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.”

Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

When will it end? Gold­man econ­o­mist gives late-stage vac­cines a good shot at tar­get­ing 'large shares' of the US by mid-2021 — but the down­side is daunt­ing

It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

With Covid-19, the same timeline has devoured all of 5 months. And the outcome will influence the lives of billions of people and a multitrillion-dollar world economy.

Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can created herd immunity in the US by the middle of next year, with Europe following a few months later.

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J&J gets a fresh OK for es­ke­t­a­mine, but is it re­al­ly the game-chang­er for de­pres­sion Trump keeps tweet­ing about?

Backed by an enthusiastic set of tweets from President Trump and a landmark OK for depression, J&J scooped up a new approval from the FDA for Spravato today. But this latest advance will likely bring fresh scrutiny to a drug that’s spurred some serious questions about the data, as well as the price.

First, the approval.

Regulators stamped their OK on the use of Spravato — developed as esketamine, a nasal spray version of the party drug Special K or ketamine — for patients suffering from major depressive disorder with acute suicidal ideation or behavior.

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FDA hands Mor­phoSys and In­cyte a quick OK on their po­ten­tial block­buster CAR-T al­ter­na­tive

Nearly three years after okaying the CAR-Ts Yescarta and Kymriah, the FDA has approved a new CD19 therapy.

MorphoSys’ Monjuvi, or tafasitamab-cxix, was cleared Friday for use in refractory diffuse large B-cell lymphoma (DBLCL). The approval sets up both MorphoSys and their commercial partner Incyte to compete with Gilead and Novartis in the ultra-competitive indication, where similar trial results and far easier delivery could allow them to cut a fair share of the market.

Sev­en plucky di­ag­nos­tics com­pa­nies win a $249M round of con­tracts af­ter sur­viv­ing NI­H's Covid-19 'Shark Tank' com­pe­ti­tion

As US Covid-19 deaths creep past 150,000 and officials stress the importance of contact tracing, the NIH’s Rapid Acceleration of Diagnostics (RADx) program has inked contracts totaling $248.7 million to expand testing capabilities.

The seven contracts, which were chosen “Shark Tank”-style from a pool of 100 proposals, are part of an effort to bump daily testing capacity to 2% of the country’s population by late summer or fall. That would be about 6 million people per day, compared to the current 520,000 to 823,000 tests being administered daily.

Covid-19 roundup: Eli Lil­ly retro­fits RVs for first-of-its-kind an­ti­body tri­al with NIH; Am­gen, Ab­b­Vie, Take­da team on a drug

Eli Lilly and the NIH are about to start a first-of-its-kind trial that researchers and developers have talked about for months as a way of providing temporary immunity to the most at-risk populations.

Lilly announced this morning that it will start a 2,400-person trial with the National Institute for Allergy and Infectious Diseases to test whether its experimental Covid-19 neutralizing antibody can prevent people in nursing homes and assisted living facilities from developing the disease. The idea, known as passive immunity, is that rather than waiting on a vaccine to induce people to develop antibodies, doctors can give them lab-grown antibodies. Ideally, those antibodies will either attack the new SARS-CoV-2 infection, if the patient has recently been exposed, or persist in the blood for several weeks and prevent infection or disease for that period.

So Covid-19 leader BioN­Tech has a can­cer vac­cine in de­vel­op­ment? Yes, and Re­gen­eron just jumped in for the PhII com­bo study

Before the coronavirus global emergency stole the R&D show in biopharma, the leaders in the race to develop new mRNA therapies had a big interest in determining if their tech could be used to create an effective cancer vaccine after all the first-gen tries had failed to impress. So perhaps it’s not surprising that an early cut of the data at frontrunner BioNTech went largely unnoticed.

Unless you were at Regeneron.

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Sanofi un­der for­mal in­ves­ti­ga­tion for De­pakine al­le­ga­tions; Beam li­cens­es CAR-T tech from Ox­ford Bio­med­ica

Sanofi is facing a formal investigation on manslaughter charges, due to accusations that its epilepsy drug Depakine caused birth malfunctions and slow neurological development when taken during pregnancy.

The French pharma was formally charged in February, years after evidence surfaced that the drug, sodium valproate, posed neurodevelopmental risks. Sodium valproate first hit the market in 1967 for the treatment of epilepsy and bipolar disorder, and is currently prescribed in more than 100 countries.

Rich Heyman (ARCH)

Rich Hey­man joins PMV Phar­ma, a p53 biotech, as it adds $70 mil­lion in Se­ries D

Less than a year after pulling in an impressive $62 million Series C round, PMV Pharma is back at it again.

The Cranbury, NJ-based biotech announced Monday an additional $70 million in Series D financing as it seeks to develop cancer therapies targeting p53 mutations. Additionally, PMV also introduced longtime biotech entrepreneur Rich Heyman as chairman of the board of directors.

“This financing provides PMV Pharma with the resources to expand our pipeline and to potentially advance multiple p53 therapies into the clinic,” said PMV president and CEO David Mack in a statement.

Days af­ter seal­ing Sanofi pact, Kymera beats a path to the Nas­daq with $100M IPO pitch

Back in March, when Kymera Therapeutics closed $102 million in Series C funding led by Biotechnology Value Fund and Redmile Group, CEO Nello Mainolfi noted the protein degradation player was “at the cusp of transitioning” into a fully integrated R&D company. Five months and a major Sanofi pact later, he’s back asking for another little push to get there.

Kymera has penciled in $100 million in its first IPO pitch — although given the public market’s seemingly insatiable appetite for biotechs these days the final figure is anyone’s guess.