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

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Janet Woodcock (AP Images)

End­points poll: Janet Wood­cock takes the (in­ter­im) helm at the FDA. And a large ma­jor­i­ty of our read­ers want her to stay there

It’s official: Janet Woodcock is now the acting chief of the FDA.

And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed.

To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come.

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What’s next for End­points — and how to sup­port our in­de­pen­dent bio­phar­ma news mis­sion

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

Eli Lil­ly's an­ti­body cuts risk of Covid-19 by up to 80% among the most vul­ner­a­ble — but will it have a place next to vac­cines?

Eli Lilly says bamlanivimab lowered the risk of contracting symptomatic Covid-19 in a first-of-its-kind trial involving nursing home residents and staff, paving the way for a new option to protect against the virus.

But how big of an impact it might have, and what role it will play, at a time vaccines are being rolled out to the exact population it is targeting still remains unclear.

Among 965 participants in the study — all of whom tested negative for the coronavirus at baseline — the number of symptomatic cases reported in the bamlanivimab arm was 57% lower than that in the placebo arm (odds ratio 0.43, p=0.00021). In addition to that primary endpoint, all secondary endpoints reached statistical significance.

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Michelle McMurry-Heath, BIO CEO (BIO via YouTube)

BIO looks to re­struc­ture, lay­ing off staff amid chal­lenge to the trade org's nor­mal face-to-face style

The biopharma industry, on the whole, had a red-letter year in 2020 amid Covid-19, with fundraising at an all-time high and major players speeding vaccines ahead to approval. But for BIO, the industry’s leading trade organization, the pandemic has prompted a reconsideration of the game plan.

BIO will pivot to digital as the Covid-19 pandemic continues to rage, making “some staff reductions” as it looks to bring its roughly 37,000 in-person meetings each year to the web, the organization said Thursday.

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Hal Barron, GSK R&D chief (GSK via YouTube)

Glax­o­SmithK­line's $4B bis­pe­cif­ic can­cer drug al­liance with Mer­ck KGaA hit by big set­back with a PhI­II fail­ure on NSCLC

Close to 2 years ago, GSK’s R&D team eagerly agreed to pay up to $4 billion-plus to ally itself with Merck KGaA on a mid-stage bispecific called bintrafusp alfa, which intrigued them with the combination of a TGF-β trap with the anti-PD-L1 mechanism in one fusion protein.

But today the German pharma company says that their lead study on lung cancer was a bust, as independent monitors said there was no reason to believe that the experimental drug — targeting PD-L1/TGF-Beta — could beat Keytruda.

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Covid-19 roundup: Italy won­ders aloud if it can sue Pfiz­er for vac­cine short­falls; Flood, dead­ly fire threat­en As­traZeneca vac­cine plants

As reports crop up that deliveries of Pfizer and BioNTech’s Covid-19 vaccine are being unexpectedly cut, Italy wonders if it can take the vaccine developers to court, according to the Wall Street Journal. 

After its shipment for this week was cut by 29%, the Italian government consulted its attorney general about taking legal action, the WSJ reported. Pfizer and BioNTech had warned the EU and Canada last week that their allocations would be reduced as Pfizer upgrades its Belgium factory. What Italy says it doesn’t appreciate, though, is the short notice.

Mike Grey, Plexium chairman (Horizon Therapeutics)

Plex­i­um adds in­dus­try vet Mike Grey to the brain trust with new in­vestor cash fund­ing its pro­tein degra­da­tion play

About 15 months since closing a $28 million Series A, a San Diego protein-degradation upstart returned to the venture well Thursday with an extension of that round and some new hires, including one of the city’s best-connected biotech execs.

Plexium has bagged an additional $35 million in financing, the biotech said, money that will push undisclosed oncology and immuno-oncology programs into the clinic. In addition, longtime industry vet Mike Grey is jumping on as chairman of the board, and two others from Thursday’s leads — Adam Goulburn from Lux Capital and Rob Hopfner from Pivotal BioVentures — joined the board too.

With patent con­cerns loom­ing, Roche gets a new pri­or­i­ty re­view on block­buster IPF drug

Seven years after the FDA first approved Esbriet, the blockbuster Roche IPF drug is getting an expedited review for a second indication.

On Thursday, the agency gave Esbriet priority review for unclassified interstitial lung diseases, or forms of pulmonary inflammation and scarring that don’t fit easily into the over 200 known types of ILD. The move comes 10 months after Esbriet received breakthrough designation and sets Roche up for a decision by May.