Recently, across ChinaBallPeptideAnd fewNucleotide (TIDES）Field WelcomesComeSeriesInExpand。Novel Cancer ImmunotherapyELI-002 7P Phase 2 Clinical Trial Data Shows Promising Results,InNearly 100%CarryKRASMutation (mKRAS) Patients with pancreatic ductal adenocarcinomam was induced in ChinaKRASSpecific T cellsCell Response.Potential "first-in-class"Oncolytic PeptideVP-315In a study targetingBasalPatients with cellular carcinomaIn the phase 2 study, the objective response rate of the post-hoc analysis reached 97%, and the histological complete clearance rate reached 51%.Dawnz of Ionis Pharmaceuticalsera（donidalorsen）ObtainEuropean Medicines Agency (EMA)Recommended for Listing，For the prevention of individuals aged 12 years and aboveHereditary Angioedema (HAE) Attacks in Adult and Pediatric Patients.ThisWenA brief introduction to some of the important advances will be provided, only.For readers' reference.

ELI-002 7P: Phase 2 Clinical Trial Data Release

Elicio Therapeutics, Inc. announced the ongoing Phase 2 AMPLIFY-7P trial, where ELI-002 7P is used for treating patients carrying mKRASLatest Immunogenicity Data for Patients with Pancreatic Ductal Adenocarcinoma.ELI-002 is a novel cancer immunotherapy developed by the company, consisting of AMP-modified mKRASComposed of peptide antigens and AMP-modified CpG adjuvant ELI-004, aimed at targeting KRAS-driven tumors.Among them, ELI-002 7P contains the seven most common mKRASPeptide Antigen.

In the AMPLIFY-7P trial,ELI-002 7P induced m in 99% (89/90) of efficacy-evaluable patients.KRASSpecific T-cell responses, demonstrating strong and consistent immune activation capabilities.All seven mKRASAntigens triggered potent responses, with response rates for each mutation exceeding 80%. Additionally, 88% of patients generated immune responses to their own tumor-specific mutations. Furthermore, 86.8% (66/76) of patients exhibited cytotoxic m.KRASSpecific T-cell responses were observed, with 75% of patients activating both CD8 and CD4 T cells. Notably, these immune responses were detected across multiple HLA types, indicating that ELI-002 7P holds promise for application in a broad and genetically diverse patient population.

VP-315 (Ruxotemitide): Phase 2 Clinical Trial Data Released

Verrica Pharmaceuticals announced the results of a Phase 2 exploratory analysis of its potential "first-in-class" investigational new drug VP-315 (ruxotemitide).VP-315 is an oncolytic peptide immunotherapy that directly induces immunogenic cell death through intratumoral injection, thereby releasing various tumor antigens to activate T-cell responses.The drug is developed based on natural "host defense peptides" research, aiming to provide a non-surgical treatment option for skin cancer patients. Verrica Pharmaceuticals Inc. holds the global exclusive license for the development and commercialization of VP-315 for certain skin tumor indications, including non-metastatic melanoma and non-metastatic Merkel cell carcinoma, and intends to initially focus on basal cell carcinoma and squamous cell carcinoma as the primary indications for development.

Data show that VP-315 can remodel the tumor microenvironment, significantly increase the infiltration of cytotoxic T cells, and reduce immunosuppressive regulatory T cells. This immune mechanism provides theoretical support for the previously reported excellent clinical efficacy:In patients with basal cell carcinoma, the objective response rate of the post-hoc analysis reached 97%, and the histological complete clearance rate reached 51%.Combined with its proven good safety, VP-315 is expected to become a non-surgical immunotherapy drug for skin cancer.

Donidalorsen：Recommended for marketing authorization by EMA

EMA Announces CHMP Recommends Approval of Ionis Pharmaceuticals' Dawnzera (donidalorsen) for Prevention of HAE Attacks in Adults and Children Aged 12 Years and OlderDawnzera is a ligand-conjugated antisense oligonucleotide (LICA) drug designed to precisely target and silence the expression of plasma prekallikrein (PKK), interrupting the signaling pathway responsible for HAE attacks.PKK plays an important role in activating inflammatory mediators associated with acute HAE attacks.

Previously announced results from the Phase 3 OASIS-HAE clinical study showed that the trial met its primary endpoint. Compared to placebo, patients receiving Dawnzera subcutaneous injections once every four weeks (Q4W) experienced an 81% significant reduction in mean monthly HAE attack rates over 24 weeks. When evaluated from the second dose onwards, the average attack rate was reduced by 87% (a key secondary endpoint). Additionally,Starting from the second dose, Dawnzera reduced moderate to severe HAE attacks by approximately 90% over 24 weeks.

These results are further supported by the ongoing OASISplus open-label extension (OLE) study. In this study, over time, patients receiving Dawnzera treatment once every eight weeks (Q8W) demonstrated efficacy similar to that of Q4W.In the OLE study, both dosing regimens achieved a 94% reduction in the overall average seizure rate from baseline after one year.

