Daisy Robinton, Oviva Therapeutics co-founder and CEO

A new spin­out wades in­to ovar­i­an ag­ing, armed with a seed round and ex­per­i­men­tal drugs from Mass Gen­er­al

There aren’t many biotechs em­pha­siz­ing women’s health, but a new spin­out is try­ing to change that.

Ovi­va Ther­a­peu­tics, a pipeline com­pa­ny of New York-based Cam­bri­an Bio­phar­ma, emerged from stealth ear­li­er this week to dive in­to the idea of ex­tend­ing women’s “healthspans,” or what it says is the part of a per­son’s life spent in gen­er­al­ly good health, with a spe­cif­ic fo­cus on ovaries. The emer­gence comes both with a seed fi­nanc­ing worth $11.5 mil­lion from Cam­bri­an, and an in-li­cens­ing agree­ment with Mass­a­chu­setts Gen­er­al Hos­pi­tal for a trio of patents.

Co-founder Daisy Robin­ton, a Har­vard-trained mol­e­c­u­lar bi­ol­o­gist, will helm the spin­out as CEO.

She told End­points News that she came on board with Cam­bri­an as a sci­en­tist in res­i­dence in 2020, af­ter hav­ing a chat with CEO James Pey­er about how no one fo­cus­es on the ovaries, de­spite how it’s the first or­gan to de­cline with ag­ing. Robin­ton and Pey­er had known each oth­er since around 2014 due to be­ing in sim­i­lar cir­cles at con­fer­ences and the like.

“So when you think about in­ter­ven­ing on the ag­ing process, it’s such an ob­vi­ous thing to do. And be­cause of the lack of re­search around fe­male phys­i­ol­o­gy, there’s all this low-hang­ing fruit, so huge po­ten­tial for im­pact,” Robin­ton re­called telling Pey­er in 2019, which is how she ul­ti­mate­ly start­ed at Cam­bri­an af­ter the CEO asked if she could po­ten­tial­ly build a com­pa­ny around that idea.

When Robin­ton start­ed, though, it was March 2020, right as the Covid-19 pan­dem­ic came in­to full swing. The lock­downs took her at­ten­tion away from her orig­i­nal idea un­til the late sum­mer and fall of 2020, and Ovi­va of­fi­cial­ly launched in March and April of 2021.

Ovi­va is de­vel­op­ing an agent look­ing to lim­it fol­licu­lo­ge­n­e­sis, the process where­in fol­li­cles — hairs in the ovary that each have one egg — ma­ture to ul­ti­mate­ly ovu­late. This process even­tu­al­ly leads to the de­ple­tion of most of a woman’s eggs, reach­ing a low thresh­old that can sub­se­quent­ly trig­ger menopause. By lim­it­ing the process, the hope is that it can slow down de­ple­tion of the ovar­i­an re­serve, ex­tend­ing ovar­i­an func­tion and thus, the fe­male healthspan.

The first av­enue is look­ing at An­ti-Mül­ler­ian Hor­mone, or AMH — a hor­mone that plays a key role in sex dif­fer­en­ti­a­tion. This is where Ovi­va’s oth­er co-founders come in, two Har­vard pro­fes­sors who work out of Mass­a­chu­setts Gen­er­al Hos­pi­tal: Pa­tri­cia Don­a­hoe and David Pépin. Don­a­hoe heads up the famed hos­pi­tal’s pe­di­atric sur­gi­cal re­search lab­o­ra­to­ries, and is the Chief Emeri­ta of Pe­di­atric Sur­gi­cal Ser­vices. Pépin, an ovar­i­an phys­i­ol­o­gist, works out of the hos­pi­tal as an as­so­ciate mol­e­c­u­lar bi­ol­o­gist.

Don­a­hoe, 86, was among one of the ear­li­est re­searchers on AMH, pub­lish­ing as far back as the 1970s. While she fo­cused more on the hor­mone’s role in ovar­i­an can­cer over the decades, Pépin looked at the func­tion of the AMH gene in adult women, as they ex­press AMH. The three patents ob­tained in the li­cens­ing agree­ments were de­vel­oped at MGH by Don­a­hoe and Pépin, in­clud­ing ana­log ver­sions of AMH.

As for the biotech’s next steps, Robin­ton said Ovi­va is look­ing to start dis­cus­sions with the FDA lat­er this year and go straight for the IND stage with their first pro­gram, look­ing to mir­ror the el­e­va­tion of en­doge­nous AMH. As for more fi­nanc­ing, she added that it’s look­ing at clos­ing a Se­ries A late this year or some­time ear­ly next year.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Dipal Doshi, Entrada Therapeutics CEO

Ver­tex just found the next big ‘trans­for­ma­tive’ thing for the pipeline — at a biotech just down the street

Back in the summer of 2019, when I was covering Vertex’s executive chairman Jeff Leiden’s plans for the pipeline, I picked up on a distinct focus on myotonic dystrophy Type I, or DM1 — one of what Leiden called “two diseases (with DMD) we’re interested in and we continue to look for those assets.”

