On October 30, 2025 IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, reported that it has been invited to present a trials-in-progress abstract on the ongoing Phase 3 OVATION 3 clinical trial of IMNN-001, its investigational therapy for the treatment of women with newly diagnosed advanced ovarian cancer, at the 2025 Annual Global Meeting of the International Gynecologic Cancer Society (IGCS), being held November 5-7, 2025 in Cape Town, South Africa.

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IMNN-001, based on IMUNON’s proprietary TheraPlas technology platform, is an interleukin-12 (IL-12) DNA plasmid vector incorporated in a nanoparticle delivery system, enabling cell transfection followed by persistent, local production and secretion of the IL-12 protein in the tumor microenvironment. 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 (PFS) and overall survival (OS) in a first-line treatment setting when used with standard of care chemotherapy.

"We are very pleased that we have been invited to present on our ongoing OVATION 3 Study at two prestigious conferences in the oncology field," said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. "It is very encouraging to see the strong interest in our promising and novel IMNN-001 DNA-mediated immunotherapy among the global scientific community, and the acceptance of our TiP poster at both IGCS and ESMO (Free ESMO Whitepaper) 2025 is further validation of our therapy’s significant potential to transform the treatment of advanced ovarian cancer. Our clinical success thus far has attracted increasing interest from both clinical investigators and patients, and we continue to make meaningful progress as we advance enrollment in the Phase 3 trial as quickly as possible."

The Company treated the first patient in the pivotal Phase 3 OVATION 3 Study in July 2025 and is working with trial investigators to expand clinical sites and accelerate enrollment. Four sites have been activated to date and are open for patient enrollment, with up to 46 additional sites being considered for activation.

Details of the IGCS 2025 poster presentation are as follows:

Abstract Title: OVATION-3: A randomized phase III trial evaluating the safety and efficacy of intraperitoneal IL-12 gene therapy administered in combination with standard neoadjuvant and adjuvant chemotherapy in newly-diagnosed patients with advanced epithelial ovarian cancer

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

Poster Number: TP014/#750

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 epithelial ovarian cancer. The study is supported with unprecedented OS data from a large, 112-patient, randomized Phase 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 in 2025 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 trial 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 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 (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 30, 2025, View Source [SID1234657152])

On October 30, 2025 Lantern reported it will present two commercially deployed AI research platforms at the inaugural AI for Biology and Medicine (AI4BM) symposium at the University of North Texas. The symposium, hosted by Dr. Serdar Bozdag and the newly established Center for Computational Life Sciences, brings together leading researchers advancing the intersection of artificial intelligence and biomedicine.

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The Lantern Pharma team will deliver two presentations demonstrating how machine learning is transforming drug development and precision oncology through specific AI modules that are already delivering value to Lantern’s drug development efforts and other pharmaceutical companies and researchers:

"Machine Learning Ensemble Models for In Silico Screening and Prediction of Blood-Brain Barrier Permeability: A Comprehensive Approach Using Molecular Fingerprints and Descriptors". This presentation will showcase predictBBB.ai, Lantern’s commercially deployed platform that achieves 94.1% accuracy in predicting blood-brain barrier permeability—placing it at the top of the Therapeutic Data Commons leaderboard. The platform predicts BBB permeability in days rather than the months or years required by traditional methods, with the ability to screen 200,000 drug candidates in under a week. The ensemble model has been blindly validated on over 1,300 unseen molecules, demonstrating both accuracy and scalability for pharmaceutical companies developing CNS-targeted therapeutics and is available now as a commercial-ready resource.
"Machine Learning Models for Liquid Biopsy-Based Treatment Response Prediction and Biomarker Discovery in Cancer" Lantern will demonstrate LBx-AI, a production-ready platform that transforms liquid biopsy data into actionable insights with 86% accuracy in predicting treatment response for non-small cell lung cancer patients. Using a novel pathway-level engineering approach, the platform identifies complex biomarkers and pathway analytics that would be missed by traditional single-mutation analysis—with 20 out of 21 significant predictive markers being engineered pathway features. Beyond treatment prediction, LBx-AI can infer solid tumor characteristics from circulating tumor DNA, including accurate prediction of PD-L1 expression levels (0.76 Pearson correlation). Lantern is actively collaborating with world-class research institutions to further validate and improve the models’ performance across a number of tumor types, including GBM, and breast cancer.
Lantern believes that the platforms stand apart through three key differentiators: proven commercial deployment, dramatically compressed drug development timelines, and the generation of novel insights previously inaccessible through conventional methods. While traditional BBB permeability testing and biomarker discovery require months to years of laboratory work, Lantern’s AI models deliver comprehensive insights for drug development, candidate optimization, and target identification within days—maintaining enterprise-level scalability throughout. This transformation from lengthy experimental cycles to rapid computational analysis represents a fundamental shift in how pharmaceutical companies can approach drug discovery and development.

