On December 14, 2023 AbelZeta Pharma, Inc. ("AbelZeta" or the "Company"), a global clinical-stage biopharmaceutical company focused on discovery and development of innovative and proprietary cell-based therapeutic products, reported an amendment of its worldwide collaboration and license agreement with Janssen Biotech, Inc. (Janssen), a Johnson & Johnson company (Press release, AbelZeta, DEC 14, 2023, View Source [SID1234638557]). Under the amended agreement, Janssen will have the option to obtain exclusive commercialization rights in China for CD20-directed chimeric antigen receptor T (CAR-T) C-CAR039 and C-CAR066, which are being studied for the treatment of Non-Hodgkin Lymphoma (NHL).

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"As presented recently at the 65th ASH (Free ASH Whitepaper) Annual Meeting, the clinical data for both C-CAR039 and C-CAR066 continue to support the potential of both assets to be best in disease in relapsed or refractory (r/r) NHL," said Tony (Bizuo) Liu, Chairman and CEO of the Company. "The Centre for Drug Evaluation in China has approved the Investigational New Drug (IND) application for C-CAR039, and we are currently conducting the Phase 1b study. We are excited to leverage AbelZeta’s clinical development and product manufacturing capabilities together with Janssen’s global commercialization expertise to maximize the potential of C-CAR039 and C-CAR066 to bring innovative and life-changing therapies to patients in China and worldwide."

Under the terms of the agreement, Janssen will pay AbelZeta Pharma an option exercise fee, and AbelZeta Pharma is eligible to receive commercialization and sales milestones.

About the Studies
C-CAR039 is a novel bispecific CAR-T therapy targeting both CD19 and CD20 antigens and has received U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) clearance, and Regenerative Medicine Advanced Therapy and Fast Track designations for the treatment of patients with relapsed/refractory (r/r) diffuse large B-cell lymphoma (DLBCL). A Phase 1b study in the U.S. evaluating C-CAR039 in the treatment of patients with r/r DLBCL is underway.

C-CAR066 is an optimized, novel CD20 targeted CAR-T therapy that has also received U.S. FDA IND clearance, and a Phase 1b study in patients with r/r DLBCL, including r/r to CD19 CAR-T treatment, is underway in the U.S.

About NHL and DLBCL
Non-Hodgkin Lymphoma (NHL) is the most common hematological, or blood malignancy worldwide. NHL ranked as the 5th to 9th most common cancer in most countries globally, with an estimated 544,000 new cancer cases and 260,000 cancer deaths in 2020.1

Diffuse large B-cell lymphoma (DLBCL) is a common and aggressive form of non-Hodgkin lymphoma that accounts for one out of every three cases of NHL. Despite available frontline treatment, many patients will experience a relapse or have refractory (resistant to treatment) disease, for which there are limited treatment options and a high risk of mortality. For patients who relapse or do not respond to initial therapies, conventional treatment options that provide durable remission are limited and median life expectancy is about six months, leaving a critical need for new therapies.

On December 13, 2023 SonALAsense, a pioneer in the development of non-invasive Sonodynamic Therapy (SDT) using SONALA-001 (aminolevulinic acid HCl) in combination with Insightec’s Exablate 4000 Type-2 ultrasound device reported the presentation of positive preliminary data from the ongoing Phase 1/2 SDT-201 study in Diffuse Intrinsic Pontine Glioma (DIPG) (Press release, SonALAsense, DEC 13, 2023, View Source [SID1234638549]). These results were presented at the November 2023 Society for Neuro-Oncology (SNO) Annual Meeting in Vancouver, Canada. The preliminary data from Study SDT-201 shows signals of clinical activity and no safety concerns.

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"Currently, radiotherapy is the primary standard of care and many patients are also prescribed steroids. However, these current interventions have the potential for severe side effects."

Post this
Study SDT-201 is a dose escalation and expansion study in patients with DIPG. Six (6) patients have been treated to date and dose escalation is ongoing. No dose limiting toxicities (DLTs) have been observed and there have been no serious adverse events. There were no treatment related deaths observed. One international patient discontinued for personal reasons and there was one patient death due to metastasis outside of the treated area.

