TCR² plants its flag in for­mer Au­to­lus man­u­fac­tur­ing site, plan­ning to add 175 jobs as it ad­vances lead T cell ther­a­py

Just months af­ter Lon­don-based Au­to­lus Ther­a­peu­tics an­nounced it would let go of 20% of its staffers as it looked for a part­ner for a lead CAR-T pro­gram, the com­pa­ny re­vealed it’s aban­don­ing its Rockville, MD man­u­fac­tur­ing op­er­a­tions.

Au­to­lus’ loss is TCR²’s gain.

The Cam­bridge, MA-based biotech spe­cial­iz­ing in T cell ther­a­pies for on­col­o­gy an­nounced Mon­day it will lease Au­to­lus’ 85,000-square-foot build­ing in an­tic­i­pa­tion of clin­i­cal and com­mer­cial pro­duc­tion of ga­vo-cel. The fa­cil­i­ty is set to go on­line in 2023, TCR² said.

Ian So­maiya

“Every cell ther­a­py com­pa­ny needs to con­trol their man­u­fac­tur­ing des­tiny,” CFO Ian So­maiya told End­points News. “If you con­tin­ue to re­ly on CD­MOs, that lack of con­trol has seen ob­vi­ous, se­ri­ous set­backs.”

TCR² made waves in Ju­ly when it an­nounced that none of the five pa­tients in its Phase I/II tri­als for its lead T cell ther­a­py ex­pe­ri­enced neu­ro­tox­i­c­i­ty or on-tar­get, off-tu­mor tox­i­c­i­ties — the tri­al’s pri­ma­ry end­point. Though the sam­ple size is small, re­searchers were en­cour­aged by the re­sults. One pa­tient with ovar­i­an can­cer had pre­vi­ous­ly tried and failed six oth­er lines of ther­a­py “in a con­sis­tent man­ner,” So­maiya said.

In Rockville, TCR² in­her­its a ready-to-go cGMP fa­cil­i­ty it says will al­low it to bump up pro­duc­tion by an en­tire year.

“Time­line is one thing, but the con­trol of your man­u­fac­tur­ing process … The more you con­trol the process, the less you re­ly on a third par­ty, the bet­ter it is, the bet­ter it’s crank­ing out prod­uct for pa­tients in the fu­ture,” CSO Robert Hofmeis­ter said.

Robert Hofmeis­ter

To aid in the tran­si­tion, the biotech al­so in­her­its Au­to­lus’ Aaron Ver­non to head tech­ni­cal op­er­a­tions. Ver­non spent three years with Au­to­lus in Rockville, first over­see­ing the en­gi­neer­ing and sup­ply chain, then the glob­al tech­ni­cal op­er­a­tions, both as a vice pres­i­dent. Be­fore that, he had stops at Su­cam­po, As­traZeneca, Med­Im­mune and J&J.

“It’s in­valu­able to have some­one like Aaron with that pedi­gree,” Hofmeis­ter said. “Some­one with his back­ground and knowl­edge, it gives us a jump start, gain­ing ap­prox­i­mate­ly a year.”

When So­maiya joined the team about three years ago, he brought 20 years of ex­pe­ri­ence, large­ly in re­search, with him. Goal No.1 was tak­ing the com­pa­ny pub­lic. TCR² pock­et­ed $67 mil­lion from its IPO in 2019. TCR² “cast a wide net” when look­ing for a po­ten­tial man­u­fac­tur­ing home. It want­ed to be on the East Coast to en­sure close prox­im­i­ty to the Cam­bridge head­quar­ters, and it checked out Boston and Philadel­phia be­fore the deal in Rockville came to fruition.

The fa­cil­i­ty will add 175 jobs to the coun­ty to sup­port the pro­duc­tion of ga­vo-cel, with a ca­pac­i­ty to treat sev­er­al thou­sand can­cer pa­tients an­nu­al­ly, ac­cord­ing to a state­ment from the Mont­gomery Coun­ty Eco­nom­ic De­vel­op­ment Cor­po­ra­tion. The Mary­land De­part­ment of Com­merce ap­proved an $875,000 con­di­tion­al loan con­tin­gent on job cre­ation and cap­i­tal in­vest­ment, and Mont­gomery Coun­ty ap­proved a $100,000 eco­nom­ic de­vel­op­ment fund con­di­tion­al grant con­tin­gent on the same.

“We are very pleased to wel­come TCR² Ther­a­peu­tics and all of the new life sci­ences jobs the com­pa­ny will bring to our state,” Gov­er­nor Lar­ry Hogan said in a state­ment. “The com­pa­ny’s ef­fort in pi­o­neer­ing the T-cell re­cep­tor com­plex has the po­ten­tial to im­pact many can­cer pa­tients around the world and we are ex­cit­ed that they have cho­sen to do that im­por­tant work right here in Mary­land.”

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.

Launched by MIT grads, a small start­up gets $20M to back a ro­bot­ics rev­o­lu­tion in cell ther­a­py man­u­fac­tur­ing

As co-director of an experimental cellular therapy process development and manufacturing group at UCSF specializing in T cell therapies for autoimmune conditions, Jonathan Esensten has learned a lot about the challenges involved when his group hand-fashions a cell therapy. Esensten — who was a postdoc in Wendell Lim’s lab and counts the legendary Jeffrey Bluestone as a mentor — gives them all high marks at being great at what they do, but time and again there are variations in the treatments they construct.

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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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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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.

Stéphane Bancel, Moderna CEO (Jeff Rumans)

'Learned a lot last year': Af­ter Covid-19 suc­cess, Mod­er­na's Stéphane Ban­cel plans to give rest of pipeline a big push

A year ago, Stéphane Bancel would have described Moderna as cautious — walking step-by-step to investigate whether mRNA vaccines could prevent a host of viruses. Then the pandemic hit, and the Cambridge, MA-based biotech got a multibillion-dollar windfall to produce the world’s second-ever authorized mRNA vaccine in a matter of months.

What’s next? Bancel is planning a big acceleration and expansion of the rest of the pipeline, including the company’s Phase III-ready candidate for cytomegalovirus (CMV), which was the lead program before Covid-19 came around.

UP­DAT­ED: J&J paus­es vac­cine roll­out as feds probe rare cas­es of blood clots

The FDA and CDC have jointly decided to stop administering J&J’s Covid-19 vaccine after reviewing data involving six reported US cases of a rare and severe type of blood clot in individuals after receiving the vaccine.

CDC will convene a meeting of its Advisory Committee on Immunization Practices on Wednesday to further review these cases and assess their potential significance. “FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research and Anne Schuchat, Principal Deputy Director of the CDC, said in a joint statement Tuesday morning.

Patrizia Cavazzoni, new CDER director

Pa­trizia Cavaz­zoni named per­ma­nent di­rec­tor of CDER, adding to ques­tions around where Wood­cock will end up

Patrizia Cavazzoni on Monday became the permanent director of the FDA’s Center for Drug Evaluation and Research, which puts to rest the idea that Janet Woodcock, Cavazzoni’s predecessor, might return to lead CDER if she isn’t made permanent commissioner.

Woodcock, who’s currently serving as acting commissioner and principal medical advisor to the commissioner, a position she was detailed to last year, may not make the move to permanent commissioner because of lingering questions from Senate Democrats. She previously served as director of CDER since 1994. Cavazzoni took over as acting director of CDER when Woodcock moved over to Operation Warp Speed to run the therapeutics side of the Trump-era program.

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