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

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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Den­mark's Gubra to col­lab­o­rate with Bay­er on pep­tides; Sam­sung and Bio­gen re­ceive FDA ap­proval for Lu­cen­tis biosim­i­lar

Danish biotech Gubra announced a research collaboration and license agreement with Bayer to develop peptide therapeutics to treat cardiorenal diseases. The collaboration will utilize Gubra’s peptide drug discovery platform to identify potential candidates.

This is not the first time Gubra has partnered with a company on peptide therapeutics — they partnered with Boehringer Ingelheim back in 2017 to create peptide therapeutics to treat obesity.

Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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Rafaèle Tordjman (Jeito Capital)

Con­ti­nu­ity and di­ver­si­ty: Rafaèle Tord­j­man's women-led VC firm tops out first fund at $630M

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.

Mi­rati tri­umphs again in KRAS-mu­tat­ed lung can­cer with a close­ly watched FDA fil­ing now in the cards

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.

Ex­elix­is pulls a sur­prise win in thy­roid can­cer just days ahead of fi­nal Cabome­tyx read­out

Exelixis added a thyroid cancer indication to its super-seller Cabometyx’s label on Friday — months before the FDA was expected to make a decision, and days before the company was set to unveil the final data at #ESMO21.

At a median follow-up of 10.1 months, differentiated thyroid cancer patients treated with Cabometyx (cabozantinib) lived a median of 11 months without their disease worsening, compared to just 1.9 months for patients given a placebo, Exelixis said on Monday.