On December 7, 2022 Pimera Therapeutics, Inc., a clinical-stage biotechnology company focused on developing breakthrough medicines for cancer and other diseases with high unmet medical need, reported that Pimera’s President and CEO, Mustapha Haddach, Ph.D., will present a corporate overview at the Biotech Showcase 2023 meeting on Monday, January 9, 2023, at 5:15 PM (Press release, Pimera Therapeutics, DEC 7, 2022, View Source [SID1234624917]). The Biotech Showcase Conference is taking place in San Francisco in parallel to the J.P. Morgan (JPM) 41st Annual HealthCare Conference.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The Company will be available to meet potential partners, collaborators, and investors. One-to-one appointments may be requested as follows:

The Biotech Showcase partnering platform: https://informaconnect.com/biotech-showcase/
Biotechnology Innovation Organization (BIO) partnering platform: View Source

On December 7, 2022 Oncopeptides AB (publ) (NASDAQ Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, reported that the US Food and Drug Administration, FDA, has requested a withdrawal of the US marketing authorization for Pepaxto (melphalan flufenamide, also called melflufen) (Press release, Oncopeptides, DEC 7, 2022, View Source [SID1234624916]). The request is based on the outcome of the confirmatory phase 3 OCEAN study, which demonstrated an ITT overall survival HR of 1.1, but with significant survival result differences for both melflufen and the comparator drug pomalidomide for large relevant patient groups.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"We respect FDA´s accelerated approval regulations," says Jakob Lindberg, CEO of Oncopeptides. "Multiple myeloma remains an incurable disease, and the treatment options for patients with triple class refractory disease will ultimately become exhausted. The OCEAN study demonstrated clinical benefit for multiple myeloma patients, in particular for non-transplanted elderly patients where the unmet medical need remains very high."

Pepaxto was granted accelerated approval in the U.S., on February 26, 2021, and is indicated in combination with dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody. At the FDA’s request, Oncopeptides stopped marketing Pepaxto in the US on October 22, 2021, and Pepaxto is currently not commercially available for US patients.

The commercialization of Pepaxti in Europe is ongoing. Pepaxti has a full approval from the European Medicines Agency, EMA, since August 18, 2022, and was approved by the Medicines and Healthcare Products Regulatory Agency, MHRA, in the UK on November 11, 2022. Both approvals take the large OCEAN study overall survival differences across relevant patient groups into account. Pepaxti is indicated in combination with dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. For patients with a prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation.

The Company is developing its preclinical pipeline, including the next generation of drug candidates from the PDC platform, as well as an NK-cell engager, built on the technology platform of "Small Polypeptide based Killer Engagers," SPiKEs.

On December 7, 2022 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, reported plans to present new clinical data on its personalized and tumor-informed molecular residual disease (MRD) test, Signatera, and its hereditary cancer test, Empower, at the 2022 San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas (Press release, Natera, DEC 7, 2022, View Source [SID1234624915]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Natera will present two posters from the LEADER and I-SPY 2 clinical trials in HR+, HER2- breast cancer highlighting Signatera’s ability to detect recurrence and facilitate treatment response monitoring. A third poster from a multi-center study of over 1,900 patients will describe how hereditary cancer screening with Empower at the time of imaging can help to identify patients who may benefit from cancer risk management.

"We are excited to share data from these studies, which provide important insights about the value of MRD testing and hereditary cancer screening across the continuum of care for patients with breast cancer," said Minetta Liu, M.D., chief medical officer of oncology at Natera.

