Rene Russo (Alicia Petitti for Xilio)

Ex ni­hi­lo: Take­da leads $100M+ round to fund biotech's sneak at­tack on tu­mors, pro­pelling new IL-2, CT­LA-4 drugs to clin­ic

Since emerg­ing out of stealth in 2018 with $30 mil­lion in launch mon­ey from At­las and F-Prime, Akre­via has kept a rel­a­tive­ly low pro­file, ham­mer­ing away at its plat­form tech­nol­o­gy to de­sign im­munother­a­pies with all their po­ten­cy but lit­tle of their side ef­fects. With an of­fi­cial CEO in place for al­most a year — and now a new name — the biotech is ready to step up with an­oth­er $100.5 mil­lion to bring its two lead com­pounds in­to the clin­ic.

Tim Clack­son

Meet Xilio, a 35-strong team work­ing out of Waltham, MA. Where­as the orig­i­nal name had been de­rived from the Greek word for pre­ci­sion, Xilio draws in­spi­ra­tion from ex ni­hi­lo, a Latin term for cre­ation or big bang.

“We view how our mol­e­cules work as com­plete­ly off or dark when they’re cir­cu­lat­ing in the pe­riph­ery,” CEO Rene Rus­so told End­points News, “and this cre­ation or big bang as ef­fi­ca­cy in the tu­mor specif­i­cal­ly.”

Xilio’s pro­tein en­gi­neer­ing ap­proach­es shield the bind­ing ac­tiv­i­ty of mol­e­cules while they are trav­el­ling around the body, ex­plained Tim Clack­son, pres­i­dent and head of R&D. Once they meet the pro­teas­es in the tu­mor, the block­ing mod­ules are re­moved, re­leas­ing the ther­a­py just where it’s need­ed.

Un­der Clack­son, who ran the R&D shop at Ari­ad be­fore Take­da ac­quired it, the team went straight for IL-2 and CT­LA-4, two well-known tar­gets each with ap­proved ther­a­pies. Con­sid­er­ing the sig­nif­i­cant tox­i­c­i­ties as­so­ci­at­ed with the first-gen­er­a­tion treat­ments — Pro­leukin and Yer­voy both have black box warn­ings on their la­bels — many pa­tients can’t tol­er­ate the full dose. Xilio promis­es to change that with their re­com­bi­nant IL-2 and CT­LA-4 in­hibitor.

They are not the on­ly ones latch­ing on to IL-2, but Clack­son main­tains that theirs is a fun­da­men­tal­ly dif­fer­ent ap­proach to those tak­en by ri­vals such as Syn­thorx (now Sanofi), Ne­oleukin and Alk­er­mes — which have gen­er­al­ly fo­cused on bind­ing to spe­cif­ic re­cep­tors. The trou­bles Nek­tar has run in­to with its once-high-fly­ing NK­TR-214 af­ter Bris­tol-My­ers Squibb paid $1.85 bil­lion up­front to part­ner on it un­der­score the dif­fi­cul­ty of bal­anc­ing ef­fi­ca­cy and safe­ty.

Be­yond IL-2, Clack­son sees “clear un­tapped po­ten­tial” for cy­tokines as a class. Xilio has two pro­grams for tu­mor-se­lec­tive IL-12 and tu­mor-se­lec­tive IL-15 in the lead op­ti­miza­tion phase.

The Se­ries B, led by Take­da Ven­tures and fea­tur­ing SV Health In­vestors, MRL Ven­tures Fund (a ven­ture arm of Mer­ck), River­Vest Ven­ture Part­ners, Bay City Cap­i­tal, So­las­ta Ven­tures, M Ven­tures and Ipsen Ven­tures as well as the two orig­i­nal back­ers, gives them the fire­pow­er to steer the lead pro­grams to INDs by next year while mov­ing the oth­ers for­ward.

Jayson Pun­wani, part­ner at Take­da Ven­tures, is join­ing the board along­side Mike Ross of SV Health In­vestors, Pe­ter Dudek of MRL Ven­tures Fund and Nan­cy Hong of River­Vest Ven­ture Part­ners.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

Yong Dai, Frontera Therapeutics CEO

Scoop: Lit­tle-known Or­biMed-backed biotech clos­es $160M round to start gene ther­a­py tri­al

Frontera Therapeutics, a China and US biotech, has closed a $160 million Series B and received regulatory clearance to test its first gene therapy stateside, Endpoints News has learned.

Led by the largest shareholder, OrbiMed, the biotech has secured $195 million total since its September 2019 founding, according to an email reviewed by Endpoints. The lead AAV gene therapy program is for an undisclosed rare eye disease, according to the source.

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AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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DEM BioPharma CEO David Donabedian (L) and executive chair Jan Skvarka

Long­wood sets an­oth­er 'don't eat me' biotech in­to gear with help of for­mer Tril­li­um CEO Jan Skvar­ka

Jonathan Weissman and team are out with a cancer-fighting biotech riding the appetite for those so-called “don’t eat me” and “eat me” signals.

The scientific co-founder — alongside fellow Whitehead Institute colleague Kipp Weiskopf and Stanford biologist Michael Bassik — has launched DEM BioPharma with incubator Longwood Fund and a crop of other investors.

In all, the nascent, 10-employee biotech has $70 million to bankroll hematology- and solid tumor-based programs, including a lead asset that could enter human trials in two to three years, CEO David Donabedian told Endpoints News.

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Spanish Prime Minister Pédro Sanchez and European Commission President Ursula von der Leyen (AP Photo/Geert Vanden Wijngaert)

EU to launch vac­cine de­vel­op­ment and man­u­fac­tur­ing part­ner­ship with Latin Amer­i­can and Caribbean coun­tries

While European companies, including BioNTech, are focused on increasing vaccine access to African countries by setting up vaccine manufacturing facilities, the European Union is looking westward to Latin America and the Caribbean.

Speaking at a press conference with Spanish Prime Minister Pédro Sanchez, EU Commission president Ursula von der Leyen said that the EU is launching a new initiative for vaccines and medicines manufacturing in Latin America, to get drugs to Latin America and the Caribbean faster.

De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

Kelly Martin, Radius Health CEO

VC firms take os­teo­poro­sis drug­mak­er Ra­dius Health pri­vate for al­most $900M

After attacks from activist investors and disappointing returns on share prices, Radius Health has now agreed to new ownership, a direction resulting in leaving the Nasdaq.

Radius Health, a biotech out of Massachusetts with one approved product in its arsenal, announced Thursday morning that it agreed to be acquired by two VC firms: Gurnet Point Capital and Patient Square Capital. The deal, worth around $890 million, will include debt assumption and the payout of $1 CVR per share for investors. And on top of that, OrbiMed is providing debt financing.