On March 24, 2025 Foghorn Therpaeutics presented its corporate presentation (Presentation, Foghorn Therapeutics, MAR 24, 2025, View Source [SID1234651365]).

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On March 24, 2025 CEL-SCI Corporation (NYSE American: CVM) reported new data has been published from its prior Phase 3 study of Multikine* (Leukocyte Interleukin, Injection) in newly diagnosed, treatment naïve, resectable, locally advanced head and neck cancer patients in the highly regarded peer reviewed journal Pathology and Oncology Research (POR) (Press release, Cel-Sci, MAR 24, 2025, View Source [SID1234651383]). The article titled "Neoadjuvant Leukocyte Interleukin Injection Immunotherapy Improves Overall Survival in Low-risk Locally Advanced Head and Neck Squamous Cell Carcinoma -The IT-MATTERS Study" included a comprehensive presentation of results from CEL-SCI’s Phase 3 trial, the largest study ever conducted for newly diagnosed locally advanced head and neck cancer.

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"We are pleased that the wealth of data resulting from our completed Phase 3 study is now published in this international oncology journal," stated CEL-SCI’s Chief Scientific Officer, Dr. Eyal Talor. "We believe the marked improvement in quality of life offered by Multikine neoadjuvant treatment appeared to have had a positive impact on patients’ quality of life, and in addition to its favorable safety profile, tolerability and efficacy, it is likely to improve adoption rates for Multikine following regulatory approval."

The new, previously unpublished findings included the following patient quality of life data:

Quality of life (QoL) was assessed and validated through use of two instruments, EORTC QLQ-C30 and EORTC QLQ-H&N 35 across all clinical sites.
EORTC QLQ-C30 is a 30-item questionnaire developed by the European Organisation for Research and Treatment of Cancer (EORTC) to assess the health-related QoL of cancer patients.
EORTC QLQ-H&N 35 is a questionnaire designed to assess the QoL of head and neck cancer patients in conjunction with the general cancer-specific EORTC QLQ-C30.
QoL variables were assessed at baseline, before and after the Multikine treatment, and periodically during long-term follow up. These assessments included questions regarding pain in the mouth, jaw, and throat, problems swallowing, sense of smell and taste, ability for selfcare and mobility including walking, using the toilet, shortness of breath, emotional wellbeing including irritability and depression, and many other daily health assessment factors.
As a neoadjuvant therapy, patients were treated with Multikine before surgery. Pre-surgery objective early response to treatment with Multikine was confirmed by pathology at surgery. There were 45 objective early responders (which included 5 complete responders following 3-weeks of Multikine treatment) in the Multikine treated + standard of care group and zero (none reported by investigators) in the control group, which received the standard of care treatments only (i.e., surgery plus radiotherapy or surgery plus chemoradiotherapy; with cisplatin as the chemotherapeutic agent per the study protocol and NCCN Guidelines).
95.1% of complete responders to Multikine reported improved QoL
Complete responders reported a 100% (wherein all respondents scored the highest possible improvement from baseline) on 60% (39/65) of the QoL measures assessed including sleep, appetite, pain, emotional state, condition of mouth, sense of smell and taste, and social, family and public interactions.
QoL results for complete responders were measured and sustained for over 3 years following treatment with Multikine.
89.4% of partial responders to Multikine (those exhibiting greater than 30% reduction in tumor – confirmed by pathology at surgery) also reported improved assessed QoL measures from baseline.
About the Completed Phase 3 and Upcoming Confirmatory Registration Study

Based on the exceptional efficacy results and favorable safety profile for Multikine in a cohort of patients in the Phase 3 study, the U.S. Food and Drug Administration has given CEL-SCI the go ahead to initiate a confirmatory Registration Study of Multikine in newly diagnosed, previously untreated resectable stage 3 and 4 head and neck cancer patients who had no lymph node involvement and low PD-L1 tumor expression. There is a high unmet need in this patient population, for which no advancement in overall survival has been forthcoming in decades, despite many previous attempts by others.

Upon the Registration Study achieving full enrollment, CEL-SCI plans to seek early approval based on early tumor responses which were shown to correspond with survival rates. During the completed Phase 3 clinical trial, the 5-year overall survival rate of the target patient population (disease stage 3 and 4 patients who had no lymph node involvement and low PD-L1 tumor expression), which is the same population that will participate in the confirmatory study, increased to 73% when patients were treated with Multikine vs 45% for control patients who received only standard of care treatments.

