New­ly-pub­lic Im­muno­vant an­nounces first proof-of-con­cept suc­cess

Im­muno­vant an­nounced its first batch of proof-of-con­cept da­ta for its an­ti­body against a rare au­toim­mune dis­ease, a month af­ter its biggest ri­val slid one of its dogs out of the race.

In a tiny study of thy­roid eye dis­ease, 4 out of 7 pa­tients giv­en IMVT-1401 saw their clin­i­cal ac­tiv­i­ty score im­prove by 2 or more points and 3 out of 7 saw their prop­to­sis — eye pro­tru­sion — im­prove. There was a 65% re­duc­tion in IgG, the pro­tein IMVT-1401 is meant to block, which was “near­ly iden­ti­cal to mod­eled pre­dic­tions for dos­ing reg­i­men” in the tri­al.

Cru­cial­ly, the tri­al showed no ad­verse events and no headaches.

“We see these da­ta as a near best-case sce­nario,” SVB Leerink’s Thomas Smith wrote to in­vestors this morn­ing. “Ex­pect strength in IMVT shares this morn­ing.”

With their blank-check merg­er in Oc­to­ber, Im­muno­vant — Vivek Ra­maswamy’s 12th Vant — is new­ly pub­lic. The com­pa­ny, like many of the oth­er Vants, is based sole­ly around a sin­gle as­set: IMVT-1401, a mon­o­clon­al an­ti­body li­censed from HanAll Bio­phar­ma. It tar­gets FcRn-Im­munoglob­u­lin G. The pro­tein has been im­pli­cat­ed in sev­er­al rare au­to-im­mune dis­or­ders. Im­muno­vant hopes that the an­ti­body will stop the body from re­cy­cling im­munoglob­u­lin G, low­er­ing pro­tein lev­els and po­ten­tial­ly treat­ing those dis­or­ders.

The idea was enough to earn the com­pa­ny a deal with a $115 mil­lion blank check com­pa­ny spon­sored by RTW In­vest­ments and a cou­ple oth­er in­vestors. Be­tween thy­roid eye dis­ease and the two oth­er au­to-im­mune dis­eases Im­muno­vant is test­ing — myas­the­nia gravis and warm au­toim­mune he­molyt­ic ane­mia — Smith has pro­ject­ed $2.7 bil­lion in peak sales for the an­ti­body.

There is com­pe­ti­tion, though, even if some if it is wan­ing. Alex­ion has re­cent­ly in­vest­ed in the FcRn path­way, most no­tably with the ALXN-1830 an­ti­body they ac­quired in 2018, part of a $1.2 bil­lion buy­out of Syn­tim­mune. But last month, Alex­ion dropped ABY-039, an FcRn an­ti­body they picked up from a Swedish biotech in 2019. At the time, Baird’s Bri­an Sko­r­ney sent a note call­ing the news “an in­cre­men­tal pos­i­tive” for Im­muno­vant.

“We con­tin­ue to be­lieve that IMVT-1401 pos­sess­es best-in-class po­ten­tial as a rapid­ly ad­min­is­tered and high­ly ef­fi­ca­cious FcRn in­hibitor,” he wrote.

Im­muno­vant now has a larg­er and ran­dom­ized Phase II study un­der­way for thy­roid eye dis­ease, a Phase II un­der­way in myas­the­nia gravis and a Phase II in warm au­toim­mune he­molyt­ic ane­mia set to get un­der­way.

IMVT-1401 would be the sec­ond an­ti­body de­vel­oped for thy­roid eye dis­ease, af­ter Hori­zon Phar­ma’s Te­pez­za won ap­proval ear­li­er this year.

As­traZeneca trum­pets the 'mo­men­tous' da­ta they found for Tagris­so in an ad­ju­vant set­ting for NSCLC — but many of the ex­perts aren’t cheer­ing along

AstraZeneca is rolling out the big guns this evening to provide a salute to their ADAURA data on Tagrisso at ASCO.

Cancer R&D chief José Baselga calls the disease-free survival data for their drug in an adjuvant setting of early stage, epidermal growth factor receptor-mutated NSCLC patients following surgery “momentous.” Roy Herbst, the principal investigator out of Yale, calls it “transformative.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,500+ biopharma pros reading Endpoints daily — and it's free.

Paul Hudson, Sanofi CEO (Getty Images)

Sanofi CEO Paul Hud­son has $23B burn­ing a hole in his pock­et. And here are some hints on how he plans to spend that

Sanofi has reaped $11.1 billion after selling off a big chunk of its Regeneron stock at $515 a share. And now everyone on the M&A side of the business is focused on how CEO Paul Hudson plans to spend it.

After getting stung in France for some awkward politicking — suggesting the US was in the front of the line for Sanofi’s vaccines given American financial support for their work, versus little help from European powers — Hudson now has the much more popular task of managing a major cash cache to pull off something in the order of a big bolt-on. Or two.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,500+ biopharma pros reading Endpoints daily — and it's free.

