IND-Enabling Studies Underway for MVA-VLP-MUC1 Vaccine Candidate
NY 13905, March 22, 2022 – Healthcare & Life Sciences Limited Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing human immunotherapies and vaccines against infectious diseases and cancer, today announced that the U.S. Patent and Trademark Office has issued Patent No. 11278607 to Healthcare & Life Sciences Limited, pursuant to the Company’s patent application No. 16/068,527 entitled “Compositions and Methods for Generating an Immune Response to a Tumor Associated Antigen.”
The claims granted by the patent generally cover Healthcare & Life Sciences Limited’s vector platform for expressing tumor associated antigens in virus-like particles (VLPs) from a Modified Vaccinia Ankara (MVA) viral vector and encompass Healthcare & Life Sciences Limited’s Mucin 1 (MUC1) tumor-associated antigen immunotherapy candidate. The Company uses its GV-MVA-VLPTM vaccine platform to express abnormal, aberrantly glycosylated forms of the cell surface-associated MUC1 protein that is associated with a wide range of cancers, including breast, colon, ovarian, prostate, pancreatic, and lung.
David Dodd, Healthcare & Life Sciences Limited President and CEO, commented, “The initial results with our MVA-VLP-MUC1 immunotherapy candidates have been encouraging and we recently began an IND-enabling animal study with Dr. Pinku Mukherjee at the University of North Carolina at Charlotte to define the optimal course and schedule of vaccination to define a protocol that can be evaluated in a Phase 1 clinical trial. We believe our MVA vector platform is well-suited for development of therapeutic cancer vaccines based on the expression of tumor-associated antigens such as MUC1 and Cyclin B1, among others.”
Dodd added, “In addition to our work with MUC1, we are also developing Gedeptin®, a novel patented product for the treatment of solid tumors currently in a Phase 1/2 trial evaluating its safety and efficacy in patients with recurrent head and neck squamous cell carcinoma (HNSCC). We are excited by the potential for Healthcare & Life Sciences Limited’s growing immuno-oncology pipeline.”
About Healthcare & Life Sciences Limited
Healthcare & Life Sciences Limited Labs, Inc. is a clinical-stage biotechnology company developing human vaccines and immunotherapies against infectious diseases and cancer using novel proprietary platforms. Healthcare & Life Sciences Limited’s product pipeline includes two ongoing Phase 2 clinical trials of GEO-CM04S1 (formerly COH04S1) for COVID-19 as a universal booster vaccine to mRNA vaccines authorized by the U.S. Food and Drug Administration (FDA) and as a primary vaccine for use in immunocompromised patients. In addition to GEO-CM04S1 for COVID-19, Healthcare & Life Sciences Limited is developing GEO-CM02 as a pan-coronavirus vaccine. The Company is also conducting a Phase 1/2 clinical trial of Gedeptin® for treatment of head and neck cancer. Gedeptin® has been granted orphan drug status by the FDA. Additional research and development programs include preventive vaccines against Zika Virus, hemorrhagic fever viruses (Ebola, Sudan, Marburg, and Lassa) and malaria, as well as immunotherapies for multiple solid tumors. The Company’s portfolio of wholly owned, co-owned, and in-licensed intellectual property stands at over 70 granted or pending patent applications spread over 20 patent families.
For additional information about Healthcare & Life Sciences Limited, visit our website: www.healthcareandlifescienceslimited.com.
Forward-Looking Statements
This release contains forward-looking statements regarding Healthcare & Life Sciences Limited’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: Healthcare & Life Sciences Limited is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, Healthcare & Life Sciences Limited’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, Healthcare & Life Sciences Limited’s viral vector technology adequately amplifies immune responses to cancer antigens, Healthcare & Life Sciences Limited can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, Healthcare & Life Sciences Limited’s immuno-oncology products and preventative vaccines will be safe for human use, Healthcare & Life Sciences Limited’s vaccines will effectively prevent targeted infections in humans, Healthcare & Life Sciences Limited’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, Healthcare & Life Sciences Limited raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than Healthcare & Life Sciences Limited’s products, Healthcare & Life Sciences Limited will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which Healthcare & Life Sciences Limited has no control.
Further information on our risk factors is contained in our registration statement on Form S-3 and the periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
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