On October 28, 2025 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical-stage biopharmaceutical company leveraging its proprietary RADR artificial intelligence platform to transform oncology drug discovery and development, reported the presentation of clinical data from its ongoing Phase 1 trial of LP-284 at the 25th Annual Lymphoma, Leukemia & Myeloma (LL&M) Congress, held October 14-17, 2025, in New York City. The presentation featured a confirmed complete metabolic response in a 41-year-old patient with aggressive Grade 3 non-germinal center B-cell diffuse large B-cell lymphoma (DLBCL) who experienced rapid disease progression following four prior treatment regimens, including CAR-T cell therapy and bispecific antibody therapy.

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The patient achieved complete metabolic response with non-avid lesions after just two 28-day cycles of LP-284, administered intravenously on days 1, 8, and 15 of each cycle. At study entry, the patient presented with extensive multifocal bony lesions following treatment failure with R-CHOP chemotherapy, radiation therapy, a CD19 CAR-T, and a CD3xCD20 bispecific antibody. This clinical outcome validates LP-284’s synthetic lethal mechanism and addresses the critical gap for patients who have exhausted advanced targeted and immunotherapies.

Strategic Inflection Point: Clinical Validation Drives Partnership Momentum

"The presentation of LP-284’s clinical data at the 25th Annual LL&M Congress represents an important inflection point in the development trajectory of this drug-candidate," said Panna Sharma, President and CEO of Lantern Pharma. "Achieving complete metabolic response in a patient who failed both CAR-T and bispecific antibody therapies validates our AI-driven approach towards creating novel cancer medicines at a fraction of the time and cost of traditional approaches, and addresses a critical white space in the post-immunotherapy treatment paradigm. The interest from biopharmaceutical companies and clinical investigators underscores LP-284’s dual strategic potential: as a monotherapy for the growing post-CAR-T, post-bispecific patient population, and as a combination partner with existing FDA-approved agents where we’ve demonstrated compelling preclinical synergy with rituximab."

Strategic Value Proposition for Partnerships

Lantern believes that LP-284’s profile presents compelling partnership opportunities for biopharmaceutical companies seeking to expand their hematology franchises:

Addresses post-immunotherapy treatment gap with novel synthetic lethal mechanism distinct from current standards of care,
Demonstrated preclinical synergy with rituximab in high-grade B-cell lymphoma models, supporting combination therapy development,
Favorable early safety profile with primarily Grade 1-2 adverse events,
Efficacy unaffected by TP53 mutation or lymphoma surface antigen expression—key resistance mechanisms limiting current therapies
Multiple FDA Orphan Drug Designations including in Mantle Cell Lymphoma and High-Grade B-Cell Lymphoma providing regulatory pathway advantages and commercial exclusivity
Strong IP position with composition of matter patents through 2039 across major markets including US, EU, Japan, India, and Mexico
Rapid clinical validation and extension enabled by AI-driven development
These attributes position LP-284 as both a standalone asset for patients who have exhausted CAR-T and bispecific antibody options, and as a potential combination agent to enhance efficacy and duration of response with existing approved therapies.

Addressing Critical Market Need in Post-Immunotherapy Setting

DLBCL represents the most common aggressive non-Hodgkin’s lymphoma subtype, with approximately 200,000 new cases diagnosed globally each year. While initial treatment achieves remission in many patients, those who relapse after advanced immunotherapies face extremely poor prognoses with median survival often measured in months and limited therapeutic alternatives.

The patient featured in the LL&M Congress presentation exemplifies this devastating trajectory: despite achieving initial complete metabolic response with CAR-T therapy at day 30, disease progression occurred by day 90, followed by progressive disease with new lesions after bispecific antibody treatment. With an estimated 40,000 DLBCL patients annually progressing post-CAR-T in the US and EU alone, and average post-relapse treatment costs exceeding $500,000 per patient, LP-284’s off-the-shelf administration and demonstrated activity in this setting could address both clinical and economic burdens commonplace in aggressive blood cancers.

Advancing Development and Strategic Collaborations

Lantern’s ongoing Phase 1a dose-escalation study (NCT06132503) continues to evaluate LP-284’s safety profile and preliminary efficacy in patients with relapsed or refractory B-cell non-Hodgkin’s lymphomas and solid tumors. Initial data demonstrate LP-284 is well tolerated with primarily Grade 1-2 adverse events and validation of the mechanism of action.

Conversations initiated at the LL&M Congress with biopharmaceutical companies and clinical investigators focus on LP-284’s potential in combination regimens with FDA-approved agents, particularly bispecific antibodies and monoclonal antibodies. These discussions leverage Lantern’s RADR platform analysis, which has identified synergistic combination opportunities supported by published preclinical data demonstrating LP-284’s synergy with rituximab.

