Steve Worland. eFFECTOR

Eye­ing the 'trans­latome,' Pfiz­er ties an­oth­er knot with biotech part­ner for pre­clin­i­cal, next-gen tar­get­ed ther­a­pies

Af­ter close­ly fol­low­ing eF­FEC­TOR Ther­a­peu­tics’ work on next-gen tar­get­ed can­cer ther­a­pies in the past two years, chip­ping in its own ven­ture dol­lars and ink­ing an I/O com­bo col­lab­o­ra­tion with its PD-L1, Pfiz­er is bet­ting on a sec­ond drug can­di­date from the biotech part­ner.

The pre­clin­i­cal deal starts rel­a­tive­ly small — $15 mil­lion up­front — but Pfiz­er has com­mit­ted to $492 mil­lion in R&D fund­ing and mile­stones, as well as roy­al­ties and an op­tion to co-pro­mote in the US.

With Pfiz­er shoul­der­ing some re­spon­si­bil­i­ty, eF­FEC­TOR can now de­vote more of its re­sources and time to the clin­i­cal de­vel­op­ment of its lead pro­gram, CEO Steve Wor­land told End­points News.

Jeff Set­tle­man

The pact cen­ters around eu­kary­ot­ic ini­ti­a­tion fac­tor 4E, or eIF4E. Like MNK — the tar­get of eF­FEC­TOR’s lead ther­a­py tomivosert­ib (for­mer­ly eFT508) — eIF4E is part of the PI3k/AKT/mTOR and RAS onco­genic path­ways. Un­like tomivosert­ib, though, eIF4E in­hibitors are de­signed to act with­in the tu­mor rather than im­muno­sup­pres­sive fac­tors in T cells.

Sit­ting near the end of the whole process of mak­ing pro­teins — af­ter DNA has been tran­scribed, with the mR­NA ready to be trans­lat­ed by ri­bo­somes — eIF4E is in­stru­men­tal in ac­tu­al­ly kick­ing off the process of mak­ing pro­teins. Can­cer cells re­ly on this mech­a­nism to cre­ate what they need to pro­lif­er­ate; in fact, the trans­la­tion com­po­nent gets tur­bocharged, Wor­land said.

Hit­ting the end of that whole process al­so means tar­get­ing where mul­ti­ple mu­tat­ed genes and re­cep­tors con­verge.

“So if you’re down­stream, you may col­lect a set of dif­fer­ent mu­ta­tions that all ac­ti­vate your tar­get; any one of those mu­ta­tions can con­fer sen­si­tiv­i­ty,” he said.

By fo­cus­ing on the “trans­latome,” Wor­land added, eF­FEC­TOR al­so hopes to cir­cum­vent the feed­back loops in which tu­mor cells sense that one path­way has been blocked and quick­ly switch to an al­ter­na­tive.

“That was the ori­gin of the com­pa­ny, re­al­ly, look­ing at tar­get­ed ther­a­pies and high re­sponse rates, but un­for­tu­nate­ly some­times short dura­bil­i­ty of re­sponse, and think­ing: how can we think about the path­ways and find the points where you aren’t nec­es­sar­i­ly sus­cep­ti­ble to those re­sis­tance mech­a­nisms?” he said. “So we con­scious­ly chose to go down­stream of the onco­genes (and tar­get) the ef­fec­tor com­plex.”

The dis­cov­ery pro­gram is now in a rel­a­tive­ly ma­ture stage, ac­cord­ing to Wor­land, hav­ing de­vot­ed much ef­fort in mov­ing from a nat­ur­al lig­and that’s “lightyears from drug­like space” to an oral­ly avail­able ther­a­py that fits in­to the bind­ing site.

Jeff Set­tle­man, Pfiz­er’s chief sci­en­tif­ic of­fi­cer in on­col­o­gy, high­light­ed its promise for pa­tients with var­i­ous treat­ment-re­frac­to­ry can­cers.

The two part­ners are con­tin­u­ing to test eF­FEC­TOR’s MNK1/2 in­hibitor tomivosert­ib with Pfiz­er/Mer­ck KGaA’s Baven­cio. Pre­lim­i­nary da­ta from a Phase I/II study pre­sent­ed at AS­CO sug­gest­ed that “the com­bi­na­tion of T and avelum­ab has an ac­cept­able safe­ty pro­file with ro­bust tar­get en­gage­ment and demon­strat­ed ini­tial signs of ac­tiv­i­ty.”

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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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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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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Alon Seri-Levy, Sol-Gel Technologies CEO

Bridge­Bio com­pa­ny sells off rare dis­ease can­di­date to Gal­der­ma part­ner

Israeli biotech Sol-Gel Technologies announced Friday that it got its hands on a rare disease drug candidate from PellePharm for almost $75 million, amid claims that the drug has the potential to reach a $300 million market.

Execs said on a conference call Friday morning that patidegib, a hedgehog signaling pathway blocker, is being investigated to treat Gorlin syndrome, a rare genetic disorder that increases the risk of developing certain kinds of cancer such as basal cell skin cancer and medulloblastoma, a type of brain cancer. The disease affects around one in every 31,000 people, and an estimated 70,000 people worldwide.

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.

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.

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.