Biomedicine Daily · Saturday, 24 October 2026
CBA FRONTIER INSIGHTS
Moderna mRNA vaccine almost halves the risk of skin cancer returning
The personalized mRNA cancer vaccine intismeran, developed by Moderna and Merck, reduced the risk of melanoma recurrence or death by 42% when combined with pembrolizumab in a phase III trial of 1,137 patients with a median follow-up of about 25 months. The data will be presented at the ESMO meeting. The vaccine is tailored to neoantigens in each patient's tumor and did not increase major serious side effects. Experts consider a risk reduction of this magnitude clinically meaningful, but long-term efficacy and which patients benefit still require further analysis.
Clinical readouts and safety
ESMO 2026 Breast Cancer ADC Rapid Orals Cover Neoadjuvant Therapy, Overall Survival and Resistance Sequencing
Liangyihui compiles seven rapid oral reports on breast cancer ADCs from ESMO 2026, covering neoadjuvant treatment in HER2-positive early breast cancer, overall survival in metastatic TNBC, sequential strategies after ADC resistance, and clinical data on ADCs with novel targets.
Sino Biopharmaceutical's TQB2102 Extends Median PFS to 16.4 Months in Phase 3 HER2-Low Breast Cancer Study
Sino Biopharmaceutical presented phase 3 results for TQB2102 in HER2-low breast cancer at ESMO 2026: median progression-free survival was 16.4 months versus 5.5 months in the chemotherapy arm. APEX-Breast01 was released as LBA27, with 543 patients randomized as of May 31, 2026; HR was 0.29 in both the HR+/HER2-low population and the overall HER2-low population, with 95% CIs of 0.22–0.39 and 0.22–0.38, respectively, and p<0.0001.
ESMO G-HOPE-001 Interim Analysis: Arcotatug Tavatecan Median PFS 7.1 Months in Later-Line CLDN18.2-Positive Gastric Cancer
The ESMO 2026 LBA77 interim analysis of the phase 3 G-HOPE-001 trial in later-line CLDN18.2-positive gastric cancer showed arcotatug tavatecan met both co-primary endpoints of PFS and OS. At IA2, median PFS was 7.1 vs 3.1 months, HR 0.45 (95% CI 0.35-0.58); median OS was 10.2 vs 6.9 months, HR 0.57 (95% CI 0.45-0.73); confirmed ORR was 37.4% vs 7.7%.
Hengrui Reports Phase 3 HORIZON-Breast06: Ruzaltatug Median PFS 16.6 Months in Chemo-Naive HER2-Low Advanced Breast Cancer
Hengrui Pharma reported Phase 3 HORIZON-Breast06 results for ruzaltatug (SHR-A1811) in HER2-low advanced breast cancer. In chemotherapy-naive patients, median PFS was 16.6 months with ruzaltatug versus 6.8 months in the chemotherapy arm.
youtube.comPimicotinib for tenosynovial giant cell tumour (MANEUVER)
Phase 3 TELIGAN Trial Reports 104-Week eGFR Slope and Proteinuria Results for Telitacicept in IgA Nephropathy
The TELIGAN trial presented final 104-week results for telitacicept in IgA nephropathy at the 2026 American Society of Nephrology (ASN) annual meeting. The study enrolled 318 patients in China.
medicalxpress.comClinical trials generate promising results for improving kidney health
ASN Kidney Week 2026 presented results from three Phase III trials in IgA nephropathy. Atacicept's ORIGIN 3 interim analysis met its primary endpoint and led to FDA accelerated approval, with two-year data showing stable eGFR and a marked reduction in progression risk. Sibeprenlimab's VISIONARY trial reduced the risk of kidney function loss or kidney failure by 97% versus placebo over two years, and telitacicept's TELIGAN two-year data confirmed durable kidney protection with a good safety profile in high-risk patients.
ESMO 2026 Chinese Orals: Dual TKI Improves MET-Amplified Resistance, CS2009 and Ivonescimab Report NSCLC and Thymic Carcinoma Data
Three Chinese-led oral presentations at ESMO 2026 updated data on MET-amplification resistance, NSCLC, and thymic carcinoma. A dual-TKI regimen significantly improved PFS in a randomized phase 3 study: NCT06110663 randomized 314 patients, with IRC-assessed mPFS of 6.2 vs 4.4 months, HR 0.601, P<0.001. CS2009 showed a preliminary ORR/DCR of 81.3%/100% in the evaluable first-line PD-L1 TPS≥50% population.
