Take­da is ink­ing gene ther­a­py deals left and right. This time, it’s part­ner­ing for a sec­ond time with Chica­go-based pro­tein mak­er Evozyne.

Af­ter lin­ing up col­lab­o­ra­tions with Code Bio­ther­a­peu­tics, Po­sei­da Ther­a­peu­tics, Se­lec­ta Bio­sciences and Genevant in re­cent months, the Japan­ese phar­ma wants to go fur­ther in­to next-gen gene ther­a­pies. This time, Take­da and Evozyne will work on four rare dis­ease tar­gets.

Evozyne co-founder and sci­ence chief Ra­ma Ran­ganathan told End­points News the near­ly two-year-old start­up was able to de­liv­er re­sults on its first agree­ment with Take­da in just six months. Go­ing for­ward, the duo looks to build a “sig­nif­i­cant long-term part­ner­ship,” the co-founder said. The Uni­ver­si­ty of Chica­go pro­fes­sor launched Evozyne out of Paragon Bio­sciences, the in­cu­ba­tor be­hind Cas­tle Creek, CiRC, Emalex, Har­mo­ny and Sky­line (all end­ing in bio­sciences).

Ra­ma Ran­ganathan

Evozyne will make new pro­tein se­quences, which Take­da can then ob­tain the ex­clu­sive li­cense to de­vel­op and com­mer­cial­ize to in­clude in its gene ther­a­py pro­gram. The deal in­cludes “dou­ble-dig­it mil­lion dol­lars” up­front and in re­search pay­ments, but the ma­jor­i­ty is back-end in a $400 mil­lion biobuck pact.

“The ba­sic plat­form in­volves a sig­nif­i­cant com­pu­ta­tion­al, al­go­rith­mic front-end where we make mod­els for the way that na­ture builds these pro­tein mol­e­cules and then we use those mod­els to gen­er­ate new so­lu­tions that we then ac­tu­al­ly at Evozyne pro­duce and make all the ex­per­i­men­tal mea­sure­ments,” Ran­ganathan said.

The start­up will “ramp up these projects one at a time,” the sci­ence chief said. The com­pa­ny is al­so in talks with “a num­ber of re­al­ly in­ter­est­ing part­ners” around Evozyne’s “two broad am­bi­tions”: ther­a­peu­tics and sus­tain­abil­i­ty, he said. (The com­pa­ny al­so does work on pro­teins for re­cy­cling and car­bon cap­ture, among oth­er en­vi­ron­men­tal projects.)

Evozyne se­cured about $60 mil­lion in a Se­ries A round from Val­or Eq­ui­ty Part­ners and the tech di­vi­sion of Fi­deli­ty. The com­pa­ny is lo­cat­ed in the same Lin­coln Park build­ing as Eli Lil­ly-backed Van­qua Bio.

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Innoforce is off to the races at its new site in the city of Hangzhou, China.

The Chinese CDMO announced last week that it has started manufacturing at the new facility, which was built to offer process development and manufacturing operations for RNA, plasmid DNA, viral vectors and other cell therapeutics. It will also serve as Innoforce’s corporate HQ.

The company said it’s investing more than $200 million in the 550,000-square-foot manufacturing base for advanced therapies. The GMP manufacturing facility features space for producing plasmids with three 30-liter bioreactors. For viral vector manufacturing, Innoforce also has 200- and 500-liter bioreactors at its disposal, along with eight suites to make cell therapies. The site also includes several labs and warehouse spaces.

As the FDA remains silent on orphan drug exclusivity in the wake of a controversial court case, the agency continues to hand out new designations. The latest: Algernon Pharmaceuticals’ experimental lung disease drug ifenprodil.

The Vancouver-based company announced on Monday that ifenprodil received orphan designation in idiopathic pulmonary fibrosis (IPF), a chronic lung condition that results in scarring of the lungs.  Most IPF patients suffer with a dry cough, and breathing can become difficult.