No­var­tis sends sec­ond wag­on af­ter KRAS gold rush

Join­ing the bar­rage of com­pa­nies dig­ging head­first in­to the new­ly opened KRAS mine, No­var­tis has an­nounced a mul­ti­year agree­ment with Sixth El­e­ment Cap­i­tal and the UK Beat­son In­sti­tute for Can­cer Re­search to de­vel­op small mol­e­cules iden­ti­fied by the in­sti­tute’s drug dis­cov­ery unit.

The deal, whose specifics have not been dis­closed, is the Swiss gi­ant’s sec­ond KRAS col­lab­o­ra­tion since June, when Am­gen elec­tri­fied the field by re­veal­ing the first pa­tient ef­fi­ca­cy da­ta from a ther­a­py aimed at one of the most per­va­sive, old­est and eva­sive can­cer mu­ta­tion tar­gets. In Ju­ly, No­var­tis inked a low-mon­ey deal with Mi­rati Ther­a­peu­tics.

That deal would see No­var­tis pair­ing its SHP2 in­hibitor with Mi­rati’s years-in-the-mak­ing KRAS G12C in­hibitor, act­ing on a pop­u­lar the­o­ry that com­bin­ing a KRAS in­hibitor with an­oth­er in­hibitor – and par­tic­u­lar­ly SHP2 – will af­fect the pro­tein’s cy­cles and make it an eas­i­er tar­get.  The idea earned Rev­o­lu­tion Med­i­cines $100 mil­lion in fund­ing on the same day.

This new col­lab­o­ra­tion will see No­var­tis dig its hands di­rect­ly in­to RAS in­hibitors as it works to turn the Beat­son’s mol­e­cules in­to ac­tion­able ther­a­pies. Sixth El­e­ment Cap­i­tal’s CRT Pi­o­neer Fund will re­ceive an up­front pay­ment to fund can­cer re­search at the Beat­son In­sti­tute, along with po­ten­tial mile­stones and sin­gle-dig­it roy­al­ties.

De­spite the re­cent tor­rent of cash and col­lab­o­ra­tions that have flood­ed the KRAS field, clin­i­cal ev­i­dence is still scant. Am­gen’s sec­ond up­date from tri­als on their in­hibitor, AMG510, at the end of Sep­tem­ber was far less promis­ing than their first roll­out on lung can­cer, with a sin­gle par­tial re­sponse out of 12 col­orec­tal can­cer pa­tients. The ini­tial lung can­cer group showed 7 out of 13 pa­tients re­spond­ed.

Am­gen on­col­o­gy head Greg Friberg, though, said at the time that was to a de­gree ex­pect­ed: Colon can­cer is bi­o­log­i­cal­ly more com­plex than lung can­cer and thus a hard­er tar­get.

We’ll know more Mon­day af­ter­noon, when Mi­rati un­veils the first look at their clin­i­cal tri­al. Af­ter 40 years of mol­e­c­u­lar and pre-clin­i­cal work, the tor­rent of clin­i­cal da­ta is just be­gin­ning.

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

The End­points 11: They've got mad mon­ey and huge am­bi­tions. It's time to go big or go home

These days, selecting a group of private biotechs for the Endpoints 11 spotlight begins with a sprint to get ahead of IPOs and the M&A teams at Big Pharma. I’ve had a couple of face plants earlier this year, watching some of the biotechs on my short list choose a quick leap onto Nasdaq or into the arms of a buyer.

Vividion, you would have been a great pick for the Endpoints 11. I’m sorry I missed you.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Dave Lennon, former president of Novartis Gene Therapies

So what hap­pened with No­var­tis Gene Ther­a­pies? 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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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.

FDA+ roundup: Bs­U­FA III ready for show­time, court tells FDA to re-work com­pound­ing plan, new guid­ance up­dates and more

The FDA has now spelled out what exactly will be included in the third iteration of Biosimilar User Fee Act (BsUFA) from 2023 through 2027, which similarly to the prescription drug deal, sets fees that industry has to pay for submitting applications, in exchange for firm timelines that the agency must meet.

This latest deal includes several sweeteners for the biosimilar industry, which has yet to make great strides in the US market, with shorter review timelines for safety labeling updates and updates to add or remove an indication that does not contain efficacy data.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Paul Hudson, Sanofi CEO (Raphael Lafargue/Abaca/Sipa USA; Sipa via AP Images)

In­side look: How a po­ten­tial part­ner­ship turned in­to a $1.9B buy­out for Sanofi

A couple of months before the FDA was set to make a decision on Kadmon’s so-called “knock-your-socks-off kind of results” for its chronic graft-versus-host disease drug, Sanofi put out feelers for a potential collaboration. But an early approval triggered an offer to buy the company outright — and Sanofi didn’t win without a fight, according to an inside look.

Sanofi’s head of business development and licensing Matthieu Merlin reached out to Kadmon on June 26 with a simple request: He wanted to introduce himself and explore potential partnerships, according to an SEC filing. It had been several months since Kadmon’s belumosudil arrived on the FDA’s doorstep, and after delaying their decision once, regulators said they’d have an answer by Aug. 30. But Sanofi wasn’t the only company interested in getting to know the execs over at Kadmon.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 117,900+ biopharma pros reading Endpoints daily — and it's free.

Jean Bennett (Brent N. Clarke/Invision/AP Images)

Lux­tur­na in­ven­tor Jean Ben­nett starts a new gene ther­a­py com­pa­ny to tack­le rare dis­eases left be­hind by phar­ma, VCs

A few years ago Jean Bennett found herself in a surprising place for a woman who invented the first gene therapy ever approved in the United States: No one, it seemed, wanted her work.

Bennett, who designed and co-developed Luxturna, approved in 2018 for a rare form of blindness, had kept building new gene therapies for eye diseases at her University of Pennsylvania lab. But although the results in animals looked promising, pharma companies and investors kept turning down the pedigreed ophthalmology professor.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 117,900+ biopharma pros reading Endpoints daily — and it's free.

Maureen Hillenmeyer, Hexagon Bio CEO

Hexa­gon Bio rais­es $61M to con­tin­ue ef­forts to turn fun­gi in­to drugs

A year after raising a $47 million launch round, the fungi-loving drug hunters at Hexagon Bio have more than doubled their coffers.

Hexagon announced today that it raised another $61 million for its efforts to design cancer and infectious disease drugs based on insights mined from the DNA in millions of species of fungi. The new financing brings Hexagon’s committed funding to over $108 million.