On October 4, 2024 TiumBio Co., Ltd. (Kosdaq: 321550), a clinical-stage biopharmaceutical company focused on discovering and developing innovative therapeutics for patients with rare and incurable diseases, reported that the first patient has been dosed in its Phase 2 clinical trial of TU2218 (Press release, TiumBio, OCT 4, 2024, View Source [SID1234647042]).

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TU2218 is a novel oral dual inhibitor targeting TGFR1 and VEGFR2. TGF-ß and VEGF pathways are known to suppress the activity of immune checkpoint inhibitors (ICIs), so TU2218 is expected to improve the efficacy of ICIs by blocking the two pathways.

In Phase 1a and 1b clinical trials, TiumBio evaluated the safety, pharmacokinetics, and pharmacodynamics of TU2218 as a monotherapy and in combination with Keytruda (pembrolizumab) in 41 patients with advanced solid tumors. These profiles were used to determine the dose levels for Phase 2 trials. The Phase 2a trial is designed to assess the safety and efficacy of TU2218 in combination with Keytruda in patients with head and neck squamous cell carcinoma (HNSCC), biliary tract cancer (BTC), and colorectal cancer (CRC).

The Phase 2 trial begins at Seoul National University Hospital and Asan Medical Center in South Korea, which is planned to expand to hospitals in the United States. The first dose was administered to an HNSCC patient.

HNSCC refers to malignant tumors that occur in the oral cavity, throat, larynx, or salivary glands. The standard treatment typically involves surgery and radiation therapy. According to Global Data, as of 2023, the number of HNSCC patients worldwide is estimated to be around 610,000, and it is expected to exceed 670,000 by 2030.

"HNSCC is a disease with a high unmet medical need, as the average survival rate for first-line treatments is known to be only about one year," said Hun-taek Kim, Ph.D., MBA, CEO of TiumBio. "We have selected cancer types for the Phase 2 clinical trial based on other trials that demonstrated strong anti-cancer effects from targeting TGF- ß or VEGF pathways. Our goal is to develop TU2218 as a first-line treatment for HNSCC," he added.

In the Phase 1b trial, among 10 patients with advanced solid tumors who received a 195mg daily dose (the determined dose for Phase 2) of TU2218 with Keytruda, three patients achieved partial response (PR) and five patients had stable disease (SD), yielding an 80% disease control rate (DCR).

On October 4, 2024 HotSpot Therapeutics, Inc., a biotechnology company pioneering the discovery and development of oral, small molecule allosteric therapies targeting regulatory sites on proteins referred to as "natural hotspots," reported it will present additional Phase 1 clinical biomarker data for HST-1011, an investigational oral, selective inhibitor of Casitas B-lineage lymphoma proto-oncogene (CBL-B), in a poster presentation at the 2024 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, taking place November 6-10, 2024, in Houston, Texas. The poster will showcase exploration of potential clinical biomarkers that correlate with signs of clinical activity in patients from the ongoing Phase 1 monotherapy dose-escalation study of HST-1011.

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Presentation details are as follows:

Title: Peripheral Blood and Tumor Gene Expression as Biomarkers and Potential Predictors of Clinical Outcome with HST-1011, an Oral CBL-B Inhibitor
Session Date and Time: Sat., Nov. 9, 2024, 9:00 AM-8:30 PM CT
Location: Exhibit Halls A & B, George R. Brown Convention Center
Abstract Number: 1310

On October 4, 2024 Carisma Therapeutics Inc. (Nasdaq: CARM) ("Carisma" or the "Company"), a clinical-stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, reported its upcoming poster presentations at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), taking place in Houston, Texas, November 6 -10, 2024 (Press release, Carisma Therapeutics, OCT 4, 2024, View Source [SID1234647040]).

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Details on the poster presentations at SITC (Free SITC Whitepaper) 2024 are below:

Title: Pre-clinical efficacy of a novel anti-GPC3 in vivo CAR-M for hepatocellular carcinoma
Publication Number: 329
Session Date & Time: Friday, Nov. 8, 2024
Location: Exhibit Halls A B George R. Brown Convention Center

Title: A Phase 1, First-in-Human study of autologous monocytes engineered to express an anti-HER2 chimeric antigen receptor (CAR) in participants with HER2 overexpressing solid tumors
Publication Number: 659
Session Date & Time: Friday, Nov. 8, 2024
Location: Exhibit Halls A B George R. Brown Convention Center

The posters presented at SITC (Free SITC Whitepaper) 2024 will be available online in the "Publications" section of Carisma’s website at View Source following the start of the poster session.

On October 4, 2024 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for cancer, reported that it will present three programs at the 2024 Society of Immunology in Cancer Annual Meeting (SITC 2024) to be held in Houston from November 6-10, 2024 (Press release, Antengene, OCT 4, 2024, View Source [SID1234647039]).

