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]).

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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]).

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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."

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.

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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."

On July 30, 2024 LTZ Therapeutics, an immunotherapy-focused biotech company, reported the completion of the company’s Series A financing of over $20 million, to advance the development of its Myeloid Engager pipeline to treat cancer and autoimmune diseases (Press release, LTZ Therapeutics, JUL 30, 2024, View Source [SID1234645187]). This round was led by new investor Lapam Capital and includes new investment participation from GL Ventures. In addition, the company has received continued investment from K2 Venture Partners and Shunwei Capital. The closing of this round brings LTZ’s total funding to approximately $50 million since the company was founded in 2022.

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Proceeds from the financing will be used to accelerate development of LTZ’s pipeline, supporting the company’s Investigational New Drug (IND) process, initiating the Phase 1 clinical study of LTZ’s lead asset LTZ-301 as well as the IND-enabling work of its second asset, LTZ-232. The company will also use the new capital to further advance other programs in discovery and to expand its team.

"This round represents an important step forward in the development of our novel Myeloid Engager Platform for cancer and other conditions with unmet medical needs," said Robert Li, Ph.D., Founder and CEO of LTZ. "At the heart of our approach is the fusion of reverse translational science with a deep understanding of tumor microenvironment (TME) biology, especially myeloid biology. We’ve made significant progress this past year, not only validating the company’s platform in various preclinical test systems including cancer patient-derived organoid models, but also advancing our lead asset LTZ-301 from discovery to an IND-enabling stage. We are thankful for the ongoing support of our scientific team, advisory board and our syndicate of investors, making all of our accomplishments possible."

Macrophages appear to be one of the most prevalent immune cell populations in TME of various hematologic and solid tumors. Therefore, effectively engaging and activating macrophages to kill cancer cells represents significant therapeutic potential for patients. Based on reverse translational research to inform new discoveries and the emerging myeloid biology of TME in a broad range of cancer types, LTZ is developing its own novel Myeloid Engager Platform to primarily enhance the phagocytic function of monocytes and macrophages to foster anti-tumor immunity.

"LTZ comprises a highly skilled and passionate team that brings together a unique complement of expertise," said Zhihua Yu, Founding Partner at Lapam Capital. "We are excited about the reverse translational approach LTZ is taking to maximize the drugability of their assets. LTZ’s Myeloid Engager Platform and their pipeline have the potential to greatly impact the future of immunotherapy development, aiming to rebalance the immune system and improve patient outcomes. The preclinical results thus far carry promising clinical benefits and suggest applicability of LTZ’s model for a wide spectrum of cancer indications (liquid and solid) and autoimmune diseases, where the unmet need is incredibly high."

On July 30, 2024 City of Hope, one of the largest and most advanced cancer research and treatment organizations in the United States, and Institute for Follicular Lymphoma Innovation (IFLI) reported a $2 million, three-year collaboration to study spontaneous remission in follicular lymphoma, the most common, slow-growing non-Hodgkin’s lymphoma (Press release, City of Hope, JUL 30, 2024, View Source [SID1234645186]).

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Raju K. Pillai, M.D., City of Hope associate clinical professor, Department of Pathology, and director, Pathology Research Services Core Laboratories, and Steven T. Rosen, M.D., executive vice president and director emeritus of City of Hope’s comprehensive cancer center and its Beckman Research Institute, professor, Department of Hematology & Hematopoietic Cell Transplantation, and Ted Schwartz Family Distinguished Chair in Hematologic Malignancies, will lead the research. The collaboration aims to understand the tumor microenvironment in patients whose follicular lymphoma goes into remission without any treatment while being monitored over time.

City of Hope will analyze patient samples of follicular lymphoma and spontaneous remission of follicular lymphoma with leading-edge technologies, such as spatial proteomics and transcriptomics, as well as machine learning techniques to help explain why spontaneous remission of follicular lymphoma occurs in a rare number of patients and not in others. The study aims to determine the most relevant prognostic genetic, transcriptomic and microenvironmental factors involved in spontaneous remission of follicular lymphoma.

"Spontaneous remission in follicular lymphoma is not understood and we are excited and humbled to collaborate and support City of Hope’s prestigious team to leverage their expertise and suite of technologies and assays to better understand this phenomenon," said Michel Azoulay, M.D., M.B.A., IFLI’s chief medical officer. "IFLI is committed to funding innovative research projects, such as these important studies at City of Hope, to better understand follicular lymphoma and how we can improve treatments and outcomes for follicular lymphoma patients."

"The clinical spectrum of follicular lymphoma, which ranges from spontaneous regression on one end to highly aggressive disease at the other end, is influenced by the immune microenvironment to a large extent," Dr. Pillai said. "With IFLI’s support, we can study follicular lymphoma, leveraging City of Hope’s omics and spatial biology expertise to shed more light on why and how spontaneous remission occurs, with the goal that our discoveries will translate to advances in diagnostics and the next generation of therapies for patients with follicular lymphoma."

"I have shared the joy of my patients who have spontaneously achieved remission, and I have shared the worry, anguish and frustration of my patients whose follicular lymphoma has progressed or transformed," Dr. Rosen added. "I am thrilled to join with Dr. Pillai, IFLI and other collaborators to help answer the question ‘Why certain patients and not all?’"