Pro­men­tis rais­es $26M for glu­ta­mater­gic drug R&D; CARB-X of­fers up to $48M for fight­ing drug-re­sis­tant bac­te­ria

→  Mil­wau­kee-based Pro­men­tis Phar­ma­ceu­ti­cals has raised $26 mil­lion in a C round. Or­biMed, F-Prime Cap­i­tal Part­ners (for­mer­ly Fi­deli­ty Bio­sciences) and Ais­ling Cap­i­tal led the round. Ex­ist­ing in­vestors, in­clud­ing Black Pearl GmbH, the Gold­en An­gel Net­work and in­di­vid­ual in­vestors, al­so par­tic­i­pat­ed. The biotech is push­ing SXC-2023 — a small mol­e­cule de­signed to en­gage Sys­tem Xc-, a CNS tar­get ad­dress­ing glu­ta­mater­gic dys­func­tion and ox­ida­tive stress — in­to Phase II. The biotech has raised a to­tal of $31 mil­lion.

Robert H. Ring

→  The Com­bat­ing An­tibi­ot­ic Re­sis­tant Bac­te­ria Bio­phar­ma­ceu­ti­cal Ac­cel­er­a­tor, or CARB-X, in­vest­ed $24 mil­lion up­front and promised up to $24 mil­lion in mile­stones to help fu­el work at 11 biotech com­pa­nies and re­search teams in the US and UK on an­tibi­otics and di­ag­nos­tics need­ed to fight the grow­ing threat of drug-re­sis­tant bac­te­ria.

→  Robert H. Ring has been named CEO of Vencerx Ther­a­peu­tics, a New York-based biotech which is work­ing on neu­rode­vel­op­ment dis­or­ders like Frag­ile X. Ring was most re­cent­ly the CSO at Autism Speaks. Be­fore that he head­ed the autism unit at Pfiz­er.

→  Chi­na’s WuXi AppTec had filed for an IPO. Here’s the one and on­ly re­lease, but it’s in Chi­nese.

→  Ca­lyp­so Biotech, which launched out of the ash­es of the old Serono or­ga­ni­za­tion in Gene­va, has out-li­censed an an­ti-MMP-9 ful­ly hu­man mon­o­clon­al an­ti­body to EA Phar­ma, with plans to study it in a col­lab­o­ra­tion for in­flam­ma­to­ry bow­el dis­or­der. “This agree­ment high­lights the strong po­ten­tial for CALY-001, which pos­sess­es a unique mode of ac­tion through bind­ing and in­hibit­ing ac­tive MMP-9“ says Alain Vic­ari, CEO of Ca­lyp­so Biotech. “By team­ing with EA Phar­ma, a leader in gas­troin­testi­nal dis­eases with full val­ue chain, we will ful­fill our vi­sion to bring new ther­a­peu­tics to pa­tients suf­fer­ing from se­vere gas­troin­testi­nal dis­eases. Be­yond IBD, CALY-001 rep­re­sents a promis­ing and ad­van­ta­geous ther­a­peu­tic op­tion for sev­er­al on­col­o­gy, in­flam­ma­tion and fi­bro­sis in­di­ca­tions”.

Inside FDA HQ (File photo)

The FDA just ap­proved the third Duchenne MD drug. And reg­u­la­tors still don’t know if any of them work

Last year Sarepta hit center stage with the FDA’s controversial reversal of its CRL for the company’s second Duchenne muscular dystrophy drug — after the biotech was ambushed by agency insiders ready to reject a second pitch based on the same disease biomarker used for the first approval for eteplirsen, without actual data on the efficacy of the drug.

On Wednesday the FDA approved the third Duchenne MD drug, based on the same biomarker. And regulators were ready to act yet again despite the lack of efficacy data.

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FDA ap­proves the third NSOMD drug in 18 months as Roche/Genen­tech beefs up its port­fo­lio of drugs for neu­ro­log­i­cal dis­or­ders

There were no FDA approved treatments for neuromyelitis optica spectrum disorder at the start of 2019. Now, as of Friday, there are three.

The latest entrant to the market is the Roche/Genentech drug satralizumab after US regulators gave it the thumbs up late Friday. An IL-6 inhibitor, the drug joins Alexion’s Soliris and AstraZeneca spinout Viela Bio’s Uplizna. The annual cost of satralizumab — which will hit the market as Enspryng — will be $190,000 for 13 doses, a Genentech spokesperson said, though the first year of treatment requires 15 doses and cost about $220,000.

