Two weeks af­ter New Haven, CT biotech BioX­cel Ther­a­peu­tics won FDA ap­proval for the psy­chi­atric drug Igal­mi, the biotech is mak­ing a ma­jor new move: piv­ot­ing its fo­cus to com­mer­cial­iza­tion and spin­ning out much of the rest of its pipeline in­to a new com­pa­ny.

The biotech an­nounced ear­ly Tues­day that they have en­tered in­to strate­gic fi­nanc­ing agree­ments with funds man­aged by two firms: Oak­tree Cap­i­tal Man­age­ment and Qatar’s sov­er­eign wealth fund, Qatar In­vest­ment Au­thor­i­ty. Com­bined, the two funds will net BioX­cel up to $260 mil­lion.

Ac­cord­ing to BioX­cel, the cash will help fund the com­mer­cial launch of Igal­mi, BioX­cel’s new­ly FDA-ap­proved schiz­o­phre­nia and bipo­lar drug, in the US — and push clin­i­cal pipeline de­vel­op­ment for­ward. The biotech al­so said that the funds will push the com­pa­ny’s cash run­way in­to 2025.

CEO Vi­mal Mehta told End­points News that BioX­cel had $233 mil­lion at the end of 2021, which was enough run­way to last the com­pa­ny well in­to 2023.

The long-term strate­gic fi­nanc­ing process was led by Oak­tree and is com­prised of:

• A cred­it agree­ment, al­low­ing for up to $135 mil­lion in a de­layed draw term loan,
• A $120 mil­lion rev­enue-based fi­nanc­ing agree­ment — with up to $120 mil­lion in an un­spec­i­fied, capped rev­enue-based fi­nanc­ing on net sales of IGAL­MI and any oth­er fu­ture BX­CL501 prod­ucts, and
• A $5 mil­lion eq­ui­ty in­vest­ment in BioX­cel com­mon stock.

Un­der the agree­ment, BioX­cel would re­ceive $100 mil­lion fol­low­ing FDA ap­proval “in re­spect of the use of the Com­pa­ny’s BX­CL501 prod­uct for the acute treat­ment of ag­i­ta­tion as­so­ci­at­ed with schiz­o­phre­nia or bipo­lar I or II dis­or­der in adults.” That con­di­tion was cleared two weeks ago with the FDA’s ap­proval of their now-sole ap­proved drug Igal­mi.

In the mean­time, BioX­CEl is form­ing a new sub­sidiary: OnkosX­cel to go af­ter can­cer. Ac­cord­ing to a state­ment and with the fund­ing, OnkosX­cel plans to progress the de­vel­op­ment of BX­CL701, an in­ves­ti­ga­tion­al, oral­ly ad­min­is­tered in­nate im­mune ac­ti­va­tor, de­signed to ini­ti­ate in­flam­ma­tion in a mi­croen­vi­ron­ment around tu­mors.

Mehta said that since BioX­cel now has an ap­proved prod­uct, the com­pa­ny is piv­ot­ing to a com­mer­cial-stage com­pa­ny, and said that there was a need to cre­ate a ded­i­cat­ed re­source for BX­CL701.

“It brings that laser sharp fo­cus to con­tin­ue to ex­pand 701, to take it all the way to prov­abil­i­ty as well as ex­pand in oth­er ar­eas,” Mehta added.

The CEO con­firmed to End­points that for right now, BioX­cel’s lead­er­ship team will be lead­ing OnkosX­cel un­til a new man­age­ment team is in place, which BioX­cel will an­nounce in the sec­ond half of 2022.

BioX­cel CMO Vince O’Neill told End­points that the drug can­di­date that OnkosX­cel is look­ing at first is a DPP8/9 in­hibitor. It is cur­rent­ly be­ing test­ed in a Phase II tri­al in com­bo with Keytru­da in metasta­t­ic, cas­tra­tion-re­sis­tant prostate can­cer.

And while BioX­cel has not made any an­nounce­ments or state­ments as to which in­di­ca­tions the com­pa­ny will pur­sue, O’Neill did note that the com­pa­ny has “a num­ber of or­phan drug des­ig­na­tions.” These in­clude pan­cre­at­ic can­cer, melanoma and soft tis­sue sar­co­ma.

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.

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.

A biotech centered on treating fibrosis — born out of Mass General and Brigham and Women’s Hospital — has received a financial boost.

According to an SEC filing, the company has raised $31,761,186 in its latest funding round, which includes 17 investors. The filing lists six names attached to the company, including Meredith Fisher, a partner at Mass General Brigham Ventures and Mediar’s acting CEO.