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.

Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Ma­gen­ta halts stem cell work and may sell it­self fol­low­ing pa­tient death, clin­i­cal hold

Magenta Therapeutics said it is halting work on its stem cell transplant drug pipeline and may sell itself, a week after the company reported the death of a patient in an early stage trial of its antibody-drug conjugate.

The Cambridge, MA-based company said it will conduct a “review of strategic alternatives,” and that could include an “acquisition, merger, business combination, or other transaction.”

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How to use ex­ter­nal con­trols: FDA spells out think­ing in new draft guid­ance

The use of real-world evidence to inform the FDA’s decision-making continues apace, with the agency releasing new draft guidance yesterday on how sponsors can compare outcomes of trial participants receiving a test treatment with outcomes in a group of people external to the trial.

The practice of externally controlled trials is common, particularly in oncology or other difficult areas where it’s not ethical or feasible to use internal controls.

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Uğur Şahin, BioNTech CEO (Andreas Arnold/picture-alliance/dpa/AP Images)

BioN­Tech opens new plas­mid DNA man­u­fac­tur­ing fa­cil­i­ty in Ger­many

German mRNA player BioNTech opened the doors to a new manufacturing facility on Thursday, this one just about 75 miles north of its headquarters in Mainz, Germany.

BioNTech announced on Thursday that it has completed the construction of its first plasmid DNA manufacturing facility in Marburg, Germany. The facility will produce materials for mRNA-based vaccines and therapies along with cell therapies.

The Big Phar­ma axe: Mer­ck cuts chikun­gun­ya vax, Bris­tol My­ers drops Cy­tomX-part­nered pro­gram, and more

As fourth quarter earnings come in, Big Pharmas are disclosing changes to their pipelines during their investor calls, and sometimes more quietly in presentation appendices.

Merck dropped its chikungunya vaccine candidate, which completed a Phase II study. Merck acquired the vaccine through its purchase of Themis Bioscience in 2020. In developing a vaccine for chikungunya, a mosquito-borne virus, Valneva is the frontrunner, as it submitted its vaccine to the FDA at the end of December.

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Goldfinch Bio CEO Tony Johnson (L) and Karuna Therapeutics CEO Bill Meury

Karuna li­cens­es Goldfinch as­sets to com­pete with Boehringer In­gel­heim in neu­ro­science

Karuna Therapeutics is looking to compete with Boehringer Ingelheim on depression and anxiety with a new license to Goldfinch Bio’s assets, starting with $15 million to the shuttered biotech.

Karuna steps into an arena already being tested by Boehringer in multiple Phase II studies — the two are targeting transient receptor potential canonical 4 and 5, or TRPC4/5, which is thought to have a role in neuroscience indications. Goldfinch’s asset went through a Phase II in kidney diseases, but Karuna’s sights are set on mood and anxiety disorders for now.

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Teresa Graham, incoming Roche Pharmaceuticals CEO

In­com­ing Roche CEO builds out his top team, tap­ping Genen­tech vet to lead phar­ma di­vi­sion

Roche announced another leadership shuffle Thursday morning – the head of global product strategy, Teresa Graham, will take over as CEO of Roche Pharmaceuticals in March while the company’s corporate executive committee will make a spot for Levi Garraway, CMO and executive VP of global product development.

Thomas Schinecker will take over the top spot as Roche group CEO in March, leaving his spot as head of diagnostics.

Roche's headquarters in Basel, Switzerland (Kyle LaHucik for Endpoints News)

Roche ditch­es fi­nal PhI­II for can­cer hope­ful, re­ports set­back for key drug in $1.4B buy­out

Over the past few years, Roche has released news about its AKT inhibitor ipatasertib in drips — most of them negative. The drug yielded mixed data in a key prostate cancer trial, Phase III flops in triple-negative breast cancer forced the pharma giant to pull the plug there, and in mid-2022 Roche trimmed two more early-stage indications in prostate cancer after completing the trials.

Now, the last piece of the program is gone.

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David Kirn, 4D Molecular Therapeutics CEO (via website)

FDA places hold on 4D Mol­e­c­u­lar’s Fab­ry gene ther­a­py

4D Molecular Therapeutics quietly tucked an FDA clinical hold on its Fabry gene therapy into an SEC filing.

Meanwhile, the biotech issued a press release the same day after the closing bell on Thursday touting an IND for another asset, in diabetic macular edema.

The California biotech had paused enrollment of patients in its two trials of the Fabry gene therapy (4D-310) last month after three patients experienced kidney issues, all of which were resolved within four weeks. At the time, 4DMT said it would wait until the second half of this year to look at 12-month clinical data on six patients in the Phase I/II trials, one in the US and one in Taiwan and Australia.

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