Cap­tured in a harsh spot­light, biotech uni­corn Mod­er­na names Melis­sa Moore as its new CSO

Melis­sa J. Moore

As Mod­er­na Ther­a­peu­tics drew a harsh re­view from Stat, por­trayed as a com­pa­ny in tur­moil with an of­ten em­bit­tered staff, the biotech uni­corn named Howard Hugh­es in­ves­ti­ga­tor and Uni­ver­si­ty of Mass­a­chu­setts Med­ical School Pro­fes­sor Melis­sa J. Moore as its new CSO, now in com­mand of its full mR­NA de­vel­op­ment plat­form.

Moore was plucked from the com­pa­ny’s sci­en­tif­ic ad­vi­so­ry group at a cru­cial stage in Mod­er­na’s de­vel­op­ment. The biotech has raised $1.9 bil­lion so far — a huge amount by biotech stan­dards — es­tab­lish­ing a broad rang­ing pre­clin­i­cal ef­fort to use pa­tient cells as drug fac­to­ries. That ef­fort has now led to 11 de­vel­op­ment pro­grams and a slate of new ther­a­pies wait­ing to en­ter the clin­ic.

“Melis­sa is an ex­cep­tion­al sci­en­tist whose knowl­edge and ex­per­tise in this area will have an enor­mous im­pact on Mod­er­na,” said CEO Stephane Ban­cel. “And, im­por­tant­ly, she shares our vi­sion and com­mit­ment to help pa­tients and im­prove lives. We could not be more thrilled.”

Thrilled is prob­a­bly the last word you would hear Ban­cel use to de­scribe the new­ly post­ed in­ves­ti­ga­tion at Stat, which claims that Mod­er­na’s “caus­tic work en­vi­ron­ment” has dri­ven away top staff at a time where “signs” have ap­peared that the com­pa­ny’s top projects are run­ning in­to trou­ble. Ban­cel him­self, re­ports Stat, is over-con­trol­ling, ob­sessed with se­cre­cy and im­pa­tient with set­backs.

The sto­ry is heavy with crit­i­cism and anony­mous fin­ger point­ing, but light on de­tails. Mod­er­na’s for­mer CSO, Joseph Bolen, left last fall af­ter two years at the com­pa­ny, which Stat used to il­lus­trate its claims of a tox­ic work en­vi­ron­ment at Mod­er­na. Bolen was pushed out, ac­cord­ing to un­named “in­sid­ers,” af­ter be­ing rel­e­gat­ed to a small role. Bolen him­self, though, de­clined com­ment. And Ban­cel says he tried to get him to stay on, un­suc­cess­ful­ly.

Melis­sa Moore now gets a shot at ei­ther prov­ing or dis­prov­ing Stat’s claims at a time the com­pa­ny is near­ing the rapids of mid-stage de­vel­op­ment, when it will have to start out­lin­ing spe­cif­ic proof-of-con­cept da­ta on what its drugs can do. If the com­pa­ny can ac­com­plish that with sev­er­al pro­grams, Ban­cel tells me he plans to file for an IPO.

At this stage, it’s fair to say that every­one is watch­ing to see whether Mod­er­na suc­ceeds or fails. A fail­ure would prove high­ly em­bar­rass­ing for a line­up of top in­dus­try col­lab­o­ra­tors. Suc­cess would be ground­break­ing.

Moore her­self had this to say in a pre­pared state­ment:

“As a mem­ber of Mod­er­na’s Sci­en­tif­ic Ad­vi­so­ry Board, I’ve had a front row seat to ex­pe­ri­ence their ground­break­ing progress first-hand. And through my work at the RTI and with MassTERi, I’ve come to ap­pre­ci­ate the pow­er of aca­d­e­m­ic-in­dus­try col­lab­o­ra­tion and en­tre­pre­neur­ship. My new role at Mod­er­na is a nat­ur­al next step in my own pro­gres­sion as a ba­sic re­searcher pas­sion­ate about trans­lat­ing our ever-in­creas­ing knowl­edge of RNA bi­ol­o­gy in­to prod­ucts that im­prove the hu­man con­di­tion. I look for­ward to work­ing with the in­cred­i­bly tal­ent­ed Mod­er­na team and build­ing stronger con­nec­tions and col­lab­o­ra­tions be­tween Mod­er­na and acad­e­mia, as we work to ad­vance the promise of mR­NA ther­a­peu­tics as a com­plete­ly new modal­i­ty for cre­at­ing the med­i­cines of the fu­ture.”