About Pathology and Oncology Research (POR)

A Switzerland-based highly regarded international journal, POR is dedicated to keeping scientists informed of developments in its focused biomedical fields which span the gap between basic research and clinical medicine.

On March 24, 2025 IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, reported that the U.S. Food and Drug Administration (FDA) is aligned with the protocol for the Phase 3 pivotal trial, called OVATION 3, of its lead candidate IMNN-001 in development for the treatment of women with newly diagnosed advanced ovarian cancer (Press release, IMUNON, MAR 24, 2025, View Source [SID1234651366]). The company is currently initiating trial sites and working with trial investigators to begin enrolling study participants.

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"We are grateful for the ongoing guidance and support from the FDA and are very pleased that the agency is fully aligned on our plans related to the Phase 3 trial," said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. "The Phase 2 OVATION 2 study data are highly encouraging, demonstrating that IMNN-001 is the first immunotherapy to achieve a clinically effective response in ovarian cancer, including benefits in both progression-free and overall survival in frontline treatment, and we continue to observe strong improvements with additional monitoring and follow-up of patients. We look forward to potentially replicating these unprecedented results in the Phase 3 OVATION 3 study. We are currently initiating trial sites and are focused on enrolling study participants as quickly as possible as we work towards our goal of bringing thousands of women with advanced ovarian cancer a first-in-class and much-needed treatment option."

The Phase 3 OVATION 3 trial will assess the safety and efficacy of IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus neoadjuvant and adjuvant chemotherapy (NACT) of paclitaxel and carboplatin compared to standard of care (SoC) NACT alone. Study participants will be randomized 1:1 and include women with newly diagnosed advanced ovarian cancer (stage 3 or 4) who are eligible for neoadjuvant therapy, the intent-to-treat (ITT) population, with a sub-group of women positive for homologous recombination deficiency (HRD) including BRCA1 or BRCA2 mutations. Participants who are HRD positive will receive poly ADP-ribose polymerase (PARP) inhibitors as part of standard maintenance therapy. The primary endpoint of the study is overall survival (OS), and secondary endpoints are surgical response score, chemotherapy response score, clinical response and time to second-line treatment. The study will also assess several exploratory endpoints.

In December 2024, IMNN-001 plus NACT boosted median overall survival to 46 months—outpacing standard-of-care NACT by 13 months—up 2 months from the prior 11-month mark after 7 additional months of follow-up, with an excellent safety profile showing no cytokine release syndrome or serious adverse events. In the same month, the company also announced a positive outcome from a Type C Chemistry, Manufacturing, and Controls (CMC) meeting with the FDA regarding current good manufacturing practice (cGMP) production of IMNN-001 for the Phase 3 trial and potential commercialization. Production of IMNN-001 is conducted at IMUNON’s in-house manufacturing facility located in Huntsville, Alabama.

Conference Call and Webcast

IMUNON is hosting a conference call to discuss the Phase 3 OVATION 3 pivotal trial of IMNN-001 on Tuesday, March 25, 2025, at 2:00 p.m. ET. Company management will be joined by:

Premal H. Thaker, M.D., Interim Chief of Gynecologic Oncology, David & Lynn Mutch Distinguished Professor of Obstetrics & Gynecology, Director of Gynecologic Oncology Clinical Research at Washington University School of Medicine, and the OVATION 2 Study Chair
L.J. Wei, Ph.D., Professor of Biostatistics, Harvard T.H. Chan School of Public Health
To participate in the call, please dial 833-816-1132 (Toll-Free/North America) or 412-317-0711 (International/Toll) and ask for the IMUNON Phase 3 protocol call. A live webcast of the call will also be available here.

The call will be archived for replay until April 8, 2025. The replay can be accessed at 877-344-7529 (U.S. Toll-Free), 855-669-9658 (Canada Toll-Free) or 412-317-0088 (International Toll), using the replay access code 9074731. An audio replay of the call will also be available here for 90 days.

