News brief­ing: Mer­ck picks up SHP2 op­tion from Tai­ho-As­tex deal; Taysha ex­pands part­ner­ship with UT South­west­ern

Tai­ho and As­tex have ex­tend­ed their col­lab­o­ra­tion with Mer­ck, grant­i­ng the phar­ma an ex­clu­sive li­cense to their joint SHP2 pro­gram.

Wednes­day’s ex­ten­sion stems from the agree­ment the three com­pa­nies signed in Jan 2020. Tai­ho and As­tex will re­ceive an undis­closed op­tion fee and be el­i­gi­ble for fur­ther undis­closed mile­stones and roy­al­ty pay­ments. Mer­ck will be sole­ly re­spon­si­ble for the glob­al de­vel­op­ment of the pro­gram and fund­ing all fur­ther re­search.

How­ev­er, Tai­ho has re­tained co-com­mer­cial­iza­tion rights in Japan and an op­tion to pro­mote SHP2 prod­ucts in spe­cif­ic ar­eas of south­east Asia.

The col­lab­o­ra­tion fo­cus­es on the dis­cov­ery and de­vel­op­ment of small mol­e­cule in­hibitors against sev­er­al drug tar­gets, in­clud­ing the KRAS onco­gene.

SHP2 is a de­phos­pho­ry­lat­ing en­zyme, act­ing as a sig­nal­ing mol­e­cule that reg­u­lates var­i­ous cel­lu­lar process­es in­clud­ing pro­lif­er­a­tion and dif­fer­en­ti­a­tion. The mol­e­cule al­so helps reg­u­late the ac­ti­va­tion of the RAS sig­nal­ing path­way such as KRAS, the com­pa­nies say. — Max Gel­man

Taysha aims to ad­vance UT South­west­ern gene ther­a­pies to the clin­ic

Taysha Gene Ther­a­pies is ex­pand­ing a part­ner­ship to fur­ther ad­vance its cen­tral ner­vous sys­tem pro­grams.

The biotech will work with UT South­west­ern Med­ical Cen­ter to de­vel­op an in­no­va­tion fund to dis­cov­er and de­vel­op new gene ther­a­py can­di­dates for mono­genic dis­eases of the CNS. Their goal is to get UTSW’s ear­ly-stage can­di­dates in­to the clin­ic, and Taysha will have an ex­clu­sive op­tion on new pro­grams and IP aris­ing from the re­search agree­ment.

“We be­lieve that the com­bi­na­tion of UTSW’s trans­la­tion­al re­search ex­per­tise in gene ther­a­py and strong track record of in­no­va­tion and our ex­pe­ri­ence in drug de­vel­op­ment and GMP man­u­fac­tur­ing will cre­ate op­por­tu­ni­ties to reach more pa­tients,” Taysha CEO RA Ses­sion II said in a state­ment.

Thus far, the pair’s agree­ment has re­sult­ed in 18 prod­uct can­di­dates, in­clud­ing TSHA-101 in GM2 gan­gliosi­do­sis and TSHA-118 in CLN1. — Max Gel­man

Es­pe­ri­on in-li­cens­es oral PC­SK9 in­hibitor pro­gram

Es­pe­ri­on is shelling out $12.5 mil­lion in what it hopes can be the first oral PC­SK9 in­hibitor to reach the mar­ket.

The biotech in-li­censed the pro­gram from Serometrix in De­cem­ber, it an­nounced Wednes­day along with fourth-quar­ter re­sults from 2020. With the deal, Serometrix is able to re­ceive undis­closed mile­stone pay­ments, and Es­pe­ri­on ex­pects to pro­vide an up­date lat­er this year for tim­ing on an IND fil­ing.

No­tably, the pro­gram Es­pe­ri­on ac­quired tar­gets al­losteric in­hi­bi­tion of PC­SK9, mark­ing a dif­fer­ent mech­a­nism of ac­tion than pre­vi­ous ap­proach­es, chief de­vel­op­ment of­fi­cer Ash­ley Hall said in a state­ment. In par­al­lel, the com­pa­ny plans to pur­sue a fixed com­bi­na­tion drug prod­uct with be­mpe­doic acid, with some stud­ies show­ing an ad­di­tion­al 30% LDL-C low­er­ing on av­er­age com­pared to place­bo.

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.