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

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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.”

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In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

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Mathai Mammen (Rob Tannenbaum, Endpoints News at BIO 2018)

Math­ai Mam­men makes an abrupt ex­it as head of the big R&D group at J&J

In an after-the-bell shocker, J&J announced Monday evening that Mathai Mammen has abruptly exited J&J as head of its top-10 R&D group.

Recruited from Merck five years ago, where the soft-spoken Mammen was being groomed as the successor to Roger Perlmutter, he had been one of the top-paid R&D chiefs in biopharma. His group spent $12 billion last year on drug development, putting it in the top 5 in the industry.

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Robert Califf, FDA commissioner (Tom Williams/CQ Roll Call via AP Images)

Hop­ing to ex­pand mon­key­pox vac­cine sup­ply, US paves the way for new route of ad­min­is­tra­tion

After making it clear that the US’ current monkeypox vaccine supply is insufficient, the FDA on Tuesday authorized a new route of administration that should increase the number of available doses by five-fold.

Regulators cleared Bavarian Nordic’s Jynneos vaccine for intradermal injection in adults older than 18. Unlike subcutaneous injection — the current method by which vaccine is delivered under the skin — an intradermal jab goes directly into the skin. It’s believed that this method requires less vaccine, since the dermis is rich in dendritic cells which specialize in taking up foreign antigens and presenting them to the immune system, according to Daniel Kuritzkes, chief of infectious diseases at Brigham and Women’s Hospital in Boston.

Samantha Du, Zai Lab CEO

Any­one still look­ing for a CD47? Zai Lab shelves PhI pro­gram af­ter re­view­ing 'com­pet­i­tive land­scape'

Over the past few years, the promise of blocking CD47 — a “don’t eat me” signal co-opted by cancer cells — has sent drugmakers big and small into a frenzy. But one biotech is now bowing out.

Zai Lab is deprioritizing ZL-1201, its CD47 inhibitor, scrapping plans for a Phase II trial. It will now “pursue out-licensing opportunities,” the company said in its Q2 update. The decision was based on a review of the competitive landscape, it added, without going into further details.

Illustration: Kim Ryu for Endpoints News

Why non-opi­oid pain drugs keep fail­ing — and what's next for the field

In 1938, Rita Levi-Montalcini was forced to move her lab into her bedroom in Turin, as Mussolini’s facist government expelled Jewish people from studying or working in schools in Italy. Levi-Montalcini, then just a few years out of medical school and using sewing needles as scalpels in her makeshift lab, would soon discover nerve growth factor, or NGF, in chicken embryos.

Her discoveries formed the basis of our understanding of the peripheral nervous system and how cells talk to each other, and Levi-Montalcini went on to win the Nobel Prize in 1986. Much later, NGF was hailed as a promising target for new pain therapies, with some analysts quoting an $11 billion market. However, the latest anti-NGF candidate, Pfizer and Eli Lilly’s tanezumab, was rejected by the FDA last year because of a side effect that dissolved bone in some of its patients.

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Ted Love, Global Blood Therapeutics CEO

Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

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HHS Secretary Xavier Becerra (Patrick Semansky/AP Images)

US weighs new route of ad­min­is­tra­tion for mon­key­pox vac­cine as cas­es climb — re­port

Less than a week after HHS Secretary Xavier Becerra declared monkeypox a national health emergency, reports have emerged that the US plans to extend its vaccine supply by opting for a different route of administration.

Officials are expected to call for intradermal injection of Bavarian Nordic’s Jynneos vaccine — the only shot approved specifically for monkeypox in the US — as opposed to subcutaneous injection, unnamed sources told both the New York Times and Washington Post on Tuesday.

'Messy at best': Is the US re­peat­ing the same Covid mis­steps with mon­key­pox mes­sag­ing?

When Kyle Planck first suspected he might have monkeypox in late June, he went to the CDC website and found six photos of different types of lesions. And that was about it for general public information.

Planck, who is a sixth-year PhD pharmacology researcher at Weill Cornell, kept looking though and found a separate part of the CDC website meant for healthcare professionals. There he found a medical slide deck with more pictures, professional journal articles and more details about symptoms and diagnosis.

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US to stop sup­ply­ing Lil­ly's mAb for Covid-19 this month as com­mer­cial mar­ket awaits

Federal officials said yesterday that shipments of Eli Lilly’s bebtelovimab — one of the final two remaining mAb treatments for Covid-19 — would halt later this month, setting up a commercial market where the government no longer pays for the doses and hospitals and other clinics will have to purchase supplies.

According to ASPR, the arm of HHS that ships Covid-19 drugs, states have ordered 627,536 bebtelovimab courses, and 383,515 courses have been administered as of July 31. The US has paid Lilly a total of about $1.27 billion for all of the courses so far, amounting to about $2,100 per course to start and then receiving a discounted $1,833 ASP for the later part of the deal. According to the Wall Street Journal, Lilly’s list price for bebtelovimab is $2,100 per dose.