On October 23, 2025 IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, reported that new translational data from the Phase 2 OVATION 2 clinical trial of IMNN-001, its investigational therapy for the treatment of women with newly diagnosed advanced ovarian cancer, will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 40th Annual Meeting, being held November 5-9, 2025 in National Harbor, Maryland.

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IMNN-001, based on IMUNON’s proprietary TheraPlas technology platform, is an interleukin-12 (IL-12) DNA plasmid vector encased in a nanoparticle delivery system, enabling cell transfection followed by durable, local production and secretion of the IL-12 protein in the tumor microenvironment. IL-12 is a powerful pluripotent cytokine known for inducing strong anti-cancer immunity by promoting T-lymphocyte and natural killer cell proliferation while inhibiting tumor-mediated immune suppression. IMNN-001 is the first therapy to achieve a clinically effective response in advanced (stage IIIC/IV) ovarian cancer including benefits in both progression-free survival and overall survival in a first-line treatment setting when used with standard of care chemotherapy.

Details of the SITC (Free SITC Whitepaper) poster presentation are as follows:

Abstract Title: IMNN-001, IL-12 gene therapy, added to Neo/Adjuvant chemotherapy safely turns the tumor microenvironment cold-to-hot in newly diagnosed epithelial ovarian cancer (EOC)

Presenting Author: Douglas V. Faller, M.D., Ph.D., Chief Medical Officer, IMUNON

Date: Friday, November 7, 2025

Time: 12:15 p.m. – 1:45 p.m. ET

Poster Number: 1165

In September 2025, the Company presented positive translational data from the OVATION 2 Study at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference in Cancer Research: Advances in Ovarian Cancer Research reinforcing the favorable safety profile and efficacy benefits of IMNN-001 observed in the clinic, including increases in key anti-cancer immune cytokines and modulation of relevant anti-tumor immune cell populations, such as CD8+ T cells and myeloid dendritic cells, in the tumor and tumor microenvironment in study participants post-treatment.

About the OVATION 3 Study

OVATION 3 is IMUNON’s pivotal Phase 3 study of IMMN-001, an IL-12 gene-mediated immunotherapy, in women with advanced stage epithelial ovarian cancer. The study is supported with unprecedented overall survival (OS) data from a large, 112-patient, randomized Phase 2 OVATION 2 study showing the following:

Median 13-month increase in OS (HR 0.70) and median 3-month increase in PFS (HR 0.79) in IMNN-001 treatment arm compared to standard of care alone.
Better therapeutic effect observed with IMNN-001 treatment compared to the control arm (p=0.0375), as shown by mean 6.5-month extension of time free of progression or death (PFS + OS) captured in totality of treatment effect.
Use of poly ADP-ribose polymerase (PARP) inhibitors as part of maintenance therapy further enhanced outcomes, with median OS not yet reached in the IMNN-001 treatment arm as patients surpass 5 years since randomization in the trial compared to median OS of 37 months on standard of care (HR 0.42).

The results from the OVATION 2 Study have resulted in invitations to present data from the Phase 2 Study at both the ASCO (Free ASCO Whitepaper) and ESMO (Free ESMO Whitepaper) annual meetings and in the peer-reviewed journal Gynecologic Oncology.

The OVATION 3 trial is a robustly designed clinical study with at least 95% statistical power on the primary endpoint of overall survival. The trial design includes two planned interim analyses of the primary endpoint, designed to allow for an accelerated timeline for FDA submission of an IMNN-001 BLA if the primary endpoint reaches statistical significance. OVATION 3 is currently enrolling patients at four clinical sites with up to 46 additional sites being considered for activation.

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 (N/ACT) 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 N/ACT, 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 N/ACT plus IMNN-001 versus standard-of-care N/ACT. 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 N/ACT. 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 score.

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 durable, 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 activation and 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 neoadjuvant 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 (N/ACT) of paclitaxel and carboplatin compared to standard-of-care N/ACT 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.

(Press release, IMUNON, OCT 23, 2025, View Source [SID1234656947])

On October 23, 2025 Halia Therapeutics, Inc., a clinical-stage biopharmaceutical company pioneering therapies that target the root causes of inflammation-driven diseases, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its investigational medicine ofirnoflast (HT-6184) for the treatment of Myelodysplastic Syndromes (MDS) — a group of bone marrow disorders characterized by ineffective blood cell production and a risk of progression to acute myeloid leukemia (AML).

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The FDA grants Orphan Drug Designation to therapies intended for the treatment, prevention, or diagnosis of rare diseases or conditions that affect fewer than 200,000 people in the United States at the time of designation.

