On March 19, 2025 Theriva Biologics (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, reported that the Company’s Management will be attending and presenting at the Cancer Advocacy Group of Louisiana (CAGLA) NeauxCancer 2025 Conference being held March 27th-29th, 2025 at The Roosevelt New Orleans Hotel in New Orleans, LA (Press release, Theriva Biologics, MAR 19, 2025, View Source [SID1234651267]).

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A company presentation will take place during the conference’s Innovation track on Friday, March 28th at 9:00am. NeauxCancer conference’s Innovation track spotlights the most promising emerging biotech and healthcare companies advancing detection, treatment, and cures across critical oncology areas.

Theriva’s management team will be available for one-on-one meetings during the conference, interested investors should contact Theriva’s investor relations representative as below.

On March 19, 2025 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a late-stage immunotherapy company targeting cancer and autoimmune diseases, reported an upcoming poster presentation for the pivotal TACTI-004 Phase III trial (Press release, Immutep, MAR 19, 2025, View Source [SID1234651268]). The poster will be presented at the European Lung Cancer Congress (ELCC) 2025, taking place in Paris, France, from 26-29 March 2025.

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The Trial in Progress poster includes an overview and study design of the TACTI-004 Phase III evaluating the Company’s MHC Class II agonist, eftilagimod alfa (efti) in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 KEYTRUDA (pembrolizumab) and chemotherapy as first line therapy for patients with advanced or metastatic non-small cell lung cancer (1L NSCLC). The global trial will enrol approximately 750 patients regardless of PD-L1 expression and with non-squamous or squamous tumours at over 150 clinical sites in over 25 countries.

Immutep CSO, Frédéric Triebel, M.D., Ph.D, said, "We look forward to engaging with physicians in the lung cancer community at the ELCC conference to discuss our TACTI-004 Phase III study that is actively recruiting patients. Efti in combination with KEYTRUDA may change the treatment paradigm for patients with advanced or metastatic non-small cell lung cancer, irrespective of their PD-L1 expression, and we hope to see this registrational trial confirm the promising safety and efficacy achieved to date."

Details for the poster presentation:
Title: TACTI-004: a double-blinded, randomized phase 3 trial in patients with advanced/metastatic non-small cell cancer receiving eftilagimod alfa (MHC class II agonist) in combination with pembrolizumab (P) and chemotherapy (C) versus placebo + P + C
Presentation number: 131TiP
Presenter: Margarita Majem, MD, PhD, Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau
Session Date and Time: 26 March 2025, 13:50 CET

The poster will be available on the Posters & Publications section of Immutep’s website following the presentation.

About Eftilagimod Alpha (efti)
Efti is Immutep’s proprietary soluble LAG-3 protein and MHC Class II agonist that stimulates both innate and adaptive immunity for the treatment of cancer. As a first-in-class antigen presenting cell (APC) activator, efti binds to MHC (major histocompatibility complex) Class II molecules on APC leading to activation and proliferation of CD8+ cytotoxic T cells, CD4+ helper T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules like IFN-ƴ and CXCL10 that further boost the immune system’s ability to fight cancer.

Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD-[L]1 immunotherapy and/or chemotherapy. Efti has received Fast Track designation in first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA).

On March 18, 2025 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a pioneer in the development of targeted radiotherapies, reported a clinical program comprising of trials studying Actimab-A in combination with either KEYTRUDA (pembrolizumab) or OPDIVO (nivolumab) which are blockbuster immunotherapies known as PD-1 inhibitors which are approved in multiple solid tumor indications (Press release, Actinium Pharmaceuticals, MAR 18, 2025, View Source [SID1234651232]). KEYTRUDA developed and commercialized by Merck & Co. and OPDIVO developed and commercialized by Bristol Myers Squibb, collectively generated $38.8 billion in sales in 2024 across several solid tumor cancer indications. However, the efficacy of these drugs has shown to be limited by a certain type of cell known as MDSCs or Myeloid Derived Suppressor Cells which accumulate in the tumor microenvironment. MDSCs express the CD33 antigen which is targeted by Actimab-A. The rationale for studying Actimab-A in combination with either KEYTRUDA or OPDIVO is based on the premise that depleting MDSCs with Actimab-A will improve the efficacy of these drugs.

