Stéphane Bancel, AP Images

Mod­er­na takes on a low-risk pact with CAR-T play­er Au­to­lus for mR­NA-based can­cer drugs

Mod­er­na’s Covid-19 vac­cine has trans­formed the once-back­wa­ter biotech in­to one of the most high­ly val­ued drug­mak­ers in the world in the span of a year. But what does the fu­ture hold for Mod­er­na’s star turn? A small-scale dis­cov­ery pact could of­fer a clue.

Mod­er­na will hold ex­clu­sive rights to four mR­NA-based im­muno-on­col­o­gy can­di­dates us­ing pro­pri­etary bind­ing tech from Au­to­lus, a biotech best known for its work on “off-the-shelf” CAR-T ther­a­pies, the part­ners said Mon­day.

Un­like some oth­er dis­cov­ery pacts in­volv­ing big-name drug­mak­ers, the deal doesn’t come with up­front cash straight away. Au­to­lus will be due an up­front pay­ment for each can­di­date if Mod­er­na choos­es to opt-in with down­stream reg­u­la­to­ry and com­mer­cial mile­stones and roy­al­ty rights.

De­spite the scanty de­tails, shares of $AUTL were trad­ing up about 17% be­fore the bell.

It’s a low risk en­deav­or for Mod­er­na, which un­der the watch­ful eye of CEO Stéphane Ban­cel has seen its mar­ket cap ex­plode to near­ly $142 bil­lion amid the rise of its Covid-19 vac­cine and its plat­form po­ten­tial in oth­er in­di­ca­tions.

The pact, while mea­ger, could al­so of­fer some in­sight in­to how Mod­er­na is think­ing about its next steps, look­ing for out­side part­ners to help de­vel­op bet­ter ways to traf­fic mR­NA-based ther­a­peu­tics in­to tu­mor cells.

The linch­pin of the deal is the binders that Au­to­lus has tout­ed as a key tech­nol­o­gy. Al­though it didn’t dis­close the binders it’ll ex­plore with Mod­er­na, the com­pa­ny us­es a CAT binder in its CAR-T can­di­dates, a syn­thet­ic an­ti­body the biotech be­lieves has a short­er half-life than the stan­dard FMC63 binder used in oth­er ther­a­pies, po­ten­tial­ly lim­it­ing the se­ri­ous side ef­fects as­so­ci­at­ed with the class. In a note to clients, Mizuho an­a­lysts called the deal a “broad val­i­da­tion” of Au­to­lus’ plat­form if, ul­ti­mate­ly, a heav­i­ly qual­i­fied one.

But the tie-up will like­ly come as cold so­lace for mar­ket watch­ers wait­ing for if, or when, Mod­er­na will use its grow­ing cash po­si­tion to start ink­ing re­search deals or po­ten­tial­ly add a small­er biotech to the fold out­right. Dri­ven by grow­ing sales for its Covid-19 vac­cine and the val­i­da­tion of its mR­NA vac­cine plat­form writ large, Mod­er­na has seen its mar­ket cap sky­rock­et in re­cent days — now sur­pass­ing no less a light than old stal­wart Am­gen — with no end in sight to the growth.

How Mod­er­na will cap­i­tal­ize on that suc­cess to set it­self up in the fu­ture is still yet to be seen.

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.

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 rather narrow 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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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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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.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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Rafaèle Tordjman (Jeito Capital)

Con­ti­nu­ity and di­ver­si­ty: Rafaèle Tord­j­man's women-led VC firm tops out first fund at $630M

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.

Mi­rati tri­umphs again in KRAS-mu­tat­ed lung can­cer with a close­ly watched FDA fil­ing now in the cards

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.