Monoclonal antibodies (Amgen/Medarex)

Pictured: Chart showing rapid growth/iStock, Geerati Analysts at GlobalData report that the oncology drug market is tilting toward biologics, and that the total market for these drugs will continue to grow rapidly, reaching $786 billion by 2029. This tremendous growth is largely due to biologics’ effectiveness in treating rare solid tumors, according to the report. In contrast to chemically synthesized drugs such as small molecules, biologics are bioengineered from a variety of starting points such as proteins or living cells. Although small molecules have been the dominant type of therapy on the market for decades, the rise of biologics is changing this. In 1998, Rituximab, the first approved biologic drug, was introduced into the oncology market. Many more biologics have followed over the years, not only for cancer but for several other diseases as well. The total market value for biologics went from $124 billion in 2009 to $418 billion in 2022. Small molecules generated $354 billion last year, the GlobalData report found. This margin is forecast to expand over the years, with biologics expected to generate $786 billion and small molecules $548 billion in 2029. GlobalData reports that monoclonal antibodies alone are projected to account for more than 40% of the total 2029 biologics revenue. Jasper Morley, a drugs intelligence analyst at GlobalData, noted that within the solid tumor indication, the proportion of biologics drugs is already much higher than that of small molecules. The report shows that biologics currently account for 20% of all drugs, 51% of oncology drugs and 64% of oncology drugs targeted at solid tumors. Among the biologics topping the oncology market is Kite Pharma’s Yescarta, a CAR T cell therapy. Approved in 2017 as a treatment for non-Hodgkin lymphoma, Yescarta is predicted to generate sales of about $2.5 billion in 2029 alone. Warner Biddle, global head of commercial at Kite (a subsidiary of Gilead), said that although cell therapy is still a nascent technology and a relatively small part of the overall market, the market potential for cell therapies like Yescarta is much larger than current sales figures indicate. “When we do our market research . . . we know that we are treating, in the U.S. at least, roughly two out of ten [eligible] patients,” Biddle explained. In Europe, four or five out of every ten eligible patients are treated with Yescarta. Katherine Rubino, a partner at the law firm Caldwell who advises life science companies, noted that there are many indications where CAR T cells are gearing up to see a boom in the coming years. Morley attributes the success of biologics in the global market to their effectiveness against difficult rare cancers that small molecules cannot treat. He said several tumors exhibit rare mutations that make it challenging for small molecules, which are limited in scope, to treat. Biologics, however, are designed to handle such peculiarities. “Biologics are the dominating molecule type within solid tumors as they possess a variety of mechanisms to treat solid tumors, which small molecules do not possess,” he said. Rubino observed that another driver of growth for the biologic oncology market is the increased incidence of cancer. According to a report from the International Agency for Research on Cancer, cancer cases rose from 18.1 million in 2018 to 19.3 million in 2020, with solid tumors such as breast cancer remaining the most common cancer type worldwide. Rubino said that the growing number of cancer cases is driving many biopharmaceutical companies in search of new treatment options, and many of them have come to trust the ability of biologics to target specific tumors. “It’s not surprising that within the oncology market, specifically solid tumors, biologics are starting to dominate,” said Alex Watt, a principal research analyst for GlobalData who specializes in drug pricing. Watt said the report bears out current market trends. “We’ve been seeing more and more biologics entering the market for various indications, not just oncology,” she noted. Biddle echoed this, saying, “There is an opportunity to use CAR T cell therapies potentially in areas outside of oncology, like autoimmune diseases, and if that happens, that will expand this market even further and further generate potential in this space.” For example, the FDA announced the approval of Tezspire for the treatment of asthma in 2021. Last year, the regulator approved Novo Nordisk’s Tresiba biologic for diabetes, and this year, AbbVie’s oral biologic Rinvoq (upadacitinib) was approved for moderate to severely active Crohn’s disease. Morley noted that the biologics market is changing as big pharmas that initially made generic drugs branch into the market, a practice that was alien in the early days of the industry when biologics were exclusively made by specialized companies such as Amgen. Rubino warned, however, that the rapid growth of the biologics market might be dampened by high cost, especially in the U.S., given its lack of universal government-funded health insurance. Biologics drugs are costly to manufacture and, consequently, priced higher than small molecule drugs, making insurance companies reluctant to cover them. She suggested that the market in the U.S. could be affected if insurance companies prefer small-molecule drugs because of their affordability. “It will be interesting to see how insurance companies handle reimbursement and if they suggest using small molecules as first-line therapy in a step-wise approach to treatment,” she said. Patience Asanga is a Nigeria-based freelance science journalist who writes about the environment, biotechnology and life sciences.

