The race to de­vel­op Covid-19 drugs and vac­cines is on — here’s what’s hap­pen­ing in the UK

Weeks away from the re­sults of on­go­ing US and Chi­na tri­als test­ing its ex­per­i­men­tal an­tivi­ral remde­sivir, Gilead is go­ing to tri­al the failed Ebo­la drug in a small group of coro­n­avirus pa­tients in Eng­land and Scot­land. The Unit­ed King­dom is al­so home to a range of oth­er ther­a­peu­tic ef­forts, as the pan­dem­ic rages on across the globe.

On Tues­day, Southamp­ton, UK-based start­up Synair­gen kicked off a mid-stage place­bo-con­trolled study test­ing its ex­per­i­men­tal drug, SNG001 — an in­haled for­mu­la­tion of in­ter­fer­on-be­ta-1a — that has pre­vi­ous­ly shown to be safe and ef­fec­tive in im­prov­ing lung func­tion in asth­ma pa­tients with a res­pi­ra­to­ry vi­ral in­fec­tion in a pair of Phase II tri­als.

In­ter­fer­ons, a fam­i­ly of nat­u­ral­ly oc­cur­ring pro­teins se­cret­ed by the im­mune sys­tem, typ­i­cal­ly boost the body’s im­mune re­sponse to un­in­vit­ed guests such as virus­es, bac­te­ria and can­cer.

Richard Mars­den Synair­gen

“When we’ve col­lect­ed cells from pa­tients with COPD and asth­ma and old­er peo­ple…we find that their lung cells don’t re­spond very well to virus­es,” CEO Richard Mars­den said in an in­ter­view. “We have al­so along the way al­ways rec­og­nized that with an emerg­ing virus, the drug could be used.”

As Covid-19 start­ed to gath­er steam in Chi­na, Synair­gen tried to get things start­ed, but to no avail. Italy was the next plan. “We had some re­al­ly good in­ter­ac­tion there,” said Mars­den. “But they went from, you know, just busy to very busy to ex­treme­ly busy to un­able-to-com­mu­ni­cate busy.”

Even­tu­al­ly, they de­cid­ed their home ground — the UK, where they have an on­go­ing COPD tri­al — would be the best place to kick off a Covid-19 study. Ini­tial­ly, the pi­lot phase of the tri­al will have 100 pa­tients (50 will get a place­bo, and 50 will get SNG001). If all goes well, a piv­otal study will be con­duct­ed.

This ap­proach is one of many, as com­pa­nies race to de­sign and de­vel­op di­ag­nos­tics, drugs and vac­cines to stem the tide of the pan­dem­ic. “(W)e need high qual­i­ty clin­i­cal re­search to work out what is work­ing, what isn’t work­ing; we be­lieve place­bo-con­trolled tri­als are the way to do that,” Mars­den said.

Last week, the UK gov­ern­ment is­sued a state­ment con­firm­ing that the two decades-old malar­ia drugs: chloro­quine and hy­drox­y­chloro­quine, which have been tout­ed as po­ten­tial treat­ments for pa­tients in­fect­ed with the coro­n­avirus, have not been sanc­tioned for use against the virus in the UK.

Al­though clin­i­cal tri­als are on­go­ing, no con­clu­sions have been reached on the safe­ty and ef­fec­tive­ness of these med­i­cines, not­ed the Med­i­cines and Health­care prod­ucts Reg­u­la­to­ry Agency. In stark con­trast, in the Unit­ed States, the FDA on Sun­day is­sued emer­gency au­tho­riza­tion for the pair of drugs that Pres­i­dent Don­ald Trump has re­peat­ed­ly backed, on the ba­sis of anec­do­tal re­ports.

Mar­tin Lan­dray Ox­ford

In the UK, sci­en­tists at Ox­ford Uni­ver­si­ty are al­so look­ing at re­pur­pos­ing oth­er drugs for use against Covid-19. Last week, re­searchers an­nounced they would be test­ing lopinavir-ri­ton­avir, ap­proved used to treat HIV, and the steroid dex­am­etha­sone, in con­sent­ing adults that have test­ed pos­i­tive for Covid-19 in NHS hos­pi­tals. The project, in which pa­tients will ei­ther get one of the two drugs, or place­bo in ad­di­tion to stan­dard-of-care treat­ment, has won £10.5 mil­lion in gov­ern­ment fund­ing.

“The stream­lined de­sign of this clin­i­cal tri­al al­lows con­sent­ing pa­tients to be en­rolled in large num­bers eas­i­ly and with­out com­pro­mis­ing pa­tient safe­ty or adding sig­nif­i­cant­ly to the work­load of busy hos­pi­tals and their staff,” said the tri­al’s deputy chief in­ves­ti­ga­tor Mar­tin Lan­dray, who al­so serves as a pro­fes­sor of med­i­cine and epi­demi­ol­o­gy Uni­ver­si­ty of Ox­ford, in a state­ment.

Vac­cines in the works

Ox­ford re­searchers al­so have a vac­cine can­di­date in place.

