On January 08, 2025 EsoBiotec SA, a biotechnology company empowering cells in vivo to fight cancer, in collaboration with Pregene Biopharma, reported the first patient has been dosed in an investigator-initiated clinical trial in China of ESO-T01 for relapsed/refractory multiple myeloma (Press release, EsoBiotec, JAN 8, 2025, View Source [SID1234649799]). ESO-T01 is an immune shielded lentiviral vector that specifically reprograms T lymphocytes in vivo into highly effective BCMA CAR-T cells.

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The multi-center, single arm, open-label, dose escalation clinical trial (NCT06691685) is designed to evaluate the safety, tolerability and preliminary clinical activity, including in vivo reprogramming efficiency of a single intravenous infusion, across escalating doses of ESO-T01 in up to 24 patients with multiple myeloma. Primary endpoints for the study include incidence and severity of cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome, dose-limiting toxicities, and treatment-associated adverse effects.

"Initial clinical observations with ESO-T01 indicate a favorable safety profile and promising efficacy already at the first dose level of 0.25E+09 transducing unit per patient, with pharmacokinetic characteristics comparable to autologous ex vivo CAR-T therapies," said Principal Investigator Professor Heng MEI, Ph.D., M.D., Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. "The first patient received a starting dose of ESO-T01 without prior lymphodepletion. By Day 28, minimal residual disease in the bone marrow was undetectable, and the elevated free light chain levels secreted by tumor cells had normalized. No significant adverse events were reported during treatment."

"ESO-T01 has the potential to offer a simplified patient journey, with several benefits over current treatments for multiple myeloma that are often costly and have unfavorable side effects," said EsoBiotec CEO Jean-Pierre Latere, Ph.D. "Our treatment does not require lymphodepletion, is immediately available to patients without any waiting time, and is administrated in a single intravenous dose that takes less than 10 minutes. This is why we value our collaboration with Pregene Biopharma to develop ESO-T01, as we share the common goal of making this groundbreaking treatment affordable and available to patients globally. We look forward to sharing initial clinical data in the second half of 2025."

"The clinical success of autologous CAR-T in treating hematologic malignancies is well established," said Pregene Biopharma Chief Executive Officer and co-founder Dr. Li Hongjian. "With in vivo delivery, more multiple myeloma patients can benefit from CAR-T. Moreover, we anticipate expanding to therapeutic areas such as autoimmune diseases, enabling broader patient access to effective treatment. Through this collaboration, we are pioneering innovative scientific advancements that have the potential to redefine the future of cell therapy."

ESO-T01 is the first in vivo BCMA CAR-T candidate to be dosed in a human clinical trial, and has been developed by EsoBiotec using its third-generation immune-shielded cell specific lentiviral vector platform, ENaBL, that reprograms immune cells inside the body. Combined with a BCMA CAR-T transgene developed by Pregene Biopharma and a robust industrial manufacturing process, ESO-T01 potentially represents a transformational therapeutic to provide patients with an off-the-shelf treatment at a cost of goods possibly one order of magnitude lower compared to ex vivo CAR-T therapy, which could redefine access to advanced therapies.

About ESO-T01

ESO-T01 is a third-generation replication-deficient self-inactivating lentiviral vector expressing a BCMA-targeted CAR construct under a T cell-specific synthetic promoter. It is immune shielded and resistant to phagocytosis. ESO-T01 is an "off-the-shelf" single dose treatment, directly administered systemically without the need for lymphodepletion.

About ENaBL Platform

EsoBiotec’s Engineered NanoBody Lentiviral (ENaBL) platform vectors are designed to specifically reprogram T cells and have demonstrated a high level of CAR T potency in animal studies. In large scale clinical manufacturing, the company has preserved vector specificity with high physical titer and high purity. EsoBiotec’s lead product candidate, ESO-T01, leverages the ENaBL platform to validate this novel technological approach using a clinically proven antigen.

On January 8, 2025 Foundery Immune Studio, LLC, a biotechnology venture studio focused on translating immunology discoveries into medicines, reported its acquisition of worldwide rights for three clinical-stage immune tuning therapies from Ikena Oncology, Inc (Press release, Ikena Oncology, JAN 8, 2025, View Source [SID1234649531]).

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Unlike existing and first-generation immunotherapies that exclusively target immune T cells, these monoclonal antibodies are engineered to precisely reconfigure the underpinnings of cancer immune responses. In particular, these therapies target the functions of myeloid cells, which are prevalent in all tissues and may constitute up to 50% of the total tumor cell population. By selectively targeting specific receptors on these myeloid cells, these therapies recalibrate the immune environment within tumors with greater precision. The evolving body of research on myeloid biology suggests TREM1, TREM2, and MARCO play crucial roles in cancer, fibrotic, autoimmune, and neurodegenerative diseases like Alzheimer’s.

Antibodies PY314 and PY159, targeting TREM2 and TREM1, respectively, completed Phase 1 trials and were well tolerated. Both antibodies demonstrated promising pharmacodynamic effects alone and in combination with pembrolizumab. The third program targeting MARCO, PY265, is Investigational New Drug (IND)-ready.

