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.

Roger Perl­mut­ter lines up deals, fresh fund­ing at Eikon; Sec­ond RSV vac­cine ap­proved; Sev­er­al biotechs flash­ing red; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

As you come back to our website this weekend for ASCO news, don’t forget to check out our updated event lineup at BIO, which will cover everything from the current state of VC investing in biotech to top pharma R&D chiefs discussing how to make pipeline decisions.

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Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

Roger Perlmutter, Eikon Therapeutics CEO

Roger Perl­mut­ter builds Eikon's pipeline with deal-mak­ing flur­ry, rais­ing $106M more

Eikon Therapeutics announced three business development deals on Thursday, effectively dropping in a pipeline of cancer drugs alongside more than $100 million in fresh funding.

The Hayward, CA-based company has become one of biotech’s richest startups since its 2019 founding, having raised nearly $775 million. It’s developing a massive, automated research approach built around Nobel Prize-winning microscope science to peer inside cells and watch proteins in action. After its Series B last year, PitchBook reported a $3.02 billion valuation. And while CEO Roger Perlmutter declined to comment on that figure, he said its first tranche of nearly $106 million in Series C funding is a “meaningful step-up to our Series B valuation.”

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Grail’s blood test charts path for di­ag­nos­ing pa­tients sus­pect­ed of hav­ing can­cer in large study: #AS­CO23

Grail’s vision is simple but bold. The blood testing company has long held that people are often diagnosed with cancer too late. If seemingly healthy people were screened for early signs of the disease before symptoms appear, they may be able to get more effective treatments that nip cancer in the bud.

That premise is the basis of Grail’s commercial blood test, Galleri, which searches for the genetic fingerprints of cancer in the blood. The test, launched in 2021, reaped $55 million in sales last year, but now the company is setting its sights on a new market: patients suspected of having cancer due to symptoms such as abdominal pain, rectal bleeding or unexplained weight loss. Rather than administering expensive scans or conducting invasive biopsies right away, Grail hopes doctors will consider a simple blood test.

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GSK pro­motes rou­tine im­mu­niza­tions for adults amid post-pan­dem­ic vac­cine back­slide

GSK launched a new initiative on Thursday and committed up to $1 million in grant funding to improve adult routine vaccination rates.

While the pandemic spotlight was trained on the race for novel Covid-19 vaccines, other routine vaccination rates plummeted, raising concerns that missed doses may put children and even some adults at risk of preventable diseases such as measles or shingles. The World Health Organization last year reported the largest drop in childhood vaccinations in roughly three decades.

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Tammie Denyse speaks up about Black women and breast cancer inequity in Gilead's first TikTok campaign. (Gilead Sciences)

Gilead joins Tik­Tok with on­col­o­gy aware­ness cam­paign fea­tur­ing di­verse group of can­cer ad­vo­cates

Gilead Sciences is taking over the opening page on TikTok for the next two weeks. A Gilead-sponsored video, featuring cancer advocates talking about equity and other issues, will show up as the landing page, called the “For You” page, for millions of TikTok watchers.

The cancer awareness campaign will begin on Monday and run for two weeks, a Gilead spokesperson told Endpoints News. The TikTok ad debut is timed around the ASCO medical conference, but the work is aimed more broadly at healthcare professionals, as well as people touched by cancer and people interested in advancing Black and general health equity.

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Stephen MacMillan, Hologic CEO (Photo by Riccardo Savi/Getty Images for Concordia Summit)

Il­lu­mi­na names Ho­log­ic CEO as new board mem­ber and chair

Illumina’s board appointed two new members, including Hologic CEO Stephen MacMillan as the non-executive chair, a move that followed a proxy fight that saw shareholders oust the company’s board chair.

The DNA sequencing company also appointed Scott Ullem, the CFO of Edwards Lifesciences, to the board, according to a company statement.

Illumina’s plans to add two new board members came as Carl Icahn waged a board proxy campaign culminating with shareholders electing his candidate, Andrew Teno, over board chair John Thompson. Illumina CEO Francis deSouza survived a threat to his board seat by securing more than twice the shareholder votes than his challenger. Another Illumina candidate, Robert Epstein, was also elected and remained on the board.

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Novartis headquarters in Basel, Switzerland (Kyle LaHucik for Endpoints News)

No­var­tis’ Kisqali pre­vents breast can­cer from com­ing back for longer — but can it best Eli Lil­ly’s Verzenio? #AS­CO23

CHICAGO — Novartis’ CDK4/6 inhibitor Kisqali helped early breast cancer patients stay cancer-free for longer after surgery, according to interim study results presented at ASCO.

In a Phase III study, Kisqali was added on top of endocrine therapy — the current standard treatment for early breast cancer patients. Kisqali reduced the risk of disease relapse by 25% compared with endocrine therapy alone in patients with Stage II or III HR-positive, HER2-negative breast cancer.

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Catal­ent makes ad­di­tion­al lay­offs at In­di­ana fa­cil­i­ty

Contract manufacturer Catalent is making more staff cuts at one of its locations in the US amid dramatic corrective actions it’s been taking over the past few months.

In an email to Endpoints News, a Catalent spokesperson confirmed the company is making “a number of personnel changes” at a manufacturing facility in Bloomington, IN. While a specific number was not given to Endpoints, several local media outlets, including Indiana Public Media and the Bloomington Herald-Times, have put the number of layoffs at 150. No postings have been made to the Indiana Department of Workforce Development’s WARN notice.

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