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.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Cy­to­ki­net­ics’ ALS drug fails PhI­II, leav­ing the biotech with a sin­gle late-stage prospect

Cytokinetics’ candidate for the muscle disease amyotrophic lateral sclerosis, or ALS, failed a Phase III trial, the Bay Area biotech announced Friday morning.

At a second interim analysis of the trial, an independent review committee recommended that Cytokinetics discontinue its COURAGE-ALS trial for reldesemtiv, as it “found no evidence of effect” compared to placebo on the primary or key secondary endpoints.

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CHMP gives thumbs-up for We­govy use in ado­les­cents, along with nine new drug rec­om­men­da­tions

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended nine drugs for approval this week while also giving thumbs up for six expanded indications, including Novo Nordisk’s approved obesity medication Wegovy for younger people. Wegovy is already approved as an obesity treatment in the EU for adults, and the new indication would allow prescriptions for adolescents aged 12 and older.

Austin biotech Mol­e­c­u­lar Tem­plates lays off more than 100 staffers as pipeline nar­rows

Molecular Templates is ridding itself of a Phase I HER2 asset and fine-tuning its pipeline to focus on three programs and a preclinical Bristol Myers Squibb collaboration. With the narrowed scope on its so-called engineered toxin bodies, the Austin, TX biotech is laying off about half of its staff.

That’s a little more than 100 employees, per an SEC filing. Molecular’s layoffs, approved by its board Wednesday, add to the dozens of pullbacks in the industry in the first three months of 2023.

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Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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Sen­ate Fi­nance Com­mit­tee lobs more bi­par­ti­san pres­sure on­to PBMs

Congress is honing in on how it wants to overhaul the rules of the road for pharmacy benefit managers, with a Senate Finance Committee hearing Thursday serving as the latest example of the Hill’s readiness to make changes to how pharma middlemen operate.

While pledging to ensure patients and pharmacies “don’t get a raw deal,” Finance Committee Chair Ron Wyden (D-OR) laid out the beginning of what looks like a major bipartisan effort — moves the PBM industry is likely to challenge vigorously.

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Nicklas Westerholm, Egetis Therapeutics CEO

Ac­qui­si­tion talks on­go­ing for Swedish rare dis­ease biotech Egetis, shares up al­most 40%

Shares of the Sweden-based rare disease biotech Egetis Therapeutics skyrocketed on Thursday afternoon as the company said it’s engaged in “ongoing discussion” with external parties regarding a “potential acquisition.”

Egetis confirmed rumors with a statement on Thursday while noting that there is no certainty that a takeover offer will be made.

Nonetheless, the possibility of an acquisition has shot up Egetis’ share price. By the afternoon on Thursday, its stock price was {$EGTX.ST} up over 38%. An Egetis spokesperson told Endpoints News in an email that it has no further comments.

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Lu­pus drug de­vel­op­ment mar­ket heat­ing up, while FDA links with ad­vo­ca­cy group to fur­ther ac­cel­er­ate re­search

The long-underserved systemic lupus erythematosus (SLE) market is suddenly buzzing with treatment possibilities. Less than two years after AstraZeneca’s approval for Saphnelo — the first new SLE drug in a decade and joining just one other approved in GSK’s Benlysta – the pipeline of potential drugs numbers in the dozens.

Although most are very early stage — Spherix Global Insights estimates five in Phase II/III — the pharma R&D enthusiasm is catching on among doctors, patients and advocacy groups. On Wednesday, the Lupus Research Alliance and the FDA formed a novel private-public partnership called Lupus Accelerating Breakthroughs Consortium (Lupus ABC) to help advance lupus clinical trial success.

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Green­Light re­ceives buy­out of­fer; Apol­lomics com­pletes SPAC merg­er

RNA biotech GreenLight Biosciences has been handed an offer for potential acquisition.

GreenLight said in a release that it has received a non-binding “indication of interest” from Fall Line Endurance Fund to acquire GreenLight’s capital stock for $0.60 per share in cash. The release said any potential agreement between the two parties would depend on certain conditions.

Through a special committee, the biotech will evaluate the offer but added there’s no certainty a deal will go forward. GreenLight will also not make any more announcements until a deal comes through or “otherwise determines” a statement is necessary.