On November 16, 2021 Genenta Science, a clinical-stage biotechnology company pioneering the development of hematopoietic stem progenitor cell immuno- gene therapy for cancer (Temferon), reported that it will be presenting updated preliminary Phase I/II clinical data on Temferon at two upcoming scientific congresses (Press release, Genenta Science, NOV 16, 2021, View Source [SID1234595706]).

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The Society for Neuro-Oncology (SNO) 2021 Annual Meeting and Education Day, November 18-21, Boston, USA

Title: TEM-GBM: A Phase I-IIa Dose-Escalation Study Delivering IFN-Α within Glioblastoma Multiforme Tumor Microenvironment by Genetically Modified TIE-2 Expressing Monocytes
Type: Poster presentation
Time: Friday November 19, 2021, 7.30 PM – 9.30 PM ET

63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition 2021, December 11-14, Atlanta, USA and virtual

Title: TEM-GBM: An Open-Label, Phase I/IIa Dose-Escalation Study Evaluating the Safety and Efficacy of Genetically Modified Tie-2 Expressing Monocytes to Deliver IFN- α within Glioblastoma Tumor Microenvironment Type: Poster presentation
Day: Sunday December 12, 2021, 6 PM – 8 PM ET

On November 16, 2021 Geneoscopy Inc., a life sciences company focused on the development of diagnostic tests for gastrointestinal health, reported the closing of a Series B financing, raising a total of $105 million through a combination of debt and equity (Press release, Geneoscopy, NOV 16, 2021, View Source [SID1234595691]). The round is led by previous investors Lightchain Capital and NT Investments. Other investors in the round include Morningside Ventures, Labcorp, Cultivation Capital, BioGenerator Ventures, and Innovatus Capital Partners.

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"We are extremely pleased to secure this financing with strong support from our previous and new investors. It reflects their confidence in our ability to address the significant unmet need within the colorectal cancer (CRC) screening market for a noninvasive means to not only accurately detect cancer at an early stage, but also advanced adenomas—pre-cancerous polyps that are most likely to become cancerous," said Andrew Barnell, Geneoscopy’s co-founder and CEO. "As positive momentum continues to build for our pivotal and ongoing 10,000-patient trial, the team remains focused on ensuring a successful launch of our noninvasive multifactor RNA colorectal cancer screening test as a meaningful advancement in the fight to prevent colorectal cancer. Moreover, we have already made exciting progress towards broadening our diagnostic portfolio to address additional unmet needs within gastrointestinal health."

Unlike other noninvasive screening options that use DNA or blood-based biomarkers, Geneoscopy’s proprietary method analyzes RNA extracted from patient stool samples to provide the phenotypic and quantitative information necessary to accurately detect precancerous lesions. Early detection is critical as it allows these lesions to be removed and prevents progression to cancer. The U.S. Food and Drug Administration (FDA) granted Geneoscopy’s test its Breakthrough Device Designation in January 2020.

"Geneoscopy’s multifactor RNA screening test shows great potential to provide increased sensitivity over current noninvasive screening methods to effectively and reliably detect both early-stage CRC and high-risk precancerous lesions, including advanced adenomas, which are a precursor in up to 70% of CRC cases," said Jason Dinges of Morningside. "We are pleased to join the other investors in this round and believe Geneoscopy’s novel diagnostic approach is poised to shift the standard of care for CRC screening, lower cancer incidence in average-risk patients, and holds great promise to improve the management of additional gastrointestinal diseases."

Responsible for over 50,000 deaths annually, colorectal cancer is the second leading cause of cancer-related death in the United States.1 Disease progression begins with polyps that may develop into cancer over time. Early detection and treatment are crucial to improve survival. Unfortunately, most newly diagnosed patients suffer from advanced disease. Colonoscopy remains the gold standard for CRC screening in the U.S. However, this screening method is challenged with low patient compliance. This has only been exacerbated by the COVID-19 pandemic, which led to a more than 37% decline in CRC screenings. Noninvasive, at-home collection testing options, such as Geneoscopy’s future test, have become increasingly important options to ensure patients receive the CRC screening they need.

On November 16, 2021 ORPHELIA Pharma and K.S. KIM INTERNATIONAL (SK-PHARMA) LTD reported the execution of an exclusive distribution and marketing agreement for Kigabeq (vigabatrin) in the territory of the Russian Federation (Press release, ORPHELIA Pharma, NOV 16, 2021, View Source;utm_medium=rss&utm_campaign=orphelia-pharma-and-k-s-kim-sk-pharma-sign-an-agreement-to-supply-kigabeq [SID1234595693]).

