Tom Lynch (Rob Tannenbaum, Endpoints News)

Tom Lynch moves to re­struc­ture Fred Hutch as acad­e­mia, in­dus­try con­tin­ue to push cell ther­a­py in­to sol­id tu­mors

By the time for­mer Bris­tol My­ers Squibb CSO Tom Lynch stepped in to run the Fred Hutch Can­cer Re­search Cen­ter last year, both the po­ten­tial and lim­its of the in­sti­tute’s pre­clin­i­cal re­search had be­come clear.

The in­sti­tute’s re­searchers, in­clud­ing famed vi­rol­o­gist Lar­ry Corey, had helped make CAR-T ther­a­pies a re­al­i­ty, con­tribut­ing ba­sic sci­ence and co-found­ing Juno Ther­a­peu­tics, the cell ther­a­py start­up Cel­gene bought out for $9 bil­lion. But while cell ther­a­pies have now proven an ef­fec­tive — even some­times cu­ra­tive — ther­a­py across mul­ti­ple blood can­cers, the ap­proach has been frus­trat­ing­ly dif­fi­cult to ap­ply to sol­id tu­mors.

Lynch is try­ing to change that. In one of his first ma­jor moves as di­rec­tor — he spent most of his first months deal­ing with the pan­dem­ic — the long­time can­cer re­searcher an­nounced plans to re­struc­ture Fred Hutch’s re­la­tion­ship with two oth­er ma­jor Seat­tle in­sti­tu­tions, Seat­tle Chil­dren’s and UW Med­i­cine, and form the Fred Hutch Can­cer Cen­ter.

The move is de­signed to ac­cel­er­ate clin­i­cal re­search. It will do so, in part, by more di­rect­ly con­nect­ing pa­tients with the new work Hutch’s trans­la­tion­al re­searchers have done on sol­id tu­mors while ex­pand­ing re­searchers’ abil­i­ties to progress in the field. Pre­vi­ous­ly, Lynch said, while many blood can­cer pa­tients were re­ferred to Fred Hutch, most pa­tients with sol­id tu­mors had been treat­ed at UW.

Now, they will be un­der one roof, where pa­tients might get bet­ter ac­cess to new dis­cov­er­ies.

“We have that [depth] cov­ered in vi­rol­o­gy, we have that cov­ered in cell ther­a­pies,” Lynch told End­points News. “We don’t have that same depth in sol­id tu­mors.”

The ex­pan­sion from one of the na­tion’s top can­cer in­sti­tutes is no­table, re­flect­ing the broad­er di­rec­tion in­dus­try and acad­e­mia have tak­en over the last cou­ple years. There are nu­mer­ous hur­dles to get­ting cell ther­a­pies for sol­id tu­mors. Most no­tably, it can be dif­fi­cult to get T cells to pen­e­trate the im­mune-sup­press­ing de­fens­es many sol­id tu­mors sur­round them­selves with. It’s al­so hard to find tar­gets on sol­id tu­mors that won’t al­so send the T cells af­ter healthy tis­sues.

And that’s just the known risks. Ear­li­er this year, one of the most watched sol­id tu­mor cell ther­a­py star­tups, Tmu­ni­ty Ther­a­peu­tics, scrapped their lead prostate can­cer pro­gram af­ter two pa­tients died from un­ex­pect­ed neu­ro­tox­i­c­i­ty.

Yet the pro­found ben­e­fits blood can­cer pa­tients have seen from cell ther­a­pies have sent re­searchers search­ing for cre­ative so­lu­tions, and ven­ture cap­i­tal­ists and phar­ma com­pa­nies have poured bil­lions of dol­lars in­to new ef­forts.

Lynch said the new struc­ture, which would re­place a pri­or col­lab­o­ra­tion called the Seat­tle Can­cer Care Al­liance, would “in­crease the scope” of what re­searchers such as Hans-Pe­ter Kiem, a promi­nent gene ther­a­py re­searcher, could study. In­di­vid­ual dis­cov­er­ies could be trans­lat­ed as well. He cit­ed a re­cent study from com­pu­ta­tion­al bi­ol­o­gist Robert Bradley show­ing that RNA ther­a­pies could help T cells — and thus cell ther­a­pies — en­ter sol­id tu­mors.

“Not in the next six months — the way we did with Covid vac­cines — but over the next five to 10 years, I think you’re go­ing to see a sig­nif­i­cant ac­cel­er­a­tion in can­cer sci­ence in pa­tients with sol­id tu­mors,” Lynch said.

