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Gilead Provides Update on Phase 3 ASCENT-07 Study

On November 7, 2025 Gilead Sciences, Inc. (Nasdaq: GILD) reported the Phase 3 ASCENT-07 study investigating Trodelvy (sacituzumab govitecan-hziy) versus chemotherapy as a first-line treatment post-endocrine therapy in HR+/HER2-negative metastatic breast cancer patients did not meet the primary endpoint of progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR) according to RECIST v1.1 criteria.

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Overall survival is a key secondary endpoint and was not mature at the time of the primary analysis; however, an early trend was observed favoring patients treated with Trodelvy compared to chemotherapy. The ASCENT-07 study will continue to further assess overall survival.

"HR+/HER2-negative metastatic breast cancer is a highly heterogeneous disease, and this complexity makes it particularly challenging to manage, especially in patients whose disease has already progressed on multiple lines of endocrine therapy," said Hope S. Rugo, MD, ASCENT-07 Principal Investigator, Chief, Division of Breast Oncology, Director of Women’s Cancer Program, City of Hope Comprehensive Cancer Center. "It will be critical that we continue to follow patients for overall survival to better understand the potential impact of sacituzumab govitecan long-term in this treatment setting."

The safety profile was consistent with prior Trodelvy breast cancer studies and no new safety signals were identified in this patient population.

"Trodelvy remains a standard of care for pre-treated HR+/HER2-negative metastatic breast cancer based on the demonstrated overall survival results seen in the TROPiCS-02 study," said Dietmar Berger, MD, PhD, Chief Medical Officer, Gilead Sciences. "We are deeply grateful to the patients, their families, advocates, and investigators who continue to contribute to this important research. We look forward to sharing the full data of ASCENT-07 at an upcoming medical conference."

Trodelvy is the only globally approved Trop-2-directed antibody-drug conjugate (ADC) to show meaningful overall survival advantages in two distinct types of metastatic breast cancer: pre-treated HR+/HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) metastatic breast cancer and second-line and later metastatic triple-negative breast cancer (TNBC). Trodelvy is recognized as a Category 1 preferred treatment for both approved indications per the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelinesi) and is the only ADC with a European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) rating of 5 for metastatic TNBC and a rating of 4 for HR+/HER2-negative mBC.

Trodelvy also stands as the only ADC to demonstrate a statistically significant and clinically meaningful PFS improvement in the first-line metastatic TNBC setting regardless of PD-L1 status across two positive Phase 3 studies (ASCENT-04 and ASCENT-03) presented earlier this year.

Gilead continues to build on this foundation with a robust development program exploring Trodelvy across multiple disease stages and tumor types, including the ongoing Phase 3 ASCENT-05 study in high-risk early-stage TNBC (eTNBC) and additional Phase 3 studies evaluating its potential in lung and gynecologic cancers.

The use of Trodelvy in patients as a first treatment post-endocrine therapy in HR+/HER2-negative metastatic breast cancer is investigational, and its safety and efficacy have not been established in this population. The use of Trodelvy in first-line metastatic TNBC is also investigational and the safety and efficacy have not been established for that use.

About HR+/HER2-negative Metastatic Breast Cancer (First Treatment Post-Endocrine Therapy)
HR+/HER2-negative is the most common breast cancer subtype, representing ~70% of cases (~400,000 diagnoses globally each year). While endocrine therapies have extended survival, nearly all patients with metastatic disease eventually progress and become resistant. Once patients are no longer candidates for endocrine therapy, chemotherapy becomes the primary treatment option but is often linked to higher rates of disease resistance and limited clinical outcomes. Attrition between treatment lines is substantial, underscoring the need for more effective and better-tolerated options earlier in care, regardless of IHC status (IHC 0, 1+, 2+/ISH-).

