On March 4, 2026 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that the latest long-term survival analysis data from the China pivotal registrational Phase II study (COMPASSION-03/AK104-201) of cadonilimab as a monotherapy for patients with recurrent or metastatic cervical cancer (R/M CC) who have failed prior platinum-containing chemotherapy, were presented in a late-breaking oral presentation by Professor Wu Xiaohua from Fudan University Shanghai Cancer Center, the Principal Investigator, at the 27th European Congress on Gynaecological Oncology (ESGO 2026).

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The long-term survival data of cadonilimab monotherapy in this patient population confirms cadonilimab’s ability to convert deep tumor remission into long-term disease control and survival benefits. This study provides clinically meaningful evidence to support its use in the treatment of advanced cervical cancer, offering patients a new therapeutic option that significantly improves survival outcomes.

Best Overall Response (BOR) Analysis Demonstrates Remarkable Survival Benefit

In the updated data presented at the ESGO Congress, with a median follow-up duration of 26.5 months, a BOR-stratified analysis was conducted in all 99 efficacy-evaluable patients. This analysis further quantified the strong correlation between the depth of tumor response and long-term survival benefit associated with cadonilimab treatment.

Among all subjects who achieved a complete response (CR), the median overall survival (OS) was not reached (NR), with a 24-month OS rate of up to 100.0% (nominal p = 0.0002). The median progression-free survival (PFS) was also not reached, with a 12-month PFS rate of 84.6% (nominal p < 0.0001).

In patients achieving partial response (PR), the median OS remained unreached (NR), with a 24-month OS rate of 63% (nominal p = 0.0002). The median PFS was 11.17 months, and the 12-month PFS rate was 47.3% (nominal p < 0.0001).

The median time to response (mTTR) in the CR patients was 1.84 months, comparable to that observed in the PR patients (1.87 months). The median duration of response (mDoR) in the CR patients was not reached and was significantly longer than that in the PR patients (nominal p = 0.035).

Cadonilimab Provides Sustained Long-Term Survival Benefit Irrespective of PD-L1 Expression Status

The COMPASSION-03 study enrolled more than 18% of patients with PD-L1 CPS < 1, and 36% of participants had received ≥2 prior lines of systemic therapy. Study findings demonstrated that cadonilimab monotherapy achieved a median OS of 17.5 months (11.4, NE).

Updated long-term follow-up data showed durable survival benefit across the overall population, including both PD-L1 positive and PD-L1 negative patients, with 18-month and 24-month OS rates of 47.8% and 40.9%, respectively.

The Rising Value of a Foundational IO 2.0 Backbone

Cadonilimab, the world’s first approved cancer immunotherapy bispecific antibody that was commercially launched in 2022, has demonstrated its breakthrough clinical value across a large number of approved indications and Phase III trials. Cadonilimab addresses critical clinical gaps by benefiting cancer patients across all levels of PD-L1 expressions, earning strong recognition from clinicians and patients. Importantly, cadonilimab shows superior efficacy versus current standard of care in challenging settings like immunotherapy-resistant tumors and cold tumors that had limited response to PD-1/L1 agents.

This differentiated profile stems from its dual targeting of PD-1 and CTLA-4 with synergistic anti-tumor activity. This novel mechanism preserves the therapeutic benefits of both targets while overcoming their individual limitations. Specifically, the toxicity that restricts the clinical utility of current CTLA-4 monotherapy agents, and the poor response to PD-1/L1 agents in PD-L1 low/negative populations.

Cadonilimab is now approved for three indications in China: first-line gastric cancer, first-line cervical cancer, and recurrent/metastatic cervical cancer. It is under evaluation in 11 registrational/Phase III studies across major first-line tumor indications, various cold tumors, and IO-resistant settings, including a global Phase III trial in first-line gastric cancer and a global registrational trial in IO-resistant hepatocellular carcinoma.

While advancing cadonilimab’s global clinical development independently, Akeso remains committed to open collaboration, integrating premier worldwide resources to accelerate international market access and benefit cancer patients worldwide.

