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

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

David Baker working with a student on their protein design (Jason Mast)

Sci­en­tists are fi­nal­ly learn­ing how to de­sign pro­teins from scratch. Drug de­vel­op­ment may nev­er be the same

SEATTLE — It’s a cloudy Thursday afternoon in mid-July and David Baker is reclining into the futon in his corner office at the University of Washington, arms splayed out like a daytime talk show host as he coaches another one of his postdocs through the slings and arrows of scientific celebrity.

“Be jealous of your time,” he says, before plotting ways of sneaking her out of Zooms. “It’s this horrible cost to science that you’re tied up in some stupid meeting.”

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Pre­sent­ing a live End­points News event: Man­ag­ing a biotech in tur­bu­lent times

Biotech is one of the smartest, best educated industries on the planet. PhDs abound. We’ve had a long enough track record to see a new generation of savvy, experienced execs coming together to run startups.

And in these times, they are being tested as never before.

Biotech is going through quite a rough patch right now. For 2 years, practically anyone with a decent resume and some half-baked ideas on biotech could start a company and get it funded. The pandemic made it easy in many ways to pull off an IPO, with traditional road shows shut down in exchange for a series of quick Zoom meetings. Generalist investors flocked as the numbers raised soared into the stratosphere.

Patty Murray, D-WA (Graeme Sloan/Sipa USA)(Sipa via AP Images)

Sen­ate user fee reau­tho­riza­tion bill omits ac­cel­er­at­ed ap­proval re­forms, shows wide gaps with House ver­sion

The Senate health committee on Tuesday released its first version of the bill to reauthorize all the different FDA user fees. But unlike the House version, there are only a few controversial items in the Senate’s version, which does not address either accelerated approval reforms or clinical trial diversity (as the House did).

While it’s still relatively early in the process of finalizing this legislation (the ultimate statutory deadline is the end of September), the House and Senate, at least initially, appear to be starting off in different corners on what should be included.

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Warren Buffett, Berkshire Hathaway CEO

Berk­shire Hath­away pulls out of Ab­b­Vie, Bris­tol My­ers Squibb in­vest­ments

It looks like Warren Buffett is sticking to ice cream and railroads for the moment.

The billionaire CEO of Berkshire Hathaway backed out of two major holdings in the pharma industry, Forexlive first reported, including a $410 million investment in AbbVie and a $324.4 million stake in Bristol Myers Squibb.

The move comes after Berkshire abandoned its Teva shares just last quarter, Bloomberg reported.

Clay Siegall (Photo by Dimitrios Kambouris/Getty Images for Gabrielle's Angel Foundation)

UP­DAT­ED: Clay Sie­gall re­signs from Seagen amid in­ves­ti­ga­tion in­to do­mes­tic vi­o­lence claims

A week after Seagen revealed that longtime CEO Clay Siegall was on leave due to an allegation of domestic violence, he has resigned.

Since that shocking revelation, more details about the claims have emerged into the public eye. As Endpoints News reported, Siegall was arrested on April 23. A police report about that night and a subsequent temporary restraining order described a pattern of abusive behavior against his wife and a physical altercation that left her with multiple bruises. Siegall denied the claims.

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Long-ex­pect­ed UK lay­offs im­mi­nent for No­var­tis fol­low­ing sale

Nearly a year ago, more than 200 workers at Novartis’ Grimsby, UK, facility were able to hang on to their jobs after the pharma closed a Switzerland site as a part of its workforce restructuring plan. Now, it looks like those employees’ time is up, as the site has been sold, Grimsby Telegraph reported today.

The manufacturing site has been sold to Humber Industrials, a subsidiary of International Process Plants. None of the current staff members will be working with the new owners, however.

FDA lob­bies Con­gress over rare dis­ease court rul­ing with wide im­pli­ca­tions

Usually reserved for making decisions on drug applications or enforcing what Congress stipulates, the FDA is now dipping its toe into the wild world of congressional politics as it attempts to fix a major court decision that could have a chilling effect on rare disease R&D.

The case in question from last October saw a US appeals court overturn a prior FDA court win, saying that the agency never should’ve approved a rare disease drug because a previously approved but more expensive drug with the same active ingredient has orphan drug exclusivity barring such an approval.

Peter Marks (Greg Nash/Pool via AP)

Even FDA's Pe­ter Marks is wor­ried about the com­mer­cial vi­a­bil­i­ty of gene and cell ther­a­pies

When bluebird bio’s gene therapy to treat beta thalassemia won European approval in 2019, the nearly $2 million per patient price tag for the potential cure seemed like a surmountable hurdle.

Fast forward two years later, and bluebird has withdrawn Zynteglo, the beta thal drug, along with the rest of its gene therapy portfolio from Europe, which the company said is generally unwilling to pay a fair price for the treatment.