Vac­citech makes short move to new head­quar­ters; En­ter­o­Bi­otix rais­es more than $21M in Se­ries A

Ox­ford biotech Vac­citech is mov­ing head­quar­ters — but on­ly about 20 min­utes away.

Vac­citech signed a lease for 31,000 square feet with­in the Zeus de­vel­op­ment at Har­well Sci­ence and In­no­va­tion Cam­pus. The firm plans to re­lo­cate its head­quar­ters there next spring from its cur­rent head­quar­ters in Ox­ford. The length of the lease was not dis­closed.

The com­pa­ny’s op­er­a­tions will be tak­ing about half the space in that build­ing, ac­cord­ing to a Vac­citech state­ment.

Vac­citech COO Chris El­lis said in a state­ment: “The need for new space de­signed pri­mar­i­ly for state-of-the-art wet lab­o­ra­to­ry and of­fices to house our grow­ing team was our first pri­or­i­ty, and stay­ing with­in the Ox­ford­shire in­fra­struc­ture, drove our de­ci­sion to re­lo­cate to the Zeus build­ing at Har­well Cam­pus.”

Vac­citech is the newest com­pa­ny to join Har­well’s cam­pus, which is al­ready home to oth­er com­pa­nies in Har­well’s des­ig­nat­ed “Health Clus­ter” such as the Ros­alind Franklin In­sti­tute, Ox­ford Nanopore and the Vac­cines Man­u­fac­tur­ing and In­no­va­tion Cen­tre.

Vac­citech, the com­pa­ny that owns the tech­nol­o­gy be­hind the As­traZeneca vac­cine, al­so filed for an IPO ear­li­er this year. Paul Schloess­er

En­ter­o­Bi­otix rais­es $21.5 mil­lion in Se­ries A

Scot­tish bio­phar­ma En­ter­o­bi­otix to­day an­nounced the clos­ing of its $21.5 mil­lion Se­ries A fi­nanc­ing. The pro­ceeds will be used to fur­ther ad­vance the com­pa­ny’s mi­cro­bio­me drug pipeline and sup­port its prod­uct de­vel­op­ment and man­u­fac­tur­ing ca­pa­bil­i­ties.

One of the prod­ucts that the com­pa­ny is work­ing on is a pill to re­place a pro­ce­dure called fe­cal mi­cro­bio­ta trans­plant, or FMT. En­ter­o­Bi­otix has prid­ed it­self on com­plete in-house man­u­fac­tur­ing — a cru­cial step in con­trol­ling the sup­ply chain in or­der to make a con­sis­tent pill pos­si­ble. Ad­di­tion­al­ly, part of the fund­ing raised by the Se­ries A will fund de­vel­op­ing an­a­lyt­i­cal tools to char­ac­ter­ize what’s re­al­ly in their prod­uct.

“I think, fun­da­men­tal­ly, the ap­proach En­ter­o­Bi­otix is tak­ing is that we’re not tak­ing a re­duc­tion­ist ap­proach to the ecosys­tem,” CEO James McEll­roy said about the po­ten­tial FMT pill. “We’re ac­tu­al­ly com­bin­ing ecosys­tems to­geth­er to cre­ate a high­ly di­verse prod­uct that re­tains both the spore-form­ing frac­tion of the mi­cro­bio­me and the non-spore-form­ing frac­tion of the mi­cro­bio­me. The set­backs that have hap­pened to date have tak­en re­duc­tion­ist ap­proach­es and have de­stroyed parts of the ecosys­tem where­as what we want to do is re­tain the di­ver­si­ty, which we hope will be func­tion­al di­ver­si­ty, and cre­ate some­thing which is com­po­si­tion­al­ly con­sis­tent at the same time.”

The fi­nanc­ing was led by Scot­tish in­vest­ment firm Thairm Bio and in­cludes new US-based in­vestor Ki­neti­cos Ven­tures, join­ing oth­er in­vestors in­clud­ing Scot­tish En­ter­prise and SIS Ven­tures. — Paul Schloess­er

Citius ac­quires Phase III on­col­o­gy ther­a­py E7777

New Jer­sey bio­phar­ma Citius has en­tered in­to an agree­ment with Dr. Red­dy’s Lab­o­ra­to­ries to ac­quire its ex­clu­sive li­cense of E7777 (de­nileukin difti­tox), a late-stage on­col­o­gy im­munother­a­py for the treat­ment of a rare form of non-Hodgkin lym­phoma know as CT­CL. E7777 is an im­proved for­mu­la­tion of On­tak, which was pre­vi­ous­ly ap­proved by the FDA for treat­ment of pa­tients with per­sis­tent or re­cur­rent CT­CL.

