The Synklino team with CEO Thomas Kledal (center)

La­tent or lyt­ic in­fec­tion? Does­n't mat­ter, Dan­ish biotech says for trans­plant-re­lat­ed cy­tomegalovirus drug

Most peo­ple in the world have cy­tomegalovirus, or CMV for short, but it has no ef­fect. How­ev­er, for some im­muno­com­pro­mised in­di­vid­u­als and new­borns, the usu­al­ly harm­less virus can cause se­ri­ous dis­ease in­volv­ing fever, nau­sea and vom­it­ing. In trans­plant pa­tients who have to take im­muno­sup­pres­sive meds, an ac­tive CMV in­fec­tion can al­so raise the chance of or­gan re­jec­tion.

Those trans­plant pa­tients at risk for CMV in­fec­tion are the group that Den­mark-based biotech Syn­kli­no is hop­ing to treat with its drug can­di­date, dubbed SYN002. The biotech has raised €29.8 mil­lion ($31.9 mil­lion) to move that can­di­date to­wards clin­i­cal tri­als, it an­nounced to­day.

Syn­kli­no’s can­di­date deals with hu­man CMV, not pig CMV, which caused a re­cent xeno­trans­plant­ed heart re­cip­i­ent’s death. (Pig CMV does not in­fect hu­man cells.)

Un­like cur­rent treat­ment op­tions for CMV in­fec­tion, Syn­kli­no’s can­di­date not on­ly at­tacks ac­tive in­fec­tions, but al­so la­tent ones, Syn­kli­no CEO Thomas Kledal told End­points News. The drug tar­gets a pro­tein known as US28 which can be found on the sur­face of both the lyt­ic and la­tent ver­sions of the com­mon her­pesvirus.

Syn­kli­no’s site bold­ly claims that it has “cu­ra­tive po­ten­tial,” though Kledal not­ed that “it’s im­pos­si­ble to claim there isn’t one resid­ual vi­ral par­ti­cle left in a hu­man host, so of course we can­not claim we have a 100% cure.

“But what we are work­ing for is to have a sit­u­a­tion where we don’t see the virus come up and con­sti­tute clin­i­cal prob­lems for our pa­tient, and this is re­al­ly what we mean by a func­tion­al cure,” he added.

The Dan­ish biotech is a small chal­lenger to Take­da, which had its post-trans­plant-spe­cif­ic CMV drug with a some­what chaot­ic his­to­ry ap­proved fol­low­ing a unan­i­mous ad­comm vote. How­ev­er, a num­ber of an­tivi­rals, in­clud­ing Zir­gan (gan­ci­clovir) are in­di­cat­ed to treat CMV in­fec­tions more broad­ly.

While not try­ing to treat CMV, Mod­er­na is de­vel­op­ing a vac­cine for the virus, which is al­so the lead­ing in­fec­tious cause of birth de­fects in the US. The big biotech al­so re­cent­ly launched an aware­ness cam­paign about it.

Kledal said he hopes Syn­kli­no’s can­di­date will be in clin­i­cal tri­als in the first half of next year. The biotech is plan­ning to run tri­als in hu­mans as well as in or­gans pri­or to trans­plan­ta­tion, Kledal said.

While a trans­plant or­gan is be­ing stored, “we can add SYN002 to the cir­cu­la­to­ry cir­cuit cou­pled to the ar­ter­ies, veins of that or­gan — flush the or­gan — and be­cause we can tar­get la­ten­cy, we can ac­tu­al­ly tar­get the reser­voir cells that are in­fect­ed in that or­gan pri­or to these be­ing trans­plant­ed in­to the re­cip­i­ent,” Kledal said.

In ad­di­tion, be­cause the drug can go af­ter the virus in its sleep­ing state, the drug can first be test­ed in healthy vol­un­teers to mea­sure its im­pact on the la­tent CMV reser­voir, Kledal not­ed.

PKA pen­sion fund led Syn­kli­no’s se­ries A fund­ing round, fol­lowed by the Dan­ish Growth Fund and Eir Ven­tures.

Vac­cine doc­u­ments, young lead­ers and mar­ket tur­moil: End­points' 10 biggest sto­ries of 2022

It’s been a volatile year in the world of biopharma. Market declines reset M&A valuations, and may be beginning to tempt bigger buyers back into dealmaking. Russia’s war in Ukraine disrupted drug sales and clinical trials. A new generation of young biotech leaders emerged in the Endpoints 20(+1) Under 40. And as capital runs dry in a tough environment for raising new funds, companies big and small are taking a look at their headcounts and operations for ways to make it through lean times.

