Palm Beach, FL – January 25, 2021 Ovarian cancer is one of the most deadly gynecologic malignancy across the globe, but new treatments are gaining increased efficacy while displaying reduced toxicity. Clinical trials abound. Immunotherapy using immune-checkpoint modulators has been revolutionizing the oncology field far beyond their remarkable clinical efficacy in some patients. It creates radical changes in the evaluation of treatment efficacy and toxicity with a more holistic vision of the patient with cancer. An article in Nature.com recently said that: “The paramount achievement in cancer treatment in the last decade has undoubtedly been the introduction of T cell targeted immunomodulators blocking the immune checkpoints CTLA-4 and PD1 or PDL1… Anti-PD1/PDL1 antibodies have become some of the most widely prescribed anticancer therapies. T-cell-targeted immunomodulators are now used as single agents or in combination with chemotherapies as first or second lines of treatment for about 50 cancer types. There are more than 3000 active clinical trials evaluating T cells modulators, representing about 2/3 off all oncology trials.” Active biotech companies in the Covid-19 developments this week include BioVaxys Technology Corp. (OTCPK: LMNGF) (CSE: BIOV), VBL Therapeutics (NASDAQ: VBLT), iBio, Inc. (NYSE: IBIO), Infinity Pharmaceuticals Inc (NASDAQ: INFI), Adamis Pharmaceuticals Corporation (NASDAQ: ADMP).
The Nature.com article continued: “One of the most impressive successes of ICI has been long term remission in spite of treatment discontinuation, raising substantial hope for cure for some patients. This is particularly well documented in melanoma patients who achieve a complete response, meaning a complete disappearance of all visible metastases. This is the case for about 20% of patients with melanoma treated with anti-PD1 with or without anti-CTLA-4. It is now widely accepted that treatment can be discontinued for such patients, after at least 6 months of therapy since their risk of relapse is estimated to be less than 10% over the 5 year follow-up that is available today. Such long complete remission of the disease was totally unimaginable before the era of ICI. However, not all cancer types respond as well as melanoma and data on the possibility to discontinue therapy is not as mature for other cancers. Yet, ten years ago, just before the era of immune checkpoint inhibitors (ICI), solid tumor immunotherapy was in a grim situation. It was based on immunocytokines such as interleukin-2 or alpha-interferon that were poorly effective and highly toxic. Clinical research trials had tested diverse forms of cancer vaccines that were mostly ineffective. Immunotherapy had a small and shrinking audience at international oncology meetings while sessions related to the new booming field of targeted therapy were overflowing. However, after the first success of ICI immunotherapy and until today, the situation has reversed, immunotherapy leads the field and immunologists have regained a major influence in cancer research as illustrated by the attribution of the 2018 Nobel Prize in Medicine to the two immunologists who were at the origin of the concept of ICI-based immunotherapy, James Allison and Tasuku Honjo.”
BioVaxys Technology Corp. (OTCPK: LMNGF) (CSE: BIOV.CNQ) BioVaxys Announces Initiation of Cancer Vaccine EU Clinical Program, Completion of BVX-0320 Preclinical Program, and Vaccine Platform Expansion – BioVaxys Technology Corp. (“BioVaxys”) is pleased to provide a corporate update on recent advancements of its vaccine platforms, viral diagnostic and corporate objectives for 2021. BioVaxys is pleased to announce that it has commenced the clinical development program for BVX-0918A, its haptenized tumor antigen vaccine for ovarian cancer. The Company plans to seek a compassionate use approval in the European Union (“EU”) for Stage III & Stage IV ovarian cancer, followed by submitting an IND in the US. BioVaxys is in discussions with its designated Contract Manufacturing Organization (“CMO”) and anticipates the execution of a manufacturing contract in 1Q21. The Company plans to submit its Clinical Trial Application (“CTA”) for BVX-0918A with the European Medicines Agency (“EMEA”) later this year.
There are significant unmet therapeutic needs for ovarian cancer treatment. Over 240,000 women are currently diagnosed with ovarian cancer worldwide, and over 140,200 succumbed to the disease. Ovarian cancer is the leading cause of death from gynecologic malignancy in the United States. An estimated 21,750 new cases of ovarian cancer are expected in the United States in 2020 with 13,940 deaths. The case-to-fatality ratio is nearly three times that of breast cancer and makes ovarian cancer the deadliest gynecologic malignancy in developed countries. Like other cancers, the stage of disease is inversely proportional to survival. The 5-year relative survival rate in all stages of the disease is approximately 45%. However, ovarian cancer is usually asymptomatic in the early stages (Stage I and Stage II), and therefore about 80% of patients are diagnosed with advanced stage disease (stages III and IV). The 5-year survival rate for stage III and IV patients is approximately 29%.
