Palm Beach, FL – February 10, 2021 – The incidence of cancer is increasing every year and it has been the major factor for the growth of the cancer vaccines market. Healthcare physicians are looking for alternate therapies, due to the huge burden of cancer cases and the side effects of the present therapies. Hence, the market for cancer vaccines is expected to continue to grow at a high rate. Cancer vaccines are considered to be a new therapy and are not popular, as compared to the other alternative therapeutic drugs. However, cancer vaccines have shown great potential in both preventive and therapeutic ways. Certain factors that are driving the Cancer Vaccines market’s growth include the increasing number of cancer cases, rising investments and government funding in the development of cancer vaccines, and technological developments in cancer vaccines. A report from Fortune Business Insights said that “The increasing prevalence of cervical cancer among female population is a key factor boosting the global Human Papillomavirus Vaccine market growth. In addition to this, the increasing need to reduce HPV infections will also add impetus to the growth in the coming years. Moreover, the governments in several countries are engaging in imposing stringent policies for supplying vaccines to eradicate the burden of this disease thereby boosting the growth of the market in the coming years.” Active biotech companies in the Covid-19 developments this week include KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), BioVaxys Technology Corp. (OTCPK: LMNGF) (CSE: BIOV), Heat Biologics, Inc. (NASDAQ: HTBX), Tyme Technologies, Inc. (NASDAQ: TYME), Onconova Therapeutics, Inc. (NASDAQ: ONTX).
The Fortune report projected that The global Human Papillomavirus (HPV) Vaccine market size was valued at USD 3.80 billion in 2019 and is projected to reach USD 12.69 billion by 2027, exhibiting a CAGR of 16.3% during the forecast period. “North America (has recently) held the largest HPV vaccines market share with a revenue of USD 1.83 billion. This is attributable to the presence of well-established healthcare services, coupled with the ease of availability of necessary resources. Additionally, people are well aware about the presence of vaccines and other therapeutic procedures. The rise in preference for vaccination and treatment at the nearest healthcare institution will also add impetus to the regional market growth.”
BioVaxys Technology Corp. (OTCPK: LMNGF) (CSE: BIOV.CNQ) BREAKING NEWS: BioVaxys and Procare Health Announce Broad CO-Development, JOINT Commercialization and Marketing Collaboration for Cancer and Viral Vaccines – BioVaxys Technology Corp. (“BioVaxys”), the world leader in haptenized protein vaccines for antiviral and cancer applications, and Procare Health Iberia, S.L., of Barcelona, Spain (“Procare Health”), a leading privately-held European pharmaceutical company, announced today that they have entered into a broad collaboration for the co-development, joint commercialization, and marketing of BioVaxys vaccines for ovarian cancer, cervical cancer, and human papilloma virus (“HPV”), and the right of first refusal for marketing by BioVaxys in the United States of Procare Health’s vaginal gel product, Papilocare™, the world’s first and only product to prevent and treat HPV-dependent cervical lesions. Left untreated, HPV infection generally leads to cervical cancer (World Health Organization, HPV and Cervical Cancer, 11 November 2020). Formed in 2012 as a spin-out from Procter & Gamble Pharmaceuticals, Procare Health is a market leader in the women’s health field in the European Union (“EU”), with marketed products including Papilocare™, Libicare™, Palomacare™, Idracare™, Pronolis HD™ and Ovosicare™.
Under the terms of the agreement, which was executed on February 9th, 2021, the companies will jointly conduct a Phase I Clinical Study of BVX-0918A in Spain, BioVaxys’ autologous haptenized protein vaccine for late-stage ovarian cancer. BioVaxys will be responsible for the core technology and vaccine production, with Procare Health overseeing and making an in-kind investment in the clinical program and regulatory planning, CRO management, patient/clinical center recruitment, marketing, and opinion leader management. Both companies have agreed to equally share costs associated with engaging a European clinical research organization (“CRO”) to conduct the study. In return, Procare Health will have exclusive rights to market and distribute BVX-0918A in the European Union (“EU”), and the United Kingdom. Clinical data from the Spanish Phase I study will be used by BioVaxys to support its planned IND for BVX-0918A in the US next year, as well as for all other global markets. The two companies will be working out any remaining details by end of 2Q21.
BioVaxys President and Chief Operating Officer Ken Kovan said “This co-development gives BioVaxys access to Procare Health’s clinical development and regulatory expertise in the EU, and to its marketing & sales presence in Europe.” Kovan added that “Procare Health has an established portfolio of marketed brands that is focused heavily on the women’s health and gynecological oncology markets. As we anticipate that these will be the primary users of our ovarian cancer vaccine, the relationship with Procare Health will give access to key gynecological oncology opinion leaders for patient access, clinical trial recruitment, and a relationship that post-approval will drive vaccine sales. Having a strong EU opinion leader network will also be invaluable for our planned US launch of the vaccine.”
