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.”

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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Ex-My­lan em­ploy­ee pleads guilty to in­sid­er trad­ing, il­le­gal­ly deal­ing on FDA ap­provals, earn­ings and Up­john merg­er

A former Mylan IT executive pleaded guilty Friday to an insider trading scheme where he bought and sold stock options on another executive’s advice.

Prosecutors secured the plea from Dayakar Mallu, Mylan’s former VP of global operations information technology, after uncovering the plan. Mallu collaborated with an unnamed “senior manager,” the SEC said, to trade options ahead of Mylan public announcements regarding FDA approvals, revenue reports and its merger with the Pfizer generics subsidiary Upjohn. The two subsequently shared profits.

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Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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Rafaèle Tordjman (Jeito Capital)

Con­ti­nu­ity and di­ver­si­ty: Rafaèle Tord­j­man's women-led VC firm tops out first fund at $630M

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.

Mi­rati tri­umphs again in KRAS-mu­tat­ed lung can­cer with a close­ly watched FDA fil­ing now in the cards

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.