Information on the poster presentations are as follows:

Dec. 8, 2022, 5:00 pm CST

Monitoring for response and recurrence in neoadjuvant-treated hormone receptor-positive HER2-negative breast cancer by personalized circulating-tumor DNA testing
Poster Presentation: P5-05-05 | Presenter: Magbanua MJM
Dec. 9, 2022, 7:00 am CST

Cell-free DNA (cfDNA) monitoring in a phase II study of adjuvant endocrine therapy with CDK 4/6 inhibitor ribociclib for localized ER+/HER2- breast cancer (LEADER)
Spotlight Poster Presentation: PD17-03 | Presenter: Medford AJ
Implementation and outcomes of population-based hereditary cancer testing across a diverse multi-location breast imaging center
Poster Presentation: P6-02-06 | Presenter: Miltenburg D

On December 7, 2022 Caris Life Sciences(Caris), the leading molecular science and technology company actively developing and delivering innovative solutions to revolutionize healthcare, reported that it will present findings at the San Antonio Breast Cancer Symposium (SABCS) that illustrate the potential impact of molecular profiling on the treatment of breast cancer (Press release, Caris Life Sciences, DEC 7, 2022, View Source [SID1234624914]). SABCS is being held December 6-10, 2022 in San Antonio, Texas.

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Presentations and posters from Caris include:

George W. Sledge, Jr., M.D., one of the most influential figures in breast cancer research who recently joined Caris as Executive Vice President and Chief Medical Officer, will participate in a Clinical Case Discussion Session from 1:00 -2:00 p.m. CT on Wednesday, December 7 in the Stars at Night Ballroom 1&2.

"Our data at SABCS 2022 emphasizes Caris Life Sciences’ contributions to increasing our understanding of the rapidly-emerging area of HER2-low as a target for antibody-drug conjugates," said Dr. Sledge. "As precision oncology continues to evolve, our cutting-edge work on tumor biology and molecular biomarkers will have broad implications in helping to guide treatment decisions and the development of novel therapeutic options for patients across a range of tumor types, including breast cancer."

A special session titled "HER2-Low: A Separate Entity?" on Wednesday, December 7, from 9:45 – 11:00 a.m. CT at the 2022 SABCS in San Antonio, Texas (Presentation #HER2-12). The poster is titled "Genomic and transcriptomic landscape of HER2-low breast cancer." The studies were performed in collaboration with Duke Cancer Institute and Legorreta Cancer Center at Brown University, both members of Caris’ Precision Oncology Alliance (POA).

Human epidermal growth factor receptor 2 (HER2)-low is a newly defined subset of HER2-negative breast cancer that has been reported to account for up to half of all breast cancer cases. The molecular landscape of HER2-low compared to historical subtypes was investigated across 19,789 breast cancer samples using Caris’ Next-Generation Sequencing (NGS) technology.
Study results demonstrate that when HER2-low breast cancer is stratified by hormone receptor (HR) status, it shares common genomic features with classically defined subsets of HR+ or HRneg disease. When HR+/Her2-low tumors were compared with triple negative breast cancer, significant differences were observed in PIK3CA (an actionable mutation) and TP53 (a prognostic alteration) and warrant further assessment. These findings advance understanding of the molecular landscape of HER2-low breast cancer which has recently become a new entity for treatment. This knowledge is key to understanding the clinical and biological factors driving treatment resistance and how these factors can impact post-progression treatment options in HER2-low breast cancer.

"Caris’ Precision Oncology Alliance (POA) continues its contribution to advancing breast cancer research by presenting novel findings on the molecular features of HER2-low breast cancer at this year’s SABCS," said Chadi Nabhan, M.D., MBA, FACP, Chairman of the Caris Precision Oncology Alliance. "By leveraging Caris’ expansive real-world clinico-genomic database, our partner academic institutions are able to uncover new insights into the underpinnings of breast cancer biology and clinical outcomes."

The POA includes 75 cancer centers and academic institutions, including 34 NCI-designated cancer centers, collaborating to advance precision oncology and biomarker-driven research. POA members work together to establish and optimize standards of care for molecular testing through innovative research focused on predictive and prognostic markers that improve the clinical outcomes for cancer patients.

Additional Presentations Reveal Potential Impact of Comprehensive Molecular Profiling
Caris will present additional data from studies demonstrating the critical role of precision medicine and molecular profiling in the treatment of breast cancer. All presentations will be made available online through Caris’ website beginning December 7.