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MDSCs are immune-suppressive cells that help tumors evade immune detection and promote disease progression. They are overexpressed in the tumor microenvironment in several different solid tumors and associated with poor outcomes. They work by multiple mechanisms but most relevant to PD-1 inhibitors which work by keeping T-cells active is that MDSCs prevent T-cells from recognizing and attacking cancer cells. There is considerable preclinical scientific evidence in the literature that depleting MDSCs could be a viable strategy in improving the outcomes of PD-1 directed immunotherapy, however, there have been no viable clinical approaches that have been tried successfully to our knowledge. MDSCs are known to express the CD33 antigen which is the target of Actimab-A. Actinium has also generated published and unpublished preclinical data showing that Actimab-A can selectively deplete MDSCs in solid tumors. Actinium believes that in the clinic Actimab-A can deplete CD33 expressing MDSCs and hence improve the outcomes with PD-1 inhibitors such as KEYTRUDA and OPDIVO.

Actimab-A is Actinium’s lead radiotherapeutic that delivers Actinium-225, a potent alpha-emitter radioisotope payload that can produce lethal double strand DNA breaks to kill targeted cells. Actimab-A has been studied in over 150 patients in several clinical trials in Acute Myeloid Leukemia or AML. Based on its safety and tolerability, Actimab-A is under clinical development via an NCI CRADA in the front-line AML setting with an expected registrational study in combination with CLAG-M in relapsed/refractory AML expected to initiate in 2025.

The Actimab-A solid tumor program is comprised of several controlled, head-to-head clinical trials that will evaluate the combination of Actimab-A with KEYTRUDA versus KEYTRUDA alone, and Actimab-A with OPDIVO versus OPDIVO alone. The initial tumors that are being targeted are HNSCC or Head and Neck Squamous Cell Carcinoma and NSCLC or Non-Small Cell Lung Cancer with a separate trial for each indication. The patient population for these trials will be adults with PD-L1 expression and locally advanced metastatic HNSCC or NSCLC randomized to either Actimab-A alone or Actimab-A with a specific checkpoint inhibitor. The objective of each trial would be to evaluate the safety and tolerability as well as following endpoints including ORR – Overall Response Rate, PFS – Progression Free Survival and OS – Overall Survival. Further, the following biomarker data would be collected including the pattern of depletion of CD33+ MDSCs and T-Cell activity in peripheral blood. Actinium expects to present initial proof of concept clinical data from the first of these trials in the second half of 2025 as well as provide an update on the outlook for the rest of the trials in the Actimab-A solid tumor program.

Dr. Avinash Desai, Actinium’s Chief Medical Officer, said, "The Actimab-A solid tumor program is highly novel and has the potential to address the high unmet need of patients receiving PD-1 checkpoint inhibitors whose cancer stops responding or progresses. Our preclinical data is highly encouraging and we believe this novel approach combining Actimab-A with PD-1 inhibitors has immense potential. We are greatly enthusiastic about these head-to-head trials, and eager to present our initial proof-of-concept results by the end of 2025."

Sandesh Seth, Actinium’s Chairman and CEO, said, "We have great enthusiasm for Actimab-A in combination with PD-1 checkpoint inhibitors given the large potential addressable patient population. MDSCs are over expressed in multiple solid tumors giving Actimab-A pan tumor potential in indications that are treated with checkpoint inhibitors. Per our initial estimates this represents a treatment population in excess of 500,000 patients. Together with our efforts in myeloid malignancies, this is another important program for Actimab-A. This year, clinical data from Actimab-A as a potential backbone therapy in radiation sensitive myeloid malignancies, and in solid tumors in combination with PD-1 checkpoint inhibitors, can establish its potential to become a leading blockbuster targeted radiotherapy."

On March 18, 2025 Aptevo Therapeutics (NASDAQ:APVO), a leader in the development of novel bispecific antibodies for cancer treatment, based on its proprietary ADAPTIR and ADAPTIR-FLEX platform technologies reported an overview of solid tumor anti-cancer compound APVO603, currently in preclinical development for the treatment of solid tumors (Press release, Aptevo Therapeutics, MAR 18, 2025, View Source [SID1234651233]). APVO603 is a novel bispecific antibody designed to enhance anti-tumor immune responses through dual targeting of 4-1BB (CD137) and OX40 (CD134), two key co-stimulatory receptors involved in T cell and NK cell activation.

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APVO603 is part of Aptevo’s solid tumor anti-cancer pipeline and represents a significant step forward in leveraging the company’s proprietary ADAPTIR platform to develop safer and more effective immuno-oncology therapies.