About the ASCENT-07 Study
The ASCENT-07 study is a global, open-label, randomized Phase 3 trial evaluating the efficacy and safety of Trodelvy (sacituzumab govitecan-hziy) compared with treatment of physician’s choice chemotherapy in patients with locally advanced, inoperable, or HR+/HER2-negative (IHC 0, IHC 1+, or IHC 2+/ISH-) metastatic breast cancer who have received prior endocrine therapy and are candidates for cytotoxic chemotherapy. The study enrolled 654 patients across nearly 30 countries.

Patients were randomized 2:1 to receive either sacituzumab govitecan-hziy (10 mg/kg intravenously on Days 1 and 8 of a 21-day cycle) or treatment of physician’s choice, which included a choice of single-agent chemotherapy including capecitabine, paclitaxel and nab-paclitaxel. Treatment continued until BICR-verified disease progression or unacceptable toxicity.

The primary endpoint of the study is PFS as assessed by BICR according to RECIST v1.1 criteria. Key secondary endpoints include overall survival, objective response rate, quality of life, and safety.

More information about ASCENT-07 is available at ClinicalTrials.gov: NCT05840211.

About Trodelvy
Trodelvy (sacituzumab govitecan-hziy) is a first-in-class Trop-2-directed antibody-drug conjugate. Trop-2 is a cell surface antigen highly expressed in multiple tumor types, including in more than 90% of breast and lung cancers. Trodelvy is intentionally designed with a proprietary hydrolyzable linker attached to SN-38, a topoisomerase I inhibitor payload. This unique combination delivers potent activity to both Trop-2 expressing cells and the tumor microenvironment through a bystander effect.

Trodelvy is currently approved in more than 50 countries for second-line or later metastatic triple-negative breast cancer (TNBC) patients and in more than 40 countries for certain patients with pre-treated HR+/HER2-negative metastatic breast cancer. With more than 60,000 cancer patients treated globally over the past five years, healthcare professionals have extensive real-world experience with Trodelvy, which has shown generally consistent outcomes across clinical and real-world settings.

Trodelvy is currently being evaluated in multiple ongoing Phase 3 trials across a range of tumor types with high Trop-2 expression. These studies with Trodelvy, both in monotherapy and in combination with pembrolizumab, involve earlier lines of treatment for TNBC and HR+/HER2-negative breast cancer—including in curative settings—as well as in lung and gynecologic cancers, where previous proof-of-concept studies have demonstrated clinical activity.

INDICATIONS

TRODELVY (sacituzumab govitecan-hziy) is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with:

Unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.
Unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.
IMPORTANT SAFETY INFORMATION
BOXED WARNING: NEUTROPENIA AND DIARRHEA

TRODELVY can cause severe, life-threatening, or fatal neutropenia. Withhold TRODELVY for absolute neutrophil count below 1500/mm3 or neutropenic fever. Monitor blood cell counts periodically during treatment. Primary prophylaxis with G-CSF is recommended for all patients at increased risk of febrile neutropenia. Initiate anti-infective treatment in patients with febrile neutropenia without delay.
TRODELVY can cause severe diarrhea. Monitor patients with diarrhea and give fluid and electrolytes as needed. At the onset of diarrhea, evaluate for infectious causes and, if negative, promptly initiate loperamide. If severe diarrhea occurs, withhold TRODELVY until resolved to ≤ Grade 1 and reduce subsequent doses.
CONTRAINDICATIONS

Severe hypersensitivity reaction to TRODELVY.
WARNINGS AND PRECAUTIONS

Neutropenia: Severe, life-threatening, or fatal neutropenia can occur as early as the first cycle of treatment and may require dose modification. Neutropenia occurred in 64% of patients treated with TRODELVY. Grade 3-4 neutropenia occurred in 49% of patients. Febrile neutropenia occurred in 6%. Neutropenic colitis occurred in 1.4%. Primary prophylaxis with G-CSF is recommended starting in the first cycle of treatment in all patients at increased risk of febrile neutropenia, including older patients, patients with previous neutropenia, poor performance status, organ dysfunction, or multiple comorbidities. Monitor absolute neutrophil count (ANC) during treatment. Withhold TRODELVY for ANC below 1500/mm3 on Day 1 of any cycle or below 1000/mm3 on Day 8 of any cycle. Withhold TRODELVY for neutropenic fever. Treat neutropenia with G-CSF and administer prophylaxis in subsequent cycles as clinically indicated or indicated in Table 2 of USPI.

