Ugur Sahin, BioNTech CEO (Bernd von Jutrczenka/dpa via AP Images)

BioN­Tech ex­pects to be $18.6B rich­er af­ter this year as Covid boost­ers churn out more da­ta. But it won't change much

Pfiz­er un­veiled the rich­es that its Covid-19 vac­cine is show­er­ing on it­self and part­ners at BioN­Tech when it pegged 2021 sales at $33.5 bil­lion. If the Ger­man biotech — which is in charge of de­sign­ing the cur­rent vac­cine and fu­ture mR­NA boost­ers — is right, it could be­come a ma­jor rev­enue pil­lar for years to come.

At its lat­est quar­ter­ly up­date, BioN­Tech fore­casts a €15.9 bil­lion ($18.6 bil­lion) cut for it­self by the end of the year, af­ter bag­ging €2.0 bil­lion ($2.4 bil­lion) in the first half.

The fu­ture BioN­Tech is out­lin­ing as a ma­jor mR­NA play­er of­fers an in­ter­est­ing con­trast with Mod­er­na, which has sig­naled it will chan­nel its overnight wealth in­to new bets on gene edit­ing and gene ther­a­py. Sure, there might be some deals to add com­bo can­di­dates, but BioN­Tech made it clear the plan is to fo­cus on in­fec­tious dis­ease and im­muno-on­col­o­gy, with a broad pipeline it’s al­ready start­ed putting in place, fea­tur­ing 15 pro­grams and 18 clin­i­cal tri­als.

Un­like Mod­er­na, BioN­Tech is al­so not shy­ing away from modal­i­ties out­side of mR­NA to get there — be it small mol­e­cule im­munomod­u­la­tors, an­ti­bod­ies, TCR cell ther­a­pies or bi­o­log­ics.

Re­it­er­at­ing what they see as a need to boost the two-dose reg­i­men with a third shot six to 12 months lat­er, ex­ecs say the best ap­proach would be to adopt the cur­rent vac­cine — which is based on the wild-type, an­ces­tral strain — for the boost­er.

Swap­ping out the strain for emerg­ing vari­ants is “tech­ni­cal­ly pos­si­ble” and would on­ly take about 100 days un­der the cur­rent set­up, CEO Uğur Şahin said. The team is al­ready run­ning a tri­al for the Be­ta vari­ant while launch­ing an­oth­er against the Delta vari­ant. But the key ques­tion is “when is the best time to change our plan” so that they don’t end up mak­ing a de­ci­sion that turns out to be wrong down the road.

He raised the ex­am­ple of in­fluen­za, where the WHO de­fines the rel­e­vant strain every year for vac­cine man­u­fac­tur­ers to fol­low in up­dat­ing their jabs.

“We do not yet have such a sit­u­a­tion for the coro­n­avirus,” he said. “And the chal­lenge at the mo­ment, the glob­al chal­lenge is that there are dif­fer­ent vari­ants on dif­fer­ent con­ti­nents. Even though the Delta vari­ant is dom­i­nat­ing North re­gion, there are oth­er re­gions like South Africa,” where the Be­ta vari­ant is more preva­lent.

Mean­while, BioN­Tech plans to keep “ac­cel­er­at­ing and broad­en­ing” the rest of the pipeline, with the re­cent ac­qui­si­tion of Gilead sub­sidiary Kite’s TCR plat­form as an ex­am­ple of how it might do that. On top of a man­u­fac­tur­ing site in Mary­land, that deal brought 50 cell ther­a­py ex­perts to BioN­Tech, in­clud­ing a cell ther­a­py pro­duc­tion crew and a per­son­al­ized neoanti­gen TCR re­search team.

When asked whether BioN­Tech would be look­ing to add a PD-1 drug to an­chor its I/O port­fo­lio — the on­ly ques­tion from an­a­lysts that was not about boost­ers — Sahin said it “could be an op­tion” if it fits the cri­te­ria.

We have, at the mo­ment, our own I/O mol­e­cules al­so with the PD-1 block­ade func­tion in de­vel­op­ment as you know, and an­ti-PD-L1 plus for the 41BB bis­pe­cif­ic is one of the pos­i­tives. And we have in­ter­nal pro­grams al­so ad­dress­ing ad­di­tion­al I/O pass­es. And in the next 12 to 18 months, we will cer­tain­ly come up with this deal, al­low­ing us to in­crease our pipeline to fur­ther gain com­bi­na­tion part­ners for the vac­cines and im­mune mod­u­la­tors that we have al­ready in placed.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

What lured Hal Bar­ron away?; Top FDA minds on ac­cel­er­at­ed ap­proval re­forms; ‘Dead wrong’ Aduhelm ad blitz; 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.

