Tyra co-founders Todd Harris (L) and Daniel Bensen

Why do some tar­get­ed can­cer ther­a­pies stop work­ing? For Tyra, that's the $106M ques­tion

Tar­get­ed can­cer ther­a­pies can be quite ef­fec­tive. Un­til, for some pa­tients, the can­cer mu­tates, and the treat­ment stops work­ing.

“It’s not un­like re­sis­tance in an­tibi­otics,” said Todd Har­ris, an MIT grad and for­mer NIH fel­low. “The can­cer is mu­tat­ing a lot. It’s un­der a lot of pres­sure.”

Of­ten­times, that mu­ta­tion can be as sim­ple as a sin­gle amino acid shift­ing, es­sen­tial­ly block­ing the bind­ing site of a drug. And when that hap­pens, Har­ris said, you need new chem­istry that binds to the pro­tein dif­fer­ent­ly, avoid­ing the mu­tat­ed site.

That’s what Har­ris launched Tyra Bio­sciences to do — and on Wednes­day, the two-year-old biotech un­veiled a $106 mil­lion Se­ries B round for its push to­ward the clin­ic.

“Our goal is to de­sign drugs that are re­al­ly ef­fec­tive against the pro­tein and are still ef­fec­tive when that mu­ta­tion oc­curs,” said Har­ris, the com­pa­ny’s co-founder and CEO.

To do so, Tyra — named af­ter Tyr, the Norse god of war — us­es its x-ray crys­tal­log­ra­phy plat­form dubbed SNAP. The tech­nique isn’t new, Har­ris said. It in­volves shoot­ing x-ray beams to dis­cov­er the three-di­men­sion­al struc­ture of a par­tic­u­lar pro­tein. What dif­fer­en­ti­ates Tyra, though, is an in-house team that col­lects the so-called SNAP­shots two to five times a week — giv­ing the team an atom-by-atom look at how a drug is bind­ing to a spe­cif­ic pro­tein.

“We can lit­er­al­ly look at the types of in­ter­ac­tions that are mak­ing one mol­e­cule work bet­ter than an­oth­er, and then con­tin­ue to op­ti­mize and re­fine the de­signs of new mol­e­cules to ex­ploit, you know, a find­ing or a sur­prise that we get when we look at how this is ex­act­ly bind­ing to the pro­tein,” Har­ris said.

Har­ris has yet to re­lease which tar­gets the team is go­ing af­ter, but said they plan on nom­i­nat­ing a can­di­date this year which they hope to en­ter in­to the clin­ic next year. He plans on us­ing the Se­ries B funds to ad­vance the lead pro­gram and “sev­er­al fol­low-on pro­grams.”

When Tyra reeled in a $50 mil­lion Se­ries A in Jan­u­ary 2020, the team com­prised four peo­ple. Now, the com­pa­ny has 15 full-time staffers. Up­on an­nounc­ing the Se­ries B, Har­ris al­so shared news of two new C-suite ap­point­ments and the pro­mo­tion of Robert Hud­kins to CTO.

Hi­roo­mi Ta­da, whose re­sume in­cludes roles at In­cyte, Glax­o­SmithK­line and As­traZeneca, is join­ing Tyra as CMO. And Piyush Pa­tel, who worked with Hud­kins for a num­ber of years at Cephalon, is com­ing aboard as chief of de­vel­op­ment.

“We’re hav­ing a lot of fun. It’s re­al­ly an ex­cep­tion­al team, and a re­al­ly im­por­tant prob­lem we’re seek­ing to solve,” Har­ris said.

The ar­ti­cle has been up­dat­ed to clar­i­fy that x-ray crys­tal­log­ra­phy in­volves x-ray beams.

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?

Voting in the 2020 election (AP Images)

The right to vote is fun­da­men­tal — a let­ter from biotech­nol­o­gy in­dus­try lead­ers

Biotech Voices is a collection of exclusive opinion editorials from some of the leading voices in biopharma on the biggest industry questions today. Think you have a voice that should be heard? Reach out to senior editors Kyle Blankenship and Amber Tong.

