Ronald Crys­tal's Lex­eo Ther­a­peu­tics pulls in a $100M megaround just nine months af­ter launch

About a month af­ter Lex­eo Ther­a­peu­tics ac­quired Ste­lios Ther­a­peu­tics — bring­ing its 18-pro­gram gene ther­a­py pipeline to 21 — in­vestors are reach­ing a lit­tle deep­er in­to their pock­ets to en­sure the New York City-based biotech is up to the task.

Lex­eo un­veiled a $100 mil­lion Se­ries B round on Thurs­day morn­ing, led by D1 Cap­i­tal Part­ners and Even­tide As­set Man­age­ment. The funds will be used to sup­port the com­pa­ny’s “next phase of growth,” ac­cord­ing to CEO Nolan Townsend, with a spe­cif­ic fo­cus on three lead­ing gene ther­a­pies — one for CLN2 Bat­ten dis­ease, one for Alzheimer’s, and one for a rare con­di­tion called Friedre­ich’s atax­ia.

Ronald Crys­tal

The com­pa­ny’s roots trace back to gene ther­a­py long hauler Ronald Crys­tal, who’s been work­ing in the field since the 1980s. He took his ideas to Weill Cor­nell Med­i­cine in 1993, where he helped build a large gene ther­a­py pro­gram and spent more than a decade de­vel­op­ing po­ten­tial can­di­dates.

Af­ter de­cid­ing to splin­ter off, Crys­tal as­sem­bled a sea­soned brain trust to lead Lex­eo, in­clud­ing Townsend, who spent 12 years at Pfiz­er; chair­man Steven Altschuler, who was pre­vi­ous­ly chair­man of gene ther­a­py pi­o­neer Spark Ther­a­peu­tics; and ex­ec­u­tive VP and CMO Jay Barth, who hails from  Am­i­cus Ther­a­peu­tics and PTC Ther­a­peu­tics. Crys­tal has al­so kept his po­si­tion at Weill Cor­nell.

Nolan Townsend

The pipeline cur­rent­ly in­cludes eight can­di­dates for car­diac and CNS dis­or­ders, plus an­oth­er 13 undis­closed pro­grams. How­ev­er, on­ly two have reached the clin­ic: LX1004, which re­cent­ly com­plet­ed a Phase I/II study and is head­ed for a piv­otal tri­al in 2022 for CLN2 Bat­ten dis­ease, an au­to­so­mal re­ces­sive lyso­so­mal stor­age dis­ease; and LX100, cur­rent­ly in Phase I for APOE4-as­so­ci­at­ed Alzheimer’s dis­ease.

Townsend’s al­so lin­ing up a third can­di­date for the clin­ic, dubbed LX2006, for Friedre­ich’s atax­ia. FA is a rare, de­gen­er­a­tive mul­ti-sys­tem dis­or­der caused by a gene mu­ta­tion that dis­rupts the nor­mal pro­duc­tion of the pro­tein fratax­in, crit­i­cal to the func­tion of mi­to­chon­dria in a cell. Lex­eo is plan­ning on sub­mit­ting an IND for that in­di­ca­tion lat­er this year.

Lex­eo in­tends to main­tain an on­go­ing re­search col­lab­o­ra­tion with Weill Cor­nell to bol­ster their pre­clin­i­cal pipeline — and with the Ste­lios ac­qui­si­tion back in Ju­ly, they ac­quired a new aca­d­e­m­ic part­ner in UC San Diego’s de­part­ment of car­di­ol­o­gy.

And while Lex­eo re­mains well-fund­ed (the lat­est round brings the start­up’s to­tal raise to $185 mil­lion), Townsend says he isn’t rul­ing out an IPO: “We can cre­ate a lot of val­ue and reach clear val­ue cre­ation mile­stones with­out an IPO or an ad­di­tion­al fi­nanc­ing here. So it’s not nec­es­sary, but ob­vi­ous­ly for any com­pa­ny we’re al­ways think­ing in­to the fu­ture and that is, you know, one of the con­sid­er­a­tions that we have.”

