Look­ing for 'ex­ter­nal in­no­va­tion,' Boehringer In­gel­heim re­serves $500M+ for new Shang­hai hub

Now that Boehringer In­gel­heim’s bet on con­tract man­u­fac­tur­ing in Chi­na has paid off, the Ger­man drug­mak­er is an­te­ing up more to get in­to the re­search game.

Boehringer has set aside $507.9 mil­lion (€451 mil­lion) for a new Ex­ter­nal In­no­va­tion Hub to be built in Shang­hai over five years. The site will be­come one of its “strate­gic pil­lars” as the team strives to get 71 ap­provals — ei­ther for new prod­ucts or in­di­ca­tions — by 2030, said Fe­lix Gutsche, pres­i­dent and CEO of Boehringer In­gel­heim Chi­na.

“Boehringer In­gel­heim aims to seize the op­por­tu­ni­ty to be­come the pre­ferred part­ner in the in­no­va­tion ecosys­tem in Chi­na’s bio­phar­ma in­dus­try,” Weiyi Zhang, head of the in­no­va­tion hub, told Shang­hai Dai­ly.

The new unit will serve as an um­brel­la for cer­tain ex­ist­ing di­vi­sions such as col­lab­o­ra­tions, busi­ness de­vel­op­ment and li­cens­ing, as well as ven­ture ac­tiv­i­ties, the pa­per not­ed.

As reg­u­la­to­ry re­forms light­en the bur­den for for­eign drug­mak­ers to score ap­provals in Chi­na, Boehringer has be­gun to in­cor­po­rate Chi­nese sites in all its glob­al ear­ly-stage pro­grams. At the same time, the flour­ish­ing lo­cal biotech scene al­so makes for fer­tile soil to nur­ture new dis­cov­er­ies and fos­ter de­vel­op­ment.

Boehringer was one of the first con­tract man­u­fac­tur­ers to sign up for a pi­lot scheme when Chi­nese reg­u­la­tors loos­ened their rules to stop de­mand­ing that a drug’s own­er al­so pro­duce it. In the be­gin­ning of this year, it made his­to­ry when BeiGene land­ed an OK for its PD-1 tislelizum­ab, putting Boehringer’s Shang­hai fa­cil­i­ty to use.

Just weeks ago Boehringer un­veiled a €3 mil­lion plan to open a branch of its dig­i­tal lab, BI X, in Shang­hai — the first out­side Ger­many and on­ly the sec­ond in the world.

The team of 20 there will ded­i­cate them­selves to un­der­stand­ing the par­tic­u­lar needs of Chi­nese pa­tients and cus­tomers, whom they say have “high dig­i­tal ca­pa­bil­i­ties.”

“The COVID-19 sit­u­a­tion has high­light­ed the im­por­tance of dig­i­tal ser­vices, and our lat­est dig­i­tal ini­tia­tive hopes to in­te­grate all the method­ol­o­gy and tech­nol­o­gy with re­al busi­ness needs,” Gutsche said in an in­ter­view with Shang­hai Dai­ly. “Chi­na is the first mar­ket to see busi­ness re­bound af­ter the coro­n­avirus out­break, and we’ve seen im­prove­ment in the sec­ond-quar­ter busi­ness per­for­mance.”

Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

When will it end? Gold­man econ­o­mist gives late-stage vac­cines a good shot at tar­get­ing 'large shares' of the US by mid-2021 — but the down­side is daunt­ing

It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

With Covid-19, the same timeline has devoured all of 5 months. And the outcome will influence the lives of billions of people and a multitrillion-dollar world economy.

Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can create herd immunity in the US by the middle of next year, with Europe following a few months later.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 86,500+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine — so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 86,500+ biopharma pros reading Endpoints daily — and it's free.

Ver­sant de­buts Ridge­line's start­up #4, armed with $30M and al­ter­na­tive TCR cell ther­a­pies for sol­id tu­mors

For all the iterations and advances in TCR therapies for cancer, any experimental treatments involving T cell receptors share one trait: By definition, they only recognize antigens presented as peptides on the major histocompatibility complex (MHC) on cells.

