Tim Clackson, Theseus CEO

Or­biMed's TKI play makes its Nas­daq de­but as The­seus prices IPO

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A Boston biotech with a hefty back­ing from Or­biMed is mak­ing its Nas­daq de­but Thurs­day.

The­seus Phar­ma­ceu­ti­cals priced its IPO at $16 per share, the high end of its range, jump­ing to the pub­lic mar­ket rough­ly six months af­ter Or­biMed led the biotech’s nine-fig­ure Se­ries B. The­seus net­ted $160 mil­lion for the pub­lic of­fer­ing, bring­ing the sec­tor’s to­tal com­bined 2021 raise to $13.74 bil­lion across 86 dif­fer­ent com­pa­nies, per the End­points News tal­ly.

The IPO will make a big win­ner out of Or­biMed, which owned al­most 60% of shares pri­or to the pric­ing and has been in­volved in the com­pa­ny since it led a Se­ries A back in 2018, ac­cord­ing to the S-1. Once The­seus starts trad­ing un­der the tick­er $THRX, that slice will dwin­dle to about 45%.

Fore­site Cap­i­tal is al­so in­volved in the biotech, hav­ing joined on to the Se­ries B round in April. When The­seus com­pletes its of­fer­ing, Fore­site will own an 8.5% stake.

The­seus got start­ed by a group of col­leagues at Ari­ad Phar­ma­ceu­ti­cals fol­low­ing its $5.2 bil­lion buy­out from Take­da in 2018, strik­ing a deal with their for­mer com­pa­ny to li­cense some patents, com­pounds and a chem­i­cal li­brary to get start­ed. Ari­ad nabbed a 5.9% slice of the com­pa­ny in ex­change.

Af­ter get­ting off the ground with Or­biMed’s $20 mil­lion back­ing, the com­pa­ny laid low un­til the big Se­ries B ear­li­er this year when it un­veiled its lead pro­gram, but the biotech has still not test­ed any of its pro­grams in hu­mans. The­seus is de­vel­op­ing “pan-vari­ant” ty­ro­sine ki­nase in­hibitors to treat dif­fer­ent types of can­cer, with the hope that the can­di­dates can in­hib­it a het­ero­ge­neous mix of re­sis­tance mu­ta­tions.

Its lead pro­gram is dubbed THE-630 and tar­gets the KIT ki­nase, which re­searchers be­lieve can hit all ma­jor class­es of ac­ti­vat­ing and re­sis­tance mu­ta­tions re­lat­ed to that ki­nase in gas­troin­testi­nal stro­mal tu­mors. The­seus is plan­ning to launch the Phase I por­tion of a Phase I/II study some­time be­tween late in the fourth quar­ter this year and mid-first quar­ter in 2022. The biotech will aim to re­cruit pa­tients who have re­ceived at least four pri­or lines of ther­a­py.

The­seus al­so has an EGFR in­hibitor de­signed to beat C797S-me­di­at­ed re­sis­tance to first- or lat­er-line Tagris­so treat­ment for pa­tients with non-small cell lung can­cer. This pro­gram is well be­hind the lead, as The­seus is yet to nom­i­nate a can­di­date for the clin­ic. Cur­rent plans have that nom­i­na­tion pegged for the first half of next year.

Biotech re­mains on pace to top­ple last year’s record IPO sum of $16.5 bil­lion, but the tor­rent of cash seen ear­li­er this year slowed sig­nif­i­cant­ly in the third quar­ter. Even though things still look good for 2022 when tak­ing the last five years in­to ac­count, IPO fig­ures in the last three months were at their low­est lev­els since the start of 2020, per Deal­For­ma num­bers mae­stro Chris Doko­ma­ji­lar.

A new start for Nu­vec­tis

A small New Jer­sey biotech is look­ing to get in­to the IPO ac­tion as well, fil­ing on Wednes­day for a $30 mil­lion de­but.

Found­ed in 2020, Nu­vec­tis Phar­ma is work­ing on push­ing two in-li­censed can­cer pro­grams in­to the clin­ic, with a lead pro­gram that’s ready for Phase I. That can­di­date, brought in from Lon­don’s In­sti­tute for Can­cer Re­search, is an in­hibitor of the heat shock fac­tor 1 path­way. Nu­vec­tis is seek­ing to ini­ti­ate a Phase I study in ovar­i­an clear cell car­ci­no­ma by the end of the year.

The biotech’s sec­ond pro­gram comes from the Uni­ver­si­ty of Ed­in­burgh in Scot­land, with a deal signed this past Au­gust. It’s a can­di­date try­ing to in­hib­it the SRC and YES 1 ki­nas­es, and Nu­vec­tis is aim­ing to launch IND-en­abling stud­ies in the fourth quar­ter.

Nu­vec­tis was found­ed by a pair of ex­ec­u­tives from Stem­line Ther­a­peu­tics and a third biotech vet­er­an, Ron Bentsur, who used to be the CEO of Uro­Gen. Bentsur owns the biggest stake in the com­pa­ny at about 26%.

Once Nu­vec­tis goes pub­lic, it will trade un­der the tick­er $NVCT.

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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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.”

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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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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Spanish Prime Minister Pédro Sanchez and European Commission President Ursula von der Leyen (AP Photo/Geert Vanden Wijngaert)

EU to launch vac­cine de­vel­op­ment and man­u­fac­tur­ing part­ner­ship with Latin Amer­i­can and Caribbean coun­tries

While European companies, including BioNTech, are focused on increasing vaccine access to African countries by setting up vaccine manufacturing facilities, the European Union is looking westward to Latin America and the Caribbean.

Speaking at a press conference with Spanish Prime Minister Pédro Sanchez, EU Commission president Ursula von der Leyen said that the EU is launching a new initiative for vaccines and medicines manufacturing in Latin America, to get drugs to Latin America and the Caribbean faster.

DEM BioPharma CEO David Donabedian (L) and executive chair Jan Skvarka

Long­wood sets an­oth­er 'don't eat me' biotech in­to gear with help of for­mer Tril­li­um CEO Jan Skvar­ka

Jonathan Weissman and team are out with a cancer-fighting biotech riding the appetite for those so-called “don’t eat me” and “eat me” signals.

The scientific co-founder — alongside fellow Whitehead Institute colleague Kipp Weiskopf and Stanford biologist Michael Bassik — has launched DEM BioPharma with incubator Longwood Fund and a crop of other investors.

In all, the nascent, 10-employee biotech has $70 million to bankroll hematology- and solid tumor-based programs, including a lead asset that could enter human trials in two to three years, CEO David Donabedian told Endpoints News.

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GSK says its drug for chron­ic hep B could ‘lead to a func­tion­al cure’ — but will it be alone or in com­bi­na­tion?

GSK, newly branded and soon-to-be demerged, shared interim results from its Phase II trial on its chronic hepatitis B treatment, one that it says has the “potential to lead to a functional cure.”

At a presentation at the EASL International Liver Congress, GSK shared that in around 450 patients who received its hep B drug bepirovirsen for 24 weeks, just under 30% had hepatitis B surface antigen and viral DNA levels that were too low to detect.

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.