These advanced AI models power Lantern’s comprehensive cancer drug development ecosystem, which was initially developed as RADR. LBx-AI serves as a core component of RADR, Lantern’s AI-driven platform that accelerates precision oncology drug development, while predictBBB.ai operates as a standalone service helping pharmaceutical companies and research teams reduce development costs and improve success rates for CNS-targeted therapeutics.

"Our team is excited to share our efforts and platforms with leading researchers at this inaugural AI symposium," said Panna Sharma, President and CEO at Lantern Pharma. "We’re honored to present alongside distinguished researchers and look forward to engaging with the scientific community. Our vision extends beyond these current capabilities—we’re committed to making these powerful AI tools available as open-access platforms, democratizing advanced computational methods for researchers worldwide."

The symposium will feature keynote speaker Dr. Iman Hajirasouliha, Associate Professor of Systems and Computational Biomedicine at Weill Cornell Medicine, member of the Englander Institute for Precision Medicine and the Meyer Cancer Center, and Co-Director of the Tri-I Computational Biology and Medicine Ph.D. program.

For more information about the AI4BM symposium, visit: View Source

(Press release, Lantern Pharma, OCT 30, 2025, View Source;Research-Platforms-at-Inaugural-AI-for-Biology-and-Medicine-Symposium-at-UNT/default.aspx [SID1234657170])

On October 30, 2025 Synthekine Inc., an engineered cytokine therapeutics company, reported that data from a Phase 1a/1b clinical trial of its α/β biased IL-2 partial agonist, STK-012, will be presented in a late-breaking oral presentation at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting 2025 taking place in National Harbor, MD., from November 7-9, 2025. In this study, STK-012 is being evaluated in combination with standard-of-care pembrolizumab + chemotherapy in first-line, PD-L1 negative nonsquamous non-small cell lung cancer (NSCLC) patients. The company will also present new preclinical data on combinations of STK-012 and T cell engagers.

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"We are excited to present our first clinical data in first-line, PD-L1 negative nonsquamous NSCLC patients from the ongoing trial of STK-012, our lead program and a novel approach to biasing IL-2," said Debanjan Ray, chief executive officer of Synthekine. "PD-L1 negative patients comprise approximately one-third of the nonsquamous NSCLC population, and these patients receive significantly reduced benefit from standard-of-care chemoimmunotherapy versus PD-L1 positive patients. We look forward to sharing these results with the scientific community, and the further development of STK-012 in this setting in our SYNERGY-101 study, a global, randomized Phase 2 trial which is currently ongoing."

Details are as follows and available on the SITC (Free SITC Whitepaper) online itinerary:
(Please note that the late-breaking clinical data will be shared both as an oral presentation and a poster.)

Title: Initial Phase 1a/1b Results of STK-012, an α/β IL-2 Receptor Biased Partial Agonist, with Pembrolizumab, Pemetrexed, and Carboplatin in 1L PD-L1 Negative Non-Squamous NSCLC
Session Title: Clinical Oral Abstract Session 2
Session Date & Time: Saturday, November 8, 2025, 2:00 PM ET
Location: Gaylord National Resort and Convention Center, Potomac Ballroom
Abstract Number: 1345

Title: Initial Phase 1a/1b Results of STK-012, an α/β IL-2 Receptor Biased Partial Agonist, with Pembrolizumab, Pemetrexed, and Carboplatin in 1L PD-L1 Negative Non-Squamous NSCLC
Session Title: Exhibits and Poster Reception
Session Date & Time: Friday, November 7, 2025, 5:35 PM – 7:00 PM ET
Location: Prince George ABC Exhibit Halls, Gaylord National Resort and Convention Center
Poster Board Number: 1345
Abstract Number: 1345

Title: STK-012, a First-in-Class α/β IL-2 Receptor Biased Partial Agonist Enhances the Anti-Tumor Efficacy of Bispecific Antibodies
Session Title: Exhibits and Poster Reception
Session Date & Time: Saturday, November 8, 2025, 5:10 PM – 6:35 PM ET
Location: Prince George ABC Exhibit Halls, Gaylord National Resort and Convention Center
Poster Board Number: 682
Abstract Number: 682

Copies of the presentation and posters will be available on Synthekine’s website following presentation at the meeting.