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Tom Riga, Spectrum Pharmaceuticals CEO

Spec­trum im­plodes af­ter a harsh pub­lic slap­down and now a CRL from Richard Paz­dur

The FDA has gone out of its way several times to flatten any expectations for Spectrum’s lung cancer drug poziotinib, including slamming the regulatory door in the biotech’s face four years ago when the their executive crew came calling for a breakthrough drug designation and encouragement from the oncology wing of the FDA.

That stinging early rebuke pointed straight down the path to a corrosive in-house agency review of Spectrum’s attempt to land an accelerated approval for the oral EGFR TKI and a public whipping that included a classic takedown by none other than Richard Pazdur, who slammed the company for “poor drug development” that led to confusion over the dose needed for a slice of NSCLC patients harboring HER2 exon 20 insertion mutations.

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

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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Albert Bourla, Pfizer CEO (John Thys/POOL/AFP via Getty Images)

Pfiz­er CEO un­der fire from UK watch­dog over vac­cine com­ments — re­port

Pfizer CEO Albert Bourla told the BBC last December that he had “no doubt in my mind that the benefits, completely, are in favor” of vaccinating 5- to 11-year-olds for Covid-19. Almost a year later, those comments have reportedly landed him in trouble with a UK pharma watchdog.

Children’s advocacy group UsForThem filed a complaint with the UK’s Prescription Medicines Code of Practice Authority (PMCPA) last year accusing Bourla of making “disgracefully misleading” statements during the BBC interview, including one that “Covid in schools is thriving.” At the time, UK regulators had not yet cleared the vaccine for the 5 to 11 age group, though the vaccine did have a positive opinion from the EMA’s human medicines committee.

Sanofi's new headquarters, La Maison Sanofi, in Paris (Credit: Luc Boegly)

Sanofi wel­comes 500 staffers to new Paris HQ af­ter €30M ren­o­va­tion

When Paul Hudson took the helm at Sanofi back in 2019, he promised to reinvent the pharma giant — including its Paris headquarters. This week, the company set up shop in new “state-of-the-art” digs.

La Maison Sanofi, as the new HQ is called, is officially open for business, Hudson announced on Monday. The 9,000-square-meter (just under 97,000-square-foot) space accommodates 500 employees across the company’s government and global support functions teams, including finance, HR, legal and corporate affairs — and it was built with environmental sustainability and hybrid work in mind.

Sta­da to place $50M+ in­vest­ment in a new fa­cil­i­ty in Ro­ma­nia

While Romania may conjure up images of vast mountain ranges and tales of medieval kings, one generic manufacturer has broken ground on a new facility there.

German pharma company Stada said Monday that it has placed a €50 million ($51.9 million) investment into a 100,000 square-meter (1.08 million square-foot) site in Turda, Romania, a city in the Southeast of the country. According to a Stada spokesperson in an email to Endpoints News, the company has developed only 281,500 square feet of the site so far.

Rachael Rollins (Charles Krupa/AP Images)

US seeks jail time for co-CEO of New Eng­land com­pound­ing cen­ter af­ter dead­ly 2012 fun­gal out­break

The US attorney for the district of Massachusetts late last week called on the state’s district court to sentence the former co-owner of the now-defunct New England Compounding Center to 18 months of jail time for his role in the center’s quality deviations that led to more than 100 people dead from a fungal meningitis outbreak.

Gregory Conigliaro was convicted of conspiring with more than a dozen others at NECC to deceive the FDA and misrepresent the fact that the center was only dispensing drugs pursuant to patient-specific prescriptions.

FDA tells Catal­ent to fix is­sues at two man­u­fac­tur­ing sites on its own

The CDMO Catalent will have to fix issues at two manufacturing plants in the US and Europe that were subject to inspections by the FDA this summer, giving the company room to correct the issues without facing further regulatory action.

The FDA gave Catalent a “voluntary action indicated” response to two inspections at the contract manufacturer’s site in Bloomington, IN, and Brussels, Belgium. Fixing the issues on its own is a preferable outcome to facing an “official action indicated” response, meaning that an official warning would be sent out or a sit-down with the FDA would be required.

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Merck targets vaccine-hesitant parents in its latest 'Why Vaccines' campaign. (Image: Shutterstock)

Mer­ck­'s lat­est 'Why Vac­ci­nes' cam­paign seeks to bet­ter in­form vac­cine-hes­i­tant moms

From Hollywood couple endorsements to targeted equity efforts, Merck has been pushing the value of vaccinations, especially since the Covid-19 pandemic disruption. Now the pharma is turning to a new target — vaccine-hesitant parents, and moms in particular.

Merck’s “Why Vaccines” latest social media and digital campaign spotlights real-life new moms who have questions about vaccinating their children.

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