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HotSpot Therapeutics to Present Preclinical Data from Small Molecule IRF5 Program at FOCIS 2025

On June 18, 2025 HotSpot Therapeutics, Inc., a biotechnology company pioneering the discovery and development of oral, small molecule allosteric therapies targeting Smart Allostery platform-identified regulatory sites on proteins referred to as "natural hotspots," reported it will present preclinical data from the Company’s interferon regulatory factor 5 (IRF5) program in an oral and poster presentation at the 25th Annual Meeting of the Federation of Clinical Immunology Societies (FOCIS 2025), taking place June 24-27, 2025, in Boston, MA (Press release, HotSpot Therapeutics, JUN 18, 2025, View Source [SID1234653992]).

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Presentation details are as follows:

Title: Targeting IRF5: Discovery and Preclinical Development of Selective Small Molecule Inhibitors
Session: Late-Breaking Abstracts
Session Date and Time: Wed., Jun. 25, 3:15-5:15 PM ET
Presentation Time: 4:00-4:15 PM ET
Location: Salons H-K, Boston Marriott Copley Place, Boston, MA

Pimera Therapeutics Announces Grant Award from Medical Research Future Fund (MRFF) for Expansion of Phase 1a/b Study of PMR-116 for MYC-driven Cancers

On June 18, 2025 Pimera Therapeutics, Inc., a clinical-stage biotechnology company focused on developing breakthrough medicines for cancer and other diseases with high unmet medical need, reported a grant award from the Medical Research Future Fund (MRFF) that will enable the expansion of a Phase 1a/b study evaluating its lead program, PMR-116, for multiple difficult-to-treat cancer indications (Press release, Pimera Therapeutics, JUN 18, 2025, View Source [SID1234653991]).

Pimera has demonstrated robust preclinical efficacy in multiple MYC-driven models with PMR-116, including those that are resistant to standard-of-care treatments. PMR-116 has moved through dose escalation in the Phase 1a/b clinical trial, and with this new grant, the Company can expand the development of PMR-116 in patients with MYC overexpressing solid tumors in a tumor type-agnostic approach.

"In the ongoing Phase 1 study, PMR-116 demonstrated favorable target engagement and early clinical efficacy signals in multiple solid tumor patients, which is very encouraging," said Mustapha Haddach, Ph.D., President and CEO of Pimera. "We look forward to expanding the study into MYC overexpressing solid tumors with ANU and MRFF."

Pimera has partnered with The Australian National University (ANU) to lead the research. The Phase 1a/b trial, which is funded by the Medical Research Future Fund (MRFF), targets MYC-driven cancers – a group that includes multiple cancer types, such as prostate, breast, ovarian, and haematological cancers. Historically, the MYC protein is a key regulator of cell growth and is often implicated in cancer, contributing to tumor development.

Professor Ross Hannan, Chief Scientific Officer of Pimera, commented, "PMR-116 targets MYC-driven cancers by inhibiting an enzyme to disrupt ribosomal biogenesis – a crucial process hijacked in these cancers. We are pleased to receive this grant and partner with ANU to bring PMR-116 closer to patients in need."

Hematologist at Canberra Health Services and ANU Professor Mark Polizzotto will lead the clinical trial, known as a "basket trial", a study design that brings together patients with different cancer types based on the involvement of the MYC protein, rather than the patient’s cancer type.

"Approximately 70 percent of all cancers are fueled by abnormal MYC activity," commented Dr. Polizzotto. "MYC is one of the most notorious cancer-causing genes, and tumors driven by MYC overexpression are often among the most aggressive and difficult to treat. The trial aims to address unmet clinical needs in difficult-to-treat cancers, and its design is efficient, saving time and resources compared to having separate trials for each cancer type."

The ongoing clinical trial of PMR-116 will be conducted at hospitals including Canberra Hospital, Peter MacCallum Cancer Centre in Victoria, and St Vincent’s Hospital in Sydney. For more information about the ongoing clinical trial, please visit ANZCTR.

About PMR-116

PMR-116 is our lead therapeutic in clinical development for multiple cancer indications including solid tumors. PMR-116 acts through a novel mechanism of action, targeting the RNA polymerase I, or POL I, a transcription factor for MYC driven cancers and other diseases with high unmet medical need. In preclinical studies, PMR-116 has demonstrated robust preclinical efficacy in multiple MYC-driven models, including those that are resistant to standard-of-care treatments. PMR-116 is currently in the dose escalation stage of a Phase 1a/b clinical trial being conducted in Australia. Pimera intends to expand the development of PMR-116 in patients with MYC overexpressing solid tumors in a tumor type-agnostic approach.