(Press release, Synthekine, OCT 30, 2025, View Source [SID1234657187])

On October 30, 2025 Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, reported financial results for the third quarter ended September 30, 2025 and provided a business update.

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"The third quarter of 2025 celebrated the FDA approval of BRINSUPRI and the availability of our second commercial product, underscoring our team’s dedication to bringing forward a first-in-disease therapy for patients with non-cystic fibrosis bronchiectasis. While still early in the U.S. BRINSUPRI launch, we are very encouraged by positive feedback received from both physicians and patients," said Will Lewis, Chair and Chief Executive Officer of Insmed. "This achievement is just the beginning of numerous commercial and clinical catalysts anticipated over the next 18 months across our late-stage programs – ARIKAYCE, brensocatib, and TPIP – and our growing clinical pipeline of first- or best-in-class therapies. With these opportunities ahead, our team is more dedicated than ever to transforming the lives of patients with serious diseases."

Recent Progress and Anticipated Milestones by Program:

ARIKAYCE

•
ARIKAYCE global revenue grew 22% in the third quarter of 2025 compared to the third quarter of 2024, reflecting year-over-year growth across all geographic regions.

•
The Company anticipates the topline readout of the Phase 3 ENCORE trial in the first half of 2026 in patients with newly diagnosed or recurrent Mycobacterium avium complex (MAC) lung disease who have not started antibiotics.

•
Assuming successful results from the ENCORE trial, Insmed plans to submit a supplementary new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for ARIKAYCE in all patients with MAC lung disease in the U.S. in the second half of 2026.

Brensocatib

•
In August 2025, the FDA approved the Company’s New Drug Application (NDA) for brensocatib for patients with non-cystic fibrosis bronchiectasis (NCFB). BRINSUPRI (brensocatib 25mg and 10mg tablets) was subsequently launched commercially in the U.S.

•
In October 2025, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the approval of BRINSUPRI (brensocatib 25mg tablets) for the treatment of NCFB in the European Union (EU).

•
Regulatory submissions for brensocatib for patients with bronchiectasis in the United Kingdom (UK) and Japan have been accepted. Insmed anticipates commercial launches for the EU, UK, and Japan in 2026, pending approval in each territory.

•
Insmed expects to report topline data from the Phase 2b BiRCh study of brensocatib in patients with chronic rhinosinusitis without nasal polyps (CRSsNP) by early January 2026.

•
In October 2025, Insmed completed enrollment in the Phase 2b CEDAR study of brensocatib in patients with hidradenitis suppurativa (HS). Insmed now expects to report topline data from CEDAR in the first half of 2026.

TPIP

•
Insmed anticipates initiating PALM-ILD, a Phase 3 study of treprostinil palmitil inhalation powder (TPIP) in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD), in the fourth quarter of 2025.

•
Insmed plans to initiate a Phase 3 study of TPIP in patients with pulmonary arterial hypertension (PAH) in early 2026.

•
The Company anticipates initiating additional Phase 3 studies of TPIP in progressive pulmonary fibrosis (PPF) and idiopathic pulmonary fibrosis (IPF) in the second half of 2026.

Gene Therapy

•
Insmed completed dosing of the first cohort in the Phase 1 ASCEND clinical study of INS1201, an intrathecally-delivered gene therapy for patients with Duchenne muscular dystrophy (DMD).

•
The Company’s Investigational New Drug (IND) filing for INS1202, an intrathecally-delivered gene therapy for patients with Amyotrophic lateral sclerosis (ALS), has been cleared by the FDA.

•
Insmed’s third gene therapy candidate targeting Stargardt disease is currently advancing toward the clinic, with an IND filing expected in the first half of 2026.

