On March 24, 2026 CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a clinical-stage oncology company advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor with therapeutic potential across multiple indications, including metastatic triple-negative breast cancer ("mTNBC") and colorectal cancer ("mCRC"), reported the presentation of new preclinical and translational data supporting the potential role of CCR5 inhibition in glioblastoma multiforme (GBM) at AACR (Free AACR Whitepaper) Special Conference in Cancer Research: Brain Cancer, held March 23-25, in Philadelphia.

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Glioblastoma multiforme (GBM) is an aggressive brain cancer with poor survival and limited effective treatment options. Standard therapies such as radiation and temozolomide (TMZ) often face resistance, and immune checkpoint inhibitors have shown limited benefit. Molecular profiling has shown that the tumor "core" of GBM is frequently characterized by a hypoxic, mesenchymal and immunosuppressive environment that contributes to treatment resistance. The data presented evaluate the role of CCR5 in these tumor core features and explore whether CCR5 inhibition with leronlimab may enhance responses to standard-of-care therapies.

"Our findings show that CCR5 expression correlates with glycolytic and hypoxic tumor core signatures, as well as markers of T-cell exhaustion," said Professor Richard Pestell, M.D., Ph.D., FRCP, AO, Lead Consultant in Preclinical and Clinical Oncology at CytoDyn. "Importantly, CCR5 inhibition with leronlimab enhanced tumor cell killing when combined with temozolomide or radiation, support further clinical evaluation of leronlimab as a potential adjunct to standard-of-care therapy in glioblastoma."

"These data, including the intriguing but preliminary results from a preclinical study in GBM, reinforce observations from other clinical and preclinical studies that demonstrate a striking impact of leronlimab in solid tumor oncology," said Dr. Jacob Lalezari, M.D., Chief Executive Officer of CytoDyn. "These data outline a potential role for CCR5 in glioblastoma, where resistance to standard therapies remains a major unmet need. The observed synergy with temozolomide or radiation, combined with its association with immunosuppressive tumor core signatures, supports current plans to initiate a pilot study evaluating leronlimab in glioblastoma."

Key findings:

In primary GBM tumors (N=154), CCR5 expression was significantly elevated compared to normal brain tissue and correlated with poor prognosis.
CCR5 expression aligned with tumor "core" rather than "leading edge" gene signatures and correlated with hallmarks of glycolysis, hypoxia, inflammatory response, and the mesenchymal (MES) GBM subtype.
CCR5 expression was associated with T-cell exhaustion markers (PD-1, PD-L1, TIM3, PTX3) and immune suppressive mediators including S100A4. Single-cell sequencing confirmed expression of CCR5 and its ligand CCL5 within the GBM tumor microenvironment and tumor glial metabolic subtypes.
In human GBM cell lines, CCR5 abundance increased upon neurosphere formation. CCR5 inhibition with leronlimab or maraviroc demonstrated functional synergy with temozolomide, enhancing tumor cell killing. Pretreatment with leronlimab also enhanced radiation-induced cytotoxicity.
Metabolic profiling using Seahorse analysis showed that CCR5 inhibition reduced oxygen consumption rate (OCR) in a dose-dependent manner, consistent with modulation of glycolytic and metabolic programs that contribute to an immunosuppressive tumor microenvironment.

The poster, titled "CCR5 inhibition with the human monoclonal antibody leronlimab enhances temozolomide- and radiation-induced killing of glioblastoma multiforme cells," was presented by Ritika Harish on March 23, 2026, from 7:15 p.m. – 9:15 p.m. EDT (Poster #A002). A copy of the poster will be made available on CytoDyn’s website under the Publications & Posters section."

Leronlimab has previously demonstrated a favorable safety profile in clinical studies and has been shown to cross the blood-brain barrier in non-human primate models. Together with encouraging long-term survival observations in metastatic breast cancer in combination immunotherapy settings, these findings support continued investigation of CCR5 blockade across solid tumor indications.

(Press release, CytoDyn, MAR 24, 2026, View Source [SID1234663885])

On March 24, 2026 Silexion Therapeutics Corp. (NASDAQ: SLXN) ("Silexion" or the "Company"), a clinical-stage, oncology-focused biotechnology company, reported that it has received formal approval from the Israeli Ministry of Health to initiate its Phase 2/3 clinical trial evaluating SIL204 for the treatment of locally advanced pancreatic cancer, following positive preclinical results that demonstrated significant anti-tumor activity in mulitple models alongside successful completion of toxicology studies.