COLLEGE STATION, TX / ACCESSWIRE / August 24, 2023 / Biogenysis, Inc. (OTC PINK:ENZC) (or the "Company"). Biogenysis, a subsidiary of Enzolytics, Inc., announces the progress of its Patent Cooperation Treaty (PCT) application covering its inventions relating to Anti-SARS-CoV-2 Monoclonal Antibodies. The PCT application has now advanced to filing as a U.S. National Stage Application in the U.S. Patent Office and as a formal European Patent Organization (EPO) application. The EPO application makes possible coverage in the 39 contracting countries within the EPO. These countries include all of the countries in the European Union, the United Kingdom and the extensive list totally 39 member countries throughout Europe and adjacent regions. The pending applications contain 23 separate patent claims covering (1) the 19 discovered highly conserved antigens and epitopes (sites) on the SARS CoV-2 virus, (2) antibodies that bind to the disclosed antigens and epitopes, (3) vaccines based on the antigens, (4) methods of treating, preventing, or reducing the risks of SARS CoV-2 infection with the antigens or binding proteins, and (5) methods and kits for detecting or diagnosing infection by SARS CoV-2 using the antigens or binding proteins. Through computer analysis (Artificial Intelligence (AI)), the Company discovered 19 immutable conserved virus sites on the COVID-19 virus by analyzing 2.8 million SARS CoV-2 isolates. This analysis identified these critical, conserved, immutable epitopes of the virus. These sites are now claimed as patentable based on their novel specificity and the finding that they are conserved on SARS-CoV-2. This is significant because antibodies produced to bind to these conserved, immutable sites can neutralize the virus without the possibility of "virus escape" due to virus mutation. Specifically, virus mutants will still contain these target sites allowing these specialized monoclonal antibodies to neutralize the virus even as it mutates. The Company's patent applications claim the use of any one identified epitope or any combination of any of the multiple identified epitopes in any of the following ways: For producing a therapeutic monoclonal antibody to treat the CoronaVirus. For making a vaccine against the CoronaVirus. For creating related prophylactic/therapeutic methods relating to the epitopes/antigens. For use in any diagnostic test to identify whether a person has the CoronaVirus. The Company has produced and is producing fully human monoclonal antibodies against these claimed sites. The International Patent Office has confirmed these discoveries as being novel and inventive, capable of being patented and claimed exclusively for a 20-year term in each member country under the Patent Cooperation Treat in which the Company pursues these claims. The Company also has similar PCT applications pending covering discovered immutable conserved epitopes (binding sites) on the HIV virus and the animal Feline (cat) Leukemia Virus (FeLV). The Company has also analyzed the amino acid sequences on numerous other human and animal viruses and plans to also produce anti-mAbs targeting these sites and will U.S. and international patents on these discoveries. These discoveries include the Company's findings from analyzing the human viruses H1N1 Influenza, HTLV1 & HTLV2, Leukemia Virus, Herpes Simplex I Virus, Respiratory Syncytial Virus (RSV), Smallpox Virus, Rabies, Influenza A, Influenza B, Ebola Virus, Epstein Barr Virus, and Monkey Pox Virus. The Company has also analyzed and identified conserved and immutable epitopes in animal viruses including Equine Infectious Anemia Virus, Feline Immunodeficiency Virus, Koala Retrovirus Virus, and Elephant Endotheliotropic Herpes Virus. Using the Company's technology currently being used to produce monoclonal antibodies against human viruses, therapeutic mAbs may be produced to treat these animal viruses. The Company fully expects the issuance of multiple international patents covering these discoveries accomplished through the Company's unique process using computer analysis (AI) to identify conserved, immutable epitopes on the target virus. Biogenysis' proprietary AI platform, invented by Dr. Gaurav Chandra, Biogenysis' CEO, has been used to analyze the sequences (structure) of 2.8 Million SARS-CoV-2 virus isolates to identify conserved sites. As a part of this