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.

Im­ple­ment­ing re­silience in the clin­i­cal tri­al sup­ply chain

Since January 2020, the clinical trials ecosystem has quickly evolved to manage roadblocks impeding clinical trial integrity, and patient care and safety amid a global pandemic. Closed borders, reduced air traffic and delayed or canceled flights disrupted global distribution, revealing how flexible logistics and supply chains can secure the timely delivery of clinical drug products and therapies to sites and patients.

Feng Tian, Ambrx CEO (Ambrx)

Af­ter 5 qui­et years, a for­mer Scripps spin­out rais­es $200M and an­nounces plans to try again at an IPO

The first time San Diego biotech Ambrx tried to go public in 2014, they failed and the company’s board switched to a radically different strategy: They sold themselves for an undisclosed amount to a syndicate of Chinese investors and pharma companies.

Now, after 5 quiet years, that syndicate has raised a mountain of cash and indicated they’ll soon make another bid to go public.

Earlier this month, Ambrx raised $200 million in what they billed as a crossover round financed by Fidelity, BlackRock, Cormorant Asset Management, HBM Healthcare Investments, Invus, Adage Capital Partners and Suvretta Capital Management. It’s the largest amount they’ve ever raised and, according to Crunchbase figures, more than doubles the total amount of VC capital collected since their launch 17 years ago.

In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Michelle Longmire, Medable CEO (Jeff Rumans)

Med­able gets $91M for vir­tu­al clin­i­cal tri­als, bring­ing to­tal raise to $136M

As biotechs look to get clinical studies back on track amid the pandemic, Medable returned to the venture well for the second time this year, bagging a $91 million Series C to build out its virtual trial platform.

The software provider recently launched three new apps for decentralizing clinical trials, and saw a 500% revenue spike this year. And it isn’t alone. Back in August, Science 37 secured a $40 million round for its virtual trial tech, with support from Novartis, Sanofi Ventures and Amgen. Patients and researchers are taking a liking to the online approach, suggesting regulators could allow it to become a new normal even after the pandemic is over.

The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

Bob Nelsen rais­es $800M and re­cruits a star-stud­ded board to build the 'Fox­con­n' of biotech

Bob Nelsen spent his pandemic spring in his Seattle home, talking on the phone with Luciana Borio, the scientist who used to run pandemic preparedness on the National Security Council, and fuming with her about the dire state of American manufacturing.

Companies were rushing to develop vaccines and antibodies for the new virus, but even if they succeeded, there was no immediate supply chain or infrastructure to mass-produce them in a way that could make a dent in the outbreak.

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John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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News brief­ing: Gilead part­ner Gala­pa­gos sells off CRO for $37M; Polyphor bags $3.3M from CF Foun­da­tion

Close Gilead ally Galapagos is selling off one of its contract research organizations to a Polish pharma company.

Galapagos has agreed to sell 100% of the outstanding shares in the CRO Fidelta to Selvita, in a deal worth roughly $37 million expected to close in the first week of January. The acquisition is expected to nearly double Selvita’s revenues, the company says, as well as expand its drug discovery efforts.