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This approval represents a major regulatory milestone and a critical advancement for the Company, enabling the transition of SIL204 into human clinical evaluation and positioning Silexion as a clinical-stage biotechnology company focused on KRAS-driven cancers.

SIL204 is designed to silence KRAS mutations, which are present in over 90% of pancreatic cancers and are widely recognized as one of the most challenging targets in oncology. Unlike mutation-specific approaches, SIL204 is engineered to target a broad range of KRAS mutations, supporting its potential applicability across multiple high-value cancer indications.

The approval follows a series of major positive developments achieved by the Company, including strong positive anti-tumor activity demonstrated in multiple preclinical models, successful completion of toxicology studies, and constructive regulatory engagement supporting the Phase 2/3 trial design. Together, these achievements have enabled SIL204 to advance toward clinical-stage development. The Company also plans to submit a Phase 2/3 clinical trial application in Germany by the end of this current quarter, with additional regulatory filings across the European Union planned in early 2027.

"The receipt of this approval marks a defining and highly significant milestone for Silexion," said Ilan Hadar, Chairman and Chief Executive Officer of Silexion Therapeutics. "We are now advancing SIL204 into a pivotal clinical trial with the goal of addressing KRAS-driven cancers at their source. This progress reflects the strength of our data, the safety demonstrated during the Loder (predecessor to SIL204) clinical trial, the urgency of the unmet need in pancreatic cancer, and our continued execution toward developing a potentially transformative therapy."

The Company expects to initiate the Phase 2/3 trial in the second quarter of 2026, subject to site activation and standard clinical readiness procedures, and plans to advance SIL204 as a potential treatment across additional KRAS-driven indications, including colorectal and lung cancers.*

(Press release, Silexion Therapeutics, MAR 24, 2026, View Source [SID1234663884])

On March 24, 2026 Mosaic Therapeutics, Ltd, (‘Mosaic’, or ‘the Company’) a clinical-stage oncology therapeutics company building the category leader in Synergistic Precision Oncology, reported it will hold a poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, taking place April 17-22 in San Diego, CA.

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Poster Presentation Details:

Title: "Combination of the MDM2 antagonist ASTX295 and olaparib as a novel treatment option for BRCA2 mutant, TP53 wild-type solid tumors"
Abstract Number: 3053
Date and Time: Monday, April 20, 2026, 2:00PM – 5:00PM PST
Session Category: Novel Targets and Pathways
Session: PO.ET09.09
Location: Poster Section 15

For more information and to view the Company’s abstract, visit the AACR (Free AACR Whitepaper) Annual Meeting website.

About ASTX295

ASTX295 is a potent, highly selective, potentially best-in-class MDM2 antagonist that has completed a phase I study (NCT03975387) in over 100 patients with advanced solid tumors. Rationally designed to exhibit a short half-life, ASTX295 has demonstrated a compelling safety profile with minimal hematological toxicities, enabling use as a combination therapy.

MDM2 is a clinically validated target for cancer therapy, frequently overexpressed across multiple tumor types. As the primary negative regulator of the p53 tumor suppressor protein, MDM2 inhibition leads to p53 stabilization and re-activation, inducing cell cycle arrest and apoptosis.

Mosaic Therapeutics announced the in-licensing of ASTX295, alongside ASTX029 (an ERK1/2 inhibitor), from Astex Pharmaceuticals in April 2025, and holds full development and commercialization rights.

About MOS101

Plans for a Phase 1b/2a study evaluating the combination of ASTX295 with olaparib (an approved PARP inhibitor) for patients with biomarker-selected solid tumors are being finalized.

(Press release, Mosaic Therapeutics, MAR 24, 2026, View Source [SID1234663882])

On March 24, 2026 Ferring Pharmaceuticals reported that the U.S. Food and Drug Administration (FDA) has approved a label update for ADSTILADRIN (nadofaragene firadenovec-vncg), enabling an accelerated water-bath thawing method, completed in about 25 minutes, to enhance efficient clinical preparation for healthcare teams.