Foundery Immune Studio’s near-term focus is to refine the programs’ cancer applications and develop the programs in fibrotic and autoimmune diseases by launching its’ first subsidiary, RhBio, LLC.

"Tuning myeloid cells, rather than T cells, could revolutionize multiple diseases, as suggested by our research," said Matthew "Max" Krummel, PhD, founder of Pionyr Immunotherapies and co-discoverer of anti-CTLA-4 checkpoint blockade. "The immune phenotype of a tumor microenvironment, not the tissue of origin, appears to drive the response to these therapies, opening unexplored possibilities for treating cancers, autoimmune conditions, and inflammatory diseases."

Foundery Immune Studio’s founders Max Krummel, Michel Streuli, PhD, and Venkataraman Sriram, PhD, bring unique insight to the programs, having helped develop them at Pionyr Immunotherapeutics, Inc. The trio’s deep understanding of myeloid cell biology and extensive knowledge position them to advance these treatments in ways that have eluded others. They have individually contributed to groundbreaking commercialized therapies, including ipilimumab and pembrolizumab.

On January 8, 2025 Zetagen Therapeutics, Inc., a private, clinical stage, biopharmaceutical company focused on developing proprietary carriers delivering tumoricidal therapies for metastatic and primary breast cancer, which may minimize patient side effects with the potential to increase survival rates, reported in 2024 they nearly doubled their worldwide IP portfolio to 64 patents, spanning across 36 countries including the United States, Europe, Canada, Australia, Japan, United Kingdom, India, Sweden and Switzerland (Press release, Zetagen Therapeutics, JAN 8, 2025, View Source [SID1234649530]).

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"It is heartening to witness this significant scientific research being acknowledged with these latest patent grants," said Joe C. Loy, member of the Executive Board and CEO of Zetagen Therapeutics. "Our ambition is to continue growing our intellectual property portfolio with discoveries around the development of Zeta-BC-003 and Zeta-BC-005 for the treatments of metastatic breast cancer, but also for future discoveries towards primary breast cancer treatments."

Details of the latest patent awards for the company’s Life Science business are as follows:

New molecular pathways, proprietary carriers, and optimum dose ranges to treat breast cancer.
Zetagen has enlisted Foley & Lardner LLP as its intellectual property counsel and maintains a collaborative professional relationship with Steve Maebius, Esq. Foley & Lardner LLP is a prominent law firm with global reach and specialized expertise in Life Sciences intellectual property and strategic counsel.

"The technologies patented by Zetagen in 2024 contain landmark science, which includes new chemicals and describes novel chemistries, and formulations of their proprietary drug-carrier platform, specific to locoregional delivery of these new chemical entities, improving breast cancer treatments," said Bryan S. Margulies, MS, PhD, CSO, Zetagen Therapeutics, Inc.

On January 8, 2025 NorthStar Medical Radioisotopes, LLC and YAP Therapeutics, Inc. reported to have entered into a collaboration agreement to develop and produce radiopharmaceuticals aimed at treating cancer and other chronic diseases (Press release, NorthStar Medical Radiostopes, JAN 8, 2025, View Source [SID1234649529]).

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NorthStar is involved in the development, production, and commercialization of radiopharmaceuticals for therapeutic applications and medical imaging. YAP Therapeutics, a Fjord Ventures company, utilizes its advanced biologic and regenerative medicine technology platforms to develop treatments for chronic diseases.

Within this collaboration, NorthStar will support the development of YAP Therapeutics’ biologic products by supplying the radioisotope non-carrier added actinium-225 (n.c.a. Ac-225) and providing access to its radiopharmaceutical contract development and manufacturing (CDMO) services. NorthStar will also prepare clinical trial-ready doses of YAP Therapeutics’ investigational medicines. Additionally, upon regulatory approval, NorthStar may manufacture and supply radionuclides for YAP Therapeutics’ commercial use.

"NorthStar leads in medical radioisotope development and production. This agreement furthers our goal to deliver radiopharmaceuticals to patients," said Frank Scholz, President and Chief Executive Officer of NorthStar. "We are excited to partner with YAP Therapeutics, merging our technology with their biologics to target specific therapies. Our ability to provide key radioisotopes like Ac-225 and CDMO capabilities offers substantial support to YAP Therapeutics."

"We are thrilled about partnering with NorthStar to improve cancer treatment. Their radiopharmaceutical expertise complements our biologics development," said Olav Bergheim, Founder and Chairman of YAP Therapeutics. "This partnership offers the potential to expand our rich pipeline with leading radioisotope technology."

On January 8, 2025 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a life sciences company developing novel targeted oncology therapies and commercializing RenovoCath, a novel, FDA-cleared delivery platform, reported three abstracts were accepted to be presented at several upcoming industry conferences including ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI) 2025, Society of Interventional Oncology (SIO) 2025 and Society of Surgical Oncology (SSO) 2025 (Press release, Renovorx, JAN 8, 2025, View Source [SID1234649528]).

