On October 19, 2021 Targovax ASA, reported that members of its executive management team are invited to present and participate in upcoming conferences (Press release, Targovax, OCT 19, 2021, View Source [SID1234591525]).

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Økonomisk Ugebrev’s Life Science Investor conference
Date: 20 October 2021
Presenter: Lone Ottesen (CDO)
Time: 14:35 CET

Next Gen Immuno-Oncology Virtual Conference-UK/EU Edition
Date: 26 October 2021
Presenter: Victor Levitsky (CSO)
Time: 17:45 CET

Oncolytic Virotherapy Summit
Date: 28 October 2021
Presenter: Erik Digman Wiklund (CBO)
Time: 09:30 EDT / 15:30 CET

On October 19, 2021 Clovis Oncology, Inc. (NASDAQ: CLVS) and ITM Isotope Technologies Munich SE, a leading radiopharmaceutical biotech company, reported the signing of a clinical supply agreement that provides Clovis Oncology with ITM’s therapeutic radioisotope no-carrier-added Lutetium-177 (n.c.a. 177Lu), EndolucinBeta, for use in the clinical development of FAP-2286, Clovis’ fibroblast activation protein (FAP)-targeting therapeutic candidate (Press release, Clovis Oncology, OCT 19, 2021, View Source [SID1234591509]). FAP-2286 is the first peptide-targeted radionuclide therapeutic (PTRT) candidate directed against fibroblast activation protein undergoing clinical testing and is currently being investigated in the Phase 1/2 LuMIERE study for patients with advanced solid tumors. The agreement covers an initial period of five years. Further details of the agreement were not disclosed.

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"Clovis Oncology is committed to advancing FAP-2286’s clinical development program and emerging as a leader in targeted radionuclide therapy. A critical element to advance this program is ensuring long-term supply of radioisotopes, and this agreement allows us to achieve that goal," said Patrick Mahaffy, President and CEO of Clovis Oncology. "In particular, we value ITM’s radiopharmaceutical expertise and global reach as we advance our targeted radionuclide therapy program into the clinic."

"This agreement underscores the potential of our n.c.a. Lutetium-177 to provide therapeutic value to patients with hard-to-treat tumors. Through our proprietary pipeline of Targeted Radionuclide Therapies and our agreements with other oncology leaders, we are establishing a new era of precision oncology treatments and we are happy to contribute to this exciting Clovis program," commented Steffen Schuster, CEO of ITM.

FAP-2286 is a clinical candidate under investigation as a peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting FAP. FAP is highly expressed by cancer-associated fibroblasts (CAFs) which are found in the majority of cancer types, but with limited expression in healthy fibroblasts, potentially making it a suitable target across a wide range of tumors. FAP-2286 consists of two functional elements; a targeting peptide that binds to FAP and a site that can be used to attach medical radioisotopes, such as Lutetium-177 for therapeutic use, or Gallium-68 for imaging use.

ITM’s n.c.a. 177Lu (EndolucinBeta) is a high-purity version of the beta-emitting radioisotope Lutetium-177, that can be linked to a variety of tumor-specific targeting molecules for Targeted Radionuclide Therapy and has demonstrated significant anti-tumor effects in clinical and commercial use. ITM has developed a unique methodology to produce the highly pure form of Lutetium-177, without metastable Lutetium-177m, and manufactures n.c.a. 177Lu for development partnerships, distribution to clinics worldwide, and its own growing precision oncology pipeline.

In June 2021, Clovis initiated the Phase 1/2 LuMIERE clinical study of FAP-2286 in advanced solid tumors. The Phase 1 portion of the LuMIERE study (NCT 04939610) will evaluate the safety of the FAP-targeting investigational therapeutic agent and identify the recommended Phase 2 dose and schedule of Lutetium-177 labeled FAP-2286 (177Lu-FAP-2286), for which ITM will provide its n.c.a. 177Lu. Once the Phase 2 dose is determined, Phase 2 expansion cohorts are planned in multiple tumor types.

About FAP-2286

FAP-2286 is a clinical candidate under investigation as a peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein (FAP). FAP-2286 consists of two functional elements; a targeting peptide that binds to FAP and a site that can be used to attach radioactive isotopes for imaging and therapeutic use. High FAP expression has been shown in pancreatic ductal adenocarcinoma, cancer of unknown primary, salivary gland, mesothelioma, colon, bladder, sarcoma, squamous non–small cell lung, and squamous head and neck cancers. High FAP expression was detected in both primary and metastatic tumor samples and was independent of tumor stage or grade. Clovis holds US and global rights for FAP-2286 excluding Europe, Russia, Turkey, and Israel.

FAP-2286 is an unlicensed medical product.

For more information about FAP-2286, Targeted Radionuclide Therapy (TRT), or Clovis’ TRT development program, CLICK HERE.

