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.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Dipal Doshi, Entrada Therapeutics CEO

Ver­tex just found the next big ‘trans­for­ma­tive’ thing for the pipeline — at a biotech just down the street

Back in the summer of 2019, when I was covering Vertex’s executive chairman Jeff Leiden’s plans for the pipeline, I picked up on a distinct focus on myotonic dystrophy Type I, or DM1 — one of what Leiden called “two diseases (with DMD) we’re interested in and we continue to look for those assets.”

Today, Leiden’s successor at the helm of Vertex, CEO Reshma Kewalramani, is plunking down $250 million in cash to go the extra mile on DM1. The lion’s share of that is for the upfront, with a small reserve for equity in a deal that lines Vertex up with a neighbor in Seaport that has been rather quietly going at both of Vertex’s early disease targets with preclinical assets.

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Christian Itin, Autolus CEO (UKBIO19)

Au­to­lus tips its hand, bags $220M as CAR-T show­down with Gilead looms

The first batch of pivotal data on Autolus Therapeutics’ CAR-T is in, and execs are ready to plot a path to market.

With an overall remission rate of 70% at the interim analysis featuring 50 patients, the results set the stage for a BLA filing by the end of 2023, said CEO Christian Itin.

Perhaps more importantly — given that Autolus’ drug, obe-cel, is going after an indication that Gilead’s Tecartus is already approved for — the biotech highlighted “encouraging safety data” in the trial, with a low percentage of patients experiencing severe immune responses.

Rami Elghandour, Arcellx CEO

Up­dat­ed: Gilead, Ar­cel­lx team up on an­ti-BC­MA CAR-T as biotech touts a 100% re­sponse rate at #ASH22

Gilead and Kite are plunking down big cash to get into the anti-BCMA CAR-T game.

The pair will shell out $225 million in cash upfront and $100 million in equity to Arcellx, Kite announced Friday morning, to develop the biotech’s lead CAR-T program together. Kite will handle commercialization and co-development with Arcellx, and profits in the US will be split 50-50.

Concurrent with the deal, Arcellx revealed its latest cut of data for the program known as CART-ddBCMA, ahead of a full presentation at this weekend’s ASH conference — a 100% response rate among patients getting the therapy. Investors jumped at the dual announcements, sending Arcellx shares $ACLX up more than 25% in Friday’s morning session.

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WIB22: Am­ber Salz­man had few op­tions when her son was di­ag­nosed with a rare ge­net­ic dis­ease. So she cre­at­ed a bet­ter one

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

Amber Salzman’s life changed on a cold, damp day in Paris over tiny plastic cups of lukewarm tea.

She was meeting with Patrick Aubourg, a French neurologist studying adrenoleukodystrophy, or ALD, a rare genetic condition that causes rapid neurological decline in young boys. It’s a sinister disease that often leads to disability or death within just a few years. Salzman’s nephew was diagnosed at just 6 or 7 years old, and died at the age of 12.

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Ahead of ad­comm, FDA rais­es un­cer­tain­ties on ben­e­fit-risk pro­file of Cy­to­ki­net­ic­s' po­ten­tial heart drug

The FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet next Tuesday to discuss whether Cytokinetics’ potential heart drug can safely reduce the risk of cardiovascular death and heart failure in patients with symptomatic chronic heart failure with reduced ejection fraction.

The drug, known as omecamtiv mecarbil and in development for more than 15 years, has seen mixed results, with a first Phase III readout from November 2020 hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as key to breaking into the market.

Ab­b­Vie slapped with age dis­crim­i­na­tion law­suit, fol­low­ing oth­er phar­mas

Add AbbVie to the list of pharma companies currently facing age discrimination allegations.

Pennsylvania resident Thomas Hesch filed suit against AbbVie on Wednesday, accusing the company of passing him over for promotions in favor of younger candidates.

Despite 30 years of pharma experience, “Hesch has consistently seen younger, less qualified employees promoted over him,” the complaint states.

WIB22: Lead­ing NK cell re­searcher re­flects on roots in Iran, the UK and Texas

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

In a small but widely-cited 11-person study published in NEJM in 2020, seven patients saw signs of their cancer completely go away after getting a new therapy made from natural killer cells. The study was one of the earliest to provide clinical proof that the experimental treatment method had promise.

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Jonathan Lim, Erasca CEO (ARCH Venture Partners)

Eras­ca delves fur­ther in­to RAS/MAPK with No­var­tis drug, prices $100M of­fer­ing

After receiving feedback on pivotal studies from European regulators, but not yet the FDA, Novartis is out-licensing a pan-RAF inhibitor going after tumors excited by the RAS/MAPK pathway.

To get the exclusive worldwide license to the asset, Erasca is paying the Swiss Big Pharma $20 million upfront in cash and $80 million worth of shares. Erasca CEO Jonathan Lim told analysts Friday morning that the process was “competitive,” implying his biotech was far from the only one attempting to snag the drug from Novartis, which is going through a reorganization and a fine-tuning to its pipeline.

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