Khurem Farooq, Gyroscope

With an­oth­er $148M in the bank, Gy­ro­scope Ther­a­peu­tics looks to hus­tle its AMD gene ther­a­py through mid-stage tests

A month and a half lat­er, Gy­ro­scope Ther­a­peu­tics’ Phase I/II win for its dry-AMD gene ther­a­py is al­ready pay­ing off. On Fri­day, the biotech took the wraps off a $148 mil­lion Se­ries C round to ad­vance the can­di­date through two Phase II tri­als in pa­tients with a de­bil­i­tat­ing eye dis­or­der that caus­es grad­ual and per­ma­nent blind­ness.

Syn­cona — which found­ed Gy­ro­scope with Cam­bridge En­ter­prise — con­tributed $42.3 mil­lion to the Se­ries C round, and now main­tains a 54% stake in the Lon­don-based biotech.

Spark’s cost­ly Lux­tur­na made waves when it be­came the first gene ther­a­py ap­proved for in­her­it­ed blind­ness back in 2017. Since then, oth­er gene ther­a­pies for rare eye dis­or­ders have ad­vanced in de­vel­op­ment — but none have been ap­proved for dry, age-re­lat­ed mac­u­lar de­gen­er­a­tion (AMD), a lead­ing cause of blind­ness in peo­ple over 50 years old. About 85% to 90% of peo­ple with AMD have the dry type, ac­cord­ing to Gy­ro­scope.

Gy­ro­scope’s lead can­di­date, GT005, is cur­rent­ly in two Phase IIs for pa­tients with ge­o­graph­ic at­ro­phy, an ir­re­versible de­gen­er­a­tion of reti­nal cells caused by dry-AMD. The can­di­date is in­ject­ed un­der the reti­na to in­crease pro­duc­tion of the Com­ple­ment Fac­tor I pro­tein, which Gy­ro­scope be­lieves could damp­en an over­ac­tive com­ple­ment sys­tem that’s been tied to wors­en­ing at­ro­phy in AMD pa­tients.

“We re­cent­ly an­nounced en­cour­ag­ing Phase I/II clin­i­cal tri­al da­ta with our lead in­ves­ti­ga­tion­al gene ther­a­py, GT005, that give us con­fi­dence in its po­ten­tial as a treat­ment for ge­o­graph­ic at­ro­phy and are con­tin­u­ing to ad­vance our Phase II clin­i­cal pro­gramme,” CEO Khurem Fa­rooq said in a state­ment.

Fa­rooq, a Genen­tech vet, over­saw com­mer­cial ac­tiv­i­ties for the wet-AMD drug Lu­cen­tis and pre-launch work for Roche’s lam­pal­izum­ab, a dry-AMD can­di­date that was dropped af­ter fail­ing two Phase III tri­als in 2017.

In a Phase I/II dose-es­ca­la­tion tri­al, pa­tients who re­spond­ed to GT005 saw a 146% in­crease in their vit­re­ous Com­ple­ment Fac­tor I lev­els as well as a de­crease in down­stream bio­mark­ers tied to ge­o­graph­ic at­ro­phy for pa­tients with dry AMD, ac­cord­ing to da­ta re­leased in mid-Feb­ru­ary.

Na­dia Wa­heed

At an in­ter­im check-in, nine out of 10 pa­tients across four co­hort groups saw in­creased CFI lev­els af­ter re­ceiv­ing the ther­a­py, and eight of those nine main­tained el­e­vat­ed lev­els of CFI af­ter six months, Gy­ro­scope said.

“Con­sis­tent­ly we’re hit­ting the tar­gets we want to hit in the down­stream am­pli­fi­ca­tion loop,” CMO Na­dia Wa­heed told End­points News last month. “Every­thing so far looks like it’s point­ing in the right di­rec­tion.”

The Se­ries C funds will al­so be used to ad­vance Gy­ro­scope’s ear­ly-stage pipeline and de­liv­ery tech, ac­cord­ing to a state­ment. The round was led by For­bion’s Growth Op­por­tu­ni­ties Fund, with a hand from Sofinno­va In­vest­ments, funds and ac­counts ad­vised by T. Rowe Price As­so­ci­ates, Tetragon Fi­nan­cial Group Lim­it­ed, an undis­closed health­care-fo­cused fund, Fo­s­un Phar­ma and Cam­bridge In­no­va­tion Cap­i­tal.

Wouter Jous­tra and Ma­ha Katabi, gen­er­al part­ners at For­bion and Sofinno­va, re­spec­tive­ly, are join­ing the board. And di­rec­tor Do­minic Schmidt is on his way out.

“With the ex­pan­sion of the Board it is the right time for Do­minic (Schmidt) to step down from his po­si­tion as Di­rec­tor. We thank Do­minic for his key role in the launch and growth of Gy­ro­scope and his sup­port of the Com­pa­ny,” chief in­vest­ment of­fi­cer Chris Hol­lowood wrote in a state­ment.