Today, Leiden’s successor at the helm of Vertex, CEO Reshma Kewalramani, is plunking down $250 million in cash to go the extra mile on DM1. The lion’s share of that is for the upfront, with a small reserve for equity in a deal that lines Vertex up with a neighbor in Seaport that has been rather quietly going at both of Vertex’s early disease targets with preclinical assets.

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Christian Itin, Autolus CEO (UKBIO19)

Au­to­lus tips its hand, bags $220M as CAR-T show­down with Gilead looms

The first batch of pivotal data on Autolus Therapeutics’ CAR-T is in, and execs are ready to plot a path to market.

With an overall remission rate of 70% at the interim analysis featuring 50 patients, the results set the stage for a BLA filing by the end of 2023, said CEO Christian Itin.

Perhaps more importantly — given that Autolus’ drug, obe-cel, is going after an indication that Gilead’s Tecartus is already approved for — the biotech highlighted “encouraging safety data” in the trial, with a low percentage of patients experiencing severe immune responses.

WIB22: Am­ber Salz­man had few op­tions when her son was di­ag­nosed with a rare ge­net­ic dis­ease. So she cre­at­ed a bet­ter one

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

Amber Salzman’s life changed on a cold, damp day in Paris over tiny plastic cups of lukewarm tea.

She was meeting with Patrick Aubourg, a French neurologist studying adrenoleukodystrophy, or ALD, a rare genetic condition that causes rapid neurological decline in young boys. It’s a sinister disease that often leads to disability or death within just a few years. Salzman’s nephew was diagnosed at just 6 or 7 years old, and died at the age of 12.

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Ahead of ad­comm, FDA rais­es un­cer­tain­ties on ben­e­fit-risk pro­file of Cy­to­ki­net­ic­s' po­ten­tial heart drug

The FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet next Tuesday to discuss whether Cytokinetics’ potential heart drug can safely reduce the risk of cardiovascular death and heart failure in patients with symptomatic chronic heart failure with reduced ejection fraction.

The drug, known as omecamtiv mecarbil and in development for more than 15 years, has seen mixed results, with a first Phase III readout from November 2020 hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as key to breaking into the market.

Ab­b­Vie slapped with age dis­crim­i­na­tion law­suit, fol­low­ing oth­er phar­mas

Add AbbVie to the list of pharma companies currently facing age discrimination allegations.

Pennsylvania resident Thomas Hesch filed suit against AbbVie on Wednesday, accusing the company of passing him over for promotions in favor of younger candidates.

Despite 30 years of pharma experience, “Hesch has consistently seen younger, less qualified employees promoted over him,” the complaint states.

Stephen Squinto, Gennao Bio chairman

Scoop: Stephen Squin­to’s Yale spin­out is rais­ing a Se­ries B for ge­net­ic med­i­cines

The nucleic acid therapeutics at Stephen Squinto’s Yale-originated biotech are en route to a $40 million R&D payday.

After a Series A of that size in the spring of 2021, Hopewell, NJ-based Gennao Bio is closing on a round of the same amount, Endpoints News has learned. A Series B is in the works, according to an investor’s post on LinkedIn and as confirmed by a spokesperson. An SEC filing on Thursday outlines $15 million in equity sold thus far in the round.

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Rami Elghandour, Arcellx CEO

Up­dat­ed: Gilead, Ar­cel­lx team up on an­ti-BC­MA CAR-T as biotech touts a 100% re­sponse rate at #ASH22

Gilead and Kite are plunking down big cash to get into the anti-BCMA CAR-T game.

The pair will shell out $225 million in cash upfront and $100 million in equity to Arcellx, Kite announced Friday morning, to develop the biotech’s lead CAR-T program together. Kite will handle commercialization and co-development with Arcellx, and profits in the US will be split 50-50.

Concurrent with the deal, Arcellx revealed its latest cut of data for the program known as CART-ddBCMA, ahead of a full presentation at this weekend’s ASH conference — a 100% response rate among patients getting the therapy. Investors jumped at the dual announcements, sending Arcellx shares $ACLX up more than 25% in Friday’s morning session.

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WIB22: Lead­ing NK cell re­searcher re­flects on roots in Iran, the UK and Texas

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

In a small but widely-cited 11-person study published in NEJM in 2020, seven patients saw signs of their cancer completely go away after getting a new therapy made from natural killer cells. The study was one of the earliest to provide clinical proof that the experimental treatment method had promise.

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