With ex­pan­sive Covid-19 clin­i­cal plan in full gear, Ox­ford team re­ports pos­i­tive an­i­mal da­ta on ade­n­ovirus-based vac­cine

A few days af­ter the first UK vol­un­teers were dosed with a Covid-19 vac­cine de­vel­oped at Ox­ford Uni­ver­si­ty’s Jen­ner In­sti­tute, the team said a cru­cial an­i­mal study has come back pos­i­tive.

The pre­lim­i­nary re­sults, first re­port­ed by the New York Times, mark the sec­ond pos­i­tive ex­per­i­ment of a vac­cine can­di­date in­volv­ing rhe­sus macaque mon­keys dis­closed in re­cent days. Chi­na’s Sino­vac post­ed promis­ing da­ta with its in­ac­ti­vat­ed virus vac­cine can­di­date on a preprint serv­er last Mon­day. No­tably, US biotech Mod­er­na skipped the an­i­mal tri­als al­to­geth­er be­fore jump­ing in­to hu­man tri­als, with the promise to run those stud­ies in par­al­lel.

Ox­ford’s clin­i­cal ef­fort is no­table for its scale. While oth­er Phase I tri­als en­rolled on­ly dozens of par­tic­i­pants, the UK tri­al — which had a con­trol arm with a menin­gi­tis vac­cine — had aimed for 1,100 vol­un­teers and re­cruit­ed the ma­jor­i­ty of them by the time they kicked off the tri­al last week.

“This is re­al­ly im­por­tant, be­cause mov­ing quick­ly to as­sess a vac­cine ef­fi­ca­cy while COVID in­fec­tions are still com­mon can pro­vide valu­able in­for­ma­tion re­gard­ing Cor­re­lates of Pro­tec­tion (CoPs),” Ever­core ISI an­a­lyst Josh Schim­mer wrote in a note, adding that “vac­cines which can be ad­min­is­tered as a sin­gle dose (po­ten­tial­ly ade­n­ovirus vec­tor ones) will have a key ad­van­tage since they need few­er vials. Jen­ner is al­so study­ing a 2-dose reg­i­men.”

Dubbed ChA­dOx1 nCoV-19, the vac­cine us­es a weak­ened ver­sion of an ade­n­ovirus that in­fects chim­panzees to car­ry ge­net­ic ma­te­r­i­al that codes for the spike pro­tein on the new coro­n­avirus. The Jen­ner team, led by Sarah Gilbert, had em­ployed the same ap­proach to de­vel­op ex­per­i­men­tal vac­cines against Ebo­la, MERS and malar­ia.

Sci­en­tists at the NIH’s Rocky Moun­tain Lab­o­ra­to­ry in­oc­u­lat­ed six mon­keys with sin­gle dos­es of the vac­cine last month. When “chal­lenged” by heavy quan­ti­ties of SARS-CoV-2, the pri­mates stayed healthy on day 28, re­searcher Vin­cent Mun­ster told the Times. He ex­pects to share the re­sults with oth­er sci­en­tists with­in days.

Adri­an Hill

Should the safe­ty and ef­fi­ca­cy sig­nals be repli­cat­ed in the hu­man tri­al — and giv­en the cir­cum­stances, a dozen in­fec­tions on the place­bo arm com­pared with on­ly one or two on the vac­cine arm would count as vic­to­ry, ac­cord­ing to Jen­ner In­sti­tute di­rec­tor Adri­an Hill — Ox­ford is plot­ting a Phase II/III ef­fort with 5,000 peo­ple next month.

All of that could cul­mi­nate in an emer­gency ap­proval in Sep­tem­ber, beat­ing the 12- to 18-month time­line that seemed to have been the con­sen­sus (and would al­ready be un­prece­dent­ed). But oth­er de­vel­op­ers such as Mod­er­na CEO Stéphane Ban­cel have sim­i­lar­ly sug­gest­ed that the ear­li­est vi­able vac­cines should be avail­able by the fall — if on­ly to the most at-risk pop­u­la­tions.

On Mon­day the Oslo-based Coali­tion for Epi­dem­ic Pre­pared­ness In­no­va­tions, a ma­jor fun­der of mul­ti­ple vac­cine ef­forts, lent cre­dence to the idea.

Richard Hatch­ett, the group’s head, not­ed that sev­er­al vac­cine can­di­dates it’s back­ing may en­ter a sec­ond phase of test­ing as soon as late spring or the sum­mer. Lat­er in the day Mod­er­na — the first US biotech to launch a Covid-19 vac­cine tri­al — an­nounced it’s filed an IND to be­gin Phase II.

Fore­see­ing po­ten­tial is­sues with man­u­fac­tur­ing, CEPI is set­ting up pro­duc­tion fa­cil­i­ties and dis­tri­b­u­tion in every re­gion. While it on­ly has ca­pac­i­ty for a few mil­lion dos­es in-house, the Ox­ford team said it’s work­ing with “a half dozen” com­pa­nies across Eu­rope and Asia, in­clud­ing the Serum In­sti­tute of In­dia, to po­ten­tial­ly churn out bil­lions of dos­es if it se­cures ap­proval. No agree­ment, how­ev­er, has been reached in North Amer­i­ca.

