Nek­tar wants every­one to stay calm as they car­ry on with NK­TR-214, but #AS­CO18 spurs a stam­pede

CHICA­GO — Bris­tol-My­ers Squibb $BMY has gone all in on Nek­tar’s $NK­TR ap­proach to amp­ing up their check­point strat­e­gy, part­ner­ing on NK­TR-214. But in­stead of tak­ing a bow at #AS­CO18 on pos­i­tive da­ta, re­searchers spent the week­end ex­plain­ing why their lat­est da­ta read­out from a small study shouldn’t be cause for pan­ic.

It’s not what they were look­ing for, to put it mild­ly.

Mary Tagli­a­fer­ri

Un­like most of the more close­ly-watched pro­grams here at AS­CO, the re­searchers in­volved nev­er of­fered a pre­view of the da­ta that came out Sat­ur­day evening. And that was a se­ri­ous mis­step, par­tic­u­lar­ly as the re­porters cov­er­ing this ses­sion strug­gled to fig­ure out what was be­ing re­port­ed — and what it meant.

As it hap­pens, in­ves­ti­ga­tors ex­e­cut­ed a two-stage tri­al process, sign­ing up a small group of pa­tients to test the drug in dif­fer­ent can­cer types, then mov­ing on to the next stage with a new group of re­cruits. Do­ing that, says Mary Tagli­a­fer­ri, the chief med­ical of­fi­cer at Nek­tar, meshed well with their strat­e­gy for jump­ing in­to late-stage stud­ies as they com­mu­ni­cat­ed with reg­u­la­tors.

“The goal,” she tells me, “was al­ways to as­sess mov­ing very quick­ly in­to Phase III.”

In­vestors, though, weren’t hap­py with the way this all came down, and they bolt­ed when the mar­ket opened, with Nek­tar’s stock plung­ing a sting­ing 32% — ex­act­ly the kind of rout that Bris­tol-My­ers (down 1.6%) doesn’t need right now as it tries to re­store con­fi­dence in its pipeline. And it kept get­ting worse lat­er in the day, with shares down 42%.

Here’s what Nek­tar has found so far.

In their melanoma project, re­searchers saw that 11 of 13 pa­tients treat­ed with a com­bi­na­tion of Op­di­vo and NK­TR-214 re­spond­ed in round 1 — which is out­stand­ing. But, when they added 15 more pa­tients, they on­ly boost­ed their re­sponse rate by 3 pa­tients. And 3 out of 15 is not out­stand­ing.

In kid­ney can­cer, the step one re­sponse rate of 64% was fol­lowed up with an over­all step 2 rate of 46%.

In­vestors hate to see a falling re­sponse rate, for any rea­son, as it in­di­cates a prob­lem that can se­ri­ous­ly af­fect a can­cer drug’s longterm fi­nan­cial suc­cess.

Twit­ter’s day-trad­ing crew picked it up from there, with all sorts of #AS­CO18 chat­ter about a tri­al dis­as­ter in the mak­ing. And as of­ten hap­pens, Twit­ter is not a great source of re­al-time in­for­ma­tion, par­tic­u­lar­ly when the com­pa­nies failed to ex­plain what the num­bers meant with an­a­lysts.

In the fol­lowup dis­cus­sion, though, Tagli­a­fer­ri of­fered the ra­tio­nale that it’s ear­ly days for the sec­ond batch­es of pa­tients and they ex­pect to see more re­spons­es with time. And they have rea­son to be­lieve that, af­ter track­ing a 46% ORR in RCC at SITC that has now grown to 71% at AS­CO.

“You’ll see the ORR go­ing up,” says Tagli­a­fer­ri, as they have a chance to col­lect mul­ti­ple scans on the sec­ond-stage pa­tients. “It s a lit­tle frus­trat­ing that peo­ple aren’t un­der­stand­ing that.”

Al­so im­por­tant, they say, is clear ev­i­dence that the com­bi­na­tion of NK­TR-214 is do­ing what they re­al­ly want­ed: Spark­ing re­spons­es in PD-L1 neg­a­tive tu­mors where Op­di­vo is not suc­cess­ful. If that all plays out in the am­bi­tious piv­otal pro­gram now un­der­way, it will eas­i­ly jus­ti­fy Bris­tol-My­ers’ record $3.6 bil­lion wa­ger.