Last month, Wa­heed told us the Phase I/II FO­CUS tri­al would fin­ish en­roll­ment by the end of 2021, and that the team was “on track” to fill out en­roll­ment in the two Phase II ef­fi­ca­cy tri­als.

A cor­rec­tion has been made to re­flect that Lux­tur­na is the on­ly oc­u­lar gene ther­a­py cur­rent­ly ap­proved.

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Martin Landray, Protas CEO (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Those big bil­lion-dol­lar PhI­II stud­ies? Mar­tin Lan­dray says they can be done for a tiny frac­tion of the cost

Martin Landray knows what controversy in clinical drug development feels like, from first-hand experience.

Landray was the chief architect of RECOVERY, a study that pitted a variety of drugs against Covid-19. And he offered some landmark data that would help push dexamethasone out into broader use as a cheap treatment, while helping ice hydroxy’s reputation as a clear misfire.

“Lots of people told us we shouldn’t use it,” Landray says about dexamethasone and Covid-19. “It was dangerous. We shouldn’t even do a trial. They also cared about hydroxychloroquine and lots of people said we shouldn’t do a trial because it must be used. I’ve got the letters from both sets of people.”

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

FDA ap­proves one of the prici­est new treat­ments of all time — blue­bird's gene ther­a­py for be­ta tha­lassemia

The FDA on Wednesday approved the first gene therapy for a chronic condition — bluebird bio’s new Zynteglo (beti-cel) as a potentially curative treatment for those with transfusion-dependent thalassemia.

The thumbs-up from the FDA follows a unanimous adcomm vote in June, with outside experts pointing to extraordinary efficacy, with 89% of subjects with TDT who received beti-cel having achieved transfusion independence.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 148,400+ biopharma pros reading Endpoints daily — and it's free.

Geoffrey Porges, new Schrödinger CFO

Long­time an­a­lyst Ge­of­frey Porges de­parts SVB to lead fi­nances at a drug dis­cov­ery shop

Geoffrey Porges has ended his two-decade run as a biotech analyst, as the former SVB Securities vice chair began as CFO of Schrödinger on Thursday.

The long-running analyst, who previously headed up vaccines marketing at Merck before the turn of the millennium, will lead the financial operations of the 700-employee company as Schrödinger broadens its focus from a drug discovery partner to also building out an in-house pipeline, with clinical trial No. 1 set to begin next quarter.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 148,400+ biopharma pros reading Endpoints daily — and it's free.

Joel Dudley, new partner at Innovation Endeavors (Bosch Health Campus)

For­mer Google CEO’s VC is mak­ing a big­ger push in­to the biotech world, hir­ing promi­nent Ther­a­nos skep­tic

Venture capital firm Innovation Endeavors has mainly had its focus on investments across the tech space, but it has been slowly turning its attention to the biotech world. Now, a new partner is coming into the fold showing that its interest in biotech is likely to grow further.

The Silicon Valley-based company, which is headed up by former Google CEO Eric Schmidt, has brought on Joel Dudley as a partner. According to Dudley’s LinkedIn page, he is joining Innovation Endeavors after serving as the chief science officer of biotech startup Tempus Labs since 2020.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 148,400+ biopharma pros reading Endpoints daily — and it's free.

James Sabry, Roche global head of pharma partnering

Roche, Genen­tech plunk down $60M up­front to part­ner with Chi­nese phar­ma on PRO­TAC-based prostate can­cer drug

Roche and Genentech are always on the hunt for deals, and on Thursday they found their newest partner.

The pair will team up with the Chinese pharma company Jemincare to push forward a new program for prostate cancer, the companies announced. Roche is ponying up $60 million upfront to get its hands on the candidate and promising up to $590 million in biobucks, plus royalties, down the line.

In return, Genentech will get a worldwide license to develop the program, known as JMKX002992, and bring it to market.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 148,400+ biopharma pros reading Endpoints daily — and it's free.

Andrew Hopkins, Exscientia CEO

Ex­sci­en­tia ter­mi­nates Bay­er pact half a year ear­ly, col­lect­ing small por­tion of €240M promised

Bayer and Exscientia are winding down their three-year collaboration, leaving the big German pharma to take the AI-designed compounds born out of the pact further.

London-based Exscientia revealed in its Q2 update that the partners have “mutually agreed to end” their collaboration, which kicked off in early 2020, after recently achieving a drug discovery milestone. In an SEC filing, Exscientia said it terminated the pact on May 30, about six months early.

Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 148,400+ biopharma pros reading Endpoints daily — and it's free.

James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 148,400+ biopharma pros reading Endpoints daily — and it's free.