Assembly Biosciences, Inc.

iStock, master1305 Blujepa is also approved for uncomplicated urinary tract infection in females 12 years and older. The FDA has cleared the use of GSK’s Blujepa for the treatment of uncomplicated urogenital gonorrhea, unlocking the first new type of antibiotic for the infection in more than three decades. With the approval, announced Thursday , Blujepa can now be used in patients 12 years and older who weigh at least 45 kg, and for whom there are limited or no alternative treatment options. Blujepa can only be used in patients whose infections are caused by susceptible Neisseria gonorrhoeae strains. With around 1.57 million new cases in the U.S. per year, gonorrhea is an urgent public health threat and is the second most prevalent sexually transmitted infection in the country, according to the CDC. Many strains of N. gonorrhoeae have grown resistant to common antibiotics, such as cefixime, ceftriaxone and azithromycin, complicating treatment decisions. There are currently no licensed vaccines to prevent gonorrhea. Supporting the FDA’s decision on Thursday are data from the Phase III EAGLE-1 study, which demonstrated a 92.6% success rate in patients treated with Blujepa, as compared with 91.2% in comparators given a combination of intramuscular ceftriaxone and oral azithromycin. The Blujepa arm also saw no treatment failures at the urogenital site due to bacterial persistence, GSK said in an August news release , adding that the antibiotic triggered no serious drug-related toxicities. Taken orally, Blujepa is a first-in-class antibacterial drug classified as a triazaacenaphthylene. It works by targeting and disrupting the action of type II topoisomerases, which bacteria use to replicate their DNA. GSK has identified no clear mechanisms of resistance to Blujepa yet, according to the drug’s label . Blujepa was first approved in March this year , opening its use for uncomplicated urinary tract infection in female patients 12 years and older weighing at least 40 kg. That approval covers infections caused by Escherichia coli , Klebsiella pneumoniae , Citrobacter freundii complex, Staphylococcus saprophyticus and Enterococcus faecalis . Thursday’s label expansion comes after Assembly Biosciences scored a key victory in the infectious disease space. On Monday, Assembly reported that its oral herpes drugs—the weekly ABI-1179 and the monthly ABI-5366—strongly reduced viral shedding and lowered genital lesion rates in two Phase I studies. Reacting to the data, Guggenheim Partners on Monday called the investigational antivirals “strong candidates with both differentiated efficacy and more favorable dosing vs. standard of care.” A few weeks earlier, Merck infused the infectious disease space with $9.2 billion via its acquisition of Cidara Therapeutics, a deal anchored by the California biotech’s late-stage antiviral for flu.

