Hoth Therapeutics CEO Robb Knie to Present at BIO-Europe in Vienna, Austria November 3-5, 2025

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]).

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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.

Aethlon Medical’s Hemopurifier® shows Changes in Extracellular Vesicles, Extracellular MicroRNAs, and T Cell Numbers in Australian Oncology Clinical Trial

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.

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"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.

Anixa Biosciences Announces Completion of Final Patient Visit in Breast Cancer Vaccine Clinical Trial

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.

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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."

Circulogene Expands Solid Tumor Genomic Capabilities with Launch of OncoGenDx Tissue Assay

On October 7, 2025 Circulogene reported the national launch of OncoGenDx, an innovative tissue-based comprehensive genomic profiling (CGP) assay that delivers expanded insights into all solid tumors (Press release, Circulogene, OCT 7, 2025, View Source [SID1234656488]). Designed to complement Circulogene’s existing portfolio—including OncoGenLDx, the industry’s only plasma-based test reporting PD-L1 expression, and LungLifeAI, a targeted solution for risk stratifying incidental lung nodules—the new assay reflects Circulogene’s ongoing commitment to advancing precision oncology with fast, modular, and clinically actionable testing options.

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"OncoGenDx reflects Circulogene’s commitment to innovation that simplifies the diagnostic landscape," said Mike Mullen, CEO of Circulogene. "By integrating tissue and liquid capabilities into a unified solution, we’re enabling clinicians to make faster, more confident treatment decisions—whether they’re evaluating initial diagnoses or monitoring disease progression."

About OncoGenDx

OncoGenDx is a next-generation sequencing (NGS) assay designed to deliver a comprehensive molecular analysis of formalin-fixed paraffin-embedded (FFPE) tumor tissue across all solid tumor types. Built on Roche’s AVENIO NGS platform and leveraging FoundationOne’s bioinformatics pipeline, the assay interrogates 335 DNA genes and 72 RNA genes to identify single nucleotide variants (SNVs), insertions/deletions (Indels), copy number variations (CNVs), and structural variants (SVs), including actionable fusions. It also reports three complex genomic signatures—Tumor Mutational Burden (TMB), Microsatellite Instability (MSI), and Homologous Recombination Deficiency (HRD)—to support both targeted therapy and immunotherapy decision-making. PD-L1 IHC (22C3 clone) is also available as an add-on service using CPS scoring.

Ordering is streamlined through direct submission to Circulogene, with the option to have the pathology retrieval coordinated by the Circulogene Client Services team. Results are delivered as a unified report typically within 10–14 days. The OncoGenDx platform is performed in Circulogene’s CLIA-certified laboratory and supports clinical decision-making, trial enrollment, and longitudinal profiling.

Entry into a Material Definitive Agreement

On October 7, 2025, Thermo Fisher Scientific Inc. (the "Company") reported to have issued $500,000,000 aggregate principal amount of 4.200% Senior Notes due 2031 (the "2031 Notes"), $750,000,000 aggregate principal amount of 4.473% Senior Notes due 2032 (the "2032 Notes"), $750,000,000 aggregate principal amount of 4.794% Senior Notes due 2035 (the "2035 Notes") and $500,000,000 aggregate principal amount of 4.894% Senior Notes due 2037 (the "2037 Notes" and, collectively with the 2031 Notes, the 2032 Notes and the 2035 Notes, the "Notes") in a public offering (the "Offering") pursuant to a registration statement on Form S-3ASR (File No. 333-285159) and a preliminary prospectus supplement and prospectus supplement related to the offering of the Notes, each as previously filed with the Securities and Exchange Commission (Filing, 8-K, Thermo Fisher Scientific, OCT 7, 2025, View Source [SID1234656486]).

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The Notes were issued under an indenture, dated as of November 20, 2009 (the "Base Indenture") and the Twenty-Ninth Supplemental Indenture, dated as of October 7, 2025 (the "Supplemental Indenture" and, together with the Base Indenture, the "Indenture"), between the Company, as issuer, and The Bank of New York Mellon Trust Company, N.A., as trustee.

The 2031 Notes will mature on March 1, 2031, the 2032 Notes will mature on October 7, 2032, the 2035 Notes will mature on October 7, 2035 and the 2037 Notes will mature on October 7, 2037. Interest on the 2031 Notes will be paid semi-annually in arrears on March 1 and September 1 of each year, beginning on March 1, 2026. Interest on the 2032 Notes, the 2035 Notes and the 2037 Notes will be paid semi-annually in arrears on April 7 and October 7 of each year, beginning on April 7, 2026.

Prior to February 1, 2031, in the case of the 2031 Notes, August 7, 2032, in the case of the 2032 Notes, July 7, 2035, in the case of the 2035 Notes and July 7, 2037, in the case of the 2037 Notes (each, a "Par Call Date"), the Company may redeem each series of the Notes, in whole at any time or in part from time to time, at a redemption price equal to the greater of (1) 100% of the principal amount of the Notes of such series to be redeemed and (2) the sum of the present values of the remaining scheduled payments of principal and interest in respect of the Notes of such series being redeemed (not including any portion of the payments of interest accrued but unpaid as of the date of redemption and assuming that such Notes to be redeemed matured on their applicable Par Call Date), discounted to the date of redemption on a semi-annual basis (assuming a 360-day year of twelve 30-day months), at the Treasury Rate (as defined in the Indenture) plus 10 basis points, in the case of the 2031 Notes, 10 basis points, in the case of the 2032 Notes, 10 basis points, in the case of the 2035 Notes and 15 basis points, in the case of the 2037 Notes, plus, in each case, accrued and unpaid interest on the Notes of such series being redeemed, if any, to, but excluding, the date of redemption.

In addition, on and after the applicable Par Call Date, the Company may redeem some or all of each series of the Notes at a redemption price equal to 100% of the principal amount of the Notes to be redeemed, plus accrued and unpaid interest, if any, to, but excluding, the date of redemption.

Upon the occurrence of a change of control (as defined in the Indenture) of the Company and a contemporaneous downgrade of the Notes below an investment grade rating by at least two of Moody’s Investors Service, Inc., S&P Global Ratings, a division of S&P Global, Inc., and Fitch Ratings, Limited, the Company will, in certain circumstances, be required to make an offer to purchase the Notes at a price equal to 101% of the principal amount of the Notes, plus any accrued and unpaid interest to, but excluding, the date of repurchase.