Kintara Therapeutics Announces Data Presentation at the 2022 American Association for Cancer Research Annual Meeting

On March 15, 2022 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported that it will be presenting data at the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (Press release, Kintara Therapeutics, MAR 15, 2022, View Source [SID1234610073]). The AACR (Free AACR Whitepaper) 2022 Annual Meeting will be held from April 8 through April 13, 2022 in New Orleans.

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Data Presentation:

Track 24: Experimental and Molecular Therapeutics

Session PO.ET02.01 – Mechanisms of Drug Action 1

1843 / 15 – Dianhydrogalactitol (VAL-083) for the Treatment of Glioblastoma Multiforme (GBM): Impact of Glucose Transporters for Crossing the Blood Brain Barrier (BBB)

(Presentation Time: Monday, April 11, 2022 – 1:30 to 5:00 pm CT)

Delcath Systems to Host Fourth Quarter and Full Year 2021 Results

On March 15, 2022 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported it will host a conference call on March 25, 2022, at 8:30 AM Eastern Time to discuss results for its fourth quarter and full year ended December 31, 2021 (Press release, Delcath Systems, MAR 15, 2022, View Source [SID1234610097]).

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Conference Call Information

To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call.

Mersana Therapeutics to Present an Analysis from the Expansion Cohort of the Phase 1 Trial of Upifitamab Rilsodotin at the Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer

On March 15, 2022 Mersana Therapeutics, Inc. (NASDAQ:MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported that it will present an analysis based on the June 10th, 2021 data cut from the expansion cohort of the Company’s Phase 1 trial of upifitamab rilsodotin (UpRi) at the upcoming Society of Gynecologic Oncology Annual Meeting on Women’s Cancer being held from March 18-21, 2022 in Phoenix, Arizona (Press release, Mersana Therapeutics, MAR 15, 2022, View Source [SID1234610117]).

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UpRi is a Dolaflexin ADC targeting NaPi2b and is being studied in UPLIFT, a single-arm registrational trial in patients with platinum-resistant ovarian cancer, as well as in UPGRADE, a Phase 1/2 umbrella trial evaluating UpRi in combinations starting with carboplatin. The Company plans to initiate UP-NEXT, a Phase 3 trial of UpRi monotherapy maintenance in platinum-sensitive recurrent ovarian cancer with a design informed by FDA and CHMP feedback, in the second quarter of 2022.

"The upcoming presentation at SGO will include analysis from the nearly 100 patients with ovarian cancer treated in the expansion cohort of our UpRi Phase 1 trial based on the June 10th, 2021 data cut which supported the decision to select 36 mg/m2 as the recommended Phase 2 dose for UPLIFT. The data highlight UpRi’s robust clinical activity and differentiated safety profile which further support the design of the ongoing UPLIFT registrational trial in platinum-resistant ovarian cancer," said Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics.

Details of the presentation and posters are as follows:

Oral Plenary Session Title: Updated Results from the Phase 1 Expansion Study of Upifitamab Rilsodotin (UpRi; XMT-1536), a NaPi2b-directed Dolaflexin Antibody Drug Conjugate (ADC) in Ovarian Cancer
Abstract #: 76
Date/Time: Saturday, March 19, 2022 at 11:46 am MST
Oral Presenter: Debra L. Richardson, MD

Poster Title: Optimizing the Dose of Upifitamab Rilsodotin (UpRi; XMT-1536), a NaPi2b-directed Dolaflexin Antibody Drug Conjugate (ADC): Updated Analysis of a Phase 1b Expansion Study in Ovarian Cancer
Abstract #: 319
Poster Lead Author: Bradley J. Monk, MD

Poster Title: UPGRADE: Phase 1 Combination Trial of the NaPi2b-directed Dolaflexin Antibody Drug Conjugate (ADC) Upifitamab Rilsodotin (UpRi; XMT-1536) in ​Patients With Ovarian Cancer
Abstract #: 588
Poster Lead Author: Nehal Lakhani, MD, PhD

Poster Title: UPLIFT (ENGOT-ov67/GOG-3048): A Pivotal Cohort of Upifitamab Rilsodotin (XMT-1536; UpRi), a NaPi2b-directed Dolaflexin Antibody Drug Conjugate (ADC) in Platinum-Resistant Ovarian Cancer
Abstract #: 585
Poster Lead Author: Debra L. Richardson, MD

Additional information can be found on the SGO website.

Biognosys Partners with Kymera Therapeutics in Precision Proteomics Biomarkers

On March 15, 2022 Biognosys, a leader in next-generation proteomics solutions for drug discovery and development, and Kymera Therapeutics, a clinical-stage biopharmaceutical company advancing targeted protein degradation (TPD), reported that they are broadly collaborating across preclinical studies and clinical trials (Press release, Biognosys, MAR 15, 2022, View Source [SID1234610133]).