About n.c.a. Lutetium-177 / EndolucinBeta

No carrier-added Lutetium-177 (n.c.a. 177Lu) chloride, is a radiopharmaceutical precursor used in Targeted Radionuclide Therapy for the treatment of various diseases, like cancer. When labeled with a tumor-specific targeting molecule (e. g. peptide or antibody), the targeted radiopharmaceutical binds to a tumor-specific receptor, according to the lock and key principle. N.c.a. 177Lu has a half-life of 6.647 days and provides the highest specific activity of more than 3,000 GBq/mg at Activity Reference Time (ART). Optimal preconditions for efficient radiolabeling of biomolecules over its entire shelf-life of 9 days after production are ensured. N.c.a. 177Lu exhibits an extraordinary level of radionuclidic purity and does not contain metastable Lutetium-177m circumventing cost intensive clinical disposal management.

About Targeted Radionuclide Therapy

Targeted Radionuclide Therapy is an emerging class of cancer therapeutics, which seeks to deliver radiation directly to the tumor while minimizing delivery of radiation to normal tissue. Targeted radionuclide therapies are created by linking radioactive isotopes, also known as radionuclides, to targeting molecules (e.g., peptides, antibodies, small molecules) that can bind specifically to tumor cells or other cells in the tumor environment. Based on the radioactive isotope selected, the resulting agent can be used to image and/or treat certain types of cancer. Agents that can be adapted for both therapeutic and imaging use are known as "theranostics." Clovis, together with licensing partner 3B Pharmaceuticals, is developing a pipeline of novel, targeted radiotherapies for cancer treatment and imaging, including its lead candidate, FAP-2286, an investigational peptide-targeted radionuclide therapeutic (PTRT) and imaging agent, as well as three additional discovery-stage compounds. ITM is developing a proprietary precision oncology pipeline of targeted radiopharmaceuticals for diagnostics and treatment of a range of hard-to-treat cancer indications, such as neuroendocrine tumors, prostate cancer, glioblastoma, osteosarcoma and bone metastases, as well as folate receptor α positive tumors like lung, ovarian or breast cancer. Additionally, ITM supplies partners with its high-purity n.c.a. 177Lu for clinical and commercial development.

On October 19, 2021 NOXXON Pharma N.V. (Euronext Growth Paris: ALNOX) (Paris:ALONOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported the expansion plans of its ongoing Phase 1/2 study of NOX‑A12 in combination with radiotherapy in patients with brain cancer (glioblastoma, GBM) (Press release, NOXXON, OCT 19, 2021, View Source [SID1234591526]).

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The company plans to expand the ongoing GLORIA study to include additional patients in three new arms in the first-line chemotherapy resistant population (unmethylated MGMT promoter) at the highest 600 mg/week dose of NOX-A12 combined with radiotherapy:

– 6 patients with fully resected tumor will receive radiotherapy and NOX-A12;
– 6 patients with partially resected or unresected tumor will receive bevacizumab in combination with radiotherapy and NOX-A12;
– 6 patients with partially resected or unresected tumor will receive a PD-1 immune checkpoint inhibitor in combination with radiotherapy and NOX-A12.

These expansion arms come in addition to the ongoing Phase 1/2 trial evaluating three ascending doses of NOX-A12 (200, 400 and 600 mg/week), each combined with external-beam radiotherapy in newly diagnosed brain cancer patients. Positive data from the first two cohorts at 200 and 400 mg/week have already been reported and data from the third cohort at 600 mg/week for which patient recruitment has been completed will be reported in Q1 2022. A protocol amendment to expand the study with the first two arms above has been approved by the German Federal Institute for Drugs and Medical Devices (BfArM, Bundesinstitut für Arzneimittel und Medizinprodukte), and another amendment for the third arm is being prepared. Once enrolled in the study, patients will be treated for 6 months.

"The expansion of our Phase 1/2 study of NOX-A12 in brain tumor patients will allow us to explore three further treatment configurations, all of which are supported by the clinical data emerging from the GLORIA trial. We will extend our safety data to the full surgical resection population, as we also plan to include this population of patients in our future pivotal glioblastoma study.

In addition, the extensions will assess the safety and potential synergistic benefit of NOX-A12 with anti-PD-1 and anti-VEGF combinations. Our interest in the anti-PD-1 combination is driven by the observation that NOX-A12 appears to drive infiltration of activated cytotoxic immune cells into the tumor tissue, and thus the combination with anti-PD-1 is expected to unlock a significantly stronger tumor response. We will also test a combination with anti-VEGF therapy which is commonly used in this patient population. We look forward to evaluating all these combinations," commented Aram Mangasarian, CEO of NOXXON.

NOX-A12 targets CXCL12, a crucial signal molecule that is used by malignant cells to form the tumor microenvironment to their favor, and is designed to (i) prevent tumor recurrence after radiotherapy by blocking the influx of tumor repair cells from the bone marrow and (ii) modify the tumor microenvironment in order to enable the action of anti-cancer immune cells, such as killer T-cells.

On October 19, 2021 Lucid Diagnostics Inc., a company that produces esophageal cancer tests based on Case Western Reserve University and University Hospitals research, reported that it has completed a $70 million initial public offering (IPO) on the Nasdaq Global Market; at the IPO price, the company’s estimated value would be $467 million (Press release, Case Western Reserve University, OCT 19, 2021, View Source [SID1234591567]).