In ad­di­tion to D1 and Even­tide, a slate of new and old in­vestors chipped in­to the round, in­clud­ing CAM Cap­i­tal, Veri­tion Fund Man­age­ment, Lau­ri­on Cap­i­tal Man­age­ment, Gray’s Creek Cap­i­tal Part­ners, Lon­gi­tude Cap­i­tal, Omega Funds, Lund­beck­fonden Ven­tures, PBM Cap­i­tal, Janus Hen­der­son In­vestors, Wood­line Part­ners LP, In­vus Cap­i­tal, and Alexan­dria Ven­ture In­vest­ments.

This sto­ry has been up­dat­ed to clar­i­fy that Ronald Crys­tal still holds his po­si­tion at Weill Cor­nell. 

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

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US sees spike in Paxlovid us­age as Mer­ck­'s mol­nupi­ravir and As­traZeneca's Evusheld are slow­er off the shelf

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

Pfiz­er and CD­MOs ramp up Paxlovid man­u­fac­tur­ing with Kala­ma­zoo plant ex­pan­sion lead­ing the way

As the Covid-19 pandemic continues to evolve, pharma companies and manufacturers are exploring how to step up production on antivirals.

Pfizer is planning to expand its Kalamazoo-area facility to increase manufacturing capabilities for the oral Covid-19 antiviral Paxlovid, according to a report from Michigan-based news site MLive. The expansion of the facility, which serves as Pfizer’s largest manufacturing location, is expected to create hundreds of “high-skilled” STEM jobs, MLive reported. No details about the project’s cost and timeline have been released, but according to MLive, Pfizer will announce the details of the expansion at some point in early June.

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FDA spells out the rules and re­stric­tions for states seek­ing to im­port drugs from Cana­da

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

Simba Gill, CEO of Evelo Biosciences

While down 87% YOY, Evelo gets Flag­ship and oth­ers to in­fuse new cap­i­tal for come­back hope

Just four years after Flagship spinout Evelo Biosciences went public in an IPO worth $85 million, the biotech has seen its share price tank from $13 a share this time last year (ultimately reaching a peak of over $17) to now under $1.50. And today, it looks like Flagship still thinks the fledging biotech, in a down market, is still worth something after initial pre-IPO backing from the likes of Google’s GV, Celgene, Mayo Clinic and Alexandria Venture.

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Peter Thompson, Terremoto Biosciences interim CEO

For­mer Prin­cip­ia team looks to shake up co­va­lent small mol­e­cules again, this time at 'earthquake' scale

Terremoto Biosciences goes back a long ways, in a sense, to about a dozen years ago when Principia Biopharma was founded by UCSF professor Jack Taunton. Peter Thompson initially helmed the biotech.

The company helped expand covalent small molecule inhibitors beyond oncology and into autoimmune disease by targeting cystine. But that amino acid is uncommon in a lot of proteins, offering fewer drug targets than, say, lysine, which is present in most proteins of interest. So, over the years, Taunton went back to the drawing board to check out that second amino acid.

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Pfizer CEO Albert Bourla at the World Economic Forum (Gian Ehrenzeller/Keystone via AP Images)

All about ac­cess: Pfiz­er moves to a non-prof­it mod­el for drug sales in 45 low­er-in­come coun­tries

Leading the way to increase access to cheaper drugs worldwide, Pfizer said Wednesday it will provide all current and future patent-protected medicines and vaccines available in the US or EU on a not-for-profit basis to about 1.2 billion people in 45 lower-income countries.

Rwanda, Ghana, Malawi, Senegal and Uganda are the first five countries to sign on to this accord, which will also seek to blaze new paths for quick and efficient regulatory and procurement processes to reduce the usual delays in making new medicines and vaccines available in these countries.

Almirall is tapping artificial intelligence on behalf of its sales force for insights and efficiencies. (via Shutterstock)

Almi­rall rolls out sales rep ar­ti­fi­cial in­tel­li­gence sys­tem, cut­ting pre-call prep and 'wind­shield time'

Dermatology specialty pharma Almirall is making its sales reps smarter. Not with extra training or educational courses, but instead with artificial intelligence tools.

It began a soft launch of a sales rep AI and machine learning platform it calls Polaris last August in one of its 7 US coverage regions. The platform from Aktana gathers information from across Almirall internal sources and external ones – such as claims and prescribing data – to generate insights for reps. Now, instead of spending hours prepping for a sales call, Polaris can generate details about a physician’s preferences, past behaviors and prescription habits for reps in minutes, said Almirall head of commercial operations Vincent Cerio.

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