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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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])

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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 3, 2026 Delcath Systems, Inc. (Nasdaq: DCTH), ("Delcath" or the "Company") an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported the publication of the full results from the investigator-initiated CHOPIN randomized Phase 2 clinical trial, led by Principal Investigator Professor Ellen Kapiteijn, MD, from Leiden University Medical Center’s Department of Medical Oncology. The publication, titled "Percutaneous hepatic perfusion combined with ipilimumab and nivolumab for metastatic uveal melanoma (CHOPIN): a single-centre, open-label, randomised, phase 2 trial" is published in The Lancet Oncology and presents detailed analyses from the trial, building on the positive topline results previously presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in October 2025. The link to the article can be found at: https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(25)00720-X/abstract.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The detailed analyses in this publication reinforce the synergistic potential of combining PHP with immunotherapy, showing not only superior PFS and OS but also enhanced hepatic control and deeper, more durable responses. This approach represents a significant advancement for patients with this challenging disease, where liver-dominant metastases drive poor outcomes," said Professor Ellen Kapiteijn, MD, Principal Investigator and Lead Author from Leiden University Medical Center’s Department of Medical Oncology.

"The full publication in The Lancet Oncology validates the impressive efficacy of combining our liver-directed PHP therapy with immune checkpoint inhibition," said Gerard Michel, Chief Executive Officer of Delcath Systems. "By more than tripling the 1-year progression-free survival rate and nearly doubling the 2-year overall survival, these results strongly underscore the clinical value of this combination and give us even greater confidence in adoption by treating physicians and patients. We are also encouraged by the potential to explore this paradigm in other liver-dominant cancers."

The CHOPIN trial randomized 76 patients with metastatic uveal melanoma (mUM; n=38 per arm) to percutaneous hepatic perfusion (PHP) with melphalan using Delcath’s CHEMOSAT Hepatic Delivery System (HDS) alone or in combination with ipilimumab plus nivolumab. In both arms patients received two PHP treatments (weeks 1 and 7). In the combination arm patients also received ipilimumab (1 mg/kg) plus nivolumab (3 mg/kg) in weeks 0, 3, 6, and 9, with no maintenance therapy.

Key results (intention-to-treat population):

Primary endpoint – 1-year progression-free survival (PFS): 54.7% vs 15.8% (adjusted HR 0.34 [95% CI 0.19–0.60]; p=0.0002), Median PFS: 12.8 months vs 8.3 months
Overall Survival (OS): Median 23.1 months vs 19.6 months (HR 0.39 [95% CI 0.20–0.77]; p=0.0065) 2-year OS: 49.6% vs 22.1%
Objective Response Rate (ORR): 76.3% vs 39.5% Complete response (CR) rate: 13% vs 3%
Safety

Grade 3 or higher treatment-related adverse events occurred significantly more frequently in the combination arm (82%) than in the PHP-alone arm (41%); p=0.0006. The rate in the combination arm was similar to that reported in the FOCUS trial (81%). The most common grade 3/4 events were thrombocytopenia (34% vs 14%), leukopenia (26% vs 14%), γ-glutamyl transferase increase (18% vs 8%), and anemia (13% vs 3%). Most events were self-limiting or manageable with standard supportive care; no new safety signals were identified. One treatment-related death (immune-related triple M syndrome) occurred in the combination arm.

Overall, the authors conclude that the combination of PHP with ipilimumab and nivolumab offers a promising new approach for patients with metastatic uveal melanoma.

(Press release, Delcath Systems, MAR 3, 2026, View Source [SID1234663222])

On March 3, 2026 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune diseases, reported that management will participate in a fireside chat and host investor meetings at the Leerink Partners 2026 Global Healthcare Conference on Monday, March 9, 2026 in Miami, Florida.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Management will participate in a fireside chat at 9:20 AM ET on Monday, March 9. A live webcast of the fireside chat can be accessed under "Events & Presentations" in the Investors section of the Company’s website at www.fatetherapeutics.com. An archived replay of the webcast will be available for 90 days on the Company’s website following the event.

(Press release, Fate Therapeutics, MAR 3, 2026, View Source [SID1234663223])

On March 3, 2026 GSK plc (LSE/NYSE: GSK) reported the completion of its previously announced acquisition of RAPT Therapeutics, a California-based, clinical-stage biopharmaceutical company dedicated to developing novel therapies for patients living with inflammatory and immunologic diseases.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The acquisition includes ozureprubart, a long-acting anti-immunoglobulin E (IgE) monoclonal antibody, currently in phase IIb clinical development for prophylactic protection against food allergens. IgE is a clinically validated target and is the only approved systemic therapy shown to protect patients from a harmful allergic and inflammatory immune response. Around 94% of severe food allergies are caused by IgE-mediated reactions.1

Current anti-IgE treatment for food allergy involves injections every 2 to 4 weeks, which can be a significant burden, particularly since most patients are children. Ozureprubart’s clinical profile offers the potential for less frequent dosing of every 12 weeks, supporting improved compliance and patient outcomes, as well as providing a new option to approximately 25% of patients currently ineligible for existing therapy. Ozureprubart complements GSK’s extensive commercial footprint and prescriber base in allergy.

Data from the phase IIb trial (prestIgE) assessing use of ozureprubart as monotherapy is expected in 2027, with phase III trials to be focused on both at-risk adult and paediatric populations.

Kaivan Khavandi, SVP, R&D Head Respiratory, Immunology & Inflammation, and Head of GSK Translational & Development Sciences, GSK said: "Ozureprubart is a promising asset that complements our expanding RI&I pipeline. Food allergies continue to place a heavy burden on patients and their families, and we are committed to progressing this potential best-in-class monoclonal antibody to deliver longer‑lasting protection."

Financial considerations
The total cash consideration for this acquisition amounts to an approximate aggregate equity value of $2.2 billion. Net of cash acquired, GSK’s upfront investment is approximately $1.9 billion.

The transaction gives GSK the global rights to the ozureprubart programme, excluding mainland China, Macau, Taiwan and Hong Kong. GSK will also be responsible for success-based milestone and royalty payments for ozureprubart owed to RAPT’s partner, Shanghai Jeyou Pharmaceutical Co., Ltd.

About food allergies
In the US, over 17 million people are diagnosed with food allergies, with more than 1.3 million people suffering severe reactions.2,3,4 Notably, 65% of severe food allergy patients are children and adolescents.1 This results in more than 3 million patient visits each year to hospital and emergency care.5 Disease burden is amplified by the frequency and complexity of allergic reactions, which can escalate to anaphylaxis, emergency care and impact a patient’s wellbeing and participation in social activities. Collectively, food allergies cost US families an estimated $33 billion in 2024, underscoring the need for more effective and durable therapies.

(Press release, GlaxoSmithKline, MAR 3, 2026, View Source [SID1234663224])