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Ivan Cheung, Eisai US chairman and CEO

Bio­gen, Ei­sai re­fresh amy­loid hy­poth­e­sis with PhI­II show­ing Alzheimer's med slows cog­ni­tive de­cline

In the first look at Phase III data for lecanemab, Eisai and Biogen’s follow-up Alzheimer’s drug to the embattled Aduhelm launch, results show the drug passed with flying colors on a test looking at memory, problem solving and other dementia metrics.

One of the most-watched Alzheimer’s therapies in the clinic, lecanemab met the study’s primary goal on the CDR-SB — Clinical Dementia Rating-Sum of Boxes — giving the biotech the confidence to ask for full approval in the US, EU and Japan by next March 31. The experimental drug reduced clinical decline on the scale by 27% compared to placebo at 18 months, the companies said Tuesday night Eastern time and Wednesday morning in Japan.

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Joshua Cohen (L) and Justin Klee, Amylyx co-CEOs

BREAK­ING: Af­ter long and wind­ing road, FDA ap­proves Amy­lyx's ALS drug in vic­to­ry for pa­tients and ad­vo­ca­cy groups

For just the third time in its 116-year history, the FDA has approved a new treatment for Lou Gehrig’s disease, or ALS.

US regulators gave the thumbs-up to the drug, known as Relyvrio, in a massive win for patients and their families. The approval, given to Boston-area biotech Amylyx Pharmaceuticals, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists, following the readout of a mid-stage clinical trial in September 2020.

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Vlad Coric, Biohaven CEO (Photo Credit: Andrew Venditti)

As Amy­lyx de­ci­sion waits in the wings, Bio­haven’s ALS drug sinks (again) in plat­form tri­al

The FDA’s decision on Amylyx’s ALS drug is set to come out sometime Thursday. In a space with few drugs, any approval would be a major landmark.

But elsewhere in the ALS field, things are a bit more tepid.

Thursday morning, Biohaven announced that its drug verdiperstat failed its arm of an ALS platform trial led by Massachusetts General Hospital. According to a press release, the drug did not meet its primary endpoint — improvement on an ALS functional status test — or any key secondary endpoints at 24 weeks. The trial had enrolled 167 patients, giving them either verdiperstat or placebo twice a day.

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Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

Some­one old, some­one new: Mod­er­na pro­motes CTO, raids No­var­tis for re­place­ment amid pipeline push

Moderna CEO Stéphane Bancel made clear on the last quarterly call that “now is not the time to slow down.” On Thursday, he made a bit more room in the cockpit.

The company unveiled a new executive role on Thursday, promoting former chief technical operations and quality officer Juan Andres to president of strategic partnerships and enterprise expansion, and poaching a former Novartis exec to take his place.

Paul Hudson, Sanofi CEO (Photographer: Cyril Marcilhacy/Bloomberg via Getty Images)

Sanofi, Re­gen­eron’s Dupix­ent scores an­oth­er in­di­ca­tion with first-ever ap­proval for nodu­lar skin dis­or­der

Sanofi chief executive Paul Hudson told investors earlier this year that the Big Pharma was going to emphasize its sales kingpin Dupixent moving forward.

He wasn’t joking — the megablockbuster drug and sales king, recording just shy of $2 billion in sales this past quarter, has now officially secured its fifth indication from the FDA.

Sanofi and Regeneron, who jointly work on Dupixent development and commercialization, announced the new development on Thursday, saying that the FDA gave the all-clear to Dupixent to treat patients with prurigo nodularis, a rare autoimmune disorder characterized by a persistent, severe itch — and also visualized by hard, extremely itchy bumps known as nodules that form on the skin. The FDA noted in its announcement that it is the agency’s first approval for the disease.

Gilead names 'k­ing­pin­s' in coun­ter­feit HIV med law­suit

Gilead is mounting its counterfeit drug lawsuit, naming two “kingpins” and a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies.

The pharma giant on Wednesday provided an update on what it called a “large-scale, sophisticated counterfeiting conspiracy,” accusing two new defendants of “leading and orchestrating” a scheme to sell hundreds of millions of dollars in illegitimate drugs posing as meds such as Biktarvy and Descovy.

Tar­sus looks to raise aware­ness of eye­lid mite dis­ease in cam­paign aimed at eye­care spe­cial­ists

Eyelid mite disease may be “gross” but it’s also fairly common, affecting about 25 million people in the US.

Called demodex blepharitis, it’s a well-known condition among eyecare professionals, but they often don’t always realize how common it is. Tarsus Pharmaceuticals wants to change that with a new awareness campaign called “Look at the Lids.”

The campaign and website debut Thursday — just three weeks after Tarsus filed for FDA approval for a drug that treats the disease.

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