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Immunitas Therapeutics Presents Data for Novel Anti CLEC2D-TLR9 Conjugate Program at the Society for Immunotherapy of Cancer 2023 Annual Meeting

On October 31, 2023 Immunitas Therapeutics ("Immunitas"), a clinical stage precision immunotherapy company committed to discovering and developing novel, differentiated therapeutics for patients with cancer, reported that it will present the first proof-of-concept data on its second program, a myeloid and B cell modulating anti CLEC2D-Toll-like receptor 9 (TLR9) agonist conjugate, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 38th Annual Meeting (SITC 2023), held November 1-5 (Press release, Immunitas Therapeutics, OCT 31, 2023, View Source [SID1234636589]).

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Presentation Details for SITC (Free SITC Whitepaper) 2023
Title: Anti CLEC2D-TLR9 agonist conjugate binds to and internalizes CLEC2D on myeloid cells, plasmacytoid DCs and B cells leading to robust TLR pathway activation and inflammatory cytokine production
Abstract Number: 1131
Date/Time: Friday, November 3, 2023, 9:00am – 7:00pm PDT

About CLEC2D
CLEC2D is a protein broadly expressed on a subset of immune cells which, upon internalization, acts as a vehicle to deliver histone/CpG complexes to endosomal toll-like receptor 9 (TLR9), stimulating an inflammatory response. Harnessing this biology offers a compelling immunotherapy approach that stimulates inflammatory responses that may improve recruitment of functional T and NK cells in tumors with otherwise poor T cell infiltration. Building on biology supporting its lead investigational candidate, IMT-009, Immunitas is developing a novel anti CLEC2D-TLR9 agonist immune stimulating antibody complex (ISAC) comprising a fully human anti-CLEC2D antibody conjugated to aCpG oligonucleotide. This molecule is capable of triggering TLR9 pathway activation in myeloid cells, B cells, and plasmacytoid dendritic cells enabling induction of sustained T cell immunity.

Flare Therapeutics to Present New Translational Data in Support of Clinical Candidate FX-909’s Phase 1 Development at SITC 2023 Annual Meeting

On October 31, 2023 Flare Therapeutics Inc., a clinical-stage biotechnology company targeting transcription factors to discover precision medicines for cancer and other diseases, reported a poster presentation at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 38th Annual Meeting (SITC) (Free SITC Whitepaper) 2023, taking place November 1-5, 2023 in San Diego, California (Press release, Flare Therapeutics, OCT 31, 2023, View Source [SID1234636588]).

Details for the presentation are as follows:

Abstract Title: PPARG amplification is associated with lack of response to anti-PD1 in Muscle-Invasive Urothelial Cancer
Abstract Number: 537
Presenter: Evisa Gjini, Senior Director, Translational Medicine, Flare Therapeutics
Date, Time: Friday, November 3, 2023, 9:00am – 7:00pm PDT (12:00pm – 10:00pm EDT)
Location: Exhibit Halls A and B1, San Diego Convention Center, San Diego

Shuttle Pharma Advances Prostate Cancer Predictive Biomarker Program Through Exclusive License Agreement

On October 31, 2023 Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH), a discovery and development stage specialty pharmaceutical company focused on improving the outcomes of cancer patients treated with radiation therapy (RT), reported that it has entered into an exclusive agreement to license certain intellectual property (IP) from Georgetown University to advance Shuttle Pharma’s predictive biomarker program for prostate cancer (Press release, Shuttle Pharmaceuticals, OCT 31, 2023, View Source [SID1234636587]).

The intellectual property was originally developed through a collaboration of Shuttle Pharma scientists with investigators from Georgetown University. The intellectual property consists of patent applications prepared and filed by Georgetown University titled: "Predictive Biomarkers for Adverse Effects of Radiation Therapy."

Shuttle Pharma’s predictive marker strategy is to develop a predictive diagnostic test for prostate cancer patients who are considering elective radiation therapy which will allow them to assess their risk for treatment success or failure, while informing therapeutic decision making and follow-up management. Shuttle Pharma believes a predictive diagnostic test for the effects of radiation therapy would be a cost-effective approach to inform clinicians in their treatment choices and provide patients with a better understanding of the benefits and risks of radiation therapy.

Anatoly Dritschilo, M.D., CEO of Shuttle Pharma, commented, "Prostate cancers vary in their aggressiveness and in their responses to treatment. Some prostate cancers spread quickly to other parts of the body, while others grow slowly and can be effectively managed by radiation therapy or other conservative medical measures. While diagnostic tests are available, presently there are no predictive diagnostics tests to identify potential outcomes of available therapies. The key unmet need of the diagnostic market is having a predictive, minimally invasive blood test that provides the clinician and patient with a measurement of the potential success of radiation therapy for their cancer treatment. This unmet need in the market is what Shuttle’s predictive biomarker program looks to address."

The American Cancer Society estimates that 1 in 8 men will be diagnosed with prostate cancer during his lifetime. The National Cancer Institute of the National Institutes of Health (NIH) Surveillance, Epidemiology, and End Results (SEER) database estimated that approximately 268,000 men were diagnosed with prostate cancer in the U.S. in 2022 and approximately 30% of prostate cancer patients (~66,000) with localized disease received radiation therapy for cancer treatment.

