Palm Beach, FL – October 24, 2023 – FinancialNewsMedia.com News Commentary – Acute myeloid leukemia (AML) is a type of hematologic cancer that is distinguished by the clonal growth of myeloid blasts in the peripheral blood, bone marrow, and/or other organs. AML can affect tissues other than bone marrow and blood, such as lymph nodes, the brain, skin, and other organs. The majority of elderly people relapse or become refractory to early therapy. They are referred to as relapse/refractory AML patients. In the coming years, the Relapsed/Refractory Acute Myeloid Leukemia market is set to change due to the rising awareness of the disease, and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market. According to DelveInsight, the Relapsed/Refractory Acute Myeloid Leukemia market  is expected to witness a major change through 2032.  Refractory Acute Myeloid Leukemia (AML) affects about 50% of all patients who achieved remission after initial treatment. With a long-term disease-free survival of only approximately 30 to 40% after standard chemotherapy and a paucity of treatment options besides the standard cytarabine and anthracyclines, disease persistence or recurrence occurs in most patients with AML. Outcomes for patients with relapsed or refractory AML are poor, with overall survival (OS) estimated at no more than 10% at three years. The prognosis of relapsed acute myeloid leukemia (AML) is poor, and treatment is challenging. While the most potent treatment modality for patients who achieve a complete remission after relapse is still allogeneic haematopoietic cell transplantation (allo-HCT). Relapse after allo-HCT remains a major obstacle with 1-year post-relapse OS of ~20%. Although several therapeutic options are available for relapsed AML after transplantation, only a minority of patients survive long-term.  Active companies in the markets this week include: TC Biopharm (Holdings) PLC (NASDAQ: TCBP), CEL-SCI Corporation (NYSE American: CVM), INVO Bioscience, Inc. (NASDAQ: INVO), Sanofi (NASDAQ: SNY), Pfizer Inc. (NYSE: PFE).

A report from Taylor & Francis said: “It appears increasingly clear that approaching AML as a homogenous disease entity is unsatisfactory in view of the variations in such disease factors as cytogenetic and molecular markers, age, and disease severity at presentation; all of which contribute significantly to heterogeneity of the disease. Moving forward, treating AML would likely require tailored therapy following advances in technology such as molecular profiling, drug sensitivity and resistance testing.  A deeper understanding of the biology of AML has led to the identification of deregulated pathways that drive the proliferation of blasts. In turn, these discoveries have led to the development of specific agents that target these molecular pathways and have revolutionized the care of patients with AML.  Despite (treatment) advancements, AML remains a disease entity with a poor clinical outcome. In an analysis of more than 3012 patients treated in frontline ECOG AML studies, 58.9% of patients experienced relapse at a median of 7.2 months after achieving a CR. Even those patients treated with curative intent induction chemotherapy and having achieved CR per currently defined endpoints only had a median overall survival of 20 months in one review of over 4000 patients with AML. The management of r/r AML remains a clinically challenging one.”

TC Biopharm (Holdings) PLC (NASDAQ: TCBP) BREAKING NEWS:  TC BioPharm Announces Submission of Investigational New Drug (IND) Application to U.S. FDA for Treatment of Relapse/Refractory AML – Filing is supported by strong clinical data and IND enabling pre-clinical data associated withTCB-008 in treatment of Acute Myeloid Leukemia – TC Biopharm (Holdings) PLC (“TC Biopharm” or the “Company”), a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer, this week announced submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the use of TCB-008 in the treatment of relapse/refractory Acute Myeloid Leukemia. TCB-008, an allogeneic unmodified gamma delta t-cell, is the Company’s lead product and is currently in Phase 2b trials in the U.K. for the treatment of AML.).

The IND application leverages pioneering research on the use of Gamma Deltas in the treatment of relapse/refractory Acute Myeloid Leukemia. TCB-008 has been designated Orphan Drug Status in the treatment arena of AML previously.

“Filing of the IND for TCB-008 is the next step in the clinical development of TCB-008 and aligns with our strategic refocus announced in Q2 of this year to target our clinical strategy to US trials in the future.” said Bryan Kobel , Chief Executive Officer of TC BioPharm. “The IND application leverages supporting clinical   study data from ongoing studies in patients with Acute Myeloid Leukemia and is also a reflection of substantial pre-clinical IND enabling work done over the course of the last 6 months by the TCB team. I would like to thank our entire team, who worked tirelessly to complete the Company’s first ever US FDA trial filing.  We look forward to working closely with the FDA to garner acceptance of our IND over the coming 30 days and advancing our lead candidate through clinical phases of development.”

