On March 26, 2025 ImCheck Therapeuticsannounced reported updated results from its ongoing open-label, randomized Phase I/II study EVICTION at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025 in Chicago, Illinois, USA (Press release, ImCheck Therapeutics, MAR 26, 2025, View Source [SID1234651473]). The poster presentation will provide efficacy, safety, pharmacodynamics and dose selection data on the novel γ9δ2 T-cell activator, ICT01, in combination with azacitidine and venetoclax for the treatment of patients with newly diagnosed AML.

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Details of the poster presentation at AACR (Free AACR Whitepaper) 2025 are:

Late-breaking abstract title: "γ9δ2 T-cell (γδTC) activation and azacitidine-venetoclax (AV) for older/unfit adults with newly diagnosed (ND) acute myeloid leukemia (AML) induces high rates of complete remission (CR): Preliminary efficacy, safety, pharmacodynamics (PD) and dose selection of ICT01 in the phase 1 study EVICTION"

Session: Phase 0 and Phase I Clinical Trials

Abstract number: CT024

Presenter: Abhishek Maiti, University of Texas MD Anderson Cancer Center

Authors:Abhishek Maiti, Pierre Peterlin, Daniel Morillo, Jose-Miguel Torregrosa-Diaz, Matthew Ulrickson, Agustin Penedo, Aude De Gassart, Elisabeth Wieduwild, Emmanuel Valentin, Maelle Mairesse, Patrick Brune, Katrien Lemmens, Stephan Braun, Daniel Olive, Naval G. Daver, Sylvain Garciaz, Pierre-Yves Dumas

Date: Monday, April 28, 2025

Time: 9:00 am- 12:00 pm EST

Location: Poster Section 49 / Poster Board Number: 3

The AACR (Free AACR Whitepaper) poster presentation will provide an update on the data in AML patients most recently presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting 2024 showing that ICT01 administered in combination with azacitidine and venetoclax demonstrated promising efficacy without compromising safety.

The AACR (Free AACR Whitepaper) poster will be available on ImCheck’s corporate website after the poster sessions have been opened.

On March 26, 2025, Sonnet BioTherapeutics Holdings, Inc. (the "Company") reported the positive findings from the first safety review of the expansion cohort in its Phase 1 SB101 clinical trial evaluating SON-1010, the Company’s proprietary version of recombinant human interleukin-12 ("rhIL-12") configured using genetic fusion to the Company’s Fully Human Albumin Binding ("FHAB") platform, in combination with trabectedin ("Yondelis") in adult patients with advanced leiomyosarcoma ("LMS") or liposarcoma ("LPS") (Press release, Sonnet BioTherapeutics, MAR 26, 2025, View Source [SID1234651472]).The expansion cohort builds on the successful completion of monotherapy dose escalation and assignment of the SON-1010 maximum tolerated ("MTD") dose of 1200 ng/kg.

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The SB101 Safety Review Committee ("SRC") met to evaluate the initial status of the patients in the expansion cohort, all of whom are receiving the SON-1010/trabectedin combination, as enrollment continues. After an average treatment of slightly over two months, one patient progressed and the other six are tolerating treatment. Adverse events ("AEs") considered to be related to either drug have all been mild or moderate, suggesting that the two drugs do not appear to be adversely impacting each other. The annual review including all 30 patients dosed to date showed that common AEs considered related to SON-1010 monotherapy or in combination included fatigue, fever, chills, and myalgia in 15% or more; moderate fatigue was the only related AE in 2 or more of the patients treated with trabectedin to date. Full enrollment of the combination cohort will provide an opportunity to evaluate statistical evidence of benefit in the response using the standard RECIST paradigm, which may also confirm synergy. Meanwhile, five of the six patients in the SON-1010 high-dose monotherapy group (83%) showed stable disease at 4 months and four continue on trial at 6 months with no new safety concerns. The partial response ("PR") in one of those patients persists, confirming the potential for benefit of SON-1010 monotherapy at the MTD in this small cohort. Overall, 13 of the 24 patients studied during SON-1010 dose escalation (54%) had evidence of monotherapy clinical benefit.

The primary outcome measures for the Phase 1 SB101 trial are the safety, tolerability, pharmacokinetics ("PK") and pharmacodynamics ("PD") of SON-1010 and to establish the MTD. The Company has treated 7 patients over 2 months on average and expects to enroll up to 18 patients with unresectable, metastatic LMS or LPS in this open-label, single-arm expansion cohort. Patients are being treated with SON-1010 in combination with the standard 21-day trabectedin cycles, alternating the dosing of the two drugs. Trabectedin, the first approved chemotherapeutic drug for advanced soft-tissue sarcomas ("STS") after failure of primary therapy, works by preventing tumor cells from proliferating but has also been shown to have pro-inflammatory immune effects in the tumor microenvironment ("TME") that may be enhanced by the IL-12 activity in SON-1010. Trabectedin is approved in 76 countries globally for the treatment of advanced STS as a single-agent, and in 69 countries for relapsed ovarian cancer in combination with doxorubicin HCl liposome injection.

On March 26, 2025 Nkarta, Inc. (Nasdaq: NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies, reported financial results for the fourth quarter and year ended December 31, 2024 (Press release, Nkarta, MAR 26, 2025, View Source [SID1234651470]).

