RA, No­var­tis back Gen­tiBio's seed round, plans to launch de­vel­op­ment of En­gTreg ther­a­pies

Boston, MA-based start­up Gen­tiBio land­ed a $20 mil­lion seed fund from three in­vestors to dive in­to en­gi­neered reg­u­la­to­ry T cell (En­gTreg) de­vel­op­ment.

Mar­quee in­vestors Or­biMed, No­var­tis Ven­ture Fund and RA Cap­i­tal Man­age­ment have backed Gen­tiBio’s mis­sion to de­vel­op En­gTregs for the treat­ment of au­toim­mune, al­loim­mune, au­toin­flam­ma­to­ry, and al­ler­gic dis­eases. Un­like oth­er com­pa­nies study­ing treat­ments us­ing a pa­tient’s own Tregs, Gen­tiBio plans to make use of CD4+ im­mune cells, found in the blood.

Gen­tiBio’s co-founders hail from the  Seat­tle Chil­dren’s Re­search In­sti­tute, Be­naroya Re­search In­sti­tute at Vir­ginia Ma­son (BRI), and MI­GAL Galilee Re­search In­sti­tute (MI­GAL). All three com­pa­nies are now part­ners, and Seat­tle Chil­dren’s has agreed to li­cense its tech­nol­o­gy ex­clu­sive­ly to Gen­tiBio.

Many com­pa­nies have eyed Treg cell ther­a­pies in the last decade, but the rar­i­ty and plas­tic­i­ty of en­doge­nous Treg cells pose a sig­nif­i­cant chal­lenge.

David Rawl­ings

“Tregs are rare cells with­in the im­mune sys­tem and cur­rent ther­a­pies that source Tregs cells from the blood stream can be cost­ly and cum­ber­some. In con­trast, Seat­tle Chil­dren’s unique tech­nol­o­gy en­ables the gen­er­a­tion of en­gi­neered reg­u­la­to­ry T cells, or En­gTregs, from the more abun­dant CD4+ cell pop­u­la­tion, ad­dress­ing a crit­i­cal man­u­fac­tur­ing short­com­ing for this nov­el treat­ment,” David Rawl­ings, Gen­tiBio co-founder and se­nior sci­en­tif­ic ad­vi­sor and di­rec­tor of the Cen­ter for Im­mu­ni­ty and Im­munother­a­pies at Seat­tle Chil­dren’s Re­search In­sti­tute, said in a state­ment.

Adel Na­da

Gen­tiBio co-founder and CEO Adel Na­da added in a state­ment: “Gen­tiBio is fo­cused on ad­dress­ing the tech­ni­cal bot­tle­necks that have throt­tled Treg ther­a­peu­tics, and we are thrilled to ex­clu­sive­ly in-li­cense a port­fo­lio of un­prece­dent­ed breadth from Seat­tle Chil­dren’s and Be­naroya Re­search In­sti­tute in the U.S. and MI­GAL Galilee Re­search In­sti­tute in Is­rael,””The tech­nolo­gies li­censed from these pre­mier re­search in­sti­tu­tions are ma­ture and well-dif­fer­en­ti­at­ed, and will be fur­ther op­ti­mized in spon­sored re­search col­lab­o­ra­tions with the sci­en­tif­ic teams that dis­cov­ered them to ad­vance nov­el and po­tent ther­a­peu­tics with the po­ten­tial to treat and cure se­ri­ous au­toim­mune and in­flam­ma­to­ry dis­eases.”

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.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; 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.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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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.”

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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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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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.

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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GSK says its drug for chron­ic hep B could ‘lead to a func­tion­al cure’ — but will it be alone or in com­bi­na­tion?

GSK, newly branded and soon-to-be demerged, shared interim results from its Phase II trial on its chronic hepatitis B treatment, one that it says has the “potential to lead to a functional cure.”

At a presentation at the EASL International Liver Congress, GSK shared that in around 450 patients who received its hep B drug bepirovirsen for 24 weeks, just under 30% had hepatitis B surface antigen and viral DNA levels that were too low to detect.

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.