On November 11, 2024 Medigene AG (Medigene or the "Company", FSE: MDG1, Prime Standard), an oncology platform company focused on the research and development of T cell receptor (TCR)-guided therapies for the treatment of cancer, reported latest updates on its End-to-End (E2E) Platform technology – the UniTope and TraCR technology, a universal detection system for tagging and tracking recombinant TCRs (rTCRs), at the Protein & Antibody Engineering Summit (PEGS) in Barcelona from November 5-7, 2024, and the Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2024 conference in Houston, TX, USA from November 6-10, 2024 (Press release, MediGene, NOV 11, 2024, View Source [SID1234648080]).

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The presentation "Seamless Integration of a Universal Epitope into Recombinant TCRs for Tagging and Tracking of TCR-T Cells Expressing 3S TCRs"and the poster "UniTope & TraCR – A universal tagging and tracking system for TCR-T cells directly integrated in recombinant TCRs"are available on the Medigene website: View Source

"Precise tracking of T cells engineered to express rTCRs is essential for thoroughly vetting rTCR candidates to identify optimal 3S (specific, sensitive and safe) lead candidates, assess specific rTCR sequences during drug product development, and provide consistent monitoring of TCR-T cells throughout Good Manufacturing Practice production," said Dolores Schendel, CSO of Medigene AG. "At Medigene, we are constantly aiming to expand our End-to-End (E2E) Platform by integrating new proprietary technologies such as the UniTope & TraCR system to optimize our discovery process for selection of 3S rTCRs. With UniTope & TraCR, rTCR sequences of any specificity can also be precisely identified during drug product manufacture through accurate assessment of rTCR expression and frequency of rTCR-T cells. During the clinical phases of development, these technologies support robust quality control processes for drug product release, facilitates precise dosing calculations for therapeutic administration and provides a simple methodology for assessing the pharmacokinetics and pharmacodynamics of TCR-T cells post-infusion in patients, all of which contribute to optimizing patient safety."

The data presented at both conferences showcased Medigene’s novel UniTope and TraCR System for universal identification of rTCRs in TCR-T therapies. This system enables standardized tagging, enrichment and tracking of rTCRs by use of simple flow cytometry-based technologies with a single detection reagent.

Bioinformatic studies were used to identify a unique, six-amino-acid peptide, designated as UniTope, with predicted low immunogenicity. This sequence is absent in all natural TCR chains, enabling rTCRs to be earmarked with a unique identifier through seamless integration of UniTope directly in the rTCR sequence of either chain of any TCR heterodimer. A corresponding antibody, designated TraCR, was developed that specifically binds to UniTope-modified rTCRs, but not to any natural TCR sequence, enabling precise identification of tagged rTCRs.

Comprehensive studies compared UniTope-modified rTCRs with unmodified rTCRs for 3S attributes of specificity, sensitivity and safety. In vitro tests showed that integrating UniTope in rTCRs expressed by TCR-T cells targeting the neoantigen mKRAS G12V or the cancer-testis antigens NY-ESO-1 and PRAME preserved TCR expression as well as function, confirming that UniTope-modification had no impact on the rTCRs structural and functional attributes. Safety assessments further validated TCR-T cells with UniTope-modified rTCRs maintained a high safety profile with no signals for unintended recognition of cells originating from primary healthy tissues.

Overall, equivalent specificity, safety, and functionality of UniTope-modified rTCRs, compared with unmodified rTCRs, demonstrates the versatility of the UniTope & TraCR System as a high precision technology that facilitates optimized development of TCR-T therapies.

On November 14, 2024 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, reported the dosing of the first patient in the Phase IIa clinical trial in patients with advanced pancreatic adenocarcinoma (NCT06387342) (Press release, Can-Fite BioPharma, NOV 11, 2024, View Source [SID1234648081]).

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"We are excited to have the first patient enrolled and hope that we will be able to demonstrate the safety and efficacy of Namodenoson in the pancreatic cancer patient population. This trial provides us the opportunity to explore our innovative treatment approach for patients who are facing significant gaps in effective treatment options," stated Dr. Michael Silverman, Can-Fite’s Medical Officer.

The Phase IIa study is a multicenter open-label trial in patients with advanced pancreatic adenocarcinoma whose disease has progressed on at least first-line therapy. The trial is evaluating the safety, clinical activity, and pharmacokinetics (PK) of Namodenoson in this patient population. All patients receive oral Namodenoson 25 mg, administered twice daily for consecutive 28-day cycles. Patients are being evaluated regularly for safety. Approximately 20 evaluable patients will be enrolled. The primary objective of this trial is to characterize the safety profile of Namodenoson and the secondary objective is to evaluate the clinical activity as determined by the Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), Progression-Free Survival (PFS), Disease Control Rate (DCR), Duration of Response (DoR), and Overall Survival (OS).