(Press release, Akeso Biopharma, MAR 4, 2026, View Source [SID1234663259])

On March 4, 2026 Actuate Therapeutics, Inc. (NASDAQ: ACTU) ("Actuate" or the "Company"), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers through the inhibition of glycogen synthase kinase-3 beta (GSK-3β), reported that Dan Schmitt, President & CEO of the Company, will present at the Citizens Life Sciences Conference in Miami Beach, FL on Tuesday, March 10, 2026, at 8:25 a.m. ET.

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The webcast of Mr. Schmitt’s presentation will be available at:

https://event.summitcast.com/view/BuMiPNPtyHKimMF6k4AFMd/guest_book?session_id=PW9gAwrMfrWWSf34Hno6ah

The Actuate management team will be available for one-on-one meetings with registered conference attendees.

A live link to the presentation will be located under "Events" in the Investors section of the Company’s website at www.actuatetherapeutics.com. A replay of the webcast will be available on Actuate’s website for 30 days following the presentation.

(Press release, Actuate Therapeutics, MAR 4, 2026, View Source [SID1234663275])

On March 4, 2026 Citius Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), an oncology-focused biopharmaceutical company and majority-owned subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), reported positive topline safety and efficacy results from an investigator-initiated Phase 1 trial evaluating LYMPHIR (E7777, denileukin diftitox-cxdl) administered prior to commercial CD19-directed CAR-T therapy in patients with high-risk relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The trial was conducted by lead investigator, Dr. Veronika Bachanova, at the University of Minnesota and City of Hope. Full results were presented at the 2026 ASTCT & CIBMTR Tandem Meetings1.

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The Phase 1 trial was designed to augment the lymphodepletion regimen prior to CAR-T infusion through the administration of LYMPHIR to potentially improve the anti-tumor activity of CAR-T therapies. LYMPHIR, an engineered fusion toxin that preferentially binds to the IL-2 receptor expressed on regulatory T-cells (Tregs), is currently FDA-approved and commercially available for the treatment of relapsed or refractory cutaneous T-cell lymphoma (CTCL) after one prior systemic therapy.

"Enhancing Treg depletion prior to CAR-T infusion with LYMPHIR represents a promising immunomodulatory strategy in patients with high-risk DLBCL, and these Phase 1 data provide an encouraging signal of the potential to enhance current CAR-T regimens," said Dr. Myron Czuczman, Executive Vice President and Chief Medical Officer of Citius Oncology and Citius Pharma. "These positive data support our broader strategy of exploring LYMPHIR’s modulatory effect on Tregs in combination with other approved therapies to potentially enhance the body’s own immune system to fight cancerous tumors," he added.

Topline Results & Study Design

● All patients (n=14) completed treatment and proceeded to CAR-T infusion;

● LYMPHIR was well tolerated, with no dose-limiting toxicities observed;

● No Grade ≥3 LYMPHIR-related immune adverse events or infusion reactions were reported; and,

● Data demonstrated effective Treg depletion, and promising efficacy signals of enhanced standard lymphodepletion with the use of Treg-targeting LYMPHIR.

The Phase 1, open-label, dose-escalation study (NCT04855253), enrolled 14 patients with relapsed or refractory DLBCL exhibiting poor prognostic features, including double/triple hit genetics, primary refractory disease, and extranodal involvement. Participants received one dose of LYMPHIR (E7777) at 5, 7, or 9 µg/kg followed by low dose chemotherapy prior to standard commercial CD19-directed CAR-T cell therapy. All patients received an infusion of one of the following FDA-approved, commercially manufactured CAR-T products: axicabtagene ciloleucel (Yescarta; Kite Pharma/Gilead Sciences), lisocabtagene maraleucel (Breyanzi; Bristol Myers Squibb), or tisagenlecleucel (Kymriah; Novartis).