China Phase 3 briGHt Subgroup: Weekly Lonapegsomatropin Beat Daily GH by 1.26 cm/Year in Ages 3-6 GHD
Visen Pharma reported a subgroup analysis of the China Phase 3 briGHt study. In children with GHD aged 3-6 years, 52 weeks of once-weekly lonapegsomatropin produced an annualized height velocity 1.26 cm/year higher than a daily growth hormone formulation.
STAT+: Novartis multiple sclerosis treatment cuts rates of relapse in pivotal trials
In two Phase 3 trials in relapsing multiple sclerosis, Novartis' remibrutinib reduced the annualized relapse rate by 35.2% and 31.2% compared with Sanofi's Aubagio. Data from REMODEL-1 and REMODEL-2 were presented at MSToronto and published in the Lancet; no Hy's Law cases were seen and rates of elevated liver enzymes were very low.
INTerpath-001 Data Reportedly Leaked Ahead of ESMO 2026, Moderna Shares Plunge
Detailed INTerpath-001 data appear to have leaked ahead of ESMO 2026, raising efficacy questions and sending Moderna shares sharply lower. According to the original report, after a median follow-up of 24.6 months, adding intismeran to pembrolizumab reduced the risk of recurrence or death, HR = 0.58. At 2 years, 82.2% of patients on the combination were alive and recurrence-free versus 70.0% on pembrolizumab alone.
Regulatory and policy
FDA Approves First Once-Weekly Insulin for Type 2 Diabetes Mellitus in Pediatric Patients
The FDA has approved Awiqli (insulin icodec-abae), a long-acting insulin analog, as an adjunct to diet and exercise for children aged 10 and older with type 2 diabetes, given by subcutaneous injection once weekly. A single-dose pharmacokinetic study in 18 such children found the first dose was absorbed faster than in adults, but pharmacometric modeling showed blood levels approached those of adults after the first few doses, so similar glucose lowering is expected.
Sunvozertinib (ZEGFROVY) Launches in the US for EGFR exon20ins Non-Small Cell Lung Cancer
On October 23, 2026, Dizhe Pharmaceutical (Dizhe Cayman) announced that its global strategic partner AstraZeneca has commercially launched sunvozertinib tablets (ZEGFROVY) in the United States. The drug treats adults with locally advanced or metastatic NSCLC harboring confirmed EGFR exon20ins whose disease progressed on or who cannot tolerate prior platinum-based chemotherapy. The second/later-line monotherapy indication is now approved in both China and the US, and the first-line supplemental application has been accepted for review by the CDE and the FDA.
AMA and EMA issue joint guidance on Ebola vaccine development
AMA and EMA have issued a joint position paper on moving candidate vaccines against Ebola disease caused by Bundibugyo virus (BDBV) through clinical trial phases as quickly as possible while maintaining rigorous scientific evaluation and participant safeguards. The paper sets out minimum requirements to start clinical trials and recommends a single-dose vaccine, non-human challenge studies, and a Phase III ring trial based on randomised inclusion of close contacts of confirmed cases. For candidates with well-characterised platform data, postponing or waiving certain animal toxicity studies may be scientifically justified; trials in children and pregnant women should start once sufficient initial adult safety data are available.
Roche flags ‘final opportunity’ for Germany to reestablish as a reliable investment location
Roche says a proposed exemption from mandatory branded-medicine discounts tied to investments in Germany is the country's final opportunity to restore pharma companies' investment confidence, and the proposal must become enforceable law early next year. Germany's reform plan raises the mandatory manufacturer discount on branded medicines from 7% to 15.5% starting Jan. 1, 2027, and a clause proposed by a government committee late last month would allow reductions for companies meeting investment criteria in Germany.
Biohaven’s previously rejected rare disease drug to get fresh FDA review
The FDA has accepted Biohaven's resubmitted application for Vyglxia, a drug intended for spinocerebellar ataxia, with a new decision expected in the first quarter of next year. The company added new supportive analyses, and the FDA will convene an advisory committee to discuss the findings. The application was formally rejected last November over issues including the key trial's design.
medicalxpress.comInternational study helps support FDA approval of HIV drug for newborns
In August 2026 the FDA approved dolutegravir, in combination with other antiretrovirals, for treating HIV-1 infection in full-term newborns from birth to 4 weeks of age who weigh at least 2 kg. The phase 1 IMPAACT 2023 trial enrolled 48 full-term newborns in South Africa, Thailand and the United States and followed them for 16 weeks, finding drug levels comparable to those in treated older children and adults and generally good tolerability.
biocentury.comDraft U.S. outbound investment rule could chill cross-border collaboration
A proposed outbound investment rule released by the U.S. Treasury Department on Thursday would allow U.S. drugmakers to license molecules from Chinese companies, but could restrict joint ventures and manufacturing collaborations, producing a chilling effect on broad cooperation between U.S. and Chinese pharma companies. Treasury officials said the rule does not address licensing deals, but the industry worries joint venture and manufacturing arrangements will be limited.