“I per­son­al­ly don’t be­lieve that in a time of pan­dem­ic there should be ex­clu­sive li­cens­es,” Hill said. “So we are ask­ing a lot of them. No­body is go­ing to make a lot of mon­ey off this.”

So­cial im­age: The first vol­un­teer re­ceives a jab of the Ox­ford vac­cine. Cred­it: AP Im­ages

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

Up­dat­ed: As­traZeneca jumps deep­er in­to cell ther­a­py 2.0 space with $320M biotech M&A

Right from the start, the execs at Neogene had some lofty goals in mind when they decided to try their hand at a cell therapy that could tackle solid tumors.

Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 153,800+ biopharma pros reading Endpoints daily — and it's free.

Sana, Codex­is lay off staff, reshuf­fle pipeline in bid to fo­cus cell ther­a­py, en­zyme en­gi­neer­ing work

As its market cap shrinks to a fraction of its heyday, flashy cell therapy startup Sana Biotechnology is laying off 15% of its staffers in a move to rejig the pipeline and restructure the company.

Sana is among a growing group of biotechs that, feeling the weight of a broader market downturn and seeing their shares tumble steadily, are tightening the purse strings and adjusting their focus. Also on Tuesday, Codexis, an enzyme engineering company based in California and now helmed by former Sierra Oncology CEO Stephen Dilly, announced it will reduce the workforce by 18%.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 153,800+ biopharma pros reading Endpoints daily — and it's free.

Tim Walbert, Horizon Therapeutics CEO (via YouTube)

Hori­zon Ther­a­peu­tics in takeover talks with Am­gen, J&J, Sanofi as po­ten­tial buy­ers

Amgen, J&J’s Janssen and Sanofi are all in talks to acquire Horizon Therapeutics, the rare disease biotech disclosed late Tuesday.

Horizon confirmed “highly preliminary discussions” with those companies regarding a potential buyout offer after the Wall Street Journal reported takeover interest.

Although the company — which commands a market cap of close to $18 billion — emphasized that “there can be no certainty that any offer will be made for the Company,” shares $HZNP still surged 31% in after-hours trading to near $103, bringing it to the point where it started the year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 153,800+ biopharma pros reading Endpoints daily — and it's free.

Jeb Keiper, Nimbus Therapeutics CEO

PhI­Ib win puts Nim­bus one step clos­er to chal­leng­ing Bris­tol My­ers in TYK2

Bristol Myers Squibb might be the first to clinch an FDA approval for a TYK2 inhibitor, but Nimbus Therapeutics is out to prove that it has the best drug in the class. The biotech says it now has positive mid-stage data to back up those claims — although it’s saving the hard numbers for now.

Topline results from a Phase IIb study involving 259 patients with moderate-to-severe plaque psoriasis showed that Nimbus’ drug, NDI-034858, hit the primary endpoint of helping more patients achieve PASI-75 than placebo at 12 weeks.

John Carroll with David Chang, Allogene CEO (Credit: Jeff Rumans Photography)

Al­lo­gene takes the stage in New York to go deep on its off-the-shelf cell ther­a­pies — de­clar­ing a first for sol­id tu­mors

NEW YORK — In most cases, a biotech like Allogene would wait until the next big science conference to offer its latest series of snapshots of its data. But most biotechs aren’t like Allogene, where the veteran leaders from Kite garnered a substantial number of kudos over the years for their in-depth reviews of the company’s progress.

So on Tuesday, the leaders at Allogene converged on Manhattan once again to give a detailed breakdown of their latest steps forward, looking to stay out front in the busy off-the-shelf cell therapy arena, keep a clean bill of health on the safety front and prove that they can not only match the autologous pioneers they helped create but make the all-important leap into solid tumors. It’s another step forward in a journey that has a long way to go before even the first big regulatory finish lines appear on the track. But for CEO David Chang, who spent some time with me running through the data ahead of the Tuesday session, it all amounts to forward momentum toward the desired goal.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

UK reg­u­la­tor warns of se­vere eye re­ac­tions fol­low­ing use of Sanofi and Re­gen­eron's Dupix­ent

The UK’s Medicines and Healthcare Regulatory Agency (MHRA) on Tuesday warned of some new and serious eye-related side effects following the use of Sanofi and Regeneron’s atopic dermatitis and asthma treatment Dupixent (dupilumab).

While Dupixent is already associated with cases of conjunctivitis and allergic conjunctivitis, dry eye and with infrequent cases of keratitis and ulcerative keratitis, the MHRA is calling on health professionals to be on the lookout for any of these eye-related side effects as “it is not currently possible to predict who may experience the rarer and most severe ocular adverse reactions, such as ulcerative keratitis.”