David Chang, Allogene CEO (Jeff Rumans)

Head­ed to PhII: Al­lo­gene CEO David Chang com­pletes a pos­i­tive ear­ly snap­shot of their off-the-shelf CAR-T pi­o­neer

Allogene CEO David Chang has completed the upbeat first portrait of the biotech’s off-the-shelf CAR-T contender ALLO-501 at virtual ASCO today, keeping all eyes on a drug that will now try to go on to replace the first-wave personalized pioneers he helped create.

The overall response rate outlined in Allogene’s abstract for treatment-resistant patients with non-Hodgkin lymphoma slipped a little from the leadup, but if you narrow the patient profile to treatment-naïve patients — removing the 3 who had previous CAR-T therapy who didn’t respond, leaving 16 — the ORR lands at 75% with a 44% complete response rate. And 9 of the 12 responders remained in response at the data cutoff, offering a glimpse on durability that still has a long way to go before it can be completely nailed down.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,500+ biopharma pros reading Endpoints daily — and it's free.

The Avance Clinical leadership team: CEO Yvonne Lungershausen, Sandrien Louwaars - Director Business Development Operations, Gabriel Kremmidiotis - Chief Scientific Officer, Ben Edwards - Chief Strategy Officer

How Aus­tralia De­liv­ers Rapid Start-up and 43.5% Re­bate for Ear­ly Phase On­col­o­gy Tri­als

About Avance Clinical

Avance Clinical is an Australian owned Contract Research Organisation that has been providing high-quality clinical research services to the local and international drug development industry for 20 years. They specialise in working with biotech companies to execute Phase 1 and Phase 2 clinical trials to deliver high-quality outcomes fit for global regulatory standards.

As oncology sponsors look internationally to speed-up trials after unprecedented COVID-19 suspensions and delays, Australia, which has led the world in minimizing the pandemic’s impact, stands out as an attractive destination for early phase trials. This in combination with the streamlined regulatory system and the financial benefits including a very favourable exchange rate and the R & D cash rebate makes Australia the perfect location for accelerating biotech clinical programs.

Ear­ly sur­vival da­ta boost Zio­phar­m's 'con­trolled IL-12' im­munother­a­py for glioblas­toma

An unconventional pairing of a gene therapy and an oral drug that promises to attack recurrent or progressive glioblastoma with controlled release of IL-12 has turned up more promising — if early — overall survival data. On top of boosting its case as a monotherapy, the data can also bode well for a combination with Regeneron’s PD-1 inhibitor, Libtayo.

Both the treatment and its developer, Ziopharm Oncology, have come a long way. The stock price peaked in 2015 but cratered in 2016 following a patient death in a Phase I.

As tislelizum­ab gains trac­tion in Chi­na, BeiGene pulls the cur­tain on NSCLC da­ta sup­port­ing the PD-1 drug

In a world now brimming with checkpoint inhibitors, companies often struggle to make a mark given a raft of therapies have already captured a considerable portion of the vast oncology market.

BeiGene’s tislelizumab was the fourth PD(L)-1 inhibitor to secure approval in China — and as it works on expanding its share the company has put out detailed data on the use of the drug in certain patients with lung cancer.

Ku­ra flash­es pos­i­tive HRAS da­ta on once-failed J&J drug

Troy Wilson was working with J&J on their KRAS inhibitor and periodically thumbing through their publications when he spotted an old drug called tipifarnib that looked promising. So promising, in fact, that the large pharma had run it through over 5,000 patients across 70 trials, hoping they would at some point be able to nail down who were the small slice of patients who responded in some studies.

Af­ter star­ring at ASH last fall, Gilead’s new Forty Sev­en crew col­ors in more promis­ing da­ta for ma­grolimab at AS­CO

We now know the full, early-stage story behind the drug that inspired Gilead CEO Dan O’Day’s recent $5 billion acquisition of Forty Seven.

Following up on their ASCO abstract from a couple of weeks ago, the team at Forty Seven is making their return appearance this week holding clearly promising early-stage data on their lead drug magrolimab as they ponder whether they should roll on a quest to obtain an accelerated approval.

Pfiz­er, Mer­ck KGaA ce­ment Baven­cio blad­der can­cer win with OS da­ta — while carv­ing an­oth­er niche in rare can­cer

Pfizer and Merck KGaA have detailed the Phase III data that inspired FDA regulators to designate Bavencio a “breakthrough” for first-line advanced bladder cancer and offered an early glance at how the PD-L1 can help patients with a rare gynecological cancer — carving out niches in the checkpoint space for itself after being shut out of numerous others.

In JAVELIN Bladder 100, Bavencio led to a 31% reduction in risk of death compared to standard care alone. It also extended median survival by more than seven months — a historic feat in this setting, according to investigators at Queen Mary University of London.