On December 20, 2023 TME Pharma N.V. (Euronext Growth Paris: ALTME), a biotechnology company focused on developing novel therapies for treatment of cancer by targeting the tumor microenvironment (TME), reported that with median overall survival (mOS) has now passed 19 months and will improve further in the GLORIA expansion arm for newly diagnosed glioblastoma patients receiving NOX-A12 with the VEGF inhibitor bevacizumab and radiotherapy (Press release, TME Pharma, DEC 20, 2023, View Source [SID1234638738]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The survival data in the cohort receiving the combination of NOX-A12, bevacizumab and radiotherapy has continued to improve with treatment or follow-up of enrolled brain cancer patients. Passing 19 months suggests a large survival benefit for patients on NOX-A12-based therapy since we are seeing more than an 80% increase in survival over the 10.5 months in the matched standard of care reference cohort of patients with the same profile as those we recruited into the study of NOX-A12: newly-diagnosed aggressive brain cancer (glioblastoma) with chemotherapy refractory tumors not amenable to complete surgical resection," said Aram Mangasarian, CEO of TME Pharma. "With further perspective on the data we can now say with certainty that median overall survival will be between 19.0 and 19.9 months and plan to provide an update before the end of February 2024."

The NOX-A12-based combination with bevacizumab and radiotherapy has now further surpassed the median overall survival figures achieved in what TME Pharma believes to be all the relevant competitor studies conducted in the US or EU involving newly diagnosed, chemotherapy-resistant (MGMT unmethylated) glioblastoma patients which ranged from 13.4 to 16.5 months mOS for therapies in clinical development and 16.9 months demonstrated by the Tumor Treating Fields device that was approved by the US Food and Drug Administration (FDA) for newly-diagnosed glioblastoma in 20151. In addition, the NOX-A12-based therapy achieved this result despite having a more difficult population to treat since only patients with residual detectable tumor after surgery were included the NOX-A12 trial, while competing trials included patients with complete removal of detectable tumor.

On December 20, 2023 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported the company will participate in the upcoming 42nd Annual J.P. Morgan Healthcare Conference in San Francisco (Press release, Guardant Health, DEC 20, 2023, View Source [SID1234638737]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Guardant Health’s management is scheduled to present and participate in a Q&A session on Monday, January 8, at 3:45 p.m. Pacific Time / 6:45 p.m. Eastern Time. Interested parties may access live and archived webcasts of the sessions on the "Investors" section of the company website at: www.guardanthealth.com.

On December 20, 2023 SciTech Development ("SciTech" or the "Company"), a clinical-stage pharmaceutical company with a novel and patented drug delivery platform, reported that the company has dosed the first patient in its Phase 1 clinical trial with lead cancer drug candidate, ST-001 nanoFenretinide (Press release, SciTech Development, DEC 20, 2023, View Source [SID1234638735]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"There have been relatively few new cancer breakthroughs for T-cell lymphoma in several years, so we are excited to announce this milestone for patients suffering from this rare disease." said Earle Holsapple, SciTech’s President, and CEO. "Our scientific team has worked extremely hard to bring this new drug to the people that need it most. We currently have four active trial sites with world-renowned medical institutions in New York, California, Pennsylvania, and Michigan, with more sites coming onboard in early 2024 as the trials expand. SciTech is proud to be on the forefront of helping cancer patients and we thank everyone who has supported our journey."

The active drug fenretinide has been clinically tested and deemed safe in over 3,000+ patients in previous clinical trials. However, due to bioavailability issues of past fenretinide formulations, high concentrations of the drug could not reach and kill the target cancer cells. SciTech led the effort to find the solution with its patented methods for phospholipids and nanoparticalization to enhance fenretinide’s bioavailability, thus developing ST-001 nanoFenretinide.

SciTech’s Phase 1 clinical trials are targeting patients with T-cell non-Hodgkin’s lymphoma, including Cutaneous T-cell Lymphoma (CTCL), Mycosis Fungoides, Sézary Syndrome, and non-Cutaneous T-cell Lymphoma subtypes. The initial study will determine the Maximum Tolerated Dose (MTD) of ST-001 nanoFenretinide (IV infusion) in patients with CTCL and other T-cell non-Hodgkin’s lymphoma.

For more detailed trial information, please visit ClinicalTrials.gov; Identifier: NCT04234048.

