Geneoscopy Closes $105M in Financing to Advance its Noninvasive Multifactor RNA Screening Test for Colorectal Cancer Prevention

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.

Kineta Presented Compelling Preclinical Data on its New CD27 Antibody Program at the 2021 SITC Annual Meeting

On November 16, 2021 Kineta, Inc., a clinical stage biotechnology company focused on the development of novel immunotherapies in oncology, reported the presentation of preclinical data on the company’s new anti-CD27 agonist monoclonal antibody program at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 36th Anniversary Annual Meeting, that took place November 10-14, 2021 in Washington D.C (Press release, Kineta, NOV 16, 2021, View Source;utm_medium=rss&utm_campaign=kineta-presented-compelling-preclinical-data-on-its-new-cd27-antibody-program-at-the-2021-sitc-annual-meeting [SID1234595690]). Thierry Guillaudeux, PhD, Senior Vice President Immuno-oncology at Kineta, presented a poster revealing new binding affinity and specificity data on the company’s CD27 monoclonal antibody drug candidates as well as potent agonistic activity on cellular and T cell activation assays.

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"We are highly encouraged with the compelling preclinical data demonstrated with Kineta’s new CD27 monoclonal antibodies" said Thierry Guillaudeux, PhD, Senior Vice President Immuno-oncology at Kineta. "CD27 is a promising cancer immunotherapy approach that can mobilize new specific tumor antigen specific T cells to drive a potent anti-tumor response with single agent efficacy as well as synergistic effects with other immune checkpoint inhibitors.

Kineta has developed a diverse set of anti-CD27 agonist antibodies. They are fully human monoclonal antibodies (mAbs) that demonstrate low nanomolar (nM) binding affinity to CD27 in humans. In preclinical studies, Kineta’s selected lead anti-CD27 agonist mAbs induce T cell proliferation and secretion of cytokines involved in T cell priming and recruitment, demonstrating the ability to potentiate new anti-tumor responses. Kineta is in the final stage of lead selection and plans to nominate a clinical candidate in Q1-Q2 2022.

Key results from the SITC (Free SITC Whitepaper) poster presentation:

147 fully human anti-CD27 monoclonal antibodies with unique sequences were generated
Anti-CD27 agonist assay showed strong agonist activity for 8 pre-selected anti-CD27 antibodies
Human T cell activation assay data for 5 mAbs showed increased proliferation and cytokine secretion
Further in vitro and in vivo developments are on-going to select our lead anti-CD27 agonist antibody
Presentation Details:

Title: A promising cancer immunotherapy target: Novel agonistic human antibodies against the human T-cell costimulatory receptor CD27
Date Presented: November 12-13, 2021
Presenter: Thierry Guillaudeux, PhD
Poster: Click on the link below to view the poster:

CD27 Publications – Poster Presentation at SITC (Free SITC Whitepaper) 2021

Genprex to Present in November CEO Roadshow Webinar

On November 16, 2021 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that its President and Chief Executive Officer, Rodney Varner, will be presenting in November with CEO Roadshow to provide a company overview of its novel gene therapies in cancer and diabetes to investors (Press release, Genprex, NOV 16, 2021, View Source [SID1234595689]).

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Details for the November CEO Roadshow webinar:

Host: CEO Roadshow

Date and Time: Wednesday, Nov. 17 at 11 a.m. ET

Webinar Link: https://bit.ly/3bCwvPU

Mr. Varner will be available for questions following the company presentation. The webinar will be recorded and available for replay on Genprex’s website for a period of time. A replay will also be available on CEORoadshow.com following the webinar.

The CEO Roadshow webinar series features small and mid-cap stocks that are on the verge of a breakout or have other near-term developments making them an attractive long-term investment opportunity.

Entry into a Material Definitive Agreement

On November 15, Xenetic Biosciences, Inc. (the "Company") reported that entered into a letter agreement (the "Agreement") with the holders (the "Holders") of the Company’s common stock purchase warrants (the "Warrants") issued pursuant to that certain Securities Purchase Agreement, dated March 5, 2019, by and among the Company and the purchasers party thereto (the "Purchase Agreement") (Filing, 8-K, Xenetic Biosciences, NOV 16, 2021, View Source [SID1234595688]).

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Pursuant to the Agreement, the Purchase Agreement was amended to delete, in its entirety, Section 4.12(b) of the Purchase Agreement. Additionally, the Company and the Holders agreed to exchange the Warrants to purchase 129,084 shares of the Company’s common stock, par value $0.001 per share ("Common Stock"), for an aggregate of 51,634 shares of Common Stock (the "Exchange"). Other than the foregoing, neither party provided cash or other securities as consideration in the Exchange. As a result of the Exchange, all of the Holder’s Warrants were cancelled without further action required by either the Company or the Holders. The Agreement contains customary representations and warranties by the Company and the Holders.

AIVITA Biomedical CEO Dr. Hans Keirstead to Deliver Keynote At Vaccine World Asia Congress

On November 16, 2021 AIVITA Biomedical, Inc., a biotech company specializing in innovative stem cell applications, reported that chairman and CEO Dr. Hans S. Keirstead will deliver a keynote at the Vaccine World Asia Congress (Press release, AIVITA Biomedical, NOV 16, 2021, View Source [SID1234595687]). The Singapore-based congress is being held virtually November 17-18. Dr. Keirstead’s speaking details are as follows:

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Keynote: A Fully Personalized COVID-19 Vaccine Made at Point-of-Care
When: Wednesday, November 17, 4:00 PM (GMT +8)
Location: Virtual – Singapore

In his keynote, Dr. Keirstead will share findings from AIVITA’s ongoing trials in COVID-19 and discuss the advantages of a personalized vaccine made at point-of-care.