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."

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.

On October 6, 2025 Alligator Bioscience (Nasdaq Stockholm: ATORX), a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs, reported that two abstracts have been accepted for presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 40th Anniversary Annual Meeting, to be held 7–9 November 2025 in National Harbor, MD, USA (Press release, Alligator Bioscience, OCT 6, 2025, View Source [SID1234656454]).

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The presentations will feature new data from Alligator’s pipeline programs mitazalimab and ATOR-4066:

Presentation details
Title: CD40 agonist mitazalimab + mFOLFIRINOX in patients with metastatic pancreatic ductal adenocarcinoma: dose characterization based on exposure response and biomarker analysis from the OPTIMIZE-1 study
Abstract number: 530
Time: Saturday, 8 November 2025
Presenter: Yago Pico de Coaña, Medical Science Director, Alligator Bioscience

Title: ATOR-4066, a bispecific antibody targeting CD40 and CEACAM5, induces potent anti-tumor activity that associates with activated intra-tumoral immune cells and disassembly of extracellular tumor matrix
Abstract number: 940
Time: Saturday, 8 November 2025
Presenter: Hampus Andersson, Industrial PhD student, Alligator Bioscience

"We are pleased that data for both mitazalimab and ATOR-4066 have been acknowledged through acceptance at SITC (Free SITC Whitepaper)’s 40th Anniversary Annual Meeting," said Søren Bregenholt, CEO of Alligator Bioscience. "This is an important recognition of the strength of our pipeline and our ambition to develop transformative immunotherapies for cancer patients."
The accepted abstracts will be published on 4 November 2025 at www.sitcancer.org/2025.

On October 6, 2025 ESSA Pharma Inc. (NASDAQ: EPIX) ("ESSA" or the "Company") reported that its Securityholders (as defined below) have approved the acquisition of all of the issued and outstanding common shares of the Company (the "Common Shares" and the holders of such Common Shares, the "Shareholders") by XenoTherapeutics Inc. ("Xeno"), a non-profit biotechnology company, by way of a statutory plan of arrangement (the "Transaction" or the "Arrangement") at the special meeting of Securityholders held today (the "Meeting") (Press release, ESSA, OCT 6, 2025, View Source [SID1234656471]).

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The special resolution approving the Arrangement was approved by: (i) 99.83% of the votes cast by Shareholders present in person or represented by proxy at the Meeting, (ii) 99.85% of the votes cast by Shareholders, holders of options to purchase Common Shares of the Company, holders of pre-funded Common Share purchase warrants of the Company (collectively, the "Securityholders"), present in person or represented by proxy at the Meeting, voting together as a single class, and (iii) 99.48% of the votes cast by Shareholders, present in person or represented by proxy at the Meeting, excluding for this purpose the votes required to be excluded pursuant to Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions.

At the Meeting, Shareholders also approved: (a) on an advisory and non-binding basis, the compensation to be paid or become payable to the Company’s named executive officers that is based on or otherwise relates to the Arrangement by 99.51% of the votes cast by Shareholders present in person or represented by proxy at the Meeting; and (b) in the event the Arrangement is terminated, (1) the voluntary liquidation and dissolution of the Company by 99.77% of the votes cast by Shareholders present in person or represented by proxy at the Meeting and (2) the appointment of PricewaterhouseCoopers LLP or, in the alternative, another liquidator of nationally recognized experience, as the liquidator of the Company with authorization for the board of directors of the Company to set the remuneration of the liquidator by 99.79% of the votes cast by Shareholders present in person or represented by proxy at the Meeting.

The Arrangement is subject to the approval of the Supreme Court of British Columbia (the "Court") and other customary closing conditions. The Court hearing for the final order to approve the Arrangement is expected to take place on October 7, 2025, and the completion of the Arrangement is expected to occur on or about October 9, 2025.

On October 6, 2025 Astrazeneca reported positive high-level results from the TROPION-Breast02 Phase III trial showed Datroway (datopotamab deruxtecan) demonstrated a statistically significant and clinically meaningful improvement for the dual primary endpoints of overall survival (OS) and progression-free survival (PFS) compared to investigator’s choice of chemotherapy as 1st-line treatment for patients with locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC) for whom immunotherapy was not an option (Press release, AstraZeneca, OCT 6, 2025, View Source [SID1234656455]).

Approximately 70% of patients with metastatic TNBC are not candidates for immunotherapy, including all patients whose tumours do not express PD-L1 as well as patients with PD-L1 expressing tumours who cannot receive immunotherapy due to other factors.1 Chemotherapy remains the 1st-line standard of care for these patients.2

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "TROPION-Breast02 is the only trial ever to show an overall survival benefit in the first-line treatment of patients with metastatic triple-negative breast cancer for whom immunotherapy is not an option. We expect today’s results will mark an inflection point in the treatment of these patients who have the poorest prognosis of any type of breast cancer and urgently need better options."

