Pete Salzmann, Immunovant

Im­muno­vant flash­es se­cret da­ta be­hind po­ten­tial Roivant buy­out, but in­vestors see a dif­fi­cult fu­ture

The “non-pub­lic in­for­ma­tion” that made Roivant want to ac­quire their trou­bled Im­muno­vant spin­out at a po­ten­tial­ly sub­stan­tial pre­mi­um just be­came pub­lic. But nei­ther in­vestors nor an­a­lysts agreed with Roivant’s spin on the da­ta, sell­ing off shares of $IMVT by near­ly 40% Thurs­day

Im­muno­vant an­nounced Tues­day that they saw a path for­ward for bring­ing their lead and on­ly drug back in­to de­vel­op­ment, af­ter safe­ty is­sues forced the com­pa­ny to pause its on­ly two ac­tive tri­als over the win­ter. They now plan to launch a piv­otal tri­al for the rare dis­ease myas­the­nia gravis by ear­ly 2022, while adding three mid-stage stud­ies for oth­er au­toim­mune dis­or­ders.

Cen­tral to the plan is new da­ta from their tri­al for thy­roid eye dis­ease, one of two that was cut short af­ter it ap­peared that pa­tients on the high dose of their drug saw their LDL cho­les­terol lev­els rise 60%. Im­muno­vant now says that at a low dose, pa­tients saw sim­i­lar ben­e­fits but with on­ly “min­i­mal” el­e­vat­ed LDL.

A Roivant spokesper­son con­firmed that these were the da­ta that prompt­ed the com­pa­ny to, in an SEC fil­ing on March 8, that, as the con­trol­ling share­hold­er, they had ac­cess to con­fi­den­tial in­for­ma­tion and were con­sid­er­ing buy­ing out the re­main­ing shares of their for­mer sub­sidiary at a pre­mi­um. Baird’s Bri­an Sko­r­ney lat­er es­ti­mat­ed the pre­mi­um could be as high as 70% — or $2.6 bil­lion for a com­pa­ny that, af­ter its stock cratered over the win­ter, had a mar­ket cap of around $1.5 bil­lion.

Roivant’s fil­ing tipped off in­vestors that the com­pa­ny was plan­ning to go pub­lic, pre­sag­ing a $7.3 bil­lion SPAC merg­er last month and prompt­ing spec­u­la­tion over what, pre­cise­ly, the large biotech saw in its spin­out.

Im­muno­vant is com­pet­ing against a small hand­ful of biotechs to de­vel­op an an­ti-FcRn an­ti­body, de­signed to clean up so-called au­to-an­ti­bod­ies that can dri­ve the im­mune sys­tem to at­tack healthy tis­sue. Al­though the thy­roid eye dis­ease tri­al was abort­ed too ear­ly to reach sta­tis­ti­cal sig­nif­i­cance, Im­muno­vant says they saw a 62% re­duc­tion in an­ti­bod­ies in the low dose, com­pared to 80% in the high dose.

“Our view is that makes us com­pet­i­tive in every in­di­ca­tion,” a Roivant spokesper­son said of Im­muno­vant’s low-dose da­ta.

Yet many in­vestors came to the op­po­site con­clu­sion. Af­ter Im­muno­vant re­leased their up­date,  shares of $IMVT fell 37%, from $15.16 to $9.40.

Al­though Roivant saw po­ten­tial in the low dose, the new up­date re­vealed that Im­muno­vant con­duct­ed an analy­sis across their var­i­ous tri­als and con­firmed what had pre­vi­ous­ly on­ly been a sus­pi­cion: That the com­pa­ny’s drug led to in­creased cho­les­terol lev­els. They al­so ac­knowl­edged that the drug ap­peared less ef­fec­tive in the thy­roid eye dis­ease than they had hoped.

Ar­genx, de­vel­op­ing a ri­val an­ti-FcRn ap­proach, has not­ed that they’ve seen no such cho­les­terol-el­e­vat­ing ef­fects.

