Blue­print maps plans for $150M raise; Glax­o­SmithK­line cre­ates dis­cov­ery pact with Warp Dri­ve

Blue­print Med­i­cines $BPMC has filed to raise $150 mil­lion in a new stock of­fer­ing. Most of the new mon­ey is be­ing ear­marked for up­com­ing clin­i­cal tri­als of its pipeline drugs. And the com­pa­ny says it will add to the $268 mil­lion al­ready in re­serves at the end of 2016, stretch­ing its run­way to the mid­dle of 2019.

→ Cam­bridge, MA-based Warp Dri­ve Bio has set up a dis­cov­ery deal with Glax­o­SmithK­line, cre­at­ing a cus­tom DNA-tagged SMART li­brary that GSK will build and screen against a set of ‘un­drug­gable’ tar­gets re­lat­ed to dis­eases of high un­met med­ical need. Among the Warp Dri­ve tar­gets are RAS, SHP2 and Cbl-b. “This unique col­lab­o­ra­tion with GSK of­fers an in­valu­able op­por­tu­ni­ty to com­bine two pow­er­ful plat­forms to cre­ate an un­prece­dent­ed li­brary of up to 200 mil­lion di­verse SMART com­pounds for the dis­cov­ery of lead chem­i­cal mat­ter against a set of cur­rent­ly-in­ac­ces­si­ble tar­gets,” said Alan Rig­by, Ph.D., chief sci­en­tif­ic of­fi­cer of Warp Dri­ve Bio.

→ There’s been a change at the helm of the em­bat­tled De­pomed. The com­pa­ny, un­der as­sault by an ac­tivist in­vestor, says CEO James Schoe­neck is out, re­placed by ex-Bay­er CEO Arthur Hig­gins. The switch comes with a shake­up of the board. Gavin Mo­linel­li, part­ner of Star­board, who’s been push­ing for change, says he’s sat­is­fied with the re­or­ga­ni­za­tion.

Acor­da says it’s mak­ing good progress with long-term safe­ty stud­ies of its Parkin­son’s drug CVT-301. “We are de­light­ed with these re­sults, and plan to move for­ward with our NDA fil­ing for CVT-301. These two stud­ies, which in­clude ap­prox­i­mate­ly 700 par­tic­i­pants, rep­re­sent the largest safe­ty data­base eval­u­at­ing long-term pul­monary func­tion in peo­ple with Parkin­son’s,” said Burkhard Blank, the CMO at Acor­da.

→ Ko­rea’s Sam­sung Bi­o­Log­ics has blitzed its way to a lead­ing spot in the emerg­ing biosim­i­lars mar­ket. And it’s been build­ing up its man­u­fac­tur­ing mus­cle with its pipeline. Now a top ex­ec says the com­pa­ny is look­ing to Eu­rope or the US for the site of its next big man­u­fac­tur­ing site.

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.

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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Stéphane Bancel, Moderna CEO (AP Photo/Markus Schreiber)

Mod­er­na so­lid­i­fies deal with Kenya to build mR­NA man­u­fac­tur­ing fa­cil­i­ty

The mRNA player Moderna is further cementing its presence on the African continent.

Moderna announced on Thursday that it has finalized an agreement with Kenya’s government to partner up and bring an mRNA manufacturing facility to the east African nation. The new facility aims to manufacture up to 500 million doses of vaccines annually. Moderna also said the new facility will have the ability to spike its production capabilities to respond to public health emergencies on the continent or globally.

FDA grants full ap­proval to Keytru­da in tu­mor-ag­nos­tic set­ting; Can­del paus­es tri­al en­roll­ment

In a first, Merck has secured a full approval for Keytruda in a tumor agnostic setting — as a treatment for any unresectable or metastatic solid tumors that are classified as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).

The FDA granted Keytruda accelerated approval in this indication in 2017, and GSK’s Jemperli followed suit in 2021. But now it’s converted to a full approval for Keytruda. Before prescribing, doctors would have to make sure patients carry this biomarker, using an FDA-approved test.

Luke Miels, GSK chief commercial officer

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

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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Deborah Waterhouse, ViiV Healthcare CEO

MPP re­cruits three gener­ic man­u­fac­tur­ers to ex­pand use of Vi­iV's in­jectable PrEP drug

ViiV Healthcare has teamed up with the UN-backed Medicines Patent Pool and three generic manufacturers to expand access to medicine that can prevent HIV.

ViiV and the Medicines Patent Pool jointly announced Thursday that the MPP signed sub-licensing agreements with Aurobindo, Cipla and Viatris to manufacture generics of a long-acting form of cabotegravir for HIV pre-exposure prophylaxis (PrEP). As a result of the agreement, the manufacturers will be able to develop, manufacture and supply generic versions of cabotegravir LA in 90 countries — subject to regulatory approvals.