On December 5, 2024 Foresight Diagnostics, a leader in ultra-sensitive minimal residual disease (MRD) detection technology, reported the launch of SHORTEN-ctDNA, a clinical trial at Columbia University (Press release, Foresight Diagnostics, DEC 5, 2024, View Source [SID1234648847]). The study aims to evaluate the ability to utilize Foresight CLARITY MRD detection to enable real-time treatment optimization for patients with diffuse large B-cell lymphoma (DLBCL).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Currently the standard treatment for newly diagnosed DLBCL requires six cycles of combination rituximab and chemotherapy regardless of individual patient response. This one-size-fits-all approach leaves little room for personalization, potentially exposing patients to unnecessary treatment. The SHORTEN-ctDNA trial will investigate whether patients who achieve early clearance of circulating tumor DNA (ctDNA) can safely receive fewer cycles of chemotherapy while maintaining long-term survival outcomes.

"Although PET scans remain our standard tool for monitoring lymphoma treatment, their inconsistent results in identifying active disease limit our ability to make real-time treatment decisions," said David Kurtz, MD, PhD, Chief Medical Officer and Head of Research at Foresight Diagnostics. "Foresight CLARITY’s detection of residual disease could be the game-changer we need, potentially allowing us to confidently adjust therapy based on each patient’s actual response to treatment with a more dynamic and sensitive tool than imaging."

The study will enroll approximately 32 newly diagnosed DLBCL patients. After three cycles of R-CHOP or pola-R-CHP therapy, participants will undergo ctDNA testing. Those with detectable disease (MRD-positive) will continue with rituximab plus chemotherapy for their remaining cycles, while patients who achieve undetectable ctDNA levels (MRD-negative) will de-escalate to rituximab alone for their final two cycles.

"Recent evidence suggests many patients achieve very deep remissions earlier in their R-chemo treatment than previously thought," said Hua-Jay Cherng, MD, assistant professor of medicine at Columbia University Vagelos College of Physicians and Surgeons and Principal Investigator of the study. "By using next-generation, ultra-sensitive ctDNA technology, SHORTEN-ctDNA aims to identify these early responders and personalize their treatment strategy, potentially reducing treatment duration and associated toxicity and hopefully getting patients back to their normal lives sooner."

On December 5, 2024 FORE Biotherapeutics reported that the Company will participate in the Wells Fargo Virtual Private Biotech Symposium on Thursday, December 12 (Press release, Fore Biotherapeutics, DEC 5, 2024, View Source [SID1234648824]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

William Hinshaw, Chief Executive Officer and Michael Byrnes, Chief Financial Officer, will host and participate in one-on-one meetings. Please contact Argot Partners to schedule one-on-one meetings with the management team.

On December 5, 2024 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immuno-oncology technologies addressing hard to treat cancers, reported it has entered into a Clinical Trial Services Agreement (the "Agreement") with the Israel-based biotechnology company PeriNess Ltd. ("PeriNess") to advance the Company’s development program for its systemic DNase I candidate in combination with chemotherapy and immunotherapy platforms for the treatment of pancreatic carcinoma, colorectal cancer and other locally advanced or metastatic solid tumors toward exploratory clinical studies (Press release, Xenetic Biosciences, DEC 5, 2024, View Source [SID1234648832]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"We are pleased to be working with PeriNess, and to have the opportunity to leverage their experience for the development of Xenetic’s intravenous DNase I candidate through preclinical and early-stage clinical programs. We are excited to take this step forward on the path to the clinic and look forward to investigating our systemic DNase I candidate, XBIO-015, as an adjunctive treatment," commented James Parslow, Interim Chief Executive Officer and Chief Financial Officer of Xenetic.

"We are thrilled to enter this strategic Clinical Trial Services Agreement with Xenetic and further advance the development of their systemic DNase I platform. We believe this collaboration is a great example of where we can put substantial synergies from our projects toward accelerating the clinical development of a highly promising DNase I program for patients in need of new therapies," commented Michal Ben Attar, Chief Executive Officer of PeriNess.

A large body of published preclinical data highlights the pivotal role of Neutrophil Extracellular Traps (NETs) in modulating cancer chemotherapy and immunotherapy efficacy and provides a strong rationale for incorporating DNase I as an adjunctive treatment to improve therapeutic responses in patients with pancreatic and colorectal cancers receiving chemotherapy and immunotherapy.