On December 20, 2023 CellOrigin Biotechnology reported that a CAR-macrophage therapy product (CAR-M) SY001 was dosed to the first patient in a hospital in China (Press release, CellOrigin Biotech, DEC 20, 2023, View Source [SID1234638734]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"A single center, single-arm, dose-escalation, exploratory clinical trial to examine the safety, tolerability, pharmacokinetics and preliminary efficacy of SY001 from CellOrigin Biotechnology in patients with advanced solid tumors" is the first investigator-initiated clinical study of CAR-M cell therapy product in China. The successful completion of the first patient dosing of SY001 demonstrates the advanced technology of the company’s R&D platform and the maturity of the CMC platform. Currently, the clinical study is actively recruiting patients.

SY001 was well tolerated and no dose-limiting toxicity (DLT) was observed (n=2). Only 2 grade 3 adverse events occurred; Common grade 1 – 2 adverse events included fever, elevated C-reactive protein, etc. No cytokine release syndrome or neurotoxicity related to cell infusion occurred in any patients.

The clinical data of CAR-M products up to now suggest the excellent safety and certain clinical benefits of macrophage immunotherapy. CellOrigin expects that this innovative product will prove its safety and effectiveness in clinical trials, bringing new hope for the treatment of solid tumors, thereby improving patients’ quality of life and prolonging their life span.

Besides, in November 2023, CellOrigin collaborated with Zhejiang University to publish a paper entitled "A second generation M1-polarized CAR macrophage with antitumor efficacy" in Nature immunology, designing an exclusive CAR with antigen-dependent polarization and activation of macrophage function (TIR-CAR or M-CAR) by introducing the TIR signal transduction domain. Based on M-CAR, a functionally enhanced second generation CAR-iMAC has been developed to enhance the effectiveness of the therapy for solid tumors. The mechanism of antigen-dependent activation and polarization of the second generation CAR-iMAC and the mechanisms of solid tumor cell killing were also revealed.

In November 2020, the team published a paper in J Hematol Oncol entitled "Pluripotent stem cell-derived CAR-macrophage cells with antigen-dependent anti-cancer cell functions." It opens the door for human iPSC-derived CAR-macrophage (CAR-iMAC) and its applications in targeted anti-tumor research. The first generation CAR-iMAC was designed, and was capable of carrying out the antigen-dependent killing of tumor cells.

On September 11, 2023, the team collaborated with Dr. Wang Ben’s Research Group of Zhejiang University to publish a paper entitled "Targeted glycan degradation potentials cellular immunotherapy for solid tumors" in Proceedings of the National Academy of Sciences (PNAS). The collaboration found that simultaneous deletion of sialidase-binding immune checkpoints Siglec-5 and Siglec-10 (DKO-CAR-iMac) on macrophages significantly enhanced CAR-iMAC’s anti-solid tumor function.

Almost the same time, the team published another paper entitled "Metabolic Reprogramming via ACOD1 depletion enhances function of human induced pluripotent stem cell-derived CAR-macrophases in solid tumors" in Nature communications. A CRISPR Screen method was used to find the key metabolic genes related to CAR-iMAC polarization in tumor microenvironment. It was discovered that knockout of ACOD1 (or IRG1) could improve macrophage proinflammatory polarization, phagocytic capacity and tumor-killing activity. Furthermore, the study also found that the anti-tumor effect of ACOD1-/- MSLN-CAR-iMAC can be further enhanced by combining immune checkpoint inhibitors. These findings offer fresh concepts for remodeling macrophages based on metabolic reprogramming or editing the immune checkpoints.

Based on these research results, CellOrigin is conducting a series of pre-clinical and clinical studies of CAR-macrophage therapies for solid tumors in an effort to provide patients with safe and effective treatment choices as soon as possible.

On December 20, 2023 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the Company will webcast its corporate presentation at the 42nd Annual J.P. Morgan Healthcare Conference (Press release, Jazz Pharmaceuticals, DEC 20, 2023, View Source [SID1234638733]). Bruce Cozadd, chairman and chief executive officer, will provide an overview of the company and a business and financial update on Monday, January 8, 2024, at 2:15 p.m. PST / 10:15 p.m. GMT.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live audio webcast of the presentation may be accessed via the Investors section of the Jazz Pharmaceuticals website at View Source A replay of the webcast will be available on the website for 30 days following the conference.