The last pa­tient in a piv­otal tri­al of E7777 has been en­rolled, and a BLA for the drug’s first in­di­ca­tion in CT­CL is ex­pect­ed to be filed with the FDA by the end of next year, ac­cord­ing to a Citius state­ment.

Un­der the agree­ment, Citius will ac­quire Dr. Red­dy’s ex­clu­sive li­cense of E7777 from Ei­sai and oth­er re­lat­ed as­sets owned by Dr. Red­dy’s. Citius’ ex­clu­sive li­cense rights in­clude rights to de­vel­op and com­mer­cial­ize E7777 in all mar­kets ex­cept for Japan and cer­tain parts of Asia, which will re­main with Ei­sai. Dr. Red­dy’s will re­ceive $40 mil­lion up­front, and is en­ti­tled to up to $110 mil­lion more in mile­stone pay­ments re­lat­ed to CT­CL ap­provals in the U.S. and oth­er mar­kets, along with ad­di­tion­al in­di­ca­tions of the drug.

Ei­sai will re­ceive a $6 mil­lion de­vel­op­ment mile­stone pay­ment up­on ini­tial ap­proval and ad­di­tion­al com­mer­cial mile­stone pay­ments re­lat­ed to the achieve­ment of net prod­uct sales thresh­olds. Ei­sai will be re­spon­si­ble for com­plet­ing the cur­rent CT­CL clin­i­cal tri­al, and CMC ac­tiv­i­ties through the fil­ing of a BLA with the FDA. Citius will be re­spon­si­ble for de­vel­op­ment costs as­so­ci­at­ed with po­ten­tial ad­di­tion­al in­di­ca­tions.

My­ron Czucz­man, ex­ec­u­tive VP and CMO of Citius, said in a state­ment that “We look for­ward to the planned com­ple­tion of the piv­otal Phase 3 tri­al and sub­mis­sion of the BLA next year.”  — Paul Schloess­er

Tra­vere says it’s cleared to go af­ter ac­cel­er­at­ed ap­proval af­ter FDA snub

It ap­pears Tra­vere Ther­a­peu­tics will be able to go af­ter ac­cel­er­at­ed ap­proval af­ter all.

The biotech for­mer­ly known as Retrophin and pre­vi­ous­ly run by Mar­tin Shkre­li, Tra­vere an­nounced Tues­day that the FDA has giv­en the go-ahead for an ac­cel­er­at­ed ap­proval plan af­ter agree­ing to in­clude more da­ta from an on­go­ing study. Tra­vere is aim­ing to get a drug called sparsen­tan on the mar­ket for fo­cal seg­men­tal glomeru­loscle­ro­sis, a rare type of kid­ney scar­ring dis­ease.

“If the ad­di­tion­al da­ta fur­ther strength­en the pre­dic­tion of long-term ben­e­fit in the study as we ex­pect, we an­tic­i­pate sub­mit­ting a New Drug Ap­pli­ca­tion for ac­cel­er­at­ed ap­proval of sparsen­tan for FS­GS in the mid­dle of next year and fur­ther­ing our prepa­ra­tions to de­liv­er it as a po­ten­tial new treat­ment stan­dard for FS­GS, if ap­proved,” CEO Er­ic Dube said in a state­ment.

Reg­u­la­tors spurned Tra­vere’s ac­cel­er­at­ed pitch back in May, say­ing the da­ta at the time did not sup­port use of the path­way. The biotech want­ed to go straight to mar­ket fol­low­ing an in­ter­im analy­sis from Feb­ru­ary, say­ing 42% of pa­tients in the treat­ment arm achieved the FS­GS par­tial re­mis­sion of pro­tein­uria end­point af­ter 36 weeks, ver­sus 26% in the con­trol group (p=0.0094).

But last month, Tra­vere re­vealed new da­ta for the drug in IgA nephropa­thy, with 49.8% of pa­tients see­ing a mean re­duc­tion from base­line in ex­ces­sive pro­tein in the urine, com­pared to 15.1% in a group of pa­tients on stan­dard of care (p<0.0001). That up­date has os­ten­si­bly strength­ened Tra­vere’s ap­pli­ca­tion. — Max Gel­man

The Price of Re­lief: Ex­plor­ing So­lu­tions to the Ris­ing Costs of On­col­o­gy Drugs

In 2020, The National Cancer Institute estimated about 1.8 million new cases of cancer diagnosed in the United States, while the costs associated with treatment therapies continued to escalate. Given the current legislative climate on drug pricing, it’s never been more important to look at the evolution of drug pricing globally and control concerns of sustainable and affordable treatments in oncology.

