George Chen (D3 Bio)

Here's a $200M Chi­na start­up idea — if you can read be­yond the big words

What does it take to gath­er $200 mil­lion from top VC play­ers in Chi­na these days?

Not much that can be shared pub­licly, D3 Bio sug­gests as it launch­es with the hefty Se­ries A this morn­ing. But the in­gre­di­ents feed­ing in­to the Shang­hai-based as­pir­ing glob­al biotech may be in­dica­tive of things that would turn heads at places like Boyu Cap­i­tal, Ma­trix Part­ners Chi­na, Se­quoia Cap­i­tal Chi­na, Temasek, and WuXi AppTec’s Cor­po­rate Ven­ture Fund.

First, you need a con­nect­ed, sea­soned leader who’s been im­mersed in the ranks of glob­al bio­phar­ma.

D3 Bio co-founder and CEO George Chen put in the years at the NIH, Eli Lil­ly, Glax­o­SmithK­line, and J&J af­ter get­ting an MBA from Penn’s Whar­ton, lend­ing a hand to more than 70 INDs and 30-plus NDAs. He was chief med­ical of­fi­cer at BeiGene for two years be­fore leav­ing to head up As­traZeneca’s on­col­o­gy R&D in Chi­na.

Then it’s all about hit­ting the right themes: “Pre­ci­sion med­i­cine” has a next-gen­er­a­tion ring to it; a fo­cus on im­munol­o­gy and on­col­o­gy puts you in the same league as the big guys; talk of build­ing “back­bone” drugs that can spawn a pipeline and new com­bi­na­tions is al­so key.

Top it all with a busi­ness mod­el that lever­ages Chi­na’s grow­ing tal­ent pool, re­sources and re­search out­put, and you have a win­ning idea.

“As far as we know, D3’s ap­proach is unique,” Chen wrote in an email to End­points News, “we start with in­sights from clin­i­cal de­vel­op­ment and an as­sess­ment of mar­ket needs and, take those in­sights to the lab to guide the clin­i­cal de­vel­op­ment path.”

So rather than start­ing out with new sci­en­tif­ic dis­cov­er­ies or plat­form tech­nolo­gies, D3 — which stands for de­vel­op­ment, dis­cov­ery, then de­vel­op­ment again — would “sur­vey the clin­i­cal land­scape” to find de­fi­cien­cies in stan­dard-of-care treat­ments. The next step is iden­ti­fy­ing dis­ease tar­gets and de­liv­ery meth­ods that may plug that gap, and they go from there.

“D3 Bio an­tic­i­pates that hav­ing a clear un­der­stand­ing dur­ing pre­clin­i­cal de­vel­op­ment both of rel­e­vant can­cer bio­mark­ers and the ther­a­peu­tic im­prove­ment or re­place­ment goals will make drug dis­cov­ery and de­vel­op­ment as ef­fi­cient and fo­cused as pos­si­ble,” reads a press re­lease.

As with BeiGene, the har­bin­ger for a new breed of biotechs root­ed in Chi­na but run­ning on glob­al bio­phar­ma rules, D3 Bio prides it­self on lever­ag­ing what Chen calls an “ad­vanced” R&D sys­tem.

It will in­volve a mix of in­ter­nal dis­cov­ery and in-li­cens­ing deals for ear­ly-stage as­sets, Chen added — some­what dis­tinct from bring­ing in late-stage pro­grams for a quick flip to the mar­ket, an ap­proach that’s gained re­newed mo­men­tum. The Se­ries A should sus­tain the com­pa­ny for a few years as it cre­ates and push­es for­ward the pipeline.

So what kinds of drugs, dis­eases and pace should we ex­pect from D3 Bio?

“Stay tuned – D3 will be shar­ing specifics about its pipeline at the ap­pro­pri­ate time,” Chen wrote.

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Brad Bolzon (Versant)

Ver­sant pulls the wraps off of near­ly $1B in 3 new funds out to build the next fleet of biotech star­tups. And this new gen­er­a­tion is built for speed

Brad Bolzon has an apology to offer by way of introducing a set of 3 new funds that together pack a $950 million wallop in new biotech creation and growth.

“I want to apologize,” says the Versant chairman and managing partner, laughing a little in the intro, “that we don’t have anything fancy or flashy to tell you about our new fund. Same team, around the same amount of capital, same investment strategy. If it ain’t broke, don’t fix it.”

