Dina Radenkovic, Gameto CEO

UP­DAT­ED: Bob Nelsen, Anne Wo­j­ci­c­ki join $20M round for longevi­ty start­up hop­ing to slow down ag­ing of the ovary

Hav­ing helped birth some of the ear­li­est an­ti-ag­ing up­starts, Bob Nelsen has found an­oth­er new idea to love in the bur­geon­ing space.

The ARCH man­ag­ing di­rec­tor is among a syn­di­cate pour­ing $20 mil­lion of Se­ries A cash in­to Ga­me­to, a New York-based biotech whose stat­ed mis­sion is to re­pro­gram ovar­i­an cells to slow down the ag­ing of the ovary — which is very much “ac­cel­er­at­ed” com­pared to oth­er or­gans, ac­cord­ing to the com­pa­ny.

Oth­er in­vestors in­clude 23andMe founder Anne Wo­j­ci­c­ki, Fu­ture Ven­tures, Bold Cap­i­tal Part­ners, Lux Cap­i­tal, Plum Al­ley, TA Ven­tures and Over­wa­ter Ven­tures.

“I think this field a woman’s health tru­ly needs a suc­cess sto­ry,” CEO Di­na Radenkovic told End­points News.

Trained in the UK and the US, Radenkovic was a co-founder and CSO of a longevi­ty clin­ic in Lon­don and spent the past year as a vis­it­ing sci­en­tist at the Buck In­sti­tute in Cal­i­for­nia while boot­ing up Ga­me­to with Mar­tin Varsavsky, an en­tre­pre­neur who runs one of the largest fer­til­i­ty clin­ics in the US. She of­fi­cial­ly moved over as CEO last Au­gust while Varsavsky as­sumed the chair­man role.

“Ovaries age five times faster than oth­er or­gans, re­sult­ing in in­fer­til­i­ty, ear­ly menopause and in­creased years of poor health for women,” she said in a state­ment. “We want to change the nar­ra­tive of fe­male re­pro­duc­tive longevi­ty and ad­dress the root caus­es of sex/gen­der in­equal­i­ty in our so­ci­ety.”

Maryan­na Saenko

Lean­ing on a spon­sored re­search pact with the George Church lab, the com­pa­ny’s plat­form has three pil­lars: one to im­prove as­sist­ed fer­til­i­ty (which will be the ini­tial fo­cus), an­oth­er to ini­ti­ate drug dis­cov­ery and the last to “make the med­ical bur­den of menopause op­tion­al.”

One of the tools Ga­me­to has come up with, ac­cord­ing to Radenkovic, are “ovaroids” — ovar­i­an sup­port­ing cells and site pre­cur­sors — that, like organoids, can be used to mod­el the re­al or­gan and run ob­ser­va­tion­al ex­per­i­ments to see what ef­fects drugs may have.

As the com­pa­ny ex­plains in a press re­lease:

Based on the rapid ag­ing na­ture of ovaries, they are an ex­cel­lent mod­el to study hu­man ag­ing. Ga­me­to wants to syn­chro­nize the pace of ovar­i­an ag­ing to the rate of ag­ing in oth­er or­gans such as the liv­er, brain, or skin. When ovaries are termed “geri­atric” by many tra­di­tion­al med­ical cri­te­ria, the rest of the body is cer­tain­ly not and this has con­tributed to the so­ci­etal and de­mo­graph­ic is­sues we are fac­ing to­day. Con­sid­er­ing hu­man healthspan and lifes­pan have in­creased sig­nif­i­cant­ly, Ga­me­to be­lieves this bi­o­log­i­cal phe­nom­e­non is no longer fit for pur­pose and is a prob­lem worth solv­ing. Ga­me­to sees the po­ten­tial to ex­pand its plat­form to the en­tire ag­ing mar­ket.

Specifics are sparse, but in an in­ter­view with TechCrunch, Radenkovic not­ed that the com­pa­ny has be­gun test­ing whether ovar­i­an sup­port­ing cells could help ma­ture eggs and re­duce the num­ber of IVF cy­cles.

The tech­nol­o­gy al­so has the po­ten­tial to shake up the cur­rent treat­ment land­scape, added Maryan­na Saenko, co-founder of Fu­ture Ven­tures. Saenko de­scribed hor­mone re­place­ment ther­a­pies as “blunt ham­mers, lack­ing per­son­al­iza­tion.”

“The suf­fer­ing caused by menopause is not a bi­o­log­i­cal im­per­a­tive,” she said, “and the many com­pli­ca­tions that come along with menopause, par­tic­u­lar­ly ear­ly-on­set menopause, can be en­tire­ly avoid­ed.”

Radenkovic raised pri­ma­ry ovar­i­an in­suf­fi­cien­cy, where the ovary stops func­tion­ing ear­li­er than it’s sup­posed to, as one of the po­ten­tial con­di­tions that Ga­me­to may aim to treat with its even­tu­al cell ther­a­pies.

“I’m not gonna say that it’s not a dif­fi­cult field,” she said. “I think, you know, if I was to be 100% hon­est with you, yes, we are most — we are like­ly to fail. It is a risk. But I think be­cause it’s such an un­met need and be­cause of the way we reg­u­late it, we end up with a pa­tient pop­u­la­tion that ends up be­ing un­served is what makes us even more ex­cit­ed to do this.”

Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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Alexander Lefterov/Endpoints News

A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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Brian Thomas, Metagenomi CEO

Gen 2: Berke­ley spin­out lands $175M megaround to keep it on the cut­ting edge of the boom­ing gene-edit­ing field

The big bucks keep pumping into the gene-editing field.

This morning Metagenomi, allied with one of the biggest names in the mRNA field with a company DNA that includes the ubiquitous Jennifer Doudna, is showing off a $175 million B round that will pay for a rapid swelling of its staff in pursuit of some of the cutting-edge tech that keeps this field in the spotlight. And they’re aligning themselves with some major industry players with an eye on the clinic while getting behind some startups to help expand the work into new fields.

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Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

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Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.

Joaquin Duato, J&J CEO (Photo by Charles Sykes/Invision/AP)

New J&J CEO Joaquin Du­a­to promis­es an ag­gres­sive M&A hunt in quest to grow phar­ma sales

Joaquin Duato stepped away from the sideline and directly into the spotlight on Tuesday, delivering his first quarterly review for J&J as its newly-tapped CEO after an 11-year run in senior posts. And he had some mixed financial news to deliver today while laying claim to a string of blockbuster drugs in the making and outlining an appetite for small and medium-sized M&A deals.

Duato also didn’t exactly shun large buyouts when asked about the future of the company’s medtech business — where they look to be in either the top or number 2 position in every segment they’re in — even though the bar for getting those deals done is so much higher.

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