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

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

The End­points 11: They've got mad mon­ey and huge am­bi­tions. It's time to go big or go home

These days, selecting a group of private biotechs for the Endpoints 11 spotlight begins with a sprint to get ahead of IPOs and the M&A teams at Big Pharma. I’ve had a couple of faceplants earlier this year, watching some of the biotechs on my short list choose a quick leap onto Nasdaq or into the arms of a buyer.

Vividion, you would have been a great pick for the Endpoints 11. I’m sorry I missed you.

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Dave Lennon, former president of Novartis Gene Therapies

So what hap­pened with No­var­tis Gene Ther­a­pies? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

FDA au­tho­rizes Pfiz­er's vac­cine boost­er for se­niors, those at high risk for se­vere Covid-19

The Biden administration’s goal of kicking off its booster shot drive for the entire US population this week is not quite going as planned.

First, Pfizer applied for approval of a supplemental application for the booster shots, but since last Friday’s adcomm reviewing them, the plan has devolved into an EUA, which the FDA issued late Thursday evening.

The population that is now eligible for the booster, six months after receiving the first pair of Pfizer-BioNTech vaccines, also narrowed from what Pfizer applied for (everyone who’s eligible for the initial Pfizer shots) to just those who are 65 or older, or at high-risk of a Covid infection, including health care workers and others with occupational hazards.

Stéphane Bancel, AP Images

Fi­nal analy­sis of US-fund­ed Mod­er­na Covid vac­cine tri­al shows 98% ef­fi­ca­cy against se­vere dis­ease

A final look at the results of the placebo-controlled Moderna trial in the New England Journal of Medicine, published Thursday afternoon, shows how the vaccine continues to prevent Covid-19 and severe cases after more than five months following the second shot.

Of the more than 30,000 enrolled in the trial that ultimately led to the vaccine’s EUA, only two people in the vaccine group got a severe form of the disease, compared to 106 in the placebo group — leading to an efficacy of 98%.

Emma Walmsley, GlaxoSmithKline CEO (Credit: Fang Zhe/Xinhua/Alamy Live News)

The fire un­der Glax­o­SmithK­line's Em­ma Walm­s­ley grows as an­oth­er well-known ac­tivist in­vestor grabs its pitch­fork — re­port

Bluebell Capital Partners, a proxy brawler fresh off a campaign to oust global food giant Danone’s CEO and most of its board of directors, has bought a stake in UK drugmaker GlaxoSmithKline with its eyes trained directly on Emma Walmsley, the Financial Times reported Wednesday.

The London-based hedge fund joins another notorious activist firm in Paul Singer’s Elliott Management, which earlier this year called for a shakeup in leadership at GSK to handle what the company described as a wealth of riches across the drug giant’s portfolio hindered by limited vision from top staff.

Blue­bird sends blood dis­or­der drug to FDA for ap­proval; CG On­col­o­gy en­ters col­lab­o­ra­tion with Roche for Tecen­triq

Bluebird bio announced it completed the rolling submission of its BLA to the FDA for betibeglogene autotemcel gene therapy.

The therapy, designed for patients with beta-thalassemia who require regular red blood cell transfusions, was previously granted breakthrough therapy designation for treating transfusion-dependent beta-thalassemia (TDT). If approved, beti-cel will be the first hematopoietic stem cell ex-vivo gene therapy for patients in the US.

FDA+ roundup: Bs­U­FA III ready for show­time, court tells FDA to re-work com­pound­ing plan, new guid­ance up­dates and more

The FDA has now spelled out what exactly will be included in the third iteration of Biosimilar User Fee Act (BsUFA) from 2023 through 2027, which similarly to the prescription drug deal, sets fees that industry has to pay for submitting applications, in exchange for firm timelines that the agency must meet.

This latest deal includes several sweeteners for the biosimilar industry, which has yet to make great strides in the US market, with shorter review timelines for safety labeling updates and updates to add or remove an indication that does not contain efficacy data.

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