On March 4, 2026 Monteris Medical, the leader in minimally invasive neurosurgical technology with its NeuroBlate System, reported that a newly published randomized prospective study in the distinguished journal Nature Communications suggests that laser interstitial thermal therapy (LITT) using NeuroBlate may enhance the effectiveness of the immunotherapy drug pembrolizumab (Keytruda) for patients with recurrent high grade astrocytoma, including glioblastoma (GBM). The findings come from a Phase 1/randomized Phase 2b clinical trial (NCT02311582) led by investigators at Washington University, the University of Florida and the University of Southern California evaluating the combination of NeuroBlate LITT followed by pembrolizumab.

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High grade astrocytomas, including GBM, remain among the most aggressive and treatment resistant brain tumors. Immune checkpoint inhibitors, such as pembrolizumab, have historically shown limited benefit in this population due to multiple factors, including the impermeability of the blood-brain barrier (BBB) and tumor characteristics allowing for evasion of the body’s immune response.

This study suggests that thermal ablation – heat generated by laser energy – delivered by NeuroBlate induces BBB disruption and activates an immune response, thereby enhancing the therapeutic effect of pembrolizumab.

"What we’re seeing in this trial is that NeuroBlate may be doing more than cytoreducing the tumor – it appears to prime the immune system in ways that make pembrolizumab more effective at delivering real clinical benefit," said Dr. David Tran, lead author and division chief, neuro-oncology and co-director of the University of Southern California Brain Tumor Center in Los Angeles. "This opens the door to continue studying new treatment strategies for patients who currently have very limited options."

In the full study analysis, patients who received NeuroBlate followed by pembrolizumab demonstrated improved overall survival – more than three times – compared with those who received surgery or biopsy followed by the same therapy. The combined approach was also found to be safe and well-tolerated.

"Monteris has invested for more than a decade in pioneering the use of NeuroBlate for brain tumors and drug-resistant epilepsy, and we are proud that our technology continues to play a central role in advancing minimally invasive neurosurgery," said Martin J. Emerson, president and chief executive officer of Monteris Medical. "This new clinical evidence suggests that NeuroBlate may also serve as a powerful enabler of treatments like immunotherapy. We are honored to support the innovators and institutions pushing this field forward and, most importantly, to help bring new hope to patients and their families."

(Press release, Monteris Medical, MAR 4, 2026, View Source [SID1234663261])

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 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 Rezolute, Inc. (Nasdaq: RZLT) ("Rezolute" or the "Company"), a late-stage rare disease company focused on treating hypoglycemia caused by all forms of hyperinsulinism (HI), reported that management will participate in the Citizens Life Sciences Conference, taking place March 10-11, 2026, in Miami, FL.

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Management will be participating in one-on-one investor meetings throughout the conference. Investors interested in scheduling a meeting with the Rezolute management team should contact their Citizens representative.

(Press release, Rezolute, MAR 4, 2026, View Source [SID1234663257])

On March 4, 2026 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a clinical-stage biotechnology company developing a pipeline of proprietary small molecule drugs for the treatment of cancer and inflammatory diseases, reported results from its Phase IIa open-label study evaluating namodenoson in patients with advanced pancreatic ductal adenocarcinoma (PDAC) who had progressed following prior systemic therapies.

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The study met its primary endpoint, which was safety, demonstrating that namodenoson was very well tolerated in this heavily pretreated patient population. No new safety signals were identified, and the safety profile was consistent with the known clinical experience of namodenoson in other oncological diseases.

The study enrolled 20 patients with advanced PDAC who had received one or more prior lines of therapy. Patients represented a high-risk population, including individuals with varying performance status and advanced metastatic disease.

Secondary endpoints included overall survival (OS) and progression-free survival (PFS). Survival follow-up remains ongoing, with 1/3 of patients currently alive at the time of data cut-off. As follow-up continues, survival outcomes are expected to further mature and will be announced during upcoming scientific meetings.

"The favorable safety profile observed in this difficult-to-treat population supports continued clinical evaluation of namodenoson," Prof. Salomon Stemmer, a renowned oncologist and key opinion leader at the Davidoff Center, Rabin Medical Center, Israel. "We are continuing to monitor survival outcomes as data mature."

Namodenoson is a highly selective A3 adenosine receptor (A3AR) agonist, which has shown a compelling safety profile and demonstrated anti-tumor activity in preclinical pancreatic cancer models. The drug is also being evaluated in clinical trials for advanced liver cancer.

Namodenoson has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer.

(Press release, Can-Fite BioPharma, MAR 4, 2026, View Source [SID1234663256])