Dmitry Kuzmin, Owen Smith. 4BIO

Lon­don's 4BIO Cap­i­tal un­veils first close of $150M fund ded­i­cat­ed to ad­vanced ther­a­pies

Or­chard $OR­TX. Seres $MCRB. Ret­roSense (ac­quired by Al­ler­gan). With sev­er­al high pro­file ex­its un­der their belt, 4BIO Cap­i­tal is out to find more trail­blaz­ers to back in the drug R&D world.

The VC shop has raised $50 mil­lion in the first close of what it hopes to be a $150 mil­lion sec­ond fund at the end of next year. With a fo­cus on ad­vanced ther­a­pies — cell and gene ther­a­py, RNA-based ther­a­py, tar­get­ed ther­a­py, and the mi­cro­bio­me — they will de­vote 60% of the fund to Eu­ro­pean deals from their perch in Lon­don, while spread­ing the rest be­tween Japan and the US, go­ing in­to the Mid­west and the South for promis­ing ideas that might not have re­ceived as much love as those com­ing out of Boston.

Al­to­geth­er, 8 to 12 pri­vate com­pa­nies will re­ceive in­vest­ment from 4BIO Ven­tures II.

“With the gap in re­al com­mer­cial de­vel­op­ment of ad­vanced ther­a­pies over the last 20 years, there’s a lot of pro­grams, par­tic­u­lar­ly here in Eu­rope, that aca­d­e­mics have been sol­dier­ing on, on a shoe­string bud­get, push­ing their ideas and thoughts to a point where they can be in the clin­ic with­in a year, par­tic­u­lar­ly if they don’t suf­fer from the bot­tle­neck of man­u­fac­tur­ing,” Owen Smith, di­rec­tor of in­vest­ment, told End­points News.

While many suc­cess­es in ad­vanced ther­a­pies have been lim­it­ed to rare con­di­tions, main­ly of the reti­na, liv­er and bone mar­row — 4BIO wants to start tak­ing these cut­ting edge ap­proach­es to slight­ly more main­stream ap­pli­ca­tions, man­ag­ing part­ner Dmit­ry Kuzmin said.

“Our am­bi­tion for…Fund II is to try and bring these in­to what we jok­ing­ly call medi­um rare con­di­tions, and ba­si­cal­ly where we have to tack­le with treat­ing tens of thou­sands of pa­tients on a reg­u­lar ba­sis,” he said.

Hav­ing been at the fore­front of ad­vanced ther­a­pies in­vest­ment since 2010, the team of 9 (bol­stered by a 6-mem­ber ad­vi­so­ry board) is clear about just the kind of fron­tiers it’s keen on tack­ling in each of the fields it’s watch­ing, Kuzmin added.

That means gene ther­a­py in the brain, as well as ways to tone down, crank up or turn off gene ther­a­pies (4BIO has pre­vi­ous­ly in­vest­ed in op­to­ge­net­ics start­up Ret­roSense, but there’s al­so chemo­ge­net­ics, ther­mo­ge­net­ics, mag­ne­to­ge­net­ics, and so on).

With­in cell ther­a­py, 4BIO is look­ing for sol­id clin­i­cal and man­u­fac­tur­ing op­er­a­tions that can de­liv­er con­sis­tent and durable re­spons­es; for tar­get­ed ther­a­py it’s most in­ter­est­ed in pro­tein degra­da­tion and vi­ral ap­pli­ca­tions; and “ra­tio­nal en­gi­neer­ing” is the key word for their mi­cro­bio­me bets.

The LPs, which in­clude the Chil­dren’s Min­neso­ta among a group of fam­i­ly of­fices and in­sti­tu­tion­al in­vestors, have man­dat­ed a third of the fund be re­served to launch new star­tups.

Kuzmin en­vi­sions most­ly seed-stage and Se­ries A rounds, with the oc­ca­sion­al Se­ries B — and the more ad­vanced in clin­i­cal proof-of-con­cept, the bet­ter. “Our ide­al project is clear­ly a for­ma­tion deal that’s al­ready in the clin­ic,” he summed up.

Ex­pect some more de­tails soon on the com­pa­nies they reck­on are push­ing through the med­i­cines of to­mor­row as the first two in­vest­ments get un­der way.

A lab technician works during research on coronavirus at Johnson & Johnson subsidiary Janssen Pharmaceutical in Beerse, Belgium, Wednesday, June 17, 2020. (Virginia Mayo/AP Images)

UP­DAT­ED: End­points News ranks all 28 play­ers in the Covid-19 vac­cine race. Here's how it stacks up to­day

LAST UPDATED AUGUST 13

The 28 players now in or close to the clinical race to get a Covid-19 vaccine over the finish line are angling for a piece of a multibillion-dollar market. And being first — or among the leaders — will play a big role in determining just how big a piece.

