Juno inks deals with Eli Lil­ly, the Hutch as it looks to leapfrog lead­ers on BC­MA

Juno Ther­a­peu­tics $JUNO is adding a new ap­proach to its BC­MA strat­e­gy for mul­ti­ple myelo­ma af­ter forg­ing an in-li­cens­ing deal through a trio of al­liances that in­cludes Eli Lil­ly.

Lil­ly is hand­ing over rights on LY3039478 to Juno so it can use their gam­ma sec­re­tase in­hibitor in the biotech’s dri­ve to leapfrog the lead­ers in BC­MA — an ac­tive field that has at­tract­ed the at­ten­tion of blue­bird/Cel­gene $BLUE and oth­ers.

The drug, which in­hibits Notch sig­nal­ing, has al­ready been stud­ied in hun­dreds of pa­tients. The big idea here is that the drug can amp up lev­els of BC­MA on the sur­face of mul­ti­ple myelo­ma cells, leav­ing them as a bet­ter tar­get for its BC­MA-tar­get­ing CAR-Ts.

Sunil Agar­w­al

There are no half mea­sures in CAR-T, so Juno is al­so ex­e­cut­ing deals with On­co­Track­er and Fred Hutchin­son Can­cer Re­search Cen­ter to nail down ad­di­tion­al IP re­lat­ed to the com­bo ap­proach.

Juno is in the process of mount­ing a ma­jor come­back bid in the CAR-T field, af­ter No­var­tis $NVS and Gilead/Kite $GILD cruised past the wreck­ing of JCAR015, which had to be shelved af­ter it killed a group of pa­tients in a piv­otal study. In ad­di­tion to blue­bird, the like­ly leader on BC­MA with their break­through drug bb2121, Chi­na’s Nan­jing Leg­end Biotech made quite a splash at the last AS­CO with ri­val da­ta.

Look­ing past the CD19 bio­mark­er, BC­MA of­fers one of the most promis­ing tar­gets in CAR-T.

Look for this in a clin­i­cal tri­al, com­ing soon.

“BC­MA ap­pears to be an im­por­tant tar­get for treat­ing pa­tients with mul­ti­ple myelo­ma and Juno is ded­i­cat­ed to in­ves­ti­gat­ing nov­el ap­proach­es to max­i­mize ef­fi­ca­cy for these pa­tients. These li­cens­es open up an im­por­tant ap­proach to im­prove the ac­tiv­i­ty and out­comes for CAR T cells tar­get­ed at BC­MA,” said Sunil Agar­w­al, Juno’s pres­i­dent of re­search and de­vel­op­ment. “We plan to be­gin clin­i­cal tri­als in 2018 com­bin­ing a gam­ma sec­re­tase in­hibitor with our BC­MA CAR T prod­uct can­di­dates.”

 

 

Andre Kalil, AP Images

A 9/11-era Om­a­ha fa­cil­i­ty, an old Ebo­la drug, and the ubiq­ui­tous Dr. Fau­ci: In­side the first US nov­el coro­n­avirus tri­al

The first 11 coronavirus patients who arrived in Omaha last week, airlifted across the globe after two weeks quarantined on a cruise ship, showed only minor symptoms or none at all. And then one of them — or one of the couple of Americans who arrived later — got worse. He developed pneumonia, a life-threatening complication for coronavirus patients.

In a biocontainment room at the University of Nebraska Medical Center on Friday, doctors infused him with an experimental Gilead drug once developed for Ebola, called remdesivir. Or they gave him a placebo. For the first time in the US, neither he nor the doctors knew.

The first US novel coronavirus trial was underway and with it, a mad dash for an answer. Sponsored by the NIH, the study marked a critical point in the epidemic. Since the start of the outbreak, the agency had helped lead a global effort to contain the virus. Now, as it spread worldwide and the CDC issued warnings the US could see a major internal outbreak, they were looking at home.

“We don’t have too much time,” Andre Kalil, the trial’s lead investigator, told Endpoints News. “Everything’s moving really fast.”

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Grow­ing ac­cep­tance of ac­cel­er­at­ed path­ways for nov­el treat­ments: but does reg­u­la­to­ry ap­proval lead to com­mer­cial suc­cess?

