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.

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

'Chang­ing the whole game of drug dis­cov­ery': Leg­endary R&D vet Roger Perl­mut­ter leaps back in­to work as a biotech CEO

Roger Perlmutter needs no introduction to anyone remotely involved in biopharma. As the R&D chief first at Amgen and then Merck, he’s built a stellar reputation and a prolific career steering new drugs toward the market for everything from cancer to infectious diseases.

But for years, he’s also held a less known title: science partner at The Column Group, where he’s regularly consulted about the various ideas the VCs had for new startups.

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UP­DAT­ED: Pfiz­er hits the brakes on their piv­otal tri­al for a BC­MA/CD3 bis­pe­cif­ic on safe­ty con­cerns while FDA road­block is hold­ing up Duchenne MD PhI­II

Pfizer’s ambitious plan to take a Phase II study of its BCMA CD3-targeted bispecific antibody elranatamab (PF-06863135) and run it through to an accelerated approval has derailed.

The pharma giant said in a release this morning that they have halted enrollment for their MagnetisMM-3 study after researchers tracked three cases of peripheral neuropathy in the ongoing Phase I. They are now sharing info with the FDA as they explore the red safety flag.

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Joe Wiley, Amryt CEO

A biotech with a yen for pricey rare dis­ease drugs — and bar­gain base­ment shop­ping — adopts an­oth­er or­phan in lat­est M&A pact

After making it through a long, painful haul to get past a CRL and on to an FDA approval last summer, little Chiasma has found a buyer.

Amryt $AMYT, a company known for its appetite for acquiring expensive drugs for rare diseases at bargain prices, snagged Chiasma and its acromegaly drug Mycapssa (octreotide) capsules in an all-stock deal — with an exchange of 0.396 shares of Amryt for every share of Chiasma.

FDA ex­tends re­search agree­ment with MIT-li­censed or­gan-on-chip sys­tems

The FDA on Wednesday extended its four-year agreement with CN Bio, a developer of single- and multi-organ-on-chip systems used for drug discovery, for another three years.

CN Bio said the scope of the research performed by the FDA’s Center for Drug Evaluation and Research has expanded to include the exploration of the company’s lung-on-a-chip system to help with the agency’s evaluation of inhaled drugs, in addition to the agency’s work on its liver model.

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In quest to meet user fee goals, FDA’s per­for­mance con­tin­ues down­ward trend

A recent update to the FDA’s running tally of how it’s meeting its user fee-related performance goals during the pandemic shows an agency that is not out of the woods yet.

The latest numbers reveal that for a second straight quarter in 2021, the FDA has met its user fee goal dates for 93% of original new drug applications, which compares with 94% and 98% for the previous two quarters in 2020, respectively.

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Al­ta­sciences, true to its word, ex­pands its foot­print with ac­qui­si­tion of Penn­syl­va­nia CRO

A Canadian CDMO with roots in Seattle is coming to the east coast.

Altasciences announced the acquisition of Calvert Laboratories Wednesday, a preclinical CRO in Pennsylvania. The move will complement Altasciences’ Seattle-area operations.

Headquartered in Laval, Canada, Altasciences operates six facilities that run the gamut on early drug development: preclinical safety testing, clinical pharmacology, bioanalytical, CRO services, and even CDMO capacity. Novo Holdings scooped them up in February with the goal of courting small and medium-sized biopharma clients. CEO Chris Perkin said back in February that the move would help the company foster its ambitious growth plan, and this acquisition and the presence it brings to the east coast is evidence.

Johnson Lau (front), Athenex CEO (Derek Gee/Buffalo News via AP Images, Pool)

Bounc­ing back from a shock­ing CRL, Athenex shares soar with buy­out of nat­ur­al killer T cell play­er

Several weeks after Athenex was hit with a surprise CRL for its oral chemotherapy candidate — and a class-action lawsuit to boot — the company’s stock is getting a much-needed boost as it snatches up a natural killer T cell player.

Athenex is shelling out $70 million upfront (primarily in equity) to buy out Kuur Therapeutics, the companies announced on Tuesday. In response, the company’s stock $ATNX soared more than 49% on Wednesday morning, pricing in around $5 apiece. In addition to the upfront payment, Kuur stands to pocket another $115 million in milestones, either in cash or common stock, at Athenex’s discretion.

Cynthia Butitta (L) and Joe Jimenez

Is that an­oth­er IPO in the mak­ing? Ex-No­var­tis CEO Joe Jimenez and a lead Kite play­er take up new posts at an off-the-shelf ri­val to 2 pi­o­neer­ing drugs

Right on the heels of taking on a $160 million crossover round in a likely leap to Nasdaq, Century Therapeutics CEO Lalo Flores is now pushing ahead with the high-profile ex-Novartis chief Joe Jimenez as chairman.

Jimenez’s greatest fame at Novartis was earned for one of its weakest products, as their pioneering personalized CAR-T Kymriah won the honors for the first such drug to make it to the market. Now a host of players, including Century, are barreling in behind the frontrunners with allogeneic rivals that can be created for off-the-shelf use.

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