On October 7, 2025 Blue Earth Therapeutics reported new modelling results demonstrating that front-loaded dosing of its radiohybrid lutetium labelled, PSMA targeted, investigational radioligand therapy Lutetium (177Lu) rhPSMA-10.1 Injection may increase cumulative tumour absorbed radiation dose without a proportional increase in normal organ exposure or total administered radioactivity (Press release, Blue Earth Therapeutics, OCT 7, 2025, View Source [SID1234656493]). These findings are being presented at the European Association of Nuclear Medicine (EANM) Annual Meeting (poster EPS-187) and have been used to shape the design of the Phase 2 portion of the Phase 1/2 clinical trial (NCT05413850). The model was built from patient data from the Phase 1 portion of the trial.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In the Phase 1 study, tumor absorbed radiation doses in cycles 2 and 3 declined by 37% and 56% respectively from cycle 11. In contrast, healthy organ-absorbed doses remain broadly the same across cycles. In the model, maximum cumulative administered radioactivity was defined by the current limit of 23 Gy absorbed dose to kidneys. With the Phase 1 trial showing 0.30 Gy/GBq absorbed dose to the kidneys, administration of up to 60GBq or more was possible.

The model assessed three dosing scenarios, all with dosing at six-weekly intervals:

10 GBq in cycles 1 and 2, followed by five cycles of 7.4 GBq
14.8 GBq in cycles 1 and 2, followed by four cycles of 7.4 GBq
7.4 GBq in each of cycles 1-8 (flat dosing)
The model extrapolated the reductions in tumour-absorbed radiation doses across each of cycles 4-8 using data available from cycles 1-3 and predicted the cumulative tumour absorbed radiation dose for each dosing scenario. The results showed that the front-loaded regimens both increase tumour-absorbed radiation dose; by 15% for regimen #1 and by 34% for regimen #2 vs. a flat dosing regimen (#3).

Commenting on the results, Dr Dan Stevens, Blue Earth Therapeutics’ Chief Medical Officer, said, "There is increasing interest in exploring alternative dosing schedules for radiopharmaceutical therapies to try and optimise the potential for clinical benefit. We are taking observed data from our Phase 1 and attempting to apply this scientifically in testing different front-loading approaches in our ongoing Phase 2 study. The data collected should allow us to assess the potential benefit and any risks."

About metastatic prostate cancer
In 2025 it is estimated that there will be 50,055 new cases of metastatic prostate cancer in the United States (de novo diagnoses plus recurrence from earlier stage diagnoses).2 Five-year survival for newly diagnosed metastatic prostate cancer is low, 36.6%.3 While death rates from prostate cancer have declined over the past three decades3, there is still considerable room to improve patient outcomes.

About Radiohybrid Prostate–Specific Membrane Antigen (rhPSMA)
rhPSMA compounds are referred to as radiohybrid ("rh"), as each molecule possesses four distinct domains. The first consists of a Prostate–Specific Membrane Antigen–targeted receptor ligand. It is attached to two labelling moieties which may be radiolabeled with diagnostic isotopes such as 18F or 68Ga for PET imaging, or with therapeutic isotopes such as 177Lu or 225Ac for radioligand therapy, all of which are joined together by a modifiable linker which can be used to modulate important pharmacokinetic characteristics. Radiohybrid PSMA offers the potential for targeted treatment for men with prostate cancer and originated at the Technical University of Munich, Germany. Blue Earth Diagnostics acquired exclusive worldwide rights to rhPSMA diagnostic imaging technology from Scintomics GmbH in 2018, and therapeutic rights in 2020, and has sublicensed the therapeutic application to its sister company Blue Earth Therapeutics.