"The preliminary safety, tumor response and clinical performance data we are seeing has the potential to translate into meaningful benefit for these children and their families," said Ely Benaim, M.D., SonALAsense’s Chief Medical Officer and Executive Vice President of Development. "Currently, radiotherapy is the primary standard of care and many patients are also prescribed steroids. However, these current interventions have the potential for severe side effects."

Initial clinical activity observed in the first 5 patients showed partial responses of at least 25% reduction in tumor size in 2 (40%) patients through eight weeks post treatment and stable disease in 2 (40%) patients. Four patients treated have exceeded the median survival of 9-11 months post diagnosis. Patients treated have also maintained or improved their patient performance status.

"We are pleased with the early results and the safety profile of SONALA-001 SDT," said Hasan R. Syed, M.D., pediatric neurosurgeon at Children’s National Hospital and co-lead in Principal Investigator Roger Packer’s trial. "Sonodynamic therapy is part of a larger trend towards less invasive treatment paradigms in neurosurgery. For families of children with DIPG, this trial offers hope and a chance to potentially alter the course of this aggressive disease."

"As we continue to learn more about our non-invasive therapy through this study, we are extremely encouraged with this preliminary safety and clinical activity data," said Mark de Souza, CEO, SonALAsense. "Our team remains committed to the DIPG community by continuing to advance this study which shows promise in enhancing quality of life for these patients."

DIPGs are rare, aggressive, and deadly brain tumors affecting primarily the pediatric population. Approximately 300 children are diagnosed with DIPGs each year in the US, usually between the ages of 5 and 9. There are no effective treatments available beyond radiation, which provides minimal short-term clinical improvement, at best. DIPGs are not amenable to surgical resection.

Lisa Ward, DIPG/DMG community advocate who lost her son to DIPG, is hopeful that this study will lead to a treatment with a better quality of life. "What these children and families go through is absolutely tragic," said Ward. "The possibility of providing an incisionless, non-toxic approach with therapeutic benefits for these children, that’s everything.

On December 13, 2023 Calidi Biotherapeutics, Inc. (NYSE American: CLDI or "Calidi"), a clinical-stage biotechnology company developing a new generation of targeted immunotherapies, reported three presentations on Calidi’s NeuroNova (NNV) and SuperNova (SNV) allogeneic stem cell-based virotherapy platforms at the upcoming 8th Oncolytic Virotherapy Summit to be held December 12-14, 2023 in Boston, Mass (Press release, Calidi Biotherapeutics, DEC 13, 2023, View Source [SID1234638548]). During presentations at the summit, Jana Portnow, M.D., principal investigator, professor in the Department of Medical Oncology & Therapeutics Research and co-director of the Brain Tumor Program at City of Hope Comprehensive Cancer Center, will present the clinical trial design and safety of a Phase 1 study opened in June 2023, using multiple doses of Calidi’s NeuroNova administered intracerebrally, to recurrent high grade glioma patients. Antonio F. Santidrian PharmD, Ph.D., Chief Scientific Officer and Boris R. Minev, M.D., President, Medical & Scientific Affairs, will present updates on the company’s targeted immunotherapies, leveraging allogeneic stem cells to target tumors and deliver anti-cancer payloads in the form of cancer-killing viruses.

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"Our cell-based virotherapeutics are designed to target tumors directly and to help the immune system recognize and attack distant tumor sites," said Boris R. Minev. M.D, President, Medical & Scientific Affairs of Calidi Biotherapeutics. "We are testing this approach in high-grade glioma and anticipate initiating a new clinical trial in several difficult-to-treat advanced solid tumors in the second half of 2024."

The company has four clinical and preclinical programs utilizing different viruses and different types of allogeneic stem cells to overcome the inactivation of Calidi’s virotherapies by the patients’ immune system. This unique approach utilizes specially selected viruses to kill tumor cells and modify the tumor microenvironment, thus enabling the release of tumor antigens. Subsequently, the antigen-presenting cells are able to induce potent antitumor immune responses to detect, attack, and destroy metastatic tumor sites.

