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.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

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In a new memorandum issued Tuesday last week, the HHS chief stripped health agencies under his purview — including the FDA — of their rulemaking ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Eli Lilly CSO Dan Skovronsky (file photo)

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The press release alone, devoid of any number except for the size of the trial, added nearly $20 billion to Eli Lilly’s market cap back in June. Now investors and oncologists will get to see if the data live up to the hype.

On Sunday at ESMO, Eli Lilly announced the full results for its Phase III MonarchE trial of Verzenio, showing that across over 5,000 women who had had HR+, HER2- breast cancer, the drug reduced the odds of recurrence by 25%. That meant 7.8% of the patients on the drug arm saw their cancers return within 2 years, compared with 11.3% on the placebo arm.

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Greg Friberg (File photo)

#ES­MO20: Am­gen team nails down sol­id ear­ly ev­i­dence of AMG 510’s po­ten­tial for NSCLC, un­lock­ing the door to a wave of KRAS pro­grams

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After decades of failure targeting KRAS, sotorasib offered the first positive look at a new approach that promised to open a door to a whole new approach by targeting a particular mutation to a big target that had remained “undruggable” for decades.

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Twenty out of 20 advanced NSCLC patients had a response after taking a combination of an in-house TKI dubbed lazertinib and amivantamab, a bispecific antibody targeting both EGFR and cMET engineered on partner Genmab’s platform, J&J reported at ESMO. All were treatment-naïve, and none has seen their cancer progress at a median follow-up of seven months.

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But getting the Merck-partnered drug to the right patients remains a challenge, something the companies are hoping to change with the new data cut.

The OS numbers on the subgroup with BRCA1/2 or ATM-mutated metastatic castration-resistant prostate cancer are similar to the first look on offer when the FDA expanded the label in May: Lynparza reduced the risk of death by 31% versus Xtandi and Zytiga. Patients on Lynparza lived a median of 19.1 months, compared to 14.7 months for the anti-androgen therapies (p = 0.0175).

Exelixis CEO Michael Morrissey (file photo)

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Donald Trump and White House chief of staff Mark Meadows, before boarding Marine One (Getty Images)

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Dan Skovronsky, Eli Lilly CSO

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Eli Lilly spotlighted a success for one of 3 doses of their closely-watched Covid-19 antibody drug Wednesday morning. But analysts quickly highlighted some obvious anomalies that could come back to haunt the pharma giant as it looks for an emergency use authorization to launch marketing efforts.

The pharma giant reported that LY-CoV555, developed in collaboration with AbCellera, significantly reduced the rate of hospitalization among patients who were treated with the antibody. The drug arm of the study had a 1.7% hospitalization rate, compared to 6% in the control group, marking a 72% drop in risk.

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#ES­MO20: It’s not just Keytru­da any­more — Mer­ck spot­lights 3 top ear­ly-stage can­cer drugs

Any $12 billion megablockbuster in the portfolio tends to overshadow everything else in the pipeline. Which is something Merck can tell you a little bit about.

Keytruda not only dominates the PD-(L)1 field, it looms over everything Merck does, to the point some analysts wonder if Merck is a one-trick pony.

There’s no shortage of Keytruda data on display at ESMO this weekend, but now the focus is shifting to the future role of new drugs and combos in maintaining that lead position for years to come. And the pharma giant has a special focus for 3 early-stage efforts where Roger Perlmutter’s oncology team is placing some big bets.

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