Versant reckons it’s time to expand the arsenal. With $30 million in initial funding, its Ridgeline Discovery Engine in Switzerland has been working on a non-peptidic approach that it says has tumor-agnostic potential, especially in solid tumors. They’ve named it Matterhorn, after a Swiss mountain as they did with the three other companies that have emerged from the Basel-based incubator.

J&J gets a fresh OK for es­ke­t­a­mine, but is it re­al­ly the game-chang­er for de­pres­sion Trump keeps tweet­ing about?

Backed by an enthusiastic set of tweets from President Trump and a landmark OK for depression, J&J scooped up a new approval from the FDA for Spravato today. But this latest advance will likely bring fresh scrutiny to a drug that’s spurred some serious questions about the data, as well as the price.

First, the approval.

Regulators stamped their OK on the use of Spravato — developed as esketamine, a nasal spray version of the party drug Special K or ketamine — for patients suffering from major depressive disorder with acute suicidal ideation or behavior.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 86,500+ biopharma pros reading Endpoints daily — and it's free.

Covid-19 roundup: BAR­DA qui­et­ly pulls plug on IL-6 drugs; BioN­Tech and Fo­s­un be­gin mR­NA tri­al

IL-6 inhibitors showed some early promise in potentially treating Covid-19 patients, but recent trial flops have dashed hopes. Now it appears BARDA has officially pulled the plug.

The HHS office’s website has quietly updated to reflect that it is “no longer supporting product development” for Covid-19 in both Actemra (tocilizumab) and Kevzara (sarilumab), dealing a blow to the Roche and Regeneron/Sanofi drugs. This all but assures that IL-6 drugs repurposed to treat Covid-19 are essentially dead in the water.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 86,500+ biopharma pros reading Endpoints daily — and it's free.

CF Foun­da­tion, Long­wood team on new in­cu­ba­tor for com­pa­nies with cut­ting-edge CF treat­ments

Nine months after launching a $500 million hunt for a cure for cystic fibrosis, the Cystic Fibrosis Foundation said it will use a portion of those funds to do something it has never done before: help launch new companies.

The CF Foundation, whose venture philanthropy efforts helped fund Vertex’s line of powerful CF drugs, is teaming with Longwood Fund to create a CF incubator. The incubator will identify new companies with platforms or technologies that can be applied in the rare genetic condition. The partners can then finance early development in exchange for a commitment from the companies to focus on applications in cystic fibrosis.

Kiersten Stead, John Hamer (DCVC Bio)

Deep tech, round 2: DCVC Bio bags $350M fund to chase the tip of the life sci­ence spear

It took one trip from San Francisco to Vancouver for Kiersten Stead and her DCVC Bio crew to feel confident about throwing their weight — and cash — behind AbCellera.

CEO Carl Hansen’s academic background and the potential of the platform, which combined machine vision and robotics with microfluidics, were promising. But the site visit sealed the Series A deal, where DCVC was the lead and only investor.

Igor Splawski (CureVac)

Cure­Vac nabs a top No­var­tis sci­en­tist for CSO slot as mR­NA vac­cines seize the spot­light

One of the key players in the race to develop a new mRNA vaccine to fight Covid-19 has reshuffled the top spots in the executive suite. And they’re bringing in a Novartis vet out of Harvard to spearhead their work on mRNA.

CureVac, which just filed for an IPO that’s still taking shape, has formally handed Franz-Werner Haas the CEO title, after giving it to him on an interim basis. And the still rather stealthy German biotech largely owned by billionaire Dietmar Hopp has recruited Igor Splawski as its chief scientific officer.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 86,500+ biopharma pros reading Endpoints daily — and it's free.

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

OWS' Mon­cef Slaoui lam­basts ‘in­sult­ing’ me­dia cov­er­age: 'How are you help­ing in this pan­dem­ic?'

Ten weeks into his job as the chief advisor of Operation Warp Speed, Moncef Slaoui has found a new hurdle to the challenge of bringing a Covid-19 vaccine unprecedented speed: the media.

In an official podcast by the Department of Health and Human Services, Slaoui — a veteran of GlaxoSmithKline who came out of his retirement to take on the role, relinquishing several board directorships and selling shares in the process — counted himself naive in assuming that the press was aiming to inform.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 86,500+ biopharma pros reading Endpoints daily — and it's free.