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.

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.

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.”