GenScript | November 10, 2020
GenScript USA Inc., the world's leading research reagent provider, announced today that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for the cPass™ SARS-CoV-2 Neutralization Antibody Detection Kit. This is the first commercially available test to specifically detect neutralizing antibodies without the use of live virus. Neutralizing antibodies, a subset of antibodies that are specifically able to block the ability of the virus to enter a cell, are widely recognized biomarkers of immunity. The test measures the presence of neutralizing antibodies in any sample, from those from patients recovering from COVID-19 or those vaccinated against SARS-CoV-2. The conventional method for measuring neutralizing antibodies requires testing to be performed in a high safety-level facility (BSL3) staffed with specialized personnel. Typically, results from the live virus assay are available in several days and due to the unpredictable nature of the live virus and live cells reagents used, these tests are also difficult to standardize. Results from different facilities may vary, even if performed using the same protocol. In contrast, the cPass™ kit utilizes pure proteins that can be produced in a more reproducible way. The detection of the presence of neutralizing antibodies can also be performed in most standard research or clinical diagnostic laboratories with short turnaround time (~1hr), making it broadly available and much more consistent between different facilities. Furthermore, a comparison of the direct clinical performance between the conventional live virus and the cPass™ assay shows results from both tests are strongly correlated.
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INDUSTRIAL IMPACT
Evaxion Biotech | January 27, 2022
Evaxion Biotech A/S a clinical-stage biotechnology company specializing in the development of AI-driven immunotherapies to improve the lives of patients with cancer and infectious diseases, announced today the publication of a paper on personalized therapy with EVX-01 in patients with metastatic melanoma in the open access, peer-reviewed journal OncoImmunology.
The paper, entitled, “Personalized therapy with peptide-based neoantigen vaccine (EVX-01) including a novel adjuvant, CAF®09b, in patients with metastatic melanoma”, outlines results from a continuing Phase 1/2a trial of EVX-01, a novel personalized cancer immunotherapy based on Evaxion’s proprietary PIONEER™ AI technology.
Results from five patients in the study demonstrated that EVX-01 is safe and has encouraging early indications of clinically and meaningful antitumor activity. Data showed EVX-01 is capable of eliciting T-cell responses in a clinical setting where the patients received concurrent standard immune therapy, i.e. anti-PD-1 treatment. Results demonstrated an antitumor effect in combination with anti-PD-1 treatment.
Identification of immunogenic neoantigens is the core of establishing an effective personalized cancer immunotherapy and the evidence from this trial supports the potential of Evaxion’s PIONEER platform to successfully overcome that challenge of correctly identifying neoantigens. The results of the trial also provide evidence that implementation of a timely manufacturing process of a personalized cancer immunotherapy is feasible.
“Personalized immunotherapy with neoantigens is a promising approach in cancer treatment. The clinical data generated on EVX-01 so far are very exciting and demonstrate PIONEER’s immense potential in developing truly personalized immunotherapies to improve treatment for patients with melanoma as well as other types of cancer. We are pleased that we are well financed to further investigating EVX-01’s potential in our new Phase 2b trial in collaboration with Merck, which we expect to start in Q2 2022.”
Lars Wegner, CEO of Evaxion
About Evaxion
Evaxion Biotech A/S is a clinical-stage AI-immunology™ platform company decoding the human immune system to discover and develop novel immunotherapies to treat cancer, bacterial diseases and viral infections. Based on its proprietary and scalable AI-immunology core technology, Evaxion is developing a broad pipeline of novel product candidates which currently includes three patient-specific cancer immunotherapies, two of which are in Phase 1/2a clinical development. In addition, Evaxion is advancing a portfolio of vaccines to prevent bacterial and viral infections currently in preclinical development.
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Cision PR Newswire | August 31, 2020
Unum Therapeutics Inc. (Nasdaq: UMRX), a biopharmaceutical company focused on developing novel, best-in-class precision kinase inhibitors for a range of patients living with cancer and other unmet medical needs, announced today the sale of its cell-based BOXR programs to SOTIO, a clinical stage immuno-oncology company owned by PPF Group. Under the terms of the agreement, SOTIO will make an upfront payment of $8.1 million for the BOXR technology and will assume development of Unum's lead candidate, BOXR1030, which is on track for near-term entry into the clinic. In addition, Unum will be eligible to receive downstream milestones of up to $3.4 million. The sale to SOTIO will enable it to further advance its goal to develop the next generation of potent immunotherapies for patients with cancer. Unum will retain its antibody coupled T cell receptor (ACTR) technology and continues to explore strategic opportunities for the technology and assets. The sale is final as of August 28, 2020.
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