Martin Silverstein

Mana joins the hec­tic fight against sol­id tu­mors with an ‘off-the-shelf’ can­di­date an­gling for an IND this year

The hunt for ef­fec­tive ther­a­pies for sol­id tu­mors has heat­ed up in ear­ly 2021 with a string of biotechs tout­ing big in­vestor checks and name-brand col­lab­o­ra­tions to chase those hard-to-treat lumps. Now, with one of its can­di­dates al­ready in the clin­ic for leukemia, Mana Ther­a­peu­tics is tak­ing a new round of fund­ing to join the fray.

On Fri­day, Mana un­veiled a $35 mil­lion Se­ries A fi­nanc­ing round that will help push the Boston-area biotech’s lead can­di­date through a Phase I tri­al and could help the com­pa­ny se­cure an IND for an off-the-shelf al­lo­gene­ic mol­e­cule tar­get­ing trans­plant-in­el­i­gi­ble AML and sol­id tu­mors with­in the year.

Marc Co­hen

The biotech’s lead­ing mol­e­cule, dubbed MANA-312, is al­ready en­gaged in the Phase I study of pa­tients with acute myeloid leukemia, myelodys­plas­tic syn­drome af­ter un­der­go­ing an al­lo­genic hematopoi­et­ic stem cell trans­plan­ta­tion. Mana’s goal is to use its tech­nol­o­gy to cre­ate an in­ven­to­ry of off-the-shelf al­lo­gene­ic prod­ucts that can treat the ma­jor­i­ty of pa­tients with cer­tain tar­get­ed can­cer in­di­ca­tions us­ing what’s called a hu­man leuko­cyte anti­gen match­ing sys­tem.

It’s a dif­fer­ent take on a sim­i­lar line of at­tack for sol­id tu­mors: us­ing the body’s nat­ur­al im­mune sys­tem to ed­u­cate healthy cells al­ready in the body to tar­get anti­gens on the sur­face of the tu­mor’s can­cer cells with­out dam­ag­ing the oth­er­wise healthy cells. To do this, Mana us­es an in-house plat­form called ED­I­FY, which it says lever­ages nat­ur­al im­mune sys­tem path­ways to ed­u­cate T cells to tar­get mul­ti­ple cell sur­faces and in­tra­cel­lu­lar tu­mor-as­so­ci­at­ed anti­gens.

Through mul­ti­ple anti­gen tar­get­ing process­es, the com­pa­ny’s tech­nol­o­gy is de­signed to pre­vent the tu­mor’s im­mune es­cape, and it says the al­lo­gene­ic method — which us­es healthy donor cells to cre­ate a mas­ter cell bank and is then used for spe­cif­ic ther­a­pies — of at­tack­ing the sol­id can­cer tu­mors could pro­vide su­pe­ri­or ef­fi­ca­cy to sin­gle anti­gen and oth­er cell ther­a­py ap­proach­es.

MANA-312 al­so isn’t the biotech’s on­ly can­di­date in the works. MANA-412 is a pre­clin­i­cal off-the-shelf al­lo­gene­ic cell ther­a­py for treat­ing trans­plant-in­el­i­gi­ble acute myeloid leukemia and sol­id tu­mors and could be ready for an IND fil­ing by the end of the year, Mana said. The Se­ries A round will help fund pre­clin­i­cal de­vel­op­ment for that can­di­date as well.

Mana was found­ed based on re­search and hu­man proof-of-con­cept clin­i­cal tri­als con­duct­ed by Cather­ine Bol­lard of Chil­dren’s Na­tion­al Hos­pi­tal and her col­leagues at Johns Hop­kins Med­ical Cen­ter. Those tri­als, in both sol­id and hema­to­log­ic tu­mors, “sup­port­ed a strong safe­ty pro­file, showed im­muno­log­i­cal an­ti-tu­mor ac­tiv­i­ty and val­i­dat­ed MANA’s ini­tial set of tu­mor anti­gens,” the com­pa­ny said. Then Bol­lard co-found­ed the com­pa­ny with in­dus­try vet Marc Co­hen. Ex-Gilead ex­ec Mar­tin Sil­ver­stein is the CEO.

Cather­ine Bol­lard

“The hu­man proof-of-con­cept tri­als con­duct­ed by my team and col­leagues showed po­ten­tial for a nonengi­neered ap­proach to ed­u­cat­ing T-cells to at­tack mul­ti­ple tu­mor anti­gens, which MANA is ex­pand­ing even fur­ther through re­fine­ment of the man­u­fac­tur­ing process for an al­lo­gene­ic prod­uct and ap­pli­ca­tion to a broad­er set of anti­gens in a va­ri­ety of clin­i­cal in­di­ca­tions and set­tings,” Bol­lard said in a state­ment.

