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.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; 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.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

Kelly Martin, Radius Health CEO

VC firms take os­teo­poro­sis drug­mak­er Ra­dius Health pri­vate for al­most $900M

After attacks from activist investors and disappointing returns on share prices, Radius Health has now agreed to new ownership, a direction resulting in leaving the Nasdaq.

Radius Health, a biotech out of Massachusetts with one approved product in its arsenal, announced Thursday morning that it agreed to be acquired by two VC firms: Gurnet Point Capital and Patient Square Capital. The deal, worth around $890 million, will include debt assumption and the payout of $1 CVR per share for investors. And on top of that, OrbiMed is providing debt financing.

Sen. Thom Tillis (R-NC) (J. Scott Applewhite/AP Images)

Phar­ma-friend­ly sen­a­tor calls on FDA for a third time to show patent pro­tec­tions should­n't be blamed for high drug prices

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”

Yong Dai, Frontera Therapeutics CEO

Scoop: Lit­tle-known Or­biMed-backed biotech clos­es $160M round to start gene ther­a­py tri­al

Frontera Therapeutics, a China and US biotech, has closed a $160 million Series B and received regulatory clearance to test its first gene therapy stateside, Endpoints News has learned.

Led by the largest shareholder, OrbiMed, the biotech has secured $195 million total since its September 2019 founding, according to an email reviewed by Endpoints. The lead AAV gene therapy program is for an undisclosed rare eye disease, according to the source.

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