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"As the validation of cellular therapy in autoimmune disease expands to include CAR NK cells, we remain confident that the potential safety and accessibility advantages of NKX019 will allow it to occupy an important place in the future treatment of autoimmune disease," said Paul J. Hastings, CEO of Nkarta. "The opportunity that novel B-cell targeting therapies like NKX019 have to become transformative is substantial, creating a highly competitive development landscape. The integration of cellular therapy into traditionally outpatient-based specialties has been challenging and has required time and investment. We plan to provide our initial clinical update from the Ntrust-1 and Ntrust-2 studies in the second half of 2025."

"To ensure that Nkarta is strongly positioned financially to achieve multiple value-generating milestones within our existing cash and to set the stage for an efficient regulatory pathway for NKX019, we have implemented a restructuring plan, including a significant reduction of our workforce. The restructuring prioritizes investment in clinical execution and impacts every level of the organization, including reducing the executive leadership team by over 50%."

"We believe that this decision is necessary in today’s challenging financial and competitive environment to fulfill Nkarta’s vision of bringing potentially life-saving cellular therapies to people with autoimmune disease. Saying goodbye to cherished and talented team members is very difficult, and we pay tribute to them and their families for their dedication to Nkarta."

NKX019 is an allogeneic, off-the-shelf, chimeric antigen receptor (CAR) NK-cell therapy candidate engineered to deplete CD19-positive cells in B-cell mediated autoimmune disease. The approach leverages the potential advantages of NK cell therapy, including deep and rapid B-cell killing, a lower risk of cytokine release syndrome and neurotoxicity, the opportunity for potential fludarabine-free lymphodepletion to reduce toxicity, the added utility of on-demand dosing allowing for better accessibility, and the opportunity for repeated dosing as needed.

On March 26, 2025 Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company developing a potentially first-in-class and best-in-class WEE1 inhibitor for patients with ovarian cancer and other tumor types, reported financial results for the year ended December 31, 2024, and highlighted recent corporate accomplishments (Press release, Zentalis Pharmaceuticals, MAR 26, 2025, View Source [SID1234651469]).

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"Zentalis reported significant progress in the development of azenosertib in 2024 and made important advancements this year. We plan to maintain strong execution on the late-stage development of azenosertib," said Julie Eastland, Chief Executive Officer of Zentalis. "The clinical data we recently presented supports rapid advancement of azenosertib as a monotherapy therapy for patients with Cyclin E1+ PROC, and the continued development of azenosertib in other settings of ovarian cancer and other tumor types. With a sharpened focus on clinical development, and strong cash position into late 2027, Zentalis is well-positioned to execute on our objectives with the goal of bringing azenosertib to patients as quickly as possible."

On March 26, 2025 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immuno-oncology technologies addressing difficult to treat cancers, reported that its collaboration partner, PeriNess Ltd. ("PeriNess"), has entered into a Clinical Study Agreement (the "Agreement") to support an exploratory clinical study of Xenetic’s systemic DNase I candidate, XBIO-015, in patients with relapsed/refractory osteosarcoma and Ewing sarcoma (Press release, Xenetic Biosciences, MAR 26, 2025, View Source [SID1234651468]).

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Prof. Ronit Elhasid, Director of Pediatric Hemato-Oncology and Bone Marrow Transplantation Department at the Dana-Dwek Children’s Hospital in the Tel-Aviv Sourasky Medical Center ("Sourasky Center"), will act as the principal investigator and co-sponsor of the study along with the Health Corporation of the Tel Aviv Medical Center, an affiliate of the Sourasky Center.

"The primary objective of this study is to explore safety and tolerability in patients with relapsed/refractory osteosarcoma or Ewing sarcoma receiving XBIO-015 in combination with relapsed chemotherapy regimens. Secondary objectives include efficacy to be evaluated by the measure of objective response rate and progression-free survival. The study has a strong translational component with a complex assessment of biomarker response. Data on DNase I efficacy in combinations with chemotherapy in experimental models has encouraged us to support the study," stated Reid P. Bissonnette, Ph.D., Executive Consultant for Translational Research and Development of Xenetic.

Ewing sarcoma and osteosarcoma are aggressive orphan pediatric cancers that grow in bones or soft tissues. There is a lack of effective treatment options for children with recurrent and refractory disease where the five-year survival rate is only 20 to 30 percent. Studies conducted at Tel Aviv Sourasky Medical Center between 2013 and 2024 showed that the formation of neutrophil extracellular traps (NETs) in the tumor microenvironment of pediatric sarcomas is an independent prognostic factor, with a clear association between NETs burden and poor prognosis. According to the above research, elevated levels of NETs at diagnosis predicted a poor response to neoadjuvant chemotherapy, relapse, and death from the disease. Xenetic’s proprietary recombinant DNase I is an enzyme that digests NETs in a tumor microenvironment.

James Parslow, Interim Chief Executive Officer and Chief Financial Officer of the Company stated, "As part of our overall development strategy, we aim to participate in a series of exploratory studies to evaluate XBI0-015 combinations with chemotherapy, radiotherapy and immunotherapy in various oncology indications. Our commitment to the DNase program remains steadfast and we are pleased to further expand our body of clinical data."

As previously announced, in December 2024, Xenetic entered into a Clinical Trial Services Agreement with PeriNess, under which 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.