Drag­on­fly gets Mer­ck on sec­ond TriN­KET can­di­date since 2018 col­lab; Chi­nese eye gene ther­a­py de­vel­op­er nabs $60M

Drag­on­fly Ther­a­peu­tics is do­ing bet­ter and bet­ter in get­ting Big Phar­ma on its TriN­KET plat­form. First Cel­gene, then BMS, and now Mer­ck — again.

Af­ter Mer­ck li­censed its first can­di­date from the plat­form back in No­vem­ber 2020, the phar­ma gi­ant is back for sec­onds as part of a 2018 col­lab­o­ra­tion be­tween the two com­pa­nies, which was ini­tial­ly fo­cused on a num­ber of sol­id tu­mor tar­gets.

The com­pa­nies ex­pand­ed their col­lab­o­ra­tion last year with an agree­ment to de­vel­op and com­mer­cial­ize NK cell en­gag­ing im­munother­a­pies for mul­ti­ple tar­gets in on­col­o­gy, in­fec­tious dis­eases and im­mune dis­or­ders.

“We are de­light­ed that Mer­ck has now ex­er­cised its op­tion for this sec­ond im­munother­a­py can­di­date from our ini­tial col­lab­o­ra­tion, and ex­cit­ed by the progress we are mak­ing to­geth­er on bring­ing Drag­on­fly’s TriN­KET tech­nol­o­gy to tar­gets across a broad­er set of dis­eases,” said Drag­on­fly’s CEO Bill Haney.

Mer­ck ex­er­cised its op­tion to li­cense ex­clu­sive world­wide in­tel­lec­tu­al prop­er­ty rights on its sec­ond im­munother­a­py can­di­date de­vel­oped us­ing the TriN­KET plat­form, un­der a pre-ex­ist­ing agree­ment. As for Drag­on­fly, it re­ceived an pay­ment from Mer­ck at an undis­closed amount.

Chi­nese eye dis­ease biotech Neu­roph­th rais­es $60M in Se­ries C to progress pipeline

Chi­nese eye dis­ease biotech Neu­roph­th Ther­a­peu­tics closed $60 mil­lion in a Se­ries C round, the com­pa­ny an­nounced to­day.

The round, co-led by CMG-SDIC Cap­i­tal and Se­quoia Cap­i­tal Chi­na, in­clud­ed new in­vest­ing funds and ac­counts man­aged by Sun­shine In­sur­ance and Chi­na Mer­chant Bank In­ter­na­tion­al Cap­i­tal.

Ac­cord­ing to Neu­roph­th, this round of fi­nanc­ing will be used to progress its lead clin­i­cal pro­gram in LHON (Leber Hered­i­tary Op­tic Neu­ropa­thy) out­side of Chi­na, im­prove its R&D pipeline and pro­grams through busi­ness de­vel­op­ment and ex­pand Neu­roph­th’s gene ther­a­py man­u­fac­tur­ing plat­form.

Neu­roph­th’s lead can­di­date NR082 was the first AAV2 gene ther­a­py to get IND ap­pli­ca­tion ap­proval in Chi­na, with the first pa­tient be­ing dosed in June.

“We are very pleased to have lead­ing Chi­na and ex-Chi­na in­vestors to sup­port the com­pa­ny mis­sion and vi­sion,” said Neu­roph­th chair­man and founder Bin Li.

Ieso rais­es $53M in Se­ries B to de­vel­op dig­i­tal ther­a­py sys­tems for men­tal health

UK-based dig­i­tal ther­a­peu­tics de­vel­op­er ieso has more mon­ey, thanks to lead in­vestor Morn­ing­side.

The com­pa­ny an­nounced to­day that it has fin­ished its Se­ries B round — with a to­tal of $53 mil­lion raised. Oth­er in­vestors that tagged along in­clude Sony In­no­va­tion Fund, IP Group and Molten Ven­tures.

The funds raised will help ieso de­vel­op au­tonomous dig­i­tal ther­a­py sys­tems to de­liv­er a high­er stan­dard of care — ones “that match the high stan­dards of hu­man care de­liv­ery,” ac­cord­ing to the com­pa­ny — at sig­nif­i­cant­ly low­er cost to health sys­tems.

Ieso plans to de­vel­op these AI-en­abled dig­i­tal as­sess­ment tools and ther­a­peu­tics on their out­comes-linked ther­a­py dataset, which in­cludes at least 460,000 hours of in­for­ma­tion.

Ieso in­tends to seek reg­u­la­to­ry ap­proval for these dig­i­tal tools in the US and UK ahead of bring­ing them to mar­ket. And as part of the raise, ieso will ex­pand its com­mer­cial teams to the US and tar­get both co-de­vel­op­ment and dis­tri­b­u­tion part­ner­ships.

“Through the sup­port of our in­vestors, who share our pur­pose, we’ll con­tin­ue on our mis­sion of com­bin­ing clin­i­cal ex­per­tise, da­ta sci­ence and tech­nol­o­gy to en­able bet­ter and more ac­ces­si­ble men­tal health­care,” said ieso chair­man Andy Richards in a state­ment.

FDA ex­tends re­view for Am­ryt Phar­ma’s EB drug

Am­ryt Phar­ma an­nounced this morn­ing that the FDA has ex­tend­ed the re­view pe­ri­od for the NDA for its epi­der­mol­y­sis bul­losa (EB) treat­ment Oleogel-S10. EB, a rare ge­net­ic skin dis­or­der, has no ap­proved treat­ment.

The FDA ex­tend­ed the PDU­FA by three months to Feb­ru­ary 28 of next year. And ad­di­tion­al­ly, the FDA al­so is­sued a new In­for­ma­tion Re­quest re­gard­ing ex­ist­ing study da­ta in or­der to con­tin­ue the agency’s eval­u­a­tion of Am­ryt’s NDA.

Mean­while, across the At­lantic, the EMA’s re­view process for Oleogel-S10 in EB is on­go­ing — and Am­ryt is in the process of re­spond­ing to the re­main­ing Ma­jor Ob­jec­tions in the List of Out­stand­ing Is­sues sent by the EMA. Those ob­jec­tions re­main undis­closed. The CHMP opin­ion is ex­pect­ed in Jan­u­ary.

“We are well po­si­tioned to ad­dress these reg­u­la­to­ry re­quests from our ex­ist­ing da­ta with­in the time pe­ri­ods re­quired and we look for­ward to our con­tin­ued pro­duc­tive dis­cus­sions as the reg­u­la­to­ry agen­cies com­plete their re­view,” said Am­ryt CEO Joe Wi­ley.

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 major two 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.

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.

Pri­cy in­halers re­main ex­pen­sive due to de­vice tweaks that keep com­peti­tors at bay, re­searchers find

New research published in Health Affairs today highlights the way in which the FDA’s inhaler regulations have rewarded incremental adjustments to older products, thereby enabling companies to skirt around cheaper competition.

A DC appeals court clerk and researchers from Harvard and the University of Calgary dug through all the patents and regulatory exclusivities granted to inhalers approved by the FDA between 1986 and 2020, finding that of the 62 inhalers approved, 53 (or 85%) were brand-name products, with a median of 16 years of protection from generic competition.