LOTTE BIOLOGICS Signs Antibody Manufacturing Contract with Ottimo Pharma

On June 18, 2025 LOTTE BIOLOGICS reported that it has signed a contract manufacturing agreement for antibody therapeutics with Ottimo Pharma, a biopharmaceutical company developing first-in-class, one-of-a-kind PD1/VEGFR2 dual pathway antibodies to extend the lives of people living with cancer (Press release, Ottimo Pharma, JUN 18, 2025, View Source [SID1234653990]).

The signing ceremony took place at the LOTTE BIOLOGICS booth within the Boston Convention and Exhibition Center, where BIO INTERNATIONAL 2025 is being held. Through this agreement, LOTTE BIOLOGICS will produce antibody drug substance for Ottimo Pharma’s Jankistomig at its Syracuse Bio Campus in New York.

James Park, CEO of LOTTE BIOLOGICS, stated, "This agreement serves as further validation of our competitiveness as a CDMO in the global antibody therapeutics market. We will continue striving not only to supply high-quality medicines that meet global standards, but also to become a company that delivers greater value to both our partners and patients."

Joseph Shultz, Vice President Technical Development & Manufacturing at Ottimo PHARMA said, "This manufacturing collaboration marks a significant milestone in our commitment to advancing Jankistomig with speed and precision. Partnering with Lotte’s proven biomanufacturing capabilities enhances our operational readiness and supports our rapid path to IND submission and clinical trial initiation."

LOTTE BIOLOGICS currently provides CDMO services at its Syracuse Bio Campus, ranging from cell line development to large-scale contract manufacturing of biopharmaceuticals. Additionally, the company aims to begin operation of Plant 1 at its Songdo Bio Campus in 2027. Plant 1 will be a large-scale biopharmaceutical manufacturing facility with a production capacity of 120,000 liters, enabling the company to handle major global contracts.

Recently, LOTTE BIOLOGICS has been broadening its partnerships with various global biopharmaceutical companies across Asia and Europe. Centered around its two production hubs in North America and Asia, the company is solidifying its position in the CDMO market not only for antibody therapeutics but also for ADC modalities. LOTTE BIOLOGICS aims to secure clients by providing an integrated service through collaboration, delivering superior and trustworthy solutions.

Furthermore, to provide client-specific end-to-end services, LOTTE BIOLOGICS has entered into strategic collaborations with global contract development organizations (CDOs) and drug product (DP) companies. Through these partnerships, it offers fully customized CDMO solutions spanning early drug development to commercialization.

Blue Earth Diagnostics Reinforces Leadership in Prostate Cancer Imaging and Highlights Expanding Pipeline at Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2025

On June 18, 2025 Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative positron emission tomography (PET) radiopharmaceuticals, reported presentations at the upcoming Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting, to be held June 21 to 24, 2025, in New Orleans, LA (Press release, Blue Earth Diagnostics, JUN 18, 2025, View Source [SID1234653989]).

The company will unveil new clinical data on its prostate-specific membrane antigen (PSMA)-targeted PET agent and share clinical results that demonstrate potential applications of 18F -fluciclovine in detection of multiple myeloma* and for patients with negative PSMA scans. "Physicians must be equipped with accurate, actionable molecular imaging to guide more informed clinical decisions," said Marco Campione, President and CEO of Blue Earth Diagnostics. "At SNMMI, we look forward to sharing new analyses and scientific information about POSLUMA and Axumin with the molecular imaging community – highlighting our commitment to delivering innovative solutions for improved patient care."

Blue Earth Diagnostics will be presenting seven abstracts around POSLUMA at SNMMI, including an analysis on the prognostic value of baseline 18F-flotufolastat PET bone tumor metrics for the occurrence of severe hematologic toxicity in patients with metastatic castration-resistant prostate cancer (mCRPC) treated with 177Lu-PSMA-I&T.

The Company will also present clinical data around Axumin, highlighting the role of 18F-fluciclovine PET/CT in patients with biochemical recurrence of prostate cancer and a negative PSMA PET/CT, and potential applications in multiple myeloma.

Blue Earth Diagnostics invites participants at the 2025 SNMMI Annual Meeting to attend the presentations below and to visit the Company at Exhibit Booth 1513.

