The lat­est up­date on NK­TR-214/Op­di­vo from Nek­tar and Bris­tol-My­ers will keep the con­tro­ver­sy burn­ing over the ORR rate

Nek­tar Ther­a­peu­tics $NK­TR man­aged to slide 1 out of its 38 evalu­able stage 4 melanoma pa­tients in­to the win col­umn with its close­ly-watched 3-month up­date on Op­di­vo/NK­TR-214’s ob­jec­tive re­sponse rate. That man­aged to nudge up the ORR from 50% — a fig­ure that rout­ed Nek­tar’s stock at AS­CO — to 53%, which isn’t like­ly to con­vince any of the crit­ics that the biotech and its part­ners at Bris­tol-My­ers Squibb have come up with the kind of com­bo that can change the stan­dard of care in the field.

But if you ex­pect any­one di­rect­ly in­volved in this study to step back from the en­thu­si­as­tic pro­jec­tions that were made on the first op­ti­mistic da­ta points, you’d be flat wrong.

Adi Diab

While the cru­cial ORR bare­ly budged, Adi Diab from MD An­der­son point­ed straight to a high­er com­plete re­sponse rate, at 24% — “which is not seen with an­oth­er com­bi­na­tion.” He’s al­so of­fer­ing a thumbs up to a 76% dis­ease con­trol rate — up from 71% at AS­CO — as ev­i­dence that they’re on to some­thing spe­cial.

Sev­er­al an­a­lysts — in­clud­ing some in the Ever­cor­eISI team — had been look­ing for some­thing in the 60%-plus range for the ORR to win back the en­thu­si­asm that has drained away for NK­TR-214, a drug that a needy Bris­tol-My­ers Squibb paid $1.85 bil­lion up­front to part­ner on ear­li­er in the year. The drug is de­signed to bind to the CD122 re­cep­tor on the sur­face of CD-8 and CD-4 pos­i­tive im­mune cells to whip up an at­tack on var­i­ous can­cers.

And Diab says they can see ex­act­ly that re­sponse in pa­tients with pos­i­tive bio­mark­er re­sults for the tu­mor mi­croen­vi­ron­ment.

As it stands, the re­searchers have a drug that ap­pears to have clear­ly waned in the more ma­ture 7.2-month me­di­an fol­lowup time for PIV­OT-02, drop­ping from 64% at the first cut of the da­ta at SITC last year. And just days ago Bris­tol-My­ers out­lined im­pres­sive 4-year over­all sur­vival re­sults from Check­Mate-067: 53% for Op­di­vo plus Yer­voy com­bo, 46% for Op­di­vo alone, and 30% for Yer­voy alone.

Diab, though, be­lieves that with bet­ter ex­pe­ri­ence us­ing the drug, and bet­ter ed­u­ca­tion for physi­cians and pa­tients, the re­sponse rate can climb back up to 60%-plus. As for Yer­voy, he adds, the CT­LA-4 has a well known tox pro­file that leads to a high rate of ad­verse events that of­ten pre­vent pa­tients from com­plet­ing treat­ment.

“We should not do com­par­isons with oth­er tri­als, it’s not kosher,” Diab tells me at one point in our con­ver­sa­tion. “But of course we’re go­ing to do it.”

There’s been some in­tense con­tro­ver­sy over their chances with this IL-2 drug, which us­es pe­gy­la­tion tech to elim­i­nate the draw­backs of the orig­i­nal ther­a­py – Pro­leukin — that made it too tox­ic to use at full mea­sure, in turn lim­it­ing its ef­fi­ca­cy.

One like­ly take­down of the Nek­tar de­fense should come soon from Aaron Wed­lund, the ex-Ker­ris­dale an­a­lyst who wrote a lengthy di­a­tribe on NK­TR-214, which he con­sid­ers will make IL-2 the next IDO, an­oth­er drug class once wide­ly hailed as the next big thing in can­cer drug com­bos now bad­ly tar­nished fol­low­ing a cat­a­stroph­ic Phase III com­bo fail­ure with Keytru­da.

Bris­tol-My­ers en­thu­si­as­ti­cal­ly bought in­to the next-gen IL-2 drug ap­proach as it’s been un­suc­cess­ful­ly de­fend­ing its PD-1/L1 crown against a hard-charg­ing Mer­ck, which has pushed Keytru­da and chemo com­bos in­to the fore­front of the lung can­cer mar­ket. IL-2, they said, would be the next log­i­cal step to PD-1 and CT­LA-4, with Yer­voy.

Any­thing that puts this drug back in the Pro­leukin cat­e­go­ry, with more IL-2 suc­ces­sors in the pipeline, won’t be wel­come by the de­vel­op­ers.

It’s im­por­tant to keep in mind that a bunch of short in­vestors had fun — and made mon­ey — pulling Nek­tar’s stock down from some stun­ning highs that it had en­joyed. Rais­ing doubts is good for spurring cor­rec­tions, and Nek­tar’s stock has tum­bled bad­ly. The ju­ry will re­main out, though, un­til the Phase III pro­gres­sion-free sur­vival da­ta comes due around the spring of 2020.

Un­til then, and maybe even af­ter, this de­bate will con­tin­ue to rage.

Ven­ture Cap­i­tal as a Strate­gic Part­ner: Fu­el­ing In­no­va­tion be­yond Fi­nance

The average level of investment required for a biotech start-up to succeed is increasing every year, elevating the pressure even further on venture capital to make smart financial investments. Financial investment alone, however, does not always guarantee that exciting innovations can be transformed into real businesses that make a meaningful difference to patients.

