The new Cin­derel­la sto­ry: Can­cer pow­er­house Genen­tech lines up an NK al­liance with Af­fimed loaded with bil­lions in biobucks

Eight years af­ter lit­tle Af­fimed was found­ed in Ger­many, it’s be­come the new Cin­derel­la of the glob­al biotech scene, with Genen­tech play­ing the role of Prince Charm­ing — of­fer­ing the keys to the king­dom and a glass R&D slip­per that seems to fit just right.

The lit­tle Ger­man biotech Af­fimed $AFMD has snagged a $96 mil­lion up­front and near-term fi­nanc­ing op­por­tu­ni­ties to part­ner with the pow­er­house can­cer team at Genen­tech on its nat­ur­al killer cell plat­form for can­cer. And the bar­gain­ing ta­ble is weighed down with up to $5 bil­lion in biobucks in ex­change for a moth­er lode of mile­stones and roy­al­ties.

In re­turn Af­fimed — which we last saw get­ting whupped up on last sum­mer —  can now count it­self as a close part­ner with one of those trans­for­ma­tive al­liances that most biotechs can on­ly dream about.

Adi Hoess

Click on the im­age to see the full-sized ver­sion

Genen­tech “rec­og­nized that we have a new sci­ence based around in­nate im­mune cells,” Af­fimed CEO Adi Hoess tells me. While Af­firmed has a staff of 60 now, fo­cused on nat­ur­al killer cells and T cell en­gagers, Hoess and his ex­ec­u­tive team say that the new deal will be con­cen­trat­ing on NK cells, where Genen­tech has the most to gain.

This deal com­bines Genen­tech’s deep ex­pe­ri­ence with tu­mor bi­ol­o­gy with the biotech’s own know-how in ac­ti­vat­ing NK cells while us­ing a plat­form tech that the CEO de­scribes as a “sim­pli­fied en­gi­neer­ing sys­tem” that can cre­ate new ther­a­peu­tics with­out the need for adding a lot of staff. The plat­form spe­cial­izes in “tetrava­lent, mul­ti-spe­cif­ic im­mune cell en­gagers,” with an an­ti­body ap­proach that ap­plies to a va­ri­ety of dis­ease set­tings, bring­ing in the tu­mor cell killers need­ed to di­rect­ly en­gage can­cer.

And Hoess — who al­so has a sis­ter sub­sidiary com­pa­ny that spe­cial­izes in an­ti­bod­ies called AbCheck — says there’s lots for both sides to learn from as they ex­plore NK and macrophage ac­ti­va­tion, tee­ing up new pro­grams that Genen­tech will be re­spon­si­ble for tak­ing through the clin­ic.

Hoess is al­so hap­py that the new deal gives his com­pa­ny the cash it needs to start po­si­tion­ing their own lead ther­a­pies for piv­otal stud­ies — drugs that re­main whol­ly owned by the biotech.

James Sabry

This is the first new deal struck by James Sabry since he jumped from his post as deal czar at Genen­tech to the ex­ec­u­tive com­mit­tee in Basel re­spon­si­ble for BD for all of Roche. But it does have all the tra­di­tion­al thumbprints that you’d nor­mal­ly as­so­ciate with Genen­tech, which has nev­er been par­tic­u­lar­ly splashy about its deal­mak­ing plans.

I last re­port­ed on Af­fimed in the wake of the Eu­ro­pean Hema­tol­ogy As­so­ci­a­tion meet­ing last June, when its stock was banged up af­ter the biotech not­ed that its lead drug AFM13, an NK cell en­gager can­di­date, had hit its tar­get on 16 of 18 pa­tients.

By the end of the day Tues­day, though, the stock punched through the roof at Nas­daq, ris­ing 247% on the deal.

Genen­tech has been steadi­ly bleed­ing tal­ent in the wake of the big Roche buy­out. And a re­cent re­or­ga­ni­za­tion in the Bay Area has spurred some trou­bled think­ing that Roche’s long­time hands-off ap­proach to the big biotech has come to a close. 

Sabry, though, is still swing­ing away.

“This col­lab­o­ra­tion is based on Af­fimed’s in­nate im­mune cell drug dis­cov­ery and de­vel­op­ment ex­per­tise and our team’s deep un­der­stand­ing of can­cer im­munol­o­gy,” com­ment­ed Sabry, the new­ly dubbed head of part­ner­ing for Roche. “Our part­ner­ship with Af­fimed pro­vides an op­por­tu­ni­ty to en­hance our ex­ist­ing ef­forts to un­der­stand how the im­mune sys­tem can be ac­ti­vat­ed to help peo­ple liv­ing with can­cer.”

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Janet Woodcock, acting FDA commissioner (Al Drago/Bloomberg via Getty Images)

New Alzheimer's drug ap­proval fall­out: Pub­lic Cit­i­zen seeks re­moval of FDA's Wood­cock, Cavaz­zoni and Dunn

As Capitol Hill begins to wake up to the financial and scientific mess behind the FDA’s approval of Biogen’s new controversial Alzheimer’s drug Aduhelm, nonprofit watchdog Public Citizen is now calling for the top three FDA officials who are responsible to be removed from their positions.

