On February 25, 2025 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported that the first new subject has been dosed in Phase 2 of the Phase 1b/2 clinical trial involving AIM’s Ampligen (rintatolimod) and AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab) in the treatment of late-stage pancreatic cancer ("DURIPANC") (Press release, AIM ImmunoTech, FEB 25, 2025, View Source [SID1234650513]). Several subjects from Phase 1 who received the highest dose will also be included in Phase 2.

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DURIPANC is an investigator-initiated, exploratory, open-label, single-center study in the Netherlands at the Erasmus Medical Center. Up to 25 patients are expected to be enrolled in the Phase 2 portion of DURIPANC.

AIM CEO Thomas K. Equels stated: "Unlike with many pancreatic cancer studies where accrual can be a major obstacle, we expect to continue to enroll subjects in Phase 2 of DURIPANC at a steady pace."

Read more at about DURIPANC at ClinicalTrials.gov NCT05927142 – "Combining anti-PD-L1 immune checkpoint inhibitor durvalumab with TLR-3 agonist rintatolimod in patients with metastatic pancreatic ductal adenocarcinoma for therapy efficacy (DURIPANC)"

On February 25, 2025 2seventy bio, Inc. (Nasdaq: TSVT), reported that members of the management team will participate in a fireside chat at the upcoming TD Cowen 45th Annual Healthcare Conference on March 5, 2025 at 11:10 a.m. ET in Boston, Mass (Press release, 2seventy bio, FEB 25, 2025, View Source [SID1234650512]).

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A live webcast of the fireside chat will be available via the Investors and Media section of 2seventy bio’s website at View Source Replays will be archived on 2seventy bio’s site for 30 days following the event.

On February 24, 2025 Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostic testing and precision medicine, and PATHOMIQ, Inc., a developer of artificial intelligence (AI)-enabled prognostic and predictive tests for advancing access to personalized medicine and empowering treatment decisions, reported that they have entered into a strategic collaboration for Myriad to exclusively license PATHOMIQ_PRAD, PATHOMIQ’s AI technology platform for prostate cancer, in the United States (Press release, Myriad Genetics, FEB 24, 2025, View Source [SID1234650509]).

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Machine learning and AI-enabled diagnostics are transforming the way clinicians approach cancer patient care. Adding PATHOMIQ_PRAD to Myriad’s Oncology Solutions allows Myriad to provide urologist and radiation oncologists with molecular and AI-powered testing solutions to inform decisions both before treatment at the time of biopsy for active surveillance and following surgery or radiation treatment. This complements Myriad’s existing offerings of combined germline and comprehensive tumor profiling as recommended by NCCN guidelines for prostate cancer care.

"Along with our Prolaris Prostate Cancer Prognostic Test, we are pleased to leverage PATHOMIQ’s prognostic and predictive capabilities across different phases of the patient journey in prostate cancer," said George Daneker, Jr., MD, President and Chief Clinical Officer, Oncology, Myriad Genetics. "Having both genetic and morphologic insights at the time of biopsy combined with the enhanced ability to predict disease recurrence after initial therapy can lead to more informed treatment decisions and enhance the potential for better patient outcomes. This partnership is the latest step in the strategic expansion of Myriad’s oncology portfolio. Our molecular science expertise, combined with the latest in machine learning and AI, will uniquely position Myriad to deliver higher-quality insights for patients and clinicians in the fight against cancer."

PATHOMIQ’s AI-technology platform decodes hidden information from complex morphological structures across all landscapes of cancer pathology to quickly and efficiently deploy new use cases to predict patient outcome, treatment response, and genotype mutations. This image-based technology can deliver results in one to two days after receiving the digital images from the patient’s sample.

"I am excited to have co-developed, with the PATHOMIQ team, the PATHOMIQ-PRAD AI model for prostate cancer treatment response prediction and identification of high-risk prostate cancer patients who will experience early metastasis post Radical Prostatectomy," said Ashutosh K. Tewari, Chairman, Milton and Carroll Petrie Department of Urology at the Icahn School of Medicine at Mt Sinai. "The AI model has achieved high prediction accuracy and outperformed some of the currently used markers in both Caucasian and African American patient cohorts for a much-improved patient outcome."

In addition to expanding Myriad’s prostate cancer testing portfolio to include post-surgical treatment testing solutions, the collaboration with PATHOMIQ is also envisioned to accelerate the timelines for meeting Simon level 1 evidence for both Prolaris and PATHOMIQ_PRAD. While the current PATHOMIQ_PRAD model is specific for use in patients with prostate cancer after surgery, the underlying foundational model provides opportunities for applications in virtually all solid tumor cancers that are diagnosed through a biopsy with H&E staining.

"Our collaboration with Myriad, a leader in cancer diagnostic tests, will help to advance precision medicine and improve prostate cancer disease outcomes," said Rajat Roy, CEO and co-founder of PATHOMIQ. "Our AI-powered model has been successfully validated across multiple medical institutions and pharmaceutical partners. Combining Myriad’s extensive clinical expertise and broad customer reach with PATHOMIQ’s AI technology platform will allow more personalized treatment options for clinicians and their patients."

Paul J. Diaz, President and CEO of Myriad, adds "PATHOMIQ’s technology platform, together with Myriad’s infrastructure and commercial capabilities allows for an accelerated pace of innovation to bring advanced diagnostic products to market that are clinically validated with faster turnaround times and at a lower cost."

