BioN­Tech teams up with Fo­s­un Phar­ma to test Covid-19 mR­NA vac­cine in Chi­na — and scores $50M in­vest­ment

Hav­ing qui­et­ly launched its own mR­NA vac­cine ef­forts against the nov­el coro­n­avirus to match the high­er pro­file cam­paigns of Mod­er­na and Cure­Vac, Ger­many’s BioN­Tech has of­fered a glimpse on its progress as it un­veils an al­liance with a promi­nent Chi­nese play­er.

Ugur Sahin

Fo­s­un Phar­ma will team up with BioN­Tech to con­duct tri­als of its Covid-19 vac­cine, BNT162, in Chi­na. To get on board, Fo­s­un bought $50 mil­lion worth of BioN­Tech eq­ui­ty $BN­TX and promised up to $85 mil­lion more in pay­ments.

In a sep­a­rate state­ment, BioN­Tech said it plans to ini­ti­ate clin­i­cal test­ing in late April, rolling out a glob­al de­vel­op­ment pro­gram in Eu­rope (start­ing in Ger­many), the US and Chi­na.

Shares surged 39.02% to $43 in pre-mar­ket trad­ing, buck­ing the down­ward trend in a tur­bu­lent mar­ket (the Nas­daq Biotech In­dex is al­so trad­ing up).

While Fo­s­un has rights to com­mer­cial­ize the re­sult­ing vac­cine in Chi­na, BioN­Tech is still ex­plor­ing what to do in the rest of the world. It’s in “ad­vanced dis­cus­sions” with Pfiz­er around that — echo­ing com­ments made by its phar­ma part­ner ear­li­er this month.

The deal marks the first pub­lic an­nounce­ments BioN­Tech has made on Pro­ject Light­speed, its de­vel­op­ment pro­gram in re­sponse to the vi­ral in­fec­tion that’s fast en­gulf­ing the world, since qui­et­ly dis­clos­ing the project ini­ti­a­tion in a Feb­ru­ary SEC fil­ing. As of Mon­day morn­ing, world­wide cas­es are edg­ing to­ward 170,000, with mul­ti­ple Eu­ro­pean coun­tries and parts of the US now on lock­down.

Like fel­low Ger­man biotech Cure­Vac — whom the US gov­ern­ment has re­port­ed­ly tried to lure in­to mov­ing state­side — BioN­Tech’s vac­cine ap­proach in­volves us­ing mR­NA to trick the body in­to pro­duc­ing a ver­sion of the SARS-CoV-2, which would then in­cite an im­mune re­sponse. Its man­u­fac­tur­ing part­ner Poly­mun will be in charge of pro­duc­ing a glob­al sup­ply out of fa­cil­i­ties in Eu­rope.

“In ad­di­tion, we are work­ing on a nov­el ther­a­peu­tics ap­proach for those pa­tients who have al­ready been in­fect­ed – we plan to dis­close more on that ef­fort in the com­ing weeks,” Ugur Sahin, founder and CEO, said in a state­ment.

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

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

President Donald Trump (via AP Images)

Signs of an 'Oc­to­ber Vac­cine Sur­prise' alarm ca­reer sci­en­tists

President Donald Trump, who seems intent on announcing a COVID-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the FDA and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.

#ES­MO20: Push­ing in­to front­line, Mer­ck and Bris­tol My­ers duke it out with new slate of GI can­cer da­ta

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

Anthony Fauci (AP Images)

A press of­fi­cer at An­tho­ny Fau­ci’s NI­AID was un­masked as a hard-right Covid troll. He just re­tired to­day

William B Crews had been a public affairs specialist at the NIH’s National Institute of Allergy and Infectious Diseases.

That ended today when he informed the agency of his decision to retire, after he was identified as the managing editor at RedState, a prominent Trump loyalist website.

Crews’ RedState duties are performed under the alias streiff. While enjoying the benefits of pseudonymity, he disparaged and worked against NIAID with an incendiary level of rhetoric in the midst of a pandemic.

Eli Lilly CSO Dan Skovronsky (file photo)

UP­DAT­ED: #ES­MO20: Eli Lil­ly shows off the da­ta for its Verzenio suc­cess. Was it worth $18 bil­lion?

The press release alone, devoid of any number except for the size of the trial, added nearly $20 billion to Eli Lilly’s market cap back in June. Now investors and oncologists will get to see if the data live up to the hype.

On Sunday at ESMO, Eli Lilly announced the full results for its Phase III MonarchE trial of Verzenio, showing that across over 5,000 women who had had HR+, HER2- breast cancer, the drug reduced the odds of recurrence by 25%. That meant 7.8% of the patients on the drug arm saw their cancers return within 2 years, compared with 11.3% on the placebo arm.

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Greg Friberg (File photo)

#ES­MO20: Am­gen team nails down sol­id ear­ly ev­i­dence of AMG 510’s po­ten­tial for NSCLC, un­lock­ing the door to a wave of KRAS pro­grams

The first time I sat down with Amgen’s Greg Friberg to talk about the pharma giant’s KRAS G12C program for sotorasib (AMG 510) at ASCO a little more than a year ago, there was high excitement about the first glimpse of efficacy from their Phase I study, with 5 of 10 evaluable non-small cell lung cancer patients demonstrating a response to the drug.

After decades of failure targeting KRAS, sotorasib offered the first positive look at a new approach that promised to open a door to a whole new approach by targeting a particular mutation to a big target that had remained “undruggable” for decades.

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#ES­MO20: Out to beat Tagris­so, J&J touts 100% ORR for EGFR bis­pe­cif­ic/TKI com­bo — fu­el­ing a quick leap to PhI­II

J&J’s one-two punch on EGFR-mutant non-small cell lung cancer has turned up some promising — although decidedly early — results, fueling the idea that there’s yet room to one up on third-generation tyrosine kinase inhibitors.

Twenty out of 20 advanced NSCLC patients had a response after taking a combination of an in-house TKI dubbed lazertinib and amivantamab, a bispecific antibody targeting both EGFR and cMET engineered on partner Genmab’s platform, J&J reported at ESMO. All were treatment-naïve, and none has seen their cancer progress at a median follow-up of seven months.

#ES­MO20: Bris­tol My­ers marks Op­di­vo's sec­ond ad­ju­vant win — eye­ing a stan­dard of care gap

Moving into earlier and earlier treatment lines, Bristol Myers Squibb is reporting that adjuvant treatment with Opdivo has doubled the time that esophageal or gastroesophageal junction cancer patients stay free of disease.

With the CheckMate-577 data at ESMO, CMO Samit Hirawat said, the company believes it can change the treatment paradigm.

While a quarter to 30% of patients typically achieve a complete response following chemoradiation therapy and surgery, the rest do not, said Ronan Kelly of Baylor University Medical Center. The recurrence rate is also high within the first year, Hirawat added.

Donald Trump, AP

Covid-19 roundup: Trump sug­gests Pfiz­er vac­cine could be first ap­proved; VBI Vac­cines inks de­vel­op­ment deal with Cana­da

President Donald Trump commented Monday morning that Pfizer’s Covid-19 vaccine candidate could be the first to win approval by regulators.

During an interview on a Fox News’ morning show, the president said Pfizer was doing “very well” when asked which candidate could be approved, according to a Reuters report. He added that J&J could follow up afterward, saying “they’ll probably be a little later.”