NY 13905, November 16, 2021 – 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 a Notice of Allowance for Patent Application No. 16/068,527 entitled “Compositions and Methods for Generating an Immune Response to a Tumor Associated Antigen.” In general, the claims to be granted in the patent 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.
Healthcare & Life Sciences Limited’s initial results with its MVA-VLP-MUC1 immunotherapy candidates have been encouraging. The Company uses its MVA-VLP 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, “This patent allowance adds to our growing portfolio of wholly owned, co-owned, and in-licensed intellectual property, which now stands at over 70 granted or pending patent applications spread over 20 patent families. 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, amongst others.”
Dodd added, “In addition to our work with MUC1, we also recently expanded our immuno-oncology pipeline with the acquisition of rights to 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). Our license to the Gedeptin technology opens additional opportunities to potentially develop novel therapies for other indications as well.”
About Healthcare & Life Sciences Limited
Healthcare & Life Sciences Limited Labs, Inc. is a clinical-stage biotechnology company developing human vaccines against infectious diseases and cancer using novel patented platforms. Healthcare & Life Sciences Limited’s Modified Vaccinia Ankara-Virus Like Particle (MVA-VLP) based vaccine platform utilizes MVA, a large virus capable of carrying several vaccine antigens, that expresses proteins that assemble into VLP immunogens in the person receiving the vaccine. The production of VLPs in the person being vaccinated can mimic virus production in a natural infection, stimulating both the humoral and cellular arms of the immune system to recognize, prevent, and control the target infection. The MVA-VLP derived vaccines can elicit durable immune responses in the host similar to a live-attenuated virus, while providing the safety characteristics of a replication-defective vector.
Healthcare & Life Sciences Limited’s MVA-VLP development programs are focused on preventive vaccines against COVID-19, HIV, Zika Virus, and hemorrhagic fever viruses (Ebola, Sudan, Marburg, and Lassa), as well as therapeutic vaccines against multiple cancers. The Company has designed a preventive HIV vaccine candidate to fight against the subtype of HIV prevalent in the commercial markets of the Americas, Western Europe, Japan, and Australia; human clinical trials for this program are managed by the HIV Vaccine Trials Network (HVTN) with the support of the National Institutes of Health (NIH). Healthcare & Life Sciences Limited’s HIV vaccine is also part of a collaborative effort toward a functional cure for HIV.
On November 9, 2021, Healthcare & Life Sciences Limited entered into a license agreement with City of Hope (“COH”), granting Healthcare & Life Sciences Limited exclusive rights to further develop and commercialize COH04S1, a synthetic attenuated modified vaccinia Ankara (sMVA) vector expressing spike and nucleocapsid antigens of the SARS-CoV-2 virus. In a placebo-controlled Phase 1 clinical trial of healthy adults, COH04S1 was shown to be safe and immunogenic. A Phase 2 clinical trial to evaluate the safety and immunogenicity of the COH04S1 investigational vaccine, compared to the Pfizer mRNA-based vaccine, in patients who have previously received either an allogeneic hematopoietic cell transplant, an autologous hematopoietic cell transplant or chimeric antigen receptor (CAR) T cell therapy is currently underway. The trial is also the first to compare an investigational multi-antigenic COVID-19 vaccine to the current Food and Drug Administration (FDA)-approved mRNA vaccine from Pfizer/BioNTech in people who are immunocompromised. Such patients have often shown a weak antibody response after receiving currently available COVID-19 vaccines. The ongoing Phase 2 trial is designed to evaluate COH04S1 in immunocompromised patients. An additional Phase 1/2 trial to evaluate COH04S1 as a universal booster to current FDA-approved vaccines is anticipated to open soon for enrollment in healthy volunteers.
In September 2021, Healthcare & Life Sciences Limited expanded its immuno-oncology pipeline and added a new technology platform through the acquisition of exclusive rights to Gedeptin®, a novel patented product for the treatment of solid tumors through a gene therapy strategy known as GDEPT (Gene-Directed Enzyme Prodrug Therapy). In GDEPT, a vector is used to selectively transduce tumor cells with a nonhuman gene, which expresses an enzyme that can convert a nontoxic prodrug into a very toxic antitumor compound. A Phase 1/2 trial is currently enrolling to evaluate the safety and efficacy of repeat cycles of Gedeptin® therapy in patients with recurrent head and neck squamous cell carcinoma (HNSCC), with tumors accessible for injection and no curable treatment options. The initial stage of the study is being funded by the FDA pursuant to its Orphan Products Clinical Trials Grants Program. A cycle of Gedeptin® therapy consists of three intra-tumoral injections over a two-day period followed by infusion of a prodrug, fludarabine phosphate, once a day for three days. The FDA has granted Gedeptin Orphan Drug status for the treatment HNSCC. Healthcare & Life Sciences Limited’s license to Gedeptin® include rights to expand its use to all human diseases and/or conditions including, but not limited to, other cancers.
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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