Dr. Dritschilo expanded, "Our mission is to accelerate investigation of the prostate cancer metabolite-based predictive assay to improve outcomes of radiation therapy. Shuttle Pharma aims to change the way that clinicians select patients for radiation therapy and provide informed consent. The potential market for these predictive assays includes clinicians offering radiation therapy for prostate cancer treatment in the initial selection process and in personalizing follow up management of patients by considering anticipated late effects."

Shuttle Pharma scientists have collaborated with investigators from Georgetown University to complete Phase I and Phase II NIH SBIR contracts to develop predictive biomarkers of radiation therapy outcomes and late effects. Shuttle Pharma will also seek to leverage eligibility to apply for project bridge funding via an NIH Phase IIb SBIR mechanism.

BerGenBio Announces Poster Presentation at Upcoming SITC Meeting

On October 31, 2023 BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, reported that a poster highlighting data from pre-planned biomarker analyses in second line Non-Small Cell Lung Cancer (NSCLC) patients treated with bemcentinib, a highly selective AXL inhibitor in combination with MSD’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) will be presented at the Society for Immunotherapy for Cancer (SITC) (Free SITC Whitepaper) meeting being held on November 1-5, 2023 in San Diego, California (Press release, BerGenBio, OCT 31, 2023, View Source [SID1234636586]).

The poster abstract was published today in the Journal for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (JITC), an open-access journal. The full poster will be available on BerGenBio’s website shortly following presentation on November 4th.

Poster Details

Title: Bemcentinib + Pembrolizumab show promising efficacy in metastatic NSCLC patients harboring mutations associated with poor prognosis: exploratory sub-analysis from the BGBC008 trial

Poster Board Number: 598

Presentation Time: Saturday, Nov. 4, 2023 beginning at 0900 Pacific Time

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA

Curocell Completes Korea’s First Phase 2 Clinical Trial for Next-Generation CAR-T

On October 31, 2023 Curocell, South Korea based CAR-T specialized company (CEO: Gunsoo Kim), reported that it has completed Phase 2 clinical trial for its next-generation CD19 CAR-T therapy "Anbal-cel" that targets relapsed or refractory DLBCL (Diffuse Large B-cell Lymphoma) (Press release, Curocell, OCT 31, 2023, View Source [SID1234636585]).

This announcement is a significant milestone and is paving the way towards the launch and approval of Korea’s first CAR-T therapy. It has also provied typo new hope for the treatment of patients with DLBCL, an aggressive form of cancer that is growing in prevalence within Korea.

The Phase 2 clinical trial evaluated the safety, efficacy and tolerability of "Anbal-cel" in patients with relapsed or refractory DLBCL. It was conducted over a period of 20 months starting in February 2022, enrolling a total of 80 patients from six hospitals across Korea, including Samsung Medical Center, Asan Medical Center, Seoul National University Hospital, National Cancer Center, Chonnma typo National University Hospital, and Pusan National University Hospital.

"Anbal-cel" is a next-generation CAR-T therapy based on Curocell’s OVIS technology that significantly inhibits the expression of PD-1 and TIGIT, two types of immune checkpoint receptors, which are known to inhibit anti-tumor function/activity of CAR-T cells. This technology has substantially improved the therapeutic performance of CAR-T therapy in patients with relapsed or refractory DLBCL with a poor prognosis.

Curocell made international headlines during the company’s oral presentation of its Phase 2 clinical trial interim results at the International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland back in June. The interim results analyzed the efficacy and safety of its CAR-T treatment in 41 patients participating in the Phase 2 trial. The complete response rate (CRR: Rate at which the cancer enters into full remission) observed in the interim results was 71%, showing an improved therpeutic effect compared to the 40 to 50% CRR range for three FDA-approved CAR-T therapies currently on the market.

Curocell plans to officially announce the final results of its Phase 2 clinical trial for "Anbal-cel" in the first half of next year and submit an BLA application to Korea’s Ministry of Food and Drug Safety for approval next September. Starting from the expected year of approval in 2025, the company is planning to launch the supply of commercial products from Korea’s only large-scale GMP facility dedicated to the production of CAR-T boasting state-of-the-art equipment.

CEO of Curocell, Gunsoo Kim said that, "I am extremely proud that we were able to complete Korea’s first clinical Trial or study for CAR-T therapy in such a short period of time, which I believe is one of the most remarkable achievement in the history of drug development in Korea." He added, "We will make every effort to obtain approval for Anbal-cel in 2025 and ensure sustained growth for the company through future expansion in our overseas business."

The clinical trial for "Anbal-cel" was officially selected by the Korea Drug Development Fund (KDDF) in 2021 as the target of a government grant. It was conducted with the support of the National New Drug Development Project Team, funded by the Ministry of Science, ICT, and Future Planning, the Ministry of Trade, Industry and Energy, and the Ministry of Health and Welfare. (Project Number: HN21C0653)