Se­cre­tive? Mod­er­na de­tails its pipeline strat­e­gy at JPM but at least one crit­ic bites back

Stephane Ban­cel, Mod­er­na CEO

Mod­er­na out­lined its pipeline strat­e­gy at JP Mor­gan this week, fo­cus­ing specif­i­cal­ly on five clin­i­cal-stage pro­grams for new vac­cines as a rel­a­tive­ly low-risk ap­proach to demon­strat­ing that their mes­sen­ger RNA tech­nol­o­gy and the plat­form work. But the kick­back didn’t take long to strike, as a per­sis­tent crit­ic at Stat picked at one trou­bled pro­gram while rais­ing ques­tions about the over­all val­ue of an en­try-lev­el ap­proach fo­cused on a high vol­ume, low-mar­gin busi­ness like vac­cines.

Af­ter rais­ing $1.9 bil­lion from a host of deep-pock­et in­vestors and part­ners, the uni­corn biotech has be­come the sub­ject of in­tense in­ter­est, par­tic­u­lar­ly in Boston biotech cir­cles. And Mod­er­na’s re­luc­tance to de­tail its work in the past has left the biotech with a rep among some re­porters as a se­cre­tive, pun­ish­ing place that has seen off a string of staffers who couldn’t main­tain the fren­zied pace.

Mod­er­na CEO Stephane Ban­cel, though, says that at­tack is un­war­rant­ed. His pre­sen­ta­tion at JP Mor­gan is in­tend­ed to shine a light on what the com­pa­ny’s top prospects are as it preps for its first clin­i­cal da­ta.

Ban­cel’s strat­e­gy is sim­ple: In­stead of fo­cus­ing on a sin­gle lead ef­fort, the pri­vate biotech chose to ramp up a full pipeline of clin­i­cal pro­grams. If one fal­ters, oth­ers can step up to make the case that mR­NA is on its way to de­liv­er­ing a new ap­proach to ther­a­peu­tic de­vel­op­ment with a vast ar­ray of po­ten­tial tar­gets.

“Peo­ple are go­ing to re­al­ize one day that mR­NA is a very good way to make med­i­cines,” Ban­cel says. “We are play­ing a very long game, a 10, 20-year game. We are a very in­tense com­pa­ny. We want to get those drugs for pa­tients.” And that means tack­ling dis­eases like Zi­ka with their tech­nol­o­gy.

Mod­er­na went af­ter two pan­dem­ic flu strains ear­ly, says Ban­cel, so in­ves­ti­ga­tors could ac­cu­rate­ly mea­sure an­ti­body re­spons­es among treat­ment naive pa­tients who had nev­er been ex­posed to the virus. In ad­di­tion to Zi­ka there’s an undis­closed pro­gram part­nered with Mer­ck that’s now in the clin­ic and sev­en pre­clin­i­cal pro­grams, in­clud­ing an­oth­er Mer­ck part­ner­ship on a per­son­al­ized can­cer vac­cine.

One of the com­pa­ny’s most promi­nent crit­ics, Stat’s Dami­an Garde, re­port­ed to­day that safe­ty is­sues hob­bled a ther­a­py for Crigler-Na­j­jar syn­drome — part­nered with Alex­ion — which Ban­cel promised a year ago would get in­to the clin­ic in 2016. That safe­ty is­sue, Garde added, raised fresh ques­tions about Mod­er­na’s high-stakes gam­ble on mR­NA, un­der­min­ing its $5 bil­lion val­u­a­tion it has en­joyed while rais­ing a moun­tain of cash.

Ban­cel tells me that a long-an­tic­i­pat­ed move to cash in on their val­u­a­tion through an IPO, though, won’t be hap­pen­ing this year.

“We will not go pub­lic this year,” he tells me. “This has been dis­cussed by the board. 2017 is not the right time. 2016 and ’17 is a crit­i­cal time for the com­pa­ny to move from dis­cov­ery to a de­vel­op­ment com­pa­ny with scale.”

Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

Roger Perlmutter, Eikon Therapeutics CEO

Roger Perl­mut­ter builds Eikon's pipeline with deal-mak­ing flur­ry, rais­ing $106M more

Eikon Therapeutics announced three business development deals on Thursday, effectively dropping in a pipeline of cancer drugs alongside more than $100 million in fresh funding.