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Details of Poster Presentations:

ATG-201 (CD19 x CD3 T-cell Engager)
Title: ATG-201, a novel "2+1" CD19-targeted T-cell Engager (TCE) for the treatment of B cell malignancies and B cell related autoimmune diseases
Abstract Number: 1067
Poster Abstract Presentation at the SITC (Free SITC Whitepaper) Immune Engineering Workshop
Date: November 7, 2024
Time: 3:10 PM – 5:00 PM (Central Standard Time)
5:10 AM – 7:00 AM, Nov 8, 2024 (Beijing Time)
Poster Presentation at the SITC (Free SITC Whitepaper) 39th Annual Meeting
Date: November 8, 2024
Time: 9:00 AM – 7:00 PM (Central Standard Time)
11:00 PM, Nov 8 – 9:00 AM, Nov 9, 2024 (Beijing Time)

ATG-107 (FLT3 x CD3 T-cell Engager)
Title: ATG-107, a novel "2+1" CD3-based T-cell Engager (TCE) targeting FLT3, demonstrates potent preclinical efficacy for the treatment of AML
Abstract Number: 1068
Poster Abstract Presentation at the SITC (Free SITC Whitepaper) Immune Engineering Workshop
Date: November 7, 2024
Time: 3:10 PM – 5:00 PM (Central Standard Time)
5:10 AM – 7:00 AM, Nov 8, 2024 (Beijing Time)
Poster Presentation at the SITC (Free SITC Whitepaper) 39th Annual Meeting
Date: November 9, 2024
Time: 9:00 AM – 8:30 PM (Central Standard Time)
11:00 PM, Nov 9 – 10:30 AM, Nov 10, 2024 (Beijing Time)

ATG-106 (CDH6 x CD3 T-cell Engager)
Title: ATG-106, a novel "2+1" format CDH6-targeted T-cell Engager (TCE), shows potent T cell dependent cytotoxicity and in vivo anti-tumor efficacy
Abstract Number: 1069
Poster Presentation at the SITC (Free SITC Whitepaper) 39th Annual Meeting
Date: November 8, 2024
Time: 9:00 AM – 7:00 PM (Central Standard Time)
11:00 PM, Nov 8 – 9:00 AM, Nov 9, 2024 (Beijing Time)

About the AnTenGager Platform

The AnTenGager Platform is a proprietary "2+1" T cell engager (TCE) platform developed by Antengene. AnTenGager TCE simultaneously binds to disease-associated antigens (targets) and a unique conformational epitope on CD3 that expressed on T-cells. The bivalent binding to the targets enables detection and depletion of cells with low expression of the targets. In addition, AnTenGager TCE activates T cells in a target-dependent manner so that it demonstrates a lower risk of systemic CD3 activation and cytokine release syndrome (CRS), potentially paving the way for their use in autoimmune diseases, hematological malignancies, and solid tumors.

Our extensive and diverse pipeline features promising TCEs that aim to address unmet medical needs in autoimmune diseases and hematology/oncology, with best-in-class/first-in-class potential. A few of our lead programs in the IND-enabling stage include ATG-201, a CD19 x CD3 TCE for B cell related autoimmune diseases; ATG-102, a LILRB4 x CD3 TCE for acute myeloid leukemia (AML) and chronic myelomonocytic leukemia; ATG-106, a CDH6 x CD3 TCE for ovarian cancer and kidney cancer; ATG-107, a FLT3 x CD3 TCE for AML; and ATG-110, a LY6G6D x CD3 TCE for microsatellite stable (MSS) colorectal cancer.

On October 4, 2024 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, reported the Company will present a poster at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 39th Annual Meeting taking place November 6-10, 2024 in Houston, Texas and virtually (Press release, Candel Therapeutics, OCT 4, 2024, View Source [SID1234647038]).

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Presentation details are as follows:

Title: Therapeutic potential of CAN-3110 in Ras-Raf pathway altered melanoma
Presenter: Anne Diers, PhD, Senior Director, Research, Candel Therapeutics
Abstract Number: 995
Session Date: Friday, Nov. 8, 2024
Location: Exhibit Halls A and B – George R. Brown Convention Center

Further details from the presentation will be available following the events on the Candel website at: View Source

About CAN-3110

CAN-3110 is a first-in-class, replication-competent herpes simplex virus-1 (HSV-1) oncolytic viral immunotherapy candidate designed with dual activity for oncolysis and immune activation in a single therapeutic. Its activity is designed to be conditional to the expression of Nestin in cancer cells. CAN-3110 is being evaluated in a phase 1b clinical trial in patients with recurrent high-grade glioma (rHGG). In October 2023, the Company announced that Nature published results from this ongoing clinical trial. CAN-3110 was well tolerated with no dose-limiting toxicity reported. In the clinical trial, the investigators observed improved median overall survival compared to historical controls after a single CAN-3110 injection in this therapy-resistant condition.1 The Company and academic collaborators are currently evaluating the effects of multiple CAN-3110 injections in rHGG, supported by the Break Through Cancer Foundation. CAN-3110 has previously received FDA Fast Track Designation and Orphan Drug Designation for the treatment of rHGG.