Diarrhea: Diarrhea occurred in 64% of all patients treated with TRODELVY. Grade 3-4 diarrhea occurred in 11% of patients. One patient had intestinal perforation following diarrhea. Diarrhea that led to dehydration and subsequent acute kidney injury occurred in 0.7% of all patients. Withhold TRODELVY for Grade 3-4 diarrhea and resume when resolved to ≤ Grade 1. At onset, evaluate for infectious causes and if negative, promptly initiate loperamide, 4 mg initially followed by 2 mg with every episode of diarrhea for a maximum of 16 mg daily. Discontinue loperamide 12 hours after diarrhea resolves. Additional supportive measures (e.g., fluid and electrolyte substitution) may also be employed as clinically indicated. Patients who exhibit an excessive cholinergic response to treatment can receive appropriate premedication (e.g., atropine) for subsequent treatments.

Hypersensitivity and Infusion-Related Reactions: TRODELVY can cause serious hypersensitivity reactions including life-threatening anaphylactic reactions. Severe signs and symptoms included cardiac arrest, hypotension, wheezing, angioedema, swelling, pneumonitis, and skin reactions. Hypersensitivity reactions within 24 hours of dosing occurred in 35% of patients. Grade 3-4 hypersensitivity occurred in 2% of patients. The incidence of hypersensitivity reactions leading to permanent discontinuation of TRODELVY was 0.2%. The incidence of anaphylactic reactions was 0.2%. Pre-infusion medication is recommended. Have medications and emergency equipment to treat such reactions available for immediate use. Observe patients closely for hypersensitivity and infusion-related reactions during each infusion and for at least 30 minutes after completion of each infusion. Permanently discontinue TRODELVY for Grade 4 infusion-related reactions.

Nausea and Vomiting: TRODELVY is emetogenic and can cause severe nausea and vomiting. Nausea occurred in 64% of all patients treated with TRODELVY and Grade 3-4 nausea occurred in 3% of these patients. Vomiting occurred in 35% of patients and Grade 3-4 vomiting occurred in 2% of these patients. Premedicate with a two or three drug combination regimen (e.g., dexamethasone with either a 5-HT3 receptor antagonist or an NK1 receptor antagonist as well as other drugs as indicated) for prevention of chemotherapy-induced nausea and vomiting (CINV). Withhold TRODELVY doses for Grade 3 nausea or Grade 3-4 vomiting and resume with additional supportive measures when resolved to Grade ≤ 1. Additional antiemetics and other supportive measures may also be employed as clinically indicated. All patients should be given take-home medications with clear instructions for prevention and treatment of nausea and vomiting.

Increased Risk of Adverse Reactions in Patients with Reduced UGT1A1 Activity: Patients homozygous for the uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28 allele are at increased risk for neutropenia, febrile neutropenia, and anemia and may be at increased risk for other adverse reactions with TRODELVY. The incidence of Grade 3-4 neutropenia was 58% in patients homozygous for the UGT1A1*28, 49% in patients heterozygous for the UGT1A1*28 allele, and 43% in patients homozygous for the wild-type allele. The incidence of Grade 3-4 anemia was 21% in patients homozygous for the UGT1A1*28 allele, 10% in patients heterozygous for the UGT1A1*28 allele, and 9% in patients homozygous for the wild-type allele. Closely monitor patients with known reduced UGT1A1 activity for adverse reactions. Withhold or permanently discontinue TRODELVY based on clinical assessment of the onset, duration and severity of the observed adverse reactions in patients with evidence of acute early-onset or unusually severe adverse reactions, which may indicate reduced UGT1A1 function.

