On July 21, 2020 Genor Biopharma Co. Inc, a pre-commercial stage biopharmaceutical company focused on developing and commercializing oncology and autoimmune therapeutics, reported that the new drug application (NDA) for Geptanolimab, a novel PD-1 mAb drug candidate, has been accepted by the National Medical Products Administration ("NMPA") for the treatment of Peripheral T cell Lymphoma (PTCL) (Press release, Genor Biopharma, JUL 21, 2020, View Source [SID1234594761]).

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On the same day, Genor Biopharma announced the appointment of Mr. CHEN Wende as Chief Operation Officer. In this role, Mr. CHEN will oversee commercialization and prepare for launches of late-stage drug candidates.

Mr. CHEN brings over 20 years of experience in biopharmaceutical industry, focusing on sales and marketing and business operation at Roche, AstraZeneca, and Pfizer in China. Mr. CHEN was most recently Chief Commercial Officer at a well-known biotech company. Before that, Mr. CHEN served as Vice President at Roche China, overseeing Corporate Affairs, Market Access and Channel Management for a number of key drugs including Herceptin, MabThera, Avastin, Tarceva and Zelboraf. Mr. CHEN also served as Senior Vice President at AstraZeneca from 2010 and as Senior Sales Director at Pfizer from 2000.

"We are excited to appoint Mr. CHEN as COO of Genor Biopharma. We are looking to file NDAs for a number of our late-stage drug candidates in the near term," commented Dr. GUO, Chief Executive Officer of Genor Biopharma, "With over 20 years of experience in drug commercialization and deep insight of the landscape, Mr. CHEN will build our in-house commercialization team and lead our drug launches with differentiated strategy and drive our transformation into a biopharma company."

On July 21, 2020 QUANTRO Therapeutics GmbH reported that the company has established its operations with seed financing from Boehringer Ingelheim Venture Fund (BIVF) and Evotec (Press release, QUANTRO Therapeutics, JUL 21, 2020, View Source;utm_medium=rss&utm_campaign=quantro-therapeutics-delighted-to-join-biotech-austria [SID1234578387]). As a research-based company, QUANTRO will combine and exploit innovative functional genetics and transcriptomics technologies to generate an unprecedented drug discovery pipeline transforming the precision and scope of cell-based compound screens. By introducing ‘Transcriptional Fingerprinting’ to drug discovery, QUANTRO intends to revamp the scope of pharmacologic interventions in a variety of cellular, target and disease contexts. A prime focus will be the discovery and development of drug candidates blocking the activity of oncogenic transcription factors, a class of particularly promising therapeutic targets that has so far remained largely unamenable to pharmacological intervention.

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The company was founded by Dr. Stefan Ameres and Dr. Johannes Zuber as a spin-off of the Institute of Molecular Biotechnology (IMBA) and the Research Institute of Molecular Pathology (IMP), both located in Vienna, Austria. Bringing together expertise in time-resolved transcriptomics and functional genomics, the founders have pioneered innovative methods to study gene regulatory functions of oncogenic transcription factors and drugs in a variety of cellular models. Supported by two Proof-of-Concept grants of the European Research Council (ERC), they explored new applications of these cutting-edge technologies, thereby laying the groundwork for QUANTRO’s discovery pipeline. Meanwhile, the team has been reinforced by extensive pharma R&D and senior executive experience with Dr. Dieter Nachtigall, who is a chemist by training and has been appointed CEO of QUANTRO. Boehringer Ingelheim Venture Fund and Evotec acquired equal minority stakes in QUANTRO and will be represented on the Company’s Supervisory Board by Dr. Sebastian Kreuz and Dr. Dirk Ullmann, respectively. Furthermore, Evotec will provide hit identification services for QUANTRO’s proprietary anti-tumor projects.

Dr. Dieter Nachtigall, Chief Executive Officer of QUANTRO, said: "QUANTRO Therapeutics has designed and set up a new discovery approach and technology platform based on world-leading scientific expertise by our founders and excellent support from our highly committed corporate venture partners. We are extremely motivated and ambitious to start operations in our facilities at the Startup Labs Vienna Biocenter and turn our vision of identifying and developing new anti-cancer agents with breakthrough potential into a reality."

Dr. Sebastian Kreuz, Boehringer Ingelheim Venture Funds, added: "The BIVF focuses on groundbreaking therapeutic approaches and technologies that have the potential to advance patient care in areas of high unmet medical need. We are looking forward to supporting QUANTRO and its dedicated founders to apply time-resolved RNA sequencing in an industrialized setting with the aim to unlock transcription factors as a highly promising target class for drug discovery in oncology and other disease areas."

