment of DNA data­base-de­rived mol­e­cules with more in­vestor cash

In­vestors like to see big plans, and Kevin Ju­dice has plen­ty. The DiCE Mol­e­cules CEO is plot­ting a clin­i­cal tri­al launch for the biotech’s lead small mol­e­cule for pso­ri­a­sis and wants to dou­ble the staff in the next year and a half.

On Fri­day, those big plans land­ed him an $80 mil­lion Se­ries C round.

“We’re very ex­cit­ed about it,” he said of the raise led by RA Cap­i­tal Man­age­ment.

The round comes around two years af­ter a $50 mil­lion Se­ries B. While the B round was used for op­ti­miz­ing tech­nol­o­gy and build­ing a pipeline, Ju­dice says the Se­ries C will pro­pel the biotech’s IL-17 an­tag­o­nist to the clin­ic and fund the de­vel­op­ment of two oth­er undis­closed pro­grams.

“This new cap­i­tal al­lows us to ex­pand our reach and get at more tar­gets and have more op­por­tu­ni­ties to make high im­pact,” Ju­dice said.

DiCE’s de­vel­op­ment process re­volves around its DNA-en­cod­ed li­brary. Such li­braries al­low re­searchers to screen mil­lions — even bil­lions — of com­pounds in par­al­lel, us­ing DNA tags that Ju­dice com­pared to bar­codes, which tell you what the con­stituent pieces of a mol­e­cule are.

“Usu­al­ly you do some kind of screen, like a high-through­put screen, or a DNA-en­cod­ed li­brary screen, some­thing like that, and you get a few hits. And then there’s a long phase of just lab chem­istry, where you’re mak­ing in­di­vid­ual com­pounds and try­ing to progress those hits, those ini­tial binders, to some­thing that’s clos­er to a drug,” Ju­dice said.

That hit-to-lead phase is typ­i­cal­ly la­bor-in­ten­sive and slow, the CEO said. But DiCE’s ap­proach ac­cel­er­ates that work by us­ing a small­er DNA-en­cod­ed li­brary — much small­er but rich­er in in­for­ma­tion, Ju­dice said — to screen in dif­fer­ent ways af­ter get­ting a hit.

“What we’re ac­tu­al­ly look­ing for is the dif­fer­ence be­tween just bind­ing and some­thing that is func­tion­al,” Ju­dice said.

DiCE’s lead pro­gram is an ag­o­nist for cy­tokine re­cep­tor IL-17, which is im­pli­cat­ed in dis­eases like pso­ri­a­sis and pso­ri­at­ic arthri­tis. Cur­rent an­ti­body treat­ments tar­get­ing IL-17 are quite ef­fec­tive at treat­ing pso­ri­a­sis, but they are in­jectable and lack in con­ve­nience. DiCE’s can­di­date would be oral, and the biotech is hop­ing to top the ef­fi­ca­cy of Am­gen’s al­ready ap­proved oral PDE4 in­hibitor Ote­zla.

“What we’re work­ing on is an oral that will work as well as the an­ti-IL-17 an­ti­bod­ies. So it com­bines the con­ve­nience and safe­ty of some­thing like Ote­zla with the ef­fi­ca­cy of an an­ti­body like Cosen­tyx,” Ju­dice said. “The an­ti­bod­ies tell us that IL-17 is ex­act­ly the right tar­get.”

Since 2017, DiCE has grown from a sev­en-per­son, “peanut-sized” com­pa­ny to a 29-per­son staff. And in the next 18 months, Ju­dice is look­ing to bring that num­ber to 58. The biotech inked a $2.3 bil­lion dis­cov­ery pact with Sanofi years ago, and is cur­rent­ly part­ner­ing with them on an I/O small mol­e­cule pro­gram that Ju­dice says isn’t far be­hind the IL-17 can­di­date.

“We should be ready to go pub­lic with more da­ta on ear­li­er pro­grams over the course of the next 12 months. And then I’m re­al­ly ex­cit­ed about the op­por­tu­ni­ty to grow the pipeline by adding new pro­grams to it,” he said. “That’s one of the things that is par­tic­u­lar­ly great, from my per­spec­tive, about hav­ing RA Cap­i­tal lead this round.”

