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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]).

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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.

Hoth Therapeutics Reports Positive Preclinical Safety Data for Cancer Fighting HT-KIT — Dose-Dependent Liver Activity with No Observed Toxicity Supports IND Pathway

On June 18, 2025 Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company developing innovative therapeutics for rare and inflammatory diseases, reported encouraging preclinical results from a multi-dose study of HT-KIT, its investigational oncology candidate targeting the c-KIT pathway (Press release, Hoth Therapeutics, JUN 18, 2025, View Source;dose-dependent-liver-activity-with-no-observed-toxicity-supports-ind-pathway-302484836.html [SID1234653987]).

The study demonstrated a clear dose-responsive effect on liver mass with no observable toxicity or organ pathology, reinforcing the favorable safety profile of HT-KIT as the Company prepares for further toxicology studies and regulatory advancement.

Key Preclinical Findings (HT-KIT):

Liver weight increased from 1.11g at 0 mg/kg to 1.32g at 3.0 mg/kg, consistent with pharmacological engagement.
Kidney and spleen weights remained stable, indicating no off-target or systemic toxicity.
Thymus and other critical organ weights were within normal range across all groups.
No gross pathology or visible lesions observed in any treated animal.
"These clean and compelling safety results validate our confidence in HT-KIT," said Robb Knie, CEO of Hoth Therapeutics. "A dose-dependent biological signal without organ damage strongly supports our plan to move forward with GLP studies and an IND submission."

Hoth Therapeutics expects to initiate GLP toxicology studies, with plans to submit an Investigational New Drug (IND) application soon after.

GRAIL Announces Positive Top-Line Results From The Galleri® PATHFINDER 2 Registrational Study

On June 18, 2025 GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, reported positive top-line performance and safety results from the pre-specified analysis of the first 25,578 participants in GRAIL’s registrational PATHFINDER 2 study (Press release, Grail, JUN 18, 2025, View Source [SID1234653986]). PATHFINDER 2 was initiated in 2021 to evaluate the safety and performance of the Galleri multi-cancer early detection (MCED) test when added to standard of care single cancer screening in 35,878 adults over 50 years of age with no clinical suspicion of cancer.

In the previously published PATHFINDER study, adding Galleri to standard of care cancer screening more than doubled the overall number of cancers detected by screening. In PATHFINDER 2, adding Galleri to standard of care screening demonstrated substantially greater additional cancer detection than in PATHFINDER.

In PATHFINDER, Galleri demonstrated a positive predictive value (PPV), or likelihood that a positive Galleri test was confirmed to be cancer, of 43%; specificity of 99.5%; and 88% cancer signal origin (CSO) accuracy. Data from evaluable PATHFINDER 2 participants with 12 months of follow-up showed a substantially higher PPV than that observed in the PATHFINDER study. CSO accuracy and specificity were consistent with that observed in the PATHFINDER study.

There were no serious safety concerns reported in PATHFINDER 2.

"We are delighted to see very encouraging performance of the Galleri MCED test as a cancer screening tool in broad intended use populations of asymptomatic adults over 50 years of age in both the PATHFINDER 2 study and the NHS-Galleri trial’s prevalent screening round," said Josh Ofman, MD, MSHS, President at GRAIL. "We would like to extend our sincere gratitude to all of the participants and investigators in both of these pivotal studies, who are collectively helping to realize the potential of this groundbreaking technology for population-scale multi-cancer early detection and move the field forward. We look forward to sharing the detailed PATHFINDER 2 data at a medical congress later this year."

PATHFINDER 2 study results will be submitted to the U.S. Food and Drug Administration (FDA) as part of the Galleri premarket approval application (PMA), along with data from the prevalent screening round of the NHS-Galleri trial. In addition, GRAIL will submit to the FDA bridging analyses to compare performance of the version of Galleri used in the PATHFINDER 2 study and the NHS-Galleri trial to the updated version that GRAIL plans to submit to the FDA for premarket approval. The PMA for Galleri is currently in process with a modular submission under a Breakthrough Device Designation from the FDA. GRAIL expects to complete the PMA modular submission in the first half of 2026.

Detailed results from the PATHFINDER 2 study will be submitted for presentation at a leading international oncology meeting before the end of the year.

About the PATHFINDER 2 Study (NCT05155605)
PATHFINDER 2 is a prospective, multi-center, interventional study evaluating the safety and performance of Galleri in approximately 35,000 individuals aged 50 years and older who are eligible for guideline-recommended cancer screening in the United States. The primary objectives of the study are 1) to evaluate the safety and effectiveness of the Galleri MCED test based on the number and type of diagnostic evaluations performed in participants who receive a cancer signal detected test result, and 2) to evaluate the performance of the Galleri MCED test across various measures, including PPV, negative predictive value (NPV), sensitivity, specificity, and CSO prediction accuracy. Participants who receive a cancer signal detected result undergo additional diagnostic testing based on the predicted CSO to determine if a cancer is present. Secondary objectives include utilization of guideline-recommended cancer screening procedures after use of the MCED test, and participant reported outcomes (PRO) over several time points, including an assessment of participants’ anxiety and satisfaction with the MCED test.