Embryo-Fetal Toxicity: Based on its mechanism of action, TRODELVY can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. TRODELVY contains a genotoxic component, SN-38, and targets rapidly dividing cells. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TRODELVY and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with TRODELVY and for 3 months after the last dose.

ADVERSE REACTIONS

In the pooled safety population, the most common (≥ 25%) adverse reactions including laboratory abnormalities were decreased leukocyte count (84%), decreased neutrophil count (75%), decreased hemoglobin (69%), diarrhea (64%), nausea (64%), decreased lymphocyte count (63%), fatigue (51%), alopecia (45%), constipation (37%), increased glucose (37%), decreased albumin (35%), vomiting (35%), decreased appetite (30%), decreased creatinine clearance (28%), increased alkaline phosphatase (28%), decreased magnesium (27%), decreased potassium (26%), and decreased sodium (26%).

In the ASCENT study (locally advanced or metastatic triple-negative breast cancer), the most common adverse reactions (incidence ≥25%) were fatigue, diarrhea, nausea, alopecia, constipation, vomiting, abdominal pain, and decreased appetite. The most frequent serious adverse reactions (SAR) (>1%) were neutropenia (7%), diarrhea (4%), and pneumonia (3%). SAR were reported in 27% of patients, and 5% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the ASCENT study were reduced neutrophils, leukocytes, and lymphocytes.

In the TROPiCS-02 study (locally advanced or metastatic HR-positive, HER2-negative breast cancer), the most common adverse reactions (incidence ≥25%) were diarrhea, fatigue, nausea, alopecia, and constipation. The most frequent serious adverse reactions (SAR) (>1%) were diarrhea (5%), febrile neutropenia (4%), neutropenia (3%), abdominal pain, colitis, neutropenic colitis, pneumonia, and vomiting (each 2%). SAR were reported in 28% of patients, and 6% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the TROPiCS-02 study were reduced neutrophils and leukocytes.

DRUG INTERACTIONS

UGT1A1 Inhibitors: Concomitant administration of TRODELVY with inhibitors of UGT1A1 may increase the incidence of adverse reactions due to potential increase in systemic exposure to SN-38. Avoid administering UGT1A1 inhibitors with TRODELVY.

UGT1A1 Inducers: Exposure to SN-38 may be reduced in patients concomitantly receiving UGT1A1 enzyme inducers. Avoid administering UGT1A1 inducers with TRODELVY.

Please see full Prescribing Information, including BOXED WARNING.

(Press release, Gilead Sciences, NOV 7, 2025, View Source [SID1234659644])

Phio Pharmaceuticals to Present Recent Clinical Results from Skin Cancer Trial with siRNA based INTASYL PH-762

On November 7, 2025 Phio Pharmaceuticals Corp. (NASDAQ: PHIO) a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL gene silencing technology to eliminate cancer, reported that it will present clinical data from its ongoing Phase 1b clinical trial at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), which will be held in National Harbor, Maryland from November 7-9, 2025.

Phio’s poster presentation will highlight the clinical results from the ongoing Phase 1b dose escalation clinical trial. This clinical trial is designed to evaluate the safety and tolerability of intratumoral injection of PH-762 in patients with cutaneous squamous carcinoma, Merkel cell carcinoma, and melanoma.

Presentation Details are as follows:

Title: PD-1 Directed Intratumoral Immunotherapy for Cutaneous Carcinomas: A Clinical Study of INTASYL PH-762
Abstract Number: 610
Presenting Author: Mary Spellman, M.D.
Date: Saturday November 8, 2025
Location: Prince George ABC Exhibit Halls Gaylord National Resort and Convention Center

(Press release, Phio Pharmaceuticals, NOV 7, 2025, View Source [SID1234659643])

Xilio Therapeutics Announces Late-Breaking Phase 2 Data for Vilastobart in Patients with MSS mCRC and High Plasma Tumor Mutational Burden at Society for Immunotherapy of Cancer (SITC) 40th Annual Meeting

