(L-R) Samta Kundu (COO), Jake Becraft (CEO), Tasuku Kitada (head of R&D) [Strand Therapeutics]

A pair of for­mer MIT re­searchers think they've un­locked the next gen­er­a­tion of mR­NA us­ing syn­bio 'log­ic cir­cuit­s'

The time of mR­NA is in full swing as Mod­er­na and Pfiz­er/BioN­Tech have blown the doors off the field. But in drug de­vel­op­ers’ eyes, cur­rent-gen mR­NA vac­cines are just an ap­pe­tiz­er to the full course of ther­a­peu­tics fur­ther down the menu — at least that’s what two for­mer MIT re­searchers with syn­thet­ic bi­ol­o­gy roots are gam­bling on.

Strand Ther­a­peu­tics emerged from stealth Wednes­day with a $52 mil­lion Se­ries A to ad­vance its pipeline of pro­gram­ma­ble, self am­pli­fy­ing mR­NA ther­a­pies ini­tial­ly tar­get­ed at sol­id tu­mor im­muno-on­col­o­gy, the biotech said.

The team’s re­search stems from the work of CEO Jake Be­craft and head of R&D Tasuku Ki­ta­da at MIT’s Syn­thet­ic Bi­ol­o­gy Cen­ter and the Weiss Lab, where the pair met and fo­cused on ap­ply­ing syn­bio prin­ci­ples to mR­NA ther­a­peu­tic de­vel­op­ment. Along the way, their work formed Strand’s plat­form, which turns out long act­ing mR­NA ther­a­pies with greater speci­fici­ty and a wider ther­a­peu­tic in­dex than the cur­rent gen­er­a­tion of mR­NA vac­cines.

The biotech is us­ing self am­pli­fy­ing tech, which in­duces a sin­gle copy of the mR­NA drug to repli­cate it­self in vi­vo. That of­fers a much longer ther­a­peu­tic win­dow than cell ther­a­pies like the Covid-19 vac­cines from Mod­er­na and BioN­Tech, Be­craft told End­points News, which work on the scale of days rather than weeks.

But per­haps the biggest dif­fer­ence from its range of com­peti­tors is Strand’s use of “ge­net­i­cal­ly pro­gram­ma­ble log­ic cir­cuits,” which al­low its mR­NA drugs to en­ter a spe­cif­ic cel­lu­lar en­vi­ron­ment and turn pro­tein ex­pres­sion on or off de­pend­ing on a se­ries of bio­mark­ers. It’s a for­mu­la fa­mil­iar in syn­thet­ic bi­ol­o­gy: Use “sen­sors” to iden­ti­fy the tar­get en­vi­ron­ment, “log­ic process” or com­pute those sig­nals, and then ef­fect a tar­get out­put.

The com­pa­ny’s syn­bio plat­form serves a dual pur­pose of al­low­ing tight con­trol over RNA self-repli­ca­tion, en­sur­ing the ther­a­py is on­ly around in the cell as long as it needs to be.

“One of the ma­jor prob­lems with self repli­ca­tion mR­NA is that you ac­tu­al­ly need to con­trol their repli­ca­tion at a much tighter lev­el — and that’s ac­tu­al­ly what syn­thet­ic bi­ol­o­gy is re­al­ly per­fect for,” Be­craft said. “You go in­to the se­quence of the repli­ca­tion ma­chin­ery and you can make mod­i­fi­ca­tions to how it repli­cates and ac­tu­al­ly con­trol it.”

All that, ul­ti­mate­ly, means one drug could the­o­ret­i­cal­ly have an ef­fect on a range of dis­ease types — par­tic­u­lar­ly in a het­ero­ge­neous ther­a­peu­tic area such as can­cer. No sur­prise, then, that can­cer is ex­act­ly where Strand is aim­ing first.

The biotech is hop­ing to take its lead drug, which is fo­cused in the sol­id tu­mor I/O space in­to the clin­ic by 2022. The com­pound is the tar­get of a li­cens­ing pact with Chi­nese drug­mak­er BeiGene, which has pledged to cov­er some de­vel­op­ment and com­mer­cial­iza­tion costs in the re­gion. Can­cer is no easy area to jump head­first in­to, but it is a prof­itable one. Be­craft high­light­ed the field’s well-es­tab­lished bi­ol­o­gy as ripe with big tar­gets for Strand’s drugs.

“I think can­cer is a great first tar­get for things like the next gen­er­a­tion of RNA ther­a­peu­tics be­cause can­cer has a lot of known tar­gets and known bi­ol­o­gy for ther­a­peu­tic in­ter­ven­tion,” Be­craft said. “It just gives you a great start­ing point to de­vel­op a new plat­form. Can­cer kills peo­ple; we got­ta do some­thing.”

Be­craft said his com­pa­ny would look to sign sim­i­lar deals in the com­ing months, aim­ing to sign on “high­ly strate­gic” part­ners to ad­vance Strand’s pipeline and com­mer­cial op­por­tu­ni­ties.

It’s the first go-round as CEO for Be­craft, who made the jump straight from MIT as he worked to build Strand in stealth mode along­side Ki­ta­da start­ing in 2018. He said his first pri­or­i­ties are dri­ving the com­pa­ny’s lead pro­gram ahead while build­ing the pipeline and adding a strong team around him. The com­pa­ny is cur­rent­ly on a hir­ing spree with 25 on board and hopes to hit as many as 80 em­ploy­ees as it nears the clin­ic, Be­craft said.

The Se­ries A round was joined by a syn­di­cate of in­vestors in Red­mile Group, BeiGene and Cam­ford Cap­i­tal, as well as ex­ist­ing in­vestors Play­ground Glob­al and AN­RI.

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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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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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.”

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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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.

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.