No thanks: Roche backs out of EGFR-re­lat­ed pro­tein de­graders in re­vised deal with C4

Roche and C4 Ther­a­peu­tics have been col­lab­o­ra­tors since 2016, and the re­la­tion­ship has proved fruit­ful for the biotech that just went pub­lic a lit­tle over a month ago.

But the Swiss Phar­ma is now punt­ing on one of the pro­tein degra­da­tion pro­grams in the part­ner­ship. Roche is hand­ing back the pro­gram tar­get­ing EGFR to C4, the biotech said Thurs­day in re­port­ing its third-quar­ter fi­nan­cials. C4 was orig­i­nal­ly no­ti­fied by Roche in June.

When the com­pa­nies first en­tered in­to their agree­ment, the deal had al­lowed C4 to de­vel­op their pro­tein de­graders for up to 10 tar­gets, with Roche hand­ing over $15 mil­lion up­front. C4 was al­so el­i­gi­ble to re­ceive up to $277 mil­lion in mile­stone pay­ments for each pro­gram Roche de­cid­ed to pick up, as well as up to $150 mil­lion in one-time pay­ments for the first prod­uct to hit a cer­tain lev­el of net sales.

Roche and C4 then re­vised the agree­ment in De­cem­ber 2018, down­siz­ing the num­ber of tar­gets to 6 and se­cur­ing an­oth­er up­front Roche pay­ment of $40 mil­lion. The amend­ed deal al­so called for split­ting de­vel­op­ment costs in re­turn for a larg­er share of fu­ture sales. Ad­di­tion­al­ly, Roche picked up three of the six po­ten­tial tar­gets.

Now though, Roche is re­turn­ing EGFR pro­tein de­graders en­tire­ly to C4. Through the col­lab­o­ra­tion, the com­pa­nies are al­lowed to break off on a pro­gram-by-pro­gram ba­sis and by mode of ac­tion. As such, EGFR in­hibitors are now en­tire­ly Roche prop­er­ty while EGFR de­graders be­long sole­ly to C4.

Noth­ing in C4’s cur­rent pipeline, which con­tains two pre­clin­i­cal can­di­dates and two still in the dis­cov­ery phase, fea­tures an EGFR pro­tein de­grad­er, though it’s un­clear for how long that will re­main. The one pro­gram in C4’s pipeline that’s emerged from this col­lab­o­ra­tion so far is tar­get­ing ge­net­i­cal­ly de­fined re­sis­tant sol­id tu­mors. That mol­e­cule works by bind­ing on one end to the dis­ease-caus­ing tar­get pro­tein with the oth­er end bind­ing to the E3 lig­ase.

Pro­tein degra­da­tion has been a hot top­ic in on­col­o­gy in re­cent years, with C4 com­pet­ing with the likes of Arv­inas and Kymera in the field. Roche al­so has a deal with Arv­inas, signed back in 2015, and paid $135 mil­lion in cash this past May to part­ner with Vi­vid­ion.

But the Swiss phar­ma has de­cid­ed it no longer wants to work on EGFR de­graders with C4.

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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So what hap­pened with No­var­tis' gene ther­a­py group? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

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.

Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a specific market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval.

The research comes as the FDA is at a crossroads with its expedited-review pathways. The accelerated approval pathway is under fire as the agency recently signed off on a controversial new Alzheimer’s drug, with little precedent to explain its decision. Meanwhile, top officials like Rick Pazdur have called for a major push to simplify and clarify all of the various expedited pathways, which have grown to be must-haves for sponsors of nearly every newly approved drug.

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Lat­est news: It’s a no on uni­ver­sal boost­ers; Pa­tient death stuns gene ther­a­py field; In­side Tril­li­um’s $2.3B turn­around; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Next week is shaping up to be a busy one, as our editor-in-chief John Carroll and managing editor Kyle Blankenship lead back-to-back discussions with a great group of experts to discuss the weekend news and trends. John will be spending 30 minutes with Jake Van Naarden, the CEO of Lilly Oncology, and Kyle has a brilliant panel lined up: Harvard’s Cigall Kadoch, Susan Galbraith, the new head of cancer R&D at AstraZeneca, Roy Baynes at Merck, and James Christensen at Mirati. Don’t miss out on the action — sign up here.

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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.