“All con­sid­ered, we do think this dos­ing con­sid­er­a­tion will make it some­what more dif­fi­cult for IMVT-1401 to com­pete with ar­genx’s ef­gar­tigi­mod and oth­er FcRn as­sets, cloud­ing the pic­ture,” Baird’s Bri­an Sko­r­ney wrote in a note to in­vestors.

SVB Leerink’s Thomas J. Smith sim­i­lar­ly dropped their price tar­get for Im­muno­vant from $38 to $17. He said the safe­ty da­ta add new risks, but ar­gued they were off­set by the like­li­hood that Roivant steps up for a buy­out.

” While no fi­nan­cial de­tails have been dis­closed, we ex­pect in­vestors will con­tin­ue to weigh the like­li­hood and na­ture of any po­ten­tial trans­ac­tion be­tween Roivant and IMVT,” he said. (SVB Leerink has been hired by Roivant to ad­vise on a po­ten­tial Im­muno­vant buy­out).

Im­muno­vant said in a state­ment that they be­lieve that with cre­ative dos­ing and pa­tient mon­i­tor­ing they can man­age the ef­fects. “These re­sults present an op­por­tu­ni­ty for flex­i­bil­i­ty in dos­ing, dose in­ter­vals, and a low­er-vol­ume in­jec­tion to ex­plore in our fu­ture clin­i­cal tri­als,” CEO Pe­te Salz­mann said in a state­ment.

They will plan those tri­als, though, with­out the CMO they hired just five months ago, Ri­ta Jain. In ad­di­tion to the IMVT-401 news, Im­muno­vant al­so an­nounced that Jain had de­part­ed and will be re­placed by long­time Eli Lil­ly ex­ec­u­tive William Ma­cias.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'


Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

Rahul Singhvi, Resilience CEO

A Bob Nelsen start­up turns to Har­vard to help sharp­en its tech, in­spir­ing first spin­out

One of Bob Nelsen’s latest projects is headed to Harvard.

Resilience, a company started with the goal of establishing itself as a “one-stop-shop” for companies looking to scale manufacturing, including for hard-to-develop cell and gene therapies, is less than a year old. Friday, it announced a five-year R&D deal with Harvard University that includes $30 million to develop biologics, including vaccines, nucleic acids and cell and gene therapies.

Susan Galbraith speaking at Endpoints News' virtual EUBIO21 summit

Imfinzi/treme­li­mum­ab com­bo scores As­traZeneca an­oth­er OS win — this time in liv­er can­cer

Is the tide turning on AstraZeneca’s battered PD-L1/CTLA4 combo?

A single priming dose of the experimental tremelimumab, followed by Imfinzi every four weeks, beat Nexavar (sorafenib) in helping a group of liver cancer patients live longer in a Phase III study, the company reported, meeting the primary endpoint.

Specifically, the two drugs extended overall survival for patients with unresectable hepatocellular carcinoma who had not received prior systemic therapy and were not eligible for localized treatment.

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FDA+ roundup: Marks on Wood­cock­'s tenure as act­ing com­mis­sion­er; FDA lead­ers of­fer per­spec­tive on bar­ri­ers to di­ver­si­ty in re­search

CBER director Peter Marks praised Janet Woodcock’s work as acting FDA commissioner, and while noting that Biden needs to nominate someone to fill the role permanently by Nov. 16, he said he has “no idea” when that actually might occur.

“Dr. Woodcock has been at the agency for over three decades and she, during that time, has proven herself to be a remarkably capable manager,” Marks said at the Alliance for Regenerative Medicine’s meeting Tuesday. “And she’s been managing as if she’s commissioner, unlike some previous acting [commissioners] who are afraid to actually do things. She doesn’t appear to be afraid to do things. I have not felt any different now from when we had a commissioner in place,” he added.

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