Myriad intends to commercially launch its first AI-driven prostate cancer clinical test later this year.

On February 24, 2025 Synnovation Therapeutics, a precision medicine company focused on the discovery and development of best-in-class targeted medicines, reported that the first patient has been dosed in a Phase I trial evaluating SNV4818 as a monotherapy and in combination with fulvestrant, in patients with breast cancer and other solid tumors (Press release, Synnovation Therapeutics, FEB 24, 2025, View Source [SID1234650499]). SNV4818 is a potentially best-in-class pan-mutant-selective PI3Kα inhibitor that may effectively cover kinase (H), helical domain (E), and other PI3Kα mutations clinically. This marks the second Synnovation program to enter the clinic in just over three years since company formation. Synnovation’s lead candidate and potentially best-in-class PARP1 selective program, SNV1521, entered a Phase I trial in January of 2024.

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The SNV4818 Phase I trial, which is being led by Timothy Yap, M.D., Ph.D., Professor of Investigational Cancer Therapeutics at the University of Texas MD Anderson Cancer Center, is designed to evaluate the safety, tolerability and preliminary efficacy of SNV4818 as a monotherapy in tumor agnostic patients with PI3Kα activating mutations as well as in combination with fulvestrant in HR+/HER2- advanced breast cancer patients.

"We are excited to initiate the clinical development of our second potential best-in-class program, both of which were discovered at Synnovation," said Kevin O’Hayer, M.D., Ph.D., Senior Vice President, Head of Clinical Development at Synnovation. "SNV4818 has the potential to address a significant unmet need for a large population of patients with breast cancer and multiple other tumor types."

The potential of the PI3Kα inhibitor class has been limited by a lack of selectivity against wild type PI3Kα. First generation PI3Kα-isoform specific inhibitors are limited by significant toxicities due to wild type PI3Kα inhibition, including stomatitis, hyperglycemia and rash. A pan-mutant selective, wild-type-sparing, inhibitor enables a wider therapeutic index leading to greater target inhibition which may improve clinical efficacy while decreasing toxicity, unlocking significant potential for this therapeutic class.

SNV4818 is a potentially best-in-class, highly potent pan-mutant PI3Kα inhibitor with excellent selectivity against wild type PI3Kα. This selectivity may allow for broad spectrum PI3Kα mutation coverage including targeting both H1047X and E545/542X classes of driver mutations in breast cancer and other solid tumor indications.

On February 24, 2025 LTZ Therapeutics, an immunotherapy-focused biotech company, reported that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for LTZ-301, a first-in-class myeloid engager immunotherapy intended to treat relapsed or refractory non-Hodgkin lymphoma (r/r NHL) (Press release, LTZ Therapeutics, FEB 24, 2025, View Source [SID1234650498]).

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LTZ-301 is the first asset in the company’s platform to enter clinical trials to determine an initial proof of concept for their myeloid engager approach, to foster immunotherapy. LTZ expects to initiate its Phase 1, open-label, multicenter study in Q2 2025.

"The FDA’s clearance, signaling the initiation of our Phase I study for LTZ-301, represents a significant milestone for the company," said Robert Li, Ph.D., Founder and CEO of LTZ. "We look forward to advancing our lead asset into the clinic to evaluate our myeloid engager approach and its potential as an effective therapy for cancer and other indications, such as autoimmune diseases. Additionally, the recent appointment in October 2024 of Dr. Wayne Godfrey, as LTZ’s Chief Medical Officer, strengthens our company’s scientific and clinical leadership – providing us with great optimism as we move forward in our next phase of clinical development. We’re also delighted to welcome Dr. Alan J. Korman, a globally recognized pioneer in cancer immunology, to LTZ’s scientific advisory board."

LTZ’s approach focuses on the fusion of reverse translational science, with a deep understanding of tumor microenvironment (TME) biology – especially myeloid biology. 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 offers significant therapeutic potential for patients. LTZ is developing its own novel Myeloid Engager Platform to primarily enhance the phagocytic function of monocytes and macrophages of different polarization states to foster anti-tumor immunity.

"The company’s preclinical results have demonstrated promising activity and safety, suggesting applicability of LTZ’s platform to treat a variety of cancer indications and autoimmune diseases – where the unmet need is incredibly high," said Dr. Godfrey. "Through our first in-human trial, we aim to advance our understanding of the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of LTZ-301, targeting CD79b-expressing B-cell lymphoma. I’m excited about the potential of LTZ’s innovative scientific approach and the opportunity to work with LTZ’s accomplished scientific team, with the end goal of improving patient outcomes."

About LTZ-301

LTZ-301 is a novel myeloid engager bi-specific antibody that depletes CD79b+ B-cells via enhancing Fc-gamma receptor (FcγR)-independent antibody dependent cellular phagocytosis (ADCP). CD79b is a unique tumor antigen receptor that is highly expressed in B-cell malignancies, including the ones of relapse/resistance to the existing CD19 or CD20-based therapies. LTZ-301 works by redirecting monocytes and macrophages toward CD79b+ B-cells, leading to enhanced phagocytosis and depletion of cancer cells. The initial study of LTZ-301 will be conducted in patients with r/r NHL for whom no standard therapy is available or where standard treatment has failed. Preclinical studies of LTZ-301 demonstrated potent pharmacology in both in vitro and in vivo studies with a favorable safety profile.