Sum­i­to­vant sub­sidiaries En­zy­vant and Al­ta­vant merge in­to com­bined com­pa­ny

Two Sum­i­to­vant Bio­phar­ma en­ti­ties are merg­ing un­der one name, ef­fec­tive im­me­di­ate­ly.

Bill Symonds

En­zy­vant Ther­a­peu­tics and Al­ta­vant Sci­ences an­nounced they have merged to form a sin­gu­lar en­ti­ty fo­cused on de­vel­op­ing ther­a­pies for pa­tients with rare dis­eases. The com­bined com­pa­ny will keep the name En­zy­vant and along with clin­i­cal de­vel­op­ment will even­tu­al­ly in­clude in-house man­u­fac­tur­ing.

Bill Symonds, the cur­rent CEO of both Al­ta­vant and En­zy­vant, is now CEO of the merged com­pa­ny.

As to why the com­pa­nies are merg­ing, Symonds ex­plained in an email to End­points News:

Merg­ing En­zy­vant and Al­ta­vant brings the two com­pa­nies’ com­ple­men­tary ca­pa­bil­i­ties in com­mer­cial­iza­tion and de­vel­op­ment, re­spec­tive­ly, in­to one bio­phar­ma­ceu­ti­cal com­pa­ny in ul­tra-rare and rare dis­eases. With a full range of ca­pa­bil­i­ties in non­clin­i­cal and clin­i­cal de­vel­op­ment, com­mer­cial­iza­tion, and in-house man­u­fac­tur­ing, the com­bined com­pa­ny can achieve more for the rare dis­ease com­mu­ni­ty than each com­pa­ny could sep­a­rate­ly.

En­zy­vant, which net­ted FDA ap­proval for its re­gen­er­a­tive tis­sue-based ther­a­py Rethymic last year, will con­tin­ue to in­ves­ti­gate an­oth­er prod­uct dubbed ro­da­tri­s­tat eth­yl, which is de­signed to ad­dress a root cause of pul­monary ar­te­r­i­al hy­per­ten­sion. En­zy­vant scored FDA ap­proval for Rethymic last year af­ter be­ing in de­vel­op­ment for 25 years, and af­ter a 2019 re­jec­tion over a man­u­fac­tur­ing is­sue.

The deal al­so in­cludes a man­u­fac­tur­ing com­po­nent, with the new com­pa­ny head­quar­tered in the Raleigh sub­urb of Cary, NC. The com­pa­ny is in the mid­dle of de­vel­op­ing a 26,000-square-foot man­u­fac­tur­ing fa­cil­i­ty in the near­by town of Mor­risville, NC.

Ac­cord­ing to Symonds, the site, which start­ed de­vel­op­ment ear­li­er this year, will pro­vide the merged com­pa­ny with the size and flex­i­bil­i­ty to serve its com­mer­cial and clin­i­cal needs.

“When it is com­plet­ed in the sec­ond half of 2024, the fa­cil­i­ty will have three pro­cess­ing suites where En­zy­vant will man­u­fac­ture Rethymic … and oth­er re­gen­er­a­tive med­i­cines that our com­pa­ny will be in­ves­ti­gat­ing. The new man­u­fac­tur­ing fa­cil­i­ty is be­ing co-de­vel­oped by and op­er­at­ed with Sum­i­to­vant Phar­ma,” Symonds said in an email to End­points.

Symonds said that the com­pa­ny plans to hire around 40 lab­o­ra­to­ry sci­en­tists over the next two years to man­u­fac­ture med­i­cines at the fa­cil­i­ty, which is be­ing co-de­vel­oped and op­er­at­ed with Sum­i­to­vant Phar­ma.

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

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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.

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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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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John Rim, Samsung Biologics CEO (Samsung/PR Newswire)

Sam­sung Bi­o­log­ics spells out ex­pan­sion plans in South Ko­rea and US

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.

Eliot Forster, F-star CEO (Rachel Kiki for Endpoints News)

F-star gets down to the wire with $161M sale to Chi­nese buy­er as na­tion­al se­cu­ri­ty con­cerns linger

With the clock ticking on F-star Therapeutics’ takeover by a Chinese buyer, the companies are still scrambling to remove a hold on the deal from the US government’s Committee on Foreign Investment in the United States.

F-star and invoX Pharma said they are “actively negotiating” with CFIUS “about the terms of a mitigation agreement to address CFIUS’s concerns regarding potential national security risks posed by the transaction.”

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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

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

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

FDA re­ports ini­tial 'no sig­nal' for stroke risk with Pfiz­er boost­ers, launch­es con­comi­tant flu shot study

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.