Carolyn Magill, Aetion CEO

RWE up­start maps a new glob­al plan as in­vestors pour in the lat­est mega-round

As reg­u­la­tors con­tin­ue to re­ly more on re­al world ev­i­dence, New York-based RWE leader Ae­tion said Tues­day that it has closed a $110 mil­lion Se­ries C fund­ing round, led by War­burg Pin­cus.

The com­pa­ny said it will use the new funds to ex­tend the ca­pa­bil­i­ties of its RWE plat­form, used by many top bio­phar­ma com­pa­nies, ex­pand its Eu­ro­pean and Asian-Pa­cif­ic foot­print, and grow its com­mer­cial team to serve new clients. Ae­tion has now raised a to­tal of $212 mil­lion to date.

“In some in­stances it makes sense for us to have a plat­form bet­ter suit­ed for these re­gion­al needs, es­pe­cial­ly as it re­lates to Asia,” Ae­tion CEO Car­olyn Mag­ill told End­points News in an in­ter­view. “We’ll be build­ing out our team in both places.”

The last year has proven to be a suc­cess­ful one for the com­pa­ny as it near­ly dou­bled its rev­enue and se­cured 100% of cus­tomer re­newals.

Ae­tion ini­tial­ly made its name by es­tab­lish­ing a part­ner­ship with the FDA and more re­cent­ly be­came the first RWE com­pa­ny to es­tab­lish an Covid-19 re­search col­lab­o­ra­tion with the agency. With for­mer FDA com­mis­sion­er Scott Got­tlieb serv­ing on the com­pa­ny’s board, Ae­tion al­so re­cent­ly poached the FDA’s top pol­i­cy of­fi­cial, Low­ell Schiller. Mean­while, the In­sti­tute for Clin­i­cal and Eco­nom­ic Re­view al­so se­lect­ed Ae­tion to help pro­vide RWE for the in­sti­tute’s val­ue as­sess­ments of drugs.

In ad­di­tion to War­burg Pin­cus, B Cap­i­tal and Fore­site Cap­i­tal al­so joined in on the fund­ing in this round, as did Ae­tion’s ex­ist­ing back­ers New En­ter­prise As­so­ci­ates (an­oth­er Got­tlieb em­ploy­er) and Flare Cap­i­tal Part­ners.

So is an IPO in the cards for Ae­tion?

“We are fo­cused on sup­port­ing our cus­tomers, build­ing our busi­ness, build­ing glob­al stan­dards for trans­form­ing da­ta in­to ev­i­dence and do­ing this on such a scale that bio­phar­ma man­u­fac­tur­ers, pay­ers, providers, da­ta providers and reg­u­la­tors can all look to use RWE more rou­tine­ly in how they make these high-stakes de­ci­sions,” Mag­ill added. She al­so ex­plained how RWE is in­creas­ing­ly used by reg­u­la­tors.

In 2019, 48% of FDA drug ap­provals in­clud­ed RWE in sub­mis­sions, and in 2020, it was 75%, ac­cord­ing to Ae­tion analy­ses. “That’s an in­di­ca­tor of the in­creas­ing re­cep­tiv­i­ty and im­por­tance of re­al world ev­i­dence in reg­u­la­to­ry de­ci­sion mak­ing,” she said.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Rafaèle Tordjman (Jeito Capital)

Con­ti­nu­ity and di­ver­si­ty: Rafaèle Tord­j­man's women-led VC firm tops out first fund at $630M

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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Ex­elix­is pulls a sur­prise win in thy­roid can­cer just days ahead of fi­nal Cabome­tyx read­out

Exelixis added a thyroid cancer indication to its super-seller Cabometyx’s label on Friday — months before the FDA was expected to make a decision, and days before the company was set to unveil the final data at #ESMO21.

At a median follow-up of 10.1 months, differentiated thyroid cancer patients treated with Cabometyx (cabozantinib) lived a median of 11 months without their disease worsening, compared to just 1.9 months for patients given a placebo, Exelixis said on Monday.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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Time for round 2: Il­lu­mi­na-backed VC snags $325M for its next fund

Illumina Ventures closed off its second investment fund with a total commitment of $325 million, offering fresh fuel to back a slate of startups that have already included a smorgasbord of companies, covering everything from diagnostics to biotech drug development and genomics.

Fund II brings the total investment under Illumina Ventures’ oversight to $560 million, which has been focused on early-stage companies. And it has a transatlantic portfolio that includes SQZ, Twist and Encoded Therapeutics.