Updates to be presented at the upcoming 8th Oncolytic Virotherapy Summit include:

Progress in Recurrent High Grade Glioma (HGG) Trial. Calidi’s collaborator: City of Hope Comprehensive Cancer Center dosed the first patient in June 2023 in a Phase 1 clinical trial of NeuroNova (NNV2) and has dosed 6 patients to-date. Dr. Portnow will present an initial update on this trial. Of note, Calidi holds an exclusive worldwide licensing agreement with City of Hope and the University of Chicago for patents covering the NSC-CRAd-S-pk7 technology (NeuroNova).
Plans to Commence a Dose Escalation Trial in Newly Diagnosed HGG in 1H 2024. Calidi plans to commence a Phase 1b/2 clinical trial for NeuroNova (NNV1) in collaboration with Northwestern University during the first half of 2024. The Phase 1b dose escalation lead portion of this anticipated trial will explore the final dosing regimen for NNV1, including the feasibility of repeated dosing.
Plans to File IND Application for Clinical Trial Initiation in Advanced Solid Tumors in 2H 2024. SuperNova (SNV1) is the company’s first internally developed preclinical product candidate utilizing the SuperNova Delivery Platform. The company plans to file its IND application for the clinical development of CLD-201 to enable the initiation of a Phase 1 clinical trial for SNV1 during the second half of 2024.
Systemic Programs for Metastatic Solid Tumors. Calidi is currently engaged in early discovery research involving its next generation cell-based virotherapies. The company’s research is focused on engineered oncolytic vaccinia virus to increase the tumor specificity and oncolytic potency with improved systemic anti-tumor immunity.
Full details for the conference presentations are below:

City of Hope Comprehensive Cancer Center Presentation:

Title: Neural Stem Cell Based-Oncolytic Virotherapy for Treatment of Glioblastoma (Calidi NNV2 Clinical Update)
Speaker: Dr. Jana Portnow
Date: December 14, 2023
Time: 4:45 p.m. EST

Calidi Presentations:

Title: The Oncolytic Virotherapy Innovation Showcase
Speaker: Dr. Antonio F. Santidrian
Date: December 13, 2023
Time: 4:15 p.m. EST

Title: Optimized Cell-Based Delivery & Potentiation of Oncolytic Virotherapies
Speaker: Dr. Boris R. Minev
Date: December 14, 2023
Time: 9:30 a.m. EST

On December 13, 2023 Vergent Bioscience, a clinical-stage biotechnology company developing tumor-targeted imaging agents, reported that the company has enrolled the first patients in a Phase 2, multi-center study evaluating the efficacy and safety of VGT-309 in patients with cancer in the lung (Press release, Vergent Bioscience, DEC 13, 2023, View Source [SID1234638547]). The international VISUALIZE study will assess the potential of Vergent’s tumor-targeted fluorescent imaging agent to improve the visibility of difficult-to-find and previously undetected tumors during minimally invasive and robotic-assisted surgical procedures, and reduce the possibility that cancer is left behind. Investigators at six clinical trial sites in the United States and Australia plan to enroll 100 patients.

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The widespread adoption of minimally invasive lung cancer surgery, coupled with increasing detection of small tumors, have made it more challenging for surgeons to see all tumor tissue during surgery. Data from three Phase 1 and 2 clinical studies, including findings presented in September 2023 at the World Conference on Lung Cancer (WCLC), have yielded favorable data that suggest VGT-309 is active and can safely be used to detect tumor tissue in the lung.

"We are thrilled to advance VGT-309 to this next stage of clinical development, working with leading thoracic surgeons, academic institutions and large community cancer centers to gather additional evidence regarding its potential utility in lung cancer surgery," said John Santini, Ph.D., president and chief executive officer at Vergent Bioscience. "We look forward to sharing the VISUALIZE results as soon as they are available."

