Ofer Sharon, OncoHost CEO

Can On­co­Host's PROphet pre­dict host re­sponse to can­cer treat­ments? In­vestors are wait­ing to find out

Last year, a small biotech out of Is­rael scored a mod­est $8 mil­lion in a Se­ries B to help fi­nance clin­i­cal tri­als and pre­pare for the up­com­ing launch of its main prod­uct, a ma­chine learn­ing-based di­ag­nos­tics plat­form. Re­cent­ly, the biotech went back for more — and got it.

On­co­Host an­nounced Tues­day morn­ing that it suc­cess­ful­ly raised $35 mil­lion in a Se­ries C fi­nanc­ing round led by Is­raeli healthtech VC ALIVE, with ad­di­tion­al in­vestors in­clud­ing the Se­ries B lead in­vestor, Our­Crowd. As to the com­pa­ny’s first goal, it is fo­cus­ing on the com­mer­cial launch of its plat­form named PROphet, which CEO Ofer Sharon told End­points News is slat­ed to launch some­time in Q3 this year — first­ly in the US.

The com­mer­cial launch is the first part of the biotech’s three-front ap­proach for the fi­nanc­ing, ac­cord­ing to Sharon, with the oth­er two fronts be­ing a fo­cus on pipeline de­vel­op­ment and in­creas­ing in­di­ca­tions for PROphet.

“A lot of the fund­ing that was se­cured is go­ing to be di­rect­ed to the com­mer­cial launch of the prod­uct. We al­ready have in place the tech­ni­cal abode, or team, but we are go­ing to in­vest a lot in ex­pand­ing the team, adding mar­ket­ing and sales po­si­tions,” Sharon said. He al­so added that the biotech is look­ing to have 50 em­ploy­ees by year’s end, more than dou­ble its cur­rent count of 20 or so em­ploy­ees.

The $35 mil­lion should last On­co­Host for 2 years, ac­cord­ing to the CEO.

The PROphet plat­form, ac­cord­ing to Sharon, is an ef­fort to take ad­van­tage of “host re­sponse,” or the body’s re­sponse specif­i­cal­ly to dif­fer­ent an­ti-can­cer treat­ments — some­thing that had been un­der re­search at the in­te­grat­ed Can­cer Re­search Cen­ter at the Tech­nion – Is­rael In­sti­tute of Tech­nol­o­gy. Sharon elab­o­rat­ed that from his view, the body’s re­sponse to cer­tain can­cer treat­ments such as im­munother­a­pies, tar­get­ed ther­a­pies and chemother­a­py doesn’t al­ways end up work­ing against the tu­mor — but rather ends up work­ing against the body in what he called can­cer re­sis­tance.

In short, the biotech has gone the pro­teomics route. The com­pa­ny’s plat­form works by an­a­lyz­ing two blood sam­ples: the first ap­prox­i­mate­ly a month be­fore treat­ment, and the sec­ond ap­prox­i­mate­ly 2-4 weeks af­ter the first treat­ment dose. Lab tech­ni­cians then sep­a­rate plas­ma from the blood and mea­sure the lev­els of ap­prox­i­mate­ly 7,000 pro­teins in that plas­ma. Es­sen­tial­ly, the plat­form looks for the over­ex­pres­sion of cer­tain pro­teins and us­es that in­for­ma­tion to pre­dict a pa­tient’s “re­sponse tra­jec­to­ry” to cer­tain treat­ments in the first 3, 6 and 12 months.

Be­ing able to pre­dict cer­tain as­pects of host re­sponse and drug re­spon­sive­ness via blood tests is some­what new, and there are oth­er com­pa­nies look­ing to uti­lize a sim­i­lar ap­proach. Pre­ci­sion med biotech Sci­pher Med­i­cine has a whole blood test to iden­ti­fy “dis­ease sig­na­tures,” al­so known as gene ex­pres­sion da­ta cur­rent­ly for an­ti-TNF drugs. It has its own plans to ex­pand af­ter net­ting over $100 mil­lion in a round backed by Khosla Ven­tures and North­pond Ven­tures ear­li­er this year.

As a doc­tor by train­ing and for­mer­ly a med­ical di­rec­tor for both As­traZeneca’s and Mer­ck’s Is­raeli di­vi­sions, Sharon said that the pro­teomics test on­ly tells a par­tial sto­ry.

“You know what’s go­ing to be the clin­i­cal tra­jec­to­ry for your pa­tient for the first 12 months. This is, of course, not enough. It’s not enough for clin­i­cians, be­cause it’s not good enough to tell a clin­i­cian that the pa­tient is not go­ing to re­spond. Be­cause as a clin­i­cian, what you want to do is treat your pa­tients,” Sharon added.

That leads to the sec­ond part of the ma­chine-learn­ing plat­form, which takes a look at the “re­sis­tance-as­so­ci­at­ed” pro­teins and path­ways and tries to cor­re­late them to ei­ther ex­ist­ing drugs or can­di­dates in on­go­ing, Phase II and III clin­i­cal tri­als.

On­co­Host’s plat­form is start­ing out with one in­di­ca­tion: NSCLC. How­ev­er, the com­pa­ny is look­ing at adding in­di­ca­tions for melanoma and small cell lung can­cer. And in terms of pipeline de­vel­op­ment, pro­teomics was on­ly the first stop. While Sharon wouldn’t say too much about de­tails, the com­pa­ny is look­ing at ex­pand­ing to the mi­cro­bio­me, sin­gle-cell analy­sis and cell-free DNA over the next few years. As to how long that might take un­til peo­ple see some­thing sub­stan­tive, On­co­Host is go­ing to do two tri­als with dras­ti­cal­ly dif­fer­ent timeta­bles.

“We can do two things here. If we are go­ing for a proof of con­cept, we will aim our clin­i­cal tri­al at stage IV metasta­t­ic can­cer pa­tients, where the fol­low-up pe­ri­od, for­tu­nate­ly, is rel­a­tive­ly short. It’s good for the com­pa­ny in terms of the abil­i­ty to un­der­stand ear­ly,” Sharon said, adding that most of the in­dus­try is look­ing at ear­li­er stages of dis­ease — which can take longer to get re­sults.

That said, the first tri­al is look­ing at stage IV can­cer pa­tients with a two-year fol­low-up, and an up­com­ing study will be launched some­time in the near fu­ture look­ing at pa­tients in ear­li­er stages of can­cer with a fol­low-up pe­ri­od of five years. While Sharon em­pha­sized the com­pa­ny’s need to be pa­tient, he added that from his view, the over­all ben­e­fit in terms of clin­i­cal val­ue will be much high­er.

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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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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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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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.

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.

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.