Five Prime cuts 41 jobs, days be­fore pre­sent­ing da­ta at AS­CO meet­ing of GI can­cers

Things have not been the same at can­cer-fo­cused drug de­vel­op­er Five Prime Ther­a­peu­tics $FPRX since late 2017, when its Bris­tol-My­ers $BMY part­nered drug cabi­ral­izum­ab in com­bi­na­tion with Op­di­vo showed signs of weak ef­fi­ca­cy and a trou­bling safe­ty pro­file in an ear­ly-stage pan­cre­at­ic can­cer tri­al. On Tues­day, the com­pa­ny said it had cut 41 jobs to fo­cus its re­sources on its late-stage pipeline.

The lay­offs — which ac­count for rough­ly 20% of the com­pa­ny work­force — will large­ly be from po­si­tions in re­search, pathol­o­gy and man­u­fac­tur­ing, and will cul­mi­nate in net cash sav­ings of $10 mil­lion in fis­cal year 2019. The South San Fran­cis­co-based biotech will al­so in­cur $2 mil­lion in pre-tax charges as­so­ci­at­ed with sev­er­ance and oth­er costs in con­nec­tion with the re­struc­tur­ing in the first quar­ter of 2019.

Bris­tol-My­ers Squibb hand­ed Five Prime $350 mil­lion up­front in 2015 in an up to $1.74 bil­lion deal to part­ner on Five Prime’s pipeline, in­clud­ing its colony stim­u­lat­ing fac­tor 1 re­cep­tor (CSF1R) an­ti­body pro­gram, which in­clud­ed cabi­ral­izum­ab as the lead in the clin­ic. How­ev­er, Five Prime’s lead drug is now part­nered with Chi­na’s Zai Lab $ZLAB. The an­ti­body drug be­mar­ituzum­ab, which is de­signed to im­pede a pro­tein called fi­brob­last growth fac­tor re­cep­tor 2 (FGFR2B), is cur­rent­ly be­ing test­ed in a late-stage study in pa­tients with gas­tric and gas­tro-esophageal junc­tion can­cer. Five Prime al­so has var­i­ous ear­ly-stage pro­tein ther­a­pies in its ar­se­nal of drugs-in-de­vel­op­ment.

The com­pa­ny now ex­pects to end 2019 with $148 mil­lion to $153 mil­lion in cash and oth­er as­sets. On Mon­day, Five Prime said it was gear­ing up to present a snap­shot of da­ta from on­go­ing stud­ies of be­mar­ituzum­ab and cabi­ral­izum­ab at a med­ical con­fer­ence — the Amer­i­can So­ci­ety of Clin­i­cal On­col­o­gy’s Gas­troin­testi­nal Can­cer Sym­po­sium (AS­CO GI) — sched­uled lat­er this week.

Donald and Melania Trump watch the smoke of fireworks from the South Lawn of the White House on July 4, 2020 (via Getty)

Which drug de­vel­op­ers of­fer Trump a quick, game-chang­ing ‘so­lu­tion’ as the pan­dem­ic roars back? Eli Lil­ly and Ab­Cellera look to break out of the pack

We are unleashing our nation’s scientific brilliance and will likely have a therapeutic and/or vaccine solution long before the end of the year.

— Donald Trump, July 4

Next week administration officials plan to promote a new study they say shows promising results on therapeutics, the officials said. They wouldn’t describe the study in any further detail because, they said, its disclosure would be “market-moving.”

— NBC News, July 3

Something’s cooking. And it’s not just July 4 leftovers involving stale buns and uneaten hot dogs.

Over the long weekend observers picked up signs that the focus in the Trump administration may swiftly shift from the bright spotlight on vaccines being promised this fall, around the time of the election, to include drugs that could possibly keep patients out of the hospital and take the political sting out of the soaring Covid-19 numbers causing embarrassment in states that swiftly reopened — as Trump cheered along.

So far, Gilead has been the chief beneficiary of the drive on drugs, swiftly offering enough early data to get remdesivir an emergency authorization and into the hands of the US government. But their drug, while helpful in cutting stays, is known for a limited, modest effect. And that won’t tamp down on the hurricane of criticism that’s been tearing at the White House, and buffeting the president’s most stalwart core defenders as the economy suffers.

We’ve had positive early-stage vaccine data, most recently from Pfizer and BioNTech, playing catchup on an mRNA race led by Moderna — where every little sign of potential trouble is magnified into a lethal threat, just as every advance excites a frenzy of support. But that race still has months to play out, with more Phase I data due ahead of the mid-stage numbers looming ahead. A vaccine may not be available in large enough quantities until well into 2021, which is still wildly ambitious.

So what about a drug solution?

Trump’s initial support for a panacea focused on hydroxychloroquine. But that fizzled in the face of data underscoring its ineffectiveness — killing trials that aren’t likely to be restarted because of a recent population-based study offering some support. And there are a number of existing drugs being repurposed to see how they help hospitalized patients.

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Shoshanna Shendelman, Applied Therapeutics CEO (Applied Therapeutics)

A lit­tle biotech slaps back at a 'crim­i­nal' short at­tack, vow­ing to pur­sue a pros­e­cu­tion of their case

As short attacks go, Biotech Research Partners’ assault on Applied Therapeutics’ “cherry picked” data and a variety of so-called red flags didn’t cause a whole lot of damage. Ahead of the July 4 holiday, its shares $APLT were dinged and showed signs of quick recovery.