On October 7, 2025 TORL BioTherapeutics LLC (TORL), a clinical stage biotechnology company discovering and developing new antibody-based immunotherapies to improve and extend the lives of patients with cancer worldwide, reported closing of a $96 million Series C financing (Press release, TORL Biotherapeutics, OCT 7, 2025, View Source [SID1234656492]). Additionally, updated results from the ongoing Phase 1 study of the Company’s Claudin 6 (CLDN6) targeted antibody-drug conjugate (ADC) TORL-1-23 in patients with advanced cancer will be presented in poster sessions at the 2025 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress (ESMO 2025) in Berlin, Germany.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"This financing ensures TORL is able to further the clinical development of TORL-1-23, our first- and potentially best-in-class Claudin 6 targeted ADC for women living with platinum-resistant ovarian cancer," said Mark J. Alles, Chairman and Chief Executive Officer of TORL BioTherapeutics. "We appreciate the support from our new and existing world-class life sciences investors who share our passion to discover and develop new targeted treatment options for patients with cancer."

Proceeds from this financing will advance CATALINA-2, the ongoing pivotal Phase 2 study of TORL-1-23 for CLDN6+ patients with platinum-resistant ovarian cancer (PROC) to pivotal data readout in 2027, and CATALINA-3, the confirmatory Phase 3 study of TORL-1-23 in CLDN6+ PROC initiating in 2026. In addition, funds will support registration-enabling Phase 2 and Phase 3 studies, as well as ongoing Phase 1 studies and IND-enabling work across TORL’s pipeline of novel high-value targets in solid tumors and hematologic malignancies.

Updated data from the TORL-1-23 Phase 1 study will be presented at ESMO (Free ESMO Whitepaper) 2025 (#1074P). In this ongoing study, patients with heavily pretreated CLDN6+ ovarian, testicular, endometrial, non-small cell lung and other cancers were enrolled across multiple dose cohorts. Emerging efficacy data from this study supported further evaluation of TORL-1-23 in larger, registrational studies.

In November 2024, TORL initiated CATALINA-2, a study designed to support accelerated registration of TORL-1-23 for CLDN6+ PROC. CATALINA-2 is a global, multi-institutional, randomized, open-label Phase 2 study of TORL-1-23 in women with CLDN6+ PROC who have received one to three prior lines of therapy. A CATALINA-2 Trial-in-Progress poster will be presented at ESMO (Free ESMO Whitepaper) 2025 (#1225TiP).

"The maturing clinical profile of TORL-1-23 continues to demonstrate the potential to improve treatment outcomes for patients with CLDN6+ platinum-resistant ovarian cancer, a defined subset of the disease with particularly poor prognosis," said Scientific Co-founder and Board Member Dennis Slamon, MD, PhD, Professor of Medicine, and Chief of the Division of Hematology/Oncology at UCLA’s David Geffen School of Medicine. "TORL-1-23 is the first of multiple high potential therapeutics to emerge from this unique academic-industry collaboration to redefine drug development from bench to bedside."

"TORL’s mission is to discover, develop and commercialize antibody-based therapeutics to improve and extend the lives of people with cancer worldwide," said Dave Licata,Co-founder, Board Member, President, and Chief Financial Officer. "Thanks to our dedicated employees and committed investors, we are well-positioned to advance the TORL-1-23 clinical program and our emerging pipeline across solid tumors and hematologic malignancies."

About Claudin 6

Claudin 6 (CLDN6) is overexpressed in several cancers with limited to no detectable expression observed in normal tissues, making it an ideal target for ADC development. CLDN6 is a transmembrane protein and member of a family of proteins important for cell-to-cell connectivity in normal tissues. CLDN6 expression normally occurs during embryonic and fetal development but not in adult tissues. Overexpression of CLDN6 occurs in specific malignancies and has been implicated in the pathogenesis of certain cancers including ovarian, non-small cell lung, endometrial and testicular malignancies. High expression correlates with shortened survival outcomes for patients with ovarian cancer.

