Oncoinvent Announces Progression of Radspherin® to Third Dose Level Cohort in Ongoing RAD-18-001 Phase 1 Trial in Platinum Sensitive Recurrent Ovarian Cancer Patients with Peritoneal Carcinomatosis

On March 8, 2021 Oncoinvent AS, a clinical stage company advancing a pipeline of radiopharmaceutical products across a variety of solid cancers, reported the advancement of its ongoing Phase 1 clinical study of Radspherin in ovarian cancer patients suffering from peritoneal carcinomatosis to the third level dose cohort following approval from the trial Safety Monitoring Committee (Press release, Oncoinvent, MAR 8, 2021, https://www.oncoinvent.com/press-release/oncoinvent-announces-progression-of-radspherin-to-third-dose-level-cohort-in-ongoing-rad-18-001-phase-1-trial-in-platinum-sensitive-recurrent-ovarian-cancer-patients-with-peritoneal-carcinomatos/?utm_source=mailpoet&utm_medium=email&utm_campaign=oncoinvent-announces-progression-of-radspherin-r_32 [SID1234576246]). In this cohort, patients will receive 4MBq of Radspherin, and enrollment is expected to begin imminently. Radspherin, a versatile α-emitting radionuclide therapy, is also being evaluated in an ongoing Phase 1 study in colorectal cancer patients with peritoneal carcinomatosis.

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"Peritoneal carcinomatosis is a very serious complication of ovarian cancer, often leaving patients with a poor prognosis, and we believe that Radspherin represents a potentially safe and transformative product candidate, offering patients a new treatment option," said Jan A. Alfheim, Chief Executive Officer of Oncoinvent. "Radspherin leverages the unique properties of alpha-emitting microparticles to safely deliver localized radiation to cancer cells, while also minimizing off-target effects and the killing of healthy tissue. We are excited by our continued progress, and look forward to reporting dose-ranging data in the second quarter of 2021."

"I am pleased to see how, when administered, Radspherin is well tolerated and seems quite evenly distributed in the abdominal cavity of the patients that have been recruited to the RAD-18-001 study here at the Radium Hospital. With the safety results that have been seen in both the RAD-18-001 and RAD-18-002 studies, I am looking forward to initiating treatment of patients at the 4 MBq dose level." Said Dr. Yun Wang, Principle Investigator for the RAD-18-001 study at the Radium Hospital.

About RAD-18-001
RAD-18-001 is an ongoing phase 1 open-label, dose-escalation clinical trial is designed to assess the dose, safety and tolerability of Radspherin, an α-emitting radionuclide therapy, administered into the intraperitoneal cavity in subjects with peritoneal carcinomatosis from ovarian cancer following complete cytoreductive surgery. Key objectives in the study include determining maximum tolerated dose, abdominal biodistribution, and preliminary anti-tumor activity. Please refer to www.clinicaltrials.gov for additional clinical trial details.

About Radspherin
Radspherin is a novel alpha-emitting radioactive microsphere suspension designed for treatment of metastatic cancers in body cavities. The radium-224 based therapeutic, Radspherin has shown strong and consistent anticancer activity at doses being essentially non-toxic in preclinical studies. It is anticipated that the product can potentially be used to treat several forms of metastatic cancer.

DiaMedica Therapeutics to Participate at Upcoming Investor Conferences

On March 8, 2021 DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and kidney diseases, reported that the company will participate in three upcoming investor conferences. Details of the company’s participation are as follows (Press release, DiaMedica, MAR 8, 2021, View Source [SID1234576334]):

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33rd Annual Roth Conference
Details: DiaMedica Therapeutics management will deliver a fireside chat and participate in 1-on-1 meetings
Company conference participation date: March 15th, 2021
Oppenheimer’s 31st Annual Healthcare Conference
Details: DiaMedica Therapeutics management will deliver a corporate presentation and participate in 1-on-1 meetings
Company conference participation date: March 16th, 2021
Maxim’s Emerging Growth Conference
Details: DiaMedica Therapeutics management will deliver a corporate presentation and participate in 1-on-1 meetings
Company conference participation date: March 17th, 2021

Enlivex Receives Notice of Allowance for Japanese Patent Application Covering the use of Allocetra in Combination with CAR-T Therapies

On March 8, 2021 Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the "Company"), a clinical-stage macrophage reprogramming immunotherapy company targeting diseased macrophages in patients with sepsis, COVID-19 and solid tumors, reported that the Japan Patent Office issued a notice of allowance for a new patent application (number 2017-543802) covering AllocetraTM, the Company’s immunotherapy product candidate (Press release, Enlivex Therapeutics, MAR 8, 2021, View Source [SID1234576197]). Upon issuance, the patent, titled "Combination Immune Therapy and Cytokine Control Therapy for Cancer Treatment", will provide added intellectual property protection in Japan with respect to certain methods, uses and pharmaceutical compositions for AllocetraTM in combination with CAR-T therapies. The company expects that this new patent will be issued in Japan in the second quarter of 2021.