On Jan­u­ary 10 — long be­fore the coro­n­avirus in­fec­tion was named Covid-19 or as­sumed pan­dem­ic pro­por­tions — a team of Ox­ford re­searchers led by Pro­fes­sors Sarah Gilbert, An­drew Pol­lard, Adri­an Hill and Dr. Sandy Dou­glas had be­gun their search for a vac­cine. On March 18, they honed in on a can­di­date: a chim­panzee ade­n­ovirus vac­cine vec­tor (ChA­dOx1).

Chim­panzee ade­n­ovi­ral vec­tors are well stud­ied, hav­ing been used in vac­cines tar­get­ing over 10 dif­fer­ent dis­eases. The Ox­ford vac­cine con­tains the ge­net­ic se­quence of the sur­face spike pro­tein found on SARS-CoV-2 — the virus be­hind Covid-19 — in­side the ChA­dOx1 con­struct. If the project is suc­cess­ful, vac­ci­na­tion with this prod­uct will pro­duce the sur­face spike pro­tein of the coro­n­avirus, prim­ing the im­mune sys­tem to at­tack the coro­n­avirus if it lat­er in­fects the body.

The re­searchers — who have pre­vi­ous­ly de­vel­oped a vac­cine for MERS that showed promise in ear­ly clin­i­cal tri­al — said last week they would start screen­ing peo­ple for a clin­i­cal tri­al, al­though the vac­cine is still weeks away from be­ing ready for hu­man test­ing. The en­roll­ment goal is to hit 510 vol­un­teers, and work is be­ing done to scale up man­u­fac­tur­ing in haste.

About a two-hour dri­ve away, re­searchers at the Uni­ver­si­ty of Cam­bridge al­so have a Covid-19 vac­cine in the works.

Pro­fes­sor Jonathan Heeney, head of the lab­o­ra­to­ry of vi­ral zoonotics and chief of spin­off com­pa­ny DIOSyn­Vax, has spear­head­ed re­search, aid­ed by com­put­er mod­el­ing of the virus’ struc­ture.

By putting the ge­net­ics of the virus un­der a mi­cro­scope, the com­pa­ny has iden­ti­fied a key part of the ge­net­ic code that the virus us­es to pro­duce the es­sen­tial part of its coat: the spikes, which is what the vac­cine is en­gi­neered to tar­get.

“A vac­cine strat­e­gy needs to be laser spe­cif­ic, tar­get­ing those do­mains of the virus’ struc­ture that are ab­solute­ly crit­i­cal for dock­ing with a cell, while avoid­ing the parts that could make things worse,” he said in a state­ment. “Our tech­nol­o­gy does just that.”

Pre­clin­i­cal tri­als are yet to be con­duct­ed, but he ex­pects the vac­cine can­di­date could be ready for hu­man tri­als by June. Fund­ing, how­ev­er, is re­quired.

“We need a ‘Big Phar­ma’ part­ner to help us scale up our ac­tiv­i­ties,” he said.

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

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; 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.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

Sanofi, GSK tout 72% Omi­cron ef­fi­ca­cy in PhI­II tri­al of next-gen, bi­va­lent shot — with an eye to year-end roll­out

Sometimes, being late can give you an advantage.

That’s what Sanofi and GSK are trying to say as the Big Pharma partners report positive results from a late-stage trial of their next-gen bivalent Covid-19 vaccine, which was designed to protect against both the original strain of the SARS-CoV-2 virus and the Beta variant. Specifically, against Omicron, they note, the vaccine delivered 72% efficacy in all adults and 93.2% in those previously infected.

Rwanda president Paul Kagame and BioNTech CEO Uğur Şahin (via BioNTech)

BioN­Tech breaks ground on first mR­NA vac­cine man­u­fac­tur­ing fa­cil­i­ty in Africa

Covid vaccine access to lower- and middle-income nations has been a concern during the length of the pandemic, but BioNTech is now pushing forward with plans to increase vaccine access for Africa.

Construction work has kicked off for an mRNA manufacturing facility in Kigali, Rwanda. According to BioNTech, the facility, dubbed the African modular mRNA manufacturing facility, has a target for the first set of manufacturing tools to be delivered to the site by the end of this year.

Stéphane Bancel (AP Photo/Charles Krupa)

Mod­er­na to se­cure a UK pres­ence with $1B+ in new man­u­fac­tur­ing and R&D fa­cil­i­ties

As Moderna keeps up the fight against Covid-19, recently winning authorization in the US for children under the age of five, the company is also looking to make a serious investment in the UK.

According to the UK government, Moderna will be looking to establish a vaccine research center and a manufacturing site for a series of vaccines.

Moderna will establish this new mRNA Innovation and Technology Centre to develop mRNA vaccines for a wide range of respiratory diseases, including Covid-19.

GSK says its drug for chron­ic hep B could ‘lead to a func­tion­al cure’ — but will it be alone or in com­bi­na­tion?

GSK, newly branded and soon-to-be demerged, shared interim results from its Phase II trial on its chronic hepatitis B treatment, one that it says has the “potential to lead to a functional cure.”

At a presentation at the EASL International Liver Congress, GSK shared that in around 450 patients who received its hep B drug bepirovirsen for 24 weeks, just under 30% had hepatitis B surface antigen and viral DNA levels that were too low to detect.