In ad­di­tion to RA, Even­tide As­set Man­age­ment, New Leaf Ven­ture Part­ners, Soleus Cap­i­tal, Driehaus Cap­i­tal Man­age­ment, Os­age Uni­ver­si­ty Part­ners and Asym­me­try Cap­i­tal Man­age­ment, North­pond Ven­tures, Sands Cap­i­tal, Sanofi Ven­tures, Alexan­dria Ven­ture In­vest­ments, Al­ti­tude Ven­tures and Agent Cap­i­tal al­so chipped in­to the Se­ries C.

BY­OD Best Prac­tices: How Mo­bile De­vice Strat­e­gy Leads to More Pa­tient-Cen­tric Clin­i­cal Tri­als

Some of the most time- and cost-consuming components of clinical research center on gathering, analyzing, and reporting data. To improve efficiency, many clinical trial sponsors have shifted to electronic clinical outcome assessments (eCOA), including electronic patient-reported outcome (ePRO) tools.

In most cases, patients enter data using apps installed on provisioned devices. At a time when 81% of Americans own a smartphone, why not use the device they rely on every day?

Image: Shutterstock

Eli Lil­ly asks FDA to re­voke EUA for Covid-19 treat­ment

Eli Lilly on Friday requested that the FDA revoke the emergency authorization for its Covid-19 drug bamlanivimab, which is no longer as effective as a combo therapy because of a rise in coronavirus variants across the US.

“With the growing prevalence of variants in the U.S. that bamlanivimab alone may not fully neutralize, and with sufficient supply of etesevimab, we believe now is the right time to complete our planned transition and focus on the administration of these two neutralizing antibodies together,” Daniel Skovronsky, Lilly’s CSO, said in a statement.

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Osman Kibar (Samumed, now Biosplice)

Os­man Kibar lays down his hand at Sa­mumed, step­ping away from CEO role as his once-her­ald­ed an­ti-ag­ing biotech re­brands

Samumed made quite the entrance back in 2016, when it launched with some anti-aging programs and a whopping $12 billion valuation. That level of fanfare was nowhere to be found on Thursday, when the company added another $120 million to its coffers and quietly changed its name to Biosplice Therapeutics.

Why the sudden rebrand?

“We did that for obvious reasons,” CFO and CBO Erich Horsley told Endpoints News. “The name Biosplice echoes our science much more than Samumed does.”

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J&J faces CDC ad­vi­so­ry com­mit­tee again next week to weigh Covid-19 vac­cine risks

The CDC’s Advisory Committee on Immunization Practices punted earlier this week on deciding whether or not to recommend lifting a pause on the administration of J&J’s Covid-19 vaccine, but the committee will meet again in an emergency session next Friday to discuss the safety issues further.

The timing of the meeting likely means that the J&J vaccine will not return to the US market before the end of next week as the FDA looks to work hand-in-hand with the CDC to ensure the benefits of the vaccine still outweigh the risks for all age groups.

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Ex­clu­sive in­ter­view: Pe­ter Marks on why full Covid-19 vac­cine ap­provals could be just months away

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, took time out of his busy schedule last Friday to discuss with Endpoints News all things related to his work regulating vaccines and the pandemic.

Marks, who quietly coined the name “Operation Warp Speed” before deciding to stick with his work regulating vaccines at the FDA rather than join the Trump-era program, has been the face of vaccine regulation for the FDA throughout the pandemic, and is usually spotted in Zoom meetings seated in front of his wife’s paintings.

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Near­ly a year af­ter Au­den­tes' gene ther­a­py deaths, the tri­al con­tin­ues. What hap­pened re­mains a mys­tery

Natalie Holles was five months into her tenure as Audentes CEO and working to smooth out a $3 billion merger when the world crashed in.

Holles and her team received word on the morning of May 5 that, hours before, a patient died in a trial for their lead gene therapy. They went into triage mode, alerting the FDA, calling trial investigators to begin to understand what happened, and, the next day, writing a letter to alert the patient community so they would be the first to know. “We wanted to be as forthright and transparent as possible,” Holles told me late last month.

