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Second quarter earnings 2024

On July 30, 2024 Hanmi reported its second quarter 2024 results (Presentation, Hanmi, JUL 30, 2024, View Source [SID1234646098]).

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Takeda Quarterly Financial Report For the Quarter Ended June 30, 2024

On July 30, 2024 Takeda reported its Financial Report For the Quarter Ended June 30, 2024 (Presentation, Takeda, JUL 30, 2024, View Source [SID1234645449]).

Pfizer Reports Strong Second-Quarter 2024 Results And Raises 2024 Guidance

On July 30, 2024 Pfizer reported financial results for the second quarter of 2024 and raised its full-year 2024 guidance for both Revenues and Adjusted diluted EPS (Press release, Pfizer, JUL 30, 2024, View Source [SID1234645357]).

Agendia Announces Publication of Utility of MammaPrint® in Prediction of Extended Endocrine Therapy in Journal of Clinical Oncology

On July 30, 2024 Agendia, Inc. reported that the NSABP B-42 study evaluating the MammaPrint assay in predicting the benefit of extended endocrine therapy (EET) in early-stage breast cancer patients was published in the July issue of Journal of Clinical Oncology (Press release, Agendia, JUL 30, 2024, View Source [SID1234645189]).

The published study, Utility of the 70-gene MammaPrint Assay for Prediction of Benefit from Extended Letrozole Therapy in the NRG Oncology/NSABP B-42 Trial, found that MammaPrint was predictive of EET benefit in early-stage hormone receptor positive (HR+) breast cancer patients who were classified by MammaPrint (MP) as Low Risk (0.000 to +0.355), having exhibited improved outcomes with EET.

NSABP B-42 (NCT00382070) was a prospective randomized, double-blind, placebo-controlled, phase III trial that enrolled 3,966 postmenopausal women with HR+ early-stage breast cancer who were disease-free after 5 years of endocrine therapy (with an Aromatase inhibitor (AI) or ≥3 years of tamoxifen followed by an AI). Patients were then randomized to receive 5 additional years of either letrozole or placebo. Results showed EET modestly reduced risk of recurrence in postmenopausal women and established a need to further stratify patients who could benefit from EET.

In a subset of 1,866 randomized patients, which were representative of the parent trial, MammaPrint classified tumors as either MammaPrint High Risk (n=706) or MammaPrint Low Risk (n=1160). MammaPrint Low Risk tumors were further stratified into UltraLow Risk (+0.356 to +1.000) (n=252) or Low (non-UltraLow) Risk (n=908). The data revealed that only MammaPrint Low (non-UltraLow) Risk tumors showed a statistically significant 10-year EET benefit of 9.5% for disease-free survival (DFS) and 7.9% for breast cancer-free interval (BCFI). Conversely, MammaPrint UltraLow and High Risk tumors did not derive statistically significant EET benefit. This highlights that MammaPrint Low (non-UltraLow) Risk is a predictive biomarker for improved outcomes with EET. These findings underscore MammaPrint’s utility in accurately predicting a subset of patients who benefit from the addition of EET to their treatment regimens, establishing MammaPrint as the most comprehensive standalone genomic test for short and long-term treatment planning.

"The work published by the NSABP B-42 group confirms the utility of MammaPrint for identifying women with early-stage HR+ breast cancer who will or will not benefit from extended endocrine therapy," said William Audeh, MD, MS, Chief Medical Officer at Agendia. "While we know that clinical factors are associated with the risk of developing a late recurrence in ER+ breast cancer, they do not indicate whether those late recurrences are preventable. These data support the utility of MammaPrint in predicting which women have a risk of late recurrence which is preventable by extended endocrine therapy. We are pleased to be able to add this study to the growing body of literature supporting the use of MammaPrint for answering many important questions in early breast cancer management with the goal of improving the standard of care in breast cancer."

Tempus Announces Expanded Data and Sequencing Collaboration with Remix Therapeutics

On July 30, 2024 Tempus AI, Inc. (NASDAQ: TEM), a leader in artificial intelligence and precision medicine, reported an expanded collaboration with Remix Therapeutics, a clinical-stage biotechnology company developing small molecule therapies to modulate RNA processing and address underlying drivers of disease (Press release, Tempus, JUL 30, 2024, View Source [SID1234645188]). The collaboration between Remix and Tempus began with the licensing of specific, de-identified data cohorts and has since expanded into a broader, strategic alliance.

Remix is leveraging Tempus’ multimodal data to interrogate specific cohorts, including Adenoid Cystic Carcinoma (ACC) and Acute Myeloid Leukemia (AML) with Tempus’ data analytics platform, Lens. The newly expanded scope of work also includes next-generation sequencing support for Remix’s Phase I trial for REM-422, the company’s potent, selective, oral small molecule messenger RNA (mRNA) degrader.

To support its research, Remix is utilizing Tempus’ xT and xR assays to capture DNA and RNA data, as well as tracking treatment response on an exploratory research basis with xM Monitor, the company’s circulating tumor DNA (ctDNA) assay, which detects and monitors changes in circulating tumor fraction to determine response to therapy for patients with advanced cancers.

"We’re excited to work with a biotech like Remix that understands and embraces the value that Tempus’ multimodal data can bring to their important work," said Ryan Fukushima, Chief Operating Officer of Tempus. "We were able to quickly expand our collaboration and provide Remix with an array of our offerings that are uniquely positioned to support them in achieving their research and development goals."

"Tempus’ multimodal data, analytics, and sequencing support will be invaluable tools as we advance our lead candidate, REM-422, into the clinic," said Dominic Reynolds, Ph.D., Chief Scientific Officer of Remix. "This collaboration provides us with robust resources and data to propel our research forward, ultimately advancing our goal of creating meaningful new treatment options for patients."