Industry and deals
Gilead shops in IL-23, inking $1.3B upfront I&I deal with China’s PepStar
Gilead Sciences will acquire PepStar Therapeutics' IL-23R inhibitor program for a $1.3 billion upfront payment, with the deal expected to close by the end of the quarter. The program's asset, HCXT-2001, is an oral macrocyclic peptide inhibitor. Gilead plans to explore it alone or in combination with emvistegrast in IBD, and to extend it to psoriasis.
STAT+: AI drug firm Pathos raises $237 million, pushing valuation to $3 billion
AI drug company Pathos announced a $237 million Series E round led by Bristol Myers Squibb, at a valuation of about $3 billion. Using Tempus AI data and a partnership with BMS, the company will expand from oncology into neurological diseases such as Alzheimer's. Its proprietary model Foundry runs thousands of agents that compute the probability of success for clinical assets, guiding drug selection, population choice, and trial design.
Roche bets up to $813M on Zymeworks’ lung cancer trispecific T cell engager
Roche is paying $55 million upfront for an exclusive global license to Zymeworks' ZW209 and plans to develop it for lung cancer, in a deal worth up to $813 million. If ZW209 begins Phase 1b testing, Roche will pay another $40 million, plus up to $718 million in development, commercial and sales milestones. Zymeworks is eligible for high-single-digit to mid-teen royalties on future net sales.
Protein degrader specialist Lycia prices $318M IPO
Lycia Therapeutics has priced a $318 million IPO, selling more shares than planned. Its stock begins trading Friday on the Nasdaq under the ticker LYCA.
Research papers
youtube.comMultisystem response to a viral infection
youtube.comMatrix remodeling function of Lyve-1+ tissue resident macrophages" by Dr. Veronique Angeli
Perforin triggers iron-induced mitochondrial damage to drive ferroptosis and anti-tumor immunity
Perforin can trigger ferroptosis by promoting iron uptake and mitochondrial iron overload, constituting a tumor cell killing mechanism independent of granzymes. This pathway links cytotoxic immunity to iron metabolism and predicts patient response to immune checkpoint blockade. The authors propose that iron supplementation may be a way to enhance anti-tumor immunity.
Nature Biotechnology study engineers CAR-NK cells in vivo with ligand-directed LNPs
A Nature Biotechnology paper reports that an MIT team built targeted LNPs carrying NK receptor ligands, termed NtLNPs, achieving efficient NK cell transfection in mice and in vivo engineering of CAR-NK cells. The strategy was evaluated for therapeutic potential in B cell depletion, autoimmune hepatitis, solid tumor, and humanized hematologic tumor models.
Taurine lowers inflammaging by regulating the NLRP3 inflammasome in macrophages
Taurine lowers inflammaging by regulating the NLRP3 inflammasome in macrophages. Taurine levels rise with age in both mice and humans; further raising taurine levels in aged mice extends health span and reduces inflammation.
youtube.comA cellular vampire builds the perfect feeding trap / Curr. Biol., June 24, 2026 (Vol. 36, Issue 14)
doi.orgAdhesion integrity activates mechanosensitive proliferative signaling
Experiments in MCF10A cells show that adhesion integrity maintained by P-cadherin and FAK enhances Src-dependent myosin II and ERK activation, and strengthens ERK and SRF signaling to support cell proliferation.
Accessing invasion-competent Plasmodium vivax merozoites reveals antibody-dependent NK cell activation.