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Franz-Werner Haas, CureVac CEO

UP­DAT­ED: On the heels of a snap $1B raise, Cure­Vac out­lines plans to seek emer­gency OK for Covid-19 vac­cine -- shares rock­et up

CureVac is going from being one of the quietest players in the race to develop a new vaccine to fight the worst public health crisis in a century to a challenger for the multibillion-dollar market that awaits the first vaccines to make it over the finish line. Typically low-key at a time of brash comments and incredibly ambitious development timelines from the leaders, CureVac now is jumping straight into the spotlight.

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US gov­ern­ment re­port­ed­ly be­gins prepar­ing for Covid-19 chal­lenge tri­als. Are they eth­i­cal?

Controversial human challenge trials for potential Covid-19 vaccines reportedly have a new booster — the US government.

Scientists working for the government have begun manufacturing a strain of the novel coronavirus that could be used in such studies, Reuters reported Friday morning. The trials would enroll healthy volunteers to be vaccinated and then intentionally infected with a weakened coronavirus.

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Stéphane Bancel speaks to President Donald Trump at the White House meeting on March 2 (AP Images)

UP­DAT­ED: Mod­er­na of­fers steep dis­count in US sup­ply deal — but still takes the crown with close to $2.5B in vac­cine con­tracts

The US pre-order for Moderna’s Covid-19 vaccine is in.

Operation Warp Speed is reserving $1.525 billion for 100 million doses of Moderna’s Phase III mRNA candidate, rounding out to about $15 per dose — including $300 million in incentive payments for timely delivery. Given that Moderna has a two-dose regimen, it’s good for vaccinating 50 million people. The US government also has the option to purchase another 400 million doses for a total of $6.6 billion, or $16.5 per dose.

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Sanofi vet Kather­ine Bowdish named CEO of PIC Ther­a­peu­tics; As the world Terns: Liv­er dis­ease biotech makes ex­ec­u­tive changes

PIC Therapeutics hasn’t raised much money, yet. But the fledgling biotech has attracted a high-profile player to the helm.

The Boston-based biotech has handed the reins to Katherine Bowdish as its president and CEO. Bowdish will also join the board of directors of PIC. Bowdish joins from Sanofi where she served as VP and head of R&D strategy, as well as helping launch and lead Sanofi Sunrise, a venture investment and partnering vehicle at Sanofi. Before that, Bowdish held several exec roles at Permeon Biologics, Anaphore, Alexion Pharmaceuticals and Prolifaron (acquired by Alexion).

Cal­lid­i­tas bets up to $102M on a biotech buy­out, snag­ging a once-failed PBC drug

After spending years developing its oral formulation of the corticosteroid budesonide, Sweden’s Calliditas now has its sights set on the primary biliary cholangitis field.

The company will buy out France-based Genkyotex, and it’s willing to bet up to €87 million ($102 million) that Genkyotex’s failed Phase II drug, GKT831, will do better in late-stage trials.

Under the current agreement, Calliditas $CALT will initially pay €20.3 million in cash for 62.7% of Genkyotex (or €2.80 a piece for 7,236,515 shares) in early October, then circle back for the rest of Genkyotex’s shares under the same terms. If nothing changes, the whole buyout will cost Calliditas €32.3 million, plus up to  €55 million in contingent rights.

Qi­a­gen in­vestors spurn Ther­mo Fish­er’s takeover of­fer, de­rail­ing a $12B+ deal

Thermo Fisher Scientific had announced an $11.5 billion takeover of Dutch diagnostics company Qiagen back in March, but the deal apparently did not sit well with Qiagen investors.

After getting hammered by critics who contended that Qiagen $QGEN was worth a lot more than what Thermo Fisher wanted to spend, investors turned thumbs down on the offer — derailing the buyout even after Thermo Fisher increased its offer to $12.6 billion in July. Qiagen’s share price has been boosted considerably by Covid-19 as demand for its testing kits surged.

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A lab technician works during research on coronavirus at Johnson & Johnson subsidiary Janssen Pharmaceutical in Beerse, Belgium, Wednesday, June 17, 2020. (Virginia Mayo/AP Images)

UP­DAT­ED: End­points News ranks all 28 play­ers in the Covid-19 vac­cine race. Here's how it stacks up to­day

(This piece was last updated on August 14. Endpoints News will continue to track the latest developments through the FDA’s marketing decisions.)

The 28 players now in or close to the clinical race to get a Covid-19 vaccine over the finish line are angling for a piece of a multibillion-dollar market. And being first — or among the leaders — will play a big role in determining just how big a piece.

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