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ADSTILADRIN is the first and only FDA-approved non-replicating intravesical gene-therapy for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS) with or without papillary tumors (±Ta/T1). In the United States, bladder cancer is the sixth most common cancer, with NMIBC comprising about 75% of all new cases.1,2

"The reduction in thawing time for ADSTILADRIN streamlines preparation and handling for healthcare providers treating patients with high-risk non-muscle invasive bladder cancer," said Vikram M. Narayan, MD, FACS, Associate Professor at Emory University Department of Urology, Chief of Urology at Grady Memorial Hospital. "This updated preparation process has the potential to save valuable time and enable healthcare providers and practices to deliver this treatment option to more patients efficiently."

ADSTILADRIN is shipped and stored as a sterile frozen suspension and must be brought to room temperature (20° C to 25° C [68° F to 77° F]) prior to use. The FDA’s approval is supported by a thawing and handling study demonstrating that frozen vials remained stable when thawed for about 25 minutes in a water bath maintained at 25°C (77°F). The storage conditions for ADSTILADRIN remain unchanged once thawing begins and permit storage for up to 24 hours at room temperature or up to 7 days refrigerated (2-8°C), including thaw time.

"At Ferring, we remain deeply committed to evolving our therapies in ways that address the real-world needs of patients and the healthcare providers who care for them," said Denise D’Andrea, MD, FACP, Senior Director, Medical Affairs Uro-Oncology, Ferring Pharmaceuticals. "ADSTILADRIN already offers convenient, once-every-three-months dosing that helps reduce visit frequency, travel burden and clinic workflow demands. The new 25 minutes at 25°C thaw option provides additional flexibility and represents another important step in our ongoing efforts to streamline operational workflow across care settings."

About Non-Muscle Invasive Bladder Cancer (NMIBC)
NMIBC is a form of bladder cancer that is found in the inner layer cells of the bladder and does not invade into or beyond the muscle wall.3 In the United States, bladder cancer is the sixth most common cancer,1 fourth among men,4 and it is estimated that there will be approximately 84,870 new cases of bladder cancer in the U.S. in 2025.4 Historically, 75% of bladder cancer presents as NMIBC.2 In patients with high-risk NMIBC, intravesical BCG remains the first-line standard-of-care; however, approximately one third of patients with NMIBC will not respond to BCG therapy and 50% of those with an initial response will experience recurrence or progression of their disease.5 Current treatment options for BCG-unresponsive patients are very limited and National Comprehensive Cancer Network (NCCN) guidelines recommend cystectomy (partial or complete removal of the bladder).6

About ADSTILADRIN
ADSTILADRIN (nadofaragene firadenovec-vncg) is the first and only FDA-approved intravesical non-replicating gene-therapy for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors (±Ta/T1). It is a non-replicating adenovirus vector-based therapy containing the gene interferon alfa-2b, administered locally as a monotherapy by catheter directly into the bladder once every three months. The vector enters the cells of the bladder wall, releasing the active gene and causing the bladder’s cell walls to secrete high and transient local expression of interferon alfa-2b protein, a naturally occurring protein the body uses to fight cancer. This approach essentially turns the bladder wall cells into interferon microfactories, enhancing the body’s own natural defenses against the cancer.

ADSTILADRIN has been studied in a clinical trial program that includes 157 patients with high-risk, BCG-unresponsive NMIBC, who had been treated with adequate BCG previously and did not see benefit from additional BCG treatment (full inclusion criteria published on clinicaltrials.gov: NCT02773849 and final five-year follow-up analysis published in The Journal of Urology).7-8

INDICATION
ADSTILADRIN is a non-replicating adenoviral vector-based gene therapy indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS) with or without papillary tumors (±Ta/T1).

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS: ADSTILADRIN is contraindicated in patients with prior hypersensitivity reactions to interferon alfa or to any component of the product.

WARNINGS AND PRECAUTIONS:

Risk with delayed cystectomy: Delaying cystectomy in patients with BCG-unresponsive CIS could lead to development of muscle invasive or metastatic bladder cancer, which can be lethal. If patients with CIS do not have a complete response to treatment after 3 months or if CIS recurs, consider cystectomy.
Risk of disseminated adenovirus infection: Persons who are immunocompromised or immunodeficient may be at risk for disseminated infection from ADSTILADRIN due to low levels of replication-competent adenovirus. Avoid ADSTILADRIN exposure to immunocompromised or immunodeficient individuals.
DOSAGE AND ADMINISTRATION: Administer ADSTILADRIN by intravesical instillation only. ADSTILADRIN is not for intravenous use, topical use or oral administration.

