On October 4, 2024 Nouscom, a clinical stage immuno-oncology company developing off-the-shelf and personalized viral vector-based cancer vaccines targeting neoantigens, reported that updated safety data, as well as compelling immunogenicity and durability of T cell response from its Phase 1b/2 study evaluating NOUS-209 in Lynch Syndrome carriers will be presented at the 39th Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2024 annual meeting (6th – 10th November 2024, Houston, TX, USA) (Press release, NousCom, OCT 4, 2024, View Source;utm_medium=rss&utm_campaign=nouscom-to-present-updated-positive-data-on-nous-209s-potential-to-intercept-cancer-in-lynch-syndrome-carriers-at-sitc-2024 [SID1234647033]).

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NOUS-209 is an innovative and unique off-the-shelf vaccine encoding 209 neoantigens that are shared across sporadic and hereditary Microsatellite Instable (MSI) tumors. Lynch Syndrome (LS) is one of the most prevalent hereditary cancer syndromes affecting approximately one in 300 people. LS carriers have a high-risk predisposition to developing MSI tumors with an up to 80% lifetime risk of developing colorectal cancer (CRC). Currently, there are no treatment options for LS carriers, other than active surveillance and / or prophylactic surgery. NOUS-209 monotherapy has the potential to ‘intercept’ cancer before it occurs in these individuals.

Interim results in the first ten LS participants from a Phase 1b/2 study (NCT05078866) were reported in a late-breaking abstract and presented at the SITC (Free SITC Whitepaper) 2023 demonstrating good safety and robust and broad CD4 and CD8 T cell immunity of NOUS-209 monotherapy (D’Alise et al.1).

Abstract details are as follows:

Abstract Title: Nous-209 vaccine induces shared neoantigen immunogenicity for cancer interception in healthy Lynch Syndrome carriers: results from Phase Ib/II trial
Abstract Number: 638
Presenter: Dr Eduardo Vilar

NOUS-209 is also being evaluated in a randomized, global multicenter Phase 2 trial for the treatment of deficient mismatch repair (dMMR)/MSI-High tumor patients with unresectable or metastatic CRC in combination with pembrolizumab (NCT04041310).

On October 4, 2024 Biodexa Pharmaceuticals PLC ("Biodexa" or "the Company"), (Nasdaq: BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs reported an update in respect of its open label Phase 1 study of MTX110 in recurrent glioblastoma (Press release, Biodexa Pharmaceuticals, OCT 4, 2024, View Source [SID1234647032]).

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In October 2023, the Company announced completed recruitment of four patients into cohort A of its Phase 1 study of MTX110 (also known as MAGIC-G1 study)(NCT 05324501) in patients with recurrent glioblastoma (rGBM).

MAGIC-G1 is an open-label, dose escalation study designed to assess the feasibility and safety of intermittent infusions of MTX110 administered by convection enhanced delivery (CED) via implanted refillable pump and catheter. Patients received MTX110 via intermittent repeated CED infusions. As of today, the status of patients in Cohort A is as follows:

Patients #1 and #2 have deceased with overall survival (OS) since start of treatment of 12 months and 13 months, respectively.

Patients #3 and #4 remain in post-study follow-up. Patient #3 had progression free survival (PFS) of six months and OS thus far of 13 months since start of treatment. Patient #4 has not yet had confirmed progression and, as of today, has PFS and OS of 12 months since start of treatment.

Glioblastoma (GBM) is the most aggressive central nervous system (CNS) primary malignancy in adults with an annual incidence is approximately 3 per 100,000 population. The standard of care in newly diagnosed GBM includes maximal safe surgical resection, followed by concurrent radiotherapy and temozolomide (TMZ). GBM virtually always recurs with median PFS of 1.5–6.0 months and median OS of 2.0–9.0 months (source: Birzu et al. View Source).