"This designation underscores the potential of our approach in Myelodysplastic Syndromes and supports our commitment to developing new treatment options for patients living with MDS," said David Bearss, PhD, Chief Executive Officer of Halia Therapeutics. "Ofirnoflast represents a first-in-class approach to modulating inflammasome biology, an upstream driver of inflammation, with the goal of restoring healthy bone marrow function."

Ofirnoflast is a selective NEK7 allosteric modulator designed to prevent the formation and promote the disassembly of the NLRP3 inflammasome, a central driver of chronic inflammation in multiple diseases. In MDS, inflammasome activation is increasingly recognized as a key contributor to ineffective hematopoiesis and bone marrow failure. By modulating NEK7, ofirnoflast aims to restore immune balance and improve blood-cell production without broad immunosuppression.

"Inflammasome biology represents a promising frontier for hematologic innovation," said Alan F. List, MD, member of Halia Therapeutics’ Scientific Advisory Board and former President and CEO of Moffitt Cancer Center. "Ofirnoflast’s approach is distinctive in that it seeks to modulate the underlying inflammatory drivers of MDS rather than just its downstream effects. This strategy has the potential to redefine how inflammation-linked bone marrow failure is treated."

Under the FDA’s Orphan Drug Act, orphan-drug status provides several incentives, including tax credits for qualified clinical testing, exemption from FDA user fees, and potential for seven years of U.S. market exclusivity upon approval. The FDA also administers grant programs to support clinical research and advance the development of therapies for rare diseases.

About Myelodysplastic Syndromes (MDS)

Myelodysplastic Syndromes are a group of bone marrow disorders characterized by defective blood-cell formation, leading to anemia, infection risk, and bleeding complications. MDS primarily affects older adults and can progress to acute myeloid leukemia (AML). Current therapies, including hypomethylating agents and growth factors, often provide limited benefit and do not address the underlying inflammatory biology of the disease.

About Ofirnoflast (HT-6184)

Ofirnoflast (HT-6184) is Halia Therapeutics’ lead investigational compound and a first-in-class NEK7 modulator that regulates activation of the NLRP3 inflammasome — an upstream molecular complex involved in chronic inflammation. The drug is currently being evaluated across multiple disease areas, including:

Myelodysplastic Syndromes (MDS) – completed Phase 2 study evaluating safety and hematologic outcomes
Obesity (in combination with semaglutide) – ongoing Phase 2 study targeting adipose inflammation and metabolic dysregulation
Alzheimer’s Disease – early-stage program focused on genetically at-risk populations

(Press release, Halia Therapeutics, OCT 23, 2025, View Source [SID1234656964])

On October 22, 2025 Charles River Laboratories International, Inc. (NYSE: CRL) and The Francis Crick Institute (Crick) reported a new collaboration around Antibody-Drug Conjugate (ADC) drug discovery and development, leveraging combined strengths to accelerate the development and delivery of next-generation targeted therapies.

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This agreement leverages an integrated approach to streamline discovery and characterization—bringing promising ADC candidates to the clinic faster and more efficiently. This end-to-end approach—spanning antibody discovery, conjugation, in vitro profiling, and preclinical studies—will be fully integrated and managed jointly by Charles River and the Crick to minimize timelines and maximize efficiency.

"This integrated ADC development agreement represents a powerful synergy between cutting-edge antibody discovery and rigorous safety profiling," said Justin Bryans, PhD, Chief Scientific Officer, Charles River. "Together, we’re enabling the development of smarter, safer therapeutics that are more likely to succeed in the clinic—ultimately supporting the mission of delivering life-changing therapies to patients."

This collaboration will feature antibody generation leveraging phage display libraries, ensuring high-affinity, target-specific antibodies as the foundation for ADC development. It will also utilize Charles River’s advanced Retrogenix platform, an in vitro profiling technology designed to evaluate off-target interactions and enhance safety and therapeutic index early in the development process.

David Allen, Director of Translation at the Crick, added, "This collaboration marks a powerful convergence of innovation and execution. Working together will allow us to translate our research discoveries into new treatments at a scale and speed that simply wouldn’t be possible alone."

(Press release, Charles River Laboratories, OCT 22, 2025, View Source [SID1234656913])

On October 22, 2025 Boston Scientific Corporation (NYSE: BSX) reported net sales of $5.065 billion during the third quarter of 2025, growing 20.3 percent on a reported basis, 19.4 percent on an operational1 basis and 15.3 percent on an organic2 basis, all compared to the prior year period. The company reported GAAP net income attributable to Boston Scientific common stockholders of $755 million or $0.51 per share (EPS), compared to $469 million or $0.32 per share a year ago, and achieved adjusted3 EPS of $0.75 for the period, compared to $0.63 a year ago.

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"We delivered another exceptional quarter of strong performance across businesses and regions thanks to the winning spirit of our global team," said Mike Mahoney, chairman and chief executive officer, Boston Scientific. "As we shared at our recent Investor Day meeting, we are well-positioned for differentiated growth that is fueled by our category leadership strategy, relentless focus on innovation and commitment to scaling capabilities."