Plus, news about Scancell Holdings, Immutep, Dr. Reddy’s, Sensorion and Convergen: 💵 Sidera Bio reportedly gets $109M: Investors including Novo Holdings, Forbion, RA Capital Healthcare Fund and Gilde Healthcare participated in the Series A round, according to a report in MarketWatch and a LinkedIn post from CVX Ventures. Forbion holds up to a third of Sidera, and Novo had already provided seed funding to the stealthy Danish biotech. There may be further funding to come, though neither Sidera nor Forbion would comment on the deal. Sidera was reportedly founded under the name GhostBio in 2023. The startup is believed to have licensed a GLP-1/GIP and FGF21 agonist from the Chinese company Lepu Medical Technology in October. The drug is intended for obesity and other metabolic disorders. Sidera obtained ex-China rights to the Phase 2-stage drug, codenamed MWN105, via Lepu’s subsidiary Minwei Biotech, in exchange for an upfront payment of $35 million plus near-term milestone payments, the news website Synopulse reported . Minwei also took a 9.9% equity stake in Sidera, and could get up to $1.01 billion in biobucks. Another Chinese company has a drug with the same mechanism, and is also seeking a Western partner. Zhejiang Doer Biologic told Endpoints News that it intends to start Phase 3 trials of its triple agonist candidate for high triglyceride levels next year. — Elizabeth Cairns 💊 Assembly Biosciences’ oral herpes drugs post encouraging early data : One of the pills, ABI-1179, cut the HSV-2 shedding rate by 98% and high viral load shedding rate by more than 99% over placebo, according to interim data from two Phase 1b trials. Subjects given a 50 mg weekly dose had a 91% reduction in virologically confirmed genital lesions, which Assembly said exceeded its expectations. In another Phase 1 trial, a monthly dose of a different antiviral, called ABI-5366, decreased the HSV-2 shedding rate and high viral load shedding rate by 76% and 81%, respectively. It yielded an 88% cut in virologically confirmed genital lesion rate. Assembly is working to move ABI-1179 into Phase 2. It is also planning longer Phase 2 trials of a once-weekly version of ABI-5366 to start mid-2026. Both drugs are herpes simplex virus helicase-primase inhibitors; under a 2023 agreement Gilead has an option to license Assembly’s helicase-primase inhibitor program following the completion of the Phase 1b trials. — Elizabeth Cairns 🧬 Scancell Holdings’ DNA-based skin cancer vaccine beats standard care: A new data cut from the third cohort in the Phase 2 SCOPE trial showed that the iSCIB1+ therapy significantly improved progression-free survival in patients with advanced melanoma. The drug was given on top of checkpoint inhibitors as first-line therapy, and yielded a 74% PFS rate at 16 months. The UK biotech said this beats the PFS of 50% at 11.5 months seen with the standard care regimen of Opdivo and Yervoy. Overall response rate for the target population in the third cohort was 56%, with a disease control rate of 79%. Early overall survival data showed a 14% improvement over standard care at 26 months. The data will be presented at the ESMO IO conference on Thursday, and Scancell is aiming to start Phase 3 trials in late 2026. It is seeking a partner, and looking at financing options for the drug. — Elizabeth Cairns 🤝 Immutep makes a deal with Dr. Reddy’s: The companies inked a licensing agreement in which Dr. Reddy’s gets development and commercialization rights to the investigational cancer drug eftilagimod alpha except for North America, Europe, Japan and Greater China. Dr. Reddy’s will pay $20 million upfront, with $349.5 million in milestone payments on the table. There’s also double-digit royalties on commercial sales in markets covered by the deal. — Reynald Castaneda 👂 Sensorion’s deafness gene therapy trial to continue : The data monitoring committee overseeing the Phase 1/2 Audiogene trial of SENS-501 has raised no safety concerns, the French company said Monday. The study, testing intra-cochlear administration of the gene therapy in infants and toddlers with a form of congenital deafness caused by mutations in the gene for otoferlin, can therefore continue. Sensorion said that so far, two of the three patients in the trial’s second cohort had shown early improvements within three months of receiving the therapy. Further data are due in the first quarter of next year. — Elizabeth Cairns 🇨🇳 Chinese biotech raises $10M: Convergen will use its seed funding to work on its bifunctional degrader platform called TrimTAC and its R&D pipeline in neurodegenerative disorders. Qiming Venture Partners supported the raise. — Reynald Castaneda

iStock, masterzphotois A mid-stage study for ABI-5366 will begin mid next year, while Assembly continues to assess the Phase II potential of ABI-1179. Two of Assembly Biosciences’ investigational long-acting therapies showed strong antiviral activity in Phase I studies in recurrent genital herpes, opening the company’s path to mid-stage development. Analysts at Guggenheim Partners, in a Monday note to investors, called the California biotech’s data “striking,” adding that the readout “strongly reinforces the greater efficacy potential of [Assembly’s] more potent, next-gen oral helicase-primase inhibitors.” On Monday, Assembly released interim results from two Phase I studies of its oral herpes drug candidates, the weekly ABI-1179 and the monthly ABI-5366. Both trials were randomized and placebo-controlled, and enrolled patients positive for herpes simplex virus 2 (HSV-2) infection with recurrent genital herpes. In its study, a 50-mg dose of ABI-1179 lowered viral shedding by 98% versus placebo over a 29-day observation period, which exceeds Assembly’s previous target of 80% to 85% shedding reduction, according to the company’s announcement. ABI-1179 also lowered genital lesion rates by 91% compared to placebo. Meanwhile, the trial for ABI-5366 showed that drug cut viral shedding by 76% over 29 days, accompanied by an 88% decrease in confirmed genital lesions. The number of samples with high viral load, a potential surrogate indicator for HSV-2 transmission, was 81% lower in those on Assembly’s drug compared to placebo. In a follow-up note on Monday evening, sent after a call with Assembly management, Guggenheim analysts reiterated that in ABI-1179 and ABI-5366, the biotech “has two strong candidates with both differentiated efficacy and more favorable dosing vs. standard of care.” The former, in particular, could unlock a “potential blockbuster novel weekly treatment opportunity” for the company. Moving forward, Assembly plans to push both assets into mid-stage development. ABI-5366 is expected to start Phase II trials by mid-2026, according to a Mizuho Securities note on Monday, while the company continues to assess the Phase II potential of ABI-1179. ABI-5366 and ABII-1179 work by targeting a key viral enzyme complex involved in HSV-2 replication. Disrupting this crucial viral function, Assembly claims on its website , can lead to “superior efficacy” than the current nucleoside analogs used for herpes treatment. ABI-1179 came to Assembly from Gilead under an October 2023 partnership , according to the biotech’s Monday release . The pharma at the time fronted $100 million to collaborate with the biotech on its infectious disease assets, giving Gilead the ability to gain exclusive rights over Assembly’s pipeline programs.