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.”

John Hood [file photo]

UP­DATE: Cel­gene and the sci­en­tist who cham­pi­oned fe­dra­tinib's rise from Sanofi's R&D grave­yard win FDA OK

Six years after Sanofi gave it up for dead, the FDA has approved the myelofibrosis drug fedratinib, now owned by Celgene.

The drug will be sold as Inrebic, and will soon land in the portfolio at Bristol-Myers Squibb, which is finalizing a deal to acquire Celgene.

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Ab­b­Vie gets its FDA OK for JAK in­hibitor upadac­i­tinib, but don’t look for this one to hit ex­ecs’ lofty ex­pec­ta­tions

Another big drug approval came through on Friday afternoon as the FDA OK’d AbbVie’s upadacitinib — an oral JAK1 inhibitor that is hitting the rheumatoid arthritis market with a black box warning of serious malignancies, infections and thrombosis reflecting fears associated with the class.

It will be sold as Rinvoq — at a wholesale price of $59,000 a year — and will likely soon face competition from a drug that AbbVie once controlled, and spurned. Reuters reports that a 4-week supply of Humira, by comparison, is $5,174, adding up to about $67,000 a year.

The top 10 fran­chise drugs in bio­phar­ma his­to­ry will earn a to­tal of $1.4T (tril­lion) by 2024 — what does that tell us?

Just in case you were looking for more evidence of just how important Amgen’s patent win on Enbrel is for the company and its investors, EvaluatePharma has come up with a forward-looking consensus estimate on what the list of top 10 drugs will look like in 2024.

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UP­DAT­ED: AveX­is sci­en­tif­ic founder was axed — and No­var­tis names a new CSO in wake of an ethics scan­dal

Now at the center of a storm of controversy over its decision to keep its knowledge of manipulated data hidden from regulators during an FDA review, Novartis CEO Vas Narasimhan has found a longtime veteran in the ranks to head the scientific work underway at AveXis, where the incident occurred. And the scientific founder has hit the exit.

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UP­DAT­ED: Sci­en­tist-CEO ac­cused of im­prop­er­ly us­ing con­fi­den­tial in­fo from uni­corn Alec­tor

The executive team at Alector $ALEC has a bone to pick with scientific co-founder Asa Abeliovich. Their latest quarterly rundown has this brief note buried inside:

On June 18, 2019, we initiated a confidential arbitration proceeding against Dr. Asa Abeliovich, our former consulting co-founder, related to alleged breaches of his consulting agreement and the improper use of our confidential information that he learned during the course of rendering services to us as our consulting Chief Scientific Officer/Chief Innovation Officer. We are in the early stage of this arbitration proceeding and are unable to assess or provide any assurances regarding its possible outcome.

There’s no explicit word in the filing on what kind of confidential info was involved, but the proceeding got started 2 days ahead of Abeliovich’s IPO.

Abeliovich, formerly a tenured associate professor at Columbia, is a top scientist in the field of neurodegeneration, which is where Alector is targeted. More recently, he’s also helped start up Prevail Therapeutics as the CEO, which raised $125 million in an IPO. And there he’s planning on working on new gene therapies that target genetically defined subpopulations of Parkinson’s disease. Followup programs target Gaucher disease, frontotemporal dementia and synucleinopathies.

But this time Abeliovich is the CEO rather than a founding scientist. And some of their pipeline overlaps with Alector’s.

Abeliovich and Prevail, though, aren’t taking this one lying down.

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Chi­na has be­come a CEO-lev­el pri­or­i­ty for multi­na­tion­al phar­ma­ceu­ti­cal com­pa­nies: the trend and the im­pli­ca­tions

After a “hot” period of rapid growth between 2009 and 2012, and a relatively “cooler” period of slower growth from 2013 to 2015, China has once again become a top-of-mind priority for the CEOs of most large, multinational pharmaceutical companies.

At the International Pharma Forum, hosted in March in Beijing by the R&D Based Pharmaceutical Association Committee (RDPAC) and the Pharmaceutical Research and Manufacturers of America (PhRMA), no fewer than seven CEOs of major multinational pharmaceutical firms participated, including GSK, Eli Lilly, LEO Pharma, Merck KGaA, Pfizer, Sanofi and UCB. A few days earlier, the CEOs of several other large multinationals attended the China Development Forum, an annual business forum hosted by the research arm of China’s State Council. It’s hard to imagine any other country, except the US, having such drawing power at CEO level.

ICER blasts FDA, PTC and Sarep­ta for high prices on DMD drugs Em­flaza, Ex­ondys 51

ICER has some strong words for PTC, Sarepta and the FDA as the US drug price watchdog concludes that as currently priced, their respective new treatments for Duchenne muscular dystrophy are decidedly not cost-effective.

The final report — which cements the conclusions of a draft issued in May — incorporates the opinion of a panel of 17 experts ICER convened in a public meeting last month. It also based its analysis of Emflaza (deflazacort) and Exondys 51 (eteplirsen) on updated annual costs of $81,400 and over $1 million, respectively, after citing “incorrect” lower numbers in the initial calculations.

The key dates for KRAS watch­ers through the end of the year — the trail is nar­row and risks are ex­treme

There’s nothing quite like a big patent win when it comes to burnishing your prospects in the pipeline. And for Amgen, which seems to have rescued Enbrel for a run to 2029, the cheering section on Wall Street is now fixed on AMG 510 and a key rival.

And it didn’t take much data to do it. 

There was the first snapshot of a handful of patients, with a 50% response rate. Then came word that Amgen researchers are also tracking responses in different cancers, at least one in colorectal cancer and appendiceal too. 

Bain's Or­ly Mis­han joins Pfiz­er's neu­ro spin­out Cerev­el; On­colyt­ic virus biotech taps Sil­la­Jen ex­ec He­le­na Chaye as CEO

→ Bain Capital is deploying one of its top investors to Cerevel Therapeutics, steering a $350 million-plus neuro play carved out of Pfizer. Orly Mishan — a co-founder and principal of Bain’s life sciences unit — was involved in the partnership that birthed the biotech spinout in the first place. As Cerevel’s first chief business officer, she is tasked with corporate development, program management as well as technical operations.