Tak­ing on biode­fense threats, an­tibi­otics mak­er Spero inks $54M in gov­ern­ment deals

Cam­bridge, Mass­a­chu­setts start­up Spero Ther­a­peu­tics is join­ing forces with US de­fense or­ga­ni­za­tions to see if their in­ves­ti­ga­tion­al an­tibi­ot­ic could be use­ful against biode­fense threats.

To help find out, Spero was award­ed $15.7 mil­lion in fund­ing from the Bio­med­ical Ad­vanced Re­search and De­vel­op­ment Au­thor­i­ty, or BAR­DA, with po­ten­tial to see an ad­di­tion­al $28.5 mil­lion over the next 5 years.

Ankit Ma­hade­via

As part of an in­ter-agency col­lab­o­ra­tion, the US Army is step­ping up to test Spero’s an­tibi­ot­ic, SPR994, to see how it works against biode­fense threats like an­thrax, plague, and me­lioi­do­sis. Those stud­ies will be con­duct­ed by the US Army Med­ical Re­search In­sti­tute of In­fec­tious Dis­eases.

The De­fense Threat Re­duc­tion Agency is chip­ping in $1.25 mil­lion to fund non­clin­i­cal biode­fense as­pects of the col­lab­o­ra­tion, Spero says, with an ad­di­tion­al $8.75 mil­lion tied to mile­stones down the road.

“We are hon­ored to be the re­cip­i­ent of an award and to join BAR­DA and DTRA in this unique in­ter-agency col­lab­o­ra­tion,” said Ankit Ma­hade­via, CEO of Spero, in a state­ment. “We look for­ward to ad­vanc­ing SPR994 through clin­i­cal de­vel­op­ment for pub­lic and biode­fense use as we tar­get pub­lic health needs caused by emerg­ing drug-re­sis­tant in­fec­tions. We be­lieve the fund­ing is a val­i­da­tion of the clin­i­cal po­ten­tial of SPR994 across a broad treat­ment land­scape, and of the abil­i­ty of a small biotech com­pa­ny to work to­wards bring­ing these in­no­v­a­tive ther­a­pies to pa­tients in col­lab­o­ra­tion with our part­ners at BAR­DA and DTRA.”

The fund­ing from these gov­ern­ment deals will al­so sup­port Spero’s clin­i­cal tri­als of SPR994 for the treat­ment of com­pli­cat­ed uri­nary tract in­fec­tions, the com­pa­ny said.

SPR994 is Spero’s in­ves­ti­ga­tion­al oral for­mu­la­tion of tebipen­em, a car­bapen­em-class an­tibi­ot­ic mar­ket­ed by Mei­ji Sei­ka Phar­ma in Japan as Orapen­em since 2009 for com­mon pe­di­atric in­fec­tions. Spero plans to start a Phase III tri­al of SPR994 for the treat­ment of cU­TI around year-end 2018.

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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Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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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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Roche has terminated one of two Phase II trials testing its drug ralmitaront in patients with schizophrenia, the Big Pharma confirmed to Endpoints News.

The study was terminated last month, according to a June 22 update to the registry on clinicaltrials.gov. Begun in September 2020, the trial was looking at ralmitaront in patients with acute schizophrenia. The trial enrolled 286 patients out of an originally planned 308.

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Matt Gline, Roivant CEO (John Sciulli/Getty Images for GLG)

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Six programs from four of its “vants” are being wound down as part of “a company-wide cost optimization and pipeline reprioritization initiative to reduce our expected operating expenses and prioritize our capital resources.”

When reached by Endpoints News, a spokesperson said, “We don’t anticipate a material reduction in headcount but we will likely reassign some folks to higher value projects as part of winding down specific programs.”

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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

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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.

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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Years af­ter link­ing arms with Bris­tol My­ers and both Mer­cks, Sutro finds its lat­est part­ner in Tokyo

Astellas and Sutro Biopharma are linking arms on a new field of antibody-drug conjugates that they hope will improve upon existing cancer immunotherapies.

The Tokyo pharma will dole out $90 million in cash for the collaboration, the companies said Monday afternoon. That upfront payment will extend the South San Francisco biotech’s runway from late 2023 into the first half of 2024, Cowen analysts noted.

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.