Affimed CEO Adi Hoess

Af­fimed spurs promis­ing re­sponse num­bers in NK cell study, but dura­bil­i­ty will be the big ques­tion

Ger­man biotech Af­fimed caught some at­ten­tion ear­li­er this year with a pair of com­plete re­spons­es in an ear­ly study of its NK cell reg­i­men for lym­phoma. The biotech is back with more da­ta from that study, and the re­sults look promis­ing — but will dura­bil­i­ty hold up?

A com­bi­na­tion reg­i­men of donor NK cells and Af­fimed’s CD30-tar­get­ing in­nate cell en­gager AFM13 spurred re­spons­es in 16 of 18 pa­tients with re­lapsed or re­frac­to­ry Hodgkin and non-Hodgkin lym­phomas, in­clud­ing sev­en com­plete re­spons­es, as part of the first of two rounds of treat­ment in a Phase I/II study, the biotech said Mon­day.

In a co­hort of pa­tients treat­ed with the high­est dose of the com­bi­na­tion ther­a­py in the first of two treat­ment rounds, all 12 post­ed an ob­jec­tive re­sponse, in­clud­ing five com­plete re­spons­es and sev­en par­tials, Af­fimed said. All of those pa­tients will be con­tin­ued on a sec­ond round of treat­ment, which in­cludes lym­phode­plet­ing chemother­a­py fol­lowed by a sin­gle in­fu­sion of cord blood-de­rived NK cells “pre-com­plexed” with AFM13 and then three week­ly in­fu­sions of AFM13 so­lo.

Af­fimed al­so tout­ed ear­ly safe­ty da­ta for the ther­a­py with five cas­es of tran­sient in­fu­sion-re­lat­ed re­ac­tions af­ter the monother­a­py in­fu­sions of AFM13 and no se­ri­ous side ef­fects re­port­ed.

This MD An­der­son-spon­sored study turned a few heads back in April when Af­fimed churned out ear­ly da­ta show­ing sig­nif­i­cant dis­ease re­duc­tion in all four lym­phoma pa­tients evalu­able at the time, in­clud­ing two com­plete re­spons­es. The pa­tients in this study were heav­i­ly pre­treat­ed with a me­di­an of six pri­or lines of ther­a­py, and Af­fimed’s think­ing is that AFM13 adds a boost to pa­tients’ in­nate im­mune sys­tems that al­lows NK cells to be more ef­fec­tive in at­tack­ing can­cer. That could po­ten­tial­ly crack wide open the use of ther­a­py in lat­er-line pa­tients, the hard­est to treat.

NK cells them­selves of­fer a tan­ta­liz­ing al­ter­na­tive to T cells, which have shown high ef­fi­ca­cy in at­tack­ing tu­mors but al­so come with well-known dele­te­ri­ous side ef­fects. On the flip side, NK cells have strug­gled to show long-last­ing dura­bil­i­ty in ear­ly tri­als, po­ten­tial­ly re­quir­ing re­peat­ed dos­ing over time.

In Af­fimed’s case, all eyes will be on the sec­ond course of ther­a­py that these ear­ly pa­tients face and whether the com­bo reg­i­men can con­tin­ue to hold up over time. In­vestors ap­peared to be wary of draw­ing too many con­clu­sions head­ing in­to that phase, with shares of the biotech trad­ing down about 3% at the open­ing bell.

Out­side of the AFM13 da­ta, it’s been a qui­et year for Af­fimed af­ter it signed a deal with Roivant back in No­vem­ber 2020 worth $60 mil­lion in cash and down­stream biobucks for a li­cens­ing pact cen­tered on bis­pe­cif­ic an­ti­bod­ies. The Ger­man firm had pre­vi­ous­ly signed a sim­i­lar deal with Genen­tech back in 2018 for $96 mil­lion up­front and a whop­ping $5 bil­lion in mile­stones.

Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

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Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

FDA slams door to piv­otal tri­al for bub­ble boy dis­ease gene ther­a­py as Mus­tang Bio runs in­to an­oth­er hold

Mustang Bio is in familiar territory, but that isn’t a place it necessarily wants to be.

The FDA has placed a hold on Mustang Bio’s pivitol trial for its gene therapy to treat patients with bubble boy disease, citing issues surrounding chemistry, manufacturing and controls clearance. It’s the second hold due to CMC issues the company has received in roughly 18 months.

An investigational new drug application was submitted in December 2021. If granted an IND, a Phase II study will then assess safety, tolerability and efficacy of MB-207. If approved by the FDA, the therapy would one day be eligible for a rare pediatric disease voucher.

Steve Worland, eFFECTOR CEO

Sur­prise piv­ot rocks eF­FEC­TOR's I/O plans — al­though ex­ecs promise big­ger slice of the NSCLC mar­ket in the long run

When eFFECTOR Therapeutics went public last summer on the coattails of a reverse merger with Locust Walk’s SPAC, the potential of its lead drug, tomivosertib, as a combo agent with Merck’s flagship PD-1 Keytruda was hailed as the main draw.

But the biotech is now axing those plans and essentially starting over.

In a surprise move, San Diego-based eFFECTOR said it’s halting the development of tomivosertib in non-small cell lung cancer patients who have already progressed on Keytruda monotherapy after running into enrollment challenges in a Phase IIb trial.

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Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.