On June 8, 2021 CytoSMART Technologies reported the launch of two new fluorescence live-cell imaging systems – the Lux3 FL Duo Kit and the Multi Lux3 FL (Press release, Lifescience Newswire, JUN 8, 2021, View Source [SID1234583712]). The CytoSMART Lux3 FL Duo Kit is a compact and cost-effective imaging system consisting of two fluorescence microscopes, designed for side-by-side comparison of cell cultures. The CytoSMART Multi Lux3 FL fluorescence live-cell imaging system consists of four compact Lux3 FL devices, equipped with two fluorescent (green and red) and one brightfield channel, and designed for long-term comparative studies and larger research teams.

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Both systems operate from within a standard CO2-incubator or hypoxia chamber, allowing to analyze cells in their desired culture environment. Each system of two and four microscopes is connected to a single laptop, maximizing precious laboratory space. Monitoring and analysis of the running experiments can be done at any time from anywhere via the CytoSMART Cloud.

Said Jan-Willem van Bree, CTO at CytoSMART Technologies, "Last year we launched our first fluorescence live-cell imager, the CytoSMART Lux3 FL, and our customers were pleased with its performance and expanded research possibilities. This year we decided to scale up fluorescence live-cell imaging possibilities by launching two new advanced systems: the Lux3 FL Duo Kit and the Multi Lux3 FL. We always aim to develop and offer versatile and flexible solutions to life scientists. For example, the Multi Lux3 FL allows to run up to four individual imaging experiments simultaneously, without affecting the time-lapse imaging experiments of other lab members. This is a very convenient lab equipment for every research group that studies cell viability, co-culture models, single-cell migration, and many other cell-based assays can benefit from it."

The main features and benefits of the CytoSMART fluorescence live-cell imaging systems include:

Ideal for comparative studies – directly compare fluorescently-labeled cell cultures.
Versatile – expand the number of variables you can examine using fluorescent labeling.
Flexible – connect devices to the same laptop and control them individually.
Incubator-friendly – study cells in their desired culture environment.
Full remote access via the CytoSMART Cloud – no need to enter the lab to inspect cell cultures.
Indispensable tool for long-term comparative studies – run up to four experiments simultaneously for days or weeks.
Cost-effective and efficient solution – two or four fluorescence imaging devices connected to one laptop, including unlimited storage and unlimited number of user accounts.
Visit the official CytoSMART website for more information on the CytoSMART Lux3 FL Duo Kit and the CytoSMART Multi Lux3 FL.

On June 8, 2021 Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology Company pioneering a differentiated approach to treating neurodegenerative disease and cancer through the inhibition of SEMA4D, reported that the first clinical sites have been activated to screen and enroll patients in its Phase 1/2 study evaluating pepinemab as a single agent in Alzheimer’s disease (AD) and in its phase 2 study in of pepinemab combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) as front-line treatment for advanced, recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) (Press release, Vaccinex, JUN 8, 2021, View Source [SID1234583711]). The Company plans to activate at least 13 U.S. sites for the Alzheimer study and 18 U.S. sites for HNSCC.

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The Alzheimer’s proof-of-concept study is expected to enroll at least 40 patients with key efficacy endpoints that include measures of cognition and brain imaging. This study has received funding support from the Alzheimer’s Drug Discovery Foundation and the Alzheimer’s Association. The HNSCC study will enroll up to 65 patients allocated to different levels of combined positive score (The HNSCC study is expected to enroll up to 65 patients allocated to different levels of combined positive score (CPS) of PD-L1 expression. CPS is a biomarker associated with benefit in response to immunotherapy. Efficacy endpoints will focus on objective response rate (ORR) per RECIST 1.1 criteria, as well as progression-free survival (PFS), overall survival (OS) and duration of response (DOR).

Dr. Maurice Zauderer, chief executive officer of Vaccinex, stated, "With this Alzheimer’s study, we are building on prior data from our SIGNAL phase 2 study in Huntington’s disease that we believe indicated cognitive benefit to patients at an early stage of this devastating neurodegenerative disease. It was particularly encouraging that this was accompanied by evidence of increased brain metabolic activity which has been shown in several independent studies to correlate with cognitive change in AD as well. AD patients are in urgent need of new therapies to effectively slow or halt disease progression, and we are looking forward to results from this important study.

"In addition, we recently published results of a prior phase 2 study of pepinemab in combination with a checkpoint inhibitor, EMD Serono’s Bavencio, that we believe indicated treatment benefit to patients with non-small cell lung cancer. We are pleased to have now initiated this new trial in HNSCC in collaboration with Merck, a global immunotherapy leader. We and others have shown that SEMA4D is highly expressed in head and neck cancer and triggers increased levels of myeloid-derived suppressor cells that inhibit immune responses to tumor, providing a compelling scientific rationale for this study," Dr. Zauderer concluded.

