On July 7, 2025 Mustang Bio, Inc. ("Mustang" or the "Company") (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell therapies into potential cures for difficult-to-treat cancers, reported that the U.S. Food and Drug Administration ("FDA") has granted Orphan Drug Designation to Mustang for MB-101 (IL13Ra2-targeted CAR T-cells) for the treatment of recurrent diffuse and anaplastic astrocytoma (astrocytomas) and glioblastoma (GBM) (Press release, Mustang Bio, JUL 7, 2025, View Source [SID1234654265]).

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The FDA grants Orphan Drug Designation to drugs and biologics that are intended for safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the U.S. Orphan Drug Designation provides certain incentives, such as tax credits toward the cost of clinical trials upon approval and prescription drug user fee waivers. If a product receives Orphan Drug Status from the FDA, that product is entitled to seven years of market exclusivity for the disease in which it has Orphan Drug designation, which is independent from intellectual property protection.

Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, "We are thrilled that MB-101 received Orphan Drug Designation on time and with a designation that is broader than the indication proposed. The Orphan Drug Designation for MB-101, coupled with the Orphan Drug Designation granted previously for MB-108, is strong validation for our science, as we hope to advance MB-101, in combination with MB-108, as a potential treatment option for patients living with malignant glioma, including patients with recurrent glioblastoma ("GBM") and high-grade astrocytomas. Our novel therapeutic strategy, combining our MB-101 CAR-T cell therapy with our MB-108 oncolytic virus, leverages MB-108 to reshape the tumor microenvironment ("TME") to make cold tumors "hot," thereby potentially improving the efficacy of MB-101 CAR-T cell therapy. This progress demonstrates our dedication to exploring new possibilities for improving outcomes in patients with challenging-to-treat cancers."

As previously reported, preclinical data presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) ("AACR") Annual Meeting in 2022 supported a combination therapy to potentially optimize results to treat recurrent GBM. The combination leverages MB-108 to reshape the TME and make cold tumors "hot," thereby potentially improving the efficacy of MB-101 CAR-T cell therapy. Data presented separately on MB-101 and MB-108 showed that administration of these therapies was well tolerated in recurrent GBM patients. As reported in City of Hope’s 2024 Nature Medicine paper, 2 patients treated solely with MB-101 who had high levels of intratumoral CD3+ T cells pre-therapy (i.e., "hot" tumors) achieved complete responses lasting 7.5 and 66+ months, respectively. Importantly, of the 57 City of Hope Phase 1 patients evaluable for survival in that paper, these 2 complete responses were observed in the cohort of 3 patients with the "hottest" tumors prior to treatment with MB-101. Phase 1 clinical trials of MB-101 at City of Hope and of MB-108 at The University of Alabama at Birmingham continue to enroll patients.

The Company’s ability to further develop the MB-109 program for recurrent GBM and high-grade astrocytomas is contingent upon raising additional funding and / or consummating a strategic partnership.

About MB-109 (MB-101 (IL13Rα2 targeted CAR-T cells) + MB-108 oncolytic virus)
MB-109 is Mustang’s designation for the treatment regimen combining MB-101 (IL13Rα2‐targeted CAR-T cell therapy licensed from City of Hope) with MB-108 (HSV-1 oncolytic virus licensed from Nationwide Children’s Hospital). The combination is designed to leverage MB-108 to make cold tumors "hot" and potentially improve the efficacy of MB-101 CAR-T cell therapy. MB-108 oncolytic virus is first injected to infect tumor cells which, in turn, leads to reshaping of the TME through recruitment of endogenous CD8- and CD3-positive effector T-cells. This inflamed TME potentially permits MB-101 CAR-T cells injected into and around the tumor to better infiltrate into and throughout the tumor mass, undergo activation and, ideally, effect tumor cell killing.

On July 7, 2025 Myosin Therapeutics, a clinical-stage biotechnology company advancing first-in-class therapies targeting molecular motor proteins, reported the publication of two major papers in the journal Cell that establish non-muscle myosin II (NMII) as a druggable target with broad therapeutic implications (Press release, Myosin Therapeutics, JUL 7, 2025, View Source [SID1234654267]).

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The first article in Cell, "Development of Clinically Viable Non-Muscle Myosin II Small Molecule Inhibitors," details the optimization and development of a new pharmacological class of small molecule inhibitors of the enzyme NMII, an actin-binding motor protein that regulates cellular functions such as division, synaptic remodeling, and immune evasion. The study describes how an iterative structure-based approach overcame historical challenges to yield brain-penetrant small molecules with high specificity and excellent tolerability.