USE IN SPECIFIC POPULATIONS: Advise females of reproductive potential to use effective contraception during ADSTILADRIN treatment and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during ADSTILADRIN treatment and for 3 months after the last dose.

ADVERSE REACTIONS: The most common (>10%) adverse reactions; including, laboratory abnormalities (>15%), were increased glucose, instillation site discharge, increased triglycerides, fatigue, bladder spasm, micturition (urination urgency), increased creatinine, hematuria (blood in urine), decreased phosphate, chills, pyrexia (fever) and dysuria (painful urination).

You are encouraged to report negative side effects of prescription drugs to FDA. Visit View Source or call 1-800-332-1088. You may also contact Ferring Pharmaceuticals at 1-888-FERRING.

Please click to see the full Prescribing Information.

(Press release, Ferring Pharmaceuticals, MAR 24, 2026, View Source [SID1234663881])

On March 24, 2026 Intensity Therapeutics, Inc., (Nasdaq: INTS) ("Intensity" or the "Company"), a late-stage clinical biotechnology company focused on the discovery and development of proprietary cancer therapies using its non-covalent, drug-conjugation technology that creates drug products designed to kill tumors and increase immune system recognition of cancers, reported an update on its patent portfolio including the recent issuance in December 2025 of a new US patent in the U.S., US Patent Number 12,496,345, entitled "A Method of Treating Cancer".

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Lewis H. Bender, Founder, President & CEO, said, "The issuance of this new patent supports the novelty of our unique technology in the U.S. and around the world. The Company now has four U.S. patents and one pending U.S. patent application. We have protection in 41 countries, including our European patent, which is validated in 27 countries. We have registered trademarks, know-how, and continue to generate additional potential new intellectual property."

About Intensity Therapeutics Intellectual Property Portfolio

The Company has a robust intellectual property position with 19 issued patents (with four of such patents being issued in the U.S.). We have the ability to enforce our patent claims in 41 countries, including the U.S. and all external major pharmaceutical markets. The four United States Patent and Trademark Office ("PTO") issued patents are as follows; (i) US Patent Number 9,351,997 is directed to a method of treating cancer, with a registration date of May 31, 2016 and an expiration date of December 6, 2033, (ii) US Patent Number 9,636,406 is directed to a method of treating cancer, with a registration date of May 2, 2017 and an expiration date of September 15, 2033, (iii) US Patent Number 10,888,618 is directed to a method of treating cancer, with a registration date of January 12, 2021 and an expiration date of September 15, 2033, and (iv) new US Patent Number 12,496,345 is directed to a method of treating cancer and an intratumoral formulation, with a registration date of December 16, 2025 and an expiration date of September 15, 2033. In addition, the Company received Orphan drug status for the three main components of INT230-6, which allows for seven more years of market exclusivity post approval.

Prosecution of patents is in every major market and claims have been granted in patents in Australia, Brazil, Canada, China, 27 European countries (Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Liechtenstein, Luxembourg, Macedonia, Malta, Monaco, Netherlands, Norway, Poland, Portugal, Romania, San Marino, Spain, Sweden, Switzerland, Turkey, and the United Kingdom), India, Israel, Japan, Macau, Mexico, Russia, Singapore, South Africa and South Korea.

Together with trade secrets, know-how, and continuing technological innovation, we believe that our IP position is thorough, novel, non-obvious, and has been reduced to practice. The technology underlying the Company’s patents and patent applications is directed to our lead product candidates, has been developed by us and not acquired from in-licensing from any third party.

About INT230-6

INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug consists of two proven, potent anti-cancer agents, cisplatin and vinblastine sulfate, and a diffusion and cell penetration enhancer molecule ("SHAO") that non-covalently conjugates to the two payload drugs, facilitating the dispersion of potent cytotoxic drugs throughout tumors and allowing the active agents to diffuse into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression, which often occurs with systemic chemotherapy.

(Press release, Intensity Therapeutics, MAR 24, 2026, View Source [SID1234663880])