MiNK Therapeutics CEO Jennifer Buell

In wan­ing Covid mar­ket, MiNK un­veils da­ta on nat­ur­al killer T cell ther­a­py for ARDS, pend­ing con­tract with DARPA

In an SITC poster, Agenus’ spin­out MiNK Ther­a­peu­tics dropped the re­sults of a Phase I/II study of its lead can­di­date, made from rare im­mune cells known as in­vari­ant nat­ur­al killer T cells, or iNKT cells for short, for treat­ing acute res­pi­ra­to­ry dis­tress syn­drome (ARDS), a se­ri­ous com­pli­ca­tion of Covid.

MiNK was and still is de­vel­op­ing the iNKT ther­a­py, dubbed agenT-797, for treat­ing can­cer, but like oth­ers, it piv­ot­ed dur­ing the pan­dem­ic and start­ed a small 20-per­son study in ARDS pa­tients who were in­tu­bat­ed or at high risk of be­ing in­tu­bat­ed. In the tri­al, pa­tients who got MiNK’s ther­a­py had a 70% chance of sur­vival com­pared to 10% in a case con­trol group of 20 pa­tients at 30 days. In a more se­vere sub­group, three of four pa­tients who were on EC­MO, es­sen­tial­ly an ar­ti­fi­cial lung ma­chine, and got agenT-797 on top of that sur­vived through 90 days.

Pa­tients were dosed through Oc­to­ber 2020 to Feb­ru­ary of this year, span­ning mul­ti­ple strains of Covid.

MiNK CEO Jen­nifer Buell em­pha­sized that MiNK is still very much a can­cer com­pa­ny, but it gen­er­at­ed da­ta around ARDS be­cause of the pan­dem­ic. “We hadn’t launched the com­pa­ny to study the cells in this set­ting, but we knew his­tor­i­cal­ly that the cells were ac­tive in SARS-CoV-1, MERS,” Buell said.

How­ev­er, the da­ta come at a time at which com­pa­nies are see­ing their Covid-re­lat­ed sales fall. This past quar­ter, Pfiz­er saw its first rev­enue dip since its vac­cine was au­tho­rized in 2020. And Mod­er­na al­so cut its sales fore­cast dur­ing its Q3 re­port.

Mov­ing for­ward, MiNK will con­tin­ue to fo­cus on the can­cer ap­pli­ca­tions of its iNKT cell ther­a­py, but it will push the ARDS in­di­ca­tion for­ward in a “non-di­lu­tive way” through a pend­ing DARPA con­tract, Buell said.

Buell not­ed that they are still in ne­go­ti­a­tions, but added that they could al­so look at oth­er non-can­cer in­di­ca­tions. “We think that the ben­e­fit that we’ve ob­served in vi­ral ARDS may be ap­plic­a­ble to oth­er lung dis­eases, fi­bro­sis — there are a few oth­er id­io­path­ic lung dis­eases,” she said.

MiNK al­so pre­sent­ed very ear­ly can­cer da­ta with a me­di­an fol­low-up of 4 months.  In pa­tients with sol­id tu­mors who were treat­ed with two to 11 lines of pre­vi­ous ther­a­py, 5 had sta­ble dis­ease while 9 had pro­gres­sive dis­ease af­ter re­ceiv­ing the iNKT cell ther­a­py. Some got agenT-797 alone while oth­ers got it in com­bi­na­tion with Keytru­da or Op­di­vo. In eight evalu­able pa­tients with mul­ti­ple myelo­ma, two had sta­ble dis­ease while the rest had pro­gres­sive dis­ease.

MiNK went pub­lic in Oc­to­ber of last year un­der $INKT, but while it start­ed out at around $12 a share, it’s now trad­ing at around $2.50 — down around 80% all-time — amid the wider mar­ket down­turn.

Big Phar­ma's Twit­ter ex­o­dus; Mer­ck wa­gers $1.35B on buy­out; $3.5M gene ther­a­py; and more

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As you start planning for #JPM23, we hope you will consider joining Endpoints News for our live and virtual events. For those who are celebrating Thanksgiving, we hope you are enjoying the long weekend with loved ones. And if you’re not — we’ll see you next week!

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Paul Perreault, CSL Behring CEO

CSL lands FDA ap­proval for he­mo­phil­ia B gene ther­a­py, sets $3.5M list price

The FDA has approved the world’s first gene therapy for hemophilia B, ushering into the market a treatment that’s historic in both what it promises to do and how much it will cost.

CSL will be marketing the drug, Hemgenix, at a list price of $3.5 million — which sets a new record for the most expensive single-use gene therapy in the US.