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The abstracts support RenovoRx’s novel and patented TAMP therapy platform via additional human PK data and pre-clinical data. TAMP is designed to ensure precise therapeutic delivery across the arterial wall near the tumor site to bathe the target tumor, while potentially minimizing a therapy’s toxicities versus systemic intravenous therapy. RenovoRx’s novel approach to targeted treatment offers the potential for increased safety, tolerance, and improved efficacy.

RenovoRx’s pivotal ongoing Phase III TIGeR-PaC clinical trial is evaluating the Company’s first product candidate, a novel investigational oncology drug-device combination utilizing the Company’s FDA-cleared RenovoCath device via TAMP for the intra-arterial administration of chemotherapy, gemcitabine. RenovoRx currently anticipates completion of both patient enrollment and the second interim analysis for TIGeR-PaC by the end of the first half of 2025.

Abstract Details:

ASCO GI 2025

Title: Intra-arterial Gemcitabine Versus Intravenous Gemcitabine: Pharmacokinetic Sub-study of the TIGeR-PaC Phase 3 Clinical Trial
Authors: Paula Novelli MD, Amer Zureikat MD, Michael Pishvaian MD, Kenneth Meredith MD, Hassan Hatoum MD, Emmanuel Zervos MD, Reza Nazemzadeh MD, Sandeep Loria MD, Ramtin Agah MD
Location: Moscone West, San Francisco CA
Date/Time: January 24, 2025 at 11:30 a.m. PT
SIO 2025

Title: Micro-CT imaging following intra-arterial delivery of a radiopaque silicone polymer using a double-balloon occlusion catheter in pigs: a model to analyze tissue penetration via the trans-arterial micro perfusion (TAMP) technique
Authors: Paula Novelli MD, Christopher Laing MD, Aloke Finn MD, Frank Kolodgie PhD, Robert Strasser BSc, Ramtin Agah MD
Location: Horseshoe Las Vegas, Las Vegas NV
Date/Time: February 2, 2025 at 12:30 p.m. PT
SSO 2025

Title: Pharmacodynamics of Intra-arterial vs. Intravenous Gemcitabine in Locally Advanced Pancreatic Cancer: Results of a Phase III Randomized Clinical Trial
Authors: Emmanuel Zervos MD, Paula Novelli MD, Amer Zureikat MD, Michael Pishvaian MD, Kenneth Meredith MD, Hassan Hatoum MD, Reza Nazemzadeh MD, Sandeep Loria MD, Ramtin Agah MD
Location: Tampa Convention Center, Tampa FL
Dates: March 27 – 29, 2025
The abstracts accepted at ASCO (Free ASCO Whitepaper) GI 2025 and SSO 2025 are sub-studies of the ongoing Phase III TIGeR-PaC clinical trial.

"These abstracts support the potential for our TAMP therapy platform to provide a meaningful advancement in the standard of care for cancer treatment," said Ramtin Agah, MD, Chief Medical Officer and Founder of RenovoRx. "TAMP focuses on drug concentration optimization in tumors by delivering therapies with our RenovoCath delivery system. This targeted approach to cancer treatment is designed to enable physicians to isolate segments of the vascular anatomy closest to tumors and ensure precise therapeutic delivery, while potentially minimizing a therapy’s toxicities versus the standard of care. Specifically, our approach enables physicians to utilize RenovoCath to use pressure to force chemotherapy across the arterial wall near the tumor site to bathe the target tumor."

Dr. Agah added, "We also look forward to the completion of patient enrollment and our second interim analysis in our pivotal Phase III TIGeR-PaC clinical trial in LAPC by the end of the first half of 2025."

About RenovoCath

Based on its FDA clearance, RenovoCath is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system. RenovoCath is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. For further information regarding our RenovoCath Instructions for Use ("IFU"), please see: IFU-10004-Rev.-F-Universal-IFU.pdf.

About the TIGeR-PaC Clinical Trial

TIGeR-PaC is an ongoing Phase III randomized multi-center study evaluating the proprietary TAMP (Trans-Arterial Micro-Perfusion) therapy platform for the treatment of Locally Advanced Pancreatic Cancer (LAPC.) RenovoRx’s first product candidate using the TAMP technology, is a novel investigational oncology drug-device combination utilizing the Company’s FDA-cleared RenovoCath device for the intra-arterial administration of chemotherapy, gemcitabine.

The first interim analysis in the Phase III clinical trial was completed in March 2023, with the Data Monitoring Committee recommending a continuation of the study. The study’s primary endpoint is an Overall Survival benefit with secondary endpoints including reduced side effects versus standard of care. The second interim analysis for this study will be triggered by the 52nd event (i.e., patient death), which is estimated to occur in late 2024 or early 2025. The second interim data readout would follow thereafter, with the timing for such readout depending on customary factors such as time needed for analysis. RenovoRx is also aiming to complete patient enrollment in the TIGeR-PaC study in the first half of 2025.