The FDA will review the application and determine the acceptability of the data before TC BioPharm begins its first clinical trial for TCB-008 It is possible that the FDA will require additional information.  CONTINUED… Read this full press release and more news for TC Biopharm at:  https://ir.tcbiopharm.com/news     

Other recent developments in the markets of note include

CEL-SCI Corporation (NYSE American: CVM) recently reported it has filed a request with the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) to discuss a pathway for approval of Multikine* (Leukocyte Interleukin, Injection) immunotherapy for the treatment of newly diagnosed head and neck cancer.

At the meeting, CEL-SCI will present MHRA with new results that demonstrate pre-surgical response rates and overall survival advantages that are superior to those published by CEL-SCI previously. These new results arose from an improved selection algorithm of the Multikine target population. The improvements in the selection algorithm were based on discussions and feedback from regulators and consultants. This improved selection algorithm is able to more accurately predict the patients who would benefit most from the Multikine therapy.

INVO Bioscience, Inc. (NASDAQ: INVO) and NAYA Biosciences Inc. (“NAYA”), a company dedicated to increasing patient access to breakthrough treatments in oncology and regenerative medicine, recently jointly announced that they have entered into a definitive merger agreement (the “Merger”) for INVO to acquire NAYA Biosciences in an all-stock transaction. Under the terms of the agreement, NAYA Biosciences’ shareholders will receive 7.3333 shares of INVO for each share of NAYA Biosciences at closing, for a total of approximately 18,150,000 shares of INVO. Following the closing of the Merger, the combined company is expected to operate under the name “NAYA Biosciences”. Dr. Daniel Teper, currently Chairman & CEO of NAYA Biosciences, will be named Chairman & CEO of the combined company.

As described in greater detail below, the Merger – which remains subject to certain closing conditions including shareholder approval, an estimated $5 million or more (at NAYA’s discretion) in interim private financing in INVO at a premium of INVO’s market price at time of financing (“Interim PIPE”), and a private offering by the combined company at a target price of $5.00 – values INVO at $12,373,780 and NAYA at $90,750,000. Subject to the Interim PIPE, post-transaction and prior to the private offering, INVO and NAYA shareholders will own approximately 12% and 88%, respectively, of the combined company.

Sanofi (NASDAQ: SNY) recently said that positive results from a Phase 3 trial demonstrated the efficacy and safety profile of Dupixent^® (dupilumab) for up to one year (52 weeks) in children aged 1 to 11 years with eosinophilic esophagitis (EoE) was consistent. 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.

Mirna Chehade, M.D., MPH – Mount Sinai Center for Eosinophilic Disorders, Icahn School of Medicine, Mount Sinai “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. Dupilumab is the first and only therapeutic approved for adults and adolescents 12 years and older who weigh at least 40 kg 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.”  

Pfizer Inc. (NYSE: PFE) recently announced that the U.S. Food and Drug Administration (FDA) has approved PENBRAYA (meningococcal groups A, B, C, W and Y vaccine), the first and only pentavalent vaccine that provides coverage against the most common serogroups causing meningococcal disease in adolescents and young adults 10 through 25 years of age. PENBRAYA combines the components from two meningococcal vaccines, Trumenba^® (meningococcal group B vaccine) and Nimenrix^® (meningococcal groups A, C, W-135, and Y conjugate vaccine) to help protect against the five most common meningococcal serogroups that cause the majority of invasive meningococcal disease (IMD) globally.

“As a pioneer in vaccines, one of our goals is to deliver vaccines that evolve the paradigm and help simplify the standard of care in the U.S.,” said Annaliesa Anderson, Ph.D., Senior Vice President and Head, Vaccine Research and Development, Pfizer. “Today marks an important step forward in the prevention of meningococcal disease in the U.S. In a single vaccine, PENBRAYA has the potential to protect more adolescents and young adults from this severe and unpredictable disease by providing the broadest meningococcal coverage in the fewest shots.”

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