Robert Habib (Credit: Imperial College London)

Mi­NA Ther­a­peu­tics bags near­ly $30M Se­ries A to push ac­ti­vat­ing mR­NA tech through the clin­ic

Sev­en years af­ter leav­ing in­vest­ment bank­ing to take the helm at Mi­NA Ther­a­peu­tics, CEO Robert Habib is on a mis­sion to de­vel­op a “new class of med­i­cines” us­ing small ac­ti­vat­ing mR­NA tech­nol­o­gy. And on Thurs­day, the Lon­don-based biotech an­nounced it land­ed a mod­est £23 mil­lion (near­ly $30 mil­lion) Se­ries A to work with.

Nagy Habib

Habib’s fa­ther, the promi­nent Im­pe­r­i­al Col­lege Lon­don pro­fes­sor Nagy Habib, co-found­ed Mi­NA in 2008. The com­pa­ny’s lead mR­NA pro­gram is de­signed to “switch genes on,” and po­ten­tial­ly help treat what the CEO called “the un­drug­gable”: dif­fi­cult-to-treat dis­eases, start­ing with liv­er can­cer.

“It’s sort of en­cour­ag­ing the cell’s own ma­chin­ery to pay at­ten­tion and to start pro­duc­ing a bit more of the gene that we are in­ter­est­ed in. And that gene ob­vi­ous­ly will pro­duce more mes­sen­ger RNA. And that mes­sen­ger RNA will re­sult in more pro­tein. And if we’re tar­get­ing the right pro­tein, we’re go­ing to have a ther­a­peu­tic ben­e­fit,” Habib said.

In 2017, So­sei put down about $45 mil­lion for 25.6% of Mi­NA’s eq­ui­ty. Pe­ter Bains, So­sei CEO at the time, laid out a $534 mil­lion plan to ac­quire Mi­NA, which was putting its lead can­di­date in a Phase I/IIa tri­al for liv­er can­cer. Bains said the deal was an­oth­er step in ex­pand­ing So­sei’s glob­al reach. About a year and a half lat­er, So­sei passed on that op­tion, but kept its stake.

Mi­NA’s lead pro­gram goes af­ter CEB­PA in the hopes of re­duc­ing im­mune sup­pres­sion caused by im­ma­ture myeloid cells to im­prove the ef­fi­ca­cy of can­cer ther­a­pies. Its can­di­date, MTL-CEB­PA, is be­ing test­ed as a com­bi­na­tion ther­a­py with Bay­er’s so­rafenib in ad­vanced liv­er can­cer pa­tients and Mer­ck’s pem­brolizum­ab in pa­tients with ad­vanced sol­id tu­mors.

The drug doesn’t di­rect­ly af­fect the can­cer — just the en­vi­ron­ment in which it is grow­ing.

“That strat­e­gy of re­duc­ing im­mune sup­pres­sion and clear­ing those im­ma­ture myeloid cells … is be­lieved to be an im­por­tant strat­e­gy in im­prov­ing the ef­fects of a range of can­cer ther­a­pies,” Habib said.

The Se­ries A fund­ing will be used to con­duct a Phase II study of MTL-CEB­PA with so­rafenib for the liv­er can­cer in­di­ca­tion, and com­plete an on­go­ing Phase I/Ib study of the pem­brolizum­ab com­bi­na­tion. In the Phase II study, Mi­NA will fo­cus on dura­bil­i­ty. Habib ex­pects the study to be­gin ear­ly next year, with up to 70 pa­tients in the UK, US, and some Asian and Eu­ro­pean coun­tries.

When ad­min­is­tered on its own, so­rafenib typ­i­cal­ly has an ob­jec­tive re­sponse rate of be­tween 0 to 10%, ac­cord­ing to Habib. But when giv­en with MTL-CEB­PA, “we’re see­ing ob­jec­tive re­spons­es above that ab­solute pro­por­tion, and we’re see­ing com­plete re­spons­es of liv­er pa­tients which is an ab­solute­ly ex­tra­or­di­nary fea­ture,” he added.

“Liv­er can­cer is one of the can­cers which has re­al­ly not im­proved by a huge amount over sev­er­al decades,” Habib said. ” … The con­cept of com­plete re­mis­sion is a con­cept which is very for­eign to pa­tients and to physi­cians in liv­er can­cer.”

The com­pa­ny is ac­tive­ly look­ing to ex­pand its plat­form to oth­er in­di­ca­tions as well.

aMoon, an Is­rael-based healthtech and life sci­ences ven­ture fund, led the Se­ries A round and ex­ist­ing in­vestors pitched in. As part of the deal, aMoon man­ag­ing di­rec­tor Gur Rosh­walb is join­ing Mi­NA’s board of di­rec­tors.

Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Uğur Şahin, BioNTech CEO (Andreas Arnold/picture-alliance/dpa/AP Images)

BioN­Tech opens new plas­mid DNA man­u­fac­tur­ing fa­cil­i­ty in Ger­many

German mRNA player BioNTech opened the doors to a new manufacturing facility on Thursday, this one just about 75 miles north of its headquarters in Mainz, Germany.

BioNTech announced on Thursday that it has completed the construction of its first plasmid DNA manufacturing facility in Marburg, Germany. The facility will produce materials for mRNA-based vaccines and therapies along with cell therapies.

Teresa Graham, incoming Roche Pharmaceuticals CEO

In­com­ing Roche CEO builds out his top team, tap­ping Genen­tech vet to lead phar­ma di­vi­sion

Roche announced another leadership shuffle Thursday morning – the head of global product strategy, Teresa Graham, will take over as CEO of Roche Pharmaceuticals in March while the company’s corporate executive committee will make a spot for Levi Garraway, CMO and executive VP of global product development.

Thomas Schinecker will take over the top spot as Roche group CEO in March, leaving his spot as head of diagnostics.

David Kirn, 4D Molecular Therapeutics CEO (via website)

FDA places hold on 4D Mol­e­c­u­lar’s Fab­ry gene ther­a­py

4D Molecular Therapeutics quietly tucked an FDA clinical hold on its Fabry gene therapy into an SEC filing.

Meanwhile, the biotech issued a press release the same day after the closing bell on Thursday touting an IND for another asset, in diabetic macular edema.

The California biotech had paused enrollment of patients in its two trials of the Fabry gene therapy (4D-310) last month after three patients experienced kidney issues, all of which were resolved within four weeks. At the time, 4DMT said it would wait until the second half of this year to look at 12-month clinical data on six patients in the Phase I/II trials, one in the US and one in Taiwan and Australia.

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Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

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Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

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Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.