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Proteome editing with TPD is a new frontier of medicine, aimed at expanding the druggable proteome. Biognosys’ TrueSignature platform uniquely offers high-precision proteomic panels that provide actionable insights based on highly specific and sensitive, absolute quantification of pharmacodynamic and efficacy biomarkers. These custom panels allow Kymera to monitor and quantify protein degradation. The ease of transferability of the assays — from early discovery, across preclinical evaluation, to clinical development — enables integration into all stages of Kymera’s drug development process. The panels are developed and performed at Biognosys’ state-of-the-art facility, the largest high-end, GLP certified and GCP compliant mass spectrometry laboratory worldwide for large-scale proteomics contract research.

"Kymera’s novel approach to targeted protein degradation is a great example of the power of proteomics-enabled drug development," said Kristina Beeler, Ph.D., Chief Business Officer of Biognosys. "We are glad to see the impact our TrueSignature platform is having, not only on the advancement of Kymera’s clinical trial programs, but also on patients’ lives."

The current partnership between Kymera and Biognosys builds upon the longstanding scientific relationship between the two companies across early R&D, preclinical, and clinical settings across oncology and inflammation.

"Biognosys has been a valued partner as we continue to expand our clinical pipeline across a diverse set of diseases and indications," said Nello Mainolfi, Ph.D., Co-Founder, President and CEO, Kymera Therapeutics. "The company’s high-precision custom proteomics panels enable us to monitor and quantify protein degradation across all aspects of drug development, including preclinical and clinical programs."

About TrueSignature

The Biognosys TrueSignature platform provides high-precision customizable proteomics panels for pharmacodynamic readouts and clinical biomarker monitoring.

Parallel Reaction Monitoring mass-spectrometry powers the platform, allowing complete customization and independence from affinity-based recognition and reagent availability. The TrueSignature panels offer an unprecedented level of multiplexing, enabling the simultaneous absolute quantification of up to 100 proteins.

TrueSignature panels can be developed within weeks and are available both as a standalone solution or an integrated solution, in which insights from TrueDiscovery studies guide the choice of proteins in the custom panel. The measurements are performed with unprecedented speed and throughput at Biognosys’ state-of-the-art facility, the world’s largest high-end GLP-certified and GCP-compliant mass spectrometry laboratory. For more information, visit truesignature.bio

Sanofi provides update on Phase 2 study evaluating amcenestrant in ER+/HER2- advanced or metastatic breast cancer

On March 14, 2022 Sanofi reported The Phase 2 AMEERA-3 clinical trial evaluating amcenestrant, an investigational optimized oral selective estrogen receptor degrader (SERD), did not meet its primary endpoint of improving progression-free survival (PFS) as assessed by an independent central review (Press release, Sanofi, MAR 14, 2022, View Source [SID1234610015]). The trial evaluated amcenestrant as monotherapy compared to endocrine treatment of physician’s choice in patients with locally advanced or metastatic estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer who progressed on or after hormonal therapies. No new safety signals were identified and the safety profile of amcenestrant in AMEERA-3 was consistent with earlier studies.

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John Reed, MD, PhD
Head of Research and Development at Sanofi
"This Phase 2 trial evaluated amcenestrant as a monotherapy in a patient population with advanced disease where limited treatment options remain. While we are disappointed with the AMEERA-3 results, we continue to investigate amcenestrant in patients with earlier stages of breast cancer with different tumor profiles and where different standard of care treatments are used."

Sanofi will continue to assess data from the AMEERA-3 trial and work with investigators on the publication of the full results. The ongoing clinical trial program for amcenestrant continues as planned, including AMEERA-5 and AMEERA-6.

Amcenestrant is an optimized oral SERD that binds to the estrogen receptors (ER) in breast cancer cells to inhibit their normal function and trigger degradation so they can no longer be used by tumor cells to grow. Amcenestrant is currently under clinical investigation and its safety and efficacy have not been evaluated by any regulatory authority.

About the AMEERA-3 trial

AMEERA-3 was an open-label, Phase 2 randomized trial evaluating the efficacy and safety of amcenestrant as a monotherapy compared to single-agent endocrine treatment of the physician’s choice in patients with ER+, HER2- locally advanced or metastatic breast cancer with prior exposure to hormonal therapies. The primary objective of AMEERA-3 was to determine whether amcenestrant improved PFS assessed by an independent central review compared to endocrine monotherapy. The key secondary efficacy endpoint was overall survival and other secondary endpoints were objective response rate, disease control rate, clinical benefit rate and duration of response. The study also compared the overall safety profile in the two treatment arms and evaluated health-related quality of life in the two treatment arms based on patient-reported outcomes.

About the amcenestrant clinical program

The comprehensive development program for amcenestrant has been designed to evaluate its potential as an oral endocrine backbone therapy across treatment lines, including: as a single agent in second-line or later lines of treatment of ER+/HER2- metastatic breast cancer (MBC) (AMEERA-3), in combination with palbociclib in the first-line treatment of ER+/HER2- MBC (AMEERA-5), and to explore its potential in early-stage breast cancer patients in the adjuvant setting (AMEERA-6). Initiated in late 2020, the Phase 3 AMEERA-5 clinical trial is now fully enrolled. The Phase 3 AMEERA-6 trial, in partnership with the Breast International Group (BIG), the European Organization for Research and Treatment of Cancer (EORTC), and the Alliance Foundation Trials (AFT) is now enrolling.