The study is being conducted by Dr. Salomon Stemmer, a leading key opinion leader, at the Institute of Oncology, Rabin Medical Center, Israel and by Dr. Al Mutar from the UT Southwestern Medical Center in the US. Orphan Drug Designation has been granted lately by US FDA.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson was evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

On November 11, 2024 Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage allogeneic cell therapy and genetic medicines company advancing differentiated non-viral treatments for patients with cancer, autoimmune and rare diseases, reported that the Company will participate in the following upcoming investor conferences (Press release, Poseida Therapeutics, NOV 11, 2024, View Source [SID1234648082]):

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Stifel 2024 Healthcare Conference
Date: Monday, November 18, 2024
Time: 10:20am ET

Piper Sandler 36th Annual Healthcare Conference
Date: Wednesday, December 4, 2024
Time: 12:00pm ET

Webcasts will be available on the Investors & Media Section of Poseida’s website, www.poseida.com. A replay of the webcast will be available for approximately 90 days following the presentation.

On November 11, 2024 Abcuro, Inc., a clinical-stage biotechnology company developing therapies for the treatment of autoimmune diseases and cancer through precise modulation of cytotoxic T cells, reported that Alex Martin, Chief Executive Officer, will present at the following investor conferences (Press release, Abcuro, NOV 11, 2024, View Source [SID1234648065]).

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Stifel 2024 Healthcare Conference: Presentation on November 18, 2024, at 3:00 pm E.T.
Piper Sandler 36th Annual Healthcare Conference: Presentation on December 3, 2024, at 4:10 pm E.T.

On November 11, 2024 HOOKIPA Pharma Inc. (NASDAQ: HOOK, "HOOKIPA", the "Company"), a clinical-stage biopharmaceutical company developing next generation immunotherapeutics for the treatment of cancer and serious infectious disease, reported that clinical collaborator Alan Ho, MD, PhD, Chief of the Head and Neck Oncology Service at Memorial Sloan Kettering Cancer Center, presented updated Phase 2 data from a study evaluating eseba-vec in combination with pembrolizumab as front line (1L) therapy in the setting of human papillomavirus type 16 positive (HPV16+) relapsed or metastatic head and neck squamous cell carcinoma (R/M HNSCC) at the 39th Annual Meeting for the Society for Immunotherapy in Cancer (SITC2024), being held in Houston Texas from November 8 – 10, 2024 (Press release, Hookipa Pharma, NOV 11, 2024, View Source [SID1234648083]).

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The late-breaking poster presentation focused on results from a subset of patients (PD-L1 CPS >20, n=27, with 25 response evaluable patients). The data showed an overall response rate (ORR) of 52% for all eseba-vec doses tested, with a disease control rate (DCR) of 80%, as of the September 30, 2024 data cut-off. While progression free survival (PFS) and overall survival (OS) data are still maturing, preliminary median PFS is greater than 16 months, with a 12-month OS rate of 83%, and 66.7% of confirmed responders ongoing. In addition, the observed clinical activity is supported by a rapid, robust, and durable tumor antigen specific T-cell response. Data are generally consistent for the selected Phase 3 dose level, including a 55% ORR, which is an approximately 2-fold increase compared to historical pembrolizumab monotherapy data. Patients experienced manageable toxicity and a low level of serious treatment related adverse events (7.6%).

"The expanded data presented at SITC (Free SITC Whitepaper) 2024 are encouraging to HOOKIPA. They provide highly consistent proof-of-concept results which suggest that the combination treatment could lead to improved clinical outcomes and survival in patients with HPV16+ R/M HNSCC CPS>20 in the first line setting," said Mark Winderlich, PhD, Chief Research and Development Officer.

Dr. Ho commented, "As a medical oncologist who specializes in head and neck cancers, I am inspired by the results of the expanded eseba-vec/pembrolizumab Phase 2 study because of the potentially clinically meaningful response rate and encouraging PFS and OS data. In addition, the regimen has a manageable safety profile that ensures most patients can maintain treatment."

The late-breaking poster: Eseba-vec (HB-200) plus pembrolizumab as first-line treatment of recurrent/metastatic HPV16-positive head and neck cancer: updated results in PD-L1 CPS ≥20 patients will be available on November 11, 2024 on the HOOKIPA website on the "Scientific Publications" tab of the "Our Science" page.

About Eseba-vec
Eseba-vec (also known as HB-200) is an investigational immunotherapeutic agent being evaluated for HPV16 positive cancers. The first indication for eseba-vec is for the potential treatment of patients with HPV16+ recurrent/metastatic oropharyngeal squamous cell carcinoma (R/M OPSCC) with a PDL1 CPS of 20 or higher, in combination with pembrolizumab, in the first line (1L) setting. Eseba-vec has received Fast Track Designation from the U.S. Food and Drug Administration and PRIME designation from the European Medicines Agency for the treatment of 1L HPV16+ OPSCC. Eseba-vec was developed using HOOKIPA’s proprietary arenavirus platform.