In a letter to HHS Secretary Xavier Becerra on Wednesday, the group highlighted the “litany of flaws” in the FDA’s approval of the new drug, including the “unprecedented, inappropriately close” collaboration between the FDA and Biogen in the analysis of key trial data, basing approval on an unvalidated surrogate endpoint, not following the advice of its expert advisory committee (3 members of which have since resigned), and the wide label that the agency granted.

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Barry Greene, Sage CEO

UP­DAT­ED: Sage's sec­ond chance at de­pres­sion hits the PhI­II pri­ma­ry, but ques­tions re­main over dura­bil­i­ty, side ef­fects

Looking to make a comeback after a big Phase III flop, Sage Therapeutics revealed data they believe could change the entire depression treatment landscape, given the vast array of failures in the field. But some results are spooking investors, sending Sage $SAGE shares down early Tuesday.

First, the primary: Sage and Biogen reported Phase III data for once-daily zuranolone Tuesday morning, saying the experimental drug hit its primary endpoint by spurring a statistically significant change from baseline in the 17-item Hamilton Rating Scale for Depression total score. After 15 days, patients in the drug arm saw an average change of -14.1 points, compared to -12.3 on placebo.

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In a first, Re­gen­eron's an­ti­body cock­tail re­duces deaths for a sub­group of hos­pi­tal­ized Covid-19 pa­tients

Scientists have come up with the first evidence that Regeneron’s antibody cocktail, which has so far only been authorized for the outpatient setting, may reduce deaths of hospitalized Covid-19 patients — albeit only a subset.

The combination of casirivimab and imdevimab is the subject of the latest data cut from RECOVERY, the large-scale UK-based trial testing a variety of potential treatments. In total, 9,785 patients hospitalized with Covid-19 were enrolled in this arm of the study and were randomly assigned to receive either usual care plus the intravenous combo or usual care alone.

Bio­gen sig­nals a big PhI­II fail­ure as the lead gene ther­a­py in their $800M Night­star buy­out goes down in flames

That $800 million buyout of Nightstar has turned into a bust for Biogen as the lead therapy in the deal failed a pivotal study, signaling a severe setback for the biotech’s ambitions in gene therapies.

The big biotech put out the word after the market closed on Monday that the gene therapy they picked up in the deal for a degenerative blindness called choroideremia failed the Phase III study, just a month after their #2 drug in the deal also flopped in a mid-stage study.

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Lynn Fitch, Mississippi Attorney General (Rogelio V. Solis/AP Images)

Mis­sis­sip­pi sues Eli Lil­ly, Sanofi and No­vo over in­sulin prices as in­ter­change­able biosim­i­lars may ar­rive soon

Mississippi Attorney General Lynn Fitch last week sued the top three insulin manufacturers, which collectively cover almost the entire US insulin market, alleging that they’ve colluded to raise their prices in lockstep, and in some cases by more than 1,000% for drugs that are decades old.

“Because of Manufacturer Defendants’ collusive price increases, nearly a century after the discovery of insulin, diabetes medications have become unaffordable for many diabetics,” the lawsuit says.

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CEO Harith Rajagopalan (Fractyl)

Af­ter a decade in the type 2 di­a­betes game, Fractyl Lab­o­ra­to­ries recharges with a fresh $100M and a new name

Harith Rajagopalan compared the way type 2 diabetes is managed to sticking your fingers in a dam that’s leaking from a number of places.

You can take drugs to lower your blood sugar, cholesterol, or blood pressure, but you’re not addressing what he says is the core issue — the metabolic abnormality that causes the disease.

“We’re so busy plugging the holes in the dam, we don’t have time to see that the whole infrastructure is at risk,” he said. “That infrastructure is a full-body systemic metabolic abnormality called metabolic syndrome, that we’re ignoring while we’re so busy trying to treat all of the individual symptoms of the condition.”

Michel Sade­lain puts his name and new cell en­gi­neer­ing tech be­hind 'ag­nos­tic' CAR-T start­up chas­ing epi­ge­net­ic anti­gens

It felt natural for Alain Maiore and Sebastian Amigorena to bring in Michel Sadelain as a co-founder of Mnemo Therapeutics. A CAR-T pioneer, Sadelain had been involved as an advisor since the early days — enthusiastic about Amigorena’s work in a genetic knockout that could enhance T cell memory and a new class of potential targets he’s discovered — and could introduce some well-known technologies to the toolbox. So they got the initial cash from Sofinnova Partners to plant roots in Paris and New York in early 2019; within a few months, they began to see more clearly just what the antigen discovery platform might unlock.

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Andrew Hopkins, Exscientia CEO

Ex­sci­en­tia spends Soft­Bank's cash in bid to edge out AI ri­vals

Exscientia is sprinting to win the great AI biotech race.

The UK company, having long labored on small discovery deals with large pharmas, raised up to $525 million in a Series D led by the infamous Japanese conglomerate SoftBank in April and followed it up less than a month later with a Bristol Myers Squibb deal that paid $50 million cash and $1.2 billion in milestones.

Now, the Oxford spinout is splurging on a shiny new tool. On Monday they announced they purchased the three-year-old molecule-screening biotech Allcyte, a longtime collaborator, for $60.6 million in cash and stock.

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