Vikram Sheel Kumar, Clear Creek Bio CEO

In search for next-gen Covid treat­ment, Pfiz­er taps tiny biotech for re­search deal

Pfiz­er has inked a deal to de­vel­op a new Covid ther­a­py with Clear Creek Bio — a 10-per­son biotech out of RA Cap­i­tal with an of­fice in Cam­bridge, MA, but one that op­er­ates ful­ly re­mote­ly.

Paxlovid has be­come a big mon­ey­mak­er for Pfiz­er this year, pro­ject­ing $22 bil­lion in sales on the year. But the Big Phar­ma has be­gun its search for a next-gen­er­a­tion Covid an­tivi­ral and po­ten­tial com­bi­na­tion ther­a­pies as sup­ply of Paxlovid great­ly eclipses ac­tu­al use of the an­tivi­ral.

While Paxlovid binds to Mpro, the new deal cen­ters around Mpro’s sis­ter, the vi­ral en­zyme pa­pain-like pro­tease (PL­pro), both of which the SARS-CoV-2 virus needs in or­der to build its RNA copi­er ma­chine — the repli­case pro­tein com­plex that helps it make more of it­self. The duo will work to­geth­er to iden­ti­fy a PL­pro in­hibitor, but Pfiz­er will take sole re­spon­si­bil­i­ty for any work in the clin­ic and be­yond.

Pfiz­er will pay Clear Creek Bio an undis­closed up­front pay­ment, and will be on the line for po­ten­tial mile­stone pay­ments and roy­al­ties on prod­uct sales. In an in­ter­view with End­points News, Clear Creek Bio’s CEO Vikram Sheel Ku­mar de­clined to share any more fi­nan­cial de­tails on the deal, though he did say that Clear Creek Bio was “in a po­si­tion where we don’t need to raise mon­ey. This part­ner­ship al­lows us to dri­ve this pro­gram to where we think it needs to go.”

Ku­mar, a ven­ture part­ner at RA Cap­i­tal, start­ed Clear Creek Bio in 2017 as a can­cer ther­a­peu­tics com­pa­ny af­ter he lost his fa­ther to can­cer. Be­fore Clear Creek, he worked in health soft­ware, co-found­ing the health da­ta com­pa­ny Dima­gi in 2008.

When the pan­dem­ic hit, Clear Creek Bio, like oth­er biotechs, tran­si­tioned to look­ing for Covid treat­ments. They start­ed with their lead can­cer can­di­date bre­quinar, a drug that in­hibits di­hy­drooro­tate de­hy­dro­ge­nase. Bre­quinar start­ed with DuPont Phar­ma­ceu­ti­cals and then moved to Bris­tol My­ers Squibb when it bought DuPont in 2001. In 2017, it found a place at Clear Creek Bio. But bre­quinar as a Covid treat­ment was “not enough alone,” Ku­mar said, adding that the biotech is look­ing to part­ner off that drug.

An­drew Levin

In April 2021, Clear Creek Bio got a man­date from its in­vestors to look for new Covid treat­ments. “That day, we went from a de­vel­op­ment com­pa­ny to a dis­cov­ery com­pa­ny,” Ku­mar said.

The Pfiz­er col­lab­o­ra­tion was seed­ed ear­li­er this year start­ing with a con­ver­sa­tion be­tween RA Cap­i­tal man­ag­ing di­rec­tor and Clear Creek Bio board mem­ber An­drew Levin and for­mer Pfiz­er CBO John Young, Ku­mar said. From that, Ku­mar con­nect­ed with Pfiz­er’s team and hashed out a deal.

Ku­mar said that mov­ing for­ward, the PL­pro pro­gram would be Clear Creek Bio’s main fo­cus.

Pfz­er de­clined to com­ment be­yond the press re­lease for this piece.

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.