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Kigabeq, the first pediatric form of vigabatrin developed by ORPHELIA Pharma, is notably indicated in the treatment of infantile spasms (West syndrome). Kigabeq is approved in the European Union, where this medicine, intended exclusively for children, benefits from a centralized marketing authorization (Pediatric Use Marketing authorization, PUMA).

"We are delighted to sign this agreement with K.S. KIM, which is based on the value of Kigabeq in paediatrics", says Hugues BIENAYME, Founder and CEO of ORPHELIA Pharma, "With their strong footstep in the distribution of orphan medicines in the Russian territory, K.S. KIM is an excellent partner for Kigabeq."

"With Kigabeq, the only pediatric presentation of vigabatrin, K.S. KIM is expanding its portfolio of drugs intended for rare and serious pathologies in children" adds Dr. Shlomo Sadoun, CEO of K.S. KIM, "Kigabeq is a drug which address unmet medical needs for young patients affected by severe and resistant epilepsies. Our ultimate objective is to register Kigabeq as an orphan drug in Russia, nevertheless we will start distributing it immediately as an unlicenced medicine augmenting unmet needs ".

"Our objective is to make Kigabeq available as widely as possible, so that all children affected by infantile spasms can benefit." concludes Gilles ALBERICI, President of ORPHELIA Pharma, "Thanks to this agreement with K.S. KIM, we are very confident that Russian children suffering from infantile spasms will have access to Kigabeq as quickly as possible."

On November 16, 2021 CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, reported that Health Canada authorized the emergency use of leronlimab for the treatment of a patient with metastatic triple-negative breast cancer (mTNBC) (Press release, CytoDyn, NOV 16, 2021, View Source [SID1234595694]).

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Nader Pourhassan, Ph.D., CytoDyn’s President and Chief Executive Officer, said, "We are encouraged by Health Canada’s emergency use approval of leronlimab, which we believe could have potential benefit as a therapeutic option for treating mTNBC. We now plan to ask Health Canada to allow expanded access use for all mTNBC patients who might have no other treatment options. We are also seeking similar approvals in other countries and look forward to providing leronlimab for mTNBC patients, as well as for treatment of other solid tumor cancers, in the future. In addition, we will be filing for expanded access use for mTNBC patients in the U.S. shortly."

On November 16, 2021 NOXXON Pharma N.V. (Euronext Growth Paris: ALNOX) (Paris:ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported that its key opinion leader (KOL) webinar on NOX-A12 and radiotherapy combination, which is a promising new approach to treating brain cancer, will be hosted on Tuesday, November 23, 2021 at 02:00 p.m. CET (08:00 a.m. EST) (Press release, NOXXON, NOV 16, 2021, View Source [SID1234595710]).

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The webinar will feature a presentation from Frank A. Giordano, M.D., Director and Chair of the Department of Radiation Oncology, University Hospital Bonn, Germany, who will discuss the current treatment landscape and high unmet medical need in treating patients with brain cancer, particularly glioblastoma multiforme, GBM. Following his presentation at the Society for Neuro-Oncology (SNO) Annual Meeting on November 19, Dr. Giordano will further discuss the latest promising patient results from the GLORIA study, evaluating NOX-A12 in combination with radiotherapy in first-line brain cancer patients with unmethylated MGMT promoter.

NOXXON’s management team will also give a corporate overview and an update on clinical programs. Dr. Giordano will be available for questions following the formal presentation.

To register for the event, please click here.

NOX-A12 is an inhibitor of the chemokine CXCL12 and has been granted orphan drug status in the US and EU for the treatment of certain brain cancers and produced encouraging clinical data thus far. Dr. Giordano will also compare NOXXON’s trial data to historical data evaluating how a matched patient cohort responded to the treatment according to current standard of care, which has remained unchanged since 2006.

Frank Giordano, M.D., is Director and Chair of the Department of Radiation Oncology at the University Hospital Bonn, Germany. He is an expert in precision radiation therapy and intraoperative irradiation of malignant tumors and has received international recognition for his brain tumor research, including an award from the American Society of Radiation Oncology (ASTRO) and an honorary membership of the Spanish Society of Radiation Oncology (SEOR). Dr. Giordano received his medical degree from the University of Heidelberg, Germany, and did his post-doctoral training as a Peter Engelhorn fellow at the German Cancer Research Center (DKFZ). He received clinical training at the National Center for Tumor Diseases (NCT) Heidelberg and the University Medical Center Mannheim, where he served as acting chairman and director of the Department of Radiation Oncology before moving to Bonn. For many years, his research has focused on optimized radiation therapy of brain cancers to offer cancer patients personalized and even more effective treatment. As one of the few Else-Kröner-Fresenius Excellence Fellows, Dr. Giordano developed innovative therapy options that even found their way in clinical practice. He sees great potential in the combination of radiotherapy and immunomodulatory therapy.