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.

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,700+ biopharma pros reading Endpoints daily — and it's free.

Credit: Shutterstock

How Chi­na turned the ta­bles on bio­phar­ma's glob­al deal­mak­ing

Fenlai Tan still gets chills thinking about the darkest day of his life.

Three out of eight lung cancer patients who received a tyrosine kinase inhibitor developed by his company, Betta Pharma, died in the span of a month. Tan, the chief medical officer, was summoned to Peking Union Medical College Hospital, where the head of the clinical trial department told him that the trial investigators would be conducting an autopsy to see if the patients had died of the disease — they were all very sick by the time they enrolled — or of interstitial lung disease, a deadly side effect tied to the TKI class that’s been reported in Japan.

ARCH-backed SciNeu­ro kicks off search for CNS au­toan­ti­bod­ies with new deal; Mer­ck + Gilead an­nounce PhII tri­al for HIV com­bo

From the very beginning at SciNeuro, CEO Min Li has envisioned a mix of licensing deals and scientific efforts to replicate the breakout success of China’s oncology companies in neuroscience.

The GlaxoSmithKline vet has now inked a deal that somewhat straddles the line between the two strategies.

Teaming up with Mabylon out of Zurich, SciNeuro is now looking to test the hypothesis that the human immune system can play a role in fighting neurodegenerative diseases by discovering and developing human autoantibodies against neurological “targets of mutual interests.” The new partners offered TAR DNA binding protein-43 (TDP-43) and apolipoprotein E (APOE), which are linked to ALS and Alzheimer’s, as examples.

Ugur Sahin, AP Images

As pres­sure to share tech­nol­o­gy mounts, BioN­Tech se­lects Rwan­da for lat­est vac­cine site

BioNTech’s first mRNA-based vaccine site in Africa will call Rwanda home, and construction is set to start in mid-2022, the company announced Tuesday at a public health forum.

The German company signed a memorandum of understanding, after a meeting between Rwanda’s Minister of Health, Daniel Ngamije, Senegal’s Minister of Foreign Affairs Aïssata Tall Sall, and senior BioNTech officials. Construction plans have been finalized, and assets have been ordered. The agreement will help bring end-to-end manufacturing to Africa, and as many as several hundred million doses of vaccines per year, though initial production will be more modest.

No­var­tis dumps AveX­is pro­gram for Rett syn­drome af­ter fail­ing re­peat round of pre­clin­i­cal test­ing

Say goodbye to AVXS-201.

The Rett syndrome gene therapy drug made by AveXis — the biotech that was bought, kept separate, then renamed and finally absorbed by Novartis into its R&D division — has been dropped by the biopharma.

In Novartis’ third quarter financial report, the pharma had found that preclinical data did not support development of the gene therapy into IND-enabling trials and beyond. The announcement comes a year after Novartis told the Rett Society how excited it was by the drug — and its potential benefits and uses.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,700+ biopharma pros reading Endpoints daily — and it's free.

Vas Narasimhan, Novartis CEO (Simon Dawson/Bloomberg via Getty Images)

With San­doz con­tin­u­ing to drag on No­var­tis, Vas Narasimhan says he may fi­nal­ly be ready for a sale or spin­off

After years of rehab work aimed at getting Sandoz in fighting trim to compete in a market overshadowed by declining prices, CEO Vas Narasimhan took a big step toward possibly selling or spinning off the giant generic drug player.

The pharma giant flagged plans to launch a strategic review of the business in its Q3 update, noting that “options range from retaining the business to separation.”

Analysts have been poking and prodding Novartis execs for years now as Narasimhan attempted to remodel a business that has been a drag on its performance during most of his reign in the CEO suite. The former R&D chief has made it well known that he’s devoted to the innovative meds side of the business, where they see the greatest potential for growth.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,700+ biopharma pros reading Endpoints daily — and it's free.

FDA is much worse than its reg­u­la­to­ry peers at proac­tive­ly dis­clos­ing da­ta, re­searchers find

The European Medicines Agency and Health Canada continue to outpace the FDA when it comes to proactively releasing data on drugs and biologics the agency has reviewed, leading to further questions of why the American agency can’t be more transparent.

In a study published recently in the Journal of Law, Medicine, & Ethics, Yale and other academic lawyers and researchers found that between 2016 and April 2021, the EMA proactively released data for 123 unique medical products, while Health Canada proactively released data for 73 unique medical products between 2019 and April 2021. What’s more, the EMA and Health Canada didn’t proactively release the same data on the same drugs. In stark contrast, the FDA in 2018 only proactively disclosed data supporting one drug that was approved that year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,700+ biopharma pros reading Endpoints daily — and it's free.

James Peyer, Cambrian CEO

Brent Saun­ders joins $100M Se­ries C for a com­pa­ny out to be the Bridge­Bio of ag­ing

About a year ago, James Peyer, a CEO and co-founder of the little known longevity biotech Cambrian Biopharma, was trying to find some R&D talent last year when he met with more than a bit of experience in that department: David Nicholson, the former R&D chief of the erstwhile pharma giant Allergan.

It turned out Nicholson already had an interest in Peyer’s field. In their Allergan days, he and COO Brent Saunders held weekly meetups where they tried to figure out how to take the company’s dominance in aesthetics — which, until recently, was often what people meant by anti-aging science — and expertise with more traditional drug development, and use it to make drugs that extend people’s lifespan.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,700+ biopharma pros reading Endpoints daily — and it's free.