Genomic Testing Cooperative Hematology Profile Plus, Solid Tumor Profile Plus, and Liquid Biopsy Profiles Receive CE-IVD Mark

On May 25, 2022 Genomic Testing Cooperative (GTC) reported it received CE-IVD marks for its Hematology Profile Plus, Solid Tumor Plus as well as its liquid biopsy profiles for both solid tumors and hematology that are designed to provide a wide range of clinically actionable insights about a patient’s tumor (Press release, Genomic Testing Cooperative, MAY 25, 2022, View Source [SID1234615021]). The CE mark will allow GTC and its partner, TherapySelect (Heidelberg, Germany), to make available GTC’s menu of DNA and targeted transcriptome profiling for patients in Europe. The Solid Tumor Profile Plus provides information on targetable mutations, fusion genes, tumor cell of origin, and the presence or absence of homologous recombination deficiency (HRD). The Hematology Profile Plus provides molecular data for selecting targeted therapy and also accurate diagnosis and classification of various myeloid and lymphoid neoplasms including gene fusions, chromosomal gains and losses, and molecular immunoprofiling. The Hematology Liquid Biopsy Profile is designed to reduce the need for bone marrow biopsy in certain circumstances. The Solid Tumor Liquid Biopsy Profile is designed for tumor-informed monitoring.

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"We are excited to expand our molecular profiling offerings to Europe and to make membership in the Cooperative available internationally. This will strengthen the network and accelerate innovation by building broader knowledge-based artificial intelligence algorithms," stated Dr. Maher Albitar, Founder, Chief Executive Officer and Chief Medical Officer, GTC.

Dr. Frank Kischkel, Managing Director and Scientific Director at TherapySelect stated, "We elected to partner with GTC because of the superior quality and comprehensive offering of the tests along with their commitment to innovation. GTC tests are designed with patients and best practices in oncology in mind. In addition, the co-op business model allows us to internalize the testing in our laboratories as our volumes grow in Europe. We are very excited to be GTC’s authorized representative in Europe and look forward to growing our partnership."

TherapySelect will be the authorized representative in the EU to offer CE certified in vitro diagnostic medical devices. Membership in the Co-Op allows other member labs to internalize GTC testing, which now includes the EU and countries recognizing the CE mark.

Vaccinex, Inc. to Participate in the Jefferies Healthcare Conference on Friday, June 10, 2022 at 10:30 a.m. ET

On May 25, 2022 Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating cancer and neurodegenerative disease through the inhibition of SEMA4D, reported that Maurice Zauderer, Ph.D., President and Chief Executive Officer, along with Elizabeth Evans, Ph.D., Chief Operating Officer, will present at the Jefferies Healthcare Conference on Friday, June 10, 2022 at 10:30 a.m. Eastern Time (Press release, Vaccinex, MAY 25, 2022, View Source [SID1234615037]). The Company will provide an update on enrollment in phase 2 trials of its lead product in Head and Neck Cancer and in Alzheimer’s disease. Interested investors are invited to participate in one-on-one meetings, June 8 to 10.

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Jefferies Healthcare Conference (in-person) Details:

Please contact your Jefferies representative if you would like to schedule a one-on-one meeting during the conference, June 8 to 10, 8:00 am to 5:00 pm.

Dynavax to Present at the William Blair 42nd Annual Growth Stock Conference

On May 25, 2022 Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines, reported that Ryan Spencer, Chief Executive Officer and Kelly MacDonald, Chief Financial Officer, will participate in a fireside chat during the William Blair 42nd Annual Growth Stock Conference in Chicago, Illinois on Monday June 6, 2022 at 4:40 p.m. C.T (Press release, Dynavax Technologies, MAY 25, 2022, View Source [SID1234615053]).

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A live webcast of the presentation can be accessed through the "Events & Presentations" page on the "Investors" section of the Company’s website at View Source and a replay will be available following the event.

Oxford Vacmedix announces Innovate UK funding for development of novel T-cell potency assays

On May 25, 2022 Oxford Vacmedix UK Limited (OVM) reported the award of a Small Business Research Initiative contract from Innovate UK to fund research into the development of novel T-cell based potency assays (Press release, Oxford Vacmedix, MAY 25, 2022, View Source;utm_medium=rss&utm_campaign=innovate-uk-funding-for-development-of-novel-t-cell-potency-assays [SID1234615022]). These assays will support the development of vaccines for diseases of epidemic potential using the company’s proprietary recombinant overlapping peptide (ROP) technology and will pave the way for more cost-effective, rapid testing and improved control of manufacturing for vaccines. This is particularly important in the development of new vaccines for low- and middle-income countries and the findings may also be important in cancer research.

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One of the key issues in vaccine development is the need for potency assays for Quality Control release and stability testing. Traditionally, in vivo testing is used to determine vaccine potency; however, these assays are time-consuming and costly and can show high variability. Cell-based potency assays are typically more reliable and have significantly reduced costs. This project will demonstrate a platform application, so that the assay format can be modified for use with different vaccine antigens including those with epidemic potential. The research will be carried out in collaboration with the Department of Oncology at the University of Oxford and with RSSL.

Spun out from the University of Oxford, OVM is commercialising the research on ROPs developed initially in the University. The principal application of the ROP platform technology is the development of novel therapeutic cancer vaccines with the potential for increased efficacy, simpler regulatory pathways and lower costs. OVM’s lead cancer vaccine, OVM-200 which targets survivin, is in a Phase 1 clinical trial in the UK for solid tumours.

This research is funded by the Department of Health and Social Care as part of the UK Vaccine Network (UKVN), a UK Aid programme to develop vaccines for diseases with epidemic potential in low- and middle-income countries.

Dr Shisong Jiang, CSO and Founder of OVM, said:

"We are very pleased to have received the support from Innovate UK and this funding from the UK Vaccine Network to enable work on this important project to be undertaken. The development of this novel potency assay technology could demonstrate real utility in the development of vaccines for diseases of epidemic potential and be a valuable addition for the progression of all vaccines that employ T cells in the immune response, such as our cancer vaccines."

Professor Xiao-Ning Xu, Chair in Human Immunology, Imperial College, London: added:

"This project is an excellent opportunity to widen the applications of the Oxford Vacmedix’s ROP technology and to build on the company’s expertise in immunology and infectious disease. We look forward to a successful outcome and to these novel assays being able to speed up the development of new vaccines as prophylactics or therapies for cancer and infectious disease".

Entry Into a Material Definitive Agreement

On May 25, 2022, Brickell Biotech, Inc. (the "Company") reported that entered into a Subscription and Investment Representation Agreement (the "Subscription Agreement") with a single accredited investor (the "Purchaser"), pursuant to which the Company agreed to issue and sell one (1) share of the Company’s Series A Preferred Stock, par value $0.01 per share (the "Preferred Stock"), to the Purchaser for $10 in cash (Filing, 8-K, Vical, MAY 25, 2022, View Source [SID1234615038]). The sale closed on May 25, 2022. Additional information regarding the rights, preferences, privileges and restrictions applicable to the Preferred Stock is set forth under Item 5.03 of this Current Report on Form 8-K and is incorporated herein by reference.

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The Subscription Agreement contains customary representations and warranties and certain indemnification rights and obligations of the parties.

The foregoing summary of the Subscription Agreement does not purport to be complete and is subject to, and qualified in its entirety by, such document, which is filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated herein by reference.