Eye­ing com­mer­cial­iza­tion, a Shang­hai-based CAR-T start­up nabs a $186M megaround

Three years af­ter its last fi­nanc­ing and with six pro­grams now in the clin­ic, Shang­hai-based CARs­gen ther­a­peu­tics has raised $186 mil­lion to push for­ward a broad plat­form of CAR-T ther­a­pies for liq­uid and sol­id tu­mors.

Zong­hai Li

The Se­ries C mega-round drew from both mar­quee and less­er-known re­gion­al in­vestors, with the well-heeled Chi­nese pri­vate eq­ui­ty firm Loy­al Val­ley Cap­i­tal lead­ing the raise and Lil­ly Asia Ven­tures, Shiyu Cap­i­tal, and Sum­mer Cap­i­tal chip­ping in. The com­pa­ny will use that cash in part to tran­si­tion, ad­vanc­ing tri­als on three con­ti­nents and lay­ing the ba­sis for an even­tu­al com­mer­cial launch, founder and CEO Zong­hai Li said in a state­ment.

Loy­al Val­ley Cap­i­tal man­ag­ing di­rec­tor Roy (Rong­gang) Xie praised the pipeline’s broad­ness and said the round could help CARs­gen “achieve mar­ket ap­proval of its lead­ing as­sets.”

Found­ed in 2014, at the height of the CAR-T hype, CARs­gen first made a mark at ASH in 2018, when they showed off da­ta for their CAR-T that tar­get­ed BC­MA — the same cell ther­a­py in­di­ca­tion where J&J-part­nered Leg­end Biotech would make a huge splash the fol­low­ing year and where blue­bird and Bris­tol My­ers Squibb now await an FDA de­ci­sion. The com­pa­ny re­port­ed 100% re­sponse rate in 14 pa­tients, with 11 achiev­ing what they deemed to be ei­ther a “very good re­sponse” or a com­plete re­mis­sion.

Roy Xie

Full da­ta re­leased last No­vem­ber showed 21 re­spons­es in 24 pa­tients, with five show­ing com­plete re­spons­es and 14 show­ing strin­gent com­plete re­spons­es. The re­sults helped earn CARs­gen a Re­gen­er­a­tive Med­i­cine Ad­vanced Ther­a­py des­ig­na­tion.

That year, they al­so launched a Phase I US tri­al for the ther­a­py, part of a broad ex­pan­sion of their clin­i­cal pipeline. Al­though most of the new da­ta are still pend­ing, the com­pa­ny is now run­ning 6 dif­fer­ent clin­i­cal-stage CAR-T pro­grams: BC­MA for mul­ti­ple myelo­ma, CD19 for non-Hodgkin lym­phoma, GPC3 for liv­er can­cer, EGFR for glioblas­toma, and a pro­gram for gas­tric can­cer that tar­gets a pro­tein called Claudin 18.2. An an­ti­body tar­get­ing Claudin 18.2 is al­so in the clin­ic.

Most of those tri­als are in Chi­na, but CARs­gen re­ceived clear­ance in May to start a study of their gas­tric can­cer CAR-T in the US. Last month, the FDA gave it or­phan des­ig­na­tion. Leg­end Biotech has de­vel­oped a sim­i­lar ex­per­i­men­tal ther­a­py.

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.

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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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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Overnight for­tunes are be­ing made in biotech these days — and it's both en­cour­ag­ing and more than a lit­tle bit scary

Just to complete the last leg of a running story I’ve been tracking for a few weeks, Olema $OLMA has come through its IPO from the Thursday night pricing at $19 a share with a market cap just north of $2 billion.

That leaves newly-named CEO Sean Bohen holding a batch of 1,110,896 shares with a strike price of $4.82. As of Tuesday morning, the stock is now trading at $53.40, giving him a portfolio value of $53.4 million. Not bad for someone who was hired in September.

Vas Narasimhan, Novartis CEO (Jason Alden/Bloomberg via Getty Images)

Vas Narasimhan's 'Wild Card' drugs: No­var­tis CEO high­lights po­ten­tial jack­pots, as well as late-stage stars, in R&D pre­sen­ta­tion

Novartis is always one of the industry’s biggest R&D spenders. As they often do toward the end of each year, company execs are highlighting the drugs they expect will most likely be winners in 2021.

And they’re also dreaming about some potential big-time lottery tickets.

As part of its annual investor presentation Tuesday, where the company allows investors and analysts to virtually schmooze with the bigwigs, Novartis CEO Vas Narasimhan will outline what he thinks are the pharma’s “Wild Cards.” The slate of five experimental drugs covers a wide range of indications that Novartis hopes can be high-risk, high-reward entrants into the market over the next half-decade or so.

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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The flu virus (CDC)

Roche tacks on an­oth­er Xofluza in­di­ca­tion as flu sea­son meets pan­dem­ic

Xofluza was heralded as the first new flu drug in 20 years when it got the FDA OK back in 2018. But even so, Roche saw tough competition from cheaper Tamiflu generics that appeared to be nearly as — if not just as — effective.

Now, the pharma says the drug also can be used to prevent influenza after exposure, snagging a new approval and adding to Xofluza’s appeal as flu season meets the pandemic.

A poll sug­gests vac­cine da­ta boost­ed Pfiz­er's pub­lic im­age, but oth­er da­ta point to long road ahead

For much of the pharmaceutical industry, the pandemic presented an opportunity: to prove their value to the world and turn public opinion around on a business much of the country had come to disdain.

That theory — that helping pull the country from a pandemic could neutralize years of anger over high drug prices — was put to its biggest test this month, as three different drugmakers announced data from their Covid-19 vaccines, offering the first major evidence that industry-built inoculations could turn the tide of the outbreak in the US.

Covid-19 roundup: Rus­sia prices vac­cine 't­wo or more times cheap­er' than mR­NA shots; Sino­vac PhI­II da­ta ex­pect­ed in ear­ly De­cem­ber

The world can now purchase its first registered vaccine — at less than $10 per dose.

RDIF, the Russian sovereign wealth fund and an avid backer of Sputnik V, said the vaccine will be available internationally starting from March 2021. A two-dose regimen of the adenovirus-based vaccine, which it has said is more than 90% effective, will cost less than $20.

And they are not shy about inserting themselves right into a rivalry with Western frontrunners, namely Pfizer/BioNTech and Moderna.

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