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.

Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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Pfizer CEO Albert Bourla (Drew Angerer/Getty Images)

Pfiz­er is on the verge of claim­ing a multi­bil­lion-dol­lar first-mover ad­van­tage with their Covid-19 vac­cine — an­a­lyst

From the beginning, Pfizer CEO Albert Bourla eschewed government funding for his Covid-19 vaccine work with BioNTech, willing to take all the $2 billion-plus risk of a lightning-fast development campaign in exchange for all the rewards that could fall its way with success. And now that the pharma giant has seized a solid lead in the race to the market, those rewards loom large.

SVB Leerink’s Geoff Porges has been running the numbers on Pfizer’s vaccine, the mRNA BNT162b2 program that the German biotech partnered on. And he sees a $3.5 billion peak in windfall revenue next year alone. Even after the pandemic is brought to heel, though, Porges sees a continuing blockbuster role for this vaccine as people around the world look to guard against a new, thoroughly endemic virus that will pose a permanent threat.

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Philipp Spycher

Promis­ing bet­ter link­er tech to ADC field, Araris has 'very, very am­bi­tious' plans for the clin­ic

A couple months after raising CHF 2.5 million ($2.76 million) in initial seed funding, one-year-old Araris Biotech is topping off the round with another CHF 12.7 million ($14 million).

The Paul Scherrer Institute and ETH Zurich spinout now has CHF 15.2 million to work with, and CEO Philipp Spycher has big plans. He hopes to bring one of the company’s antibody-drug conjugates (ADC) to the clinic by late 2022 or early 2023. “It’s very, very ambitious, but we are very optimistic that we actually can make it,” he said.

UP­DAT­ED: Brazil­ian vol­un­teer in As­traZeneca Covid-19 vac­cine tri­al has died in the place­bo arm — re­ports

A volunteer in AstraZeneca’s Covid-19 vaccine trial in Brazil has died, Brazilian health authorities said Wednesday, triggering fresh alarms over the future of the Oxford program. But later reports noted that the death was in the placebo group and AstraZeneca issued word that there were no concerns about continuing the study.

The Brazilian health agency Anvisa said it had received data from an investigation into the issue, per a Reuters report. The report was then updated citing a Brazilian newspaper with unnamed sources saying that the volunteer was in the placebo arm of the trial.

David Hung (file photo)

Mas­ter deal­mak­er David Hung re­tools a SPAC sedan in­to a fi­nanc­ing mus­cle ve­hi­cle that leaves his can­cer start­up with $850M and a place on Wall Street

It’s only right that one of the industry’s top dealmakers just completed one of the biggest SPAC-related deals in the pipeline.

David Hung, of Medivation fame, has completed a back flip into the market, merging with EcoR1 Capital’s SPAC Panacea and landing neatly on Wall Street with an $NUVB stock ticker after filling out the blank check in his name. In addition to the $144 million held in the SPAC — provided none of the investors opt out — Hung is getting ahold of $500 million more being chipped in by a slate of institutional investors who feel that Hung could have the keys to another Medivation-style success.

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Covid-19 roundup: FDA has fi­nal­ly post­ed dis­cus­sion items for to­mor­row's ad­comm; As­traZeneca could soon re­sume US vac­cine tri­als

It may have come a day late, but the FDA has finally posted the discussion items that its outside experts will review during tomorrow’s adcomm on the new wave of Covid-19 vaccines now in the clinic.

There are no specific vaccines or data to discuss. Instead, the agency wants feedback on its overall approach. And they’re willing to go late into the evening to get it.

Here’s the rundown:

1. Please discuss FDA’s approach to safety and effectiveness data as outlined in the respective guidance documents.

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UP­DAT­ED: CRISPR Ther­a­peu­tics gets a snap­shot of off-the-shelf CAR-T suc­cess in B-cell ma­lig­nan­cies — marred by the death of a pa­tient

Just days after scientific founder Emmanuelle Charpentier shared the Nobel prize for her work on CRISPR/Cas9, CRISPR Therapeutics $CRSP is showing off a snapshot of success in their early-stage study for an off-the-shelf CAR-T approach to CD19+ B cell malignancies — a snapshot marred by the death of a patient who had been given a high dose of the treatment.

Using their gene editing tech, researchers for CRISPR engineered cells from healthy donors into an attack vehicle aimed at cancer, something that has been achieved with great success using patients’ own cells — the autologous approach. But autologous CAR-T is hampered by the more complex vein-to-vein requirement that delays treatment, and now CRISPR Therapeutics along with other players like Allogene are determined to replace the pioneers with CAR-T 2.0.

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