IBI3016: Phase 1 Clinical Trial Data Released

Innovent Biologics and Saint-Bio jointly announced the first-in-human Phase 1 clinical study of their co-developed angiotensinogen (AGT)-targeting small interfering RNA (siRNA) drug IBI3016 for the treatment of hypertension.Main ResultsIBI3016 is developed based on Saint Biotech's proprietary small nucleic acid drug development platform using GalNAc liver-targeting delivery technology, inhibiting the synthesis of AGT through the RNAi mechanism.Preclinical trial data show that IBI3016 can inhibit the synthesis of AGT in the liver, which may lead to a sustained reduction in AGT protein, further resulting in a decrease in Ang II, ultimately causing vasodilation and blood pressure reduction.

As of July 1, 2025, a total of 40 healthy subjects and subjects with mild hypertension were randomly assigned to 5 cohorts (the ratio of IBI3016 dose group to placebo group in each cohort was 6:2). Single dosing of IBI3016 achieved a sustained and potent reduction in AGT levels as well as a preliminary decrease in blood pressure.: Serum AGT levels were significantly and persistently reduced, with a maximum reduction of over 95%, and the reduction remained stable for 6 months; at 3 months, all dose groups of IBI3016 achieved a decrease in blood pressure.IBI3016 demonstrated good safety and tolerability within 6 months, with no severe adverse events or serious adverse events observed, and no hypotension events occurred. All adverse events were mild to moderate and reversible.

RN0361: Announcement of Phase 1 Clinical Trial Data

Daru Biotech announced its long-acting ApoC3-targeted siRNA drug RN0361 for the treatment of patients with dyslipidemia.Phase 1 Clinical Study ResultsPublicly available data shows that the elevation of ApoC3 promotes the aggregation of triglyceride-rich lipoproteins, thereby increasing the risk of acute pancreatitis and cardiovascular diseases, especially in patients with diabetes. Current treatment options often struggle to achieve sustained control in critically ill patients.

The results announced this time show,RN0361 shows significantDose-dependentApoC3 and TG Inhibition Effects Persist Until Day 180 Post-Dosing, with ApoC3 Reduction Reaching up to 93% and Triglyceride Reduction up to 69%.Meanwhile, RN0361 also achieved significant and sustained reductions in non-high-density lipoprotein cholesterol, very low-density lipoprotein cholesterol, and remnant cholesterol. The product was well-tolerated with no serious adverse events observed; injection site reactions were mild and self-limiting; transient elevations in ALT and AST were consistent with the typical characteristics of GalNAc-conjugated siRNA drugs.

Olezarsen: Phase 3 Clinical Trial Data Released

Ionis Pharmaceuticals announced that its antisense oligonucleotide therapy, olezarsen, achieved positive results in the CORE and CORE2 pivotal Phase 3 studies conducted in patients with severe hypertriglyceridemia (sHTG).Positive Results。Olezarsen aims to inhibit the body's production of ApoC3.。The U.S. FDA granted the therapy Orphan Drug Designation and Breakthrough Therapy Designation (BTD) in February 2024, and approved it in December as an adjunct to dietary control to reduce triglycerides in adult patients with familial chylomicronemia syndrome.

Research showsOlezarsen achieved a significant reduction of up to 72% in placebo-adjusted fasting triglyceride (TG) levels at 6 months, and this reduction was maintained at 12 months.At the same time, olezarsen significantly reduced the risk of acute pancreatitis events by 85%, with good safety and tolerability. According to the press release.，This is the first investigational treatment regimen that has significantly reduced the incidence of acute pancreatitis events in sHTG patients.

Eloralintide (LY3841136): Phase 2 Clinical Trial Data Released

Eli Lilly and Company announced today that its investigational weight-loss peptide therapy, eloralintide (LY3841136), met the primary endpoint in a Phase 2 clinical trial. Based on these results, Eli Lilly plans to initiate patient enrollment next month for a Phase 3 clinical study of eloralintide for the treatment of obesity.Eloralintide is a once-weekly subcutaneously injected selective long-acting amylin receptor agonist with good tolerability and clear weight loss effects.

The trial enrolled a total of 263 adult subjects who were obese or overweight with at least one obesity-related comorbidity but without type 2 diabetes.At Week 48, all eloralintide treatment groups reached the primary endpoint, with average weight reductions ranging from 9.5% to 20.1%, compared to only 0.4% in the placebo group, demonstrating a significant efficacy difference.In addition, the trial also showed that all doses of eloralintide demonstrated clinically meaningful improvements over placebo in secondary endpoints such as weight loss and reduction in Body Mass Index (BMI). Moreover, the treatment was associated with comprehensive improvements in cardiometabolic risk markers, including decreases in waist circumference, blood pressure, lipid levels, blood glucose control, and inflammatory marker levels.

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