The work originated in the lab of neuroscientist Courtney Miller, Ph.D., who teamed up with medicinal chemist, Theodore Kamenecka, Ph.D., and structural biologist, Patrick Griffin, Ph.D. With support from the National Institute of Neurological Disorders and Stroke (NINDS/NIH) Blueprint Neurotherapeutics Program and National Institute for Drug Abuse (NIDA), the three led a program to develop and bring NMII inhibitors to the clinic. The team identified MT-110 as a clinical candidate for the treatment of stimulant use disorder. MT-110 and MT-125, another NMII inhibitor being pursued in oncology, serves as the cornerstone of the company they co-founded, Myosin Therapeutics.

The potential of MT-125 in glioblastoma (GBM) is detailed in the second Cell article, "MT-125 Inhibits Non-Muscle Myosin IIA and IIB and Prolongs Survival in Glioblastoma." GBM is an extremely aggressive, treatment-resistant brain cancer. The team collaborated with Mayo Clinic scientist and neuro-oncologist Steven Rosenfeld, M.D., Ph.D. The research was supported by NINDS and the National Cancer Institute (NCI).

In preclinical GBM models, MT-125 demonstrated robust monotherapy activity, as well as synergy with radiation and FDA-approved oncology therapeutics at suppressing tumor growth and extending survival. The publication provides detailed mechanistic insight into these therapeutic actions and informs MT-125’s clinical development strategy.

"As a clinician treating glioblastoma my entire career, collaboration with Myosin Therapeutics is meaningful," said Dr. Rosenfeld. "There’s great promise that our research will translate into improved outcomes for patients who urgently need them."

Miller said," The work detailed in these articles establishes NMII inhibitors as a new therapeutic class and we’re passionate about using them to tackle big health challenges, starting with glioblastoma and addiction."

On July 7, 2025 Lutris Pharma, a clinical stage biopharmaceutical company focused on improving anti-cancer therapies by reducing cutaneous dose limiting toxicities, reported the presentation of results from its double-blind, placebo-controlled phase 2 randomized clinical trial of lead compound, LUT014 gel (Press release, Lutris Pharma, JUL 7, 2025, View Source [SID1234654268]). The topically-applied novel B-Raf inhibitor is optimized for paradoxical MAPK activation, for use by patients treated with epidermal growth factor receptor (EGFR) inhibitor therapy who develop dose-limiting acneiform rash. The clinical data was presented by Dr. Ofer Purim, Head of Gastrointestinal Malignancy Unit at the Helmsley Cancer Center, Shaare Zedek Medical Center, Jerusalem, Israel, in an oral presentation, entitled, "A double-blind placebo-controlled randomized phase 2 clinical trial to assess the efficacy of a topical BRAF inhibitor for acneiform rash toxicities from anti-EGFR therapies," during a Proffered Paper Session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Gastrointestinal Cancers Congress 2025.

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"EGFR inhibitors, like cetuximab and panitumumab, are critical components of cancer therapy, but their effectiveness is often compromised by skin toxicities that can lead to dose modifications or treatment discontinuation," said Benjamin W. Corn, M.D., Chief Medical Officer of Lutris Pharma. "LUT014 is designed to mitigate these toxicities by restoring downstream signaling in skin cells disrupted by EGFR inhibition. In our clinical trial, the high dose of LUT014 demonstrated statistically significant efficacy in improving acneiform rash across both cetuximab and panitumumab-treated patients. Additionally, encouraging results were observed in the open-label extension, where even the low dose of LUT014 showed meaningful efficacy, with up to 69% of patients in the per-protocol population achieving improvement. LUT014 was also well tolerated, with fewer and mostly mild adverse events compared to placebo. We believe these results underscore LUT014’s potential to be a key therapeutic, offering significant benefits to patients by enabling them to remain on optimal anti-EGFR treatment without interruption."