These interim data in rGBM build on the data announced by the Company on July 2, 2024, and presented at the recent 21st International Symposium on Paediatric Neuro-Oncology (ISPNO 2024) of a Phase 1 study of MTX110 in nine patients with Diffuse Midline Glioma ("DMG") which showed, after only two infusions and a single patient at optimum dose, median OS of 16.5 months. In an earlier Phase 1 study conducted by the University of California San Francisco of MTX110 in seven patients with DMG which showed median OS of 26.1 months. These data compare favorably with median OS in a cohort of 316 cases of 10.0 months (source: Jansen et al, 2015. Neuro-Oncology 17(1):160-166).

About MTX110
MTX110 is a water-soluble form of panobinostat free base, achieved through complexation with hydroxypropyl-β-cyclodextrin (HPBCD), that enables convection-enhanced delivery (CED) at potentially chemotherapeutic doses directly to the site of the tumor. Panobinostat is a hydroxamic acid and acts as a non-selective histone deacetylase inhibitor (pan-HDAC inhibitor). The currently available oral formulation of panobinostat lactate (Farydak) is not suitable for treatment of brain cancers owing to poor blood-brain barrier penetration and inadequate brain drug concentrations. Based on favourable translational science data, MTX110 is being evaluated clinically as a treatment for recurrent glioblastoma (NCT05324501) and recurrent medulloblastoma (NCT04315064). MTX110 is delivered directly into and around the patient’s tumor via a catheter system (e.g. CED or fourth ventricle infusions) to bypass the blood-brain barrier. This technique exposes the tumor to very high drug concentrations while simultaneously minimising systemic drug levels and the potential for toxicity and other side effects. Panobinostat has demonstrated high potency against DIPG (DMG) and GBM tumor cells in in vitro and in vivo models, and in a key study it was the most promising of 83 anticancer agents tested in 14 patient-derived DIPG (DMG) cell lines (Grasso et al, 2015. Nature Medicine 21(6), 555-559).

On October 4, 2024 Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical‑stage T-cell reprogramming company advancing a diverse pipeline of cell therapies for patients with solid tumors or hematologic malignancies, reported that three abstracts highlighting its pipeline of clinical product candidates and anti-exhaustion technology have been accepted for presentation at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) taking place in Houston, TX, Nov. 6-10, 2024 (Press release, Lyell Immunopharma, OCT 4, 2024, View Source [SID1234647031]).

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The three presentations highlight anti-exhaustion technology and product candidates being advanced in Lyell’s pipeline of cell therapies for solid tumors and hematologic malignancies, including the first presentation at a scientific conference of translational data from the LYL797 Phase 1 clinical trial demonstrating solid tumor infiltration and cell killing by reprogrammed ROR1 CAR T cells.

Details of the poster presentations are below:

LYL797 ROR1 CAR T-cell Translational Data Demonstrated T-cell Reprogramming Limited Exhaustion, Maintained Stemness, and Resulted in Tumor Infiltration and Cell Killing in Patients with Solid Tumors

Abstract Number: 285
Presentation Date & Time: Friday, Nov. 8, 2024, 12:15-1:45 p.m. and 5:25-6:55 p.m.
Multiomic profiling of LYL119: A Reprogrammed ROR1 CAR T Product Generates T cells with Reduced Exhaustion and Enhanced Memory Characteristics Associated with Increased AP-1 and Reduced NR4A Bindings

Abstract Number: 283
Presentation Date & Time: Friday, Nov. 8, 2024, 12:15-1:45 p.m. and 5:25-6:55 p.m.
Utilizing Stim-R Technology to Reduce Irradiated Feeder Cells in the Tumor Infiltrating Lymphocyte Culture Process

Abstract Number: 440
Presentation Date & Time: Saturday Nov. 9, 2024, 12:00-1:30 p.m. and 7-8:30 p.m.

On October 4, 2024 Kineta, Inc. (OTC Pink: KANT) , a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, reported that its abstract on the KVA12123 clinical program has been accepted for poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 40th Annual Meeting to be held November 6-10, 2024, in Houston, Texas and virtually (Press release, Kineta, OCT 4, 2024, View Source;utm_medium=rss&utm_campaign=kineta-announces-kva12123-abstract-accepted-for-poster-presentation-at-society-for-immunotherapy-of-cancer-sitc-2024 [SID1234647029]).