POSLUMA (flotufolastat F 18)

DATE: Sunday, June 22, 2025
Title: Impact of Baseline 18F-Flotufolastat PET Bone Tumor Volume for Prognosticating Severe Hematologic Toxicity in Patients with Metastatic Castration-Resistant Prostate Cancer Receiving 177Lu-Labeled PSMA-Targeted Radioligand Therapy
Presenter: Isabel Rauscher, Technical University of Munich, School of Medicine, Klinikum rechts der Isar, Department of Nuclear Medicine, Markt Schwaben, Germany
Session Type: Oral presentation
Session Time: 5:00 – 5:30 PM CT
Abstract ID.: 251321

DATE: Sunday, June 22, 2025
Title: Prognostic 18F-Flotufolastat PET Parameters for Outcome Assessment of 177Lu-labeled PSMA-targeted Radioligand Therapy in Metastatic Castration-resistant Prostate Cancer
Presenter: Isabel Rauscher, Technical University of Munich, School of Medicine, Klinikum rechts der Isar, Department of Nuclear Medicine, Markt Schwaben, Germany
Session Type: Poster presentation
Session Time: 5:30 – 6:15 PM CT
Abstract ID.: 1324

DATE: Sunday, June 22, 2025
Title: Follow-up 18F-Flotufolastat PET after negative baseline PET in Patients with Suspected Biochemical Recurrence of Prostate Cancer after Radical Prostatectomy
Presenter: Isabel Rauscher, Technical University of Munich, School of Medicine, Klinikum rechts der Isar, Department of Nuclear Medicine, Markt Schwaben, Germany
Session Type: Poster presentation
Session Time: 5:30 – 6:15 PM CT
Abstract ID.: 1319

DATE: Sunday, June 22, 2025
Title: 18F-Flotufolastat PET/MRI in Suspicious Prostate Cancer: Correlation with Histopathological Biopsy Results
Presenter: Nicola Gabler, Technical University of Munich, School of Medicine, Klinikum rechts der Isar, Department of Nuclear Medicine, Markt Schwaben, Germany
Session Type: Poster presentation
Session Time: 5:30 – 6:15 PM CT
Abstract ID.: 1318

DATE: Sunday, June 22, 2025
Title: Real-World Experience on the Diagnostic Efficacy of 18F-Flotufolastat PET/CT in Preoperative N-Staging as Assessed by Readers of Varying Experience Levels
Presenter: Isabel Rauscher, Technical University of Munich, School of Medicine, Klinikum rechts der Isar, Department of Nuclear Medicine, Markt Schwaben, Germany
Session Type: Poster presentation
Session Time: 5:30 – 6:15 PM CT
Abstract ID.: 1457

DATE: Sunday, June 22, 2025
Title: Impact of PSMA-PET based eligibility criteria using 18F-rhPSMA-7.3 (Flotufolastat) on outcome of Lutetium PSMA radioligand therapy
Presenter: Sonia Grigorascu, Technical University of Munich, School of Medicine, Klinikum rechts der Isar, Department of Nuclear Medicine, Markt Schwaben, Germany
Session Type: Poster presentation
Session Time: 5:30 – 6:15 PM CT
Abstract ID.: 251150

DATE: Sunday, June 22, 2025
Title: Prognostic Value of 18F-rhPSMA-7.3 (Flotufolastat-F18) PET Using Visual RECIP During Taxane-based Chemotherapy in Prostate Cancer
Presenter: Isabel Rauscher, Technical University of Munich, School of Medicine, Klinikum rechts der Isar, Department of Nuclear Medicine, Markt Schwaben, Germany
Session Type: Poster presentation
Session Time: 5:30 – 6:15 PM CT
Abstract ID.: 1821

Axumin (fluciclovine F 18) and investigational 18F-fluciclovine
DATE: Sunday, June 22, 2025
Title: 18F-Fluciclovine PET/CT detects more lesions with higher quantitative PET parameters than 18F-FDG PET/CT in multiple myeloma*
Presenter: Liza Lindenberg, M.D., Associate Research Physician, National Cancer Institute, Molecular Imaging, Bethesda, Maryland
Session Type: Poster presentation
Session Time: 5:30 – 6:15 PM CT
Abstract ID.: 251312

DATE: Monday, June 23, 2025
Title: Do racial differences impact salvage radiotherapy outcomes for prostate cancer recurrence?
Presenter: Ismaheel Lawal, Senior Research Fellow, Emory University, Department of Radiology and Imaging Sciences, Atlanta, Georgia
Session Type: Poster presentation
Session Time: 12:30 – 1:15 PM CT
Abstract ID.: 251471

DATE: Tuesday, June 24, 2025
Title: Role of 18F-Fluciclovine PET/CT in patients with biochemical recurrence of prostate cancer and a negative PSMA PET/CT
Presenter: Nadine Mallak, M.D., Associate Professor, Oregon Health and Science University, Department of Diagnostic Radiology Molecular Imaging & Therapy, Body Imaging Director, PET/MRI, Clinical, Portland, Oregon
Session Type: Poster presentation
Session Time: 9:30 – 9:40 AM CT
Abstract ID.: 251638

