Reg­u­lus dumps first-gen ADP­KD treat­ment in fa­vor of sec­ond it­er­a­tion; Sutro joins BioNo­va in $200M deal

Reg­u­lus Ther­a­peu­tics just fin­ished dos­ing in IND-en­abling tox­i­c­i­ty stud­ies for its sec­ond-gen­er­a­tion au­to­so­mal dom­i­nant poly­cys­tic kid­ney dis­ease (ADP­KD) can­di­date RGLS8429.

Based on FDA dis­cus­sions and da­ta from a Phase Ib tri­al on orig­i­nal ADP­KD can­di­date RGLS4326, Reg­u­lus is shift­ing away from the first-gen­er­a­tion can­di­date and pri­or­i­tiz­ing the new­er can­di­date, ac­cord­ing to a state­ment.

“We have de­ter­mined that ad­vanc­ing our next-gen­er­a­tion com­pound RGLS8429 is more com­pelling than fur­ther de­vel­op­ment of RGLS4326,” said Reg­u­lus CEO Jay Ha­gan. “The ex­ten­sive work and in­vest­ment we have made in RGLS4326 will di­rect­ly in­form the ad­vance­ment of RGLS8429, and we be­lieve will make this tran­si­tion both ex­pe­di­tious and pro­duc­tive.”

The Cal­i­for­nia biotech is ex­pect­ing to meet with the FDA pre-IND by the end of the year —  and pend­ing an FDA de­ci­sion on their IND, they an­tic­i­pate start­ing a Phase I study on their can­di­date in Q2 next year.  By ear­ly 2023, Reg­u­lus ex­pects to be able to re­port top-line da­ta in the first co­hort of RGLS8429-treat­ed pa­tients.

Sutro and BioNo­va launch op­tion agree­ment for an­ti-CD74 ADC worth $200M

The San Fran­cis­co biotech Sutro Bio­phar­ma and Shang­hai-based BioNo­va joint­ly an­nounced an op­tion agree­ment for BioNo­va to de­vel­op and com­mer­cial­ize an­ti-CD74 ADC STRO-001 for pa­tients with hema­to­log­ic can­cers. The com­mer­cial­iza­tion deal is for cer­tain Asian mar­kets, in­clud­ing Chi­na, Hong Kong, Macau and Tai­wan.

As part of the agree­ment, BioNo­va has the op­tion to re­ceive ex­clu­sive rights to de­vel­op and com­mer­cial­ize the ADC in those spe­cif­ic Asian mar­kets. In the mean­time, BioNo­va will pur­sue clin­i­cal de­vel­op­ment, reg­u­la­to­ry ap­proval, and com­mer­cial­iza­tion of STRO-001 in mul­ti­ple in­di­ca­tions, in­clud­ing non-Hodgkin’s lym­phoma, mul­ti­ple myelo­ma, and leukemia.

Sutro will re­tain both de­vel­op­ment and com­mer­cial rights of STRO-001 glob­al­ly out­side of those Asian mar­kets, in­clud­ing the US.

BioNo­va will pay Sutro an ini­tial li­cens­ing op­tion pay­ment of $4 mil­lion, with po­ten­tial mile­stone pay­ments to­tal­ing up to $200 mil­lion. Sutro will al­so re­ceive tiered and dou­ble-dig­it roy­al­ties based on an­nu­al net sales in those Asian mar­kets.

Sutro will pro­vide STRO-001 to BioNo­va un­der ap­pro­pri­ate clin­i­cal and com­mer­cial sup­ply ser­vice agree­ments.

“This strate­gic part­ner­ship of STRO-001 at this stage of its clin­i­cal de­vel­op­ment demon­strates the shared vi­sion of Sutro and BioNo­va of the po­ten­tial for this promis­ing ADC,” said Sutro CEO Bill Newell in a state­ment.

Bris­tol My­ers Squibb shows in­ter­im re­sults from five-year ex­ten­sion tri­al on Zeposia

Bris­tol My­ers Squibb un­veiled in­ter­im re­sults to­day from the Phase III open-la­bel ex­ten­sion tri­al Day­break, show­ing five years of da­ta on the ap­proved MS drug ozan­i­mod in pa­tients with re­laps­ing mul­ti­ple scle­ro­sis.

In the ex­ten­sion study, safe­ty was con­sis­tent with pri­or find­ings. Treat­ment with ozan­i­mod, al­so known as Zeposia, lead to a low re­lapse rate — 0.103. Ac­cord­ing to a Bris­tol My­ers state­ment, 75% and 71% of pa­tients were re­lapse-free when test­ed at the 3- and 4-year mark, re­spec­tive­ly.

“Ear­ly and ef­fec­tive in­ter­ven­tion can sig­nif­i­cant­ly im­pact phys­i­cal and cog­ni­tive re­sults over time, with low re­lapse rates an im­por­tant in­di­ca­tor of pa­tient out­comes,” said study in­ves­ti­ga­tor and clin­i­cal re­search di­rec­tor for the UCSF MS Cen­ter in San Fran­cis­co Bruce Cree. “These da­ta from the DAY­BREAK tri­al pro­vide a clear pic­ture of the long-term safe­ty and ef­fi­ca­cy pro­file of Zeposia, and re­in­force its po­ten­tial when used ear­ly in the treat­ment process for peo­ple liv­ing with re­laps­ing forms of MS.”

This sto­ry has been cor­rect­ed to clar­i­fy that RGLS8429 has not yet reached clin­i­cal test­ing.

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.

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.

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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.

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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.

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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.

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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.

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Etleva Kadilli, director of UNICEF’s supply division

GSK lands first-ever UNICEF con­tract for malar­ia vac­cine worth $170M

GSK has landed a new first from UNICEF the first-ever contract for malaria vaccines, worth up to $170 million for 18 million vaccine doses distributed over the next three years.

The vaccine, known as Mosquirix or RTS,S, won WHO’s backing last October after a controversial start, but UNICEF said these doses will potentially save thousands of lives every year.

“We hope this is just the beginning,” Etleva Kadilli, director of UNICEF’s supply division, said. “Continued innovation is needed to develop new and next-generation vaccines to increase available supply, and enable a healthier vaccine market. This is a giant step forward in our collective efforts to save children’s lives and reduce the burden of malaria as part of wider malaria prevention and control programmes.”

Joe Jonas (Photo by Anthony Behar/Sipa USA)(Sipa via AP Images)

So­lo Jonas broth­er car­ries Merz's new tune in Botox ri­val cam­paign

As the lyrics of his band’s 2019 pop-rock single suggest, Joe Jonas is only human — and that means even he gets frown lines. The 33-year-old singer-songwriter is Merz’s newest celebrity brand partner for its Botox rival Xeomin, as medical aesthetics brands target a younger audience.

Merz kicked off its “Beauty on Your Terms” campaign on Tuesday, featuring the Jonas brother in a video ad for its double-filtered anti-wrinkle injection Xeomin.

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