About the Phase 2 OVATION 2 Study

OVATION 2 evaluated the dosing, safety, efficacy and biological activity of intraperitoneal administration of IMNN-001 in combination with neoadjuvant and adjuvant chemotherapy (NACT) of paclitaxel and carboplatin in patients newly diagnosed with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. Treatment in the neoadjuvant period is designed to shrink the tumors as much as possible for optimal surgical removal after three cycles of chemotherapy. Following NACT, patients undergo interval debulking surgery, followed by three additional cycles of adjuvant chemotherapy to treat any residual tumor. This open-label study enrolled 112 patients who were randomized 1:1 and evaluated for safety and efficacy to compare NACT plus IMNN-001 versus standard-of-care NACT. In accordance with the study protocol, patients randomized to the IMNN-001 treatment arm could receive up to 17 weekly doses of 100 mg/m2 in addition to NACT. As a Phase 2 study, OVATION 2 was not powered for statistical significance. Additional endpoints included objective response rate, chemotherapy response score and surgical response.

About IMNN-001 Immunotherapy

Designed using IMUNON’s proprietary TheraPlas platform technology, IMNN-001 is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system that enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anticancer immunity acting through the induction of T-lymphocyte and natural killer cell proliferation. IMUNON previously reported positive safety and encouraging Phase 1 results with IMNN-001 administered as monotherapy or as combination therapy in patients with advanced peritoneally metastasized primary or recurrent ovarian cancer and completed a Phase 1b dose-escalation trial (the OVATION 1 Study) of IMNN-001 in combination with carboplatin and paclitaxel in patients with newly diagnosed ovarian cancer. IMUNON previously reported positive results from the recently completed Phase 2 OVATION 2 Study, which assessed IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus neoadjuvant and adjuvant chemotherapy (NACT) of paclitaxel and carboplatin compared to standard-of-care NACT alone in 112 patients with newly diagnosed advanced ovarian cancer.

About Epithelial Ovarian Cancer

Epithelial ovarian cancer is the sixth deadliest malignancy among women in the U.S. There are approximately 20,000 new cases of ovarian cancer every year and approximately 70% are diagnosed in advanced Stage III/IV. Epithelial ovarian cancer is characterized by dissemination of tumors in the peritoneal cavity with a high risk of recurrence (75%, Stage III/IV) after surgery and chemotherapy. Since the five-year survival rates of patients with Stage III/IV disease at diagnosis are poor (41% and 20%, respectively), there remains a need for a therapy that not only reduces the recurrence rate, but also improves overall survival. The peritoneal cavity of advanced ovarian cancer patients contains the primary tumor environment and is an attractive target for a regional approach to immune modulation.

On March 24, 2025 Agilent Technologies Inc. (NYSE: A) reported its role in supporting Autolus Therapeutics’ FDA approval for AUCATZYL, a recently approved CAR T therapy. Agilent’s advanced cell analysis instrumentation, specifically the xCELLigence Real-Time Cell Analysis (RTCA) technology, was applied in developing and validating AUCATZYL. The xCELLigence RTCA technology supported the development and implementation of the potency assay (Press release, Agilent, MAR 24, 2025, View Source [SID1234651384]). By providing precise and reliable cell analysis solutions, Agilent assisted Autolus in achieving the high standards required for FDA approval.

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Dr. Xiaobo Wang, Vice President and General Manager of the Cell Function and Phenotyping Business at Agilent stated, "Agilent is honored to have contributed to this significant milestone in cancer treatment. The collaboration between Agilent and Autolus highlights the importance of innovative technologies and cooperative efforts in advancing cancer therapies."

David Brochu, Chief Technical Officer at Autolus Therapeutics added, "Agilent’s support was invaluable in our journey to FDA approval. Agilent’s state-of-the-art xCELLigence RTCA technology facilitated the accuracy, reliability and precision of our potency analytical procedure."

The xCELLigence Real-Time Cell Analysis (RTCA) technology is a cutting-edge platform that continuously monitors cell behavior in real-time without using labels or dyes. This technology measures electrical impedance to provide dynamic information on cell numbers, viability, and morphology. Unlike traditional endpoint assays, xCELLigence RTCA offers real-time insights, enabling more accurate and timely decision-making in drug development. Its ability to deliver continuous, real-time data sets it apart in the market, providing researchers with a deeper understanding of cellular responses and enhancing the development of effective therapies.