Lat­est news on Pfiz­er's $3B+ JAK1 win; Pacts over M&A at #JPM22; 2021 by the num­bers; Bio­gen's Aduhelm reck­on­ing; The sto­ry of sotro­vimab; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

For those of you who attended #JPM22 in any shape or form, we hope you had a fruitful time. Regardless of how you spent the past hectic week, may your weekend be just what you need it to be.

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A $3B+ peak sales win? Pfiz­er thinks so, as FDA of­fers a tardy green light to its JAK1 drug abroc­i­tinib

Back in the fall of 2020, newly crowned Pfizer chief Albert Bourla confidently put their JAK1 inhibitor abrocitinib at the top of the list of blockbuster drugs in the late-stage pipeline with a $3 billion-plus peak sales estimate.

Since then it’s been subjected to serious criticism for the safety warnings associated with the class, held back by a cautious FDA and questioned when researchers rolled out a top-line boast that their heavyweight contender had beaten the champ in the field of atopic dermatitis — Dupixent — in a head-to-head study.

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Robert Califf, FDA commissioner nominee (Graeme Sloan/Sipa USA/Sipa via AP Images)

Rob Califf ad­vances as Biden's FDA nom­i­nee, with a close com­mit­tee vote

Rob Califf’s second confirmation process as FDA commissioner is already much more difficult than his near unanimous confirmation under the Obama administration.

The Senate Health Committee on Thursday voted 13-8 in favor of advancing Califf’s nomination to a full Senate vote. Several Democrats voted against Califf, including Sen. Bernie Sanders and Sen. Maggie Hassan. Several other Democrats who aren’t on the committee, like West Virginia’s Joe Manchin and Ed Markey of Massachusetts, also said Thursday that they would not vote for Califf. Markey, Hassan and Manchin all previously expressed reservations about the prospect of Janet Woodcock as an FDA commissioner nominee too.

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Michel Vounatsos, Biogen CEO (World Economic Forum/Ciaran McCrickard)

Bio­gen vows to fight CM­S' draft cov­er­age de­ci­sion for Aduhelm be­fore April fi­nal­iza­tion

Biogen executives made clear in an investor call Thursday they are not preparing to run a new CMS-approved clinical trial for their controversial Alzheimer’s drug anytime soon.

As requested in a draft national coverage decision from CMS earlier this week, Biogen and other anti-amyloid drugs will need to show “a meaningful improvement in health outcomes” for Alzheimer’s patients in a randomized, placebo-controlled trial to get paid for their drugs, rather than just the reduction in amyloid plaques that won Aduhelm its accelerated approval in June.

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CRO own­er pleads guilty to ob­struct­ing FDA in­ves­ti­ga­tion in­to fal­si­fied clin­i­cal tri­al da­ta

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

Susan Galbraith, AstraZeneca EVP, Oncology R&D

Can­cer pow­er­house As­traZeneca rolls the dice on a $75M cash bet on a buzzy up­start in the on­col­o­gy field

After establishing itself in the front ranks of cancer drug developers and marketers, AstraZeneca is putting its scientific shoulder — and a significant amount of cash — behind the wheel of a brash new upstart in the biotech world.

The pharma giant trumpeted news this morning that it is handing over $75 million upfront to ally itself with Scorpion Therapeutics, one of those biotechs that was newly birthed by some top scientific, venture and executive talent and bequeathed with a fortune by way of a bankroll to advance an only hazily explained drug platform. And they are still very much in the discovery and preclinical phase.

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‘Skin­ny la­bels’ on gener­ics can save pa­tients mon­ey, re­search shows, but re­cent court de­ci­sions cloud fu­ture

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.

A patient in Alaska receiving an antibody infusion to prevent Covid hospitalizations in September. All but one of these treatments has been rendered useless by Omicron (Rick Bowmer/AP Images)

How a tiny Swiss lab and two old blood sam­ples cre­at­ed one of the on­ly ef­fec­tive drugs against Omi­cron (and why we have so lit­tle of it)

Exactly a decade before a novel coronavirus broke out in Wuhan, Davide Corti — a newly-minted immunologist with frameless glasses and a quick laugh — walked into a cramped lab on the top floor of an office building two hours outside Zurich. He had only enough money for two technicians and the ceiling was so low in parts that short stature was a job requirement, but Corti believed it’d be enough to test an idea he thought could change medicine.

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