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.

Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

Roger Perlmutter, Eikon Therapeutics CEO

Roger Perl­mut­ter builds Eikon's pipeline with deal-mak­ing flur­ry, rais­ing $106M more

Eikon Therapeutics announced three business development deals on Thursday, effectively dropping in a pipeline of cancer drugs alongside more than $100 million in fresh funding.

The Hayward, CA-based company has become one of biotech’s richest startups since its 2019 founding, having raised nearly $775 million. It’s developing a massive, automated research approach built around Nobel Prize-winning microscope science to peer inside cells and watch proteins in action. After its Series B last year, PitchBook reported a $3.02 billion valuation. And while CEO Roger Perlmutter declined to comment on that figure, he said its first tranche of nearly $106 million in Series C funding is a “meaningful step-up to our Series B valuation.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,400+ biopharma pros reading Endpoints daily — and it's free.

Peter van de Sande, Synaffix CEO

Lon­za shells out $107M cash to snap up Synaf­fix and its ADC plat­form

After lining up a string of partnerships over the years, Dutch antibody-drug conjugate specialist Synaffix has found a new home: Lonza, the contract development and manufacturing giant.

Lonza is paying about $107 million (€100 million) in cash to acquire Synaffix, with up to $64 million (€60 million) in “additional performance-based consideration” on the table. Synaffix’s ADC tech platform will now become part of Lonza’s offering for biopharma clients, lending its bioconjugate technologies to not just ADCs but also targeted gene therapy, immune cell engagers and other applications.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,400+ biopharma pros reading Endpoints daily — and it's free.

Eu­ro­pean Par­lia­ment calls mem­ber states to ac­tion on an­timi­cro­bial re­sis­tance

Members of the European Parliament have called on EU countries to develop national action plans against antimicrobial resistance (AMR), calling it a top-three priority health threat.

Parliament on Thursday announced recommendations for the fight against AMR, including national action plans that must be updated at least every two years, an EU-level database tracking AMR and antimicrobial use and increased partnership between the pharma industry, patient groups and academia.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,400+ biopharma pros reading Endpoints daily — and it's free.

Roche plans to di­vest from lega­cy Genen­tech man­u­fac­tur­ing fa­cil­i­ty in Cal­i­for­nia

Roche is planning to make some changes to its subsidiary’s manufacturing network in California.

The Swiss pharma announced Wednesday that it plans to divest from Genentech’s manufacturing facility in Vacaville, CA, around 58 miles northeast of San Francisco. According to a statement from Roche, the move is part of a “broader strategy” to bring its manufacturing capabilities in line with its future pipeline. Roche is starting the process of finding a buyer for the site but has not named any candidates yet.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,400+ biopharma pros reading Endpoints daily — and it's free.

Who's con­fi­dent­ly in­vest­ing in biotech star­tups dur­ing these tense days? We've got some an­swers

We’ve got a changeup to our event schedule in Boston next week, where we’ll be doing a mix of live/streaming events at our base at The Seaport Hotel as part of a two-day lineup of webinars, virtual firesides and a cocktail hour Q&A with a veteran of the biotech financing scene.

The 9:30-10:30 am ET live slot on Tuesday, June 6, will now feature a panel conversation on the current state of affairs for VC investing in biotech, focusing on what startups are getting cash — and how. Alaa Halawa, head of US ventures at Mubadala, is confirmed, along with Brian Goodman at MPM and Geoff von Maltzahn, a general partner at Moderna-buoyed Flagship. I have a couple of other invites out and will let you know how that plays out.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,400+ biopharma pros reading Endpoints daily — and it's free.

The Modulo Bio team with CEO Michael Horowitz (fourth from right in semicircle)

Ex­clu­sive: With $8M, neu­ro start­up Mod­u­lo Bio emerges to test small mol­e­cules for ALS, de­men­tia in CEO’s per­son­al mis­sion

Embarking on a personal mission after his best friend’s mother was diagnosed with a mutation-driven case of frontotemporal dementia, Michael Horowitz has pulled together $8 million in venture funding at Modulo Bio to create small molecules for neurodegenerative diseases.

The San Diego and Bay Area biotech will select its lead development candidate and some backup options within six months and then raise a Series A to investigate therapeutics for C9orf72 mutation-driven cases of ALS and frontotemporal dementia, Horowitz told Endpoints News.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,400+ biopharma pros reading Endpoints daily — and it's free.

Albert Bourla, Pfizer CEO (Michel Euler/AP Images, Pool)

FDA ap­proves Pfiz­er’s RSV shot for old­er adults, tee­ing up a com­pet­i­tive $17B vac­cine mar­ket

The FDA approved Pfizer’s RSV vaccine called Abrysvo for older adults on Wednesday, placing another Big Pharma onto the commercial stage ahead of the next RSV season.

Pfizer’s approval comes weeks after GSK won approval for its rival shot, Arexvy. Those two vaccines are both approved for use in adults 60 years and older and will be reviewed by a CDC panel in June before they’re expected to commercially launch this fall. Wall Street analysts see RSV as the next multibillion-dollar vaccine market, with Jefferies analysts recently forecasting the RSV market will grow to $17 billion over the next decade.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,400+ biopharma pros reading Endpoints daily — and it's free.

Richard Pazdur, FDA's OCE director (Flatiron Health via YouTube)

FDA's can­cer chief weighs in on com­mon chemo short­ages — re­port

Richard Pazdur, director of the FDA’s Oncology Center of Excellence, attributes the current shortage of two cancer drugs to drug companies that haven’t invested in building out their production capacity.

In an interview with The Cancer Letter, a weekly cancer publication, Pazdur said that the current shortages of cisplatin and carboplatin, a pair of drugs used to treat a wide range of cancer patients, are the result of two problems: manufacturers not investing in enhancing production capacity, and drug companies being dependent on one supplier of raw ingredients. The cisplatin shortage followed an inspection that revealed quality issues at a manufacturing facility, which then led to the shutdown of production. This led to a surge in carboplatin demand, creating a secondary shortage.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,400+ biopharma pros reading Endpoints daily — and it's free.