On May 19, 2022 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a biopharmaceutical company and innovator in targeted cancer therapy, reported that it will present preclinical research supporting its planned second clinical indication, bile duct cancer, also known as cholangiocarcinoma, at the Global Embolization Oncology Symposium Technologies (GEST) 2022, in New York City (Press release, Renovorx, MAY 19, 2022, View Source [SID1234614885]). The study demonstrates the potential utility of RenovoRx’s proprietary Trans-Arterial Micro-Perfusion (RenovoTAMPTM) therapy platform for the treatment of cholangiocarcinoma.

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Cholangiocarcinoma is a rare and aggressive cancer that forms in the bile ducts — thin tubes that carry a digestive fluid, called bile, from the liver to other digestive organs. Most people with cholangiocarcinoma do not have symptoms until the disease becomes more advanced, making early diagnoses difficult. Like pancreatic cancer, which the Company is evaluating in a Phase 3 study, bile duct tumors that grow outside of the liver lack tumor feeder blood vessels, which provide a pathway between the blood stream and the tumor. Tumor feeders are critical to the effectiveness of systemic chemotherapy. Published research supports that without direct access to the tumor, systemic chemotherapy circulates through the body, without a significant amount of chemotherapy reaching the tumor.

RenovoRx plans to launch a Phase 2/3 study in cholangiocarcinoma in the second half of 2022. The Company also received Orphan Drug Designation for this clinical indication in April 2021.

"We are pleased to present our preclinical research data studying RenovoTAMP’s utility in cholangiocarcinoma at this peer-reviewed, scientific meeting – GEST 2022," said Dr. Ramtin Agah, Chief Medical Officer and Co-Founder at RenovoRx. "To be effective, chemotherapy must be able to reach the tumor. RenovoTAMP was designed to bring the chemotherapy to the tumor when there is no other pathway available. Through localized delivery of chemotherapy, we are hoping to provide a more effective treatment option for cancer patients, reduce the debilitating side effects typical of standard of care systemic chemotherapy and improve patient survival for cancers like cholangiocarcinoma."

The purpose of the preclinical study was to compare the effectiveness of delivery of a chemotherapeutic agent inside the bile duct via the gall bladder versus intra-arterially, into the tissue surrounding the bile duct (RenovoTAMP). This study determined that delivery via the gallbladder resulted in zero tissue penetration. In comparison, intra-arterial delivery resulted in extensive tissue penetration, confirming the Company’s plan to utilize RenovoTAMP in its planned Phase 2 study.

The abstract and poster for the study, "Localized Delivery of Chemotherapy Through the Bile Duct Using a Double Balloon Catheter in A Porcine Model," are available on RenovoRx’s website: View Source

RenovoTAMP is currently being investigated in the Phase 3 TIGeR-PaC clinical trial as a potential treatment option for patients with unresectable locally advanced pancreatic cancer. RenovoRx received Orphan Drug Designation for pancreatic cancer in 2018.

On May 19, 2022 Enterome, a clinical stage biopharmaceutical company developing first-in-class immunomodulatory drugs based on its bacterial Mimicry drug discovery platform, reported that it will present for the first time proof-of-concept data from clinical trials with EO2401, its first-in-class off-the-shelf OncoMimics cancer immunotherapy at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place June 3-7, 2022 in Chicago and virtually (Press release, Enterome, MAY 19, 2022, View Source [SID1234614902]).

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OncoMimics peptides – generating strong CD8+ T-cell responses derived from pre-existing memory cells

OncoMimics peptides are gut microbiome-derived peptides that closely mimic antigens expressed by tumor cells. In contrast to tumor antigens, however, OncoMimics peptides are recognized by the immune system as "non-self" and can generate a strong human cytotoxic CD8+ response steming from memory T cells, offering enormous potential to create a new class of cancer vaccines targeting solid and liquid tumors.

Enterome’s pioneering work on its OncoMimics pipeline leverages the fundamental understanding that the gut is the largest lymphoid organ in the body and is home to most of its memory T-cells. As a result, there is constant interaction and presentation of peptides and proteins secreted by gut bacteria to the body’s immune system, resulting in the formation of a pool of effector memory T cells protecting the human body against bacterial invasion. In the event that the bacterial antigens are mimics of tumor antigens, this process leads to the generation of circulating effector memory T cells with a preserved ability to recognize tumor antigens.

To-date, Enterome has generated a repertoire of OncoMimics peptides correlating to tumor antigens across a wide range of solid and liquid tumor types. From this, the Company is creating a pipeline of off-the-shelf cancer immunotherapies designed to act via the same novel mode of action. The first candidates include EO2401 (in clinical trials for glioblastoma and adrenal malignancies), EO2463 (in clinical development for liquid tumors) and EO4010 (in development for colorectal cancer, and targeted to enter clinical trials in 2023).