Agilent and Autolus will attend the 2025 Hybrid US Bioassay Conference from March 24-25 in Tucson, Arizona. Mike Merges, Vice President of Analytical Development, QC Control Operations, Automation, and CMC (Chemistry, Manufacturing, and Controls) at Autolus, along with Jakub Dragun, Quality Control Consultant at Autolus, and Xiaobo Wang, VP/GM of the Cell Function and Phenotyping Business at Agilent, will present a Main Session Podium Talk titled: ‘Lessons Learned in CAR T Cell Product Potency Measurement: A Cross-Functional Investigation and the Importance of Partnership.’ The talk will be held Monday, March 24, from 1:30-2:00 PM in the Sabino Room at the Marriott Tucson University Park Hotel and is open to all conference attendees.

Agilent is committed to advancing scientific innovation and supporting groundbreaking therapies that enhance health outcomes. To learn more about Agilent’s real-time cell analysis solutions, visit Agilent Cell Analysis.

On March 24, 2025 CStone Pharmaceuticals (stock code: 2616.HK), an innovation-driven biopharmaceutical company focused on developing oncology drugs, reported that it has submitted a new indication application (NDA) for sugemalimab to the European Medicines Agency (EMA) for the treatment of patients with unresectable Stage III non-small cell lung cancer (NSCLC) who have not progressed after concurrent or sequential chemoradiotherapy (CRT) (Press release, CStone Pharmaceauticals, MAR 24, 2025, View Source [SID1234656219]). This is the second indication CStone has advanced in the European market, following its initial EMA approval in 2024 for the first-line treatment of metastatic squamous and non-squamous NSCLC. If approved, sugemalimab will address a critical unmet need in Stage III NSCLC, becoming the second PD-(L)1 antibody approved for this indication in Europe . Furthermore, sugemalimab’s dual application in both Stage III and Stage IV NSCLC will further solidify its position as a core immunotherapy for lung cancer.

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This application is based on a multicenter, randomized, double-blind Phase III clinical study called GEMSTONE-301 , which aims to evaluate the efficacy and safety of sugemalimab as consolidation therapy for patients with unresectable Stage III NSCLC after CRT. The results of the GEMSTONE-301 study have been published in The Lancet Oncology, and the results show that:

Sugemalimab can significantly prolong patients’ progression-free survival (PFS) and reduce the risk of disease progression or death by 36%;
A clear trend toward overall survival (OS) benefit, with a 56% reduction in the risk of death ;
Consistent clinical benefits were observed regardless of whether patients received concurrent or sequential chemoradiotherapy;
The safety profile was good and no new risk signals were found.
Dr. Jianxin Yang, CEO, President of R&D, and Executive Director of CStone Pharmaceuticals, said: "Following the successful approval of sugemalimab for the treatment of Stage IV NSCLC in Europe, we have been working closely with the EMA to actively expand its indication for earlier-stage lung cancer and other tumor types. Based on its outstanding efficacy and favorable safety profile, sugemalimab has the potential to address the unmet clinical needs of patients with Stage III NSCLC. Furthermore, we will continue to deepen our international strategic collaborations and work closely with regulatory agencies to increase global access to sugemalimab and ensure that this innovative therapy can benefit patients worldwide as soon as possible."

About Sugemalimab

Sugemalimab was developed by CStone Pharmaceuticals using the OmniRat transgenic animal platform licensed from US-based Ligand Corporation . This platform enables the one-stop production of fully human antibodies. As a fully human, full-length anti-PD-L1 monoclonal antibody, sugemalimab closely resembles the natural G-type immunoglobulin 4 (IgG4) response in humans, minimizing the potential risk of immunogenicity and related toxicities in patients. This offers unique advantages over similar drugs.

The European Commission (EC) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA) have approved sugemalimab in combination with platinum-based chemotherapy for the first-line treatment of patients with metastatic NSCLC who do not have sensitizing EGFR mutations or genomic tumor alterations in ALK, ROS1, or RET.

Currently, the China National Medical Products Administration (NMPA) has approved five indications for Sugemalimab (Zegemet ) :

First-line treatment in combination with chemotherapy for metastatic non-squamous NSCLC and metastatic squamous NSCLC without EGFR or ALK gene mutations;
For the treatment of patients with unresectable, stage III NSCLC who have not experienced disease progression after concurrent or sequential chemoradiotherapy;
Treatment of patients with relapsed or refractory extranodal NK/T-cell lymphoma;
Combined with fluorouracil and platinum chemotherapy drugs as the first-line treatment for patients with unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma;
In combination with fluorouracil-containing and platinum-based chemotherapy, it is used for the first-line treatment of unresectable locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma expressing PD-L1 CPS ≥ 5.