Under the terms of the Agreement, PeriNess will lead in the regulatory approval, operational execution and management of potential exploratory, investigator initiated studies of recombinant DNase as an adjunctive treatment in patients with pancreatic carcinoma and other locally advanced or metastatic solid tumors receiving chemotherapy and immunotherapy in Israeli medical centers.

On December 5, 2024 Mission Bio, a leader in single-cell multiomics solutions for precision medicine, reported the full list of presentations by leading researchers and clinicians spanning multiple indications of blood cancer, leveraging the Tapestri Platform to advance therapeutic research and development at the 66th ASH (Free ASH Whitepaper) Annual Meeting and Exposition (Press release, Mission Bio, DEC 5, 2024, View Source [SID1234648848]). More than 20 presentations at the event, which takes place Dec. 7-10 in San Diego, will shine a spotlight on how Mission Bio’s customers are using Tapestri and associated products to gain a broader and deeper understanding of Multiple Myeloma, AML, Lymphoma, and CAR-T therapy development.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Among these presentations, Mission Bio will showcase new datasets for the first time, demonstrating how the Tapestri Single-cell Multiple Myeloma Multiomics Solution, which became commercially available this year, can be used to integrate genomic, immunophenotypic, and clonotypic assessment to pinpoint disease-driving clones in Multiple Myeloma (MM). The team behind the data was led by Mission Bio CTO and co-founder Adam Sciambi.

"Our ongoing mission is to provide scientists with the means to understand hard-to-treat diseases like MM in ways that will lead to new, more effective treatments," Sciambi said. "We’re looking forward to sharing our findings on the role of rare clones in the progression from precursor conditions like monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM) to full-blown MM, as well as the comprehensive clonal architecture underlying relapse and treatment resistance. We’re equally excited to see what our customers are doing to advance research into other forms of cancer."

A new study from Heidelberg University Hospital will showcase the value of single-cell DNA+protein multiomics sequencing to refine minimal residual disease (MRD) assessment in acute myeloid leukemia (AML). Presented under the title "Clonal Dynamics of Leukemic and Clonal Hematopoiesis Mutations Predict Relapse in Single Cell MRD Analysis of AML in First Complete Remission," the research uses patient samples to demonstrate how this approach offers greater precision than current techniques, potentially establishing a way to redefine AML MRD.

Researchers from the University of Cincinnati will also introduce the first-ever data demonstrating the feasibility of integrating DNA and fusion profiling at the single-cell level as a multiomic approach. The presentation, titled "Single-Cell Multi-Omic Analysis of KMT2A-Rearranged Pediatric Acute Leukemia Clonal Evolution," is the first of its kind to utilize the combination of simultaneous molecular profiling and fusion identification at the single-cell level for pediatric leukemia.

Following a recent publication in the New England Journal of Medicine, new findings from Stanford University highlight the power of single-cell DNA sequencing to uncover critical genomic insights in chimeric antigen receptor (CAR) T-cell therapy, revealing myeloid predominance for TP53 clonal hematopoiesis in post-CAR therapy myeloid neoplasms (tMN) among non-Hodgkin lymphoma patients. These findings, presented under the title "Single Institution Analysis of Lymphoma Treatment Related Post-CAR Myeloid Neoplasms," underscore the potential of single-cell DNA sequencing to inform CAR T therapy development, enabling safer treatments by addressing risks tied to therapy-induced molecular changes.

Additional institutions included among the presentations at ASH (Free ASH Whitepaper) include the National Institutes of Health, Weill Cornell Medical College, University of Pennsylvania, Berlin Institute of Health, Oxford University Hospitals, University of Miami Miller School of Medicine, and University of Toronto. For the full list of poster and oral presentations, or to schedule a one-on-one meeting with the Mission Bio team at the 2024 ASH (Free ASH Whitepaper) Annual Meeting, please visit View Source Attendees can also learn more about the Tapestri Platform and all of Mission Bio’s multiomics solutions by visiting booth #2112.