Enterome’s lead candidate EO2401 combines three OncoMimics peptides that closely mimic IL13Ra2, BIRC5 and FOXM1, all of which are known driver antigens present on aggressive solid tumors and generate strong human CD8+ responses. In addition, EO2401 contains a CD4 helper peptide UCP4.

At ASCO (Free ASCO Whitepaper), in the first two abstracts, Enterome will present, for the first time, clinical proof-of-concept data from Phase 1/2 clinical trials of EO2401 in combination with an immune checkpoint inhibitor (nivolumab, Opdivo), for the treatment of patients with first progression/recurrence of glioblastoma (the ROSALIE trial, EOGBM1-18) and for the treatment of patients with locally advanced or metastatic adrenocortical carcinoma, or malignant pheochromocytoma/paraganglioma (the SPENCER trial, EOADR1-19).

In a third abstract, the Company will present the use of its second therapeutic vaccine program, EO2463 as monotherapy and in combination with lenalidomide and rituximab, for treatment of patients with indolent non-Hodgkin lymphoma (the SIDNEY trial, EONHL1-20). EO2463 combines four OncoMimics peptides that exhibit molecular mimicry with the B cell markers CD20, CD22, CD37, and CD268 (BAFF-receptor), respectively.

Jan Fagerberg, Chief Medical Officer of Enterome said, "As a proof-of-concept for the entire Mimicry platform, we have put in action a clinical development strategy for EO2401 that is designed to identify a clinical efficacy signal in various tumor types that have in common the same tumor antigens (IL13Ra2, BIRC5 and FOXM1). In both the ROSALIE and SPENCER trials, EO2401 in combination with checkpoint blockade generated strong systemic immune responses directed against human tumor antigens. We look forward to sharing these very promising clinical data at ASCO (Free ASCO Whitepaper) while continuing to progress these trials, with the aim of providing a more mature set of data at ESMO (Free ESMO Whitepaper), Europe’s leading medical oncology conference, later in the year."

Enterome’s Mimicry Platform

Enterome’s Mimicry drug discovery platform is based on its unique ability to decode the interaction between the gut microbiome and the immune system. The Mimicry platform uses best-in-class biocomputational tools and bioassays to identify novel therapeutics from its proprietary database of 21 million full-length gut microbiome peptides and proteins.

The Mimicry platform is highly productive and has already generated first-in-class small protein and peptide drug candidates targeting multiple therapeutic areas that modulate the immune system by closely mimicking the structure, effect or actions of specific human antigens, hormones or cytokines.

"We are thrilled to be able to present the first clinical data demonstrating the potential of our unique OncoMimics pipeline at ASCO (Free ASCO Whitepaper) this year. We are using our Mimicry platform to generate multiple pipelines of transformative drug candidates, targeting a broad range of therapeutic areas. Presently we are advancing two pipelines of distinct drug candidates – OncoMimics and EndoMimics – which have the potential to address cancer, inflammatory and autoimmune diseases," said Pierre Belichard, CEO of Enterome. "We believe that our unique platform has the potential to create effective new medicines that make a real difference to patients. Our corporate strategy is designed to advance the development of these new therapies as quickly and robustly as possible while generating significant value for our shareholders. Enterome’s future has never looked so exciting."

On May 19, 2022 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer, reported that it will present preclinical findings evaluating the characteristics and function of donor-derived allogeneic CAR T cells (Press release, Allogene, MAY 19, 2022, View Source [SID1234616277]). Data showed that cells from a diverse set of younger donors had improved characteristics and better in vitro anti-tumor activity compared to cells from older donors. The study also showed that cells from patients with certain cancers generally performed suboptimally based on functional assays and often could not be used to generate viable CAR T therapies. The findings will be presented during an oral session at the 2022 American Society of Gene and Cell Therapy Annual Meeting (ASGCT) (Free ASGCT Whitepaper) at 10:45am ET.

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"These results further support the benefits and characteristics of allogeneic CAR T cells produced from healthy donors and the potential for AlloCAR Ts to improve patient outcomes," said Rafael G. Amado, M.D., Executive Vice President of Research and Development and Chief Medical Officer at Allogene. "Cells derived from healthy, younger donors were more abundant, with greater fitness and cancer killing potential and have the potential to eliminate the risk of manufacturing failures seen with autologous CAR T therapies."

The study evaluated the characteristics and performance of CAR T cells derived from healthy donors aged 19 to 62, comparing the healthy donor cells to those derived from patients with cancer. Based on the analysis, CAR T cells produced from younger donors had stronger T cell phenotypes and better in vitro anti-tumor activity cytotoxicity compared to older donors. The expression of specific exhaustion and activation markers was also correlated with increased donor age and in vitro anti-tumor activity decreased with donor age. Regardless of age, the CAR T cells derived from healthy donors performed better and had a lower manufacturing failure rate compared to those derived from patients with cancer.