The use of LYMPHIR in this study was investigational and outside of its FDA-approved indication. The Phase 1 study was not designed or powered to evaluate clinical efficacy, and no conclusions can be drawn regarding comparative effectiveness or long-term outcomes.

Key Findings from the Phase 1 Trial

● Overall response rate (ORR) was 86% at one month, including 57% complete responses (CR) and 29% partial responses (PR);

● One-year progression-free survival (PFS) was 77% (95% CI: 43–92%);

● One-year overall survival (OS) was 84% (95% CI: 49–96%);

● A single LYMPHIR dose resulted in depletion of circulating Tregs in all but one patient;

○ Median reduction of 24 Tregs/µL (range 8–65);

○ Treg nadir was observed 24 hours post-LYMPHIR;

● LYMPHIR was well tolerated with no dose-limiting toxicities (DLTs) observed up to 9 µg/kg; and,

● Reported adverse events included manageable Grade 1–2 capillary leak syndrome, fever, and transient liver enzyme elevations; Grade 3 cytopenias were consistent with expected lymphodepletion. CAR-T related cytokine release syndrome (CRS) occurred in 43% of patients (all Grade 1/2), and immune effector cell-associated neurotoxicity syndrome (ICANS) occurred in 21% (primarily low grade).

"In this high-risk population, LYMPHIR showed a favorable safety profile and promising pharmacodynamic effects when administered prior to CAR-T therapies. This data sets the stage for a larger study to assess its potential to enhance CAR-T efficacy through longer duration of LYMPHIR use," said Dr. Veronika Bachanova, Principal Investigator and Professor of Medicine at the University of Minnesota.

Dr. Bachanova presented the topline data at the 2026 Tandem Meetings | ASTCT CIBMTR.

Title: E7777 to Enhance Regulatory T-Cell Depletion Prior to CAR-T for High-Risk LBCL

Presentation ID: 677608

Abstract ID: 296369

About Diffuse Large B-Cell Lymphoma (DLBCL)

Diffuse large B-cell lymphoma (DLBCL) is the most common subtype of non-Hodgkin lymphoma (NHL), accounting for approximately 30%–40% of newly diagnosed cases in the United States. DLBCL is an aggressive and rapidly growing cancer of B lymphocytes, a type of white blood cell responsible for producing antibodies. While frontline chemoimmunotherapy regimens such as R-CHOP can be curative for many patients, up to 40% experience relapse or refractory disease. High-risk features are associated with poor outcomes and limited responses to standard therapies, including CAR-T cell therapy. Novel strategies that modulate the tumor microenvironment, such as transient regulatory T-cell depletion, are under investigation to improve treatment efficacy and long-term remission rates in this difficult-to-treat population.

About LYMPHIR (denileukin diftitox-cxdl)

LYMPHIR is a targeted immune therapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL) indicated for use in Stage I-III disease after at least one prior systemic therapy. It is a recombinant fusion protein that combines the IL-2 receptor binding domain with diphtheria toxin (DT) fragments. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis. After uptake into the cell, the DT fragment is cleaved and the free DT fragments inhibit protein synthesis, resulting in cell death. Denileukin diftitox-cxdl demonstrated the ability to deplete immunosuppressive regulatory T lymphocytes (Tregs) and antitumor activity through a direct cytocidal action on IL-2R-expressing tumors.

In 2021, denileukin diftitox received regulatory approval in Japan for the treatment of relapsed or refractory CTCL and peripheral T-cell lymphoma (PTCL). Subsequently, in 2021, Citius acquired an exclusive license with rights to develop and commercialize denileukin diftitox in all markets except for India, Japan and certain parts of Asia. LYMPHIR (denileukin diftitox-cxdl) was approved by the FDA and subsequently launched in the U.S. in December 2025.

(Press release, Citius Pharmaceuticals, MAR 4, 2026, View Source [SID1234663244])

On March 4, 2026 Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company advancing breakthrough therapies for diseases, reported the deployment of the OpenAI API to support IND-enabling development of HT-KIT, its orphan-designated therapy targeting rare and aggressive KIT-driven cancers.