"This is the first placebo-controlled, randomized trial to demonstrate both efficacy and safety of a treatment for anti-EGFR-induced acneiform rash, a major advancement in our effort to become the first company to provide a therapeutic that addresses the dose-limiting side effects of cancer treatments," added Sumant Ramchandra, M.D., Ph.D., Chief Executive Officer of Lutris Pharma. "Following its initial recognition at the AACR (Free AACR Whitepaper) Annual Meeting, the selection of our LUT014 data for oral presentation at the ESMO (Free ESMO Whitepaper) Gastrointestinal Cancers Congress further validates the clinical importance and growing momentum behind our lead program. Importantly, patients who respond best to EGFR inhibitor therapy are often the ones who experience the most severe cutaneous side effects, underscoring the urgent need for an effective solution in this underserved market. Our successful $30 million financing in January 2025 has enabled us to accelerate development of LUT014 and advance toward commercialization. Currently, there is no accepted standard of care or approved drugs for EGFR inhibitor associated cutaneous toxicity. We are hopeful that the ongoing development of LUT014 will be able to provide for this significant unmet medical need. As such, Lutris is well-positioned to help patients remain on life-saving cancer treatments, enhancing outcomes and dramatically improving quality of life."

The trial enrolled 118 colorectal cancer patients from 23 clinical sites, all of whom had developed grade 2 or non-infected grade 3 acneiform rash while receiving cetuximab or panitumumab. Participants were randomized in a 1:1:1 ratio to receive either LUT014 gel 0.03%, LUT014 gel 0.1%, or a placebo gel. The gel was applied daily for 28 days.

The primary endpoint was the proportion of patients who achieved treatment success, measured by an improvement of at least one grade in Common Terminology Criteria for Adverse Events (CTCAE) scoring or an improvement of at least 5 points in the Functional Assessment of Cancer Therapy (FACT)-EGFRI-18 HRQoL skin-specific assessment. The study employed both an intention-to-treat (ITT) analysis and a Per-Protocol (PP) analysis (i.e., patients who dropped out or did not discontinue their EGFR inhibitor for reasons unrelated to the rash, such as disease progression were excluded from the analysis). Sample size calculation was based on an expected treatment success of 20% for the placebo group and 50% for one of the treatment groups. A total of 117 patients were required for a two group ꭕ2 test with a 0.05 two-sided significance and 80% power.

Efficacy is shown in the table below. The high dose of LUT014 demonstrated statistically significant rates of success improving acneiform rash in both the cetuximab and panitumumab ITT groups, compared to placebo. Additionally, patients randomized to LUT014 gel had lower rates of interruption of cetuximab or panitumumab therapy due to acneiform rash.

N

Success Rate

P value

Panitumumab

High dose LUT014 (0.1%)

28

64.3 %

0.028

Low dose LUT014 (0.03%)

21

47.6 %

0.321

Placebo

27

33.3 %

Cetuximab

High dose LUT014 (0.1%)

11

81.8 %

0.021

Low dose LUT014 (0.03%)

19

47.4 %

0.448

Placebo

12

33.3 %

About EGFR Inhibitor-Induced Rash
EGFR is a receptor on the surface of cells which is expressed in many normal epithelial tissues, including skin. The EGFR signaling pathway is one of the key pathways that regulate growth, survival, proliferation, and differentiation of cells. B-Raf is a protein encoded by the BRAF gene and is a downstream effector component of the EGFR signaling pathway. EGFR has been shown to be over-activated in various human cancers, including colorectal, lung, head and neck, urinary bladder, pancreatic and breast cancers, eliciting downstream phosphorylation and activation of the MAP Kinase pathway.

EGFR inhibitors can block the EGFR signal responsible for cell growth. Among the various types of pharmacological therapies for cancer, EGFR inhibitors are increasingly being used both as primary therapy as well as in patients who have progressed on prior chemotherapy treatments. Although effective as anti-cancer therapy leading to tumor shrinkage, EGFR inhibitors have many adverse reactions associated with their use. The majority of patients treated with EGFR inhibitors will experience adverse dermatological side effects typically manifested as a papulopustular skin rash, also known as acneiform lesions, which can impact quality of life and affect adherence to therapy.

About LUT014
LUT014 is a novel B-Raf inhibitor which is applied topically to the skin. When the B-Raf protein is mutated, as is the case in some human cancers such as melanoma, blocking this pathway leads to apoptosis of the cells and tumor shrinkage. However, when the same pathway is blocked in normal, non-mutated cells, the opposite happens: the MAPK pathway is activated, and cells start growing. This phenomenon is recognized as the paradoxical effect of B-Raf Inhibitors. LUT014 harnesses the paradoxical effect of B-Raf Inhibitors in order to enhance cell proliferation and balance cell destruction, typical to radiation dermatitis.

On July 7, 2025 Sirtex Medical ("Sirtex"), a leading manufacturer of interventional oncology solutions, reported that the U.S. Food and Drug Administration (FDA) approved SIR-Spheres Y-90 resin microspheres for the treatment of unresectable hepatocellular carcinoma (HCC) in the United States (Press release, Sirtex Medical, JUL 7, 2025, View Source [SID1234654269]). With this approval, SIR-Spheres is the only radioembolization therapy approved for the treatment of both metastatic colorectal cancer (mCRC) of the liver and HCC in the U.S.

