Vimal Mehta, BioXcel CEO

On heels of psych drug ap­proval, BioX­cel dives head first in­to on­col­o­gy R&D with new cash in­fu­sion

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.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Albert Bourla, Pfizer CEO (Efren Landaos/Sipa USA/Sipa via AP Images)

Pfiz­er makes an­oth­er bil­lion-dol­lar in­vest­ment in Eu­rope and ex­pands again in Michi­gan

Pfizer is continuing its run of manufacturing site expansions with two new large investments in the US and Europe.

The New York-based pharma giant’s site in Kalamazoo, MI, has seen a lot of attention over the past year. As a major piece of the manufacturing network for Covid-19 vaccines and antivirals, Pfizer is gearing up to place more money into the site. Pfizer announced it will place $750 million into the facility, mainly to establish “modular aseptic processing” (MAP) production and create around 300 jobs at the site.

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Yuling Li, Innoforce CEO

In­no­force opens new man­u­fac­tur­ing site in Chi­na

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.

FDA grants or­phan drug des­ig­na­tion to Al­ger­non's ifen­prodil, while ex­clu­siv­i­ty re­mains un­clear

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.

Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

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Vas Narasimhan, Novartis CEO (Thibault Camus/AP Images, Pool)

No­var­tis bol­sters Plu­vic­to's case in prostate can­cer with PhI­II re­sults

The prognosis is poor for metastatic castration-resistant prostate cancer (mCRPC) patients. Novartis wants to change that by making its recently approved Pluvicto available to patients earlier in their course of treatment.

The Swiss pharma giant unveiled Phase III results Monday suggesting that Pluvicto was able to halt disease progression in certain prostate cancer patients when administered after androgen-receptor pathway inhibitor (ARPI) therapy, but without prior taxane-based chemotherapy. The drug is currently approved for patients after they’ve received both ARPI and chemo.

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Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

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.

Pfiz­er-backed Me­di­ar Ther­a­peu­tics ropes in an­oth­er Big Phar­ma in­vestor

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.

Ken Greenberg, SonoThera CEO

Gene ther­a­py goes acoustic as ARCH-backed biotech launch­es with ul­tra­sound gene de­liv­ery plat­form

After co-founding two biotechs off virus-based therapies, one for pain and one for cancer, Ken Greenberg decided to go in a different direction for his newest biotech, SonoThera.

Based out of San Francisco, SonoThera announced Monday morning that it raised $60.75 million to develop new gene therapies — but delivered by ultrasound, which Greenberg says can address the major challenges facing more conventional viral gene therapies.

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