On March 14, 2023 Orum Therapeutics, Inc. ("Orum"), a private biotechnology company pioneering the development of tumor-directed targeted protein degraders (TPDs), reported that it will present new preclinical data for its ORM-5029, ORM-6151, and PD-1-Cbl-b programs in three separate presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023 taking place April 14-19 in Orlando (Press release, Orum Therapeutics, MAR 14, 2023, View Source [SID1234628732]).

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ORM-5029 is a potential first-in-class targeted protein degrader therapy currently in a Phase 1 clinical trial for HER2-expressing breast cancer. ORM-6151 is currently in the IND-enabling stage for CD33-positive hematologic malignancies, such as acute myeloid leukemia (AML). Orum’s PD-1-Cbl-b immuno-oncology program utilizes a novel approach designed to deliver proprietary Cbl-b inhibitors specifically to PD-1-expressing exhausted T cells, while blocking PD-1/PD-L1 interaction. This strategy is expected to limit systemic exposure of Cbl-b inhibitors and minimize c-Cbl inhibition that can lead to off-target toxicity.

Presentation Details

Poster Title: Development of RNAscope multiplex-based assay for exploratory pharmacodynamic biomarkers assessment in breast cancer patients from Phase I clinical trial of ORM-5029, a potent GSPT1 degrader
Date and Time: Monday April 17, 9:00 AM – 12:30 PM ET
Session Category: Clinical Research Excluding Trials
Session Title: Biomarkers for Elucidation of Tumor Biology and Metastasis
Session Location: Section 38
Poster Board Number: 21
Abstract number: 2118

Poster Title: ORM-6151: A first-in-class CD33-antibody enabled GSPT1 degrader for AML
Date and Time: Monday, April 17, 1:30PM – 5:00PM ET
Session Category: Experimental and Molecular Therapeutics
Session Title: Drug Delivery Systems
Session Location: Section 15
Poster Board Number: 3
Abstract number: 2700

Poster Title: A novel antibody-enabled dual precision targeted protein stabilization (TPS²) that augments anti-tumor immune response by targeting CBL-B inhibitor to exhausted T cells while blocking checkpoint molecule, PD-1
Date and Time: Tuesday Apr 18, 9:00 AM – 12:30 PM ET
Session Category: Clinical Research Excluding Trials
Session Title: Immunomodulatory Agents and Interventions
Session Location: Section 40
Poster Board Number: 22
Abstract number: 4436

About Orum’s GSPT1 Platform Using the TPD² Approach

Orum’s GSPT1 platform uses the company’s unique Dual-Precision Targeted Protein Degradation (TPD²) approach to build novel targeted protein degraders combined with the precise tumor cell delivery mechanisms of antibodies to generate innovative, first-in-class, cell-specific TPDs for the treatment of cancer. Orum has developed new molecular glue degrader payloads to specifically degrade an intracellular target protein within cancer cells via the E3 ubiquitin ligase pathway. Conjugated to antibodies, the payloads are designed to be delivered specifically to cancer cells and degrade the intracellular target protein GSPT1 and cause tumor cell death.

About Orum’s TPS² Approach

Orum’s Dual-precision Targeted Protein Stabilization (TPS²) approach combines novel targeted protein inhibitors with the precise cell delivery mechanism of antibodies to increase the levels of intracellular target proteins in a cell-type-specific manner for oncology and immuno-oncology. The first program applying the TPS² approach is a Cbl-b inhibitor (Cbl-bi) conjugated to anti-PD-1 antibody. By delivering Cbl-bi specifically to exhausted T cells, the conjugate restores effector T cell function where PD-1 checkpoint blockade alone is insufficient, while also enabling T cells to overcome the immunosuppressive mechanisms in a tumor microenvironment.

On March 14, 2023 Asher Biotherapeutics, a biotechnology company developing precisely-targeted immunotherapies for cancer, autoimmune, and infectious diseases, reported that the company will present two poster presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023, being held in Orlando, Florida, April 14-19, 2023 (Press release, Asher Biotherapeutics, MAR 14, 2023, View Source [SID1234628731]).

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A poster highlighting Asher Bio’s lead immunotherapy candidate, AB248, a CD8+ T cell-selective IL-2, will be featured as a clinical trial in progress for the ongoing Phase 1a/b study of AB248 alone and in combination with pembrolizumab in patients with advanced solid tumors who failed prior standard of care treatments. (NCT05653882).

