An­a­lyst of­fers Am­gen a boost for its ri­val an­ti-BC­MA BiTE, blem­ish­ing GSK as well as CAR-T ri­vals Cel­gene and blue­bird

Baird’s Bri­an Sko­r­ney is giv­ing Am­gen a thumbs up to­day for a snap­shot of hu­man da­ta from its an­ti-BC­MA BiTE pro­gram AMG 420, pos­si­bly caus­ing a few headaches among its ri­vals in the close­ly watched space.

In a note out at mid-day, Sko­r­ney wrote:

Over the week­end, ini­tial clin­i­cal da­ta for AMG 420 were pre­sent­ed at the Myelo­ma 2018 meet­ing. No­tably, in the high dose group there were five pa­tients with strin­gent com­plete re­spons­es (sCR). This in­clud­ed four MRD-neg­a­tive pa­tients. The pre­sen­ta­tion in­di­cat­ed that four of the pa­tients had re­spons­es on­go­ing > 10 months. We think this com­pares fa­vor­ably to Cel­gene/blue­bird’s CART-BC­MA pro­gram, bb2121, which has a 50% CR/sCR, 36.4% VG­PR and ORR of 95.5% and a me­di­an dOR of 10.8 months in 22 pa­tients ad­min­is­tered > 150 x 106. The an­ti­body ap­proach to tar­get­ing BC­MA has, so far, been dis­ap­point­ing.

In par­tic­u­lar, he adds, that an­ti­body ap­proach in­cludes GSK’s an­ti­body-drug con­ju­gate — GSK2857916 — which had a 60% re­sponse rate with on­ly 2% in the CR range. GSK has high­light­ed this par­tic­u­lar pro­gram as one of its most ad­vanced for their on­col­o­gy group. Am­gen no­table scrapped its own an­ti-BC­MA ADC last Ju­ly af­ter con­clud­ing that BiTE was the bet­ter route.

Bri­an Sko­r­ney

The sup­port­ive note backs a pro­gram that Am­gen — which bought the BiTE from Boehringer in 2016 — has long felt is com­pet­i­tive to CAR-T, able to of­fer a dis­tinct al­ter­na­tive to pa­tients. 

The bb2121 pro­gram has been wide­ly cred­it­ed with the lead, and while it con­tin­ues to de­liv­er sol­id ef­fi­ca­cy da­ta that stays well with­in the range need­ed for an ap­proval, it’s al­so like­ly still quite vul­ner­a­ble to com­pe­ti­tion. 

That’s helped add at­ten­tion to J&J’s work, which part­nered with Chi­na’s Leg­end Biotech­nol­o­gy on their an­ti-BC­MA af­ter re­port­ing stel­lar ini­tial re­sults for its pro­gram at the 2017 AS­CO meet­ing.

So how is all this play­ing out on the street? 

Cel­gene $CELG and blue­bird {BLUE} are both down slight­ly, 1.5% and 3%. Am­gen $AMGN is up 3% and J&J is es­sen­tial­ly flat. GSK $GSK, which has been floun­der­ing, is al­so down slight­ly.

Sko­r­ney notes that the first snap­shot is still large­ly un­der the radar with the fo­cus shift­ing to more ma­ture da­ta at ASH. 

#ES­MO20: Trodelvy da­ta show that Gilead­'s $21B buy­out may have been worth the big pre­mi­um

Gilead CEO Dan O’Day has been on a shopping spree. And while some analysts gawked at the biotech’s recent $21 billion Immunomedics buyout, new data released at virtual ESMO 2020 suggest the acquisition may have been worth the hefty price.

The deal, announced last weekend, gives California-based Gilead $GILD Trodelvy, which was recently approved for metastatic triple-negative breast cancer (mTNBC).

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Dan Skovronsky, Eli Lilly CSO

UP­DAT­ED: 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 bur­nish­es Tagris­so's ad­ju­vant NSCLC pro­file with 'un­prece­dent­ed' re­duc­tion in brain mets. Can they win over skep­tics?

When AstraZeneca trumpeted “momentous” and “transformative” results for Tagrisso earlier this year at ASCO, some practitioners threw cold water on the ADAURA fervor. Sure, the disease-free survival data look good, but overall survival is the endpoint that matters when it comes to choosing adjuvant therapy for non-small cell lung cancer patients, the experts said.

The OS data still aren’t here, but AstraZeneca is back at ESMO to bolster their case with a look at brain metastasis data.

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.

Christian Itin, Autolus CEO (Autolus)

#ES­MO20: Au­to­lus pro­vides glimpse of next-gen­er­a­tion CAR-T pro­gram, show­ing ear­ly pos­i­tive safe­ty da­ta

CAR-T therapies were hailed as a breakthrough when Novartis received the first FDA approval for Kymriah back in 2017. Though highly effective at treating certain types of blood cancers, CAR-Ts are also associated with severe and potentially deadly side effects, including lethal instances of cytokine release syndrome.

With this in mind, Autolus Therapeutics is looking to take a crack at a safer CAR-T and presented Phase II cohort data for its AUTO3 program at virtual ESMO 2020. The data showed that, among the 35 patients in the cohort being treated for r/r diffuse large B cell lymphoma, there were no instances of Grade 3 or higher CRS. Eight individuals saw Grade 1 inflammation while another four patients reached Grade 2.

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#ES­MO20: Alk­er­mes of­fers their first snap­shot of a ben­e­fit for their next-gen IL-2 drug. But why did 1 pa­tient starve to death?

Everyone in the cancer R&D arena is looking to build new franchises around better drugs and combos. And one busy pocket of that space is centered entirely on creating an IL-2 drug that can be as effective as the original without the toxicity that damned it to the sidelines.

Alkermes $ALKS formally tossed its hat into the ring of contenders at virtual ESMO today, highlighting the first glimpse of efficacy for their candidate, ALKS 4230, as both a monotherapy as well as in combination with Merck’s Keytruda.

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Albert Bourla (Photo by Steven Ferdman/Getty Images)

Pfiz­er match­es Mod­er­na with their full Covid-19 tri­al blue­print — As­traZeneca says it will un­veil its pro­to­col 'short­ly'

Yesterday, after sustained public pressure as Moderna released its Phase III Covid-19 trial blueprint, Pfizer released its own full trial design for their vaccine trials. The move was designed to boost transparency and shore up public trust in the vaccines, but it also revealed differences in how the two companies are approaching the much-watched studies while failing to satisfy the demands of the fiercest advocates for transparency.

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Stronger to­geth­er? Boehringer and Mi­rati team to put first KRAS-KRAS com­bo in the clin­ic

Researchers are still waiting to see how much any of the vaunted KRAS drugs now in the clinic can, after decades of preclinical research and some early human studies, help patients. But while they do, two of the leading developers will look to see whether a KRAS-KRAS combo might pose a better shot than any KRAS alone.

Boehringer Ingelheim and Mirati have signed a collaboration to combine Mirati’s closely-watched lead KRAS inhibitor, MRTX849, in a clinical trial with the pan-KRAS blocker that Boehringer has quietly developed with high expectations behind their flashier contenders.

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