Johnston Erwin, TRexBio CEO

Big Phar­ma back­ers jump on board 'Treg' car­tog­ra­pher's lead round with up to six can­di­dates in the pipe

Among the wealth of emerg­ing tar­gets in on­col­o­gy, im­mune sys­tem sup­press­ing reg­u­la­to­ry T cells — bet­ter known as “Tregs” — have earned some big-name in­ter­est in re­cent years. Now, a West Coast start­up map­ping Tregs in hu­man tis­sue has scored a slate of Big Phar­ma back­ers to dri­ve its grow­ing pipeline in­to the clin­ic.

South San Fran­cis­co-based TRexBio emerged from stealth Tues­day with a $59 mil­lion Se­ries A and the back­ing of in­vest­ment funds from Big Phar­ma gi­ants Eli Lil­ly, J&J and Pfiz­er, the biotech said in a re­lease.

Car­ol Gal­lagher

TRex’s plat­form maps the bi­ol­o­gy and func­tion of hu­man tis­sue Tregs to iden­ti­fy tar­gets in on­col­o­gy and au­toim­mune dis­or­ders. The com­pa­ny’s “deep bi­ol­o­gy” plat­forms pro­duce high-res­o­lu­tion pro­fil­ing of hu­man tis­sues to cre­ate “tis­sue-like” Tregs, the com­pa­ny said.

The biotech says it has six pre­clin­i­cal can­di­dates cur­rent­ly in its pipeline and is on pace to name its two lead drugs with­in the next year. TRex’s plat­form has iden­ti­fied 20 nov­el tar­gets so far, it said.

The biotech will be led by chair­man Car­ol Gal­lagher, the for­mer CEO of Cal­is­to­ga Phar­ma­ceu­ti­cals and a part­ner at New En­ter­prise As­so­ci­ates for the last sev­en years, and John­ston Er­win, a 36-year Lil­ly vet­er­an who will take the role of CEO. Er­win most re­cent­ly worked as VP of cor­po­rate busi­ness de­vel­op­ment.

“The com­pa­ny has a sig­nif­i­cant foun­da­tion in place, with a com­pelling vi­sion, ded­i­cat­ed team and ro­bust sci­ence,” Er­win said in a state­ment. “I am ex­cit­ed to lead the com­pa­ny in­to its next stage of de­vel­op­ment and ul­ti­mate­ly trans­form the lives of pa­tients by bring­ing a new gen­er­a­tion of im­mune-based ther­a­pies to the world.”

Ovid Tri­fan

Mean­while, TRex’s clin­i­cal pro­gram will be led by Ovid Tri­fan, most re­cent­ly CMO and VP of de­vel­op­ment at Apex­i­gen. Pri­or to that, Tri­fan held se­nior roles in clin­i­cal re­search at Bris­tol My­ers Squibb and J&J, fo­cus­ing on the on­col­o­gy space. Tri­fan will gear up to bring TRex’s lead pro­grams in­to the clin­ic by the end of the year.

The found­ing team is al­so joined by CSO Melanie Klein­schek, who will dri­ve the boat on TRex’s dis­cov­ery plat­form.

Tap­ping in­to im­muno­sup­pres­sant reg­u­la­to­ry T cells, which con­trol the pro­lif­er­a­tion of cy­tokines and T cells to main­tain what’s called tis­sue home­osta­sis, has seen a wealth of in­ter­est in re­cent years as com­pa­nies look to tamp down over­ac­tive im­mune sys­tems.

Melanie Klein­schek

In Feb­ru­ary, Mer­ck signed away $1.85 bil­lion to ac­quire Pan­dion Phar­ma­ceu­ti­cals and its pipeline of drugs tar­get­ing Tregs for au­toim­mune con­di­tions with the lead com­pound look­ing to bind with IL-2. That lead drug, dubbed PT101, will go af­ter ul­cer­a­tive col­i­tis and scored a win in a Phase Ia tri­al ear­li­er this year. In that 56-pa­tient study, PT101 in­creased Treg lev­els by 260% and in­creased the lev­el of high CD25-ex­press­ing Tregs, known as CD25 bright Tregs, by a whop­ping 6,250%, Pan­dion said. The drug al­so hits its marks on safe­ty and tol­er­a­bil­i­ty.

On a much small­er scale, No­var­tis and RA Cap­i­tal backed a $20 mil­lion seed round back in Au­gust for a com­pa­ny called Gen­tiBio, which is al­so look­ing to de­vel­op Treg can­di­dates. But those cer­tain­ly aren’t the on­ly two play­ers in that race.

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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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.

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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