Jeremy Levin, Ovid CEO (BIO via YouTube)

Ovid shuf­fles C-suite, lays off staff in wake of PhI­II An­gel­man syn­drome fail

Fol­low­ing a Phase III flop and a culling of its pipeline, Ovid Ther­a­peu­tics is shak­ing things up again — this time at the C-suite lev­el.

Amit Rakhit

Ovid CMO Amit Rakhit will leave his role in Au­gust and tran­si­tion to the sci­en­tif­ic and clin­i­cal ad­vi­so­ry board, the biotech an­nounced Thurs­day af­ter­noon. In ad­di­tion, Ovid has anoint­ed chief com­mer­cial of­fi­cer Ja­son Tar­dio as the new COO and el­e­vat­ed Claude Nicaise to head of R&D. The moves come amidst a larg­er work­force re­struc­tur­ing, as the New York, NY-based biotech has re­duced its staff by about 25% since March.

“It was a priv­i­lege to have Amit as part of the Ovid man­age­ment team,” Ovid CEO Je­re­my Levin said in a state­ment. “He is a friend and col­league and made sig­nif­i­cant con­tri­bu­tions. While his dai­ly pres­ence with­in Ovid will be missed, we look for­ward to his con­tri­bu­tions on the sci­en­tif­ic and clin­i­cal ad­vi­so­ry board.”

In an email to End­points News, an Ovid spokesper­son said the search for a new CMO won’t be­gin right away, with most of the ef­forts cen­tered around find­ing a new chief sci­en­tif­ic of­fi­cer. “As re­gards to CMO, we have all the req­ui­site skills and qual­i­fi­ca­tions al­ready in the com­pa­ny and will make fur­ther moves in this re­gard once Dr. Rakhit leaves in Au­gust,” the spokesper­son said.

Claude Nicaise

On top of the C-suite moves, Ovid is fur­ther ap­point­ing a new board mem­ber in As­traZeneca and Pfiz­er vet­er­an Michael Poole. Levin al­so tapped three new staffers to serve in roles di­rect­ly un­der­neath him and Nicaise — Luke Rosen will re­port to Levin as the se­nior VP of ac­cel­er­at­ed de­vel­op­ment and com­mu­ni­ty en­gage­ment; Todd Baum­gart­ner will be in charge of reg­u­la­to­ry af­fairs un­der Nicaise; and Ju­lia Tsai will head up clin­i­cal de­vel­op­ment and med­ical af­fairs un­der Nicaise.

In its an­nounce­ment, Ovid said the goal of the changes is to re-cen­ter its pipeline ef­forts on ear­ly-stage clin­i­cal as­sets, rather than its pre­vi­ous late-stage fo­cus. The biotech has three pro­grams in an ar­ray of neu­ro­log­i­cal dis­eases, two of which have yet to hit the pre­clin­i­cal phase.

Rakhit joined Ovid back in 2016 and helped over­see much of the brouha­ha over the biotech’s lead An­gel­man syn­drome pro­gram. Af­ter most an­a­lysts agreed the can­di­date flunked a Phase II study in 2018, Levin con­tin­ued in­sist­ing the fi­nal re­sult was pos­i­tive and Ovid had sim­ply mis­com­mu­ni­cat­ed the re­sults to the pub­lic.

Ja­son Tar­dio

Ovid pushed the pro­gram, dubbed OV101, in­to a Phase III study to look at an end­point that had been list­ed 16th out of 17 sec­on­daries in the Phase II, but it came up short again last De­cem­ber. That prompt­ed the biotech to of­fi­cial­ly cut bait in April, in a de­ci­sion Levin said at the time was due to “the to­tal­i­ty of the da­ta” across four clin­i­cal tri­als.

The com­pa­ny is still look­ing to make a mark on An­gel­man syn­drome, as one of its new pipeline can­di­dates aims to tack­le the dis­ease. Where­as OV101 was a delta-se­lec­tive GABAA re­cep­tor ag­o­nist, the new OV882 can­di­date is a short hair­pin RNA ther­a­py tar­get­ing UBE3A gene ex­pres­sion in neu­rons.

In ad­di­tion to the An­gel­man can­di­date, Ovid is re­search­ing a GA­BA amino­trans­ferase in­hibitor to treat seizures as­so­ci­at­ed with tuber­ous scle­ro­sis com­plex and in­fan­tile spasms, as well as an­oth­er pro­gram for KIF1A as­so­ci­at­ed neu­ro­log­i­cal dis­or­der, or KAND. They al­so have soti­cle­stat for de­vel­op­men­tal and epilep­tic en­cephalopathies, which they li­censed to Take­da in March. Ovid net­ted a $196 mil­lion up­front pay­ment for soti­cle­stat and is el­i­gi­ble for up to $660 mil­lion in mile­stones.

Adap­tive De­sign Meth­ods Of­fer Rapid, Seam­less Tran­si­tion Be­tween Study Phas­es in Rare Can­cer Tri­als

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy.

Adaptive designs, which allow for prospectively planned modifications to study design based on accumulating data from subjects in the trial, can be used to optimize rare oncology trials (see Figure 1). Adaptive design studies may include multiple cohorts and multiple tumor types. In addition, numerous adaptation methods may be used in a single trial and may facilitate a more rapid, seamless transition between study phases.

Tadataka Yamada (Photographer: Kiyoshi Ota/Bloomberg via Getty Images)

Sci­ence pi­o­neer, phar­ma re­search chief, glob­al health ad­vo­cate and biotech en­tre­pre­neur Tadata­ka ‘Tachi’ Ya­ma­da has died

Tadataka Yamada, a towering physician-scientist who made his name in academia before transforming drug development at GlaxoSmithKline and developing vaccines for malaria and meningitis at the Gates Foundation, died unexpectedly of natural causes at his home in Seattle Wednesday morning.