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Gastroesophageal reflux disease (GERD) affects about 20% of people in the United States. Many individuals with chronic GERD develop Barrett’s esophagus, which can lead to highly lethal esophageal cancer, the sixth-most common cause of cancer deaths worldwide.

Lucid Diagnostics Inc. (Nasdaq: LUCD), a subsidiary of New York-based PAVmed Inc. (Nasdaq: PAVM), licensed the EsoCheck and EsoGuard technology through Case Western Reserve’s Technology Transfer Office (TTO) in 2018. The U.S. Food and Drug Administration awarded both products Breakthrough Device designation, granted to novel medical devices with the potential to provide more effective treatment and diagnosis of life-threatening or irreversibly debilitating diseases and conditions. EsoCheck received a 2020 Edison Award as one of the year’s most significant innovations in the Medical Testing category.

EsoGuard is a next-generation sequencing (NGS) DNA assay performed on surface esophageal cells collected with EsoCheck. It has been shown to be highly accurate at detecting esophageal precancer and cancer. EsoGuard is commercially available in the United States and has received European CE mark certification. EsoCheck is a U.S. Food and Drug Administration-cleared and European CE Mark-certified noninvasive swallowable balloon capsule catheter device capable of performing targeted and protected sampling of surface esophageal cells in a less-than-five-minute office procedure.

The underlying technology for EsoCheck and EsoGuard was co-invented by Sanford Markowitz, the Ingalls Professor of Cancer Genetics and Medicine at the School of Medicine and an oncologist at University Hospitals (UH) Seidman Cancer Center; Amitabh Chak, a professor of medicine at the School of Medicine, gastroenterologist at the University Hospitals Digestive Health Institute and the Brenda and Marshall B. Brown Master Clinician in Innovation and Discovery at UH Seidman Cancer Center; and Joseph Willis, a professor of pathology at the School of Medicine and pathology vice-chair for translational research at UH.

Photo of the Lucid Diagnostics founders the Nasdaq desk
(From left) Chak, Markowitz and Willis at Nasdaq.
Markowitz, Chak and Willis were at Nasdaq in New York on Friday to ring the ceremonial bell, marking the close of the day’s stock trading.

"This is a wonderful milestone on a path aimed at preventing death from a miserable cancer through enabling simple early detection of the silent and curable precursor lesions," Markowitz said. "It is a culmination of years of work from an incredibly talented and committed team and is a superb example of the inventive environment and culture that the university and its Technology Transfer Office have created and fostered."

The researchers developed the technology as part of the Case Comprehensive Cancer Center’s GI SPORE Program of Research Excellence and BETRNet (Barrett’s Esophagus Translational Research Network) programs, and was first tested in patients during a clinical trial led by Chak at University Hospitals.

Translational support for the founders’ research to develop the technology came from the National Cancer Institute’s GI SPORE and BETRNet programs, the Case-Coulter Translational Research Partnership, Clinical and Translational Science Collaborative, Ohio Third Frontier, Nottingham Spirk Design Collaborative, the Case TTO, and from University Hospitals Seidman Cancer Center funds in support of SPORE clinical trials.

"The continued research accomplishments focused on public and community benefit and clinical value brought by Sandy Markowitz and his team are not only unparalleled, but bring a scientific impact halo to this school and the university that will remain a shining star for a very long period to come," said Stan Gerson, dean of the School of Medicine and the Asa and Patricia Shiverick–Jane Shiverick (Tripp) Professor of Hematological Oncology.

"This remarkable achievement reflects the incredible hard work and dedication of our colleagues to combat esophageal cancer, a devastating illness," said Mukesh Jain, the Ellery Sedgwick Chair and Distinguished Scientist and vice dean and Distinguished University Professor at the School of Medicine and chief scientific officer for the University Hospitals Health System. "This milestone also reflects the importance of the robust partnership between the two institutions that is advancing the science of health to improve the lives of patients locally and globally."

"Drs. Sandy Markowitz, Amitabh Chak and Joe Willis have partnered with PAVmed Inc. and its CEO, Dr. Lishan Aklog, to bring this transformative technology—a unique device and genetic test combination—to patients for the earliest detection and treatment of esophageal cancer," said Daniel Simon, professor of medicine at the School of Medicine and president of academic and external affairs and chief scientific officer at University Hospitals. "Case Western Reserve University and University Hospitals are committed to create partnerships to advance the health of our patients and our community."

On October 19, 2021 Cerus Corporation (Nasdaq: CERS) reported that its third quarter 2021 financial results will be released on Tuesday, November 2, 2021, after the close of the stock market (Press release, Cerus, OCT 19, 2021, View Source [SID1234591510]). The Company will host a conference call and webcast at 4:30 P.M. ET that afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook.

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To listen to the live webcast and view the presentation slides, please visit the Investor Relations page of the Cerus website at View Source Alternatively, you may access the live conference call by dialing (866) 235-9006 (U.S.) or (631) 291-4549 (international).

A replay will be available on Cerus’ website, or by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and entering conference ID number 3970817. The replay will be available approximately three hours after the call through November 16, 2021.