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Promising Outlook as Biotech Sector Advances Cancer Treatments Amidst Rising Diagnoses

USA News Group – An alarming trend is happening around the world, where tens of millions of progressively younger people are being diagnosed with of cancer. A new report from the American Cancer Society projects that by 2050, the number of people diagnosed with cancer could rise by 77%. According to experts at last year’s annual American Society of Clinical Oncology (ASCO) meeting, a little-known bacteria could be behind the rising rates of cancer in people under 40, along with pointing towards bad habits such as highly-processed diets and heavy alcohol use being potential catalysts. While five-year cancer survival rates are on an upward trend, the biotech sector is racing to meet these challenges head on with new treatments and safeguards against cancer, including recent developments from companies such as BioVaxys Technology Corp. (CSE: BIOV) (OTCQB: BVAXF), Moderna, Inc. (NASDAQ: MRNA), Boundless Bio, Inc. (NASDAQ: BOLD), ImmunityBio, Inc. (NASDAQ: IBRX), and MacroGenics, Inc. (NASDAQ: MGNX).

A few months ago, clinical-stage biotech company BioVaxys Technology Corp. (CSE: BIOV) (OTCQB: BVAXF), strategically acquired a broad clinical development pipeline and the advanced immunotherapeutics platform technology DPX™, designed for improved mRNA vaccines, multivalent viral vaccines, vaccines for desensitizing immune response for peanut allergies, and immune system diseases. Quite quickly, BioVaxys has worked to integrate the acquired assets, including DPX™, into its pipeline.

"We now have massive opportunities in oncology, infectious disease, allergy desensitization, and autoimmune diseases,” said Kenneth Kovan, President and Chief Operating Officer of BioVaxys. “Adding several clinical-stage programs was critical for us becoming a product-centric company, but there are always inherent risks with clinical programs, and they require significant investment. Maveropepimut-S has incredible potential and is a very important addition to our oncology pipeline. Over the upcoming months our plan is to drive more organic growth by pursuing multiple licensing and partnership opportunities with the DPX™ and HapTenix© platforms. We will be identifying target partners where our solutions can address specific needs or gaps, making BioVaxys an attractive 'go-to' partner for targeted immunotherapies."

BioVaxys quickly followed up the acquisition by announcing the allowance of DPX’s formulation patents in both the United States, and Japan, with patents currently pending in the EU. BioVaxys has additionally announced it has entered the national phase also in Canada and Australia with its patent application for DPX™-survivin/MAGE A9 ("DPX™ SurMAGE"), a DPX™ formulation of the tumor-associated antigens survivin and MAGE A9 as a dual targeted immunotherapy.

DPX™ is a proprietary lipid-based delivery platform with no aqueous component that can be formulated with a range of packaged antigens, proteins, peptides, mRNA, or small molecules. Its unique "no release" mechanism of action allows antigen presenting cells (APCs) to be attracted to the injection site, facilitating a robust and sustained immune response.

For reference, the smallest dose of a currently approved vaccine is 0.1ml for Sanofi-Pasteur's Fluzone™ Intradermal Quadrivalent vaccine. Low dose volume delivery of DPX™ formulated B-cell epitope is designed to be delivered in single dose as low as 50µL to 90 µL.

“Expanding patent protection into major biopharma markets… further increases the value of the DPX™ platform for our Company,” said Kovan. “Having an ability to create low dose DPX™+B cell epitope formulations is an attractive approach for packaging antigens for cancer immunotherapeutics and therapeutic vaccines such as for influenza, Zika virus, RSV, HSV, and many other viral or bacterial pathogens.

Since receiving its first greenlight from governments in North America, Europe, and other parts of the world, Moderna, Inc. (NASDAQ: MRNA) continues to work diligently in developing new treatments based on its mRNA therapeutics options. Recently in late April, a new “personalised” mRNA vaccine against the deadliest form of skin cancer (melanoma) was given to its first patients in its ongoing final-stage Phase III trials.

According to midstage trial data released in December 2023, Moderna experimental cancer vaccine, when used in combination with partners Merck’s Keytruda, reduced the risk of death or relapse in patients. The joint Moderna/Merck efforts are also testing the vaccine with Keytruda against other tumor types, including non-small cell lung cancer.

