Fail­ure-prone Unum cuts jobs, los­es sci­en­tif­ic chief, and changes fo­cus yet again

At­las Ven­ture-backed Unum, which once har­bored am­bi­tions to ri­val the two CAR-T ther­a­pies Kym­ri­ah and Yescar­ta, is pay­ing the price for a laun­dry list of set­backs.

Seth Et­ten­berg Unum

On Mon­day, the Cam­bridge, Mass­a­chu­setts-based com­pa­ny said it was cut­ting its work­force by 43 em­ploy­ees (rough­ly 60% of the to­tal head­count) to fo­cus its ef­forts on a pre­clin­i­cal pro­gram. It al­so dis­closed the de­par­ture of its chief sci­en­tif­ic of­fi­cer, Seth Et­ten­berg, as it ceas­es the de­vel­op­ment of tri­als har­ness­ing its maid­en tech­nol­o­gy: AC­TR.

The tri­als shelved in­clude an ear­ly-stage lym­phoma pro­gram test­ing the ex­per­i­men­tal drug, AC­TR707, in com­bi­na­tion with rit­ux­imab (Roche’s MabThera), as well as a Phase I sol­id tu­mor tri­al eval­u­at­ing the com­bi­na­tion of AC­TR707 and trastuzum­ab (Roche’s Her­ceptin).

Cell ther­a­pies un­der the plat­form were en­gi­neered to arm a pa­tient’s T cells with the ar­se­nal to launch a dou­ble at­tack on can­cer cells. First, the cells are de­signed to ex­press AC­TR — a chimeric pro­tein made out of com­po­nents from T cells and nat­ur­al killer cells — and then are com­bined with the tu­mor-tar­get­ing abil­i­ty of co-ad­min­is­tered an­ti­bod­ies.

The plat­form has seen fail­ure af­ter fail­ure. Back in 2018, in its IPO fil­ing, the com­pa­ny dis­closed that two out of nine pa­tients in the high-dose arm of a clin­i­cal tri­al for their then-lead cell ther­a­py — AC­TR087 — had died, forc­ing the FDA to im­pose a clin­i­cal hold that was lift­ed just ahead of their bid to go pub­lic. While it broke no laws, the com­pa­ny’s ap­proach to trans­paren­cy didn’t win it any plau­dits — the IPO was priced at the bot­tom of the range.

Then, last year, things got worse. Ex­ec­u­tives in Ju­ly re­vealed that the FDA had slapped an­oth­er clin­i­cal hold on AC­TR087,  af­ter a pa­tient in the safe­ty co­hort of a Phase I study ex­pe­ri­enced a raft of se­ri­ous ad­verse events. By this time, Unum — which is al­so backed by F-Prime Cap­i­tal — had repri­or­i­tized its pipeline to fo­cus on AC­TR707.

Come No­vem­ber, AC­TR087 was for­mal­ly aban­doned amid a broad­er shift from hema­tol­ogy to sol­id tu­mors. The com­pa­ny’s oth­er tech plat­form, BOXR, hit the spot­light.

The tu­mor mi­croen­vi­ron­ment in many sol­id tu­mor can­cers is deeply im­muno­sup­pres­sive, block­ing T cells from func­tion­ing nor­mal­ly. Unum’s Bolt-on Chimeric Re­cep­tor (BOXR) is de­signed to “bolt-on” trans­genes to boost in­trin­sic T cell func­tion­al­i­ty to con­quer that im­muno­sup­pres­sion.

In Unum’s lat­est up­date, it looks like AC­TR707 has al­so made the scrap heap — leav­ing pre­clin­i­cal BOXR1030 as the sole fo­cus. The com­pa­ny’s shares $UM­RX wad­ed deep­er in­to pen­ny stock ter­ri­to­ry, dip­ping slight­ly pre­mar­ket to 54 cents.

Re­gen­er­a­tive stem cell play­er Blue­Rock Ther­a­peu­tics, mean­while, has scored the ser­vices of Unum’s erst­while CSO Et­ten­berg.

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.

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So what hap­pened with No­var­tis' gene ther­a­py group? 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.

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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.

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 specific 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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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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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.