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

Take­da swoops in to buy lit­tle biotech part­ner and its celi­ac drug poised to 'change stan­dard of care'

Having spent three years carefully grooming PvP Biologics and its drug for celiac disease, Takeda is happy enough with the proof-of-concept data to buy it all.

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Dan O'Day (AP Images)

A name emerges out of the Gilead M&A ru­mor mill, and it’s a can­cer biotech

After months of questions and speculation about when and if Gilead will make a major acquisitions, a name has emerged.

The California-based drugmaker has approached Forty Seven Inc, a cancer biotech, with a takeover offer, Bloomberg News reports. With Forty Seven’s market cap at $2.3 billion, an acquisition would likely be Gilead’s largest since they acquired Kite Pharma for $11.9 billion in 2017.

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Biogen head of R&D Al Sandrock, Sangamo CEO Sandy Macrae

UP­DAT­ED: Bio­gen makes an­oth­er bold Alzheimer’s bet, drop­ping $350M up­front to part­ner with genome-edit­ing fo­cused Sang­amo

While the fate of Biogen’s resurrected Alzheimer’s drug aducanumab remains uncertain, the Cambridge, MA-based drugmaker is joining forces with genome editing company Sangamo Therapeutics to develop therapies for neurological conditions.

Sangamo is set to receive a meaty $350 million upfront in cash and stock and is eligible to receive up to $2.37 billion in milestone payments, in addition to royalties. In return, Biogen gets the rights to two Sangamo preclinical compounds: ST-501 (for use in tauopathies including Alzheimer’s disease) and ST-502 (for synucleinopathies including Parkinson’s disease).

“The partnership represents a lower-cost way to expand its work in neurologic disease,” Credit Suisse’s Evan Seigerman said in a note, referring to Biogen.

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Spark los­es an­oth­er top ex­ec in the wake of $4.3B takeover by Roche — re­port

Days after bidding farewell to co-founder Kathy High, Spark Therapeutics — now operating under Roche — has one more opening on its C-suite.

Kathy Reape

Kathy Reape, who joined the Philadelphia-based biotech in 2016 as head of clinical R&D and became chief medical officer in 2018, is reportedly set to leave.

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'The head­lines are the head­lines, but': Bio­Marin talks up po­ten­tial sav­ings as he­mo­phil­ia gene ther­a­py launch looms

BioMarin execs are still staying tight-lipped about their pricing plans for what is poised to be the world’s first hemophilia gene therapy. But as the company enters the final regulatory stretch and approaches a potential launch this summer, they are also dropping more hints to get investors ready.

First thing to know: They really, really don’t expect an advisory committee to be convened for valrox, which is under priority review, to pop up before its PDUFA date on August 21.

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Vlad Coric (Photo Credit: Andrew Venditti)

Bio­haven scores CGRP OK for acute mi­graine — can the com­mer­cial team catch up with Al­ler­gan on its de­but?

Seven years after spinning out of Yale, Biohaven has entered the ranks of commercial-stage biotechs.

The FDA handed down an OK for its CGRP drug, rimegepant, as an acute treatment. Dubbed Nurtec, the orally dissolving pill will join Allergan’s (soon to be AbbVie’s) Ubrelvy and Lilly’s Reyvow on the market amid a new wave of migraine therapies reshaping the disease space.

In a pivotal Phase III trial, Nurtec hit the co-primary endpoints on pain freedom and freedom from most bothersome symptoms at two hours post dose, proving superior to placebo.

Mi­cro­bio­me Q&A: New study maps the vagi­na's 'op­ti­mal mi­cro­bio­ta' — and its im­pli­ca­tions for bio­phar­ma

The widely-held notion that the “optimal” vaginal microbiota is dominated by one strain of lactic-acid producing bacteria has now been challenged in a new paper, published in Nature Communications on Wednesday, which used advanced gene sequencing methods to map out the most comprehensive gene catalog of the human vaginal microbiome.

Things have changed in the more than 50 years since the concept of vaginal microbiota transplants was proposed and subsequently tainted by a Texas-based gynecologist who transplanted the vaginal fluid of women who had bacterial vaginosis into healthy females, suspecting he had isolated the bacteria responsible for the condition.

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