Fresh from haul­ing in GSK’s bud­get-priced gene ther­a­py group, Or­chard har­vests $150M mega-round. Is it time to IPO?

Just a few months ago Or­chard Ther­a­peu­tics was hand­ed the op­por­tu­ni­ty of tak­ing over Glax­o­SmithK­line’s gene ther­a­py group, which had pushed the field’s sec­ond prod­uct, Strimvelis, to the Eu­ro­pean mar­ket — with­out see­ing much in the way of a re­turn.

An­drea Spezzi

This morn­ing, Or­chard is back in the news, adding $150 mil­lion to the re­port­ed $140 mil­lion it had al­ready raised to get to this stage. And that may well in­clude an IPO in the near fu­ture.

Like­ly to add to the IPO buzz, crossover in­vestor Deer­field is lead­ing the in­dus­try’s lat­est mega-round, which comes with lit­tle de­tail about how the com­pa­ny plans to use it — aside from pipeline work.

Or­chard Ther­a­peu­tics’ ex­ec­u­tive crew in­cludes co-founder An­drea Spezzi, one of a group of ex-GSK staffers with close ties to Strimvelis, a pi­o­neer­ing gene ther­a­py that was a key part of the GSK deal. Af­ter shop­ping the group for months — with Or­chard fig­ur­ing promi­nent­ly in the ru­mors cir­cu­lat­ing around the deal — the GSK team end­ed up vir­tu­al­ly giv­ing it away in ex­change large­ly for a chunk of eq­ui­ty, un­der­scor­ing their in­abil­i­ty to cre­ate much val­ue in the ef­fort.

Hal Bar­ron

Aside from Strimvelis, the ex vi­vo gene ther­a­py for “bub­ble boy syn­drome,” the deal bas­ket al­so in­clud­ed two late-stage clin­i­cal pro­grams for metachro­mat­ic leukody­s­tro­phy and Wiskott Aldrich syn­drome, one clin­i­cal pro­gram for be­ta tha­lassemia, and rights to three pre­clin­i­cal pro­grams. In ex­change, GSK grabbed a 19.9% stake and a board seat in the UK biotech.

GSK has slimmed down the pipeline in prepa­ra­tion for a change of re­search di­rec­tion un­der new R&D chief Hal Bar­ron, but Bar­ron has done lit­tle in the 9 months since his ap­point­ment to spell out what that ac­tu­al­ly means.

The full syn­di­cate at Or­chard is a big one. It in­cludes: RA Cap­i­tal Man­age­ment, Ven­rock, Fore­site Cap­i­tal, Per­cep­tive Ad­vi­sors, Cor­morant As­set Man­age­ment LP, Ar­row­Mark Part­ners, Sphera Glob­al Health­care, Medi­son Ven­tures, Driehaus Cap­i­tal Man­age­ment and Ghost Tree Cap­i­tal Group. Ex­ist­ing in­vestors came along for the ride, in­clud­ing Temasek, Bail­lie Gif­ford, RTW In­vest­ments, LP, Cowen Health­care In­vest­ments and Agent Cap­i­tal.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA have vowed not to let politics get in the way of science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped health agencies under his purview — including the FDA — of their rulemaking ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Eli Lilly CSO Dan Skovronsky (file photo)

#ES­MO20: Eli Lil­ly shows off the da­ta for its Verzenio suc­cess. Was it worth $18 bil­lion?

The press release alone, devoid of any number except for the size of the trial, added nearly $20 billion to Eli Lilly’s market cap back in June. Now investors and oncologists will get to see if the data live up to the hype.

On Sunday at ESMO, Eli Lilly announced the full results for its Phase III MonarchE trial of Verzenio, showing that across over 5,000 women who had had HR+, HER2- breast cancer, the drug reduced the odds of recurrence by 25%. That meant 7.8% of the patients on the drug arm saw their cancers return within 2 years, compared with 11.3% on the placebo arm.

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Greg Friberg (File photo)

#ES­MO20: Am­gen team nails down sol­id ear­ly ev­i­dence of AMG 510’s po­ten­tial for NSCLC, un­lock­ing the door to a wave of KRAS pro­grams

The first time I sat down with Amgen’s Greg Friberg to talk about the pharma giant’s KRAS G12C program for sotorasib (AMG 510) at ASCO a little more than a year ago, there was high excitement about the first glimpse of efficacy from their Phase I study, with 5 of 10 evaluable non-small cell lung cancer patients demonstrating a response to the drug.

After decades of failure targeting KRAS, sotorasib offered the first positive look at a new approach that promised to open a door to a whole new approach by targeting a particular mutation to a big target that had remained “undruggable” for decades.