Beyond just capital

At Astellas Venture Management (AVM) – a wholly-owned venture capital organization within Astellas, headquartered in the San Francisco Bay Area – capital is just one of the ingredients we offer to add value to our biotechnology investments and partnerships. We generally take a strategic investor approach for companies in our invested portfolio, providing access to expertise, technology and/or resources in addition to the injection of finance. An equity investment from AVM can include access to Astellas’ research and development (R&D) capabilities and expertise, and a global network of partner academic institutions and biotechnology companies, to help advance and accelerate the start-up’s innovation.

UP­DAT­ED: Ver­tex joins Mer­ck, Pfiz­er — re­vamp­ing multi­bil­lion-dol­lar tri­al strat­e­gy as biotech R&D crum­bles

You can add Pfizer, Merck and — as we found out Friday morning — Vertex to the growing list of pharma giants hitting the pause button on a range of clinical trials. But not everyone in R&D is getting a red light.

Vertex says that it’s doing its best to keep working its pipeline strategy, coming up with a plan “to enable virtual clinic visits and home delivery of study drug to ensure study continuity and medical monitoring, and to facilitate study procedures.”

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Covid-19 roundup: In­ter­cept, blue­bird and a grow­ing list of biotechs feel the pain as pan­dem­ic man­gles FDA, R&D sched­ules

Around 100 staffers at Boston area hospitals have now tested positive for Covid-19, spotlighting the growing risk that the pandemic will sideline many of the most essential workers in healthcare as caseloads peak in the US and around the globe. With more than 3,400 deaths, Spain has become the latest country to surpass the official death count attributed to the new coronavirus in China, where the outbreak originated. As of Thursday morning, confirmed global cases had crossed 470,000 and the death count eclipsed 21,000.

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Af­ter crit­ics lam­bast­ed Gilead for grab­bing the FDA's spe­cial rare drug sta­tus on remde­sivir, they're giv­ing it back

Two days after Gilead won orphan drug status for remdesivir as a potential treatment for Covid-19, they’re handing it back.

The company was slammed from several sides after Gilead reported that the FDA had come through with the special status, which comes with 7 years of market exclusivity, the waiver of FDA fees and some tax credits as well. Typically, everyone who can get orphan status lands it without much of a fuss, but Democratic presidential candidate Bernie Sanders, Public Citizen and other consumer groups were outraged.

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Mod­er­na CEO Stéphane Ban­cel out­lines a short path for emer­gency use of a coro­n­avirus vac­cine

NIAID director Anthony Fauci has left no doubts that it takes 12 to 18 months to get a new vaccine tested and in commercial use, in the best of circumstances. But in times of a global emergency — like these — maybe there’s another, faster route to follow.

In an SEC filing on Tuesday, Moderna $MRNA staked out a record-setting pathway to getting their mRNA vaccine into the frontline of the healthcare response as early as this fall. The SEC filing notes that CEO Stéphane Bancel told Goldman Sachs that an emergency use approval could allow the vaccine to go to healthcare workers and certain individuals in a matter of months — presumably provided the NIH sees the safety and efficacy data they would need from the Phase I.

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Caught in a Covid-19 mael­strom, Eli Lil­ly locks down clin­i­cal tri­als as multi­bil­lion-dol­lar R&D ops de­rail

The Covid-19 pandemic has derailed Eli Lilly’s $6 billion R&D operations.

The pharma giant reported Monday morning that it has decided to hit the brakes on most new study starts and pause enrollment for most ongoing studies. Lilly adds that it is continuing dosing for ongoing studies, “but with study-by-study consideration.”

The pandemic has severely disrupted healthcare systems around the globe, says Lilly, making it difficult or impossible to conduct studies at many research sites. And there’s no timeline for when it expects to get back on track.

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As share buy­backs come un­der scruti­ny, what's in store for the bio­phar­ma in­dus­try?

Stock buybacks are not to be permitted for companies that will be bailed out in the coronavirus stimulus package, Congressional leaders have signaled. To what degree the biopharma industry has relied on buybacks for earnings growth in recent years, and if the trend continues, are the big questions as scrutiny into the practice heightens and balance sheets weaken with the coronavirus pandemic wreaking havoc on global economies.

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A Sin­ga­pore VC rais­es $200M for a new round, but will Covid-19 pre­vent it from rais­ing the rest?

A top Singaporean biotech venture fund is nearly halfway toward its largest ever fund, but in a sign of what could be in store for VCs amid a global economic freeze, said they could face headwinds raising the other half.

Vickers Venture Partners has secured $200 million out of a targeted $500 million for its 6th fund, first announced in early 2018. They’ve given themselves 13 months to complete the financing, Vickers founder Finian Tan told Deal Street Asia, but the financial frost settling amid the Covid-19 pandemic could slow efforts.

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Strug­gling Unum ex­ecs are ready to con­sid­er a sale, merg­er or any deal that comes its way

Unum $UMRX is working its way through a survival plan of sorts.

After getting hit with a trio of FDA holds in its brief public history and triggering its second pivot to a new lead drug program while laying off 60% of the staff, the troubled penny stock biotech Unum Therapeutics has hatched new plans to secure financial backing while lining up a go-forward strategy for the company.

First, Lincoln Park Capital Fund has agreed to buy up to $25 million of the long-suffering stock, as Unum directs. And the executive team — led by CEO Chuck Wilson — has put everything on the table for consideration: a sale, acquisition, merger, licensing deal, you name it. The ACTR707 program, meanwhile, is being formally wrapped up — their second failed lead program.