process, 3-dimensional models of these conserved targets were generated, and the targets were analyzed for linearity, accessibility by antibodies, and neutralizability by antibodies. From this, Biogenysis scientists are producing multiple broadly neutralizing antibodies targeting these multiple conserved, immutable epitopes on the targeted virus. The monoclonal antibodies directed against these targets will expectedly be universal, durable, broadly neutralizing, and unaffected by virus mutation. The Company considers the expected patent protection to be highly significant, recognizing that for a monoclonal antibody to be effective (that is, to be fully capable of neutralizing a virus), it must target an immutable site on the virus. Otherwise, virus mutation will render the therapeutic ineffective. Biogenysis' methodology for producing monoclonal antibodies is unique and innovative, unlike those other biotech companies employ. The Company's antibodies are made from human "immune-B cells" obtained from convalescent individuals (or animals in the case of veterinarian monoclonal antibodies) who have recovered from the target virus. The Company's monoclonal antibodies are not "humanized" but are fully human monoclonal antibodies where the original antibody affinity and specificity are maintained, and the chances of immunogenicity are minimized. The Company believes its discoveries will be significant to the success of the Company. Although the COVID-19 pandemic was reported to be over, it is now recognized that COVID-19 will be with us from year to year. The global market size for effective treatments in 2022 was $16.43 billion. The global Monoclonal Antibodies market size was $185.50 Billion in 2021, with an expected compound annual growth rate (CAGR) of 11.30% from 2022 to 2030. The Company's near-term objective is to collaborate with pharma entities and license its technology or partner with major pharma entities now producing therapies for COVID-19. Regarding the Company's therapeutic against HIV, the Company has produced a fully human anti-HIV monoclonal Antibody, Clone 3. The Company is now producing additional anti-HIV mAbs to be used in combination. Experts agree that a cure for HIV may be found in the production and administration of multiple anti-HIV monoclonal antibodies. This is the Company's goal. The Company has successfully produced and tested, in vitro, one HIV monoclonal antibody (Clone 3) and has identified 7 additional immutable conserved sites on the HIV virus against which it is in the process of producing anti-monoclonal antibodies. These antibodies will be produced as fully human, with the starting point being human "immune-B cells" from long-term non-progressor HIV patients. This production is being conducted with pharmaceutical entities to accelerate the process of production and testing of the monoclonal antibodies. In 2021, the global HIV drugs market was $30.46 billion, with this market projected to grow to $45.58 billion by 2028. The global Monoclonal Antibody market size was $185.50 Billion in 2021, with an expected compound annual growth rate (CAGR) of 11.30% from 2022 to 2030. The global market for Human Monoclonal Antibodies in 2022 was $55 Billion. The Company's near-term objective is collaboration with pharma companies producing treatments for HIV. The current HIV treatments available do not cure and must be taken for a lifetime. The Company is focused on licensing or partnering with major pharma entities now producing treatments for HIV. To accelerate and fully execute the successful production of the multiple monoclonal antibodies, the subject of the Company's intellectual property, the Company continuously engages with multiple pharma entities to accomplish the successful goal of production, testing, and delivery of successful therapeutics. Gaurav Chandra, Biogenysis' CEO, stated, "Amid alarming concerns regarding COVID mutations, it is crucial to prioritize efforts towards achieving broader immunity against variants, longer-lasting protection, and preventing infection and transmission. Utilizing intranasal IgA monoclonal antibodies effectively attains high secretory IgA levels, reflecting mucosal immunity. The Biogenysis anti-COVID monoclonal antibodies, both IgG and IgA, being universal, broadly neutralizing, durable, and unaffected by mutations, are a critical solution to this