Multiple prior preclinical studies suggested that inhibition of SEMA4D has unique mechanisms of action that reduce activation of inflammatory glial cells in brain but increases immune infiltration and alters the balance of cytotoxic and immunosuppressive cells in a tumor microenvironment. The Company is pleased and excited to have the opportunity to develop this potentially promising therapy in multiple important indications.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

Bavencio is a registered trademark of EMD Serono, Inc., the U.S. biopharmaceutical business of Merck KGaA, Darmstadt, Germany.

On June 8, 2021 MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases, reported that its Chief Executive Officer, Michael Castagna, PharmD, will present at the Lytham Partners Summer 2021 Investor Conference on Monday, June 14, 2021 at 11:45 AM (ET) (Press release, Mannkind, JUN 8, 2021, View Source [SID1234583709]).

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Interested parties can access a link to the webcast from the Events & Presentations section of the Company’s website at View Source The webcast replay will remain available for 14 days following the live presentation.

On June 8, 2021 Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on development and commercialization of therapies for the treatment of several eye disorders, reported the closing of its previously announced registered direct offering of 3,076,923 shares of the Company’s common stock (the "Shares") and warrants to purchase 1,538,461 shares of the Company’s common stock (the "Warrants", and together with the Shares, the "Securities") at a combined purchase price of $4.875 per one Share and 0.5 Warrant in an offering priced at-the-market under Nasdaq rules (Press release, Rexahn, JUN 8, 2021, View Source [SID1234583708]). The Warrants have an exercise price of $6.09 per share, will be exercisable on issuance date, and will expire five years following the issuance date. Gross proceeds from the offering were approximately $15 million, before deducting placement agent fees and other offering expenses payable by the Company.

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Lincoln Park Capital Fund, LLC was the lead investor in the offering. Additional investors participating in the offering included Ayrton Capital, District 2 Capital Fund LP, Altium Capital, and other new and existing institutional healthcare investors.

A.G.P./Alliance Global Partners acted as sole placement agent for the offering.

The Company intends to use the net proceeds from the offering to cover clinical (2nd Phase 3 trial and pediatric trial), manufacturing (including commercial batches) and regulatory costs associated with the submission of a New Drug Application for Nyxol for the reversal of pharmacologically-induced mydriasis, as well as for working capital and general corporate purposes. The Company expects that this offering combined with cash on hand will fund operations until late 2022.

This offering was made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-252715) previously filed with the U.S. Securities and Exchange Commission (the "SEC"). A final prospectus supplement describing the terms of the proposed offering has been filed with the SEC and is available on the SEC’s website located at View Source Electronic copies of the prospectus supplement may be obtained from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at [email protected].

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

On June 8, 2021 Sonnet BioTherapeutics Holdings, Inc., (NASDAQ:SONN) a biopharmaceutical company developing innovative targeted biologic drugs, reported that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 11,028,166 entitled, "Albumin Domain Fusion Proteins" (Press release, Sonnet BioTherapeutics, JUN 8, 2021, View Source [SID1234583707]). The patent covers Sonnet’s Fully Human Albumin Binding (FHAB) technology and includes therapeutic fusion proteins that utilize FHAB for tumor targeting and retention and provide extended pharmacokinetics (PK), and the patent carries a term effective until March 2039.

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"This intellectual property approval is an important milestone that provides significant differentiation from any existing or emerging competitive technologies that may leverage Human Serum Albumin," said Pankaj Mohan, Ph.D., Founder and CEO. "This represents the strategic foundation underpinning our product pipeline roadmap and provides important validation for our FHAB platform. Through the development of our product pipeline, we are very excited to extend our unique and patent-protected technology to patients."

Sonnet’s FHAB platform consists of a single, fully human construct of a FHAB antibody fragment that has high affinity to bind to human albumin. The platform provides an off-the-shelf lock and load opportunity to rapidly develop numerous therapeutic biologics.

John Cini, Co-Founder and CSO, commented "The FHAB platform technology endows all Sonnet pipeline assets with a mono- or bi-specific mechanism of action. When tested in vivo against numerous wild type cytokines, Sonnet’s FHAB-derived candidates have reproducibly shown improved efficacy. Based on a linear, flexible structure, FHAB displays improved penetration and retention in the TME, and enhanced payload delivery to the tumor, via both passive and active transport mechanisms, as well as extended pharmacokinetics."