On April 16, 2021 Shenzhen Chipscreen Biosciences, a China headquartered biopharmaceutical company developing and marketing novel drugs based on its unique technology of Chemical Genomics Drug discovery platform, reported that it has received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) to proceed with a Phase 1b/2 clinical trial of Chiauranib/CS2164, a potential treatment for multiple oncological indications including Small Cell Lung Cancer (SCLC), Ovarian Cancer, Liver Cancer, and Breast Cancer, etc (Press release, Shenzhen Chipscreen Biosciences, APR 16, 2021, View Source [SID1234578133]). Chiauranib is the third novel drug candidate discovered and developed by Chipscreen to be marketed, submitted NDA or in the late-stage phases of clinical studies.

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Chiauranib is an innovative, 3-pathway targeted kinase small molecule inhibitor with high selectivity against Auroa B /VEGFRs/CSF1R currently entering Phase III clinical trials in China. Its treatments to SCLC and Ovarian Cancer have been just designated as "breakthrough therapies" by National Medical Products Administration (NMPA) of China in the past months. The molecular mechanism of Chiauranib is to inhibit the rapid proliferation of tumor cells via targeting novel DNA replication pathway, as well as enhancement of antitumor immunity and inhibition of tumor angiogenesis concomitantly.

The primary objective of this Phase Ib/2 study in the USA is to demonstrate safety, tolerability and efficacy of Chiauranib as a monotherapy in 24 to 36 patients with SCLC.

"With this clearance of US FDA IND application for CS2164, it will certainly increase success of our global development strategy based on early efficacy and safety data obtained from China trials," said Dr. Xianping Lu, Chairman and President of Chipscreen.

On April 15, 2021 ArcticZymes Technologies reported its report for the first quarter 2021 on Thursday, 22. April 2021 at 08.30 a.m (Press release, Biotec Pharmacon, APR 15, 2021, View Source [SID1234578075]).

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Due to the ongoing situation with spread of coronavirus, a number of measures are being implemented to prevent the spread of infection. These measures are being taken to safeguard the health and security of the Company’s shareholders, employees and other stakeholders, and to ensure compliance with applicable national and local restrictions and guidelines. The Company will therefore conduct the presentation only as a webcast over Teams and as a telephone conference.

CEO, Jethro Holter and CFO, Børge Sørvoll will hold the presentation.

Participants who want to participate in the live webcast are asked to send an email to [email protected] for a separate invitation, which will be distributed 1 day prior to the meeting.

Participants who want to participate by telephone should dial in on +47 21 40 24 87 with conference id: 246 245 401#. It will be possible to post questions through the webcast and over the phone after the presentation is finished. The report for the first quarter 2021 will be available on www.newsweb.no and on the company’s homepage www.arcticzymes.com from 07.00 a.m. on 22. April 2021.

On April 15, 2021 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported that the results from the Company’s preclinical studies of its targeted cancer immunotherapeutic agent will be presented as a poster at the New York Academy of Science’s (NYAS) Frontiers in Cancer Immunotherapy Symposium 2021 (Press release, Navidea Biopharmaceuticals, APR 15, 2021, View Source [SID1234578092]). The poster is titled, "Targeted Delivery of Doxorubicin (DOX) to Tumor Associated Macrophages (TAMs) Beneficially Alters the Tumor Immune Microenvironment and Synergizes the Activity of Anti-CTLA4."

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In these studies, Navidea’s CD206-targeted therapeutic construct containing doxorubicin linked to its mannosylated dextran backbone (Man-Dox) demonstrated the ability to drive phenotypic change in immune cells towards an activated pro-inflammatory and cell-killing state in vitro and, in conjunction with an approved immunotherapeutic, demonstrated a synergistic effect on tumor growth inhibition in a relevant animal model. The cellular target of Navidea’s Man-Dox agent is the macrophage mannose receptor, CD206. CD206 is expressed on TAMs that play a critical role in regulating the tumor microenvironment and which provide a target for immunotherapies to rally the body’s own immune system in the fight against cancer.