Asher Bio will also present new preclinical data for CAR-T-specific IL-2 and IL-21 therapies demonstrating highly selective delivery of cytokine support to CAR-T cells and enhanced anti-tumor activity via distinct mechanisms. Asher Bio has engineered cis-targeted cytokine fusion molecules that specifically activate only CAR-T cells by delivering either IL-2 or IL-21, while exhibiting minimal activity on bystander cells, to offer the potential for greater activity and durability of CAR-T cell therapy.

Details of the poster presentations are as follows:

Title: An open-label, phase 1a/b study of AB248, a CD8+ selective IL-2 mutein fusion protein, alone or in combination with pembrolizumab in patients with advanced solid tumors
Authors: Elizabeth I. Buchbinder, M.D., David R. Spigel, M.D., Constantine Albany, M.D., Michael Chisamore, Ph.D., Kelly D. Moynihan, Ph.D., Xiaohan Liu, Pharm. D., Christopher DelNagro Ph.D., Matt Axt, Andrea Pirzkall, M.D.
Session Title: Phase I and First-in-Human Clinical Trials in Progress
Session Date & Time: Tuesday, April 18, 2023, 1:30 – 5:00 p.m. ET
Poster Section: 46
Poster Board Number: 13
Abstract Number: CT250

Title: Engineered cell surface tag-targeted IL-2 and IL-21 selectively and safely enhance CAR-T anti-tumor activity via different mechanisms
Authors: Nathan D. Mathewson, Ph.D., Wei Chen, Ph.D., Paul Bessette, Ph.D., Sara Sleiman, M.D., Meghana Sukthankar, Kelly D. Moynihan, Ph.D., Chris Kimberlin, Ph.D., Terrence Park, Audrey Hollingsworth; Saar Gill, M.D., Ph.D., Andy Yeung, Ph.D., Ivana Djuretic, Ph.D.
Session Title: Immunomodulatory Agents and Interventions 2
Session Date & Time: Monday, April 17, 2023, 9:00 a.m. – 12:30 p.m. ET
Poster Section: 24
Poster Board Number: 19
Abstract Number: 1847

The abstracts are now available on the AACR (Free AACR Whitepaper) conference website.

On March 14, 2023 Flare Therapeutics Inc., a private biotechnology company targeting transcription factors to discover precision medicines for cancer and other diseases, reported that it will give an oral presentation highlighting the discovery of its clinical candidate FX-909, at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023, taking place April 14-19 in Orlando, Florida (Press release, Flare Therapeutics, MAR 14, 2023, View Source [SID1234628730]).

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Presentation Details are as follows:

Abstract Title: Discovery of FX-909, a first-in-class inverse agonist of the peroxisome proliferator-activated receptor gamma (PPARG) lineage transcription factor, to treat patients with the luminal subtype of advanced urothelial cancer (UC)
Session Category: Drug Development Track Special Session
Session Title: New Drugs on the Horizon: Part 2
Presenter: Robert Sims, Ph.D., Chief Scientific Officer and Co-founder of Flare
Date/Time: Sunday, April 16, 2023 from 3:00 to 4:30 p.m. ET
Location: Tangerine Ballroom 2, Convention Center

Flare is advancing FX-909 into the clinic in patients with advanced urothelial cancer (UC). FX-909 is a potent, selective, small molecule inhibitor of the PPARG lineage transcription factor. In pre-clinical models, FX-909 displays meaningful PPARG target gene silencing in UC cell lines as well as tumor regression in PPARG-amplified and RXRA-mutant UC xenograft models.

On March 14, 2023 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company, reported the data from the Phase I/II trials evaluating camonsertib (RP-3500/RG6526, partnered with Roche) in combination with three poly (ADP-ribose) polymerase inhibitors (PARPi) has been selected for the clinical plenary session at the 2023 AACR (Free AACR Whitepaper) Annual Meeting, held April 14-19, 2023, in Orlando, Florida (Press release, Repare Therapeutics, MAR 14, 2023, View Source [SID1234628729]). An AACR (Free AACR Whitepaper) assigned discussant of the presentation will interpret the data in this plenary session. Two poster presentations for RP-6306, a first-in-class, oral PKMYT1 inhibitor, will also be introduced in the Clinical Research session.

