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."

On March 14, 2023 Zymeworks Inc. (Nasdaq: ZYME), a clinical-stage biotechnology company developing novel, multifunctional biotherapeutics, reported the acceptance of eleven abstracts for poster presentation at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place at the Orange County Convention Center in Orlando, FL from April 14 – 19, 2023 (Press release, Zymeworks, MAR 14, 2023, View Source [SID1234628727]).

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"AACR represents an important opportunity for us to share recent progress in developing the next generation of novel therapeutics and highlights the unique capabilities of our proprietary engineering platforms and integrated technologies," stated Paul Moore, Ph.D., Chief Scientific Officer at Zymeworks. "The acceptance of eleven abstracts reflects the rapid progress we have made in developing our robust and differentiated pipeline. During the meeting we look forward to sharing new preclinical data on our anticipated 2024 IND candidates, ZW171 and ZW191, as well as other programs that represent potential future therapeutic opportunities and areas of interest."

Presentation Details

Antibody Drug Conjugates

Title: Revisiting the dogma of antibody drug conjugates (ADCs): Emerging data challenge the benefit of linker stability and the primacy of payload delivery
Abstract: 1538
Session Category: Experimental and Molecular Therapeutics
Session Title: Antibody Drug Conjugates

Title: ZW191, a novel FRa-targeting antibody drug conjugate bearing a topoisomerase 1 inhibitor payload
Abstract: 2641
Session Category: Experimental and Molecular Therapeutics
Session Title: Antibody Technologies

Title: ZW220, a novel NaPi2b-targeting antibody drug conjugate bearing a topoisomerase 1 inhibitor payload
Abstract: 1533
Session Category: Experimental and Molecular Therapeutics
Session Title: Antibody Drug Conjugates

Title: ZW251, a novel glypican-3-targeting antibody drug conjugate bearing a topoisomerase 1 inhibitor payload
Abstract: 2658
Session Category: Experimental and Molecular Therapeutics
Session Title: Antibody Technologies

Multispecific Antibody Therapeutics

Title: ZW171, a T cell-engaging, bispecific antibody for the treatment of mesothelin-expressing solid tumors
Abstract: 2942
Session Category: Immunology
Session Title: Therapeutic Antibodies 2

Title: TriTCE Co-stim, next generation costimulatory trispecific T cell engagers for the treatment of solid tumors
Abstract: 5121
Session Category: Immunology
Session Title: Combination Immunotherapies 2

Title: TriTCE CPI, next generation trispecific T cell engagers with integrated checkpoint inhibition (CPI) for the treatment of solid tumors
Abstract: 2982
Session Category: Immunology
Session Title: Therapeutic Antibodies 3

Title: PROTECT, a novel trispecific antibody masking platform with integrated immune modulation displays unique activity and differentiated modes of action
Abstract: 2926
Session Category: Immunology
Session Title: Therapeutic Antibodies 2

Title: ZW270, a conditionally masked IL-12 cytokine fusion protein displaying potent anti-tumor activity absent systemic toxicity
Abstract: 2935
Session Category: Immunology
Session Title: Therapeutic Antibodies 2

Clinical Product Candidates

Title: ERBB2 amplification detected in ctDNA as a surrogate for tumor tissue FISH analysis of HER2 status in a phase 1, study with zanidatamab for the treatment of locally advanced or metastatic HER2 expressing cancers
Abstract: CT2781
Session Category: Clinical Trials Posters
Session Title: Phase I Clinical Trials 2

Title: Zanidatamab zovodotin (ZW49) induces hallmarks of immunogenic cell death and is active in patient-derived xenograft models of gastric cancer
Abstract: 2633
Session Category: Experimental and Molecular Therapeutics
Session Title: Antibody Technologies

Abstracts can be found on AACR (Free AACR Whitepaper)’s website located at www.aacr.org. Posters will be available at the time of presentation at the conference on the Company’s website located at www.zymeworks.com.

1 Clinical trials abstract texts are embargoed until noon ET on April 14, 2023

Conference Call and Webcast Information:

Zymeworks management will host a conference call and webcast for investors and analysts on April 18, 2023, at 6:30 pm EST. The event will be webcast live with dial-in details and webcast replays available on Zymeworks’ website at View Source

On March 14, 2023 Ellipses Pharma ("Ellipses"), a global drug development company focused on accelerating the development of cancer medicines and treatments through an innovative drug development model, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to EP0042, a dual FLT-3 and Aurora kinase inhibitor, for the treatment of acute myeloid leukaemia (AML) (Press release, Ellipses Pharma, MAR 14, 2023, View Source [SID1234628726]).

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The FDA grants ODD based on review of promising early clinical data from investigational treatments for rare diseases, such as AML, defined as affecting fewer than 200,000 people in the US. ODD qualifies the developer for certain incentives with the goal of accelerating drug development for patients, including tax credits and seven years of market exclusivity in the US upon approval by the FDA. In February 2023, the FDA approved EP0042’s Investigational New Drug Application, which allowed for the opening of additional trial sites in the US for this compound.

EP0042 is being developed as a new potential treatment to combat acquired resistance to FLT3 inhibitors in patients with AML. Around one third of patients with AML are diagnosed with FLT3-mutations, which are associated with a higher risk of relapse and poor clinical outcome.1

EP0042 is currently being investigated in an adaptive phase 1/2 dose ranging and optimisation study in patients with relapsed / refractory acute myeloid leukaemia, and Ellipses plans to further evaluate it as both a potential monotherapy and in combination with standard treatments once a phase 2 dose is confirmed. Preliminary data from this study was presented at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2022, which demonstrated acceptable safety and tolerability for EP0042, and evidence of prolonged disease control in a number of heavily pre-treated AML patients.2

Dr Rajan Jethwa, Chief Executive Officer & co-Founder of Ellipses, commented:

"Receiving an FDA Orphan Drug Designation for EP0042 validates this compound’s potential in a currently underserved area of medicine. The designation is an important milestone in the development of EP0042, and underscores the work we are already undertaking towards accelerating its potential access to patients. We believe its early clinical data merits its continued study, and this FDA decision further focuses our vision as we continue our drive towards bringing EP0042 to more patients."

Professor Sir Christopher Evans, Chairman and Founder of Ellipses Pharma, said:

"Achievements like this FDA Orphan Drug Designation for EP0042 are why Rajan and I made the decision to found Ellipses Pharma, and underline the validity of our model of rapidly identifying and developing assets which we believe can have the most impact on patients around the world. I look forward to supporting the team as we continue to drive this compound through the clinic and as we continue our search for assets of promise."

Professor Tobias Arkenau, Global Head of Drug Development and Chief Medical Officer, Ellipses Pharma commented:

"We believe that this FDA decision is a reflection of the strength of the early clinical data for EP0042, which was demonstrated in a presentation at ASH (Free ASH Whitepaper) in December 2022. We are excited to continue the positive momentum in the clinical development of this drug, including progressing the ongoing phase 1/2 trial following the IND received earlier this year."

EP0042’s ongoing clinical-stage study follows earlier drug discovery and development work led by The Institute of Cancer Research, London, which was funded by organisations including The Institute of Cancer Research, Breast Cancer Now and Cancer Research UK.