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.

On October 19, 2021 Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for cancer and other serious diseases, reported that data evaluating the company’s NAM-enabled NK cell platform will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 36th Annual Meeting (SITC 2021) taking place in Washington, DC, and virtually November 10-14, 2021 (Press release, Gamida Cell, OCT 19, 2021, View Source [SID1234591527]).

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Details about the SITC (Free SITC Whitepaper) poster presentations are as follows:

Title: Cytotoxicity of nicotinamide enhanced natural killer cells GDA-201 is based on metabolic modulation as demonstrated by AI assisted analysis of NK cell transcriptome and metabolome
Abstract number: 217
Time: Friday, November 12, 2021, 7:00 a.m. – 8:30 p.m. EST
Location: Hall E

Title: Nicotinamide rejuvenates ex-vivo expanded NK cells and enhances their tumor killing capacity
Abstract Number: 162
Time: Saturday, November 13, 2021, 7:00 a.m. – 8:30 p.m. EST
Location: Hall E

About GDA-201

Gamida Cell applied the capabilities of its nicotinamide (NAM)-enabled cell expansion technology to develop GDA-201, an innate NK cell immunotherapy for the treatment of hematologic and solid tumors in combination with standard of care antibody therapies. GDA-201, the lead candidate in the NAM-enabled NK cell pipeline, has demonstrated promising initial clinical trial results, as reported at the 2020 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition1. GDA-201 addresses key limitations of NK cells by increasing the cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs. Furthermore, GDA-201 improves antibody-dependent cellular cytotoxicity (ADCC) and tumor targeting of NK cells. For more information about GDA-201, please visit View Source

GDA-201 is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.

On October 19, 2021 /PRNewswire/ — PharmAbcine Inc. (KOSDAQ: 208340ks), a clinical-stage biotech company focusing on the development of next-generation antibody therapeutics, reported that the patent for PMC-309, one of the Company’s first immuno-oncology assets, has been granted by IP Australia, the Australian government agency that administers intellectual property rights (Press release, PharmAbcine, OCT 19, 2021, View Source;bmode=view&idx=8574626&t=board [SID1234649186]).

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The Australian grant represents PMC-309’s third global patent approval since it received grants from Russia in June 2021 and South Korea in July 2021. The Company also plans to get more patents approved in other countries, including the U.S, Canada, China, Japan, European nations, and etc.

PMC-309 is a first-in-class antibody that antagonizes VISTA (V-domain Ig Suppressor of T cell Activation) and is in development to treat various tumor types. VISTA plays a pivotal role in maintaining the immunosuppressive environment around the tumor cells and is expressed primarily on immunosuppressive cells, such as MDSC (Myeloid-Derived Suppressor Cells) and Tregs (regulatory T cells). Blocking VISTA pathways on immunosuppressive cells promotes T cells’ immune responses and leads to better anti-tumor effects.

According to the nonclinical data of PMC-309 presented at AACR (Free AACR Whitepaper) (American Association for Cancer Research) 2021, PMC-309 showed promising anti-tumor effects comparable to an existing anti-PD-1 drug. However, when used in combo with an anti-PD-1 drug, PMC-309 demonstrated significantly improved tumor growth inhibitions than either mono therapies.

In April 2021, PharmAbcine initiated IND-enabling studies of PMC-309. The studies are required to establish the safety profile in animals before entering the human trial. The Company expects to enter a Phase I global trial in 2022.

"This patent grant is one of the key milestones that underlines our approach to help patients with unmet medical needs with a novel first-in-class antibody candidate and builds stronger intellectual property position in the immuno-oncology field," said Dr. Jin-San Yoo, CEO of PharmAbcine. "Our team believes that PMC-309, with its unique mode of action that does not overlap with the existing drugs, will be a new treatment option in both mono and combo therapies for patients who do not respond well to the current immunotherapies."