GSK, J&J and Pfiz­er vie for $10B RSV vac­cine mar­ket, with Bavar­i­an Nordic and Mod­er­na hot on their trail

Covid-19 isn’t the on­ly res­pi­ra­to­ry virus wreak­ing hav­oc around the world and push­ing a bevy of drug­mak­ers to in­vest in a vac­cine.

Res­pi­ra­to­ry syn­cy­tial virus, or RSV, has al­so seen an un­usu­al sum­mer resur­gence, and al­though it usu­al­ly caus­es mild, cold-like symp­toms, ac­cord­ing to the CDC, RSV can be dead­ly, es­pe­cial­ly for in­fants and old­er adults.

In the US, the CDC es­ti­mates that more than 177,000 of adults over the age of 65 are hos­pi­tal­ized from RSV, and 14,000 of them die each year.

Dri­ving the fight against this virus, in a field po­ten­tial­ly worth up to $10 bil­lion an­nu­al­ly by 2030, are Glax­o­SmithK­line, J&J, and Pfiz­er, all of which will in­tense­ly com­pete for mar­ket share in the com­ing years, po­ten­tial­ly as ear­ly as the end of 2023, ac­cord­ing to a new re­port from SVB Leerink.

Last week, Pfiz­er kicked off its vac­cine’s Phase III tri­al in old­er adults, ex­pect­ing to en­roll about 30,000 par­tic­i­pants, which is like­ly to be larg­er than the near­ly 25,000 par­tic­i­pants planned in both GSK’s and J&J’s late-stage tri­als. The Pfiz­er tri­al’s piv­otal read­out could come as ear­ly as the first quar­ter of next year.

“We be­lieve that PFE’s COVID vac­cine com­mer­cial in­fra­struc­ture will en­able a rapid glob­al launch if their RSV vac­cine is ap­proved and there­fore rep­re­sents sig­nif­i­cant com­pe­ti­tion to GSK’s pro­gram,” SVB Leerink an­a­lyst Ge­of­frey Porges wrote in an in­vestor note on Mon­day.

GSK, mean­while, said their piv­otal tri­al re­sults in old­er adults could come in the sec­ond half of next year, and it kicked off an­oth­er Phase III study last Feb­ru­ary to eval­u­ate its vac­cine can­di­date’s im­muno­genic­i­ty, safe­ty, re­ac­to­genic­i­ty and per­sis­tence.

J&J al­so launched its piv­otal adult RSV vac­cine tri­al last month, which could align the Big Phar­ma with Pfiz­er’s time­line.

“Giv­en more or less equal tim­ing, and the low prob­a­bil­i­ty of re­al dif­fer­en­ti­a­tion be­tween the pro­grams, we have re­duced our ex­pect­ed share for GSK and al­lo­cat­ed share to PFE and JNJ who ap­pear to be on a sim­i­lar time course and al­so added lim­it­ed share for BA­VA and MR­NA,” Porges wrote.

While not yet at fron­trun­ner sta­tus, Bavar­i­an Nordic last week re­leased promis­ing re­sults from a small chal­lenge tri­al, and Porges sin­gled out how the can­di­date is dif­fer­ent from the oth­ers.

Based on the Phase II chal­lenge tri­al re­sult, Bavar­i­an Nordic “could have the first adult RSV vac­cine to show ef­fi­ca­cy not based on the F-pro­tein anti­gen mono­va­lent (sin­gle anti­gen) used by com­peti­tor pro­grams,” Porges wrote.

Mod­er­na, which is haul­ing in tens of bil­lions from its mR­NA Covid vac­cine this year and next, ear­ly last month nabbed a fast-track des­ig­na­tion from the FDA to try to take that mR­NA plat­form in­to RSV. A Phase 1 study to eval­u­ate the RSV vac­cine can­di­date’s tol­er­a­bil­i­ty and re­ac­to­genic­i­ty in younger adults, old­er adults and chil­dren is on­go­ing.

None of the oth­er com­pa­nies’ pe­di­atric de­vel­op­ment pro­grams have ad­vanced to piv­otal tri­als yet, ac­cord­ing to Porges, and GSK said in Ju­ly that it’s dis­con­tin­u­ing its RSV pe­di­atric can­di­date “fol­low­ing as­sess­ment that tar­get ef­fi­ca­cy pro­file was un­like­ly to be met.”

But that doesn’t damp­en SVB Leerink’s over­all mar­ket pro­jec­tion, as it pre­dicts that by 2030, 72% of the rough­ly $10 bil­lion will come from the adult seg­ment, 10% from ma­ter­nal im­mu­niza­tion, and 18% from in­fant pro­phy­lax­is.

Sanofi is al­so work­ing with As­traZeneca on a mon­o­clon­al an­ti­body that aims to pro­tect in­fants en­ter­ing their first RSV sea­son, which could be ready for an FDA sub­mis­sion as soon as next year, and may hit block­buster sta­tus by 2030.

“Of our to­tal ex­pect­ed 2030 rev­enue, we ex­pect GSK to cap­ture 27% ($2.9bn), PFE 20% ($2.1bn), SNY 11% ($1.2bn), JNJ 16% ($1.7bn) and oth­ers 25% ($2.6bn),” Porges wrote.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 117,700+ biopharma pros reading Endpoints daily — and it's free.

Mi­rati tri­umphs again in KRAS-mu­tat­ed lung can­cer with a close­ly watched FDA fil­ing now in the cards

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.

Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a rather narrow market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 117,700+ biopharma pros reading Endpoints daily — and it's free.

FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.

Mi­rati's KRAS drug looks like the ear­ly fa­vorite in colon can­cer with new da­ta, putting the pres­sure square on Am­gen

With Amgen already providing proof-of-concept for KRAS inhibitors with its sotorasib, Mirati Therapeutics is piecing together a follow-up effort in lung cancer with data it thinks are superior. But in colon cancer, where solo sotorasib has turned in a dud, Mirati may now have a strong case for superiority.

Mirati’s adagrasib, dosed solo or in combination with chemotherapy cetuximab, showed numerically higher response rates than sotorasib solo and as part of a combination study in a similar patient population also revealed this week at #ESMO21. Mirati’s data were presented as part of a cohort update from the Phase II KRYSTAL-1 study testing adagrasib in a range of solid tumors harboring the KRAS-G12C mutation.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 117,700+ biopharma pros reading Endpoints daily — and it's free.

Ex­elix­is pulls a sur­prise win in thy­roid can­cer just days ahead of fi­nal Cabome­tyx read­out

Exelixis added a thyroid cancer indication to its super-seller Cabometyx’s label on Friday — months before the FDA was expected to make a decision, and days before the company was set to unveil the final data at #ESMO21.

At a median follow-up of 10.1 months, differentiated thyroid cancer patients treated with Cabometyx (cabozantinib) lived a median of 11 months without their disease worsening, compared to just 1.9 months for patients given a placebo, Exelixis said on Monday.