BioVaxys has developed its vaccine technology platforms based on the established immunological concept that modifying tumor or viral antigens with simple chemicals called haptens makes them more visible to the immune system. The process of haptenization “teaches” a patient’s immune system to recognize and make target proteins more ‘visible’ as foreign, thereby stimulating an immune response. In Phase I and Phase II clinical studies previously conducted by BioVaxys, co-founder and Chief Medical Officer, David Berd MD, using an earlier generation of the BioVaxys cancer vaccine on nearly 500 patients with melanoma or ovarian cancer, the haptenized cell platform showed significant clinical promise. BioVaxys Founder, President & Chief Operating Officer Ken Kovan says: “The autologous approach may have advantages over other approaches, such as those involving a search for specific antigens. Because autologous tumor cells by definition have the patient’s unique set of antigens already on them, the challenge is to increase the immune system’s ability to recognize the ovarian tumor cells as foreign, breaking the “self-tolerance”. A way to achieve this is by the use of a hapten, which is the foundation for the BioVaxys’ haptenized protein vaccine platform.”
BioVaxys intends to develop its vaccine together with a “checkpoint inhibitor” that reduces or decreases the cellular function of an immune checkpoint gene or gene product. Checkpoint inhibitors are a type of drug that blocks proteins called ‘checkpoints’ that are made by some types of immune system cells, such as T cells and some cancer cells. These checkpoints help keep immune responses from being too strong, but also can sometimes keep T cells from killing cancer cells. When these checkpoints are blocked, T cells can more effectively kill cancer cells. BioVaxys’ focus is on combinations of immune checkpoint inhibitors with its haptenized tumor antigen vaccine—primarily anti-CTLA4, anti-PD1, or PDL1 checkpoint antibodies—for treatment of ovarian cancer and other solid tumors. BioVaxys’ rationale is that there is (1) a persistent unmet clinical need because the majority of ovarian cancer patients do not benefit from anti-checkpoint monotherapy; (2) evidence that not all patients make immune responses to their tumors; (3) evidence that immune responses to autologous tumor antigens can be induced by patient-specific vaccines; and (4) clinical evidence from the pre-checkpoint era that suggests survival can be positively impacted by such patient-specific vaccines.
BioVaxys also recently completed its preclinical program for its SARS-CoV-2 vaccine candidate, BVX-0320, which included those studies suggested by the U.S. Department of Health and Human Services, Food and Drug Administration (“FDA”) Center for Biologics Evaluation and Research “(CBER”) in their published guidance on Development and Licensure of Vaccines to Prevent COVID-19.
Source: (1) American Cancer Society, Cancer facts and figures; (2) Cannistra SA. Cancer of the Ovary. N Engl J Med 2004 Dec 9;351(24):2519-29; and (3) McGuire WP, Hoskins WJ, Brady MF, Kucera PR, Partridge EE, Look KY, et al. Cyclophosphamide and cisplatin compared with paclitaxel and cisplatin in patients with stage III and stage IV ovarian cancer. N Engl J Med 1996;334(1):1-6.
The FDA’s non-binding Guidance is intended to assist in the clinical development and licensure of vaccines for the prevention of COVID-19, and reflect the Agency’s current thinking on the issue. Conducted by Charles River Laboratories, Inc. under contract with BioVaxys, the preclinical program which began in September 2020 evaluated the anti-virus immune response elicited by BVX-0320 in a controlled murine model by measuring the development of antibodies to the protein that binds the virus to human cells. Following two injections of BVX-0320 together with the immunological adjuvant, QS21, to 28 mice at four dosage levels, 96.4% developed positive antibody responses detected at week 6. The BioVaxys team also found that its haptenized SARS-CoV-2 s-spike vaccine activated CD4+ helper T-cells and CD8+ killer T-cells that express the activation markers, CD69 and CD25. This result indicates that immunization with BVX-0320 at two different dose levels of 3µg or 10µg stimulated immune system memory ‘helper’ T-cells as well as killer T-cells. CD4+ T-cells are crucial in achieving a regulated effective immune response to viral pathogens, and are central to adaptive immune responses. Generated following an immune response, memory ‘helper’ CD4+ T-cells retain information about the virus, which enables them to respond rapidly after viral exposure. CD8+ T-cells have the capacity to kill cells infected by the virus, thereby stopping viral replication in those cells. Read this full release and more news for BioVaxys Technology at: https://www.financialnewsmedia.com/news-biov/
Other recent developments in the biotech industry include:
VBL Therapeutics (NASDAQ: VBLT) recently announced the expansion of its ongoing OVAL Phase 3 study investigating ofranergene obadenovec (VB-111), for the treatment of platinum-resistant ovarian cancer into Europe, where the first patient has now been enrolled. The study continues to actively recruit patients in the U.S. and Israel, with over 200 patients enrolled to date.