Near-Term Development Milestones & Potential for Expansion of Indication

Patient follow-up assessment with response durability data expected by year-end 2025
Ongoing partnership discussions for combination therapy trial development
Additional clinical site activation to accelerate enrollment and expand geographic reach
LP-284’s demonstrated selective B-cell depletion activity extends its potential beyond oncology applications. Lantern is advancing preclinical programs targeting autoimmune and inflammatory conditions, representing substantial additional market opportunities in indications focused on inflammation and immune conditions.

Building on Strategic Momentum

This announcement follows the company’s July 2025 disclosure of European Patent Office allowance for LP-284’s composition of matter patent, strengthening global IP protection through early 2039. The expanding international patent portfolio, combined with validated clinical activity and growing partnership interest, positions LP-284 for accelerated development pathways and strategic collaborations that could enhance both development efficiency and commercial potential.

About LP-284

LP-284 is an investigational next-generation acylfulvene designed to exploit synthetic lethal interactions in cancer cells with DNA damage repair deficiencies. Developed through Lantern’s RADR AI platform, LP-284 induces DNA lesions primarily repaired by transcription-coupled nucleotide excision repair (TC-NER), creating a distinct anti-tumor profile. The compound’s efficacy remains unaffected by TP53 mutation or lymphoma surface antigen expression, and preclinical studies demonstrate synergistic activity with rituximab and the ability to overcome ibrutinib resistance. LP-284 is currently in Phase 1 evaluation (NCT06132503) and has received multiple FDA Orphan Drug Designations for mantle cell lymphoma and high-grade B-cell lymphomas.

About the 25th Annual Lymphoma, Leukemia & Myeloma Congress

The Lymphoma, Leukemia & Myeloma Congress is a globally recognized medical education meeting focused exclusively on hematologic malignancies. For 25 years, the Congress has convened international experts to share evidence-based strategies and new drug data. The 2025 Congress, held October 14-17 at the Sheraton New York Times Square Hotel, featured over 75 expert faculty. For more information, visit www.hmpglobalevents.com/llmcongress.

(Press release, Lantern Pharma, OCT 28, 2025, View Source [SID1234657085])

On October 28, 2025 Orion reported Interim Report for the period of January to September 2025.

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(Presentation, Orion, OCT 28, 2025, View Source [SID1234661698])

On October 28, 2025 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported positive topline results from the Phase 3 LITESPARK-022 trial in patients with clear cell renal cell carcinoma (RCC) following nephrectomy. In this study, KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with WELIREG (belzutifan), Merck’s first-in-class, oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, given in the adjuvant setting, demonstrated a statistically significant and clinically meaningful improvement in disease-free survival (DFS), the study’s primary endpoint, compared to KEYTRUDA in combination with placebo. The trial will continue to evaluate overall survival (OS), a key secondary endpoint.

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"KEYTRUDA monotherapy given in the adjuvant setting remains an important treatment choice for patients with renal cell carcinoma at an increased risk of recurrence following surgery and is the only approved option to have significantly improved disease-free survival and overall survival in this disease setting. Still, many of these patients do remain at risk of recurrence and continue to represent an unmet need," said Dr. M. Catherine Pietanza, vice president, global clinical development, Merck Research Laboratories. "These encouraging results of KEYTRUDA in combination with WELIREG from LITESPARK-022 demonstrate the potential to provide additional treatment options for those most in need."

The safety profiles of KEYTRUDA plus WELIREG in this trial were overall consistent with those observed in previously reported studies for the individual therapies. Results will be presented at a future medical meeting and shared with regulatory authorities worldwide.

KEYTRUDA is approved for the adjuvant treatment of certain patients with RCC in the U.S., Canada, European Union (EU), Japan and other countries worldwide based on data from KEYNOTE-564.

WELIREG is approved in over 40 countries including the U.S., Canada, EU, and Japan for the treatment of adult patients with advanced RCC following a PD-1/PD-L1 inhibitor and 1-2 VEGF-TKIs based on results from the Phase 3 LITESPARK-005 trial.

Merck has an industry-leading clinical development program in RCC, leveraging multiple approved therapeutic options across multiple settings, including adjuvant and advanced disease.

About LITESPARK-022
LITESPARK-022 is a multicenter, randomized, double-blind Phase 3 trial (ClinicalTrials.gov, NCT05239728) evaluating WELIREG in combination with KEYTRUDA compared to KEYTRUDA plus placebo for the treatment of patients with clear cell RCC following nephrectomy. The primary endpoint is DFS; the key secondary endpoint is OS; other secondary endpoints include safety and quality of life outcomes. The trial enrolled 1,841 patients who were randomized to receive either:

WELIREG (120 mg orally once daily for approximately one year), plus KEYTRUDA (400 mg intravenously every six weeks for approximately one year) or;
KEYTRUDA plus oral placebo.
About renal cell carcinoma
Renal cell carcinoma is the most common type of kidney cancer, with about nine out of 10 kidney cancer diagnoses being RCC. In 2022, there were about 435,000 new cases of kidney cancer diagnoses and approximately 156,000 deaths from the disease worldwide. RCC is about twice as common in men as in women. Most cases of RCC are discovered incidentally during imaging tests for other abdominal diseases. Approximately 30% of patients with kidney cancer are diagnosed at an advanced stage.