About TORL-1-23

TORL-1-23 is a first- and potentially best-in-class clinical-stage ADC for the treatment of CLDN6+ solid tumors. TORL-1-23 has received Fast Track Designation from the U.S. Food and Drug Administration. TORL BioTherapeutics is currently enrolling the pivotal Phase 2 CATALINA-2 study of TORL-1-23 in women with CLDN6+ PROC. Further details can be found at View Source

About CATALINA-2

CATALINA-2 is a global, randomized, open-label Phase 2 study of novel CLDN6-targeted ADC TORL-1-23 in women with CLDN6+ PROC who have received one to three prior lines of therapy. The primary endpoint is objective response rate (ORR) per RECIST v1.1 by blinded independent central review. Secondary endpoints consist of duration of response, ORR by investigator assessment, progression-free survival, overall survival and safety. Further details can be found at View Source

On October 7, 2025 Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical company focused on developing first-in-class therapeutics for dermatological, oncology, and Alzheimer’s, reported that Chief Executive Officer Robb Knie will be presenting at the upcoming BIO-Europe 2025 Conference, taking place November 3–5, 2025, in Vienna, Austria (Press release, Hoth Therapeutics, OCT 7, 2025, View Source [SID1234656491]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

At the conference, Mr. Knie will highlight the Company’s two leading development programs:

HT-001 – a topical therapeutic designed to reduce rash and skin toxicity associated with cancer therapies, including EGFR inhibitors and radiotherapy.

HT-KIT – a precision oncology program targeting cancers driven by dysregulated KIT signaling.
"BIO-Europe is one of the premier global events for biopharma partnering and innovation," said Robb Knie, CEO of Hoth Therapeutics. "We look forward to sharing progress on our lead programs and engaging with potential collaborators who share our vision of developing breakthrough therapies for patients with high unmet needs."

Hoth’s presentation and partnering schedule will be available to registered attendees through the BIO-Europe partneringONE platform.

On October 7, 2025 Aethlon Medical, Inc. ("Aethlon" or the "Company") (Nasdaq: AEMD) reported observations on the preliminary changes in extracellular vesicle (EV), microRNA and lymphocyte counts in the first patient cohort in its ongoing oncology clinical trial in Australia (Press release, Aethlon Medical, OCT 7, 2025, View Source [SID1234656490]). The study is a safety, feasibility, and dose-finding trial evaluating the company’s Hemopurifier (HP) in patients with cancer not responding to anti-PD-1 therapy.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"As we promised during our last earnings call, we are sharing early observations from our ongoing safety, feasibility, and dose-finding clinical trial of the Aethlon Hemopurifier, which is currently being evaluated in cancer patients in Australia," said James (Jim) Frakes, CEO and CFO of Aethlon Medical. In the initial three patients, there were encouraging changes in extracellular vesicles (EVs), microRNAs, and lymphocytes, following a single Hemopurifier treatment.

We observed interesting directional changes in EV numbers, microRNAs and lymphocytes following a single Hemopurifier treatment in the three participants in the first cohort. Additional data from the subsequent two cohorts will help determine whether these observations are reproducible, and whether there is a dose response with additional Hemopurifier treatments in terms of the magnitude and duration of the changes.

Additional details of these early observations are provided below:

EVs: Two of the three participants in the trial showed decreases in large EVs also known as microvesicles. EVs are nanoparticles that are involved in cell-to-cell communication and are implicated in the spread of cancer (metastasis), growth of new blood vessels to the tumor, (angiogenesis), cell death (apoptosis), and inhibition of the body’s T cells, which are important for killing tumor cells.
Platelet Derived EVs: Decreases were observed in large and small platelet-derived EVs in two of the three patients.
EV PD-L1: Decreases in the subset of large EVs carrying PD-L1 were observed in all three participants during the Hemopurifier treatment. Persistently elevated counts of EVs with PD-L1 have been associated with lack of response to anti-PD-1 agents.
MicroRNAs: Following a single 4-hour HP treatment, decreases were observed in seven out of ten miRNAs examined in two of the three participants. MicroRNAs are one component of the cargo of extracellular vesicles, previously reported to promote cancer growth and metastasis.