Dr. Werner Lanthaler, Chief Executive Officer of Evotec, commented: "QUANTRO is a very promising academic spin-off company with great potential to lead the way in time-resolved RNA sequencing with a potentially ground-breaking technology to address ‘undruggable’ drug targets. Through our partnership and equity investment, we will further validate QUANTRO’s approach and hope to be able to open many new doors across a broad range of therapeutic modalities together in the future."

Dr. Stefan Ameres, Founder and Scientific Advisor of QUANTRO, commented: "The definition of direct transcription factor targets and, more generally, the unbiased detection of direct transcriptional effects has remained challenging due to the limited time resolution of conventional techniques for gene perturbation and transcriptional profiling. Overcoming this hurdle adds great possibilities for new therapeutic interventions with previously inaccessible targets in different cancer types and disease contexts."

Dr. Johannes Zuber, Founder and Scientific Advisor of QUANTRO, added: "Transcription factors shape and maintain the identity of cancer cells and have long been recognized as promising therapeutic targets. After studying these factors and their therapeutic potential for many years, QUANTRO’s discovery pipeline takes an unprecedented approach to finally exploit transcription factors for cancer therapy."

QUANTRO Management Board and Team
Dr. Dieter Nachtigall, CEO of QUANTRO, holds a PhD in Analytical Chemistry and contributes 23 years in pharmaceutical research and development experience to QUANTRO. Additionally, he brings more than 10 years in senior executive roles at Boehringer Ingelheim.

Dr. Stefan Ameres, Founder and Scientific Advisor of QUANTRO, is a distinguished expert in RNA biology and transcriptomics and has since 2012 held the position of group leader at the IMBA, Vienna. Dr. Ameres has a track-record of highly ranked publications in Nature, Cell, Science and other peer-reviewed journals.

Dr. Johannes Zuber, also Founder and Scientific Advisor of QUANTRO, is a licensed MD and renowned expert in functional cancer genetics. He has been a group leader at the IMP, Vienna, since 2011, and his outstanding scientific accomplishments are documented in more than 160 publications in highly ranked journals.

On July 21, 2020 Glytherix, an unlisted public Australian immuno-oncology company, reported that it is actively seeking AUD 7m (USD 5m) in a Series A equity round, after securing up to AUD 6m in non-dilutive funding, said CEO Brad Walsh (Press release, Glytherix, JUL 21, 2020, View Source [SID1234565156]).

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The Sydney-based company has secured AUD 3m in grant funding from Round 9 of the Federal Government’s Cooperative Research Centres Projects (CRC-P) program, as announced last week (16 July), with Sydney-based R&D Capital Partners agreeing to provide another AUD 3m once the AUD 7m is raised, Walsh said.

Glytherix, which is fielding interest from potential investors in Australia, the US, Hong Kong and China, including family offices and institutions, welcomes approaches from other interested investors, Walsh said. Its advisors are New York-and Melbournebased Biosynergy Partners and Sydney-based private placement firm Litmus Equity.

While the novel coronavirus (COVID-19) pandemic initially made it more difficult for the company to engage with potential investors, people are now used to the ‘new normal’ and it is proving easier to connect with people in their home offices, Walsh said.

Glytherix is confident of closing the raise in the next four to eight weeks with the credibility boost provided by the grant funding and on the back of advances made since the 2018 spin-off from its parent, Sydney-based non-invasive prostate cancer diagnostic developer Minomic, Walsh said.

It has completed a 12-patient first-in-human study for its Miltuximab antibody, which reached its primary endpoint of safety and tolerability, and its secondary endpoint of tumour targeting. The company now plans other pre-clinical work including a glioblastoma (brain cancer) study, he noted.

Equity capital raised will be used to support a Phase I trial in patients with prostate, pancreatic, bladder and glioblastoma cancers and will also be used to make more clinical-grade antibodies to prepare for a US Food and Drug Administration (FDA) Investigational New Drug (IND) application and a US Phase I trial, Walsh said.

The equity funding is expected to last two years, with financing options for a Phase II US trial including a NASDAQ listing, licensing deals or trade sales, he added. The company has some 200 shareholders comprising management and high net worth investors.

In collaboration with other Australian companies and research bodies, Glytherix will use grant funding to develop Miltuximab as a flagship molecule for radio-immunotherapies (RITs), which are combinations of radiation therapy and immunotherapy using antibodies to selectively deliver radiation to kill cancer cells, while limiting damage to healthy cells.