Researchers established a platform for synchronized release and isolation of invasion-competent Plasmodium vivax merozoites from ex vivo cultures, and showed that antibody-opsonized merozoites activate human NK cells. Reversible inhibition of parasite egress with the PKG inhibitor ML10 synchronizes parasites at the segmented schizont stage, followed by rapid merozoite release using liposome-based extrusion; recovery exceeds 75% while preserving structural integrity and invasive capacity. The paper was published in Science Advances, DOI: 10.1126/sciadv.aeh3417.
youtube.comHow songbirds fill their brains with new neurons / Curr. Biol., April 17, 2026 (Vol. 36, Issue 9)
Cell-state-specific metabolic networks govern ferroptosis versus apoptosis in small cell lung cancer
Distinct cell states in small cell lung cancer correspond to specific metabolic networks that determine whether cells undergo ferroptosis or apoptosis under metabolic stress. The finding links cell-state differences to metabolic plasticity and provides mechanistic context for how these two death fates arise.
medicalxpress.com'Molecular glue' stabilizes protein that inhibits development of non–small cell lung cancer and uterine cancer
In two peer-reviewed studies, a University of Michigan team showed that RPT04402, a molecular glue targeting PP2A, stabilizes the PP2A complex and suppresses the growth of KRAS-mutant non-small cell lung cancer and high-grade uterine cancer in models.
Human-artificial intelligence collaboration for comanaging epilepsy in real time.
Researchers validated an inpatient prototype in 13 patients with epilepsy, linking scalp and intracranial EEG to a secure AI system based on large language models and communicating bidirectionally with patients through a smartphone app. The system analyzes biomarkers including sleep, medication, cognition and seizure probability, notifies patients of clinical events and trends, records symptoms and responses, and retrains its seizure detector with feedback to reduce false alarms. All patients were undergoing video-EEG monitoring: scalp EEG n = 11, intracranial EEG n = 2.
medicalxpress.comNew gene-editing approach shows promise in treating Huntington's disease in mice
A Cardiff University research team used Cas9 nickase to make single-strand cuts in mouse models of Huntington's disease, shortening CAG/CTG repeats in the majority of targeted neurons and improving motor function.
medicalxpress.com'Average' human genome described for first time, with implications for disease risk
A University of Exeter team analyzed whole-genome data from nearly 1 million individuals in the UK Biobank and All of Us studies to characterize the 'average' human genome for the first time. The paper was published in Genome Medicine, DOI: 10.1186/s13073-026-01792-x.
About 1 in 4 people with depression may have a ‘body clock’ type, like being stuck in permanent jet lag: late sleepers, tired mornings, worse in certain seasons. Across 11,380 people, this group got less benefit and more side effects from antidepressants, so light therapy or melatonin may help more.
A Reddit r/science post reports that a University of Sydney team, drawing on 11,380 participants in an Australian genetics-of-depression study, identified a circadian depression subtype affecting about 23-25% of participants, marked by late sleep, morning fatigue, and seasonal worsening. This subtype got less benefit and more side effects from antidepressants, suggesting light therapy or melatonin may be better matched to it.
Methods and resources
youtube.comA platform for multimodal in vivo pooled genetic screens reveals regulators of liver function
youtube.comHow to eat a good apoptotic meal – lessons from phagocytes" by Dr. Kodi Ravichandran
youtube.comMultimodal Data Integration: From Biomarkers to Mechanisms
youtube.comRory Power: Advanced custom microscopy development for service provision at the EMBL Imaging Centre
youtube.comAndrew Moore: Untangling Intermediate Filament Biology with FilaBuster: A New Tool for Light-Cont...
PsychAD Releases Largest Single-Cell Atlas of Human Brain Disease, Covering Over 6.3 Million Nuclei
On September 23, 2026, the PsychAD project published in Nature and related journals a human brain single-cell atlas covering 1494 deceased donors and more than 6.3 million nuclei, with samples taken from the dorsolateral prefrontal cortex.
Opinion and commentary
youtube.comBuilding a Petabyte-Scale Pipeline For AI-Accelerated in vivo Cell Biology
Precision Care for HER2-Altered Advanced NSCLC Continues to Advance
Precision treatment of advanced NSCLC with HER2 mutations or overexpression is moving from later-line ADC therapy toward first-line regimens and combination treatment, and HER2 TKIs are adding to the treatment options.
youtube.comPlasmodium liver stage: silently making a bang" by Dr. Maria Mota
Imprecise Label in the Precision Medicine Era: FDA Approval of Daraxonrasib
The FDA has approved the pan-RAS inhibitor daraxonrasib for previously treated metastatic pancreatic adenocarcinoma. The RASolute 302 trial showed a median overall survival of 13.2 months (HR 0.40), but the label's extension to patients "not suitable for multi-drug systemic therapy" has drawn controversy.