In in vitro studies, treatment of human macrophages with Man-Dox drove macrophages from an immunosuppressive phenotype to an immune stimulatory, pro-inflammatory state. In mouse experiments using the syngeneic CT26 tumor model, Man-Dox, in combination with anti-CTLA4 therapy, showed a significant reduction in tumor growth compared to treatments with either agent alone or with free doxorubicin. Anti-CTLA4 improves anti-tumor immune responses by blocking a check point inhibitor that prevents stimulation of adaptive immune cells by pro-inflammatory macrophages. These new findings support Navidea’s hypothesis that driving the TAM phenotype towards a pro-inflammatory state with Man-Dox in concert with an approved immunotherapy provides a synergistic effect on tumor cell killing. These results demonstrate that Navidea’s targeted Man-Dox construct can improve the efficacy of an existing immunotherapy and support further studies to help define optimal dosing strategies to maximize this synergistic effect.

This year’s conference will be virtual and will take place from May 12th through May 14th. Navidea’s presentation will provide a more detailed look at analysis of these data.

Information regarding registration for the symposium can be found on the NYAS website (link here).

Dr. Michael Rosol, Chief Medical Officer for Navidea, said, "We are delighted by the recognition of the importance of our preclinical results by the symposium committee and the opportunity to present our results at this internationally recognized meeting." Dr. Rosol continued, "This important work demonstrates both a mechanism of action as well as efficacy in relevant in vitro and in vivo model systems. These positive results help lay the foundation for moving forward into an FDA IND application followed by first in human studies."

Jed Latkin, Navidea’s Chief Executive Officer, said, "This is truly a tribute to the many hours of hard work spent by our dedicated team to hone in on a compound that shows remarkable design, enabling this and future pre-clinical clinical work."

On April 15, 2021 Bioneer reported that we will be participating in the Nordic Life Science Days 2021, from April 20th to 23rd (Press release, Bioneer, APR 15, 2021, View Source [SID1234578116]).

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Nordic Life Science Days is the largest Nordic partnering conference dedicated to the life science industry. This year the event will be in a digital format, where Bioneer will have a virtual booth, where you will find all information about our company and our high quality service.

You can book a meeting with our Sales and Business Development Manager Lovisa Sunesson ([email protected]) on the Nordic Life Science Days platform or contact us via the available online chat.

Moreover you will be able to hear more about our company and specifically our disease modelling in our company presentation featuring Christian Clausen, Chief Scientific Officer at Bioneer.

On April 15, 2021 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with cancer reported the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on the company’s Phase 1 first-line study of SBP-101 when used in combination with standard of care agents gemcitabine and nab-paclitaxel for treatment of patients with metastatic pancreatic ductal adenocarcinoma (PDA) (Press release, Panbela Therapeutics, APR 15, 2021, View Source [SID1234583757]). SBP-101 is the company’s first polyamine metabolic inhibitor therapeutic candidate.

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The company has agreed to include in the design of all future studies the exclusion of patients with a history of retinopathy or at risk of retinal detachment and scheduled ophthalmologic monitoring for all patients. Additionally, in future dose-finding studies screening for retinal toxicity will be included.

About SBP-101

SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. The molecule has shown signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, suggesting potential complementary activity with an existing FDA-approved standard chemotherapy regimen. In data evaluated from clinical studies to date, SBP-101 has not shown exacerbation of bone marrow suppression or peripheral neuropathy, which can be chemotherapy-related adverse events. Recently observed serious visual adverse events are being evaluated and patients with a history of retinopathy or at risk of retinal detachment are excluded from SBP-101 studies. The safety data and PMI profile observed in the current Panbela sponsored clinical trial provides support for continued evaluation of SBP-101 in a randomized clinical trial. For more information, please visit View Source .