This is one of the most dynamic new areas in nuclear and radiochemistry with robust research and commercial interest globally, Walsh said, noting that Novartis [SWX:NOVN] paid some USD 6bn for both Advanced Accelerator Applications [NASDAQ:AAAP] and Endocyte [NASDAQ:ECYT] in 2018. Domestically, Telix [ASX:TLX] is also developing RITs, although for different disease indications to the ones Glytherix is targeting, he said.

Miltuximab is also being used for both imaging and immunotherapy applications, with this pairing of a precision diagnostic and a corresponding precision therapeutic having the potential to treat a wide range of cancers and position both Glytherix and Australia at the forefront of the theranostics industry, Walsh added.

by Louise Weihart in Sydney

Published by Acuris Mergermarket, an ION Group company

On July 21, 2020 Fudan University’s Taizhou Health Science Institute and Singlera Genomics, focused on non-invasive early cancer detection, reported the publication of a peer reviewed manuscript demonstrating the initial results from the Taizhou Longitudinal Study (TLS), showing Singlera’s PanSeer assay can detect five types of cancer up to four years before conventional diagnosis with a single blood draw (Press release, Fudan University, JUL 21, 2020, View Source [SID1234562261]). Some results from this study were also presented at the AACC 71st Annual Scientific Meeting held August 4-8 2019 in Anaheim, California, and selected as one of three finalists in the Disruptive Technology Award competition.

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This collaborative study was a joint effort between Singlera Genomics with Professor Kun Zhang at the University of California San Diego, and Professor Li Jin at Fudan University.

The TLS study was launched by Professor Li Jin of Fudan University and began in 2007 collecting plasma samples from over 120,000 healthy individuals. Study participants were monitored for a 10-year period through linkages with local cancer registries and health insurance databases. Over 1.6 million specimens have been collected and archived to date.

"We really appreciate the reviewers and the editor for scrutinizing our study very carefully as this is one of the first retrospective longitudinal studies that demonstrates blood based non-invasive early detection of multiple cancer types four years before conventional diagnosis," said Yuan Gao, Ph.D., one of senior authors of the study and co-founder and Chairman of Singlera Genomics. Rui Liu, Ph.D., another senior author on the paper and co-founder/CTO of Singlera Genomics, added, "one unique aspect is that we use a longitudinal cohort with 10+ years of efforts to show detection of cancer before conventional diagnosis is possible, while previous work has mostly focused on a case-control design with symptomatic cancer patients that have already been diagnosed with the standard care. It is excited to see that cancer signatures can be detected so early in as little as 1ml plasma with Singlera’s PanSeer assay."

Professor Kun Zhang said: "I am very pleased to see that early developments of DNA methylation methods in my laboratory at UCSD were further improved and optimized at Singlera, leading to the PanSeer assay that is both robust and accurate in detecting cancers in blood early." Professor Li Jin said: "This study demonstrated that a large cohort such as TLS could offer a powerful tool for evaluating technologies for early and precision diagnoses."

The next logic phase would be a prospective cohort study and clinical trial. However, the difficulty for prospective study is the length of time and the amount of resource involved. Singlera Genomics is in the process of raising additional funds for this purpose. Furthermore Singlera Genomics has also met with FDA twice for its blood-based colorectal cancer colonES assay and is expected to launch the trial in the near future. The research team is in the process of extending this early detection approach to additional cancer types, and Singlera is currently looking for collaboration partners in the United States.

On June 21, 2020 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported that it has commenced an underwritten public offering, subject to market and other conditions, to issue and sell shares of its common stock (Press release, CASI Pharmaceuticals, JUL 21, 2020, View Source [SID1234562243]). In connection with the offering, CASI expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering. There can be no assurances as to whether or when the offering may be completed, or as to the actual size or terms of the offering. All of the shares of common stock in the offering will be sold by CASI.

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Oppenheimer & Co. Inc. is acting as the sole bookrunning manager, and Brookline Capital Markets, a division of Arcadia Securities, LLC is acting as co-manager, for the offering.

CASI intends to use the net proceeds of the offering for working capital and general corporate purposes, which include, but are not limited to advancing our product portfolio, acquiring the rights to new product candidates and general and administrative expenses.

The securities described above are being offered by CASI pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was filed on December 13, 2017 and declared effective by the U.S. Securities and Exchange Commission ("SEC") on December 22, 2017. The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering, when available, may also be obtained from Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY 10004, by telephone at (212) 667-8055, or by email at [email protected].

Before investing in the offering, you should read in their entirety the preliminary prospectus supplement and the accompanying prospectus and the other documents that CASI has filed with the SEC that are incorporated by reference in the preliminary prospectus supplement and the accompanying prospectus, which provide more information about CASI and the offering.

This press release does not constitute an offer to sell or a solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.