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Thierry Guillaudeux, Ph.D., Chief Scientific Officer of Kineta, has announced that on November 8, 2024 Jason Henry M.D., Associate Director, Drug Development at Sarah Cannon Research Institute, Denver Colorado will be presenting the poster with new clinical data from an ongoing Phase 1/2 clinical trial on KVA12123, Kineta’s VISTA blocking immunotherapy, alone and in combination with Merck’s (known as MSD outside of the US and Canada) anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in patients with advanced solid tumors.

Presentation Details:

Title: A phase 1/2 clinical trial of antiVISTA – KVA12123 alone and in combination with pembrolizumab in patients with advanced solid tumors

Authors: Jason T Henry, MD1, Manish R. Patel, MD2, Paul L Swiecicki, MD3, Ida Micaily, MD4, Benjamin Garmezy, MD5, Kalyan Banda, MD6, Marya F Chaney, PhD7, Julia Cohen, MD7, Vinny Hayreh, MD8, Kurt Lustig, BS8, Yulia Ovechkina, PhD8, Evan Y Yu, MD6, Shawn P ladonato, PhD8, Thierry Guillaudeux, PhD8 and Lee Rosen, MD9,
(1) Sarah Cannon Research Institute at HealthONE, Denver, CO, (2) Florida Cancer Specialists, Sarasota, FL, (3) University of Michigan Rogel Cancer Center, Ann Arbor, MI, (4) Thomas Jefferson University, Philadelphia, PA, (5) Sarah Cannon Research Institute, Nashville, TN, (6) Fred Hutchinson Cancer Center, Seattle, WA, (7) Merck & Co., Inc., Rahway, NJ, (8) Kineta, Inc., Seattle, WA, (9) UCLA Medical Center, Los Angeles, CA.

Abstract Number: 625

Date / Time: Friday, November 8 at 9:00 A.M. – 7:00 P.M. Central Time

Location: Exhibit Halls AB – George R. Brown Convention Center, Houston, Texas

Abstract titles are now available on the SITC (Free SITC Whitepaper) website. Posters will be made available on the Kineta website following presentations at the conference.

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

On October 4, 2024 IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported a late-breaking oral presentation of the Phase 1 expansion results of IDE397, a first-in-class, oral, MAT2A inhibitor in methylthioadenosine phosphorylase (MTAP)-deletion urothelial and non-small cell lung cancer (NSCLC) patients at the 36th edition of the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics taking place on October 23 to 25, 2024, in Barcelona, Spain (Press release, Ideaya Biosciences, OCT 4, 2024, View Source [SID1234647030]). In addition, IDEAYA will also have additional poster presentations at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium highlighting preclinical data for the MAT2A and PARG programs.

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Details for the oral presentation are as follows:

Presenter: Dr. Benjamin Herzberg, MD, Assistant Professor, Columbia University

Title: Phase 1 expansion results of IDE397, a first-in-class, oral, MAT2A inhibitor (MAT2Ai) in MTAP deleted(del) non-small cell lung cancer (NSCLC) and urothelial cancer (UC)

Abstract #: 501 LBA

Session: Plenary Session 7, Late Breaking Abstracts and Proffered Papers: Novel discoveries in drug development

Date and Time: Friday, October 25, 2024 at 3:00pm CEST

Poster presentation details are below:

Author: Garbett, D. et al.

Title: The mechanistic basis of both deep and durable antitumor activity by combinatorial inhibition of MAT2A and PRMT5 in MTAP-deleted tumors

Poster Number: PB204

Session Title: Combination Therapies

Date and Time: Thursday, October 24, 2024, 9:00am – 5:30pm CEST, Exhibition Hall

Author: Munoz, D. et al.

Title: IDE161, a potential first-in-class clinical candidate PARG inhibitor, selectively targets solid tumors with replication stress and DNA repair vulnerabilities

Poster Number: PB337

Session Title: DNA Repair Modulation (e.g. PARP, CHK, ATR, ATM)

Date and Time: Friday, October 25, 2024, 9:00am – 3:00pm CEST, Exhibition Hall

The oral presentation and posters will be available online at View Source following the presentations.