Prevalence and prognosis of ER-loss in advanced invasive lobular carcinoma (Presentation Number: P3-05-08)
This retrospective study aimed to use real-world data to determine the prevalence and clinical significance of estrogen receptor (ER) loss in invasive lobular carcinoma (ILC). Results demonstrate that, based on analysis of a large real-world dataset of over 20,000 patients with advanced breast cancer, ER-loss occurs in around one in ten ILC patients and has poor prognostic implications compared to ILC without ER loss or invasive ductal carcinoma with ER-loss. Genomic analysis also revealed significant differences between breast cancer patients with ER-loss who responded to treatment and those who did not. Further investigation is needed to build on these findings and potentially identify new therapeutic targets for patients with ILC and ER-loss.

Clock genes in breast cancer (Presentation Number: P4-08-06)
This study aimed to investigate the molecular and clinical associations of genes controlling circadian rhythms (clock genes) in breast cancer. Results of this molecular profiling study demonstrate that altered expression of clock genes is strongly associated with breast cancer subtype and survival. Clock gene expression also has therapeutic implications; higher clock gene scores are associated with high PD-L1 expression and triple negative breast and therefore support the use of checkpoint inhibitors. These findings show that clock genes are novel predictive and prognostic biomarkers and potential therapeutic targets in breast cancer.

On December 7, 2022 Mission Bio, the pioneer in high-throughput single-cell DNA and multi-omics analysis, and multiple biopharma and academic partners reported that they are presenting data from the company’s Tapestri Platform on a range of topics at the 64th Annual American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, beginning this weekend in New Orleans, LA (Press release, Mission Bio, DEC 7, 2022, View Source [SID1234624913]). In all, Mission Bio and its partners will share 15 heme-oncology topics highlighting the use of single-cell DNA + protein multi-omics to better understand resistance mechanisms and drivers of relapse, improve identification of Measurable Residual Disease (MRD), and precisely characterize CAR T cell therapies. These include presentations from Servier Pharmaceuticals and researchers at Memorial Sloan Kettering Cancer Center (MSK) that demonstrate Tapestri’s ability to bridge the gap between translational research and precision therapeutics, providing a deeper understanding of the patient journey and unlocking novel therapeutic approaches. These include the following:

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On Saturday, Dec. 10, Servier will share new Phase 3 findings for the combination of its TIBSOVO (ivosidenib tablets) plus azacitidine. Researchers identified potential mechanisms of acquired resistance in patients with IDH1-mutated acute myeloid leukemia (AML) using single-cell DNA sequencing with Tapestri.
On Monday, Dec. 12, researchers from MSK will present data from Mission Bio’s Single-cell Multi-omics MRD (scMRD) Assay for AML, highlighting its ability to detect clinically relevant variants missed by bulk next-generation sequencing in patient samples drawn following chemotherapy. The assay was also used to characterize both the mutational profile and immunophenotype of single cells, and to illustrate the clonal architecture distinguishing leukemic clones from preleukemic clones and hematopoietic clones.
On Sunday, Dec. 11, Mission Bio’s Senior Director for Clinical Applications, Aaron Llanso, will lead a Company Showcase giving an overview of the predictive power and potential clinical utility of the scMRD Assay, featuring data from the MSK team and researchers from the University of Texas MD Anderson Cancer.
"Mission Bio has led the way into a new era for precision therapeutics with single-cell DNA + protein multi-omics," said Todd Druley, Chief Medical Officer at Mission Bio. "The first step was enabling discoveries in heterogeneous and dynamic diseases with implications for treatment. Today, biopharma partners are increasingly adopting the Tapestri Platform for novel insights that inform late-stage clinical trials, stratifying patient populations and monitoring their disease progression, as well as ensuring product quality in targeted cell and gene therapies. And the latest findings in MRD outline a future where patient single-cell data potentially improves patient outcomes."

Mission Bio’s in-person only Company Showcase, AML single-cell multi-omics minimal residual disease (scMRD) and the horizon of clinical utility, will be held on Sunday, December 11, 2022 at 4:00 p.m. CT at the Ernest N. Morial Convention Center, Hall J, Theater 6.

For a full list of presentations sharing data from Mission Bio’s Tapestri Platform, visit View Source To meet us in person, please visit us all week at Booth 2014.

To learn more about Mission Bio and the Tapestri Platform, please visit www.missionbio.com.