Ken Takeshita, Global Head, R&D, Daiichi Sankyo, said: "Datroway is the first antibody drug conjugate and the only therapy to significantly improve overall survival compared to chemotherapy in patients with metastatic triple-negative breast cancer for whom immunotherapy is not an option. These landmark results from TROPION-Breast02 strengthen our confidence in our ongoing clinical development programme for Datroway in triple-negative breast cancer and other tumour types. We look forward to discussing these data with global regulatory authorities and to bringing Datroway to patients with triple-negative breast cancer as soon as possible."

The safety profile of Datroway was consistent with previous clinical trials of Datroway in breast cancer. These data will be presented at an upcoming medical meeting and shared with regulatory authorities.

Datroway is a specifically engineered TROP2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

AstraZeneca and Daiichi Sankyo are evaluating Datroway across stages and treatment settings of TNBC in three additional Phase III trials. TROPION-Breast03 is evaluating Datroway with or without Imfinzi (durvalumab) in patients with Stage I-III TNBC with residual invasive disease after neoadjuvant systemic therapy. TROPION-Breast04 is evaluating neoadjuvant Datroway plus Imfinzi in patients with Stage II-III triple-negative or hormone receptor (HR)-low, HER2-low or -negative breast cancer. TROPION-Breast05 is evaluating 1st-line Datroway with or without Imfinzi in patients with metastatic TNBC whose tumours express PD-L1.

Notes

Triple-negative breast cancer
TNBC accounts for approximately 15% of all breast cancer cases, with an estimated 345,000 diagnoses globally each year.3,4 TNBC is diagnosed more frequently in younger and premenopausal women, and is more prevalent in Black and Hispanic women.5-7 Metastatic TNBC is the most aggressive type of breast cancer and has the worst prognosis, with median overall survival of just 12 to 18 months and only about 14% of patients living five years following diagnosis.5,8,9

While some breast cancers may test positive for oestrogen receptors, progesterone receptors or overexpression of HER2, TNBC tests negative for all three.5 Due to its aggressive nature and absence of common breast cancer receptors, TNBC is characteristically difficult to treat.5 For patients with metastatic disease with PD-L1 expressing tumours, the addition of immunotherapy to chemotherapy has improved outcomes in the 1st-line setting.10,11 However, for the approximately 70% of patients with metastatic TNBC who are not candidates for immunotherapy, chemotherapy remains the 1st-line standard of care.1,2

TROP2 is a protein broadly expressed in several solid tumours including TNBC.12 TROP2 is associated with increased tumour progression and poor survival in patients with breast cancer.13,14

TROPION-Breast02
TROPION-Breast02 is a global, multicentre, randomised, open-label Phase III trial evaluating the efficacy and safety of Datroway versus investigator’s choice of chemotherapy (paclitaxel, nab-paclitaxel, capecitabine, carboplatin or eribulin) in patients with previously untreated locally recurrent inoperable or metastatic TNBC for whom immunotherapy was not an option. This included patients whose tumours did not express PD-L1 as well as patients with PD-L1 expressing tumours who could not receive immunotherapy due to prior exposure in early-stage disease, comorbidities or immunotherapy not being accessible in their geography. Enrolment included patients with de novo or recurrent disease, regardless of disease-free interval, and those with poor prognostic factors such as brain metastases.

The dual primary endpoints of TROPION-Breast02 are PFS as assessed by blinded independent central review and OS. Key secondary endpoints include PFS as assessed by investigator, objective response rate, duration of response, disease control rate, pharmacokinetics and safety.

TROPION-Breast02 enrolled 644 patients at sites in Africa, Asia, Europe, North America and South America. For more information, visit ClinicalTrials.gov.

Datroway
Datroway (datopotamab deruxtecan; datopotamab deruxtecan-dlnk in the US only) is a TROP2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, Datroway is one of six DXd ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programmes in AstraZeneca’s ADC scientific platform. Datroway is comprised of a humanised anti-TROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

Datroway is approved in more than 35 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HR-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease based on results from the TROPION-Breast01 trial.

Datroway is available in the US under accelerated approval for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy based on results from the TROPION-Lung05 and TROPION-Lung01 trials. Continued approval for this indication in the US may be contingent upon verification and description of clinical benefit in a confirmatory trial. Datroway is approved in Russia for the same population.

Datroway clinical development programme
A comprehensive global clinical development programme is underway with more than 20 trials evaluating the efficacy and safety of Datroway across multiple cancers, including NSCLC, TNBC and urothelial cancer. The programme includes eight Phase III trials in lung cancer and five Phase III trials in breast cancer evaluating Datroway as a monotherapy and in combination with other anticancer treatments in various settings.

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