Targeted Immune Activation for Solid Tumors
APVO603 is designed to activate the costimulatory 4-1BB and OX40 pathways in the tumor microenvironment, leading to enhanced T cell expansion, survival, and cytotoxic function while avoiding systemic toxicity. This targeted immune activation could overcome immune suppression in solid tumors, a major challenge in cancer immunotherapy.

Preclinical studies have shown that APVO603:

Enhances T cell and NK cell proliferation and tumor lysis, while maintaining a favorable safety profile and inhibiting immune exhaustion

Induces a robust anti-tumor response in preclinical tumor models, suggesting strong therapeutic potential

"We are excited about the potential of APVO603 to enhance the potency of T cells and NK cells while addressing the limitations of current therapies for solid tumors," said Michelle Nelson, PhD, Director of Immunobiology at Aptevo. "Our preclinical findings support APVO603’s ability to deliver 4-1BB and OX40 synergistically resulting in targeted immune stimulation with reduced toxicity risks, differentiating it from existing immunotherapies."

Aptevo’s Advancing Immuno-Oncology Pipeline

APVO603 is one of three promising preclinical candidates in Aptevo’s bispecific antibody pipeline, alongside APVO711, a bispecific + checkpoint inhibitor, and APVO442, a T-cell engager targeting prostate cancer. These programs build on Aptevo’s expertise in bispecific antibody engineering and reinforce the company’s commitment to developing novel immunotherapies that improve outcomes for cancer patients.

Clinical Programs
Lead Candidate Mipletamig for Acute Myeloid Leukemia (AML): Mipletamig, Aptevo’s lead bispecific antibody, is currently in a frontline Phase 1b/2 combination trial, RAINIER, following positive results from earlier studies.

RAINIER results reported to date include:

100% of patients in Cohort 1 of the trial achieved remission within 30 days

One patient experienced complete remission with minimal residual disease (MRD)-negative status (100% elimination of cancer cells)

Favorable safety profile consistent with prior trials, showing no incidences of cytokine release syndrome (CRS) in the current trial to date, a common and often dose limiting side effect seen in similar therapies

ALG.APV-527: ALG.APV-527 is being evaluated in a Phase 1 trial for solid tumors likely to express the tumor antigen 5T4. Tumor types treated to date include breast, colon, pancreatic and non-small cell lung cancer. Positive preliminary data from the study were presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in September and at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) conference in 2024. These results showed that ALG.APV-527 demonstrated positive safety and tolerability across all cohorts, ten of 17 evaluable patients (59%) achieved stable disease (SD), and biomarker analysis confirmed immune activation in the tumor microenvironment.

This drug has the potential to advance treatment in hard-to-treat solid tumors, demonstrating the versatility of Aptevo’s technology across a wide range of cancer types.

On March 18, 2025 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company developing a pipeline of proprietary small molecule drugs targeting oncological and inflammatory diseases, reported that it received a single FDA approval for the compassionate use treatment of a U.S. based pancreatic cancer patient with its anti-cancer drug Namodenoson (Press release, Can-Fite BioPharma, MAR 18, 2025, View Source [SID1234651216]).

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Compassionate use is the term used when a physician is requesting for a single patient to gain access to an investigational drug for a serious disease. Such investigational drug has not yet been approved by the FDA.

Pnina Fishman, CSO & Chairperson of Can-Fite BioPharma, commented: "We are pleased to offer this compassionate use program with Namodenoson for eligible patient in the US to address the unmet medical needs for pancreatic cancer. Initiating this program is another milestone achieved for Namodenoson, and concurrently to our ongoing Phase 2a clinical trial, as we remain committed to advancing the availability of our drug."

Namodenoson is currently being evaluated in LiverationTM, a pivotal Phase III study for advanced liver cancer that has been approved by both the FDA and the European Medicines Agency (EMA). The drug is currently being tested in Israel in a Phase IIa pancreatic cancer clinical study.

Namodenoson, has been also granted Orphan Drug Designation by the FDA for pancreatic cancer. The designation as an orphan drug will provide, among others, potential for market exclusivity for seven years after approval and several and regulatory advantages.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is currently being evaluated in a pivotal Phase III trial for advanced liver cancer, a Phase IIb trial for the treatment of Metabolic Dysfunction-associated Steatohepatitis (MASH), and in a Phase IIa study in pancreatic cancer. A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential expression may be one of the important factors that accounts for the excellent safety profile of the drug.