Third quarter financial results and recent developments:

Reported net sales of $5.065 billion, representing an increase of 20.3 percent on a reported basis, compared to the company’s guidance range of 17 to 19 percent; 19.4 percent on an operational basis; and 15.3 percent on an organic basis, compared to the company’s guidance range of 12 to 14 percent, all compared to the prior year period.
Reported GAAP net income attributable to Boston Scientific common stockholders of $0.51 per share, compared to the company’s guidance range of $0.44 to $0.46 per share, and achieved adjusted EPS of $0.75 per share, compared to the guidance range of $0.70 to $0.72 per share.
Achieved the following net sales growth in each reportable segment, compared to the prior year period:
MedSurg: 16.4 percent reported, 15.6 percent operational and 7.6 percent organic
Cardiovascular: 22.4 percent reported, 21.5 percent operational and 19.4 percent organic
Achieved the following net sales growth/(declines) in each region, compared to the prior year period:
United States (U.S.): 27.0 percent reported and operational
Europe, Middle East and Africa (EMEA): 2.6 percent reported and (2.0) percent operational
In the second quarter of 2025, management made the decision to discontinue worldwide sales of the ACURATE neo2 and ACURATE Prime Aortic Valve Systems, which had prior year global sales of approximately $50 million per quarter
Asia-Pacific (APAC): 17.1 percent reported and 16.9 percent operational
Latin America and Canada (LACA): 10.4 percent reported and 9.6 percent operational
Emerging Markets4: 11.8 percent reported and 11.5 percent operational
Announced Pharmaceuticals and Medical Device Agency (PMDA) approval in Japan for expanded labeling of the FARAPULSE Pulsed Field Ablation (PFA) System to include treatment of drug refractory, symptomatic persistent atrial fibrillation (AF).
Commenced enrollment in the AGENT DCB STANCE trial to assess the safety and effectiveness of the AGENT Drug-Coated Balloon (DCB) in patients with previously untreated coronary lesions, compared to standard of care percutaneous coronary intervention (PCI) treatment with drug-eluting stents and/or balloon angioplasty.
Published in JAMA Neurology outcomes from the five-year INTREPID study demonstrating sustained benefits of deep brain stimulation in people with moderate to advanced Parkinson’s disease, including improved motor function and quality of life.
Completed asset acquisition with Elutia, Inc. to acquire the antibiotic-eluting EluPro BioEnvelope and the CanGaroo Envelope, designed to prevent certain post-operative complications for devices such as pacemakers and defibrillators.
Announced agreement to acquire Nalu Medical, Inc., developer of the Nalu Neuromodulation System, which is designed to use peripheral nerve stimulation to deliver targeted relief for adults living with severe, intractable chronic pain of peripheral nerve origin — subject to customary closing conditions.

(Press release, Boston Scientific, OCT 22, 2025, View Source [SID1234661705])

On October 22, 2025 I-Mab (NASDAQ: IMAB) (I-Mab or the Company), is a global biotechnology platform company committed to accelerating access to innovative medicines for patients worldwide, reported that updated data from the Phase 1 study (NCT04900818) of givastomig as a monotherapy in heavily pre-treated patients (n=45) with gastroesophageal carcinoma (GEC) will be presented as a "short-talk" at the Triple Meeting on October 23, 2025 in Boston, Massachusetts (Presentation #B016). Givastomig is a bispecific antibody targeting CLDN18.2 (Claudin 18.2) and 4-1BB.

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"The Phase 1 givastomig monotherapy data that will be shared at the Triple Meeting continue to demonstrate impressive safety and efficacy, with an 18% ORR in heavily pre-treated gastric cancer patients, with favorable overall safety. These data, showing responses over a dose range from 5 mg/kg Q2W to 18 mg/kg Q3W, further enrich givastomig’s emerging product profile and bolster our confidence that givastomig has the potential to be a best-in-class Claudin18.2-directed therapy across a broad range of CLDN18.2 expression. In Q1 2026, we expect to report topline results from the fully-enrolled Phase 1b dose expansion immune-chemotherapy combination study and initiate a global, randomized Phase 2 combination study. We believe the data from these studies will clearly demonstrate givastomig’s potential to significantly improve the standard of care in the treatment of first line GEC patients with a broad range of Claudin 18.2 expression levels," said Phillip Dennis, MD, PhD, Chief Medical Officer of I-Mab.