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HCC is the most common form of liver cancer in adults in the U.S., according to the American Cancer Society. Radioembolization–commonly referred to as selective internal radiation therapy (SIRT)–with SIR-Spheres uses personalized dosimetry to deliver the optimal dose of radiation directly to tumors in patients with HCC. This approval gives clinicians expanded flexibility in selecting a liver-directed therapy that aligns with patient-specific needs and treatment goals.

"The expanded indication makes SIR-Spheres the only Y-90 treatment approved in the U.S. for both HCC and mCRC," said Matt Schmidt, CEO of Sirtex. "This milestone reflects our ongoing commitment to delivering flexible, personalized therapies—with multiple dose options available daily—that empowers physicians to treat patients when and where it works best."

This regulatory milestone is supported by results from the DOORwaY90 study, a prospective, multicenter, open-label clinical trial evaluating the safety and efficacy of SIR-Spheres in treating HCC. The study enrolled 100 patients across 18 U.S. centers, with 65 patients included in the interim primary efficacy cohort. DOORwaY90 met its prespecified co-primary endpoints, demonstrating a best overall response rate (ORR) of 98.5% as assessed by independent central review. All evaluable patients demonstrated a response, indicating a 100% local tumor control rate. Additionally, the median duration of response (DoR) exceeded 300 days. These findings highlight SIR-Spheres as a highly effective liver-directed therapy with a favorable safety profile.

"This study moves the field of radioembolization forward with reproducible dosimetry outcomes and a strong safety profile linked to very positive clinical results," said Dr. Armeen Mahvash, Interventional Radiologist at MD Anderson Cancer Center and Co-Principal Investigator of the DOORwaY90 Study. "This will give multidisciplinary care teams the confidence to recommend SIR-Spheres for HCC treatment."

On July 4, 2025 AstraZeneca reported that Imfinzi (durvalumab) has been approved in the European Union (EU) for the treatment of adult patients with resectable muscle-invasive bladder cancer (MIBC) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi as monotherapy adjuvant treatment after radical cystectomy (surgery to remove the bladder) (Press release, AstraZeneca, JUL 4, 2025, View Source [SID1234654238]).

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The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use and is based on results from the NIAGARA Phase III trial, which were published in The New England Journal of Medicine.

In a planned interim analysis, the Imfinzi-based perioperative regimen demonstrated a statistically significant 32% reduction in the risk of disease progression, recurrence, not undergoing surgery, or death versus neoadjuvant chemotherapy with radical cystectomy alone (based on event-free survival [EFS] hazard ratio [HR] of 0.68; 95% confidence interval [CI] 0.56-0.82; p<0.0001). Estimated median EFS was not yet reached for the Imfinzi arm versus 46.1 months for the comparator arm. An estimated 67.8% of patients treated with the regimen were event free at two years compared to 59.8% in the comparator arm.

Results from the key secondary endpoint of overall survival (OS) showed that the Imfinzi-based perioperative regimen reduced the risk of death by 25% versus the comparator arm (based on OS HR of 0.75; 95% CI 0.59-0.93; p=0.0106). Median survival was not yet reached for either arm. An estimated 82.2% of patients treated with the regimen were alive at two years compared to 75.2% in the comparator arm.

In 2024, over 35,000 people in the five major European countries were treated for MIBC.1 Despite this representing a curative-intent setting, many patients experience disease recurrence after surgery with current standard-of-care neoadjuvant chemotherapy.2

Dr Michiel Van der Heijden, medical oncologist and Group Leader at the Netherlands Cancer Institute, and investigator in the NIAGARA trial, said: "The durvalumab-based perioperative regimen is an important new treatment option for patients in Europe with muscle-invasive bladder cancer, as currently nearly half experience disease recurrence despite treatment with neoadjuvant chemotherapy and surgery to remove the bladder. The NIAGARA results showed how this regimen reduced the risk of recurrence by nearly a third and significantly extended survival, underscoring its potential to transform clinical practice in this curative-intent setting."

Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: "Imfinzi is poised to transform the standard of care for muscle-invasive bladder cancer in Europe as the first and only perioperative immunotherapy for these patients. In the NIAGARA Phase III trial, more than 80 per cent of patients were still alive two years after treatment with the Imfinzi regimen, setting a new survival benchmark for a disease that has seen few treatment advances in decades."