“VB-111 is our proprietary anti-cancer gene therapy product candidate that has shown overall survival benefit across multiple tumor types,” said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. “We are pleased to expand the OVAL potential registration study of VB-111 in patients with late stage ovarian cancer to Europe, which is expected to accelerate our recruitment pace, diversify the patient population in the study and support our dialogue with European regulatory authorities as we get closer to potential commercialization. If successful and approved, VB-111 has the potential to establish a new standard of care in a challenging disease setting where patients currently have limited options.”
iBio, Inc. (NYSE American: IBIO) a biotech innovator and biologics contract manufacturing organization, recently announced the appointment of Martin B. Brenner, DVM, Ph.D., as its Chief Scientific Officer (“CSO”), effective January 18, 2020.
“We are thrilled to have Dr. Brenner join our team,” said Tom Isett, Chairman & CEO of iBio. “Given his prior experience leading organizations with novel protein expression platforms to build proprietary product pipelines, Dr. Brenner should be uniquely suited to assist iBio with a similar transformation. Notably, he also brings a track-record of effective new target search and evaluation, as well as establishing productive collaborations.”
Infinity Pharmaceuticals Inc (NASDAQ: INFI) will be presenting data from MARIO-275 on the first day of the American Society of Clinical Oncology (ASCO) 2021 Genitourinary Cancers Symposium to be held virtually, February 11-13, 2021. MARIO-275 is a randomized, placebo- controlled Phase 2 study evaluating the benefit of adding eganelisib to nivolumab (Opdivo®) in platinum-refractory, I/O naïve patients with advanced urothelial cancer over nivolumab monotherapy, which is approved in this setting.
Infinity is an innovative biopharmaceutical company dedicated to advancing novel medicines for people with cancer. Infinity is advancing eganelisib, a first-in-class, oral immuno-oncology development candidate that selectively inhibits PI3K-gamma, in multiple clinical studies. MARIO-275 is a global, randomized, placebo-controlled combination study of eganelisib combined with Opdivo® in I/O naïve urothelial cancer. MARIO-3 is the first eganelisib combination study in front-line advanced cancer patients and is evaluating eganelisib in combination with Tecentriq® and Abraxane® in front-line TNBC and in combination with Tecentriq and Avastin® in front-line RCC. In collaboration with Arcus Biosciences, Infinity is evaluating a checkpoint inhibitor-free, novel combination regimen of eganelisib plus etrumadenant (dual adenosine receptor antagonist) plus Doxil® in advanced TNBC patients. With these studies Infinity is evaluating eganelisib in the anti-PD-1 refractory, I/O-naïve, and front-line settings.
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) recently announced the submission of an Investigational New Drug (IND) to FDA for the investigational use of Tempol for the treatment of Coronavirus (COVID-19). The submission of the IND to FDA followed a Pre-IND meeting with FDA in which FDA gave specific recommendations on Chemistry, Manufacturing and Controls (CMC) and Clinical aspects to be included in the IND. The Company plans to seek government and/or non-government funding to study the treatment and prevention of COVID-19 with Tempol.
Tempol has demonstrated both potent anti-inflammatory, anticoagulant, and antioxidant activity. Both inflammatory cytokines and reactive oxygen species (ROS) from cells of the immune system called macrophages and neutrophils damage the lung in Acute Respiratory Distress Syndrome (ARDS). In animal models, Tempol has been shown to decrease proinflammatory cytokines (cytokine storm), and through its potent antioxidant activity has been shown to decrease the harmful effects of ROS. In addition, Tempol has been shown to decrease platelet aggregation, a problem observed in many COVID-19 patients. Numerous published articles describing animal models of ARDS show Tempol to cause a decrease in lung inflammation and preserve lung pathology associated with acute and chronic lung injury. To this end, Tempol has been shown to decrease the genes (HIF-la and HIF-2a) associated with hypoxia. Hypoxia is a key indicator often associated with severe disease and a poor outcome. Controlling hypoxia and the cytokine storm can be considered essential to the successful treatment of COVID-19.
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