The Phase 2, multi-center, open-label VISUALIZE study is designed to evaluate the efficacy and safety of VGT-309 with near-infrared (NIR) imaging to identify cancer in patients undergoing surgery for proven or suspected cancer in the lung. Each patient in the study will receive VGT-309 as an infusion the day prior to surgery. Following an attempt to identify each tumor using standard surgical techniques, investigators will use a commercially available NIR endoscope with VGT-309 to assess the presence of tumor tissue, which will then be confirmed by pathology. Primary efficacy endpoints include visualization of tumors intraoperatively, surgical margin assessment, and identification of additional cancers or positive lymph nodes that may not have been seen preoperatively.

"Clinical data to date suggest that VGT-309 highlights tumors that would otherwise not be visible during minimally invasive surgeries," said Sunil Singhal, M.D., William Maul Measey Professor in Surgical Research at University of Pennsylvania Perelman School of Medicine, and principal investigator for the study. "We look forward to expanding on our previous studies to further evaluate this agent and its ability to facilitate the complete removal of tumor during surgery."

About VGT-309

VGT-309 is a tumor-targeted imaging agent designed to enable a complete product solution for optimal tumor visualization during open, minimally invasive, and robotic-assisted surgical procedures. VGT-309 is delivered to patients by a short infusion several hours before surgery. Invented in Professor Matt Bogyo’s Lab at Stanford University School of Medicine, the molecule binds tightly (i.e., covalently) to cathepsins, a family of proteases that are overexpressed across a broad range of solid tumors. This approach may provide distinct clinical advantages and positions VGT-309 as an ideal tumor-imaging agent. VGT-309’s imaging component is the near infrared (NIR) dye indocyanine green (ICG), which is compatible with all commercially available NIR intraoperative imaging systems that support MIS technologies and is the preferred dye to minimize confounding background autofluorescence.

On December 13, 2023 RenovoRx, Inc. (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing novel precision oncology therapies based on a local drug-delivery platform, reported that the Company has filed an international patent application under the Patent Cooperation Treaty (PCT) for its novel Trans-Arterial Micro-Perfusion (TAMP) therapy platform (Press release, Renovorx, DEC 13, 2023, View Source [SID1234638546]). The Company already holds a strong intellectual property portfolio with 9 issued patents and 9 pending patents for its proprietary TAMP platform and delivery system in the US, EU, and Asia. The patent portfolio covers two main areas, mechanical and biological.

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The new international patent application is filed under the Patent Cooperation Treaty on methods and apparatuses that may be used to deliver one or more therapeutic agents through the vaso vasorum (small blood vessels that supply the walls of larger arteries or veins) to a target tissue. RenovoRx believes that these methods and apparatuses via the TAMP therapy platform may provide a novel and important pathway for the targeted delivery of therapeutic classes across DNA/RNA-altering modalities, cell therapy, oncolytic viruses, bi-specific antibodies, and monoclonal antibodies for the treatment of a variety of clinical indications. The Company anticipates that the patent application will be published in May of 2024.

"This patent application further expands the value of TAMP into the delivery of larger therapeutic assets, as a unique platform in oncology, beyond our current Phase III clinical asset," said Shaun Bagai, CEO, RenovoRx. "Once approved, it will further extend our IP coverage, opening up new market potential, expanding the upside value proposition of TAMP commercially. We look forward to providing further highlights and updates related to this patent, as well as our progress in our Phase III TIGeR-PaC clinical program."

TAMP is being investigated in the Company’s Phase III TIGeR-PaC clinical trial, an ongoing randomized multi-center study. The study is evaluating trans-arterial delivery of an FDA-approved chemotherapy, gemcitabine, to treat Locally Advanced Pancreatic Cancer (LAPC) following stereotactic body radiation therapy (SBRT). The study is comparing treatment of gemcitabine with TAMP versus systemic IV administration of gemcitabine and nab-paclitaxel.

The first of two interim analyses was completed in March 2023, and the Data Monitoring Committee (DMC) recommended a continuation of the study. The study is prespecified to provide a primary endpoint of a 6-month Overall Survival benefit and secondary endpoints including reduced side effects versus standard of care.