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.

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His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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No­var­tis re­ports two pa­tient deaths af­ter treat­ment with Zol­gens­ma

Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

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Benjamin Oakes, Scribe Therapeutics CEO

CEO of Doud­na spin­out: With­in five years, genome ed­i­tors will have a 're­al­ly big im­pact' on pa­tients' lives

“CRISPR-by-design” is the idea behind Scribe Therapeutics, a company spun out from Jennifer Doudna’s Nobel-winning lab that’s competing in a closely-tracked field of genome editor companies just starting to make their way to the clinic.

After nabbing $100 million last March for its Series B funding round, Scribe is taking a different tack from some of its competitors, crafting a new enzyme isolated from bacteria called CasX, which has now been tweaked extensively and may be targeted to a range of genome-related diseases, offering a plethora of therapeutic options.

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House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.