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Details for the presentations are as follows:

Title: Safety and efficacy of three PARP inhibitors (PARPi) combined with the ataxia telangiectasia- and Rad3-related kinase inhibitor (ATRi) camonsertib in patients (pts) with solid tumors harboring DNA damage response (DDR) alterations
Presenter: Dr. Timothy Yap
Session Category: Clinical Trials Plenary Session
Session Title: Novel Biomarker-driven Molecularly Targeted Therapy Trials
Date and Time: Tuesday Apr 18, 2023 11:15 AM – 11:30 AM
Published Abstract Number: 23-LB-9625-AACR

Title: Characterization of CCNE1 amplifications and associated genomic features in ovarian and uterine cancers
Session Category: Clinical Research Excluding Trials
Session Title: Biomarkers of Therapeutic Benefit 5
Date and Time: Tuesday Apr 18, 2023 1:30 PM – 5:00 PM
Location: Poster Section 37
Poster Board Number: 19
Published Abstract Number: 5469

Title: Tumor heterogeneity of CCNE1 copy number assessed by fluorescence in situ hybridization (FISH) in ovarian and uterine cancers and correlation with cyclin E protein expression
Session Category: Clinical Research Excluding Trials
Session Title: Biomarkers of Therapeutic Benefit 2
Date and Time: Monday Apr 17, 2023 9:00 AM – 12:30 PM
Location: Poster Section 39
Poster Board Number: 6
Published Abstract Number: 2132

About Repare Therapeutics’ SNIPRx Platform

Repare’s SNIPRx platform is a genome-wide CRISPR-based screening approach that utilizes proprietary isogenic cell lines to identify novel and known synthetic lethal gene pairs and the corresponding patients who are most likely to benefit from the Company’s therapies based on the genetic profile of their tumors. Repare’s platform enables the development of precision therapeutics in patients whose tumors contain one or more genomic alterations identified by SNIPRx screening, in order to selectively target those tumors in patients most likely to achieve clinical benefit from resulting product candidates.

On March 14, 2023 SOPHiA GENETICS (Nasdaq: SOPH), a cloud-native software company in the healthcare space and the leader in data-driven medicine, reported that it is partnering with Agilent to offer a comprehensive solution for cancer analysis (Press release, Sophia Genetics, MAR 14, 2023, View Source [SID1234628728]).

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Through the partnership, the SOPHiA DDMTM Platform will be integrated with Agilent’s new Research Use Only SureSelect Cancer Comprehensive Genomic Profiling (CGP) Assay Kit. This will enable clinical researchers to accurately identify multiple biomarkers, lowering the risk of missing important information in cancer samples. The partnership brings together these two companies’ strengths in analytics and next generation sequencing (NGS) assay development to facilitate novel approaches to cancer research.

"Working with Agilent means combining best-in-class profiling practices with rich data and insights," said Kevin Puylaert, Vice President, Business Development & Marketing, SOPHiA GENETICS. "Together, we can break traditional barriers that often limit new discoveries, democratizing access to data-driven medicine around the world."

SOPHiA GENETICS is tailoring its analytics to work in harmony with Agilent’s target enrichment technology so that users have access to an advanced solution that allows multiple tumor markers to be detected. With the SOPHiA DDMTM Platform, users will have an integrated solution with reporting tools that go beyond simple readouts, aligned with the information and input from the latest guidelines and clinical trials reflecting relevant biomarkers.

"We chose to partner with SOPHiA GENETICS to leverage their analytical and reporting capabilities, which complements our SureSelect Cancer CGP panel, to drive toward providing clinical researchers with a complete set of tools that will make comprehensive tumor profiling possible in their own labs," said Kevin Meldrum, Vice President and General Manager, Integrated Genomics Division, Agilent Technologies.

The combined efforts of Agilent and SOPHiA GENETICS will make it possible for labs of varying sizes to bring cancer analysis in-house without having to send out samples or output data to other vendors and labs. This keeps impactful bioinformatic information in the hands of the user for future reference or research.

TomaLab, one of the largest research and genetics laboratories in Italy, is participating in an early-access program that is currently underway.

"Our laboratory is excited by the Agilent and SOPHiA GENETICS partnership and the release of their integrated CGP solution," said Vittorio Grazioli, CEO of TomaLab. "Combining high-quality reagents, automation options, and powerful analytics into one unique workflow will help us maximize insights from CGP data while improving our efficiency."