Pre-Clinical Programs

•
Insmed’s research efforts include more than 30 identified pre-clinical programs in development, all of which have the potential to become first-in-class or best-in-class therapies for the indications being pursued.

•
The Company anticipates submitting an average of one to two INDs per year from its pre-clinical research programs.

•
Insmed continues to anticipate that the totality of its pre-clinical research programs will comprise less than 20% of overall expenditures.

Corporate Updates

•
In September 2025, Insmed presented seven abstracts from across its portfolio at the European Respiratory Society (ERS) Congress 2025.

•
In October 2025, Insmed presented six abstracts from across its portfolio at the American College of Chest Physicians (CHEST) 2025 Annual Meeting.

•
In October 2025, Insmed announced that it has earned the No. 1 ranking in Science’s 2025 Top Employers Survey, marking the fifth consecutive year in which Insmed achieved the top ranking. The annual survey polls employees in biotechnology, pharmaceutical, and related industries to determine the 20 best employers, as well as their driving characteristics.

Third-Quarter 2025 Financial Results

The following table summarizes Insmed’s third-quarter and year-to-date 2025 and 2024 revenues and revenue growth across all commercial regions:

Three Months Ended
September 30,

Nine Months Ended
September 30,

(in millions)

2025

2024

Growth

2025

2024

Growth

ARIKAYCE

U.S.

$
74.0

$
66.9

11
%

$
206.9

$
187.0

11
%
International

40.3

26.6

52
%

107.6

72.3

49
%
Total

$
114.3

$
93.4

22
%

$
314.5

$
259.3

21
%
BRINSUPRI

U.S.

$
28.1

$
–

N/A

$
28.1

$
–

N/A

International

–

–

N/A

–

–

N/A

Total

$
28.1

$
–

N/A

$
28.1

$
–

N/A

Total Revenues

U.S.

$
102.0

$
66.9

53
%

$
235.0

$
187.0

26
%
International

40.3

26.6

52
%

107.6

72.3

49
%
Total

$
142.3

$
93.4

52
%

$
342.6

$
259.3

32
%

•
Cost of product revenues (excluding amortization of intangibles) was $29.4 million for the third quarter of 2025, compared to $21.2 million for the third quarter of 2024. The increase in cost of product revenues primarily reflects growth in ARIKAYCE sales and BRINSUPRI sales.

•
Research and development (R&D) expenses were $186.4 million for the third quarter of 2025, compared to $150.8 million for the third quarter of 2024. The increase in R&D expenses was primarily related to increases in compensation and benefit-related expenses and stock-based compensation costs due to an increase in headcount, as well as clinical development and research costs, and manufacturing costs.

•
Selling, general and administrative (SG&A) expenses for the third quarter of 2025 were $186.4 million, compared to $118.9 million for the third quarter of 2024. The increase in SG&A expenses was primarily related to increases in professional fees and other external expenses, as well as increases in compensation and benefit-related expenses and stock-based compensation costs due to an increase in headcount, both driven by commercial readiness and commercial activities for BRINSUPRI.

•
For the third quarter of 2025, Insmed reported a net loss of $370.0 million, or $1.75 per share, compared to a net loss of $220.5 million, or $1.27 per share, for the third quarter of 2024.

Balance Sheet, Financial Guidance, and Planned Investments

•
As of September 30, 2025, Insmed had cash, cash equivalents, and marketable securities totaling approximately $1.7 billion.

•
Insmed is raising its full-year 2025 global ARIKAYCE revenue guidance to a range of $420 million to $430 million, from a range of $405 million to $425 million previously, representing a range of 15% to 18% year-over-year growth compared to 2024.

•
The Company plans to continue to invest in the following key activities in 2025:

(i)
commercialization and expansion of BRINSUPRI in the U.S., with advancement of regulatory submissions for brensocatib in Europe, the UK, and Japan;

(ii)
commercialization and expansion of ARIKAYCE globally;

(iii)
advancement of clinical trial programs for brensocatib, including the ongoing Phase 2b BiRCh study in patients with CRSsNP and the Phase 2b CEDAR study in patients with HS;

(iv)
advancement of the Phase 3 ENCORE study for ARIKAYCE, which is intended to satisfy the post-marketing requirement for full approval of its current indication and potentially support label expansion to include all patients with a MAC lung disease;

(v)
advancement of clinical development programs for TPIP, including the initiation of a Phase 3 study in patients with PH-ILD and preparations for separate Phase 3 studies in patients with PAH, PPF, and IPF;

(vi)
advancement of the Phase 1 ASCEND study for INS1201 in DMD; and

(vii)
continued development of its pre-clinical research programs.