On November 7, 2025 Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology therapies for people living with cancer, reported new data from its ongoing Phase 2 clinical trial evaluating vilastobart, a tumor-activated, Fc-enhanced anti-CTLA-4, in combination with atezolizumab (Tecentriq) in patients with microsatellite stable (MSS) metastatic colorectal cancer (mCRC). A 40% objective response rate (ORR) was demonstrated in heavily pre-treated patients with MSS mCRC without liver metastases and with high plasma TMB (≥10 mutations/Mb), as well as a statistically significant correlation between plasma TMB status and response. These new clinical data are being presented in a late-breaking poster presentation (Abstract # 1315) today at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 40th Annual Meeting, taking place from November 5-9, 2025, in National Harbor, Maryland.

"These compelling new Phase 2 data for vilastobart in combination with atezolizumab demonstrated a 40% objective response rate in heavily pre-pretreated patients with MSS mCRC without liver metastases and with high plasma TMB, signifying an important advance in our understanding of response to novel immunotherapy in MSS mCRC," said Katarina Luptakova, M.D., chief medical officer of Xilio. "In addition, these data showed a statistically significant correlation between plasma-based TMB and response. We estimate that approximately 55% of patients with MSS CRC have high plasma TMB, representing a meaningful patient population who could ultimately benefit from combination treatment with vilastobart and a substantially greater prevalence of patients with high TMB than previously estimated using traditional tissue-based assays."

"These new data highlight the potential to use plasma TMB as a predictive biomarker and identify patients with MSS mCRC who may benefit from treatment with vilastobart, a tumor-activated anti-CTLA-4, in combination with a PD-(L)1," said Diwakar Davar, M.D., Associate Professor of Medicine, Clinical Director of the Melanoma Program and Medical Oncologist/Hematologist at the UPMC Hillman Cancer Center. "This biomarker guided approach, utilizing a feasible and reproducible biomarker, together with vilastobart’s differentiated safety profile, continue to support the promising opportunity for vilastobart in combination with PD-(L)1 or PD1-VEGF in MSS mCRC, as well as other tumor types."

Promising Opportunity for Plasma-Based TMB as a Biomarker Predictive of Response to Combination Treatment with Vilastobart in Patients with MSS mCRC

Tissue-based TMB has demonstrated potential as a biomarker predictive of response to immune checkpoint inhibitors in many tumor types. However, tissue-based TMB assays have not shown predictive utility in MSS mCRC historically, and these tissue-based assays may underestimate the mutational burden in patients. In particular, tissue-based assays are limited to evaluating mutations in a single-site biopsy specimen, which is typically taken once at the time of diagnosis, and cannot account for tumor heterogeneity or changes in TMB over time.

Newer plasma-based assays show potential to better assess TMB status and be used as a biomarker predictive of response in patients with MSS mCRC. These plasma-based assays are more sensitive than traditional tissue-based assays in that plasma-based TMB assays provide a comprehensive assessment of mutational load and account for tumor heterogeneity. In addition, plasma can be readily obtained from blood samples throughout the course of treatment, accounting for changes in TMB over time without the need for invasive procedures.

Approximately 55% of non-MSI-H CRC patients were plasma TMB high (>10 mutations/Mb) based on an analysis of the GuardantINFORM real-world clinical-genomic database in approximately 8,000 patients who received the Guardant360 Liquid (Infinity) assay and who had non-MSI-H disease and a reportable TMB result. In contrast, historical data for tissue-based TMB assays have suggested <10% of patients with MSS mCRC were TMB-high.

These data support the meaningful opportunity to use plasma-based TMB as a biomarker predictive of response to combination treatment with vilastobart in patients with MSS mCRC.

