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.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Stéphane Bancel, Moderna CEO

'This is not go­ing to be good': Mod­er­na CEO Ban­cel warns of a 'ma­te­r­i­al drop' in vac­cine ef­fi­ca­cy as Omi­cron spreads

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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With on­ly burns to show in gene ther­a­py, Astel­las inks deal with AAV spe­cial­ist Dyno in push for a bet­ter cap­sid

On the hunt for a better AAV capsid for gene therapy, Eric Kelsic’s Dyno Therapeutics has set itself apart with its focus on machine learning to help speed discovery. Now, Japanese drugmaker Astellas — fresh off a slate of gene therapy burns — is taking a bet on Dyno as it looks to the future.

Astellas and Dyno will work together as part of an R&D pact to develop next-gen AAV vectors for gene therapy using Dyno’s CapsidMap platform directed at skeletal and cardiac muscle, the companies said Wednesday. Under the terms of the deal, Dyno will design AAV capsids for gene therapy, while Astellas will be responsible for conducting preclinical, clinical and commercialization activities for gene therapy product candidates using the capsids.

Philip Dormitzer, new GSK global head of vaccines R&D

Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

Since our start in 2016, Endpoints has grown fast while executing our mission to cover biopharma’s most critical developments for industry pros worldwide. As readership has grown, our advertising business has too. Endpoints advertising partners support the mission and engage their desired audiences through announcements on our email and web platforms, brand recognition in our event coverage and sponsorships of Endpoints daily and weekly reports.

As first Omi­cron case in US crops up, re­searchers won­der: which an­ti­bod­ies, vac­cines will hold up?

As Covid-19 drug and vaccine developers race to figure out which of their products might be hampered by the new variant, the CDC on Wednesday afternoon announced the first confirmed case of the Omicron variant (B.1.1.529) in the US, found in San Francisco.

The unidentified individual was a traveler who returned from South Africa on Nov. 22, 2021, was fully vaccinated, and had mild symptoms that the CDC described as improving. All close contacts have been contacted and have tested negative, the centers said.

Can South Dako­ta's trans­genic cows help treat the flu?; A speedy re­view for Mer­ck­'s Pre­vnar ri­val in kids

Wednesday brought another win for South Dakota’s biggest transgenic cow so far.

SAB Biotherapeutics, which develops treatments by collecting and distilling antibodies from cows with humanized immune systems, announced that its antibody treatment for flu passed an early-stage challenge study.

Volunteers were intentionally exposed to the flu virus and then given infusions of the SAB antibody treatment or placebo. Those who received the antibody treatment saw a significantly greater reduction in viral load and symptoms than those who received placebo. The company didn’t release numbers but said the p-value was 0.026.

Mod­er­na los­es lat­est bat­tle in key vac­cine de­liv­ery patent fight as fed­er­al ap­peal falls flat

The US Court of Appeals for the Federal Circuit on Wednesday rejected Moderna’s attempt to overturn key patents related to the delivery vehicle for its Covid-19 vaccine after the biotech sought to preempt a potentially risky infringement lawsuit.

For years, Moderna has been battling a tiny Pennsylvania biotech known as Arbutus over patents for a technology required to deliver its mRNA drugs and vaccines, known as lipid nanoparticles or LNP. Moderna is concerned there’s a substantial risk that Arbutus will assert the ’069 patent in an infringement suit targeting Moderna’s Covid-19 vaccine, particularly as Arbutus has boasted of its patent protection and refused to grant a covenant not to sue Moderna.

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Lan Huang, BeyondSpring CEO

Months af­ter shock­ing in­vestors with lung can­cer win, Be­yond­Spring's lead drug hits road­block at the FDA

BeyondSpring shocked investors in early August after its once-marginal lead drug suddenly showed a lot of promise in a common form of lung cancer. With hopes high, the FDA has now slammed the door on that drug in another indication — does that spell bad news for BeyondSpring’s Cinderella story?

The FDA issued BeyondSpring a complete response letter for its plinabulin in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia, effectively shutting down the drug’s immediate chances at a marketing approval, the biotech said Wednesday.

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