If not….

In melanoma, re­searchers saw 5 out of 11 PD-L1 neg­a­tive pa­tients re­spond; in kid­ney can­cer it was 9 out of 17, or 53%. Those num­bers are fine.

Right now, though, they’ve cre­at­ed an at­mos­phere of doubt that will make every turn of da­ta a cat­a­lyst for the gam­blers now lin­ing up their bets for and against the com­bi­na­tion. That will ei­ther help or hurt these com­pa­nies, which are now bet­ting heav­i­ly that step 2 will ul­ti­mate­ly play out in their fa­vor.

We’ll find out more at the next SITC con­fer­ence in No­vem­ber, Tagli­a­fer­ri adds, with ab­stracts due in Au­gust.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

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US sees spike in Paxlovid us­age as Mer­ck­'s mol­nupi­ravir and As­traZeneca's Evusheld are slow­er off the shelf

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

Almirall is tapping artificial intelligence on behalf of its sales force for insights and efficiencies. (via Shutterstock)

Almi­rall rolls out sales rep ar­ti­fi­cial in­tel­li­gence sys­tem, cut­ting pre-call prep and 'wind­shield time'

Dermatology specialty pharma Almirall is making its sales reps smarter. Not with extra training or educational courses, but instead with artificial intelligence tools.

It began a soft launch of a sales rep AI and machine learning platform it calls Polaris last August in one of its 7 US coverage regions. The platform from Aktana gathers information from across Almirall internal sources and external ones – such as claims and prescribing data – to generate insights for reps. Now, instead of spending hours prepping for a sales call, Polaris can generate details about a physician’s preferences, past behaviors and prescription habits for reps in minutes, said Almirall head of commercial operations Vincent Cerio.

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Pfiz­er and CD­MOs ramp up Paxlovid man­u­fac­tur­ing with Kala­ma­zoo plant ex­pan­sion lead­ing the way

As the Covid-19 pandemic continues to evolve, pharma companies and manufacturers are exploring how to step up production on antivirals.

Pfizer is planning to expand its Kalamazoo-area facility to increase manufacturing capabilities for the oral Covid-19 antiviral Paxlovid, according to a report from Michigan-based news site MLive. The expansion of the facility, which serves as Pfizer’s largest manufacturing location, is expected to create hundreds of “high-skilled” STEM jobs, MLive reported. No details about the project’s cost and timeline have been released, but according to MLive, Pfizer will announce the details of the expansion at some point in early June.

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FDA spells out the rules and re­stric­tions for states seek­ing to im­port drugs from Cana­da

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

Greg Mayes, Antios Therapeutics CEO

An­tios' HBV col­lab axed af­ter clin­i­cal hold, but biotech be­lieves safe­ty in­ci­dent is not treat­ment-re­lat­ed

The FDA has placed a clinical hold on a Phase IIa study of Antios Therapeutics’ investigational hepatitis B med, CEO Greg Mayes confirmed to Endpoints News in an emailed statement.

A safety report was delivered to the biotech on May 17 after a patient dosed in a triple combination cohort of the study had experienced bradycardia and hypotension. The triple combo included Antios’ ATI-2173, Assembly Biosciences’ vebicorvir and Viread, an approved antiviral for HIV and hepatitis B.

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Michael Corbo, Pfizer CDO of inflammation & immunology

UP­DAT­ED: Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

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Tim Schoen, BioMed Realty CEO

Life sci­ences de­vel­op­er Bio­Med Re­al­ty buys San Fran­cis­co ho­tel for $75M — re­port

In a somewhat unconventional deal, life sciences real estate developer BioMed Realty has bought a 169-room Hilton Garden Inn in South San Francisco for $75 million, the San Francisco Business Times reported.

BioMed Realty, an affiliate of Blackstone, has multiple life sciences and technology office projects in the Bay Area, including three sites within a five-minute drive of the hotel.

While the sale of the hotel property was announced earlier this month, the sellers, Summit and GIC, did not identify the buyer at the time.

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