He was 76. Frazier Healthcare Partners’ David Socks confirmed his death.

Known widely by the mononym “Tachi,” Yamada had a globetrotting career and arrived in industry relatively late in life. A 2004 Independent article noted GSK had asked Yamada to stay on beyond his approaching 60th birthday, the company’s usual retirement age. Yamada would continue working for the next 17 years, steering the Gates Foundation’s global health division for 6 years, funding Jim Wilson’s gene therapy work when few would touch it, launching Takeda Vaccines and co-founding a series of high-profile biotechs.

Marianne De Backer (L) and Jeff Hatfield

Bay­er nabs star biotech Vi­vid­ion with a $2B buy­out and an ‘arms-length’ pact, pulling a part­ner out of the IPO con­ga line

Vividion is canceling that IPO it filed. Instead of following the industry-wide migration to Nasdaq, the biotech that has captured considerable attention for its still-preclinical work finding cryptic pockets to bind to on proteins is going to work for Bayer now.

The pharma giant is putting out word today that it has bought out Vividion for $1.5 billion in cash and another half-billion dollars in milestones.

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Josh Hoffman, outgoing Zymergen CEO (Zymergen)

UP­DAT­ED: Syn­bio uni­corn Zymer­gen jet­ti­sons found­ing CEO, cuts guid­ance as cus­tomers re­port lead prod­uct does­n't work

Zymergen, just months off a $500 million IPO that put the synthetic bio firm in rarified air, has now ejected its founding CEO and downgraded its revenue forecasts after customers reported its lead film product doesn’t work as advertised, the company said Tuesday afternoon.

CEO Josh Hoffman will leave his role and sacrifice his board seat immediately in favor of Jay Flatley, the former CEO of Illumina who will take the lead role on an interim basis as the company conducts a search for its next leader.

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UK re-in­ves­ti­gates Pfiz­er's eye-pop­ping price goug­ing on an epilep­sy drug

When a drugmaker raises the price of a drug in the US by more than 2,000% overnight, and without any particular reason for that increase, nothing typically happens to the company. No fines, no court orders, just business as usual.

Martin Shkreli’s decades-old anti-parasitic drug Daraprim was the perfect example — massive price spike on an old drug, lots of media attention, public outcry, Congressional committees dragging his former company through multiple hearings, and at the end of it? Nothing happened to the price or the company (until generic competition came).

Thomas Lingelbach, Valneva CEO

A small vac­cine de­vel­op­er fa­vored by the UK gov­ern­ment in Covid-19 touts a PhI­II first in chikun­gun­ya

Before Valneva garnered the favor of the UK government as a potential supplier of Covid-19 vaccines, the French biotech prided itself on being the first company to bring a chikungunya vaccine into Phase III.

It now has positive pivotal results to back up the breakthrough therapy designation the FDA granted just weeks ago.

There are currently no approved jabs to prevent chikungunya virus infection despite decades of R&D efforts, a fact that underscores just how arduous traditional vaccine development can be, particularly for neglected tropical disease. In a absence of a major commercial market, the US government and NGOs such as CEPI have deployed various grants and incentives to spur on a small crew of academics and industry players, with Merck, via its acquisition of Themis, claiming a spot in that race.

Jeffrey Bluestone, Sonoma CEO (Photo credit: Steve Babuljak)

Jeff Blue­stone just raised $265M to de­vel­op cu­ra­tive cell ther­a­pies. We asked him how

Jeff Bluestone had some big goals in mind when he decided to make a switch from a decades-long career in academia and non-profit research to a biotech startup CEO. And now — 18 months after the $40 million launch party — he has a whole lot more money on hand to pay for the considerable amount of work ahead at Sonoma Biotherapeutics.

This morning Bluestone is taking the wraps off a $265 million B round after boosting the core syndicate of A-list investors he started with. Even by today’s standards, that sum dwarfs the kind of $100 million-plus megarounds that have become standard fare in biotech over the last 2 years.

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Nader Pourhassan, CytoDyn CEO (Photo by Jeff Kravitz/FilmMagic for CytoDyn’s Pro)

Cy­to­Dyn faces DOJ, SEC sub­poe­nas af­ter pro­mot­ing failed Covid-19 drug

The little, PR-happy drug company publicly called out by the FDA is now getting attention from both the SEC and the Department of Justice.

CytoDyn, a one-time penny stock that has gained both money and notoriety for aggressively pushing an old HIV drug as a treatment for Covid-19, disclosed in a regulatory filing Friday the SEC and DOJ have separately subpoenaed the company and “certain of its executives” as part of investigations into the company’s promotion and marketing practices.

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Zymergen co-founders Zach Serber, Josh Hoffman, and Jed Dean (Zymergen via website)

Zymer­gen's sud­den im­plo­sion shocked biotech. A lin­ger­ing loan could make things even worse

As former synbio unicorn Zymergen picks up the pieces from its spectacular implosion Tuesday, an outstanding loan from Perceptive Advisors — the only blue-chip biotech crossover investor to touch Zymergen’s fundraising efforts — could make the situation worse, according to public documents.

In December 2019, more than a year before Zymergen filed for what would eventually become a $500 million IPO, the “biofacturing” firm signed a $100 million credit facility with Perceptive to help supplement the nearly $700 million the company had raised across four VC rounds.