But that didn’t stop an incendiary response, as the biotech swung into action bright and early Monday morning.

Applied Therapeutics accused the authors of the short report of manipulating graphs and figures, misrepresenting data and included factual misrepresentations — all of which added up, in their view, to fraud.

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UP­DAT­ED: Im­munomedics spells out PFS ben­e­fit of Trodelvy in mTNBC, hunt­ing a full OK just weeks af­ter ac­cel­er­at­ed ap­proval

By the time the FDA finally granted an accelerated OK for Immunomedics’ Trodelvy, we already got a very strong hint that their confirmatory Phase III study in metastatic triple-negative breast cancer was a success.

That’s because the independent data safety monitoring committee recommended that the trial be stopped early. But just what pointed them to the conclusion was still unclear.

“We do not know the totality of their decision other than it’s pretty evident that the primary endpoint was met; otherwise they could not request to halt the study,” Behzad Aghazadeh, the executive chairman, told Endpoints News at the time.

Cel­lec­tis slammed af­ter pa­tient dies and FDA slaps a hold on their tri­al for an off-the-shelf CAR-T for mul­ti­ple myelo­ma

Cellectis was slammed after the market close on Monday as the biotech reported that the FDA demanded it hit the brakes on their MELANI-01 trial for their off-the-shelf cell therapy UCARTCS1A after one of the patients in the study died of treatment-related cardiac arrest.

The multiple myeloma patient had previously been treated unsuccessfully with various therapies, noted the biotech, and had been given dose level two (DL2) of their allogeneic CAR-T.

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Jean-Paul Clozel, Idorsia CEO (Patrick Straub/Keystone via AP Images)

Sec­ond PhI­II study for Idor­si­a's sleep drug re­turns pos­i­tive re­sults, but al­so rais­es new ques­tions

Following a successful Phase III study in April showcasing the safety and potential of its new sleep drug, Idorsia posted some mixed news in the second Phase III study, but that won’t stop a planned filing aimed at regulatory approval.

The drug, a dual orexin receptor antagonist (DORA) called daridorexant, was found to significantly improve sleep maintenance and subjective total sleep time in 25 mg doses, replicating results from the first Phase III study. However, improvements in sleep onset and daytime functioning narrowly missed statistical significance, despite numerical consistency with the April study.

Bill Haney, Dragonfly CEO (Dave Pedley/Getty Images for SXSW)

A boom­ing Drag­on­fly is tak­ing its TriN­KETs to Copen­hagen as the lat­est Bris­tol My­ers pact spurs ex­pan­sion plans — out­side the US

Bristol Myers Squibb is making a habit out of collaborating with the crew at Dragonfly, adding their 3rd deal in a series that now will take them into newly charted R&D territory. And the fast-growing team at the Cambridge-based biotech is adding a facility in Copenhagen for its next growth spurt, where the government is making it easy to recruit scientists internationally as the U.S. throttles back.

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Ernest Loumaye, ObsEva CEO (ObsEva)

UP­DAT­ED: Ob­sE­va’s sec­ond uter­ine fi­broids PhI­II comes through, send­ing some in­vestors to the hills

In the three-company race to develop a new uterine fibroid treatment, ObsEva long lagged behind AbbVie and Myovant. Still, they hoped that better efficacy — including a 93.9% response rate in one Phase III trial — could ultimately deliver better sales.

Now, though, the second of those Phase III studies is out, and it has brought the Swedish biotech back to earth.

In the second of their Phase III trials, 75.5% of patients who took ObsEva’s experimental tablet linzagolix plus a hormone saw their bleeding reduced by at least 50% and at least 80 ml after 24 weeks. Pooling those results with new data from their first Phase III trial — which showed a 93.9% response rate at 24 weeks and a 91.6% response rate at 52 weeks — ObsEva calculated a collective 84.7% responder rate for patients taking their therapy and said the data “confirm potential best-in-class” status.

Covid-19 roundup: Teamed up with NIH, Re­gen­eron launch­es PhI­II pre­ven­tion tri­al for an­ti­body cock­tail

As Regeneron moves its antibody cocktail into Phase II/III trials testing REGN-COV2 as a treatment for both hospitalized and non-hospitalized patients with Covid-19, the biotech is also starting a Phase III in the prevention setting.

The National Institute of Allergy and Infectious Diseases — which orchestrated the large, randomized study for remdesivir that produced positive results — will jointly run the study.

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Bel­lus hit with a set­back as its PhII chron­ic cough drug flops on all 4 dos­es -- shares cre­mat­ed on Wall Street

Bellus Health says their Phase II study for a new drug to treat chronic cough failed, but they already lined up Plan B to help ease the sting with investors.

The biotech tested 4 different doses of BLU-5937 in the mid-stage study, all of which fell short of the mark for placebo-adjusted reductions in coughing — several by a wide margin. It also didn’t help that there was no clear dose response in the mix, with a jumble of outcomes to report. Bellus $BLU immediately tried to shift focus to a silver lining, noting that they hit statistical significance among a subgroup of “high cough count patients (all patients at or above the baseline median average of 32.4 coughs per hour).”