Palm Beach, FL – October 25, 2023 – FinancialNewsMedia.com News Commentary  – The R&D for cancer vaccines has been growing in the last few years and is projected to continue through the next decade. A cancer vaccine is used to either prevent or cure a certain type of cancer. Vaccines used to treat already existing cancer are called tumor antigen vaccines or therapeutic cancer vaccines. Many vaccines that are already on the market or in the developed phase are autologous vaccines which means that they are created using samples from a patient and are to be used only for that patient. As studies have shown, certain cancers can develop due to cancerous cells which attack the immune system and tumors can generate if these cells are not destroyed.  However, there are certain types of cancer that can start due to viruses like cervical cancer or liver cancer. These viruses are called oncoviruses. In such cases, cancer vaccines can be used to either prevent cancer or treat it. The first cancer case was over 3000 BC old and till 2022 there is not one cure that can guarantee the treatment of the disease and millions of people continue to die every year due to cancer.  A report from Facts and Factors projected that the global cancer vaccines market size was worth around USD 6.45 billion in 2021 and is predicted to grow to around USD 19.27 billion by 2030 with a compound annual growth rate (CAGR) of roughly 14.75% between 2022 and 2030.  Active Biotech Companies active today in markets include:  Defence Therapeutics Inc. (OTCPK: DTCFF) (CSE: DTC), Jazz Pharmaceuticals plc (NASDAQ: JAZZ), Exelixis, Inc. (NASDAQ: EXEL), Amgen (NASDAQ: AMGN), Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN).

Facts and Factors said: “The global cancer vaccine market is projected to grow due to increasing research for the development of new cancer vaccines. International government bodies are laying extreme emphasis on developing vaccines for cancer that can be prevented by administering drugs beforehand. The European wing of the World Health Organization (WHO) has insisted its member states amp up their efforts in eradicating cervical cancer from the region and vaccines are expected to play a major role in these movements.  It continued: “One of the key restrictions for global market growth is the high failure rate the vaccines have generated in the past few years. All of the vaccines have failed to pass trials and the main reason is that the antigens lack the necessary immune systems as they are created using normal human proteins which means that they generate a weak response in the patient to fight the cancer cells. Another reason for trial failure is that the antigens are too similar to cancer protein. The low success rate is why many countries do not emphasize using vaccines.  The growing efforts by government authorities may increase cancer vaccine accessibility may provide growth opportunities while the limitations with cancer vaccines could be a major challenge during the projection period (2030).”

Defence Therapeutics Inc. (OTCPK: DTCFF) (CSE: DTC):  DEFENCE’S ACCUTOX® AND ANTIGEN CROSS-PRESENTATION: DISCOVERY LEADS TOWARDS THE DEVELOPMENT OF A GROUDNBREAKING PLATFORM – Defence Therapeutics Inc. (“Defence” or the “Company”), a leading Canadian biopharmaceutical company specialized in the development of immune-oncology vaccines and drug delivery technologies, is pleased to announce the discovery of a novel function for its lead anticancer injectable drug AccuTOX® in the context of cell-based cancer vaccine engineering.

The objective of the Accum® technology is to improve the accumulation of biomolecules such as antibodies, proteins or genetic material in target cells. Defence has discovered that the delivery of unconjugated Accum® exerts powerful and potent anti-cancer properties. This observation led to the engineering of AccuTOX®, a lead Accum® variant capable of halting the growth of pre-established lymphoma, melanoma and cervical cancer when co-delivered with different immune-checkpoint blockers.

The AccuTOX® mode of action summarized as follow: i) disruption of endosomal membranes, ii) production of reactive oxygen species, iii) inducing of genotoxic effect resulting in irreversible DNA damage, and iv) triggering immunogenic cell death, which can activate the immune system leading to the development of anti-tumoral immune responses. As such, AccuTOX® not only destroys cancer tumor cells from inside-out, but it can also stimulate an immune response to protect the host from subsequent tumor re-growth.

Surprisingly, transcriptomic analysis conducted on tumor cells treated with AccuTOX® unveiled yet another therapeutic and positive effect: antigen cross-presentation. This process is very important in the context of cancer immunotherapy as it will lead the team to the future design of cell-based anticancer vaccines, capable of priming CD8 T cells, which in turns can trigger cancer destruction. In fact, the Defence team has recently completed an in vitro study demonstrating how low AccuTOX® concentrations can indeed reprogram mesenchymal stromal cells to behave like antigen presenting cells akin to Defence’s lead ARM vaccine. Once validated, Defence can advance with an optimized second-generation of its ARM vaccine.

“This recent observation is indeed exciting and groundbreaking as it demonstrates how a single agent, AccuTOX®, can be used as an anticancer injectable at a specific concentration on a target, and as an agent suitable to engineer a cell-based vaccine when used at lower concentration on additional indications”, adds M. Plouffe, the CEO of Defence Therapeutics.