Imfinzi was generally well tolerated, and no new safety signals were observed in the neoadjuvant and adjuvant settings. Further, adding Imfinzi to neoadjuvant chemotherapy was consistent with the known profile for this combination and did not compromise patients’ ability to complete surgery compared to neoadjuvant chemotherapy alone. Immune-mediated adverse events were consistent with the known profile of Imfinzi, manageable and mostly low-grade.

The European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) has published its assessment of the NIAGARA regimen against the Magnitude of Clinical Benefit Scale (MCBS), awarding it the highest possible grade of "A" in the curative setting.3 The ESMO (Free ESMO Whitepaper)-MCBS facilitates improved decision-making regarding the value of anti-cancer therapies and is used in several ways, including in clinical guidelines and in health technology assessments in a growing number of countries.4

Imfinzi is approved in the US and other countries in this setting based on the NIAGARA results. Regulatory applications for this indication are currently under review in Japan and several other countries. Imfinzi is also approved in other curative-intent settings based on the PACIFIC and AEGEAN Phase III trials in non-small cell lung cancer (NSCLC), and in limited-stage small cell lung cancer (SCLC) based on the ADRIATIC Phase III trial.

Notes

Muscle-invasive bladder cancer
Bladder cancer is the 9th most common cancer in the world, with more than 614,000 patients diagnosed each year.5 The most common type of bladder cancer is urothelial carcinoma, which begins in the urothelial cells of the urinary tract.6 Bladder cancer is considered muscle-invasive when there is evidence of the tumour invading the muscle wall of the bladder but no distant metastases.6 In MIBC, approximately 50% of patients who undergo bladder removal surgery experience disease recurrence.2 Treatment options that prevent disease recurrence after surgery are critically needed in this curative-intent setting.

NIAGARA
NIAGARA is a randomised, open-label, multi-centre, global Phase III trial evaluating perioperative Imfinzi as treatment for patients with MIBC before and after radical cystectomy. In the trial, 1,063 patients were randomised to receive four cycles of Imfinzi plus neoadjuvant chemotherapy prior to cystectomy followed by eight cycles of Imfinzi monotherapy, or neoadjuvant chemotherapy alone prior to cystectomy with no further treatment after surgery. NIAGARA is the largest global Phase III trial in this setting.

The trial is being conducted at 192 centres in 22 countries across North America, South America, Europe, Australia and Asia. Its dual primary endpoints are EFS and pathologic complete response at the time of cystectomy. Key secondary endpoints are OS and safety.

Imfinzi
Imfinzi (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

In May 2025, Imfinzi plus standard-of-care Bacillus Calmette-Guérin induction and maintenance therapy met the primary endpoint of disease-free survival for patients with high-risk non-muscle-invasive bladder cancer in the POTOMAC Phase III trial.

In lung cancer, Imfinzi is the global standard of care based on OS in the curative-intent setting of unresectable, Stage III NSCLC in patients whose disease has not progressed after chemoradiotherapy (CRT). Additionally, Imfinzi is approved as a perioperative treatment in combination with neoadjuvant chemotherapy in resectable NSCLC, and in combination with a short course of Imjudo (tremelimumab) and chemotherapy for the treatment of metastatic NSCLC. Imfinzi is also approved for limited-stage SCLC in patients whose disease has not progressed following concurrent platinum-based CRT; and in combination with chemotherapy for the treatment of extensive-stage SCLC.

Imfinzi is also approved in combination with chemotherapy in locally advanced or metastatic biliary tract cancer and in combination with Imjudo in unresectable hepatocellular carcinoma (HCC). Imfinzi is also approved as a monotherapy in unresectable HCC in Japan and the EU.

In March 2025, perioperative Imfinzi added to standard-of-care chemotherapy met the primary endpoint of EFS in the MATTERHORN Phase III trial in resectable gastric and gastroesophageal junction cancers.

Imfinzi in combination with chemotherapy followed by Imfinzi monotherapy is approved as a 1st-line treatment for primary advanced or recurrent endometrial cancer (mismatch repair deficient disease only in the US and EU). Imfinzi in combination with chemotherapy followed by Lynparza (olaparib) and Imfinzi is approved for patients with mismatch repair proficient advanced or recurrent endometrial cancer in the EU and Japan.

Since the first approval in May 2017, more than 414,000 patients have been treated with Imfinzi. As part of a broad development programme, Imfinzi is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with NSCLC, bladder cancer, breast cancer, ovarian cancer and several gastrointestinal cancers.