The collaboration with BioVaxys will help Procare Health fuel its product offerings in the gynecological oncology field. Yann Gaslain, CEO of Procare Health stated, “We are thrilled to start working the collaboration with BioVaxys as it brings a new hope in the field of gynecological cancer. We have been working for 8 years in the area of cervical cancer and HPV, investigating to understand how the immune response of the host could be stimulated to help defend versus HPV infection and persistency, and we believe that the new haptenized cell platform technology can bring a valid answer to this unmet therapeutical need, mainly when high grade lesions of the cervix or even cervical carcinoma have been characterized. The promising vaccine technology platform of BioVaxys will likely help bringing response in ovarian and cervical cancer¨
In Phase I and Phase II clinical studies previously conducted by BioVaxys, co-founder and Chief Medical Officer, Dr. David Berd, 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 has developed its vaccine technology platforms based on the established immunological concept that modifying proteins 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.
Javier Cortés, MD, Specialist in Gynecology and Cytology for the international Academy of Cytology (Chicago, USA), member of the Spanish association against Cancer (AECC) and of the European Cervical Cancer Association (ECCA) stated, “I believe that the planned clinical trial in Phase I is of a very high interest based on my experience in oncology for more than 30 years. The immunotherapy is a line of treatment with very active investigation and promising early results in some cancers (lungs, melanoma and ovarian). That is why, every single line of investigation well based and with consistent criteria of quality in the design of the investigation should be very well received and encouraged.” Continued…. 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:
KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of small molecule protease inhibitors, recently announced positive topline data from a Phase 2 clinical trial demonstrating statistically and clinically significant efficacy of KVD900 as an oral on-demand treatment for hereditary angioedema (HAE) attacks.
“We are very excited to share this positive data which shows that KVD900 is the first oral therapy to achieve clinical efficacy results comparable to current injectable therapies, while also demonstrating a promising safety and tolerability profile. The rapid onset of symptom relief and significant reduction in the use of rescue medication show that patients can confidently take KVD900 at the earliest signs of an attack and avoid the burden and discomfort of injections,” said Andrew Crockett, Chief Executive Officer of KalVista. “We look forward to working with regulatory agencies to bring the many advantages of KVD900 to patients as quickly as possible. In parallel, we remain committed to advancing our oral HAE franchise, with submission of an IND this quarter for KVD824 as a prophylactic treatment and ongoing preclinical work on our oral Factor XIIa program.”
Heat Biologics, Inc. (NASDAQ: HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, including multiple oncology product candidates and a novel COVID-19 vaccine, recently reported positive interim data of the Company’s fully-enrolled Phase 2 trial of HS-110, in combination with Bristol-Myers Squibb’s (NYSE: BMS) OPDIVO® (nivolumab) in advanced non-small cell lung cancer (NSCLC). HS-110 is an “off-the-shelf” allogeneic cell-based therapy designed to activate patients’ immune system against multiple cancer testis antigens to elicit a diverse and robust immune response against tumor cells.
Substantial survival benefit was observed in a cohort of previously treated, checkpoint inhibitor naïve patients with advanced NSCLC (Cohort A, N = 47). A median progression free survival (PFS) of 1.8 months and a median overall survival (OS) of 24.6 months was observed with a median follow-up time of 19.4 months. The one-year survival rate of Cohort A is 61.7%. The median OS data was 12.2 months and the 1-year survival rate was 50.7% in previously treated, advanced NSCLC patients who received nivolumab as a single agent, according to published data of the BMS CheckMate 057 study1. Our data suggests that addition of HS-110 to a checkpoint inhibitor has the potential to improve survival benefit for checkpoint inhibitor naïve NSCLC patients.
Tyme Technologies, Inc. (NASDAQ: TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs™), recently announced that it has received notification that the United States Patent and Trademark Office has granted additional patent claims related to the Company’s metabolomic technology platform. The patent, U.S. Patent No. 10,905,698, is directed to methods for treating COVID-19.
Unlike immune therapies that depend upon the structure of the external virus coat of COVID-19 where the therapy directs its attack, we believe TYME-19 is agnostic to this structure and any mutations to the viral coat. Like other TYME agents, TYME-19 affects cellular metabolism. It constrains viral replication after a virus has inserted its genetic blueprint into an infected cell by inhibiting the ability of the virus to use the cells synthetic apparatus to make viral proteins and lipids. As a result, we believe that TYME-19 diminishes the ability of COVID-19 to hijack an infected cell. TYME intends to initiate the appropriate clinical trials to substantiate the safety and efficacy of TYME-19.
Onconova Therapeutics, Inc. (NASDAQ: ONTX), a biopharmaceutical company focused on discovering and developing novel products to treat cancer, recently announced receipt of U.S. Food and Drug Administration (FDA) permission for a Phase 1 study to proceed under the Company’s Investigational New Drug application (IND) for ON 123300, a proprietary, differentiated, first-in-class multi-kinase inhibitor.
“We are grateful to receive this timely, favorable response from the FDA to initiate a Phase 1 trial with ON 123300,” said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova. “We are advancing the process to secure Institutional Review Board approval, and affirm our expectation that the first patient will be enrolled during the first half of 2021.”
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