(Press release, Merck & Co, OCT 28, 2025, View Source [SID1234657070])

On October 28, 2025 Ferring Pharmaceuticals reported that three abstracts featuring ADSTILADRIN (nadofaragene firadenovec-vncg) will be presented at the 101st Annual Meeting of the Western Section of the American Urological Association (AUA) being held November 2-6 in Napa, CA. ADSTILADRIN is the first and only intravesical non-replicating gene therapy approved by the U.S. Food and Drug Administration (FDA) for patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors (±Ta/T1).

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A Ferring-sponsored study will present baseline characteristics and demographics from the initial patient cohort enrolled in ABLE (ADSTILADRIN in BLadder CancEr)-41, a Phase 4 multicenter non-interventional study examining the use of ADSTILADRIN in a real-world setting. In addition, two independent real-world studies will be presented. This includes a study analyzing electronic billing records for 101 patients from 19 U.S. medical centers who received ADSTILADRIN and is exploring durability of remaining on ADSTILADRIN, and lack of progression to radical cystectomy. A third abstract is a case series evaluating re-induction with ADSTILADRIN among 17 patients across 8 academic and community settings, the findings of which were published recently in The Journal of Urology.

"Real-world evidence provides an important view of how a treatment like ADSTILADRIN is being used in routine practice," said Sia Daneshmand, MD, Professor of Urology and Medicine (Oncology) and Director of Urologic Oncology at Keck School of Medicine of University of Southern California. "The ABLE-41 study will add to this evidence by capturing early insights from a broader, more diverse patient population than prior trials, helping us understand patient experiences and inform care for those with BCG-unresponsive NMIBC."

"ADSTILADRIN is an important option for uro-oncologists, offering an effective and convenient quarterly dosing schedule administered in the urologist’s office, and a non-chemotherapy alternative to radical cystectomy," said Daniel A. Shoskes, MD, FRCS(C), Vice President, Global Medical Director- Uro-Oncology, Ferring Pharmaceuticals. "The ongoing research exploring the real-world use of ADSTILADRIN adds to the body of evidence in NMIBC patients who no longer respond to BCG. I am thrilled that this research is also exploring treatment re-induction, helping to build on the strong foundation of our Phase 3 program and further inform care for NMIBC patients."

About ADSTILADRIN Presentations at the Western Section AUA

ADSTILADRIN poster titles and presentation times at 101st Annual Meeting of the Western Section AUA, November 2-6, 2025, are:

ABLE-41, a real-world evidence study for bladder cancer patients treated with nadofaragene firadenovec: baseline patient characteristics and demographics. Abstract #257 (Poster #23), November 2, 2025, 7:00-9:00 a.m. PST
Real-world utilization of ADSTILADRIN in patients with BCG-unresponsive non-muscle invasive bladder cancer. Abstract #242 (Poster #18), November 2, 2025, 7:00-9:00 a.m. PST
Re-induction with nadofaragene firadenovec for BCG-unresponsive NMIBC: real-world data from a multicenter cohort. Abstract #301 (Poster #11), November 2, 2025, 7:00-9:00 a.m. PST
About ABLE-41

ABLE-41 is a non-interventional study following NMIBC patients aged 18 years or older who are being treated with ADSTILADRIN in a clinical setting and had not previously received this therapy in a clinical trial. In September 2023, Ferring announced the first patient enrolled in ABLE-41. Eligible patients include those who were prescribed and scheduled to receive treatment, per their physician’s discretion, or patients who received their first instillation (per physician discretion) after September 5, 2023, but before the site was activated in the trial.

The primary objective is to assess whether patients achieve a complete response (CR) at three months and/or at any time within a year of their first instillation.

Participants in ABLE-41 will be followed for 24 months, or until study discontinuation or withdrawal. Key secondary outcomes include the following: treatment patterns of use; duration of CR; recurrence-free survival, cystectomy-free survival, progression-free survival, overall survival, and bladder cancer–specific mortality; patient, caregiver, and physician experiences; adjunctive use of molecular markers; and safety. Patient experiences will be assessed with a commonly used quality of life questionnaire (EuroQol 5 Dimension 5 Level), measuring mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Caregiver experiences will be measured with the Work Productivity and Activity Impairment questionnaire, adapted for caregiving, which assesses the impact of health problems on paid and unpaid work.

Results from this prospective, multi-institutional study are expected at the end of 2026. Learn more at www.clinicaltrials.gov/study/NCT06026332.

About ADSTILADRIN

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

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

(Press release, Ferring Pharmaceuticals, OCT 28, 2025, View Source [SID1234657086])

On October 28, 2025 Starpharma reported Quarterly Activities Report and Appendix 4C for the quarter ended 30 September 2025 (Q1 FY26).

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(Press release, Starpharma, OCT 28, 2025, View Source,and%20executive%20directors%20of%20$355%2C000. [SID1234661699])