Creating allogeneic CAR T cells from healthy donors reduces product variability; reduces the risk of manufacturing failures; and enables treatment within days, eliminating the need for bridging chemotherapy. This study provides additional evidence that younger, healthy donors may improve product characteristics and potency compared to older donors.
Allogene currently has four clinical programs underway investigating the potential of AlloCAR T product candidates for the treatment of relapsed/refractory (R/R) large B cell lymphoma, RR multiple myeloma and advanced renal cell carcinoma.

On May 19, 2022 Biomea Fusion, Inc. (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, reported the nomination of its second product candidate, BMF-500, a highly selective and potent covalent investigational third-generation FLT3 inhibitor (Press release, Biomea Fusion, MAY 19, 2022, View Source [SID1234614853]).

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Approximately 30% of AML patients present with a FLT3 mutation and remain poorly controlled with currently available therapies. First and second-generation FLT3 inhibitors frequently have a narrow therapeutic window and patients often acquire rapid resistance to treatment, limiting the clinical efficacy of these agents. As a third-generation FLT3 inhibitor, BMF-500 is designed to overcome some of the characteristics that are believed to limit the duration of response and utility of these earlier generation FLT3 inhibitors.

BMF-500 was discovered and developed in-house at Biomea using the company’s proprietary FUSION System. BMF-500, like BMF-219, was designed to be clinically effective at relatively low drug concentrations in order to deliver an optimal therapeutic profile. Specifically, BMF-500 was observed in preclinical studies to be a highly active inhibitor of FLT3 with picomolar affinity for key isoforms of FLT3 while avoiding other key kinases tested, including structurally related KIT.

Because patients often acquire rapid resistance to treatment with first and second-generation FLT3 inhibitors, BMF-500 is designed to strongly inhibit FLT3 variants that are key drivers of resistance. Additionally, BMF-500 is designed to potentially have a therapeutic profile that may allow for combination with standard of care and/or targeted agents like BMF-219. Many patients with AML are older and unfit candidates for intensive chemotherapy but could benefit from BMF-500 and BMF-219 either as monotherapy or in combination.

AML is often described as the result of two broad complementary classes of mutations: Type I – those that confer a proliferative/survival advantage to hematopoietic progenitors including activating FLT3 mutations or their downstream effectors such as RAS, and Type II – those that impair hematopoietic differentiation and drive cell cycle progression, including NPM1, MLL-r, RUNX1, and DNMT3A mutations. With BMF-500 and BMF-219, Biomea plans to interrogate multiple molecular mechanisms that drive AML in the pursuit of establishing long-term disease management or a potential cure for these patients.

"FLT3 has been a challenge for companies to effectively target with either non-covalent or covalent approaches due to the homology of various kinases and other receptors, leading to off-target toxicities at potentially clinically relevant drug concentrations. Leveraging our FUSION System, we have quickly developed BMF-500, which we believe is among the most promising investigational FLT3 inhibitors to date," said Thomas Butler, Biomea’s Chief Executive Officer and Chairman of the Board. "With picomolar activity against key isoforms of FLT3, high specificity to FLT3 observed in preclinical studies, and the potential benefits of covalent engagement, we believe that BMF-500 is poised to become a leading targeted therapy for AML patients with FLT3 mutations, if approved. We look forward to leveraging the existing clinical infrastructure and know-how that we have developed through the planning and execution of our ongoing trial with BMF-219, COVALENT-101, and plan to explore the potential synergy between BMF-500 and BMF-219."

About FLT3 (fms-like tyrosine kinase 3)

FLT3 is a tyrosine kinase receptor that plays a central role in the survival, proliferation, and differentiation of immature blood cells. Notably, FLT3 gene mutations are common in patients with AML and are associated with a poor prognosis. Nearly 30% of AML patients have a FLT3 mutation, representing more than 6,000 incident patients in the United States each year. While FLT3-specific and pan-tyrosine kinase inhibitors are FDA approved across various lines of therapy in AML, these agents have produced relatively low rates of durable responses and overall survival remains an unmet need.

On May 19, 2022 CANbridge Pharmaceuticals Inc. (HKEX:1228), a China-based global biopharmaceutical company committed to the research, development and commercialization of transformative rare disease and rare oncology therapies, reported that it will participate in the Morgan Stanley Virtual China Summit 2022 to be held on May 24-26, 2022 (Press release, CANbridge Life Sciences, MAY 19, 2022, View Source [SID1234614886]).

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