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Andy Plump, Takeda R&D chief (Jeff Rumans for Endpoints News)

What kind of PhI­Ib da­ta is worth $4B cash? Take­da’s Andy Plump has some thoughts on that

A few months back, when Takeda caused jaws to drop with its eye-watering $4 billion cash upfront for a mid-stage TYK2 drug from Nimbus, it had already taken a deep dive on the solid Phase IIb data Nimbus had assembled from its dose-ranging study in psoriasis.

Now, it’s rolling that data out, eager to demonstrate what inspired the global biopharma to go long in a neighboring, but new, disease arena for the pipeline. And the most avid students of the numbers will likely be at Bristol Myers Squibb, who will have a multi-year head start on pioneering the TYK2 space with Sotyktu (deucravacitinib) as Takeda makes its lunge for best-in-class status.

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FDA in­di­cates will­ing­ness to ap­prove Bio­gen ALS drug de­spite failed PhI­II study

Ahead of Wednesday’s advisory committee hearing to discuss Biogen’s ALS drug tofersen, the FDA appeared open to approving the drug, newly released briefing documents show.

Citing the need for flexibility in a devastating disease like ALS, regulators signaled a willingness to consider greenlighting tofersen based on its effect on a certain protein associated with ALS despite a failed pivotal trial. The documents come after regulatory flexibility was part of the same rationale the agency expressed when approving an ALS drug last September from Amylyx Pharmaceuticals, indicating the FDA’s openness to approving new treatments for the disease.

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Vipin Garg, Altimmune CEO

Al­tim­mune’s shares halved af­ter in­ter­im look at PhII weight loss drug da­ta

Altimmune’s attempt to catch up to Novo Nordisk and Eli Lilly’s GLP-1 drugs hit an investor snag Tuesday after the biotech shared interim Phase II weight loss data.

The Maryland biotech’s pemvidutide is a GLP-1/glucagon dual receptor agonist meant to activate GLP-1 receptors to squash appetite and glucagon to ramp up energy use. The 2.4 mg dose showed a placebo-adjusted weight loss of 9.7% at week 24 of 48, which Jefferies analysts said would be comparable to Novo Nordisk’s semaglutide (Wegovy) and Eli Lilly’s tirzepatide (Mounjaro).

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No­vo Nordisk re­mains un­der UK scruti­ny as MHRA con­ducts its own re­view in 'in­cred­i­bly rare' case

The UK’s Medicines and Healthcare products Regulatory Agency is now reviewing Novo Nordisk’s marketing violation that resulted in its loss of UK trade group membership last week. Novo Nordisk was suspended on Thursday from the Association of the British Pharmaceutical Industry (ABPI) for two years after an investigation by its regulatory arm found the pharma broke its conduct rules.

MHRA said on Tuesday that its review of the Prescription Medicines Code of Practice Authority (PMCPA) investigation is standard practice. An MHRA spokesperson emphasized in an email to Endpoints News that the situation with Novo Nordisk is “incredibly rare” while also noting ABPI took “swift and proportionate action.”

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FDA warns Proc­ter & Gam­ble over NyQuil la­bel's in­gre­di­ent list­ings

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.

Harpreet Singh, Immatics CEO

Im­mat­ics an­nounces mul­ti­ple pipeline changes with lat­est fi­nan­cial re­sults

The T-cell biotech Immatics is looking to make some changes to its pipeline.

Immatics released its 2022 financial results on Tuesday and announced that it’s planning to discontinue its program for IMA201, an experimental cell therapy for solid tumors that express the antigens known as MAGE4/8. It plans to shift focus to IMA401, a TCR bispecific which goes after the same target.

The German-based biotech said it will treat the remaining patients enrolled in the program before the discontinuation. No other reasons were given for the discontinuation. Endpoints News reached out to Immatics for more details but did not receive a response by press time.

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Mar­ket­ingRx roundup: What could a US Tik­Tok ban mean for phar­ma? Pfiz­er, Lil­ly lead phar­ma March Mad­ness ad­ver­tis­ers

Just as pharma marketers finally make moves into TikTok, the threat of a US ban on the social media channel is now looming. Already banned on federal employee phones by an initial Congressional act, more bills and maybe bans are on the way. With rare bipartisan agreement, lawmakers have introduced legislation that would give the US president the power to ban TikTok (although not mentioned by name) and other foreign-owned technology platforms that represent a security threat to the US.

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Chat­G­PT with phar­ma da­ta de­buts for med­ical meet­ings, be­gin­ning with AACR

What do you get when you combine ChatGPT generative AI technology with specific pharma and clinical datasets? A time-saving tool that can answer questions about medical conference abstracts and clinical findings in seconds in one new application from ZoomRx called FermaGPT.

ZoomRx is debuting a public version of its generative AI product specifically for medical conferences beginning this week for the upcoming American Association for Cancer Research (AACR) annual meeting that runs April 14-19.

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