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Enlivex is developing AllocetraTM as a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Diseases such as solid cancers, sepsis, COVID-19 and many others reprogram macrophages out of their homeostatic state. These non-homeostatic macrophages contribute significantly to the severity of the respective diseases. By restoring macrophage homeostasis, AllocetraTM has the potential to provide a novel immunotherapeutic mechanism of action for life-threatening clinical indications that are defined as "unmet medical needs", as a stand-alone therapy or in combination with other therapeutic agents.

VBL Therapeutics to Participate at Upcoming Virtual Investor Conferences

On March 8, 2021 VBL Therapeutics (Nasdaq: VBLT) reported the Company will participate in the following upcoming virtual investor conferences (Press release, VBL Therapeutics, MAR 8, 2021, View Source [SID1234576214]):

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H.C Wainwright Global Life Sciences Conference
Tuesday, March 9, 2021
Presentation available on-demand beginning at 7:00 a.m. ET

33rd Annual Roth Conference
Date: Monday, March 15, 2021
Panel discussion time: 10:00 a.m. ET
Title: Cancer – Heterogeneous Approaches to a Heterogeneous Etiology

31st Annual Oppenheimer Healthcare Conference
Date: Tuesday, March 16, 2021
Fireside chat time: 8:00 a.m. ET

Seres Therapeutics Announces Discontinuation of Enrollment in SER-401 Study in Metastatic Melanoma

On March 8, 2021 Seres Therapeutics, Inc. (Nasdaq: MCRB) reported that the Company, in collaboration with study partners, The Parker Institute for Cancer Immunotherapy (PICI) and The University of Texas MD Anderson Cancer Center, has voluntarily discontinued further enrollment in the Melanoma Checkpoint and Gut Microbiome Alteration With Microbiome Intervention (MCGRAW) study evaluating the safety and drug activity of SER-401 or fecal microbiota transplant (FMT) in combination with nivolumab in patients with metastatic melanoma (Press release, Seres Therapeutics, MAR 8, 2021, View Source [SID1234576247]).

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"While we are disappointed to discontinue enrollment, we are encouraged by the opportunity to apply the learnings from this study towards future development programs at Seres that can directly benefit the oncology community in search of new treatment options," said Matthew Henn, Ph.D., Chief Scientific Officer at Seres. "We want to thank the patients, their care partners, our collaborators and the medical professionals who participated in this study, despite the COVID-19 pandemic, and helped further advance our understanding of the role microbiome therapeutics play in the treatment of cancer."

A preliminary analysis of results from 10 subjects who received either SER-401 or placebo in combination with nivolumab indicated that SER-401 was safe and well-tolerated. There were no patients enrolled in the FMT portion of the study. Subjects currently enrolled in the study will complete the study protocol. Given challenges in enrollment due to the COVID-19 pandemic, subsequent anticipated time to study completion, and progress in its preclinical oncology pipeline, Seres has decided to deprioritize further development of SER-401. The Company will continue to advance its research and development efforts in cancer, applying learnings from the SER-401 trial.

Evidence continues to emerge that suggests gut microbiome modulation may augment responses to cancer immunotherapy, including improving responses in PD-1 refractory patients1.

Seres and its collaborators continue to be excited about the opportunity to develop next-generation therapeutics targeting gut microbes for the treatment of individuals living with cancer. Seres will continue to engage with MD Anderson and PICI to advance the development of medicines in this field, and maintains a robust preclinical program in oncology as well as a collaboration with Memorial Sloan Kettering Cancer Center centered on advancing microbiome therapeutics in various settings of oncology. Seres’ immuno-oncology patent portfolio includes the option to exclusively license foundational intellectual property from MD Anderson, based upon the work of Jennifer Wargo, M.D., professor of Surgical Oncology and Genomic Medicine.