In a statement provided to Endpoints News, the Australian company noted that the current costs of treating people with moderate to severe hemophilia B can be significant over a lifetime. By some estimates, healthcare systems could spend more than $20 million per person.

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Elon Musk (GDA via AP Images)

Biggest drug com­pa­nies halt­ed Twit­ter ad buys af­ter Lil­ly in­sulin spoof

Almost all of the drug industry’s biggest advertisers cut their spending on Twitter to zero or near-zero over the last two weeks amid worries about impersonation of their brands by pranksters and the future of the social media company.

Among 18 of the biggest pharmaceutical advertisers in the US market, 12 cut their Twitter ad spending to nothing for the week beginning Nov. 14, according to Pathmatics, which tracks data on prescription drug ad spending as well as general corporate advertising. The list of drugmakers cutting spending to zero includes Merck, AstraZeneca, Eli Lilly, Novartis, Pfizer and others.

J&J's Spra­va­to pulls a PhI­II win against Sero­quel XR in treat­ment-re­sis­tant de­pres­sion

A day before Thanksgiving, J&J’s Janssen has a new cut of Phase III Spravato data to be grateful for.

The pharma giant announced on Wednesday that its nasal spray, also known as esketamine, beat extended-release quetiapine, previously sold by AstraZeneca as Seroquel XR, in treatment-resistant depression (TRD). Of 676 adults, a significantly higher number of patients on Spravato were able to achieve remission and avoid relapse after 32 weeks, according to J&J.

Isao Teshirogi, Shionogi president and CEO (Kyodo via AP Images)

Sh­ionogi's Covid an­tivi­ral lands first ap­proval in Japan's new emer­gency ap­proval path­way

Japanese regulators on Tuesday signed off on Shionogi’s homegrown antiviral for Covid-19, known as Xocova (ensitrelvir), making it the first approval under Japan’s emergency regulatory approval system.

The emergency approval, following a back-and-forth with regulators since last February, is based on a safety profile with more than 2,000 patients who have accessed the pill, and clinical symptomatic efficacy for five typical Omicron-related symptoms (primary endpoint) and antiviral efficacy (key secondary endpoint) in patients with mild to moderate SARS-CoV-2 infection, regardless of risk factors or vaccination status, and during the Omicron-dominant phase of the pandemic.

Rob Davis, Merck CEO

Up­dat­ed: No Seagen here: 'Do more' means a small $1.35B pur­chase of Ima­go for Mer­ck

Merck is making an acquisition, the Big Pharma announced before Monday’s opening bell. No, Seagen is not entering the fold, as had been speculated for quarters.

Folding under Merck’s wings will be Pfizer-backed Imago BioSciences. For nearly a year, Merck CEO Rob Davis has been saying the pharma giant needs to “do more” on the business development front after its 2021 $11.5 billion acquisition of Acceleron.

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Stanley Erck, Novavax CEO (Andrew Harnik/AP Images)

No­vavax pulls out of Covid-19 vac­cine al­liance with Gavi

Novavax is pulling out of its Covid-19 vaccine deal with Gavi, the Vaccine Alliance, a global partnership tasked with ensuring vaccine access in lower-income countries, following an alleged contract violation.

The Maryland-based company claimed on Friday that Gavi failed to purchase at least 350 million doses of its protein-based vaccine Nuvaxovid by the end of the year, per an advanced purchase agreement. Gavi, the World Health Organization and the Coalition for Epidemic Preparedness Innovations (CEPI) are co-leaders of COVAX, an effort to ensure that all participating countries, regardless of income levels, have access to vaccines.

Alzheimer’s drug bites the dust; Re­struc­ture, re­struc­ture, re­struc­ture; Land­mark di­a­betes OK; 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.

Being in the news business can give one a warped sense of time — it feels like quite a while since we published some of these stories below. But next Saturday’s Endpoints Weekly will definitely be shorter, as we take off Thursday and Friday for Thanksgiving. We will still have the abbreviated edition in your inbox at the usual time.

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Image: Shutterstock

MIT re­searchers re­veal DNA "Paste" tech be­hind lat­est gene edit­ing start­up

MIT scientists have developed a tool that they say can insert large gene sequences where they want in the genome.

In a paper published Thursday in Nature Biotechnology, MIT fellows Omar Abudayyeh, Jonathan Gootenberg and colleagues detail a technology they call PASTE, which they say can potentially be used to insert long strands of DNA and treat genetic diseases caused by many different mutations, such as cystic fibrosis and Leber congenital amaurosis, a rare eye disorder that causes blindness.