New Data from Phase 2 Trial for Vilastobart in Combination with Atezolizumab in Patients with MSS mCRC Without Liver Metastases and with High Plasma TMB

As of a data cutoff date of May 12, 2025, 44 patients with MSS mCRC had been treated with the combination of vilastobart at 100 mg once every six weeks (Q6W) and atezolizumab at 1200 mg once every three weeks (Q3W), including 27 patients without liver metastases. Patients were heavily pre-treated, with 80% having previously received three or more prior lines of anti-cancer therapy.

In a retrospective analysis, 24 patients without liver metastases were evaluable for plasma TMB status. Baseline plasma TMB was assessed using the Guardant360 Liquid (Infinity) assay, and patients with TMB ≥10 mutations/Mb were defined as having high plasma TMB.

Clinical Efficacy Data

40% ORR in patients with MSS mCRC without liver metastases and high plasma TMB, with statistically significant correlation (p=0.05) between plasma TMB status and response.

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40% ORR in plasma TMB-high patients, consisting of six partial responses (PRs), with five confirmed PRs (with one confirmed after the data cutoff date) and one unconfirmed PR.

•
In patients evaluable for plasma TMB status, 62.5% were TMB-high. All responders who were evaluable for plasma TMB status were TMB-high, and the correlation between plasma TMB status and response was statistically significant (p=0.05).

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As previously reported, responses were deep and durable, with reductions in target lesions of up to 71% from baseline.

Safety Data

Vilastobart in combination with atezolizumab continued to demonstrate a differentiated and generally well-tolerated safety profile. Treatment-related adverse events (AEs) were primarily Grade 1 or 2, consistent with the tumor-activated design for vilastobart.

As previously reported, across all patients treated as of a data cutoff date of May 12, 2025 (n=44), the combination of vilastobart at 100 mg Q6W and atezolizumab at 1200 mg Q3W was generally well-tolerated. Treatment-related AEs were primarily Grade 1 or 2. Only two patients (5%) discontinued treatment for the combination of vilastobart and atezolizumab due to a treatment-related AE, and only three patients (7%) experienced colitis of any grade.

Clinical Development Plans for Vilastobart

Based on the promising clinical activity and safety profile demonstrated by vilastobart as a combination therapy, including in patients who had high plasma TMB, Xilio is actively seeking a partner to develop vilastobart in combination with PD-(L)1 or PD1-VEGF in MSS CRC and other tumor types.

Investor Conference Call Information

Xilio will host a conference call and webcast on Monday, November 10, 2025, at 4:30 p.m. ET. The webcast will feature a discussion with expert clinicians Aparna Parikh, M.D., Associate Professor of Medicine, Harvard Medical School, Program Director, GI Medical Oncology, Colorectal, Anal, and Neuroendocrine, Director of the MGB Global Cancer Care Program, Mass General Brigham Cancer Institute, Boston, MA, and Diwakar Davar, M.D., Associate Professor of Medicine, Clinical Director of the Melanoma Program and Medical Oncologist/Hematologist at the UPMC Hillman Cancer Center, Pittsburgh, PA. During the webcast, Xilio will discuss the new Phase 2 combination data for vilastobart and the promising opportunity to use high plasma TMB as a predictive biomarker for response, as well as briefly highlight additional data updates presented at SITC (Free SITC Whitepaper) across the company’s portfolio of differentiated masked immunotherapies.

Viewers can access the webcast by using this link. Listeners are encouraged to join at least 15 minutes prior to the scheduled start time. The webcast will also be accessible under "Events & Presentations" in the "Investors & Media" section of the Xilio Therapeutics website at ir.xiliotx.com. A replay of the webcast will be archived on the website for 30 days following the presentation.

About Vilastobart and the Phase 1/2 Combination Clinical Trial

Vilastobart is an investigational tumor-activated, Fc-enhanced, high affinity binding anti-CTLA-4 monoclonal antibody designed to block CTLA-4 and deplete regulatory T cells when activated in the tumor microenvironment (TME). In 2023, Xilio entered into a co-funded clinical trial collaboration with Roche to evaluate vilastobart in combination with atezolizumab (Tecentriq) in a multi-center, open-label Phase 1/2 clinical trial. Xilio is currently evaluating the safety of the combination in Phase 1C dose escalation in patients with advanced solid tumors and the efficacy and safety of the combination in Phase 2 in patients with microsatellite stable (MSS) metastatic colorectal cancer (mCRC) with and without liver metastases. Please refer to NCT04896697 on www.clinicaltrials.gov for additional details.