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The OpenAI-powered API platform has been integrated into the HT-KIT development workflow to support preclinical data analysis, molecular modeling of KIT-driven pathways, and preparation of regulatory documentation ahead of IND submission.

HT-KIT results below have shown success in rare cancers

Potent gene-level target suppression: HT-KIT achieved >80% reduction of KIT mRNA/protein across in-vitro systems and in vivo models of systemic mastocytosis and GIST.

Favorable tolerability in early studies: No dose-limiting toxicities observed in the reported preclinical work to date.

Rapid anti-tumor activity: In xenograft models, statistically significant tumor-volume reduction by Day 8 was observed, accompanied by apoptotic signaling consistent with KIT pathway knock-down.

Bioanalytical readiness: GLP-validated bioanalytical methods completed to support pharmacokinetic, biodistribution, and exposure-response analyses for IND.

HT-KIT is advancing toward Investigational New Drug (IND) submission and Phase 1 clinical evaluation.

HT-KIT has received Orphan Drug Designation and is designed to address cancers driven by KIT mutations, an area of significant unmet medical need.

"Hoth’s integration of OpenAI’s API supports execution of our IND-enabling strategy for HT-KIT as we advance toward Phase 1," said Robb Knie, Chief Executive Officer.

(Press release, Hoth Therapeutics, MAR 4, 2026, View Source [SID1234663260])

On March 4, 2026 Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company, reported that the Tampa General Hospital (TGH) Cancer Institute is initiating a study evaluating the real-world clinical utility of sodium thiosulfate injection (PEDMARK) in reducing the risk of ototoxicity in Adolescent and Young Adult (AYA) and adult cancer patients receiving cisplatin-based treatment.

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"The TGH Cancer Institute, in collaboration with the USF Health Morsani College of Medicine, is committed to better understanding and advancing otoprotective strategies aimed at preserving auditory function in patients receiving cisplatin chemotherapy," said Gene A. Wetzstein, PharmD, BCOP, Director of Supportive Care Research & Scientific Affairs at the TGH Cancer Institute and principal investigator of the initiative. "This evaluation will examine real-world clinical data and audiology monitoring that will help inform future clinical research and quality efforts in assessing, preventing and managing ototoxicity."

PEDMARK is currently approved for pediatric patients one month of age and older with localized non-metastatic solid tumors and is also recognized by the National Comprehensive Cancer Network with a 2A recommendation for use in AYA patients.

"Real-world evidence plays a critical role in demonstrating the clinical utility of PEDMARK across diverse patient populations and tumor types," said Pierre S. Sayad, PhD, M.S., chief medical officer of Fennec Pharmaceuticals. "As more institutions generate data on its use outside of controlled trials, clinicians will gain a clearer picture of the important role of PEDMARK in providing hearing loss protection for patients receiving cisplatin."

The following sections provide general background information and labeling approved by the U.S. Food and Drug Administration for PEDMARK and are not intended to solicit participation in any research activity.

About Cisplatin-Induced Ototoxicity

Cisplatin and other platinum-based chemotherapies are widely used to treat solid tumors and have been vital in improving survival rates. Unfortunately, these life-saving treatments often result in permanent, irreversible hearing loss, also known as ototoxicity.i

Hearing loss from cisplatin treatment is not rare. Studies show that between 60-90% of patients treated with cisplatin may develop hearing loss, depending upon the dose and duration of chemotherapyii. Many of those treated with cisplatin will require lifelong hearing aids or cochlear implants, which can be helpful for some, but do not reverse the hearing loss and can be costly over time.iii Treatment-induced hearing loss can reduce quality of survivorship as it impacts many aspects of life, such as speech and language skills, academic performance, social-emotional development, career potential and the ability to live independently.iv,v While audiologic monitoring is recommended to help manage ototoxicity, it is currently underutilized in certain cancer patient populations.

