Ar­ti­zan com­pletes mi­cro­bio­me starter pack­age with Brii deal, CSO hire and some mon­ey to dash for the clin­ic

Three years af­ter giv­ing a syn­op­sis of its mi­cro­bio­me play with some seed fund­ing from Ma­lin and Hat­teras Ven­ture Part­ners, Ar­ti­zan is rais­ing the cur­tain on their first act in in­flam­ma­to­ry bow­el dis­ease.

James Rosen Ar­ti­zan

Armed with $12 mil­lion in to­tal Se­ries A cash, a part­ner­ship with Chi­na’ Brii Bio and a new CSO hire, the New Haven, CT-based biotech is ready to hun­ker down for some pre­clin­i­cal work. Mean­while, CEO James Rosen tells me he will be get­ting to work rais­ing a Se­ries B in­tend­ed to fund clin­i­cal op­er­a­tions.

Yale im­muno­bi­ol­o­gy pro­fes­sor Richard Flavell and two col­lab­o­ra­tors pi­o­neered a new way to iden­ti­fy dis­ease-caus­ing bac­te­ria by scan­ning for an an­ti­body coat­ing called im­muno­glo­bin A (IgA). That was 2014.

“The coat­ing is our body’s at­tempt to neu­tral­ize the bac­te­ria,” Flavell said in 2014. “It binds to the bad bac­te­ria. We on­ly make these IgA re­spons­es to a lim­it­ed num­ber of or­gan­isms.”

It’s a more ef­fi­cient ap­proach than the tra­di­tion­al method of screen­ing for harm­ful bac­te­ria, which typ­i­cal­ly in­volves com­par­ing vast amounts of se­quenc­ing da­ta be­tween healthy and sick in­di­vid­u­als.

Richard Flavell Ar­ti­zan

Ze­ro­ing on the mi­crobes to tar­get, though, is on­ly the first step. Ar­ti­zan is look­ing in­to a num­ber of ways to get rid of them, from small mol­e­cules and an­ti­bod­ies to a ther­a­peu­tic vac­cine that could help the im­mune sys­tem mount a more po­tent at­tack.

Un­like some well-known play­ers in the mi­cro­bio­me field such as Seres and Finch, “we’re very specif­i­cal­ly not bugs as drugs,” Rosen said.

That opens up a broad range of po­ten­tial ap­pli­ca­tions for Ar­ti­zan’s plat­form, he said, as man­i­fest­ed in Brii’s de­ci­sion to col­lab­o­rate on up to three pro­grams. Brii — a $260 mil­lion pow­er biotech play spear­head­ed by GSK vet Zhi Hong — will pick up Chi­na de­vel­op­ment and com­mer­cial­iza­tion once Ar­ti­zan pro­duces proof-of-con­cept in the next cou­ple of years.

The deal comes with an undis­closed set of up­front, mile­stone and roy­al­ty pay­ments in ad­di­tion to a ven­ture in­vest­ment, plac­ing Brii in a syn­di­cate that in­cludes John­son & John­son De­vel­op­ment In­no­va­tion – JJDC, Os­age Uni­ver­si­ty Part­ners and Elm Street Ven­tures.

Paul Miller Syn­log­ic

Co­or­di­nat­ing the whole re­search ef­fort from dis­cov­ery to drug de­vel­op­ment and join­ing the 11-per­son team would be Paul Miller, the new chief sci­en­tif­ic of­fi­cer. Miller, a sea­soned ex­ec groomed in As­traZeneca and Pfiz­er, jumps from Syn­log­ic, which spe­cial­izes in reengi­neer­ing bac­te­ria in­to ther­a­peu­tics.

“It’s an ex­cit­ing time to join Ar­ti­zan’s ef­forts to ad­dress the un­met treat­ment need in IBD, a dis­ease that af­fects more than 1.6 mil­lion Amer­i­cans,” Miller said in a state­ment.

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.

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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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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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.

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.

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.

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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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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Af­ter M&A fell through, Ther­a­peu­tic­sMD sells hor­mone ther­a­py, con­tra­cep­tive ring for $140M cash plus roy­al­ties

TherapeuticsMD, a women’s health company whose one-time billion-dollar valuation seems a distant memory as its blockbuster aspirations petered out, is finally cashing out.

Australia’s Mayne Pharma is paying $140 million upfront to license essentially TherapeuticsMD’s whole portfolio, including two prescription drugs that treat conditions relating to menopause, a contraceptive vaginal ring as well as its prescription prenatal vitamin brands.

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