On February 14, 2025 Imugene Limited (ASX: IMU), a clinical-stage immuno-oncology company, reported more positive results from its Phase 1b clinical trial evaluating azer-cel (azercabtagene zapreleucel) in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) (Press release, Imugene, FEB 14, 2025, https://mcusercontent.com/e38c43331936a9627acb6427c/files/7cb7e5ac-c469-4c73-907d-5e7846ef78e9/Azer_cel_demonstrates_two_additional_Complete_Responses.pdf [SID1234650267]). Following the previously reported results on 2 September 2024, two additional patients in the previously reported Cohort B – treatment with azer-cel, lymphodepletion (chemotherapy), and interleukin 2 (IL -2) – have now achieved a Complete Response (CR, being the disappearance of all signs of cancer in response to the treatment), bringing the total to four out of seven evaluable patients in this cohort.

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"All four Complete Responses in Cohort B were achieved in patients who had failed at least 4 lines of therapy in this hard-to-treat population, including autologous CAR T therapy," said Dr Paul Woodard, Chief Medical Officer of Imugene. "This suggests that azer-cel, in combination with IL-2, may offer a meaningful therapeutic option where other treatments have not succeeded. We are continuing to monitor these patients for persistence of response, with the longest durability ongoing at 10 months. We look forward to providing further updates as data matures."

The company remains focused on continuing enrolment in Cohort B and evaluating the long-term durability of responses. Azer-cel is being developed as a potential off-the-shelf CAR T-cell therapy, addressing key limitations of autologous CAR T approaches, including treatment accessibility and manufacturing constraints.

The 2025 Tandem Meetings event for the Transplantation & Cellular Therapy Meetings of ASTCT (American Society for Transplantation and Cellular Therapy) and CIBMTR (Center for International Blood and Marrow Transplant Research) highlights the latest research breakthroughs in hematopoietic cell transplantation (HCT), cellular therapy and gene therapy. Imugene poster presentation at this event takes place at 6:45pm Hawaii Standard Time on 13 February (3:45pm AEDT 14 February) can be viewed at the same time on Imugene’s website at View Source

The poster presentation is titled: Administration of Low-Dose, Subcutaneous (SC) Interleukin-2 (IL-2) Markedly Enhances the Pharmacokinetic (PK) Profile of Azercabtagene Zapreleucel (azer-cel), an Allogeneic Anti-CD19 Chimeric Antigen Receptor (CAR) T-Cell Therapy, without Compromising Safety and Early Evidence of Clinical Activity in Patients with Diffuse Large B-Cell Lymphoma (DLBCL) Who Have Relapsed after Prior CD19-Directed CAR T-Cell Products.

About the Phase 1b azer-cel trial

The azer-cel allogeneic CAR T trial is an ongoing, open-label, multi-centre Phase 1b clinical trial in the U.S. and Australia, for patients with DLBCL, an aggressive type of non-Hodgkin’s lymphoma blood cancer (NHL), who relapsed after prior treatment with autologous CAR T therapies. Treatment with azer-cel, lymphodepletion (LD) and IL-2 in Cohort B is showing promising results with evidence of meaningful clinical activity, and durability of response. Additionally, the safety profile is manageable and generally well tolerated.

About diffuse large B cell lymphoma (DLBCL)

DLBCL is an aggressive and fast-growing type of non-Hodgkin’s lymphoma (NHL), a type of blood cancer. DLBCL is the most common type of NHL, with approximately 80,500 cases per year and approximately 30,000 new cases per year in the U.S.

Relapsed/refractory DLBCL has a high unmet medical need; 60-65% of patients treated with approved therapies, including autologous CD19 CAR T, relapse.

About Interleukin 2 (IL-2)

IL-2 is a cytokine (a protein that affects what happens between cells in the immune system) that helps T-cells (which are part of the immune system that help fight cancer) grow and survive. IL-2 has been shown to help T cells live longer and to enhance the cancer killing functions of CAR T cells, making them more effective at targeting and killing cancer cells.

On February 13, 2025 (the "Closing Date"), Sarepta Therapeutics, Inc. (the "Company") and Sarepta Therapeutics Investments, Inc., a wholly owned subsidiary of the Company (together with the Company, the "Obligors") reported to have entered into a credit agreement (the "Credit Agreement") with JPMorgan Chase Bank, N.A., as administrative agent (in such capacity, the "Administrative Agent") and as collateral agent (in such capacity, the "Collateral Agent") and the lenders party thereto (Filing, 8-K, Sarepta Therapeutics, FEB 13, 2025, View Source [SID1234650287]). The Credit Agreement provides for a five-year, $600 million senior secured revolving credit facility (the "Revolving Credit Facility").