The Hayward, CA-based company has become one of biotech’s richest startups since its 2019 founding, having raised nearly $775 million. It’s developing a massive, automated research approach built around Nobel Prize-winning microscope science to peer inside cells and watch proteins in action. After its Series B last year, PitchBook reported a $3.02 billion valuation. And while CEO Roger Perlmutter declined to comment on that figure, he said its first tranche of nearly $106 million in Series C funding is a “meaningful step-up to our Series B valuation.”

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Eu­ro­pean Par­lia­ment calls mem­ber states to ac­tion on an­timi­cro­bial re­sis­tance

Members of the European Parliament have called on EU countries to develop national action plans against antimicrobial resistance (AMR), calling it a top-three priority health threat.

Parliament on Thursday announced recommendations for the fight against AMR, including national action plans that must be updated at least every two years, an EU-level database tracking AMR and antimicrobial use and increased partnership between the pharma industry, patient groups and academia.

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Andrey Zarur, GreenLight Biosciences CEO

Green­Light Bio­sciences se­cures merg­er as it looks to go pri­vate

GreenLight Bioscience, the developer and manufacturer of RNA vaccines and therapeutics, is set to be acquired.

The company announced earlier this week that it would be acquired by a group of buyers led by Fall Line Capital in a cash deal valuing GreenLight at around $45.5 million. According to a release, Fall Line and the group agreed to acquire all of the shares of the company for $0.30 per share. The deal is expected to close sometime in the third quarter of this year.

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Roche plans to di­vest from lega­cy Genen­tech man­u­fac­tur­ing fa­cil­i­ty in Cal­i­for­nia

Roche is planning to make some changes to its subsidiary’s manufacturing network in California.

The Swiss pharma announced Wednesday that it plans to divest from Genentech’s manufacturing facility in Vacaville, CA, around 58 miles northeast of San Francisco. According to a statement from Roche, the move is part of a “broader strategy” to bring its manufacturing capabilities in line with its future pipeline. Roche is starting the process of finding a buyer for the site but has not named any candidates yet.

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FDA lifts hold on Mol­e­c­u­lar Tem­plates’ mul­ti­ple myelo­ma tri­al af­ter less than two months

The FDA has lifted a partial clinical hold on Molecular Templates’ early-stage trial for a multiple myeloma drug, the biotech company announced Thursday morning.

Regulators had put the trial on partial hold in early April, pausing patient enrollment, following two adverse heart-related events in patients who received the highest dose of Molecular Templates’ treatment MT-0169 last year. One patient had asymptomatic grade 2 myocarditis, or heart muscle inflammation, while the other had a grade 3 cardiomyopathy. Both recovered within two months.

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Peter van de Sande, Synaffix CEO

Lon­za shells out $107M cash to snap up Synaf­fix and its ADC plat­form

After lining up a string of partnerships over the years, Dutch antibody-drug conjugate specialist Synaffix has found a new home: Lonza, the contract development and manufacturing giant.

Lonza is paying about $107 million (€100 million) in cash to acquire Synaffix, with up to $64 million (€60 million) in “additional performance-based consideration” on the table. Synaffix’s ADC tech platform will now become part of Lonza’s offering for biopharma clients, lending its bioconjugate technologies to not just ADCs but also targeted gene therapy, immune cell engagers and other applications.

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Who's con­fi­dent­ly in­vest­ing in biotech star­tups dur­ing these tense days? We've got some an­swers

We’ve got a changeup to our event schedule in Boston next week, where we’ll be doing a mix of live/streaming events at our base at The Seaport Hotel as part of a two-day lineup of webinars, virtual firesides and a cocktail hour Q&A with a veteran of the biotech financing scene.

The 9:30-10:30 am ET live slot on Tuesday, June 6, will now feature a panel conversation on the current state of affairs for VC investing in biotech, focusing on what startups are getting cash — and how. Alaa Halawa, head of US ventures at Mubadala, is confirmed, along with Brian Goodman at MPM and Geoff von Maltzahn, a general partner at Moderna-buoyed Flagship. I have a couple of other invites out and will let you know how that plays out.

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As­traZeneca gives up on late-stage IL-23 drug due to tri­al de­lays, com­pet­i­tive land­scape

AstraZeneca is shelving an IL-23 antibody that’s been through a winding journey around pharma — including stops at Amgen and Allergan — and putting an end to Phase II and III trials testing the drug for inflammatory bowel disease.

“The decision to discontinue brazikumab’s IBD development follows a recent review of brazikumab’s development timeline and the context of a competitive landscape that has continued to evolve,” a press release reads.

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