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."

On June 8, 2021 ONK Therapeutics Ltd, an innovative natural killer (NK) cell therapy company, reported that it has been awarded an Innovation Partnership Programme (IPP) grant by Enterprise Ireland (EI) to fund collaborative research at Trinity College Dublin, Ireland, led by Dr. David Finlay to optimize the metabolism and engineering of NK cells for improved cancer therapies (Press release, ONK Therapeutics, JUN 8, 2021, View Source [SID1234583706]).

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Dr. Finlay, Associate Prof. in Immunometabolism in the Schools of Biochemistry and Immunology, and Pharmacy and Pharmaceutical Sciences, at Trinity College Dublin is a world-leading expert in NK cell metabolism. His group was the first to characterize cellular metabolic pathways in NK cells (reviewed in (1)) and to demonstrate the importance of NK cellular metabolism for the cytotoxic anti-tumor functions of these cells (2).

Active research is ongoing to optimize the efficacy of NK cell therapies against solid tumors by addressing the immunosuppressive tumor microenvironment (TME), where NK cell metabolism is impaired due to low glucose levels, oxygen deprivation (hypoxia), presence of inhibitory cytokines, and the higher concentration of tumor-derived metabolic end products, such as lactate.

To date, such improvement strategies to boost the efficacy of NK cells in the tumor microenvironment of solid cancers have centred on adding cytokines and other factors.

"We are taking a completely novel approach by addressing NK cell metabolism from the inside out, fundamentally engineering NK cells to better treat cancer by increasing their resistance to the adverse metabolic conditions generated by tumors," said Prof. Michael O’Dwyer, founder and CSO at ONK Therapeutics. "In working with Dr. Finlay, we are collaborating with the pioneering expert in the field of NK immunometabolism."

Under the terms of the collaboration, Trinity College Dublin retains any intellectual property (IP) arising out of the research collaboration, with ONK Therapeutics having an exclusive option to license the IP.

"In order to understand why cellular cancer immunotherapies are not effective in all cancer patients, scientists are actively trying to identify why certain patients respond and some do not and why some types of cancer can be successfully treated while others cannot. One emerging reason is that tumors can create metabolically unfavorable environments that might impact the effectiveness of immune cell therapies. My laboratory has the foremost expertise in NK cell metabolism placing us in a very strong position to address this challenge," said Dr. Finlay.

"Manipulating NK cell metabolism to enhance anti-cancer function is completely novel and is only possible based on our discoveries over the past five years," he said. "Our goal is to discover new targets within NK cells to be edited through CRISPR deletion or overexpression strategies. Detailed evaluation of the resistance of these cells to the adverse environments generated by tumors should support the development of enhanced NK cell therapies. It is an innovative approach to developing improved cellular therapies to treat cancer, in particular solid tumors."

Lawrence Lee, Manager, Innovation Partnership Programme Enterprise Ireland, said, "We are delighted to support this innovative research that has the potential to generate real and tangible benefits for cancer patients in Ireland and across the globe. The project is aligned with Enterprise Ireland’s strategic goal of supporting world-leading research in Ireland and fostering relationships between industry and academic partners. Research initiatives such as this have the capacity to further advance Ireland’s international research reputation and lay the foundations for the jobs of the future.

The Enterprise Ireland funding(3) covers 80% of the €373,295 project costs, with the industry partner, ONK Therapeutics providing €75,000 (20%) of the project costs. Trinity College Dublin will be recruiting two additional post-doctoral scientists into Dr. Finlay’s group over the two years of the project.

Chris Nowers, CEO of ONK Therapeutics, said, "We are highly ambitious in our goal to become a world-leading engineered NK cell therapy company that not only treats, but ultimately cures cancer. Our academic partnerships will deliver rich research insights and reinforce our own expertise as we aim to deliver new therapeutic options for patients in need."

1. O’Brien KL., Finlay, DK. (2019) Immunometabolism and Natural Killer cell responses. Nature Reviews Immunology, May;19(5):282-290. doi: 10.1038/s41577-019-0139-2

2. Assmann N, O’Brien KL, Donnelly RP, Dyck L, Zaiatz-Bittencourt V, Loftus RM, Heinrich P, Oefner PJ, Lynch L, Gardiner CM, Dettmer K, Finlay DK. (2017) Srebp-controlled glucose metabolism is essential for NK cell functional responses. Nature Immunology. Sep 18. doi: 10.1038/ni.3838

3. IP 2021 0976 – ‘Metabolic reprogramming and engineering of NK cells for improved cancer therapy’