(Press release, Xilio Therapeutics, NOV 7, 2025, View Source [SID1234659642])

Soligenix Announces Recent Accomplishments and Third Quarter 2025 Financial Results

On November 7, 2025 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported its recent accomplishments and financial results for the quarter ended September 30, 2025.

"We remain focused on multiple upcoming milestones before year-end, including top-line results from our Phase 2a clinical trial in mild-to-moderate psoriasis with SGX302 (synthetic hypericin) and an enrollment update for the confirmatory Phase 3 study evaluating HyBryte (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL)," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "Recently, we were pleased to announce that the first Data Monitoring Committee (DMC) meeting for the confirmatory Phase 3 study evaluating HyBryte in the treatment of CTCL had concluded that there were no safety concerns, with HyBryte demonstrating an acceptable safety profile that remains consistent with the safety data from all prior clinical studies. Looking ahead to 2026, Phase 3 enrollment remains on track with top-line results anticipated in the second half of 2026."

Dr. Schaber continued, "With approximately $10.5 million in cash at September 30, 2025, we’re focused on carefully allocating resources to hit our strategic goals and upcoming milestones. While this cash balance provides sufficient operating runway through 2026, we continue to evaluate all strategic options, including partnership, merger and acquisition, government grants, and potential financing opportunities to advance our late-stage pipeline and the Company."

Soligenix Recent Accomplishments

On October 14, 2025, the Company announced the update of its United States (U.S.) Medical Advisory Board (MAB) for CTCL to provide medical/clinical strategic guidance to the Company as it advances the Phase 3 clinical development of HyBryte. To view this press release, please click here.
On October 7, 2025, the Company announced its first DMC meeting for its confirmatory Phase 3 study evaluating HyBryte in the treatment of CTCL had concluded that there were no safety concerns and that HyBryte has an acceptable safety profile that remains consistent with the safety data from all prior clinical studies. To view this press release, please click here.
On September 30, 2025, the Company announced the expansion of its European MAB to provide additional medical/clinical strategic guidance to the Company as it advances its confirmatory Phase 3 d study evaluating the safety and efficacy of HyBryte. To view this press release, please click here.
On September 29, 2025, the Company announced the closing of its previously announced public offering with participation from existing and certain healthcare focused institutional investors. To view this press release, please click here.
On September 23, 2025, the Company announced the appointment of Tomas J. Philipson, PhD as a Strategic Advisor, given his extensive experience and relationships at the highest levels of government, including with U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services. To view this press release, please click here.
On September 4, 2025, the Company announced a publication describing the extended stability of ebolavirus vaccines using its ThermoVax platform. To view this press release, please click here.
On August 18, 2025, the Company announced that the Office of Orphan Products Development of the FDA had granted orphan drug designation to dusquetide, the active ingredient in SGX945, for "treatment of Behçet’s Disease" following review of positive Phase 2a clinical results demonstrating biological efficacy and safety in patients with Behçet’s Disease. To view this press release, please click here.
Financial Results – Quarter Ended September 30, 2025

Soligenix reported no revenue for the quarters ended September 30, 2025 and 2024.

Soligenix’s net loss was $2.5 million, or ($0.58) per share, for the quarter ended September 30, 2025, compared to $1.7 million, or ($0.78) per share, for the quarter ended September 30, 2024. This increase in net loss was primarily due to an increase in operating expenses related to ongoing clinical trials and a decrease in interest income and a CARES Act employee retention credit received during the three months ended September 30, 2024 with no corresponding employee retention credit received during the three months ended September 30, 2025.