PEDMARK (sodium thiosulfate injection)

PEDMARK is the first and only U.S. Food and Drug Administration (FDA) approved therapy indicated to reduce the risk of ototoxicity associated with cisplatin treatment in pediatric patients 1 month of age and older with localized, non-metastatic, solid tumors. It is a unique formulation of sodium thiosulfate in single-dose, ready-to-use vials for intravenous use in pediatric patients. PEDMARK is also the first and only therapeutic agent with proven efficacy and safety data with an established dosing regimen, across two open-label, randomized Phase 3 clinical studies, the Children’s Oncology Group (COG) Protocol ACCL0431 and SIOPEL 6.

Additionally, PEDMARK is recommended for the adolescent and young adult (AYA) population by the National Comprehensive Cancer Network, or NCCN, with a 2A endorsement.

Approximately 500,000 patients in the U.S. are diagnosed annually with cancers that could be treated with a platinum-based chemotherapy.vi,vii The incidence of ototoxicity depends upon the dose and duration of chemotherapy, and many of those treated will require lifelong hearing aids. Until the FDA approval of PEDMARK, there were no preventative agents for this hearing loss. Patients with hearing loss resulting from cancer treatment have a statistically significant worse quality of life compared with peers who have no hearing loss.viii,ix

PEDMARK has been studied by co-operative groups in two Phase 3 clinical studies of survival and reduction of ototoxicity, COG ACCL0431 and SIOPEL 6. Both studies have been completed. The COG ACCL0431 protocol enrolled childhood cancers typically treated with intensive cisplatin therapy for localized and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, medulloblastoma, and other solid tumors. SIOPEL 6 enrolled only hepatoblastoma patients with localized tumors.

Indications and Usage

PEDMARK (sodium thiosulfate injection) is indicated to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors.

Limitations of Use

The safety and efficacy of PEDMARK have not been established when administered following cisplatin infusions longer than 6 hours. PEDMARK may not reduce the risk of ototoxicity when administered following longer cisplatin infusions, because irreversible ototoxicity may have already occurred.

Important Safety Information

PEDMARK is contraindicated in patients with history of a severe hypersensitivity to sodium thiosulfate or any of its components.

Hypersensitivity reactions occurred in 8% to 13% of patients in clinical trials. Monitor patients for hypersensitivity reactions. Immediately discontinue PEDMARK and institute appropriate care if a hypersensitivity reaction occurs. Administer antihistamines or glucocorticoids (if appropriate) before each subsequent administration of PEDMARK. PEDMARK may contain sodium sulfite; patients with sulfite sensitivity may have hypersensitivity reactions, including anaphylactic symptoms and life-threatening or severe asthma episodes. Sulfite sensitivity is seen more frequently in people with asthma.

PEDMARK is not indicated for use in pediatric patients less than 1 month of age due to the increased risk of hypernatremia or in pediatric patients with metastatic cancers.

Hypernatremia occurred in 12% to 26% of patients in clinical trials, including a single Grade 3 case. Hypokalemia occurred in 15% to 27% of patients in clinical trials, with Grade 3 or 4 occurring in 9% to 27% of patients. Monitor serum sodium and potassium levels at baseline and as clinically indicated. Withhold PEDMARK in patients with baseline serum sodium greater than 145 mmol/L.

Monitor for signs and symptoms of hypernatremia and hypokalemia more closely if the glomerular filtration rate (GFR) falls below 60 mL/min/1.73m2.

Administer antiemetics prior to each PEDMARK administration. Provide additional antiemetics and supportive care as appropriate.

The most common adverse reactions (≥25% with difference between arms of >5% compared to cisplatin alone) in SIOPEL 6 were vomiting, nausea, decreased hemoglobin, and hypernatremia. The most common adverse reaction (≥25% with difference between arms of >5% compared to cisplatin alone) in COG ACCL0431 was hypokalemia.

Please see full Prescribing Information for PEDMARK at: www.PEDMARK.com.

(Press release, Fennec Pharmaceuticals, MAR 4, 2026, View Source [SID1234663245])