The brief letter noted two other patients also suffered severe reactions after receiving a high dose of the therapy and were undergoing treatment. One died a month and a half later, at which point news of the deaths became public, jolting an emergent gene therapy field and raising questions about the safety of the high doses Audentes and others were now using. The third patient died in August.

“It was deeply saddening,” Holles said. “But I was — we were — resolute and determined to understand what happened and learn from it and get back on track.”

Eleven months have now passed since the first death and the therapy, a potential cure for a rare and fatal muscle-wasting disease called X-linked myotubular myopathy, is back on track, the FDA having cleared the company to resume dosing at a lower level. Audentes itself is no more; last month, Japanese pharma giant Astellas announced it had completed working out the kinks of the $3 billion merger and had restructured and rebranded the subsidiary as Astellas Gene Therapies. Holles, having successfully steered both efforts, departed.

Still, questions about precisely what led to the deaths of the 3 boys still linger. Trial investigators released key details about the case last August and December, pointing to a biological landmine that Audentes could not have seen coming — a moment of profound medical misfortune. In an emerging field that’s promised cures for devastating diseases but also seen its share of safety setbacks, the cases provided a cautionary tale.

Audentes “contributed in a positive way by giving a painful but important example for others to look at and learn from,” Terry Flotte, dean of the UMass School of Medicine and editor of the journal Human Gene Therapy, told me. “I can’t see anything they did wrong.”

Yet some researchers say they’re still waiting on Astellas to release more data. The company has yet to publish a full paper detailing what happened, nor have they indicated that they will. In the meantime, it remains unclear what triggered the events and how to prevent them in the future.

“Since Audentes was the first one and we don’t have additional information, we’re kind of in a holding pattern, flying around, waiting to figure out how to land our vehicles,” said Jude Samulski, professor of pharmacology at UNC’s Gene Therapy Center and CSO of the gene therapy biotech AskBio, now a subsidiary of Bayer.

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Pascal Soriot (AstraZeneca via YouTube)

Af­ter be­ing goad­ed to sell the com­pa­ny, Alex­ion's CEO set some am­bi­tious new goals for in­vestors. Then Pas­cal So­ri­ot came call­ing

Back in the spring of 2020, Alexion $ALXN CEO Ludwig Hantson was under considerable pressure to perform and had been for months. Elliott Advisers had been applying some high public heat on the biotech’s numbers. And in reaching out to some major stockholders, one thread of advice came through loud and clear: Sell the company or do something dramatic to change the narrative.

In the words of the rather dry SEC filing that offers a detailed backgrounder on the buyout deal, Alexion stated: ‘During the summer and fall of 2020, Alexion also continued to engage with its stockholders, and in these interactions, several stockholders encouraged the company to explore strategic alternatives.’

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Alex Leech, Alchemab CEO (SV Health Investors)

Alchemab bags fresh round of in­vestor for tar­get-ag­nos­tic an­ti­body de­vel­op­ment for Hunt­ing­ton's, Covid-19

With a “target-agnostic” approach to antibody development, the UK’s Alchemab has used lessons learned from patients with resistance to certain diseases to chase after conditions as far apart as Huntington’s and Covid-19. Now, investors are jumping on board the concept with an $86 million Series A.

The proceeds will go toward advancing the company’s target-agnostic drug discovery program, a release said. That approach looks at the antibody repertoires of patients who show resistance to typically destructive diseases regardless of genetic disposition.

Craig Parker, Surrozen CEO

The world of Wnt heads to Nas­daq as Sur­rozen an­nounces a $212M SPAC deal

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Another day, another SPAC merger in the world of biotech.

Less than 24 hours after Tango Therapeutics announced its own leap to Nasdaq through the blank check route, Surrozen has decided to take a similar step. The Wnt pathway-focused biotech is reverse-merging with Consonance Capital Management’s SPAC in a $212 million deal, which includes $92 million from the shell company and $120 million in PIPE financing.