FDA sched­ules ad­comms for En­ta­sis' an­timi­cro­bial treat­ment, In­ter­cep­t's NASH hope­ful

The FDA this morn­ing an­nounced two up­com­ing ad­vi­so­ry com­mit­tee meet­ings in April and May — with the goal of re­view­ing two drugs with a lot of his­to­ry that have gone through mul­ti­ple set­backs.

Ac­cord­ing to no­tices pub­lished in the Fed­er­al Reg­is­ter, the FDA is con­ven­ing its An­timi­cro­bial Drugs Ad­vi­so­ry Com­mit­tee on April 17 to dis­cuss En­ta­sis Ther­a­peu­tics’ NDA for sul­bac­tam-dur­lobac­tam for the treat­ment of Acine­to­bac­ter in­fec­tions.

The biotech, spun out of As­traZeneca’s for­mer an­tibi­otics di­vi­sion in 2015, is gun­ning for the an­tibi­ot­ic to win ap­proval to treat in­fec­tions of Acine­to­bac­ter bau­man­nii-cal­coaceti­cus com­plex, in­clud­ing mul­tidrug-re­sis­tant and car­bapen­em-re­sis­tant strains. En­ta­sis’ NDA was ac­cept­ed back in No­vem­ber and grant­ed pri­or­i­ty re­view, with a PDU­FA date of May 29.

The drug is part of a deal with Zai Lab, a Shang­hai-based biotech with an ex­clu­sive de­vel­op­ment and com­mer­cial­iza­tion li­cense in more than a dozen coun­tries in the Asia-Pa­cif­ic re­gion, in­clud­ing Chi­na, Ko­rea, Japan, the Philip­pines and New Zealand.

The biotech was once pub­lic on Nas­daq be­fore be­ing picked up last year by backer In­no­vi­va, which bought out all the biotech’s shares at $2.20 apiece — tak­ing the com­pa­ny pri­vate back in May.

In­no­vi­va al­ready owned 60% of the com­pa­ny at the time of the deal.

The oth­er ad­comm, sched­uled for May 19, is gath­er­ing the FDA’s Gas­troin­testi­nal Drugs Ad­vi­so­ry Com­mit­tee to re­view In­ter­cept Phar­ma­ceu­ti­cals’ obeti­cholic acid to treat non­al­co­holic steato­hep­ati­tis (NASH).

In­ter­cept has had a rough his­to­ry push­ing this liv­er drug to mar­ket. In­ter­cept’s NDA, which was giv­en an ac­tion date of June 22, is the sec­ond at­tempt bring­ing this drug past reg­u­la­tors.

The FDA pre­vi­ous­ly re­ject­ed obeti­cholic acid in 2020 af­ter the agency be­came un­cer­tain — per In­ter­cept at the time — if the sur­ro­gate end­point, re­duc­tion in liv­er fi­bro­sis, from a Phase III tri­al would trans­late in­to clin­i­cal ben­e­fit.

The drug de­vel­op­er, af­ter re­port­ing a Phase III fail back in Sep­tem­ber 2022, high­light­ed in­ter­im analy­ses from a piv­otal Phase III study, in­clud­ing one where pa­tients on 25 mg of the drug saw “dou­ble the re­sponse rate of place­bo in re­duc­tion in liv­er fi­bro­sis stage with­out wors­en­ing of any of the three his­to­log­ic com­po­nents of NASH,” the biotech said back in Jan­u­ary, call­ing the end­point in line with FDA guid­ance.

In­ter­cept CEO Jer­ry Dur­so said in a state­ment Fri­day, “We look for­ward to the op­por­tu­ni­ty to dis­cuss with the Ad­vi­so­ry Com­mit­tee our clin­i­cal tri­al da­ta.”

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.

Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

Editor’s note: This is a live story and will be updated.

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

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Feng Zhang (Susan Walsh/AP Images)

In search of new way to de­liv­er gene ed­i­tors, CRISPR pi­o­neer turns to mol­e­c­u­lar sy­ringes

Bug bacteria are ruthless.

Some soil bacteria have evolved tiny, but deadly injection systems that attach to insect cells, perforate them and release toxins inside — killing a bug in just a few days’ time. Scientists, on the other hand, want to leverage that system to deliver medicines.

In a paper published Wednesday in Nature, MIT CRISPR researcher Feng Zhang and his lab describe how they engineered these syringes made by bacteria to deliver potential therapies like toxins that kill cancer cells and gene editors. With the help of an AI program, they developed syringes that can load proteins of their choice and selectively target human cells.

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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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See­los Ther­a­peu­tics 'tem­porar­i­ly' stops study in rare neu­ro dis­or­der for busi­ness rea­sons

Microcap biotech Seelos Therapeutics is halting enrollment of its study in spinocerebellar ataxia type 3 (also known as Machado-Joseph disease) because of “financial considerations,” and in order to focus on other studies, the company said today, adding that the pause would be temporary.

The study will continue with the patients who have already enrolled, and the data from them will be used to decide whether to continue enrolling others in the future.

Alec­tor cuts 11% of work­force as it dou­bles down on late-stage neu­ro pro­grams part­nered with GSK, Ab­b­Vie

A month after revealing plans to concentrate on its late-stage immuno-neurology pipeline, Alector is trimming its headcount by 11%.

The layoffs will impact around 30 employees across the organization, the company disclosed in an SEC filing, adding that the plan will “better align the company’s resources” with the new strategy. With $712.9 million in cash, cash equivalents and investments as of the end of 2022, Alector believes the reserves will now get it through 2025.

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Hugo Peris, Spiral Therapeutics CEO

Hear­ing-fo­cused biotech grabs trio of pro­grams from Oton­o­my's fire sale

Otonomy may be shutting down, but the lessons learned there will live on at another biotech working on new treatments for hearing loss.

San Francisco-based Spiral Therapeutics has bought certain assets related to three of Otonomy’s programs, ranging from data, patent rights, and know-how to inventory. That includes data around Otonomy’s twice-failed lead program, OTO-104 (Otividex), a sustained-exposure formulation of dexamethasone.

FDA ap­proves Nar­can opi­oid over­dose re­ver­sal spray for over-the-counter sale

The FDA today approved Emergent BioSolutions’ Narcan brand naloxone nasal spray for over-the-counter sales. The nod was expected and comes on the heels of a unanimous 19-0 advisory committee vote in favor of approval last month.

The move to OTC means the opioid overdose reversal agent will now be available on grocery, convenience and gas stations shelves, as well as potentially for purchase online.

CSL CEO Paul McKenzie (L) and CMO Bill Mezzanotte

Q&A: New­ly-mint­ed CSL chief ex­ec­u­tive Paul McKen­zie and chief med­ical of­fi­cer Bill Mez­zan­otte

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.