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Interest rates under the Revolving Credit Facility are variable and equal to the Secured Overnight Financing Rate plus a credit spread adjustment of 0.10% per annum ("Adjusted SOFR"), plus a margin of 1.125% to 1.75% per annum based on the Company’s total gross leverage ratio, or, at the Company’s option, at a base reference rate equal to the highest of (a) the federal funds rate plus 0.50%, (b) the rate of interest last quoted by the Administrative Agent as its "base rate" and (c) the one-month Adjusted SOFR rate plus 1.00%, plus a margin of 0.125% to 0.75% per annum based on the Company’s total gross leverage ratio.

The Company will pay customary agency fees and a commitment fee based on the daily unused portion of the Revolving Credit Facility at a rate of 0.20% to 0.35% per annum based on the Borrower’s total gross leverage ratio. The Revolving Credit Facility is not subject to amortization and will mature on the fifth anniversary of the Closing Date.

On the Closing Date, each of the Obligors and the Collateral Agent entered into a pledge and security agreement, pursuant to which the Obligors granted a security interest in substantially all of their respective assets, in each case, subject to customary exceptions and exclusions.

The Credit Agreement contains customary representations and warranties, affirmative covenants, negative covenants and events of default. The Credit Agreement also contains financial covenants that are tested on the last day of each of the Company’s fiscal quarters. These financial covenants include a (x) maximum secured net leverage ratio of 3.5:1.0, subject to a 4.0:1.0 covenant holiday following certain permitted acquisitions or permitted collaborations, and (y) minimum consolidated interest coverage ratio of 2.5:1.0.

The foregoing description of the Credit Agreement does not purport to be complete and is subject to, and qualified in its entirety by reference to, the full text of the Credit Agreement, attached hereto as Exhibit 10.1 and incorporated herein by reference.

On February 13, 2025 CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company – a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers – reported new AlloHeme data presented at the 2025 Tandem Meetings, Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR, held February 12-15, 2025 in Honolulu, Hawaii (Press release, CareDx, FEB 13, 2025, View Source [SID1234650275]).

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In an oral presentation, a one-year interim analysis of the ACROBAT prospective, multi-center study showed that AlloHeme is an accurate and sensitive test for monitoring relapse after allogeneic stem cell transplantation in Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS). By measuring small changes in mixed chimerism, AlloHeme demonstrated excellent performance characteristics with a hazard ratio (HR) of 40.5 (p<0.001) for relapse, and a clinically meaningful median lead time to relapse of 36 days. The analysis included one-year interim follow-up data from a cohort of 229 patients with AML and MDS from 11 stem cell transplant centers across the U.S.

"We are extremely pleased with the results of the ACROBAT study which demonstrates that AlloHeme is highly accurate in predicting risk of relapse in patients who have undergone a hematopoietic cell transplant," said Dr. Monzr M. Al Malki, Associate Professor, and Director of Unrelated Donor Bone Marrow Transplant Program at City of Hope National Medical Center. "This study gets us one step closer to having a highly reliable molecular biomarker that enables us to assess the status of the stem cell engraftment and predict risk of relapse."

CareDx’s AlloHeme is an NGS-based test that has been shown to be more sensitive than the current standard of care methods for monitoring engraftment and relapse post-allogeneic hemopoietic stem cell transplantation for hematologic malignancies.

"The interim results of the ACROBAT study build upon our growth strategy to expand into hematology oncology. With AlloHeme, we can detect relapse after allogeneic stem cell transplantation prior to conventional methods, giving clinicians the significant lead time they need to intervene sooner," said Marica Grskovic, PhD, CareDx Chief Strategy Officer. "We are very pleased with these results demonstrating the high sensitivity of the AlloHeme assay and its selection for an oral presentation at the Tandem Meetings given the significant impact it may have on patient outcomes through earlier detection of malignancy recurrence."

On February 13, 2025 Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care, reported a new collaboration with the Institute for Follicular Lymphoma Innovation (IFLI), a global, non-profit, private foundation dedicated to accelerating the development of innovative treatment options for patients with follicular lymphoma (FL) (Press release, Tempus, FEB 13, 2025, View Source [SID1234650274]). The collaboration aims to develop and make available a real-world multimodal, deidentified FL data library in Lens – Tempus’ data analytics platform – through which researchers may derive AI-driven insights to accelerate the development of FL treatments in an effort to improve patient outcomes.

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IFLI is committed to supporting advances in understanding the biology of FL patients who are at high risk of cancer progression and enhancing therapeutic development to address critical unmet needs in the management of this disease. The collaboration will initially focus on prospectively generating multimodal FL data, particularly for POD24 patients who experience disease progression within 24 months of treatment, through a Tempus-sponsored study.

The availability of a follicular lymphoma data library has the potential to improve researchers’ understanding of the disease’s biology. Providing researchers with access to robust multimodal data supports their work in uncovering critical insights into the heterogeneity of FL, which may lead to the development of more targeted precision medicines. A comprehensive understanding of the disease is crucial for tailoring treatments to individual patient profiles, enhancing outcomes, and advancing the fight against this complex disease.

