Stephen Hoge (Moderna)

As Mod­er­na dou­bles down on vac­cines, Mer­ck pulls out of a long-run­ning col­lab­o­ra­tion

In the wake of their Covid-19 ef­fort, Mod­er­na is dou­bling down on vac­cines for in­fec­tious dis­ease, but they an­nounced to­day they’ll be do­ing so with­out one of their long­time part­ners.

In one of a flur­ry of an­nounce­ments Thurs­day morn­ing, the Cam­bridge biotech an­nounced that Mer­ck has ced­ed back rights to the adult res­pi­ra­to­ry syn­cy­tial virus vac­cine the pair had been co-de­vel­op­ing. One of two dif­fer­ent can­di­dates Mod­er­na was help­ing push for­ward in a hot­ly com­pet­i­tive space, the vac­cine had en­tered Phase I last year. Mer­ck will com­plete that tri­al be­fore for­mal­ly hand­ing it over, giv­ing Mod­er­na rights to both a vac­cine for adults and in­fants.

The NJ phar­ma, mean­while, will con­tin­ue on an RSV pro­gram, push­ing for­ward on an an­ti­body that is now in Phase II. On a con­fer­ence call with in­vestors, Mod­er­na pres­i­dent Stephen Hoge said he could on­ly spec­u­late on Mer­ck’s rea­son­ing, but he not­ed that there’s a tight race for RSV in­oc­u­la­tions, with oth­er com­pa­nies al­ready ahead. Most no­tably, Glax­o­SmithK­line and Pfiz­er have pro­grams in Phase II and Phase III.

Hoge called their co-de­vel­oped vac­cine a “late-en­trant.”

“RSV is a pret­ty com­pet­i­tive space,” Hoge said. “If you’re go­ing to bring an RSV for­ward, it has to ei­ther be dra­mat­i­cal­ly bet­ter in RSV, or it has to have oth­er [qual­i­ties].”

Asked for com­ment, a Mer­ck spokesper­son sim­ply said they had de­cid­ed to fo­cus their ef­forts on the an­ti­body pro­gram. Com­pa­ny sci­en­tists de­scribed that an­ti­body in Na­ture Com­mu­ni­ca­tions last year, al­though they too face steep com­pe­ti­tion; As­traZeneca has had an an­ti­body on the mar­ket for 2 decades and they are now de­vel­op­ing a new one with Sanofi.

Al­though Mod­er­na em­pha­sized it was ear­ly and they need­ed to as­sess how they would move for­ward, Hoge not­ed one way they hoped to stand apart.

As the com­pa­ny’s vac­cine port­fo­lio ex­pand­ed over the last decade, most re­cent­ly with flu and coro­n­avirus, they have talked about the po­ten­tial of cre­at­ing a sin­gle, com­bined res­pi­ra­to­ry shot, sim­i­lar to the measles, mumps and rubel­la vac­cine chil­dren have re­ceived for decades. For ex­am­ple, some­one who is at high­er risk of com­pli­ca­tions from in­fec­tion could be in­oc­u­lat­ed against flu, Covid-19, RSV and Hu­man metap­neu­movirus and parain­fluen­za virus — a sea­son­al virus that can be dan­ger­ous for in­fants and the el­der­ly — in one jab.

“There are mul­ti­ple vac­cines that are fur­ther ahead in pipelines in large phar­ma­ceu­ti­cal com­bines,” Hoge said. “From a strate­gic per­spec­tive, from our view­point, it would make more sense to come for­ward with a dif­fer­en­ti­at­ed vac­cine that com­bines mul­ti­ple dif­fer­ent virus­es.”

RSV is a res­pi­ra­to­ry virus that can be dan­ger­ous or even dead­ly for in­fants and the el­der­ly. The on­ly way to treat or pre­vent it is with the As­traZeneca an­ti­body, which is ex­pen­sive and on­ly pre­scribed for high-risk in­fants. Nu­mer­ous com­pa­nies have tried to de­vel­op a vac­cine, but it has been par­tic­u­lar­ly dif­fi­cult to do so for in­fants, be­cause the moth­er has to be in­oc­u­lat­ed and pass the an­ti­bod­ies on­to the child. Four years be­fore its Covid-19 pro­gram, No­vavax mount­ed a ma­jor ef­fort to de­vel­op a vac­cine for in­fants that failed, tank­ing the stock price, al­though some stud­ies have still shown en­cour­ag­ing signs.

Mod­er­na al­so an­nounced Thurs­day that the com­pa­ny be­gan dos­ing in a Phase I study on their RSV can­di­date for in­fants. They said the new arrange­ment will al­low them to move for­ward with a vac­cine that’s en­cased in their own lipid nanopar­ti­cle, rather than Mer­ck’s. They not­ed they had far more da­ta sup­port­ing that LNP than Mer­ck’s, which has vir­tu­al­ly on­ly been used in the RSV study.

The two com­pa­nies’ col­lab­o­ra­tion on can­cer re­mains un­af­fect­ed.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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Lisa Deschamps, AviadoBio CEO

Ex-No­var­tis busi­ness head hops over to a gene ther­a­py start­up — and she's reeled in $80M for a dash to the clin­ic

Neurologist and King’s College London professor Christopher Shaw has been researching neurodegenerative diseases like ALS and collaborating with drugmakers for the last 25 years in the hopes of pushing new therapies forward. But unfortunately, none of those efforts have come anywhere close to fruition.

“So, you know, after 20 years in the game, I said, ‘Let’s try and do it ourselves,’” he told Endpoints News. 

Vas Narasimhan, Novartis CEO (Thibault Camus/Pool via AP Images)

With gener­ic com­pe­ti­tion heat­ing up, Vas Narasimhan out­lines No­var­tis' growth plans at R&D day

Thursday marks Novartis’ annual R&D day, and with it comes CEO Vas Narasimhan’s attempt to spotlight the company’s pipeline strategy and emerging stars.

The biggest question entering Thursday’s presentation dealt with how the big biopharma will make up revenues from upcoming generic competition — Novartis says within the next five years, generics will eat away roughly $9 billion in sales. To offset this, Narasimhan outlined a strategy for 4% growth or higher until 2026, focusing on six key medicines he believes will see multibillion dollar profits during this time.

In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Reshma Kewalramani, Vertex CEO (Vertex via YouTube)

Bat­tling a line­up of skep­tics, Ver­tex claims an­oth­er ear­ly clin­i­cal win — this time in kid­ney dis­ease

Vertex claimed its second early-stage win of the fall Wednesday, announcing positive results in a small study on a genetically defined form of kidney disease.

The 16-patient, Phase II trial focused on patients with focal segmental glomerulosclerosis, a rare disease where kidneys are unable to filter blood properly. Over 13 weeks on an experimental pill, the level of protein in the patients’ urine fell by an average of 47.6%.

Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

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