Bahija Jallal (Source: MedImmune)

Wood­ford who? TCR-fo­cused Im­muno­core sol­diers on with $130M+ B round

Im­muno­core — once a dar­ling of the now-dis­graced Neil Wood­ford — is shak­ing off its past by rais­ing more than $130 mil­lion in a Se­ries B haul.

The Ox­ford­shire, UK-based com­pa­ny, which launched in 2015 to ad­vance its T cell re­cep­tor (TCR) tech­nol­o­gy with a mam­moth $320 mil­lion round, was soon glo­ri­fied with a val­u­a­tion of near­ly $1 bil­lion (£800m). That uni­corn sta­tus proved to be its Achilles heel, trig­ger­ing an ex­o­dus of top man­age­ment in re­cent years as po­ten­tial in­vestors balked at the old val­u­a­tion.

Bahi­ja Jal­lal, for­mer pres­i­dent of the now-de­funct Med­Im­mune unit at As­traZeneca, took over the reins as CEO in ear­ly 2019, promis­ing to steady the ship.

“I be­lieve for what we promised to de­liv­er, the fund­ing is ad­e­quate for that,” Jal­lal told End­points News.

Im­muno­core, which counts Genen­tech, GSK, As­traZeneca, Eli Lil­ly, and the Bill and Melin­da Gates Foun­da­tion as part­ners, has three com­pounds be­ing test­ed in hu­mans (in­clud­ing tebenta­fusp, which is in a piv­otal melanoma study) and plans to shep­herd two more in­to the clin­ic this year, she said.

The new round comes as the in­dus­try’s ap­petite for TCR ther­a­pies is bur­geon­ing. One of the key com­po­nents of the im­mune sys­tem are T cells, which oblit­er­ate aber­rant cells by us­ing T cell re­cep­tor (TCR) recog­ni­tion of cell sur­face mark­ers known as anti­gens. When a T cell rec­og­nizes a tu­mor anti­gen via the TCR, it snuffs the ma­lig­nant cell on which it re­sides. TCR tech typ­i­cal­ly in­volves reengi­neer­ing T cell re­cep­tors so that they can bet­ter rec­og­nize can­cer pro­teins, spark­ing an as­sault on tu­mors.

Im­muno­core’s in-house TCR tech­nol­o­gy has spawned bis­pecifics de­signed to over­come the lim­i­ta­tions of oth­er im­munol­o­gy agents by com­bin­ing a TCR to tar­get and rec­og­nize can­cer, in­fect­ed or au­toim­mune cells and an ef­fec­tor func­tion to ac­ti­vate (for can­cer and in­fec­tious dis­eases) or sup­press (for au­toim­mune dis­eases) the im­mune sys­tem.

One of the at­trib­ut­es of the tech­nol­o­gy is hav­ing ac­cess to any pro­tein that is processed by the body, in­clud­ing the in­tra­cel­lu­lar pro­teins that can­not be ad­dressed by mon­o­clon­al an­ti­bod­ies, Jal­lal not­ed.

“You see the suc­cess of the check­point in­hibitors in can­cer, but they’re still ad­dress­ing on­ly the anti­gen-spe­cif­ic T cells,” she said. “Our tech­nol­o­gy can bring any T cells and ren­der them, if you will, killer cells to kill the tu­mor cells.”

This B round was led by Gen­er­al At­lantic, with par­tic­i­pa­tion of old stake­hold­ers Eli Lil­ly and RTW In­vest­ments and new in­vestors CCB In­ter­na­tion­al, JDRF T1D Fund, Rock Springs Cap­i­tal, Ter­ra Mag­num Cap­i­tal Part­ners and WuXi AppTec’s Cor­po­rate Ven­ture Fund. The Tele­graph had re­port­ed in Sep­tem­ber that New York-based Gen­er­al At­lantic had com­mit­ted an ini­tial £60 mil­lion to what was shap­ing up to be a £100 mil­lion round.

Jal­lal would not com­ment on a time­line, but said an IPO re­mains one of Im­muno­core’s op­tions go­ing for­ward.

The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer drugs; 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.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

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EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

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As­traZeneca, Mer­ck cull one Lyn­parza in­di­ca­tion in heav­i­ly pre­treat­ed ovar­i­an can­cer pa­tients

Just one day after blockbuster Lynparza got access to another indication in China, its Big Pharma owners have decided to withdraw it in certain patients after reviewing Phase III data.

The two companies that work together on Lynparza decided to recall one of the indications several weeks ago in a specific type of ovarian cancer, Lynparza’s first indication when it was first FDA-approved in 2014. Initial data showed that rates of overall survival in patients with at least three rounds of chemo before getting on the PARP inhibitor were lower than in patients with less previous chemo treatment.

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Fu­ji­film con­tin­ues CD­MO ex­pan­sion, break­ing ground on $435M UK site

Fujifilm’s CDMO arm, Fujifilm Diosynth, has been on a roll this month as the company has recently broken ground on a major project in Europe and it appears to be keeping up the momentum.

Fujifilm Diosynth announced that it has kicked off an expansion project for its microbial manufacturing facility at its campus in the town of Billingham, UK, in the northeast of England.

The 20,000 square-foot, £400 million ($435 million) expansion will add clean rooms, purification suites and a packing area along with more space for the manufacturing itself.

An­oth­er Cipla site lands a Form 483 over clean­ing is­sues and QC con­trols

A Cipla drug manufacturing site in India has once again landed in the crosshairs of FDA inspectors.

The facility in question is Cipla’s drug manufacturing facility in the village of Verna, in the state of Goa in India’s southwest. In a sign that foreign inspections might ramp up again, the FDA’s visit from Aug. 16 to Aug. 22 uncovered six observations.

The 11-page report noted that environmental monitoring at the site did not properly ensure that microbial contaminants were not making any impact in the aseptic filling areas. It also found that procedures meant to stop microbial contamination were not adequately conducted in aseptic areas of the facility.

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FDA ad­comm takes down Se­cu­ra Bio's leukemia drug af­ter fi­nal tri­al re­sults show po­ten­tial OS detri­ment

The FDA’s Oncologic Drugs Advisory Committee on Friday voted 8-4 against the benefit-risk profile of Secura Bio’s PI3K inhibitor Copiktra (duvelisib), which won approval in September 2018 as a third-line treatment for relapsed or refractory CLL or SLL, but updated pivotal trial results raised safety questions.

In addition to the serious and fatal toxicities of duvelisib, FDA speakers at the ODAC meeting pointed to an evolved treatment landscape for CLL and SLL, with targeted BTK or BCL2 inhibitors (front-line or second-line), and data pointing to a “potential detriment” in overall survival for duvelisib. But some ODAC members noted that the detriment was likely small and that there is some efficacy even as the data are difficult to interpret.

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Solicitor General Elizabeth Prelogar

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.