Philip Astley-Sparke, Replimune CEO

Replimune looks to rope in $225M on the back of melanoma da­ta

The Mass­a­chu­setts-based, on­colyt­ic virus biotech Replimune is feel­ing bull­ish now that it has lift­ed the cov­er on da­ta for its lead prod­uct.

Replimune said Thurs­day it looks to nab about $225 mil­lion from a pub­lic of­fer­ing af­ter giv­ing a snap­shot of some ini­tial da­ta from its IGNYTE clin­i­cal study ear­li­er this week. The tri­al is in­ves­ti­gat­ing RP1 in com­bi­na­tion with Op­di­vo, for pa­tients with melanoma and who did not have a re­sponse when be­ing treat­ed with a PD-1.

The da­ta, which come from the first 75 pa­tients out of a to­tal of 125, show an over­all re­sponse rate (ORR) of 36%. A pri­or Phase II co­hort of 16 pa­tients, pre­sent­ed in June, showed an ORR of 37.5%. The com­plete re­sponse rate dis­closed this week was 20%.

The biotech fur­ther stat­ed that the da­ta demon­strate “sys­temic ac­tiv­i­ty, with both in­ject­ed and in un-in­ject­ed le­sion re­spond­ing, in­clud­ing in un-in­ject­ed vis­cer­al dis­ease.” Most of the re­spons­es were al­so seen in pa­tients who did not re­spond to pri­or an­ti-PD1 ther­a­py.

In a state­ment, Replimune CEO Philip Ast­ley-Sparke said the da­ta, com­bined with pre­vi­ous IGNYTE co­horts, “gives us high con­fi­dence we will be able to re­al­ize our am­bi­tion of es­tab­lish­ing a broad skin can­cer fran­chise with RP1.”

The good news has been mu­sic to in­vestors’ ears as the com­pa­ny’s share price $RE­PL has in­creased from around $18 a share on Wednes­day, when the snap­shot was re­leased, to over $24 on Fri­day.

Replimune first jumped on­to the ex­change in Ju­ly 2018 with a $100 mil­lion IPO. In Oc­to­ber, the biotech inked a $200 mil­lion loan from Her­cules Cap­i­tal over the next five years, ex­tend­ing its cash in­to 2025.

For the com­pa­ny’s oth­er ma­jor tar­gets, called RP2 and RP3, Replimune is still look­ing to go ahead with them and pur­sue a Phase II de­vel­op­ment plan, with the tar­gets aim­ing to treat pa­tients with liv­er can­cer.

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Rodney Rietze, iVexSol CEO

Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

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No­var­tis' ap­proved sick­le cell dis­ease drug fails to beat place­bo in PhI­II

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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FDA ap­proves an­oth­er in­di­ca­tion for Keytru­da, this time in the ad­ju­vant NSCLC set­ting

Merck’s blockbuster cancer treatment Keytruda has been handed another indication by the FDA.

The US regulator announced on Thursday that it has approved Keytruda to serve as an adjuvant treatment for non-small cell lung cancer (NSCLC), which is its fifth indication in NSCLC and 34th indication overall.

According to a Merck release, the approval is based on data from a Phase III trial, dubbed Keynote-091, which measured disease-free survival in patients who received chemotherapy following surgery. The data from Merck displayed that Keytruda cut down on the risk of disease recurrence or death by 27% versus placebo.

Ying Huang, Legend CEO

J&J, Leg­end say Carvyk­ti beat stan­dard ther­a­py in ear­li­er-line blood can­cer

J&J and Legend Biotech’s next step in turning their CAR-T therapy Carvykti into a potential megablockbuster has succeeded, the companies said Friday.

Carvykti achieved the primary endpoint — progression-free survival — in an open-label Phase III study testing the treatment in second- to fourth-line multiple myeloma patients. The CARTITUDE-4 trial, for which there aren’t any hard data yet, represents the biggest development for Carvykti’s ability to compete with Bristol Myers Squibb’s Abecma since its approval last February.

Dutch biotech starts liq­ui­da­tion af­ter end­ing PhI­II in GVHD

A 13-year-old Dutch biotech is going through a liquidation process after an unexpected end to its Phase III trial testing whether its combination of two monoclonal antibodies was superior to Incyte’s Jakafi.

Xenikos had hoped to prove its investigational therapy, named T-Guard, was better than Jakafi at garnering a complete response in patients experiencing life-threatening complications in which new cells from a hematopoietic stem cell transplant begin to fight the body. Jakafi was approved for the indication, steroid-refractory acute graft-versus-host disease, in May 2019.

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