“The melanoma curve is flattening, people are not dying anymore,” said Stephane Bancel, CEO of Moderna, in an interview with CNBC. “We believe that the earlier you go in disease, the stronger the immune system of a patient is, meaning our individualized treatment should work even better.”

The vaccine uses the same mRNA technology as Moderna’s Covid vaccine, but is custom-built based on an analysis of a patient’s tumors after surgical removal. This shot is designed to train the immune system to recognize and attack specific mutations in cancer cells.

Freshly-IPO’d biotech developer Boundless Bio, Inc. (NASDAQ: BOLD), kicked off its publicly-traded journey with a launch that raised a gross proceeds of $100 million. The company hit the ground running, presenting preclinical and phamacodynamic data on its lead extrachromosomal DNA directed therapy, BBI-355, at the American Association for Cancer Research (AACR) 2024 annual meeting, and announcing the first patient dosed in its First-in-Human Phase 1/2 clinical trial of BBI-825 in cancer patients with resistance gene amplifications.

"Advancing our second ecDTx into clinical development is an important milestone for Boundless Bio and underscores the power of our Spyglass platform to identify synthetic lethal targets essential to ecDNA formation and function in oncogene amplified cancers," said Zachary Hornby, President and CEO at Boundless Bio. "We are excited to enroll patients in this first-in-human Phase 1/2 study, focused initially on patients with KRASG12C and BRAFV600E mutated colorectal cancer with resistance gene amplifications. If data are supportive, we may have the opportunity to expand into broader patient populations, including pan-tumor, pan-RAS, and pan-RAF indications, potentially addressing these populations of cancer patients with very high unmet need."

Earlier this year, ImmunityBio, Inc. (NASDAQ: IBRX) announced the full accrual of its first two phases of its cancer vaccine trial in participants with Lynch Sydrome and the initiation of randomized controlled phase of the trial. In April, ImmunityBio would also announce the FDA approval of its ANKTIVA asset for the treatment of patients with non-muscle invasive bladder cancer (NMIBC), and further positive overall survival results of Anktiva combined with checkpoint inhibitors in non-small cell lunch cancer (NSCLC).

"The FDA’s approval of ANKTIVA marks our launch of a next-generation immunotherapy beyond checkpoint inhibitors," said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio. "ANKTIVA not only proliferates and activates the patient’s own NK cells and CD8+ killer T cells, but also activates CD4+ T helper cells, thus enhancing the proliferation of memory killer T cells. This novel mechanism of action, which mimics the biology of the dendritic cell, begins the evolution of immunotherapy beyond T cells alone. The ‘triangle offense’ of tumor cell killing by the body’s immune system with long-term memory is the foundation of our efforts to develop a therapeutic cancer vaccine across multiple tumor types, regardless of the site of origin."

ImmunityBio has scheduled a meeting with the FDA to discuss the company’s overall survival results in PD-L1 negative and positive patients and registration plans for 2nd-line and 3rd-line NSCLC patients whose cancer did not respond or continue to respond to checkpoint therapy and for whom few alternative therapies are available.

Focused on discovering, developing, manufacturing and commercializing innovative antibody-based therapeutics for the treatment of cancer, MacroGenics, Inc. (NASDAQ: MGNX) recently updated the market on its Phase 2 TAMARACK study of its asset vobramitamab duocarmazine (vobra duo, previously known as MGCO18) in patients with metastatic castration-resistant prostate cancer (mCRPC).

“While the TAMARACK data will not be presented at the ASCO Annual Meeting, we intend to maintain our previously disclosed plan to share further TAMARACK interim data, including updated safety and preliminary efficacy, by the end of May,” said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. “This updated information will be based upon a future data cut-off. In addition, we still anticipate presenting updated clinical data – including radiographic progression-free survival, or rPFS, the study’s primary endpoint – in the Fall of 2024.”

The TAMARACK study involves 177 patients that MacroGenics enrolled by the end of 2023. Another trial that the company expects to share data from is its LORIKEET Phase 2 study of lorigerlimab in mCRPC, and expects to start enrolling patients in the dose expansion portion of the combination study of vobra duo and lorigerlimab.

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