"In our experience, givastomig integrates well into the workflow at our center. Based on the monotherapy efficacy across a range of doses and Claudin 18.2 expression levels, and excellent overall safety, givastomig has the potential to be the best-in-class Claudin-directed therapy and combination partner for the treatment of frontline gastric cancer. These follow-up data, plus encouraging initial results from the Phase 1b immune-chemotherapy frontline combination studies, presented earlier this year, give us hope that givastomig treatment can lead to improved treatment outcomes for patients with gastric cancers. We are eager to move forward with the planned Phase 2 study and continue to advance this program," said Samuel J Klempner, MD, Associate Professor of Medicine at Massachusetts General Hospital.

AACR-NCI-EORTC "the Triple Meeting" Conference Information:

Title: Updated Safety, Efficacy and Biomarker Analysis from the Phase I Study of Givastomig, a Novel Claudin 18.2/4-1BB Bispecific Antibody, in Claudin 18.2 Positive Advanced Gastroesophageal Carcinoma (GEC)

Session: Concurrent Session 2: Bispecifics/T-cell Engagers

Speaker: Samuel J. Klempner, MD, Associate Professor of Medicine, Massachusetts General Hospital

Presentation Number: B016

Date and Time: Thursday, October 23, 2025, 6:20 – 6:35 PM ET

Location: Hynes Convention Center

A copy of the Triple Meeting presentation and poster will be available on the Publications and Presentations page of the I-Mab website on October 23, 2025.

Givastomig Phase 1 Monotherapy Updated data Summary GEC (per June 10, 2025 data cut-off):

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Givastomig was well tolerated up to 15 mg/kg Q2W and 18 mg/kg Q3W and continues to show monotherapy activity in heavily pre-treated GEC patients with a wide range of CLDN18.2 expression
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Givastomig may have the ability to target patients with lower CLDN18.2 expression compared with other CLDN18.2 agents
Patients Characteristics:

•
45 GEC patients were dosed with givastomig every two weeks (Q2W) across dose levels of: 5mg/kg (n=7), 8 mg/kg (n=5), 12 mg/kg (n=21), 15 mg/kg (n=6) and 18 mg/kg Q3W (n=6) as of the June 10, 2025 data cutoff
•
Patients had received a median of 3 prior therapies including 74% with a prior PD-L1 inhibitor
Efficacy Results:

•
Confirmed Objective Response Rate (ORR):
o
18% of patients (8/45) achieved a partial response (PR)
▪
5 mg/kg (1/7)
▪
8 mg/kg (1/5)
▪
12 mg/kg (4/21)
▪
15 mg (0/6)
▪
18 mg/kg Q3W (2/6)
o
Claudin 18.2 expression in responders ranged from 11% (1+, 10%; 2+, 1%) to 100% (2+, 10%; 3+, 90%)
•
The Disease Control Rate (DCR) was 49%, including stable disease (SD) in 14 patients
Follow-up and Biomarker Data:

•
2 patients are ongoing (4%), with 1 PR (8 mg/kg) at 33 months (mo), and 1 PR (18 mg/kg Q3W) at 10 mo
•
The median progression free survival (mPFS) and median overall survival (mOS) are 2.96 mo (95% CI 1.71-3.91) and 7.49 mo (95% CI 4.96-12.5), respectively

No statistical difference in ORR, DCR, PFS or OS, between CLDN18.2-high (n=21) and CLDN18.2-low patients (n=24): ORR 19% v. 17% (p=1.00), DCR 57% v. 42% (p=0.46), mPFS 3.68 mo v. 1.84 mo, PFS hazard ratio (HR) 0.87 (p=0.67), and mOS 7.49 mo v. 7.49 mo, OS HR 0.88 (p=0.74), respectively
Safety:

•
There were no new safety signals identified with longer follow-up
•
No dose limiting toxicities were observed
•
Common TREAEs (≥15%, any grade/grade 3) included anemia (27%/9%), white blood cell count decrease (22%/7%), nausea (20%/2%), ALT increase (16%/2%) and AST increase (16%/4%)
About Givastomig

Givastomig (TJ033721 / ABL111) is a bispecific antibody targeting Claudin 18.2 (CLDN18.2)-positive tumor cells. It conditionally activates T cells through the 4-1BB signaling pathway in the tumor microenvironment where CLDN18.2 is expressed. Givastomig is being developed for potential treatment of gastric cancer and other Claudin 18.2-positive gastrointestinal malignancies. In Phase 1 trials, givastomig has shown promising anti-tumor activity attributable to a potential synergistic effect of proximal interaction between CLDN18.2 on tumor cells and 4-1BB on T cells in the tumor microenvironment, while minimizing toxicities commonly seen with other 4-1BB agents.

Givastomig is being jointly developed through a global partnership with ABL Bio, in which I-Mab is the lead party and shares worldwide rights, excluding Greater China and South Korea, equally with ABL Bio.

(Press release, I-Mab Biopharma, OCT 22, 2025, View Source [SID1234656898])