pressing issue." Charles Cotropia, Enzolytics' CEO, said, "We have a well-defined strategy for developing an Intellectual Property portfolio to secure significant patent protection covering our therapeutic discoveries in numerous countries around the world. With these rights secured, we will focus on potential partnering or licensing the technology to international pharmaceutical companies working in the areas in which we are focused. Obtaining international patent coverage will be significant in achieving this objective. "The necessary technology is now in hand for producing these therapeutics for use in the treatment of many infectious diseases. The earlier announced plans for the sale of Biogenysis and Virogentics, subsidiaries of Enzolytics, to Sagaliam Acquisition Corp. (NASDAQ: SAGA), a special purpose acquisition company ("SPAC"), comes at an opportune time. Once completed, this transaction will provide Biogenysis and Virogentics with the capital that will make possible final development of the therapeutics now being produced." Enzolytics, Inc. Overview Enzolytics, Inc. is a drug development company committed to commercializing its proprietary monoclonal antibodies and proteins to treat debilitating infectious diseases. Biogenysis, a subsidiary of Enzolytics, uses proprietary techniques to produce fully human monoclonal antibodies (mAbs) against infectious diseases. The technology is currently being employed to produce monoclonal antibody therapeutics for treating the CoronaVirus (SARS-CoV-2), HIV-1 and the Feline Leukemia Virus. The Company has also identified conserved epitopes on and has plans to produce mAbs targeting many other viruses, including H1N1 Influenza, HTLV1 & HTLV2, Leukemia Virus, Herpes Simplex I Virus, Respiratory Syncytial Virus (RSV), Smallpox Virus, Rabies, Influenza A, Influenza B, Ebola Virus, Epstein Barr Virus, and Monkey Pox Virus. The Company has also analyzed epitopes of animal viruses and plans to produce mAbs for treating these animal viruses. Virogentics, a subsidiary of Enzolytics, is advancing multiple therapeutics targeting numerous infectious diseases. One patented and clinically tested compound, ITV-1 (Immune Therapeutic Vaccine-1), is a suspension of Inactivated Pepsin Fraction (IPF), covered by U.S. Patent Nos. 8,066,982 and 7,479,538. Studies have shown it to be effective in treating HIV/AIDS. ITV-1 has also been shown to modulate the immune system. Safe Harbor Statement: This news release contains forward-looking statements that involve risks and uncertainties associated with financial projections, budgets, milestone timelines, clinical development, regulatory approvals, and other risks described by Enzolytics, Inc. from time to time in its periodic reports filed with the SEC. The Company's therapeutics are not approved by the U.S. Food and Drug Administration or by any comparable regulatory agencies. While Enzolytics, Inc. believes that the forward-looking statements and underlying assumptions contained therein are reasonable, any of the assumptions could be inaccurate, including, but not limited to, the ability of Enzolytics to establish the efficacy of its therapeutics in the treatment of any disease or health condition, the development of studies and strategies leading to commercialization of its therapeutics in the United States, the obtaining of funding required to carry out the development plan, the completion of studies and tests on time or at all, and the successful outcome of such studies or tests. Therefore, there can be no assurance that the forward-looking statements included in this release will prove to be accurate. Such forward-looking statements are based on current expectations. They involve inherent risks and uncertainties, including factors that could delay, divert or change any of the statements made, and cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. These forward-looking statements are made as of the date of this press release. The Company expressly disclaims any intention or obligation to update the forward-looking statements or update the reasons why actual results could differ from those projected in the forward-looking statements. Company Contact: Biogenysis, Inc. Texas A&M Institute for Preclinical Studies 800 Raymond Stotzer Parkway College Station, Texas 77843-4478 SOURCE: Enzolytics, Inc. View source version on accesswire.com: