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.”

The first batch of pivotal data on Autolus Therapeutics’ CAR-T is in, and execs are ready to plot a path to market.

With an overall remission rate of 70% at the interim analysis featuring 50 patients, the results set the stage for a BLA filing by the end of 2023, said CEO Christian Itin.

Perhaps more importantly — given that Autolus’ drug, obe-cel, is going after an indication that Gilead’s Tecartus is already approved for — the biotech highlighted “encouraging safety data” in the trial, with a low percentage of patients experiencing severe immune responses.

The FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet next Tuesday to discuss whether Cytokinetics’ potential heart drug can safely reduce the risk of cardiovascular death and heart failure in patients with symptomatic chronic heart failure with reduced ejection fraction.

The drug, known as omecamtiv mecarbil and in development for more than 15 years, has seen mixed results, with a first Phase III readout from November 2020 hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as key to breaking into the market.

Another $65 million is music to the ears of the team at August Bioservices, a contract manufacturer in Nashville.

The company announced the Series B round last week, which will fund equipment in a new building expected to open in 2023, according to CEO Jenn Adams. It was led by Oak HC/FT, the same firm that led August’s Series A round in July 2020.

August Bioservices, a producer of materials such as prefilled syringes, IV bags and vials, was formed back in 2020 after the acquisition of PMI BioPharma Solutions, also based in Nashville. Adams said the goal was to build a business that could “address the scarcity of supply relative to sterile injectable manufacturing based in the US” and provide a broad range of manufacturing services.

Add AbbVie to the list of pharma companies currently facing age discrimination allegations.

Pennsylvania resident Thomas Hesch filed suit against AbbVie on Wednesday, accusing the company of passing him over for promotions in favor of younger candidates.

Despite 30 years of pharma experience, “Hesch has consistently seen younger, less qualified employees promoted over him,” the complaint states.