"This collaboration exemplifies the power of combining IFLI’s specialized focus on FL with Tempus’ cutting-edge AI-enabled solutions," said Kate Sasser, PhD, Chief Scientific Officer at Tempus. "We are excited to work with IFLI and explore a new way of working with foundations to advance research. By leveraging our combined expertise and reach, we aim to create a centralized and dynamic data library that enables researchers to better understand FL."

"IFLI is thrilled to announce our collaboration with Tempus, chosen for their exceptional leadership in the field. Together, we aim to create a robust, de-identified FL database, accelerating research and drug development to ultimately find a cure for the FL patient community," said David McCullagh, Managing Director at IFLI. " We believe Tempus is uniquely positioned to develop this comprehensive FL database, making it accessible to professionals in the field to combat this disease effectively."

On February 13, 2025 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a life sciences company developing novel targeted oncology therapies and commercializing RenovoCath, an innovative, FDA-cleared device, reported its recent abstract presentation at the 2025 Society of Interventional Oncology Annual Conference ("SIO 2025") in Las Vegas, Nevada (Press release, Renovorx, FEB 13, 2025, View Source [SID1234650273]). The abstract published promising pre-clinical data from the use of RenovoRx’s patented Trans-Arterial Micro-Perfusion (TAMP) therapy platform, which aims to optimize local and targeted drug delivery in difficult-to-treat cancers.

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The abstract, titled "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," was presented at SIO 2025 on February 3, 2025 by Paula Novelli, MD, of the University of Pittsburgh Medical Center.

The results of the study support a more optimized drug delivery method for tumors that suffer from limited blood supply and poor drug penetration. The TAMP technique was evaluated in a porcine (pig) model utilizing micro-CT imaging for precise monitoring of drug penetration into tissue.

The pre-clinical data shows that drug delivery with the patented, FDA-cleared dual balloon RenovoCath device via TAMP potentially may improve localized drug delivery by achieving greater drug penetration in the microvasculature near the target tumor. The data shows that, by using RenovoCath, researchers were able to isolate sections of the blood vessel through the adjustment of the distance between the occlusion balloons, thereby excluding any off-target side branches. Researchers were able to confirm the level of penetration into the targeted area utilizing micro-CT imaging. The penetration achieved appears to be consistent with a more optimized drug delivery. The observed effect is expected to be even stronger if radiation is applied beforehand.

"This study highlights that TAMP is an encouraging approach for improving localized drug delivery to difficult-to-treat tumor areas. By understanding how the infusion medium penetrates tissue, techniques can be refined for better clinical outcomes, especially for patients with cancers like pancreatic adenocarcinoma," said Dr. Ramtin Agah, RenovoRx’s Founder, Chairman of the Board and Chief Medical Officer and one of the study’s authors. "We look forward to continued research in hypovascular tumors using minimally invasive procedures and are also working on a radiation sub-study. With continued investigation, we believe TAMP has the potential to revolutionize how interventional oncologists approach cancer treatment, offering a more targeted, effective solution for challenging cases."

The procedure in this study utilized a porcine model, where the RenovoCath device was effectively employed to deliver a technique involved inflating the catheter balloons in the splenic artery, the superior mesenteric artery and renal artery. This approach enabled precise side branch exclusion in both vascular regions, ensuring targeted and controlled intervention, allowing for extensive filling of the microvessels with Microfil (a micro-CT imaging following an injection of a radiopaque silicone rubber imaging reagent) in the perivascular space. In comparison, the control group, where balloons in the splenic arteries were left deflated, showed minimal Microfil filling beyond the main artery, as confirmed by micro-CT imaging. These striking differences highlight the potential of this technique to drive forward the development of targeted therapies, especially for complex cancers like pancreatic adenocarcinoma.

"We are excited to highlight this pre-clinical data abstract presented at SIO 2025. Including procedures performed as part of clinical trials, intra-arterial drug delivery by RenovoCath has been used in over 500 procedures by oncologists and interventional radiologists over the past several years," said Shaun Bagai, RenovoRx CEO.

Mr. Bagai added, "Based on recent positive feedback we have received from medical practitioners, we have launched an effort to commercialize RenovoCath as a stand-alone device within its FDA-cleared indications for use in temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion."

Additionally, the TAMP therapy platform was the topic of the SIO 2025 panel discussion "Breaking Barriers in Drug Delivery: Trans-Arterial Micro-Perfusion," where key interventional oncologists including Dr. Novelli, Khashayar Farsad, MD, PhD, Oregon Health and Science University, and David Sperling, MD, FSIR, Columbia University Irving Medical Center discussed their experience with the therapy platform and the RenovoCath device.

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.