We oppose all attempts to introduce laws that reduce the rights of US citizens to vote or that restrict them from exercising that right. The right to vote is fundamental to democracy. States that have enacted, or are proposing to enact, legislation to restrict voting are undermining our democracy and posing a threat to our nation. As leaders of the life sciences industry, we stand for what we believe is right for our country, our enterprises, our employees and those who benefit from our work. We join the first groups of business leaders who have challenged these laws and will continue to make our collective voices heard on this matter.

Sajith Wickramasekara, Benchling via YouTube

Meet Bench­ling, the lat­est uni­corn seek­ing to rev­o­lu­tion­ize the way sci­en­tists do work with the help of the cloud

There’s another unicorn in biotech land, as Benchling and its leading R&D cloud platform pull in a $200 million Series E to help scientists accelerate drug development. In doing so, the company hit a lofty $4 billion valuation — nearly five times what it was worth around this time last year.

Despite the fact that drug development is becoming significantly more complex, the industry continues to run on paper, emails and spreadsheets, co-founder and CEO Sajith Wickramasekara said in a video on Benchling’s website. The MIT grad sought to change that by creating software that allows scientists to better track, model and forecast their work.

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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Covid-19 roundup: No­vavax shakes up lead­er­ship with two pro­mo­tions and de­par­ture of CFO; Mod­er­na, No­vavax shots added to mix-and-match study in the UK

Novavax has had a busy month, filled with supply chain issues and manufacturing deals that have affected the rollout of its Covid-19 vaccine. Tuesday, the company announced updates to its leadership team.

CFO Greg Covino will step down from that role after just five months for personal reasons, the release said, but take on a new role as executive advisor. John Trizzino, current chief commercial officer and chief business officer, will take the CFO role over in the interim.

Amy­lyx to move for­ward with ALS pro­gram in Eu­rope, but FDA wants an­oth­er look; Hu­ma­cyte adds $50M in debt fi­nanc­ing

Amylyx is one of several companies looking to break through in the tough ALS field, and Wednesday they announced they’re moving forward with regulatory plans.

The Cambridge, MA-based biotech said they’re submitting a marketing application to the EMA for their AMX0035 program by the end of 2021. Wednesday’s news comes a few weeks after they revealed similar plans to move forward with Canadian health regulators by June 30.

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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Barbara Weber, Tango Therapeutics CEO (Tango)

It takes two to Tan­go: The biotech us­ing CRISPR to dis­cov­er new can­cer gene tar­gets rides a $353M SPAC deal to Nas­daq

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

The latest biotech-SPAC deal has arrived, and it’s dancing its way to Nasdaq to the tune of several hundred million dollars.

Tango Therapeutics and its CRISPR-focused search for new cancer genes is reverse merging with Boxer Capital’s blank-check company, the biotech announced Wednesday morning. With a spotlight on three lead programs, Tango expects total proceeds to equal about $353 million in the deal, which includes the roughly $167 million held in the SPAC and an additional $186 million in PIPE financing.

Anand Shah (FDA)

For­mer head of FDA’s med­ical and sci­en­tif­ic af­fairs on Covid: ‘FDA has nev­er been test­ed like this’

Anand Shah has served the American public in a unique way, crisscrossing over the last two administrations between serving as an attending radiation oncologist focused on prostate cancer at NIH, serving as CMO at the Center for Medicare and Medicaid Innovation, and most recently, leading the FDA’s operations on medical and scientific affairs from within the commissioner’s office.

Shah, who stepped down from the FDA in January, caught up with Endpoints News in a phone interview on Tuesday afternoon, offering his thoughts on the agency’s latest decision to pause the J&J vaccinations in the US, and reflecting on his time at an agency during this once-in-a-lifetime pandemic.