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.”

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Big week for Alzheimer’s da­ta; As­traZeneca buys cell ther­a­py start­up; Dig­i­tal ther­a­peu­tics hits a pay­er wall; and more

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Am­gen, years be­hind ri­vals, says PhI obe­si­ty drug shows dura­bil­i­ty signs

While NBC ran “The Biggest Loser” for 17 seasons, deemed toxic by critics for the reality show’s punishing exercise and diet upheavals, researchers in pharmaceutical labs have been attempting to create prescription drugs that induce weight loss — and one pharma betting it can require less frequent dosing is out with a new crop of data.

Amgen was relatively late to the game compared to its approved competitor Novo Nordisk and green light-approaching rival Eli Lilly. But early data suggested Amgen’s AMG 133 led to a 14.5% weight reduction in the first few months of dosing, buoying shares earlier this fall, and now the California pharma is out with its first batch of durability data showing that figure fell slightly to 11.2% about 150 days after the last dose. Amgen presented at the 20th World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease on Saturday afternoon.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls

Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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Chris Kim, Liminatus Pharma CEO

A fledg­ling biotech goes SPAC route to bankroll can­cer vac­cine, CAR-T and CD47

A relatively unknown clinical-stage biotech — backed by a Korean lighting company and focused on a cancer vaccine out of a Thomas Jefferson University lab — is headed to Nasdaq via the blank check route.

Liminatus Pharma will get about $316 million in proceeds from the SPAC combination to fund its ongoing Phase IIa study of a cancer vaccine, bring a CAR-T therapy into the clinic and prep a CD47 immune checkpoint inhibitor for human trials, the company said this week.

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Bay­er starts work on $43M+ ex­pan­sion of OTC man­u­fac­tur­ing site in Penn­syl­va­nia

German pharma giant Bayer will be looking to make a significant investment into one of its US plants that produces over-the-counter drugs.

Bayer announced that it will spend $43.6 million to expand its facility in Myerstown, PA, a small town east of Harrisburg. Bayer plans to increase the site by 70,000 square feet and will have room for the installation of eight packaging lines and an area to install rooftop solar panels. The project is expected to be completed by 2025 and will add around 50 to 75 jobs.

US month­ly costs for biosim­i­lars 'sub­stan­tial­ly high­er' than Ger­many or Switzer­land, JA­MA re­search finds

As the global biologics market is expected to hit nearly the half-trillion-dollar mark this year, new JAMA research points to the importance of timely biosimilar entry, particularly as fewer biosimilars are entering the US than in Europe, and as monthly treatment costs for biosimilars were “substantially higher” in the US compared with Germany and Switzerland.

Among the three countries, biosimilar market share at launch was highest in Germany, but increased at the fastest rate in the US, the authors from the University of Zurich’s Institute of Law wrote in JAMA Network Open today.

Kirk Myers is shown in a still image from a new film series showcasing the efforts of HIV advocates funded by Gilead.

Gilead spot­lights HIV projects and the com­mu­ni­ty lead­ers dri­ving them in new mi­ni-doc­u­men­tary films

Gilead is going behind the scenes of some of the HIV initiatives it funds through grants in a new film series narrated by the people helming the projects.

The first four films and leaders come from across the US — Arianna Lint in Florida and Puerto Rico, Cleve Jones in San Francisco, June Gipson in Mississippi and Kirk Myers in Texas. Their HIV-focused efforts range from addressing unmet needs of the transgender community to delivering social services and high-quality health care in underserved communities.

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