Endpoints News writer Nicole DeFeudis has posted a snapshot of all the companies, universities and hospital-based groups now racing through the clinic, ranking them according to their place in the pipeline as well as the latest remarks available on timelines. And we’ll keep this lineup updated right through the end of the year, as the checkered flags start to fall, possibly as early as October.

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Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

James Wilson, WuXi Global Forum at JPM20

FDA puts up a red light for Pas­sage Bio’s first gene ther­a­py pro­gram, de­lay­ing a pro­gram from James Wilson's group at Penn

Gene therapy pioneer James Wilson spearheaded animal studies demonstrating the potential of new treatments injected directly into the brain, looking to jumpstart a once-and-done fix for an extraordinarily rare disease called GM1 gangliosidosis in infants. His team at the University of Pennsylvania published their work on monkeys and handed it over to Passage Bio, a Wilson-inspired startup building a pipeline of gene therapies — with an IND for PBGM01 to lead the way.

Inside FDA HQ (File photo)

The FDA just ap­proved the third Duchenne MD drug. And reg­u­la­tors still don’t know if any of them work

Last year Sarepta hit center stage with the FDA’s controversial reversal of its CRL for the company’s second Duchenne muscular dystrophy drug — after the biotech was ambushed by agency insiders ready to reject a second pitch based on the same disease biomarker used for the first approval for eteplirsen, without actual data on the efficacy of the drug.

On Wednesday the FDA approved the third Duchenne MD drug, based on the same biomarker. And regulators were ready to act yet again despite the lack of efficacy data.

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No­var­tis’ CAR-T part­ner in Chi­na wraps $383M take-pri­vate deal en­gi­neered by CEO

After 13 years on Nasdaq, Cellular Biomedicine Group is returning to private hands.

CEO Tony (Bizuo) Liu is a key advocate of the deal, leading a consortium of mostly Chinese investors including other top company execs, Yunfeng Capital and TF Capital — even as the company is getting more entrenched in the US with its CAR-T and other cell therapy work.

Shareholders are receiving $19.75 per share $CBMG, which translates to a premium of 31.4% over the 30 trading-day average price as of August 11. The stock, though, has dropped significantly since the consortium first put in its proposal in November. Compared to then, the acquisition price marks only a 11.8% increase.

How much has pre­ci­sion med­i­cine helped? A new NCI study of­fers clues

Does precision medicine work?

The approach, based on finding a drug to target a patient’s specific genes, has undoubtedly saved individual lives, spurring Lazarus-like reversals in health in once-terminally ill patients. But critics have pointed out that its pursuit has meant drug companies spending hundreds of millions of dollars to target mutations that affect narrow slices of the populations, and that many of the gains researchers thought it would bring have eroded as cancers evolve resistance.

Stéphane Bancel speaks to President Donald Trump at the White House meeting on March 2 (AP Images)

UP­DAT­ED: Mod­er­na of­fers steep dis­count in US sup­ply deal — but still takes the crown with close to $2.5B in vac­cine con­tracts

The US pre-order for Moderna’s Covid-19 vaccine is in.

Operation Warp Speed is reserving $1.525 billion for 100 million doses of Moderna’s Phase III mRNA candidate, rounding out to about $15 per dose — including $300 million in incentive payments for timely delivery. Given that Moderna has a two-dose regimen, it’s good for vaccinating 50 million people. The US government also has the option to purchase another 400 million doses for a total of $6.6 billion, or $16.5 per dose.

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Credit: Galaxy Life Sciences

Galaxy Life Sci­ences lands $50 mil­lion deal to build in cen­tral Mass­a­chu­setts bio­man­u­fac­tur­ing park

Webster, MA-based real estate developer Galaxy Life Sciences struck a roughly $50 million deal to build in a biomanufacturing park in Worcester, an up-and-coming biotech hotspot about an hour west of Boston.

Galaxy paid $1.9 million for a 6-acre plot, on which it intends to construct a $50 million building grossing 95,000 to 180,000 square feet. The space will be designed to accommodate research and development, or manufacturing, and could employ 125 to 150 workers, according to the Worcester Telegram & Gazette. Construction is expected to begin this spring and wrap up in about a year.

No­vo gets PhI­II he­mo­phil­ia tri­als for a Roche ri­val back on track af­ter com­plet­ing work-around on blood clot threat

After abruptly shutting down three hemophilia studies back in March due to serious safety issues, Novo Nordisk is getting things going again.

The Danish pharma gave the go-ahead to resume Phase III trials for its concizumab candidate, which are investigating subcutaneous prophylaxis treatment in hemophilia A and B patients regardless of inhibitor status. Novo Nordisk had halted the studies after three patients experienced non-fatal blood clots.