Nothing can really compete with Hal Barron’s departure from GlaxoSmithKline as the news of the week, but we do have plenty of original reporting and analysis from the Endpoints team in this edition. Enjoy and have a nice weekend.

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Mer­ck wins le­gal bat­tle over in­sur­ance cov­er­age af­ter ran­somware at­tack

Merck has emerged victorious from a years-long legal battle with insurers over the coverage of more than a billion dollars in losses from the malware NotPetya, with a New Jersey Superior Court judge concluding that the responsibility is on insurers to clarify their policies around cyber attacks.

The pharma giant was one of several victims of a global cyber attack back in 2017 that also hit Danish shipping company Maersk, American food company Mondelēz, French construction giant Saint-Gobain and even the systems monitoring the Chernobyl nuclear power stations, Bloomberg reported back in 2019.

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Crit­ics push back on Alzheimer’s As­so­ci­a­tion ad blitz to get Medicare to change its Aduhelm rul­ing: 'Dead wrong'

The latest Alzheimer’s Association advertising campaign encourages people to fight.

Not against the disease or for more research or treatments, but against the Centers for Medicare and Medicaid Services. More specifically, CMS’ recent reimbursement decision to only pay for Biogen and Eisai’s controversial Alzheimer’s drug Aduhelm for patients in clinical trials.

With CMS’ preliminary decision now in a 30-day comment period, patient advocates’ goal is to convince CMS to reverse its decision with a marketing blitz and public pressure.

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Dan O'Day, Gilead CEO (Jim Watson/AFP via Getty Images)

Fail­ing to con­firm clin­i­cal ben­e­fit, Gilead pulls 2 ac­cel­er­at­ed ap­proval in­di­ca­tions for can­cer drug

Gilead recently decided to pull two indications for its cancer drug Zydelig — in relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic leukemia (SLL) — after failing to complete the confirmatory trials required as part of the accelerated approvals from 2014.

“As the treatment landscape for FL and SLL has evolved, enrollment into the confirmatory study has been an ongoing challenge,” Gilead said in a statement, noting it formally notified the FDA of its decision to voluntarily withdraw these indications.

Executive Director of the EMA Emer Cooke (AP Photo/Geert Vanden Wijngaert)

Eu­ro­pean Par­lia­ment signs off on strength­en­ing drug reg­u­la­tor's abil­i­ty to tack­le short­ages

The European Parliament on Thursday endorsed a plan to increase the powers of the European Medicines Agency, which will be better equipped to monitor and mitigate shortages of drugs and medical devices.

By a vote of 655 to 31, parliament signed off on a provisional agreement reached with the European Council from last October, in which the EMA will create two shortage steering groups (one for drugs, the other for devices), a new European Shortages Monitoring Platform to facilitate data collection and increase transparency, and on funding for the work of the steering groups, task force, working parties and expert panels that are to be established.

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Sec­ondary patents prove to be key in biosim­i­lar block­ing strate­gies, re­searchers find

While the US biosimilars industry has generally been a disappointment since its inception, with FDA approving 33 biosimilars since 2015, just a fraction of those have immediately followed their approvals with launches. And more than a handful of biosimilars for two of the biggest blockbusters of all time — AbbVie’s Humira and Amgen’s Enbrel — remain approved by FDA but still have not launched because of legal settlements.

Covid-19 roundup: HHS may strug­gle to ab­sorb Op­er­a­tion Warp Speed; Eu­rope has no plans for a fourth vac­cine dose

Operation Warp Speed, perhaps the greatest achievement of the former Trump administration, promptly delivered Covid-19 vaccine supplies nationwide when they became available, thanks to collaborations between HHS and the Department of Defense, while helping to fund and aid the manufacture of billions of doses.

But since the Biden administration took over a year ago, acting FDA commissioner Janet Woodcock transitioned out of her role as the therapeutics lead in Warp Speed, which has been converted into a new operation without the fancy name (now known as the “HHS-DOD COVID-19 Countermeasures Acceleration Group”), and as of the start of 2022, the Department of Defense is no longer helping HHS on the program.

NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

An­oth­er day, an­oth­er xeno­trans­plant, as Unit­ed Ther­a­peu­tics looks to beat com­peti­tors to sci-fi-es­que break­through

Xenotransplantation is having a moment.

Last October, a team from NYU successfully transplanted a kidney from a pig into a brain-dead patient, although observers cast doubt on the importance of the experiment. Then, earlier this month, surgeons at the University of Maryland transplanted a pig heart into a dying human, who appears to still be stable.

Now, another group is planting a flag in the xenotransplantation field. Surgeons at the University of Alabama at Birmingham said Thursday they have achieved the first kidney transplant from a pig to a brain-dead patient, publishing their peer-reviewed findings online. The team, aiming to differentiate itself from the others through the genetic modifications used, is hoping there’s now enough research to soon begin clinical xenotransplantation studies.