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#ES­MO20: Out to beat Tagris­so, J&J touts 100% ORR for EGFR bis­pe­cif­ic/TKI com­bo — fu­el­ing a quick leap to PhI­II

J&J’s one-two punch on EGFR-mutant non-small cell lung cancer has turned up some promising — although decidedly early — results, fueling the idea that there’s yet room to one up on third-generation tyrosine kinase inhibitors.

Twenty out of 20 advanced NSCLC patients had a response after taking a combination of an in-house TKI dubbed lazertinib and amivantamab, a bispecific antibody targeting both EGFR and cMET engineered on partner Genmab’s platform, J&J reported at ESMO. All were treatment-naïve, and none has seen their cancer progress at a median follow-up of seven months.

Exelixis CEO Michael Morrissey (file photo)

#ES­MO20: Look out Mer­ck. Bris­tol My­ers and Ex­elix­is stake out their com­bo’s claim to best-in-class sta­tus for front­line kid­ney can­cer

Now that the PD-(L)1 checkpoints are deeply entrenched in the oncology market, it’s time to welcome a wave of combination therapies — beyond chemo — looking to extend their benefit to larger numbers of patients. Bristol Myers Squibb ($BMY} and Exelixis {EXEL} are close to the front of that line.

Today at ESMO the collaborators pulled the curtain back on some stellar data for their combination of Opdivo (the PD-1) and Cabometyx (the TKI), marking a significant advance for the blockbuster Bristol Myers franchise while offering a big leg up for the team at Exelixis.

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Donald Trump and White House chief of staff Mark Meadows, before boarding Marine One (Getty Images)

Pric­ing deal col­laps­es over Big Phar­ma's re­fusal to is­sue $100 'cash card­s' be­fore the elec­tion — re­port

Late in August, as negotiations on a pricing deal with President Trump reached a boiling point, PhRMA president Stephen Ubl sent an email update to the 34 biopharma chiefs that sit on his board. He wrote that if the industry did not agree to pay for a $100 “cash card” sent to seniors before November, White House chief of staff Mark Meadows was going to tell the news media Big Pharma was refusing to “share the savings” with the elderly — and that all of the blame for failed drug pricing negotiations would lie squarely on the industry.

Dan Skovronsky, Eli Lilly CSO

An­a­lysts are quick to pan Eli Lil­ly's puz­zling first cut of pos­i­tive clin­i­cal da­ta for its Covid-19 an­ti­body

Eli Lilly spotlighted a success for one of 3 doses of their closely-watched Covid-19 antibody drug Wednesday morning. But analysts quickly highlighted some obvious anomalies that could come back to haunt the pharma giant as it looks for an emergency use authorization to launch marketing efforts.

The pharma giant reported that LY-CoV555, developed in collaboration with AbCellera, significantly reduced the rate of hospitalization among patients who were treated with the antibody. The drug arm of the study had a 1.7% hospitalization rate, compared to 6% in the control group, marking a 72% drop in risk.

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#ES­MO20: As­traZeneca aims to spur PRO­found shift in prostate can­cer treat­ment with Lyn­parza OS da­ta

AstraZeneca has unveiled the final, mature overall survival data that cemented Lynparza’s first approval in prostate cancer approval — touting its lead against rivals with the only PARP inhibitor to have demonstrated such benefit.

But getting the Merck-partnered drug to the right patients remains a challenge, something the companies are hoping to change with the new data cut.

The OS numbers on the subgroup with BRCA1/2 or ATM-mutated metastatic castration-resistant prostate cancer are similar to the first look on offer when the FDA expanded the label in May: Lynparza reduced the risk of death by 31% versus Xtandi and Zytiga. Patients on Lynparza lived a median of 19.1 months, compared to 14.7 months for the anti-androgen therapies (p = 0.0175).

#ES­MO20: It’s not just Keytru­da any­more — Mer­ck spot­lights 3 top ear­ly-stage can­cer drugs

Any $12 billion megablockbuster in the portfolio tends to overshadow everything else in the pipeline. Which is something Merck can tell you a little bit about.

Keytruda not only dominates the PD-(L)1 field, it looms over everything Merck does, to the point some analysts wonder if Merck is a one-trick pony.

There’s no shortage of Keytruda data on display at ESMO this weekend, but now the focus is shifting to the future role of new drugs and combos in maintaining that lead position for years to come. And the pharma giant has a special focus for 3 early-stage efforts where Roger Perlmutter’s oncology team is placing some big bets.

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