Additional studies are currently ongoing to further investigate the cross-presenting potency of AccuTOX®. The versatility of AccuTOX® is adaptable to various cancer indications as well as widen the scope of AccuTOX® application by providing a line of novel therapeutic products.   CONTINUED… Read this full Press Releases for Defence Therapeutics at:  https://defencetherapeutics.com/news-releases/

In other active biotech developments in the markets this week: 

Jazz Pharmaceuticals plc (NASDAQ: JAZZ) recently announced new data that examine the comorbid risk of cardiovascular disease in patients with narcolepsy and idiopathic hypersomnia as well as the effect of sodium intake on cardiovascular health. The Company will also present results from the real-world TENOR study on individualized dosing regimens for adults with type 1 or type 2 narcolepsy transitioning to low-sodium Xywav^® (calcium, magnesium, potassium, and sodium oxybates) oral solution from high-sodium Xyrem^® (sodium oxybate) oral solution. The study will be presented today at the World Sleep 2023 Congress in an oral session on evidence-based approaches for optimizing pharmacologic treatment for narcolepsy.

Xywav is the first and only low-sodium oxybate approved in the U.S. for the treatment of cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy and for the treatment of idiopathic hypersomnia in adults. Xywavcontains the same active moiety as Xyrem, but the maximum recommended nightly dose contains only 131 mg of sodium, which is 92% less sodium than the 1,640 mg of sodium contained in the maximum recommended nightly dose of Xyrem. At the maximum recommended dose, the sodium content in Xyrem equates to 109% of the American Heart Association’s daily ideal sodium intake for most adults, while the sodium content in Xywav accounts for less than 10% of this standard. This substantial reduction could allow patients switching from Xyrem to Xywav to achieve a daily sodium intake target of 2,300 mg, and ideally 1,500 mg, as set by the American Heart Association.

Exelixis, Inc. (NASDAQ: EXEL) recently announced detailed results from CABINET, a phase 3 pivotal trial evaluating cabozantinib (CABOMETYX^®) compared with placebo in two cohorts of patients with previously treated neuroendocrine tumors: one cohort of patients with advanced pancreatic neuroendocrine tumors (pNET) and a second cohort of patients with advanced extra-pancreatic NET (epNET). The study met the primary objective for each cohort, demonstrating that cabozantinib provided dramatic improvements in median progression-free survival (PFS) for the patients in the pNET and epNET cohorts. The data are being presented today at 8:40 a.m. CET during the Proffered Paper Session – NETs and Endocrine Tumours at the 2023 European Society of Medical Oncology (ESMO) Congress (LBA53) by the Alliance for Clinical Trials in Oncology. CABINET is sponsored by the National Cancer Institute (NCI), part of National Institutes of Health, and is led by the NCI-funded Alliance for Clinical Trials in Oncology and conducted by the NCI-funded National Clinical Trials Network Group.

“Although progress has been made in recent years, there remains a critical need for new and effective therapies for patients with advanced neuroendocrine tumors. Given that there is no standard treatment for patients with progressive disease, these results showing notable improvements in progression-free survival are highly encouraging for patients and their physicians,” said Jennifer Chan, M.D., M.P.H., study chair for the CABINET trial and Clinical Director of the Gastrointestinal Cancer Center and Director of the Program in Carcinoid and Neuroendocrine Tumors at Dana-Farber Cancer Institute. “I am pleased to present these important findings at ESMO today, as they underscore the potential of cabozantinib as a much-needed new treatment option for this disease, which is rising in incidence.”

Amgen (NASDAQ: AMGN) recently announced data from the global Phase 3 CodeBreaK 300 trial evaluating two doses of LUMAKRAS^® (sotorasib) (960 mg or 240 mg) in combination with Vectibix^® (panitumumab). Both doses demonstrated a statistically significant superiority in progression-free survival (PFS) over the investigator’s choice of therapy in patients with chemorefractory KRAS G12C-mutated metastatic colorectal cancer (mCRC). The results are being presented today at the Presidential Symposium 2 session as a late-breaking oral presentation (LBA10) during the European Society for Medical Oncology (ESMO) 2023 Congress in Madrid, Spain, with simultaneous publication in the New England Journal of Medicine.

“The CodeBreaK 300 trial demonstrated the benefit of LUMAKRAS plus Vectibix to deliver statistically significant PFS outcomes for patients compared to the investigator’s choice of therapy, offering new hope to this population with historically poor outcomes,” said David M. Reese, M.D., executive vice president, Research and Development at Amgen.

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi recently announced that positive results from a Phase 3 trial evaluating the investigational use of Dupixent^® (dupilumab) showed consistent efficacy and safety for up to one year (52 weeks) in children aged 1 to 11 years with eosinophilic esophagitis (EoE). These results represent the first analysis of longer-term data in this age group and will be featured in a late-breaking session on October 25 at the American College of Gastroenterology (ACG) 2023 Annual Scientific Meeting.

“Eosinophilic esophagitis, or EoE, is a chronic and debilitating condition that can impact children in their most vulnerable years of life, causing persistent difficulties with eating, abdominal pain, and/or failure to thrive,” said Mirna Chehade, M.D., MPH, Mount Sinai Center for Eosinophilic Disorders, Icahn School of Medicine at Mount Sinai, New York and principal investigator of the trial. “Dupilumab is the first and only therapeutic approved for adults and certain adolescents with EoE. Some children with EoE may have sub-optimal response to currently unapproved standard of care therapies, underscoring the need for treatments targeting key pathways driving inflammation in EoE. Data from this Phase 3 trial support the potential of dupilumab to treat EoE in children, with sustained efficacy and safety, which is particularly critical for these children.”

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