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

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; and more

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'

 

Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

FDA ad­comm to de­cide on mol­nupi­ravir EUA; Can­cer at­las un­veils new po­ten­tial drug tar­get

The FDA has another adcomm coming down the pipeline — this time on Covid-19 oral antiviral molnupiravir.

The federal agency’s advisory committee will meet on November 30th to go over Merck and Ridgeback’s EUA request for their investigational antiviral drug, and discuss the available data supporting its use in Covid-19 patients.

This comes two weeks after Merck claimed that their antiviral pill reduced the chance that newly diagnosed Covid-19 patients would be hospitalized or die by 50%. The pharma made the announcement after interim data on 775 patients in their clinical trial showed the antiviral’s potential.

FDA ad­comm votes unan­i­mous­ly in sup­port of a J&J Covid-19 boost­er two months af­ter one-dose shot

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Friday voted 19-0 in favor of authorizing a second shot of J&J’s Covid-19 vaccine to follow at least two months after the initial dose.

Regulators don’t have to follow VRBPAC’s recommendation, but they almost always do. Considering that the CDC’s advisory committee has already been set to review the expanded EUA, VRBPAC’s recommendation is likely to be adopted.

Rahul Singhvi, Resilience CEO

A Bob Nelsen start­up turns to Har­vard to help sharp­en its tech, in­spir­ing first spin­out

One of Bob Nelsen’s latest projects is headed to Harvard.

Resilience, a company started with the goal of establishing itself as a “one-stop-shop” for companies looking to scale manufacturing, including for hard-to-develop cell and gene therapies, is less than a year old. Friday, it announced a five-year R&D deal with Harvard University that includes $30 million to develop biologics, including vaccines, nucleic acids and cell and gene therapies.