Aethlon Medical Treats Second Patient in Australian Hemopurifier® Cancer Trial

On June 18, 2025 Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases, reported a significant milestone: the treatment of the second patient with the Hemopurifier in its Australian safety, feasibility and dose-finding clinical trial of the Hemopurifier (Press release, Aethlon Medical, JUN 18, 2025, View Source [SID1234653988]). This trial is designed for patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment, such as Keytruda (pembrolizumab) or Opdivo (nivolumab) (AEMD-2022-06 Hemopurifier Study). The patient was treated with the Hemopurifier June 11, 2025 by Genesis Care and Royal North Shore Hospital/University of Sydney. Professor Stephen Clarke, Medical Oncologist, is the Principal Investigator for the study and the Hemopurifier session was supervised by Dr. Emma O’Lone.

Ongoing progress has been made in our Australian Oncology trial of the Hemopurifier in participants with solid tumors not responding to anti-PD-1 agents. We have now completed Hemopurifier treatments in 2 participants in the first cohort. Our first participant completed the Hemopurifier treatment at Royal Adelaide Hospital on January 29, 2025. Participant # 2 was treated with the Hemopurifier at Royal North Shore/University of Sydney on June 2, 2025. Both participants completed the 4-hour Hemopurifier treatment without device deficiencies or immediate complications. As of June 10, 2025, both patients have completed the pre-specified 7-day safety follow-up period that will be presented to an independent Data Safety Monitoring Board (DSMB) following the treatment of a third patient in the cohort.

The DSMB will review safety data on this first cohort and provide a recommendation to Aethlon Medical Senior Leadership about advancing to the second treatment cohort where 3 participants will receive 2 Hemopurifier treatments during a one-week period. We would expect data on extracellular removal by the Hemopurifier and effects on anti-tumor T cell activity on participants in the first cohort in approximately three months following enrollment of the third patient.

"We are pleased that both patients treated with the Hemopurifier thus far have tolerated the 4-hour treatment without immediate complications. We look forward to enrolling the third participant to trigger a safety review of the first cohort by the DSMB," stated Steven LaRosa, MD, Chief Medical Officer of Aethlon Medical.

Currently, only approximately 30-40% of patients who receive pembrolizumab or nivolumab will have lasting clinical responses to these agents. EVs produced by tumors have been implicated in the spread of cancers as well as the resistance to anti-PD-1 therapies. The Aethlon Hemopurifier has been designed to bind and remove these EVs from the bloodstream, which may improve therapeutic response rates to anti-PD-1 antibodies. In preclinical studies, the Hemopurifier has been shown to reduce the number of exosomes from the plasma of cancer patient samples.

The primary endpoint of the approximately 18-patient, safety, feasibility, and dose-finding trial is the incidence of adverse events and clinically significant changes in safety lab tests of Hemopurifier treated patients with solid tumors with stable or progressive disease at different treatment intervals, after a two-month run-in period of PD-1 antibody, Keytruda or Opdivo monotherapy. Patients who do not respond to the therapy will be eligible to enter the Hemopurifier period of the study where sequential cohorts will receive 1, 2, or 3 Hemopurifier treatments during a one-week period. In addition to monitoring safety, the study is designed to examine the number of Hemopurifier treatments needed to decrease the concentration of EVs and if these changes in EV concentrations improve the body’s own natural ability to attack tumor cells. These exploratory central laboratory analyses are expected to inform the design of a subsequent efficacy and safety, Premarket Approval (PMA), study required by regulatory agencies.

About the Hemopurifier

The Aethlon Hemopurifier is an investigational medical device designed to remove enveloped viruses and tumor-derived extracellular vesicles from circulation. The Hemopurifier is an extracorporeal device that is used in concert with a blood pump. The device incorporates plasma separation, size exclusion, and affinity binding to an affinity resin containing a plant lectin. Mannose on the surface of enveloped viruses and extracellular vesicles binds to the plant lectin within the device. Extracellular vesicles released from solid tumors have been implicated in the spread of cancers known as metastasis as well as in the resistance to immunotherapy and chemotherapeutic agents. Removal of enveloped viruses and extracellular vesicles has been observed in in vitro studies and in human subjects. The Hemopurifier holds a U.S. Food and Drug Breakthrough Device for the treatment of individuals with advanced or metastatic cancer who are either unresponsive to or intolerant of standard-of-care therapy. The Hemopurifier also holds an FDA Breakthrough Device designation and an open Investigational Device Exemption (IDE) application related to the treatment of life-threatening viruses that are not addressed with approved therapies.