But then there’s the flip side, where everything has changed. Or at least speeded into a relative blur. Here’s Bolzon:

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Law pro­fes­sors call for FDA to dis­close all safe­ty and ef­fi­ca­cy da­ta for drugs

Back in early 2018 when Scott Gottlieb led the FDA, there was a moment when the agency seemed poised to release redacted complete response letters and other previously undisclosed data. But that initiative never gained steam.

Now, a growing chorus of researchers are finding that a dearth of public data on clinical trials and pharmaceuticals means industry and the FDA cannot be held accountable, two law professors from Yale and New York University write in an article published Wednesday in the California Law Review.

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Jenny Rooke (Genoa Ventures)

Ear­ly Zymer­gen in­vestor Jen­ny Rooke re­flects on 'chimeras' in biotech, what it takes to spot a $500M gem

When Jenny Rooke first heard of Zymergen back in 2014, she knew she was looking at something different and exciting. The Emeryville, CA biotech held the promise of blending biology and technology to solve a huge unmet need for cost-effective chemicals — of all things — and a stellar founding team to boot.

But back then, West Coast venture capitalists didn’t see in Zymergen the one thing they were looking for in a winning biotech: therapeutic potential. Rooke, however, saw an opportunity and made her bets. Seven years later, that bet is paying off in a big way.

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Covid-19 man­u­fac­tur­ing roundup: Mary­land looks to grow biotech ca­pac­i­ty with $400M check; Rus­sia lands sec­ond Sput­nik V part­ner this week

A Maryland real estate project has added three new biotech-focused manufacturing and research buildings to an office park to keep up with demand created by the pandemic, the Washington Business Journal reported.

The Milestone Business Park — located off of I-270 in Germantown, MD — will see the new buildings and a total of 532,000 square feet as the campus rebrands to Milestone Innovation Park.

Saurabh Saha at Endpoints News' #BIO19

On the heels of $250M launch, Centes­sa barges ahead with an IPO to fu­el its 10-in-1 Medicxi pipeline

Francesco De Rubertis made no secret of IPO plans for Centessa, his 10-in-1 legacy play. Barely two months later, the S-1 is in.

The hot-off-the-press filing depicts the same grand vision that the longtime VC touted when he did the rounds in February: Take the asset-centric mindset that he’s been preaching at Medicxi over the years, and roll up a bunch of biotech upstarts, with unrelated risk profiles, into 1 pharma company that can carry on the development at scale.

Steffen Schuster, ITM CEO

Ra­dio­phar­ma re­mains hot as Ger­many's ITM rais­es $109M to ad­vance neu­roen­docrine can­cer pro­gram

The world of radiopharmaceuticals has been heating up over the last few years, and Thursday saw another company focused on the field pull in a new nine-figure raise.

Germany’s ITM, or Isotopen Technologien München, scored a $109 million round of loan financing to push forward its precision oncology pipeline and fund late-stage development for its lead program. As part of the agreement, the loan will convert to shares in the event of future financial or corporate transactions, ITM said.

Novavax CEO Stanley Erck at the White House in 2020 (Andrew Harnik, AP Images)

As fears mount over J&J and As­traZeneca, No­vavax en­ters a shaky spot­light

As concerns rise around the J&J and AstraZeneca vaccines, global attention is increasingly turning to the little, 33-year-old, productless, bankruptcy-flirting biotech that could: Novavax.

In the now 16-month race to develop and deploy Covid-19 vaccines, Novavax has at times seemed like the pandemic’s most unsuspecting frontrunner and at times like an overhyped also-ran. Although they started the pandemic with only enough cash to last 6 months, they leveraged old connections and believers into $2 billion and emerged last summer with data experts said surpassed Pfizer and Moderna. They unveiled plans to quickly scale to 2 billion doses. Then they couldn’t even make enough material to run their US trial and watched four other companies beat them to the finish line.

FDA of­fers scathing re­view of Emer­gent plan­t's san­i­tary con­di­tions, em­ploy­ee train­ing af­ter halt­ing pro­duc­tion

The FDA wrapped up its inspection of Emergent’s troubled vaccine manufacturing plant in Baltimore on Tuesday, after halting production there on Monday. By Wednesday morning, the agency already released a series of scathing observations on the cross contamination, sanitary issues and lack of staff training that caused the contract manufacturer to dispose of millions of AstraZeneca and J&J vaccine doses.