MANA’s $35 mil­lion fi­nanc­ing round was led by Co­bro Ven­tures and Lightchain Cap­i­tal and joined by LifeSci Ven­ture Part­ners with oth­er undis­closed in­vestors.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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IPO track­er: 2021 gets start­ed with a flur­ry of new of­fer­ings

A global pandemic couldn’t slow down what turned out to be a record year for biotech IPOs. With the calendar turning toward 2021, the Endpoints News team is prepped to track each new filing this year, and the outcome. We’re off to another hot start at least.

Below, you’ll find the companies that have filed to go public, in addition to those that have already priced. Through the first two business weeks of January, there have already been 9 biotechs that have filed or priced, and the number is only expected to grow. We’ll keep the tracker updated as it does.

Matt Gline (L) and Vivek Ramaswamy

Scoop: Vivek Ra­maswamy is hand­ing the CEO job to a top lieu­tenant at Roivant — but he’s not ex­act­ly leav­ing the biotech scene

Over the past 7 years since founding Roivant, Vivek Ramaswamy has been a constant blur of biotech building motion.

He launched his first biotech with an Alzheimer’s drug he picked up cheap, and watched the experiment implode in one of the highest profile pivotal disasters seen in the last decade. But it didn’t slow the 30-something exec down; if anything, he hit the accelerator. Ramaswamy blazed global paths and went on to raise billions to spur the creation of a large lineup of little Vants promising big things at a fast pace. He sold off a section of the Vant brigade to Sumitomo Dainippon for $3 billion. And more recently the relentless dealmaker has been building a computational discovery arm to add an AI-driven approach to kicking up new programs and companies, supplementing the in-licensing drive while pursuing advances that have created more than 700 jobs at Roivant, with $2 billion in reserves.

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Ron Cooper, Albireo CEO

Al­bireo just ad­vanced down to the 10-yard line at the FDA. And Ron Coop­er’s team is get­ting prepped for the next big play

When Albireo Pharma’s board $ALBO moved to bring in Ron Cooper as the CEO more than 5 years ago, the development-stage company went with an experienced commercial player who had a big-time position on his resume after running Bristol Myers’ commercial ops in Europe.

Now, after successfully navigating a pivotal study, putting them in a foot race with a rival toward an FDA OK, Cooper is getting a boost from regulators on the last drive back to an arena he understands completely.

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David Southwell (L) and Christoph Westphal

Har­vard spin­out kicks off 2021 with a crossover round and sights set on the clin­ic

Several months after striking an alliance with Novartis, TCR therapy-focused TScan Therapeutics has reeled in a crossover round that should hold it over for the next two years as it eyes a public debut.

The Christoph Westphal portfolio company had been arranging the crossover for the last few months, CEO David Southwell said. Just before Christmas, they nailed down what he called a “really blue-chip” syndicate of four new investors, including BlackRock, RA Capital Management and two undisclosed funds. They closed on the $100 million Series C just over a week ago, and waited until Monday morning to announce it.

Hal Barron, GSK via YouTube

What does $29B buy you in Big Phar­ma? In Glax­o­SmithK­line’s case, a whole lot of un­com­fort­able ques­tions about the pipeline

Talk about your bad timing.

A little over a week ago, GSK R&D chief Hal Barron marked his third anniversary at the research helm by taking a turn at the virtual podium during JP Morgan to make the case that he and his team had built a valuable late-stage pipeline capable of churning out more than 10 blockbusters in the next 5 years.

And then, just days later, one of the cancer drugs he bet big on as a top prospect — bintrafusp, partnered with Merck KGaA — failed its first pivotal test in non-small cell lung cancer.

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Can strug­gling Iterum turn the cor­ner to an an­tibi­ot­ic suc­cess sto­ry? They will know in six months

More than five years after Corey Fishman and Michael Dunne dusted sulopenem off Pfizer’s shelves — the second castoff antibiotic they’ve brought out of the pharma giant — and founded Iterum Therapeutics around that single drug, they have lined up a quick shot at approval with priority review from the FDA.

The decision, six months from now, will mark a make-or-break moment for a struggling biotech that has just enough cash to keep the lights on until the third quarter.

Bahija Jallal, Immunocore

Buried in Im­muno­core's IPO fil­ings? A kick­back scheme from a now for­mer em­ploy­ee

Immunocore spent much of 2019 dealing with the fallout of the Neil Woodford scandal, as the former star investor’s fall crashed the biotech’s valuation out of unicorn range. Now it turns out that the company spent 2020 dealing with another internal scandal.

The longtime UK biotech darling disclosed in their IPO filing last week that they had fallen victim to an alleged kickback scheme involving one of their employees. After a whistleblower came forward, they said in their F-1, they spent the summer and spring investigating, finding fraud on the part of an employee and two outside vendors.