Ma­gen­ta's R&D head hits the ex­it just weeks af­ter read­ing out mid-stage da­ta for lead ther­a­py, eye­ing clin­ic for an­oth­er

Cam­bridge, MA-based Ma­gen­ta Ther­a­peu­tics has had a most­ly qui­et few years as it steers its stem cell trans­plant hope­fuls through ear­ly-stage hu­man tri­als. For the past three years, that ear­ly clin­i­cal work was head­ed up by Pfiz­er vet­er­an John Davis — but now, Davis is tak­ing off right as the biotech’s lead drug preps for a late-stage test.

John Davis

Davis, Ma­gen­ta’s CMO and head of R&D, will leave the com­pa­ny as a full-time em­ploy­ee no lat­er than Ju­ly 30 for “fam­i­ly rea­sons,” leav­ing the biotech on the hunt for its next clin­i­cal lead, ac­cord­ing to an SEC fil­ing.

Davis joined up with Ma­gen­ta in Feb­ru­ary 2018, com­ing aboard pedi­greed with past work as head of ear­ly clin­i­cal de­vel­op­ment at Pfiz­er and for­mer­ly glob­al area head of im­munol­o­gy at Bax­al­ta. Davis al­so led ear­ly clin­i­cal work at Genen­tech in the in­flam­ma­tion and CV/me­tab­o­lism group.

Af­ter the brief tran­si­tion pe­ri­od, Davis will re­main on Ma­gen­ta’s sci­en­tif­ic ad­vi­so­ry board, help­ing steer the com­pa­ny’s stem cell trans­plant and gene ther­a­py ef­forts, Ma­gen­ta said. The biotech not­ed in the fil­ing that “Davis’ de­par­ture was not re­lat­ed to any dis­agree­ments with the Com­pa­ny on any mat­ter re­lat­ing to its op­er­a­tions, poli­cies, prac­tices or any is­sues re­gard­ing fi­nan­cial dis­clo­sures, ac­count­ing or le­gal mat­ters.”

As part of the de­par­ture, Ma­gen­ta ex­pects to cut a deal with Davis pay­ing him dur­ing the tran­si­tion, ac­cord­ing to the fil­ing, with all the usu­al con­fi­den­tial­i­ty and non-so­lic­i­ta­tion hand­shakes at­tached.

It’s un­for­tu­nate tim­ing for Ma­gen­ta, which just wrapped a Phase II mul­ti­ple myelo­ma study on one of its lead ther­a­pies, CX­CR2 ag­o­nist MG­TA-145, along­side bone mar­row stim­u­lant pler­ix­afor for stem cell col­lec­tion and mo­bi­liza­tion pri­or to con­di­tion­ing. Pre­lim­i­nary find­ings from that study re­leased this month showed 10 out of 10 pa­tients dosed with the com­bo met the pri­ma­ry end­point for stem cell mo­bi­liza­tion and col­lec­tion, and all six trans­plant­ed pa­tients suc­cess­ful­ly en­graft­ed as of the da­ta cut­off date, Ma­gen­ta said.

The mul­ti­ple myelo­ma study for au­tol­o­gous stem cells is a part­ner­ship with Stan­ford Uni­ver­si­ty, and fol­low-up re­sults are ex­pect­ed at AS­CO next month.

Mean­while, the biotech al­so out­lined plans this month to bring an­oth­er pro­gram in­to the clin­ic af­ter dis­cus­sions with the FDA. That ther­a­py, MG­TA-117, will be test­ed as a con­di­tion­ing reg­i­ment for trans­plants in pa­tients with re­lapsed/re­frac­to­ry AML and MDS.

Con­di­tion­ing is the phase of stem cell trans­plants in which pa­tients’ bone mar­row and some­times im­mune cells are re­moved to make way for the trans­plant. Ma­gen­ta thinks MG­TA-117, if proven suc­cess­ful, could even­tu­al­ly re­place high-in­ten­si­ty chemother­a­py, which is the stan­dard of care in con­di­tion­ing pa­tients for a trans­plant.

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Ivan Cheung, Eisai US chairman and CEO

Bio­gen, Ei­sai re­fresh amy­loid hy­poth­e­sis with PhI­II show­ing Alzheimer's med slows cog­ni­tive de­cline

In the first look at Phase III data for lecanemab, Eisai and Biogen’s follow-up Alzheimer’s drug to the embattled Aduhelm launch, results show the drug passed with flying colors on a test looking at memory, problem solving and other dementia metrics.