The EV and microRNA levels typically returned to pre-Hemopurifier treatment levels between 1 – 3 weeks.
Lymphocyte Counts:
Laboratory Ratios: After a single 4-hour-treament, improvements in laboratory ratios associated with responses to immunotherapy including Neutrophil, Lymphocyte, Monocyte, Lymphocyte, Lymphocyte, Albumin and Systemic Immune-Inflammation were observed in at least two participants.
T cells and T cell subsets: Increases were noted in total T cell numbers, CD8 and CD4 T cell subsets, and tumor specific T cells (CD137 +ve) in participants following Hemopurifier treatment without a consistent pattern in terms of timing of improvement.
Important Caveats:

We are making these observations on three patients with one participant withdrawing from the study after 1 week due to cancer progression and thus supplying only limited follow-up data.
The small number of participants allows for only "directional" descriptive statistics and not formal statistical analyses.
These participants received only a single Hemopurifier treatment and thus we cannot make any statements about "dose response" i.e., will changes be greater or more long lasting with more treatments.
There is heterogeneity within the data in terms of a) the number of Hemopurifier treated patients who experienced changes in the variables of interest, b) the magnitude of the changes observed, and (c) the timing and duration of the laboratory changes observed.
We cannot make any correlation between the changes observed above and the clinical efficacy of the Hemopurifier in cancer. These observations are from an early feasibility study and should not be interpreted as evidence of clinical benefit or safety beyond the study parameters. Determinations of the presence or absence of clinical efficacy can only be determined in a larger premarket approval or PMA trial specifically designed with this as the primary endpoint.

About the Hemopurifier

The Aethlon Hemopurifier is an investigational medical device designed to remove enveloped viruses, fragments of viruses, and tumor-derived extracellular vesicles (EVs) from circulation. It is used extracorporeally with a blood pump and combines plasma separation, size exclusion, and affinity binding using a plant lectin resin that targets mannose-rich surfaces found on EVs and viral proteins. EVs released by solid tumors are believed to play a role in metastasis and the resistance to immunotherapies and chemotherapy. Removal of enveloped viruses, fragments of viruses, and EVs has been demonstrated in both in vitro studies and in human patients.

The Hemopurifier holds a U.S. Food and Drug Breakthrough Device Designation for: The treatment of individuals with advanced or metastatic cancer unresponsive to or intolerant of standard-of-care therapy; and the treatment of life-threatening viruses not addressed with approved therapies.

On October 7, 2025 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported the completion of the final patient visit in its breast cancer vaccine clinical trial (Press release, Anixa Biosciences, OCT 7, 2025, View Source [SID1234656489]). This novel vaccine, invented at Cleveland Clinic, is being developed in partnership with Cleveland Clinic, and the Phase 1 trial is fully funded by a grant from the U.S. Department of Defense.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The vaccine is designed to stimulate the immune system to recognize and target breast cancer before it can recur or develop. A total of 35 women received the vaccine in the study, spanning three distinct patient cohorts:

TNBC Group: Women who have completed treatment for triple-negative breast cancer, are currently cancer-free, and are at risk of recurrence.
Prevention Group: Women who are cancer-free but carry genetic mutations associated with elevated breast cancer risk, and who elected to undergo preventive mastectomy.
Pembrolizumab (Keytruda ) Group: Women receiving pembrolizumab in a post-operative setting who were administered the vaccine concurrently with the checkpoint inhibitor.
The trial enrolled 26 patients in the TNBC group, four in the Prevention group, and five in the Pembrolizumab group.

With the completion of all patient visits and sample collection, comprehensive data analysis can now proceed. Following analysis, a final study report will be submitted to the Department of Defense, and a Clinical Study Report (CSR) will be filed with the U.S. Food and Drug Administration (FDA).

Cleveland Clinic will present full clinical results at the San Antonio Breast Cancer Symposium on December 11, 2025.

Dr. G. Thomas Budd, of Cleveland Clinic Cancer Institute and Prinicipal Investigator of the study, commented, "We are pleased by the data we are seeing from this trial. Preliminary results indicate that our breast cancer vaccine is well tolerated, with more than 70% of participants demonstrating protocol-defined immune responses. We look forward to presenting the final trial data at the San Antonio Breast Cancer Symposium later this year."

Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences, commented, "While cancer vaccines have historically faced considerable challenges, our approach targets a novel antigen that has not been explored in this setting. We believe this strategy could represent a new paradigm in immuno-oncology, with potential utility in both the prevention and treatment of breast cancer."