Bris­tol-My­ers takes a stake in Taris Bio­med­ical; Zai Lab, Five Prime strike a deal to de­vel­op tu­mor im­munother­a­py in Chi­na

Bris­tol-My­ers Squibb has tak­en a stake in Taris Bio­med­ical as part of their new col­lab­o­ra­tion on a Phase Ib study of a com­bo ap­proach for mus­cle in­va­sive blad­der can­cer for pa­tients who are sched­uled for rad­i­cal cys­tec­to­my. They’ll be com­bin­ing Op­di­vo with TAR-200, which con­trols re­lease of a ther­a­py in the blad­der.

Five Prime {FPRX} and Zai Lab have struck a $44 mil­lion deal to bring FPA144, the South San Fran­cis­co biotech’s tar­get­ed im­munother­a­py for tu­mors, to gas­tric and gas­tro-esophageal junc­tion can­cer pa­tients in Chi­na. Shang­hai-based Zai Lab $ZLAB paid $5 mil­lion up­front for de­vel­op­ment and com­mer­cial­iza­tion rights, and promised $39 in mile­stones. The part­ners plan to jump in­to Phase III (in com­bi­na­tion with chemother­a­py) in the sec­ond half of 2018, with Zai Lab re­spon­si­ble for the Greater Chi­na por­tion of the glob­al study. “Chi­na ac­counts for more than 40% of new gas­tric can­cer cas­es glob­al­ly, so it is crit­i­cal to align strate­gi­cal­ly with a strong col­lab­o­ra­tor with the in­fra­struc­ture, re­la­tion­ships and re­sources to help us ad­vance FPA144 glob­al de­vel­op­ment ex­pe­di­tious­ly,” said Aron Knicker­bock­er, cur­rent COO and in­com­ing CEO, in a state­ment. Per the li­cens­ing agree­ment, both sides are al­so el­i­gi­ble to re­ceive roy­al­ties on sales on each oth­er’s turfs, with Five Prime com­mand­ing a high­er per­cent­age.

→ Keep­ing with ear­li­er promis­es, Loxo On­col­o­gy $LOXO has be­gun sub­mit­ting a rolling NDA for its lead drug larotrec­tinib for un­re­sectable or metasta­t­ic sol­id tu­mors. In­stead of fo­cus­ing on the anato­my, larotrec­tinib goes af­ter a fam­i­ly of sig­nal­ing pro­teins called tropomyosin re­cep­tor ki­nas­es (TRK). That ap­proach has earned the in­hibitor des­ig­na­tions for break­through ther­a­py, rare pe­di­atric dis­ease and or­phan drug from the FDA. The com­pa­ny plans to wrap things up in ear­ly 2018. Bay­er will be watch­ing (and like­ly help­ing with) this process close­ly, as it is in­vest­ing at least $400 mil­lion for this drug and is bank­ing on its reg­u­la­to­ry suc­cess both in the US and over­seas.

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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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.

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.

Aim­ing for fourth nod, Sarep­ta files an­oth­er DMD gene ther­a­py to FDA; Ax­some head­ed to­ward mi­graine re­sub­mis­sion

Sarepta Therapeutics has filed the data needed for an FDA accelerated approval, which would be the biotech’s fourth if granted by the agency.

The biotech has yet to complete confirmatory trials for those first three conditional nods. The filing for its fourth Duchenne muscular dystrophy treatment, disclosed Thursday, is not a surprise. Sarepta said in late-July it would do so after releasing positive results for the Roche-partnered gene therapy.

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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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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