News brief­ing: Small merg­er to ad­vance an­ti-ag­ing pro­gram; Sanger In­sti­tute spin­out nabs $50M from Se­ries C

Small-cap play­er Ak­ers Bio­sciences $AK­ER has en­gi­neered a re­verse merg­er with pri­vate com­pa­ny MyMD Phar­ma­ceu­ti­cals.

The new com­bined biotech, which will re­tain the name MyMD, is ex­pect­ed to trade un­der the new tick­er $MYMD once the trans­ac­tion clos­es. MyMD will ob­tain an 80% stake in Ak­ers, and the deal comes with an $18 mil­lion pri­vate place­ment that val­ues the Ak­ers at $1.85 per share, a rough­ly 7.5% pre­mi­um above Wednes­day’s clos­ing price.

MyMD is aim­ing to fo­cus on its MYMD-1 pro­gram, a syn­thet­ic plant al­ka­loid be­ing de­vel­oped to treat au­toim­mune and age-re­lat­ed dis­eases, in­clud­ing ag­ing it­self. The com­pa­ny claims the ex­per­i­men­tal drug is the first oral small mol­e­cule reg­u­la­tor of tu­mor necro­sis fac­tor al­pha ca­pa­ble of cross­ing the blood-brain bar­ri­er.

Two Phase II tri­als for the pro­gram are ex­pect­ed to be­gin some­time in the first quar­ter of 2021, and MyMD seeks to con­tin­ue launch­ing oth­er Phase II stud­ies through­out the year.

MyMD is al­so work­ing on its SU­PERA-1R plat­form, which based on a syn­thet­ic de­riv­a­tive of CBD that seeks to tar­get key cannabi­noid re­cep­tors. The com­pa­ny hopes to ad­dress anx­i­ety, chron­ic pain and seizures and is ex­pect­ed to be­gin hu­man tri­als as a ther­a­py for epilep­sy, fol­lowed by chron­ic pain. — Max Gel­man

Sanger In­sti­tute spin­out gets a $50M Se­ries C

When a hand­ful of en­tre­pre­neurs and sci­en­tists de­cid­ed to spin a ge­nomics start­up out of the Well­come Trust Sanger In­sti­tute, they had a plat­form that ad­vanced pro­gram­mers could use and rough­ly no one else.

In the six years since, said Con­geni­ca CEO David Atkins, they’ve de­vel­oped soft­ware vir­tu­al­ly any spe­cial­ists can use to quick­ly di­ag­nose rare and ul­tra-rare dis­eases and drug de­vel­op­ers can use to spot con­nec­tions be­tween dif­fer­ent genes and dif­fer­ent symp­toms. And now, for the first time, they’ve got a sig­nif­i­cant amount of cash to ex­pand.

Con­geni­ca an­nounced Mon­day a $50 mil­lion Se­ries C led by Ten­cent and Le­gal Gen­er­al, more than dou­bling the amount they cash raised to date. They’ll use the mon­ey to ex­pand in­to di­ag­nos­tics for can­cer  — quick­ly find­ing genes for tar­get­ed ther­a­pies — and gen­er­al well­ness, while al­so con­tin­u­ing their of­fer on rare dis­ease. So far, they’ve reached clients in 18 dif­fer­ent coun­tries.

“When it came out of Sanger, it was a very ad­vanced re­search soft­ware pro­gram: the pro­gram­mers could run it but you couldn’t give it to a third par­ty,” Atkins told End­points News. “It’s come a long way.” —Ja­son Mast

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.