Conference Call

Insmed will host a conference call beginning today, October 30, 2025, at 8:00 AM Eastern Time. Shareholders and other interested parties may participate in the conference call by dialing (888) 210-2654 (U.S.) and (646) 960-0278 (international) and referencing access code 7862189. The call will also be webcast live on the Company’s website at www.insmed.com.

A replay of the conference call will be accessible approximately 1 hour after its completion through November 6, 2025, by dialing (800) 770-2030 (U.S.) and (609) 800-9909 (international) and referencing access code 7862189. A webcast of the call will also be archived for 90 days under the Investor Relations section of the Company’s website at www.insmed.com.

(Press release, Insmed, OCT 30, 2025, View Source [SID1234657153])

On October 30, 2025 Forlong Biotechnology, a clinical-stage biotech company focusing on developing transformative cytokine therapies for patients with severe unmet needs, reported that the first patient has been treated in a Phase 2 clinical trial investigating FL115 in combination with Bacillus Calmette-Guérin (BCG). The study will assess the anti-tumor effect of the combination therapy, including Complete Response Rate and Duration for carcinoma in situ (CIS) NMIBC patients, and Disease Free Survival and Relapse Free Survival for papillary (Ta/T1) NMIBC patients.

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FL115 is an engineered IL-15/IL15Rα-Fbody fusion protein aiming to enhance anti-tumor immunity via IL-15-mediated signaling on NK and CD8+ T cells while minimizing complexity from Fc. The start of the Phase 2 clinical trial builds on positive data from the Phase 1 trial where FL115 demonstrated favorable safety and efficacy in the same patient population. As a monotherapy at the recommended dose for expansion, 4/6 patients achieved responses longer than 3 months, of which 2 patients achieving responses longer than 9 months. This dose of FL115 in combination with BCG will be investigated in the Phase 2 trial.

"Dosing the first patient in our Phase 2 trial for FL115 marks a defining moment for Forlong, as we advance our lead candidate further into clinical development and continue to validate the potential of our synthetic immunology platforms," said Dong Wei, Ph.D., Chief Executive Officer of Forlong Biotechnology, "FL115 stands out with favorable safety and preliminary efficacy observed in multiple Phase 1 clinical studies in advanced solid tumors and NMIBC. With FL115 interim data for advanced solid tumor to be presented as Late Breaking Abstract on Nov 8 at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC 2025), this trial gives us the opportunity to further validate FL115 as potential Best-in-class IL-15 superagonist, and bring new treatment options for cancer patients in need."

The Phase 2 clinical trial plans to enroll three arms: BCG unresponsive CIS NMIBC patients, BCG unresponsive high risk papillary NMIBC patients, and BCG naïve medium/high risk NMIBC patients. The trial will be conducted at over 15 investigator sites in China.

About FL-115

FL115 is an engineered IL-15/IL15Rα-Fbody fusion protein, aiming to enhance anti-tumor immunity via IL-15-mediated signaling on NK and CD8+ T cells while minimizing complexity from Fc. FL115 has demonstrated significant anti-tumor activities as a monotherapy or as part of combination therapy in vivo, and can be manufactured by a robust and efficient process with excellent product stability. Clinically, FL115 has demonstrated favorable safety profile and preliminary clinical responses as a monotherapy, and has the best-in-class potential to synergize with current and emerging T cell-targeting immunotherapies through combination therapy to significantly improve the treatment outcome for patients. It is currently being investigated in combination with Bacillus Calmette-Guérin (BCG) in a Phase 2 clinical trial to evaluate safety and preliminary efficacy in patients with nonmuscle invasive bladder cancer (NMIBC) and in combination with an anti-PD1 monoclonal antibody in a Phase 1b/2 clinical trial to evaluate safety and preliminary efficacy in patients with advanced solid tumors.

(Press release, Forlong Biotechnology, OCT 30, 2025, View Source [SID1234657188])