On December 5, 2024 Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE), a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, reported an update from its ongoing Phase 1/2 open-label, multicenter study of MRT-2359 in patients with MYC-driven solid tumors (Press release, Monte Rosa Therapeutics, DEC 5, 2024, View Source [SID1234648825]). MRT-2359 is an investigational, orally bioavailable, GSPT1-directed MGD discovered and developed by Monte Rosa Therapeutics.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"These latest interim results from our ongoing Phase 1/2 study of MRT-2359 continue to indicate a favorable safety profile, and degradation of GSPT1 to desired levels in patients with heavily pretreated, solid tumors, including those that express high levels of MYC. Importantly, we believe the MRT-2359 safety profile supports further clinical development, with no signs of hypotension, cytokine release syndrome (CRS), or clinically significant hypocalcemia observed at any dose level and regimen, all of which have been reported as safety limitations of other GSPT1 degraders. We’re pleased to confirm the selection of 0.5 mg daily at a 21 days on, 7 days off drug dosing schedule as our recommended Phase 2 dose, a schedule that enables dosing of MRT-2359 more than twice as frequently per cycle as compared to the 5 days on, 9 days off regimen previously explored in our study and that we also believe to be more patient compliance-friendly," said Markus Warmuth, M.D., Chief Executive Officer of Monte Rosa Therapeutics. "Trial enrollment has been strong and we are working towards completing the biomarker and activity assessment of our monotherapy dose escalation study using the 21 days on, 7 days off schedule, including backfill cohorts. We have started safety assessments of MRT-2359 in combination with enzalutamide in previously treated metastatic prostate cancer patients as well as with fulvestrant in previously treated metastatic estrogen receptor-positive breast cancer patients. We look forward to providing an update on clinical data from the study as well as plans for potential expansion cohorts in the first quarter of next year."

Summary of Interim Data on Enrollment, Safety & Pharmacodynamics

Enrollment Highlights

•
Patients have been dosed with MRT-2359 in 6 dose levels across two dosing schedules, namely a 5 days on, 9 days off drug (5/9) dosing schedule and a 21 days on, 7 days off drug (21/7) dosing schedule.
•
The study has enrolled patients with a diverse set of tumor types, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), neuroendocrine (NE) tumors of the prostate, bladder and other organs of origin, androgen receptor-positive prostate cancer, and estrogen receptor-positive breast cancer.

Safety Highlights

•
Using the 5/9 dosing schedule, doses of 0.5 mg and 1 mg per day were identified as having a generally favorable safety profile, while doses of 1.5 mg or higher were above the maximum tolerated dose (MTD) with thrombocytopenia being a dose limiting toxicity (DLT).
•
Using the 21/7 schedule, both 0.5 and 0.75 mg were identified as having a generally favorable safety profile.
•
0.5 mg using the 21/7 dose schedule was selected as the recommended phase 2 dose (RP2D) for any expansion cohorts of the Phase 1/2 study.
•
Safety assessments of MRT-2359 in combination with enzalutamide in previously treated metastatic prostate cancer as well as with fulvestrant in previously treated metastatic estrogen receptor- positive breast cancer have been initiated.

Pharmacodynamic Highlights

•
Pharmacodynamic effects were assessed utilizing mass spectrometry measurements of GSPT1 protein levels from paired tumor biopsies. The target levels of approximately 60% GSPT1 degradation were observed in tumor biopsies across all dose levels in relevant tumor types, supporting that the dose of 0.5 mg per day provides optimal degradation consistent with its designed activity based on preclinical studies.

Monte Rosa continues to collect and evaluate clinical results from the MRT-2359 Phase 1/2 study and expects to share updated data, including biomarker and activity data, in Q1 2025.

About MRT-2359

MRT-2359 is a potent, highly selective, and orally bioavailable investigational molecular glue degrader (MGD) that induces the interaction between the E3 ubiquitin ligase component cereblon and the translation termination factor GSPT1, leading to the targeted degradation of GSPT1 protein. The MYC transcription factors (c‑MYC, L-MYC and N-MYC) are well-established drivers of human cancers that maintain high levels of protein translation, which is critical for uncontrolled cell proliferation and tumor growth. Preclinical studies have shown this addiction to MYC-induced protein translation creates a dependency on GSPT1. By inducing degradation of GSPT1, MRT-2359 is designed to exploit this vulnerability, disrupting the protein synthesis machinery, leading to anti-tumor activity in MYC-driven tumors.