Af­ter an RTF and some stern warn­ings, FDA slaps Cy­to­Dyn with two clin­i­cal holds

Cy­to­Dyn’s col­or­ful and in­fa­mous CEO may be gone, but the is­sues that be­gan fes­ter­ing dur­ing his long reign are very much here to stay.

The biotech dis­closed two FDA clin­i­cal holds on its lead drug, the CCR5 an­tag­o­nist leron­limab, af­ter mar­ket close on Wednes­day: a par­tial hold on the HIV pro­gram, and a full one on the Covid-19 pro­gram. As a re­sult, some pa­tients on HIV ex­ten­sion tri­als will have to be tran­si­tioned to oth­er ther­a­py op­tions, while Cy­to­Dyn would not be able to start new Covid-19 tri­als in the US.

While Cy­to­Dyn did not go in­to de­tail about the rea­sons for the holds, it’s not the first time reg­u­la­tors have rep­ri­mand­ed the com­pa­ny, a one-time pen­ny stock that cap­i­tal­ized on the pan­dem­ic and soared to record heights be­fore crash­ing back down.

Un­der for­mer CEO Nad­er Pourhas­san, Cy­to­Dyn be­came known for its ag­gres­sive — bor­der­ing on the reck­less — pro­mo­tion­al cam­paigns, pump­ing press re­lease af­ter press re­lease to tout the (un­sub­stan­ti­at­ed) po­ten­tial of leron­limab as a Covid-19 treat­ment. At the same time, Pourhas­san went on we­b­casts and record­ed videos to talk up the drug, un­de­terred even af­ter the FDA re­ject­ed a BLA for its use in HIV, its orig­i­nal in­di­ca­tion, and the drug failed a pair of Covid-19 stud­ies.

Any­thing, ac­cord­ing to the com­pa­ny at the time, could be pos­i­tive news, whether it’s start­ing a com­pas­sion­ate use pro­gram for leron­limab in the Philip­pines or win­ning a court fight against its clin­i­cal tri­al ser­vice provider.

In the wake of the Covid-19 flop (and sub­se­quent com­mu­ni­ca­tions from Cy­to­Dyn try­ing to spin the re­sults as pos­i­tive), the FDA is­sued a rare pub­lic re­buke, ex­plain­ing the tri­als failed on all end­points.

Ear­li­er this year, the agency’s Of­fice of Pre­scrip­tion Drug Pro­mo­tion sent an­oth­er harsh warn­ing for a pro­mo video in which Pourhas­san again made claims about leron­limab that were not backed up by da­ta.

It got so out of hand that both the SEC and the De­part­ment of Jus­tice de­cid­ed to in­ter­vene, is­su­ing sub­poe­nas to look in­to its pro­mo­tion and mar­ket­ing prac­tices.

In an at­tempt to re­deem it­self and ac­tu­al­ly up the chances of ap­proval and com­mer­cial­iza­tion, Cy­to­Dyn oust­ed Pourhas­san and put the CFO in charge as the board set up a search for a new chief.

The biotech said it is now in the process of eval­u­at­ing which pro­grams to pri­or­i­tize.

As part of that ef­fort, Cy­to­Dyn paused its Brazil Covid-19 tri­als pend­ing re­sults from a da­ta safe­ty mon­i­tor­ing com­mit­tee meet­ing and will re­con­sid­er the tim­ing of its HIV BLA re­sub­mis­sion.

How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Pearl Huang, Dunad Therapeutics CEO (Ken Richardson, PR Newswire)

Long­time biotech leader Pearl Huang takes the reins as CEO of No­var­tis-backed up­start

It has only been a few months since Pearl Huang exited the top seat at Cygnal Therapeutics, but now she’s back at the helm of another biotech.

After taking a few months off — passing an exam in that time to get her captain’s license from the US Coast Guard — she’s been named CEO of Dunad Therapeutics, a biotech focused on developing a small molecule covalent therapies that was founded in 2020. Huang told Endpoints News that two factors attracted her to going back to the c-suite: the company’s technology and its co-founders.

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Laurence Reid, Decibel CEO

Still in pre­clin­i­cal test­ing for ear gene ther­a­pies, Deci­bel touts small snap­shot of chemo-in­duced hear­ing loss drug

Though Decibel Therapeutics has largely pivoted toward gene therapies for the inner ear, its lead clinical candidate simply aims to protect cancer patients from chemotherapy-induced hearing loss. On Tuesday, the biotech presented its first efficacy data for the program, and execs like what they see.

Decibel reported interim results from a Phase Ib study showing the experimental drug, dubbed DB-020, largely protected a small group of patients from losing their hearing. Researchers used a particularly unique study design, administering the compound in one of each patients’ ears before they received cisplatin chemotherapy and placebo in the other.

State bat­tles over mifepri­s­tone ac­cess could tie the FDA to any post-Roe cross­roads

As more than a dozen states are now readying so-called “trigger” laws to kick into effect immediate abortion bans following the overturning of Roe v. Wade on Friday, these laws, in the works for more than a decade in some states, will likely kick off even more legal battles as states seek to restrict the use of prescription drug-based abortions.

Since Friday’s SCOTUS opinion to overturn Americans’ constitutional right to an abortion after almost 50 years, reproductive rights lawyers at Planned Parenthood and other organizations have already challenged these trigger laws in Utah and Louisiana. According to the Guttmacher Institute, other states with trigger laws that could take effect include Arkansas, Idaho, Kentucky, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Wyoming.

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Ben Zimmer, Priovant CEO

Roivant un­veils lat­est spin­out as Pfiz­er en­trusts JAK1/TYK2 to Pri­o­vant

In November, Pfizer disclosed it’s spun out the Phase II dual JAK1/TYK2 inhibitor to a startup formed in collaboration with an unnamed, experienced partner.

We now know who the partner is. And as Pfizer and Roivant officially take the wraps off Priovant Therapeutics, the companies reveal that they have started two registrational trials of the drug, brepocitinib, as part of a broader plan to develop a big, first-in-class franchise spanning multiple orphan and specialty autoimmune diseases.

No stranger to gene ther­a­py woes, Astel­las runs in­to an­oth­er safe­ty-re­lat­ed clin­i­cal hold

Astellas Pharma, which has been at the forefront of uncovering the risks associated with gene therapies delivered by adeno-associated viruses, must take another safety alarm head-on.

The FDA has slapped a clinical hold on Astellas’ Phase I/II trial of a gene therapy candidate for late-onset Pompe disease, after investigators flagged a serious case of peripheral sensory neuropathy.

It marks the latest in a streak of setbacks Astellas has encountered since making a splashy entry into the gene therapy space with its $3 billion buyout of Audentes. But the lead program, AT132 for the treatment of X-linked myotubular myopathy (XLMTM), had to be halted more than once after a total of four patients died in the trial — and the scientific community still doesn’t have all the answers of what caused the deaths.

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Albert Bourla, Pfizer CEO (Gian Ehrenzeller/Keystone via AP Images)

Up­dat­ing the Covid-19 vac­cine: FDA of­fers a qual­i­fied thumbs-up ahead of ad­comm

The FDA’s adcomm of outside vaccine experts will meet tomorrow to discuss how to protect the US from a likely coming wave of Omicron cases in the fall and winter, and whether to deploy vaccines that specifically target the Omicron variant.

While the data so far are limited, the FDA sounded an upbeat tone in the briefing documents on Pfizer/BioNTech’s candidates, released this weekend ahead of the VRBPAC meeting.

Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.