Research and development expenses were $1.6 million for the quarter ended September 30, 2025 as compared to $1.0 million for the same period in 2024. The increase was primarily due to costs associated with the second confirmatory Phase 3 CTCL trial as well as increases in third party contract manufacturing.

General and administrative expenses were $1.0 million for the quarter ended September 30, 2025 as compared to $0.9 million for the same period in 2024. The decrease was primarily attributable to increases in professional expenses.

As of September 30, 2025, the Company’s cash position was approximately $10.5 million.

(Press release, Soligenix, NOV 7, 2025, View Source [SID1234659641])

Replimune Presents Late-Breaking Abstract and Additional Posters on RP1 at 40th Annual Meeting of the Society for the Immunotherapy of Cancer (SITC 2025)

On November 7, 2025 Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, reported that biomarker data and updated clinical data from the IGNYTE clinical trial of RP1 plus nivolumab was presented as a late-breaking abstract during an oral session at the 40th Annual Meeting of the Society for the Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC 2025) in National Harbor, Maryland. Two additional posters on RP1 are also being presented.

"These data are important because they demonstrate that RP1 plus nivolumab can potentially reprogram the tumor microenvironment and reverse mechanisms of resistance to immune checkpoint blockade," said Kostas Xynos, M.D., Ph.D., Chief Medical Officer of Replimune. "Low T cell levels in tumors, tumor PD-L1 expression, T-cell activation and IFNy gene signature expression, as well as the loss of antigen presentation machinery are well known mechanisms of resistance to immune checkpoint blockade."

Data from the late-breaking abstract (#1327) presented by Trisha Wise-Draper, M.D., Ph.D., show:

Pharmacodynamic changes that were not achieved during prolonged prior anti–PD-1 therapy demonstrate that the addition of RP1 reverses multiple resistance mechanisms to PD-1 blockade and highlights the contribution of RP1 in melanoma patients who previously failed such treatment.
Treatment with RP1 plus nivolumab led to upregulation of gene signatures associated with responsiveness to PD-1 blockade.
With additional follow-up (7 months), RP1 combined with nivolumab continues to demonstrate a clinically meaningful response rate (ORR: 33.6%) and durability (median duration of response: 24.8 months).
Consistent duration of response was observed across PD-L1–positive and negative tumors, as well as in both primary and secondary resistance settings. Median duration of response for PD-L1-negative patients was 24.8 months and for patients with primary resistance was 22.6 months.
Additional posters being presented at the meeting include:

Abstract 611: RP1 plus nivolumab in patients with and without prior BRAF-directed therapy: A subgroup analysis of patients with anti-PD-1 failed BRAF-mutant melanoma from the IGNYTE clinical trial (Katy Tsai, M.D.)
RP1 plus nivolumab demonstrated comparable efficacy in BRAF-mutant and BRAF–wild-type advanced melanoma.
Greater activity was observed in BRAF-naïve patients – similar to findings from the SECOMBIT and DREAMseq trials.
Abstract 600: Retreatment with RP1 in combination with nivolumab in patients with advanced anti-PD-1- failed melanoma (Gino K. In, M.D.)
Extended RP1 treatment beyond 8 doses was well tolerated providing clinical benefit in a majority of patients.
About IGNYTE
The IGNYTE phase 2 cohort enrolled 140 patients with stage IIIB-IV cutaneous melanoma and confirmed progression on anti-PD1- based therapy for > 8 weeks as the last prior treatment. RP1 was administered intratumorally into superficial and/or deep/visceral tumors once every 2 weeks for up to 8 doses (≤10 mL per cycle) with intravenous nivolumab (240 mg); nivolumab was then given alone (240 mg every 2 weeks or 480 mg every 4 weeks) for up to 2 years, with further RP1 allowed if indicated.

About RP1
RP1 (vusolimogene oderparepvec) is Replimune’s lead product candidate and is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF, intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.

(Press release, Replimune, NOV 7, 2025, View Source [SID1234659640])