One of the most-watched Alzheimer’s therapies in the clinic, lecanemab met the study’s primary goal on the CDR-SB — Clinical Dementia Rating-Sum of Boxes — giving the biotech the confidence to ask for full approval in the US, EU and Japan by next March 31. The experimental drug reduced clinical decline on the scale by 27% compared to placebo at 18 months, the companies said Tuesday night Eastern time and Wednesday morning in Japan.

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Gilead names 'k­ing­pin­s' in coun­ter­feit HIV med law­suit

Gilead is mounting its counterfeit drug lawsuit, naming two “kingpins” and a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies.

The pharma giant on Wednesday provided an update on what it called a “large-scale, sophisticated counterfeiting conspiracy,” accusing two new defendants of “leading and orchestrating” a scheme to sell hundreds of millions of dollars in illegitimate drugs posing as meds such as Biktarvy and Descovy.

Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

Vlad Coric, Biohaven CEO (Photo Credit: Andrew Venditti)

As Amy­lyx de­ci­sion waits in the wings, Bio­haven’s ALS drug sinks (again) in plat­form tri­al

The FDA’s decision on Amylyx’s ALS drug is set to come out sometime Thursday. In a space with few drugs, any approval would be a major landmark.

But elsewhere in the ALS field, things are a bit more tepid.

Thursday morning, Biohaven announced that its drug verdiperstat failed its arm of an ALS platform trial led by Massachusetts General Hospital. According to a press release, the drug did not meet its primary endpoint — improvement on an ALS functional status test — or any key secondary endpoints at 24 weeks. The trial had enrolled 167 patients, giving them either verdiperstat or placebo twice a day.

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Work taking place in the clean rooms at Vor (Credit: Vor)

Vor Bio opts to keep man­u­fac­tur­ing op­er­a­tions in-house for de­vel­op­ing stem cell, CAR-T ther­a­pies

While it is not uncommon for a biotech to go down the route of having the product manufactured by a contract organization, one small biotech is looking to keep its card close to its chest.

Vor Biopharma has started manufacturing operations at an in-house facility at its HQ in Cambridge, MA after beginning construction last summer.

According to the biotech, the facility aims to develop Vor’s hematopoietic stem cells (eHSCs) and CAR-T therapies for patients with blood cancers. The site will initially manufacture a clinical supply of its candidate VCAR33allo to support its IND, which is slated to be submitted in the first half of next year. It also plans to transfer the production of VOR33 to the facility. Vor is getting to work quickly as engineering runs for VCAR33allo has started this week.

Aim­ing for fourth nod, Sarep­ta files an­oth­er DMD gene ther­a­py to FDA; Ax­some head­ed to­ward mi­graine re­sub­mis­sion

Sarepta Therapeutics has filed the data needed for an FDA accelerated approval, which would be the biotech’s fourth if granted by the agency.

The biotech has yet to complete confirmatory trials for those first three conditional nods. The filing for its fourth Duchenne muscular dystrophy treatment, disclosed Thursday, is not a surprise. Sarepta said in late-July it would do so after releasing positive results for the Roche-partnered gene therapy.

Phillip Gomez, Siga Technologies CEO

Siga nabs $10.7M from the US gov­ern­ment in deal for its mon­key­pox an­tivi­ral

The US government is all set to buy $10.7 million worth of Siga Technologies’ monkeypox oral antiviral, the company announced Thursday.

Of the total doses, $5.1 million worth of oral antivirals called Tpoxx (tecovirimat) will be delivered this year, with the US Department of Defense having the option of buying the rest at a later point.

The new contract follows an earlier one in which the government had purchased $7.4 million worth of Tpoxx from the company.

Renhong Tang, Simcere co-CEO

Almi­rall part­ners up with Sim­cere in po­ten­tial $500M+ deal — with plans to take IL-2 can­di­date glob­al

A Chinese pharma is looking to go international with one of its preclinical candidates, and it’s teaming up with a Spanish company in a new pact potentially worth half a billion dollars to do just that.

Simcere and Almirall announced Thursday that the two companies had reached a deal for Simcere’s IL-2 mutant fusion protein drug candidate, called SIM0278. According to a statement, Almirall gets an exclusive right to develop and commercialize the drug candidate in all indications and markets outside of China, Hong Kong, Taiwan and Macau.

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