On March 26, 2025 Mabwell (688062.SH), an innovation-driven biopharmaceutical company with entire industry chain, reported that it will present results of 6 studies as poster presentation at the AACR (Free AACR Whitepaper) Annual Meeting to be held in Chicago, USA, from April 25-30, 2025 (Press release, Mabwell Biotech, MAR 26, 2025, View Source [SID1234651484]).

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The AACR (Free AACR Whitepaper) Annual Meeting is one of the largest cancer research conferences in the world. The abstracts have been published on the AACR (Free AACR Whitepaper) official website.

#01
Title: A B7-H3-targeting antibody-drug conjugate, 7MW3711, and PARP inhibitors synergistically potentiate the antitumor activity in B7-H3-positive cancers
Published Abstract Number: 830
Location: Poster Section 34
Poster Board Number: 18
Session Date and Time: Apr. 27, 2025 2:00 PM-5:00 PM (local time)

#02
Title: Design and synthesis of the novel camptothecin analog MF6 for application into site-specific antibody-drug conjugate
Published Abstract Number: 5733
Location: Poster Section 25
Poster Board Number: 4
Session Date and Time: Apr. 29, 2025 2:00 PM-5:00 PM (local time)

#03
Title: MW-C01/C02, novel CLDN1-targeting antibody-drug conjugates, demonstrate compelling anti-tumor efficacy and favorable safety profiles in preclinical studies
Published Abstract Number: 1573
Location: Poster Section 15
Poster Board Number: 22
Session Date and Time: Apr. 28, 2025 9:00 AM-12:00 PM (local time)

#04
Title: 2MW7061, a novel LILRB4xCD3 bispecific T-cell engager targeting monocytic acute myeloid leukemia
Published Abstract Number: 2116
Location: Poster Section 34
Poster Board Number: 2
Session Date and Time: Apr. 28, 2025 9:00 AM-12:00 PM (local time)

#05
Title: An innovative T cell engager platform with optimized CD3 affinity and formats for targeting hematologic and solid tumors
Published Abstract Number: 2866
Location: Poster Section 15
Poster Board Number: 5
Session Date and Time: Apr. 28, 2025 2:00 PM-5:00 PM (local time)

#06
Title: 7MW4911, a novel cadherin 17-targeting ADC, demonstrates potent efficacy in preclinical models of gastrointestinal cancers
Published Abstract Number: 5466
Location: Poster Section 15
Poster Board Number: 24
Session Date and Time: Apr. 29, 2025 2:00 PM-5:00 PM (local time)

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 Vaximm AG, a subsidiary of OSR Holdings, Inc. and a pioneering biotechnology company focused on developing innovative immunotherapies, reported final data from the successful conclusion of its open-label Phase 2a clinical trial assessing the safety and tolerability of VXM01, an investigational oral anti-VEGFR-2 vaccine, in combination with avelumab (PD-L1 inhibitor) in patients with recurrent glioblastoma (GBM). The trial was part of a collaboration with Merck KGaA, Darmstadt, Germany (Press release, Vaximm, MAR 26, 2025, View Source [SID1234651485]).

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Key results and observations:

The VXM01-avelumab combination therapy was generally well-tolerated, with the majority of safety events being mild to moderate in severity. These safety and tolerability data are in-line with previously reported data on avelumab alone with no additional safety signals for the combination of VXM01 and avelumab.
No serious adverse events (SAEs) were attributed to VXM01, while 9 of 11 (81.8%) were related to the target disease, underscoring the well manageable safety profile of this combination therapy in a frail patient population.
The non-resected patient cohort showed a 12.0% objective response rate (ORR). 12.0% of these patients showed a partial remission and 4.0% had stable disease. This suggests that, with further investigation, VXM01 in combination with PD-L1 inhibition (e.g. avelumab) could offer meaningful clinical benefit for this challenging patient population. In resected patients, the overall survival (OS) ranged from 2.2 to 46.5 months, highlighting the variability in response and the need for additional studies to determine optimal treatment regimens for specific subgroups of GBM patients.
Despite the small size of this open-label trial (n=25), the observed median time to progression of 2.7 months (95% CI: 2.7 – 2.7, range 0.3 – 22.1 months), and median OS of 11.1 months (95% CI: 8.5 – 16.3, range 3.8- 38.2 months), are encouraging initial results in the context of prognosis for patients with recurrent glioblastoma, reported to have a median PFS of 1.5 to 6 months and median OS of 2 to 9 months.(Birzu et al. 2020)
Decreased tumor size was observed in responding patients independent of tumor size at baseline, supporting the expectation that VXM01 vaccine treatment may be effective in patients with larger sized tumors as well as patients with early-stage cancer or very small tumors.
Exploratory biomarker investigations identified potential predictive and pharmacodynamic biomarkers of a VXM01-mediated tumor response
Moving Forward:

The reported safety and tolerability data, together with early indications for the potential relevance of a VXM01dependent, VEGFR-2 specific immune response in GBM therapy warrant further study.

"The completion of this Phase 2a study is a significant milestone for Vaximm AG, as it provides strong evidence that VXM01, in combination with avelumab is generally well-tolerated in patients with recurrent glioblastoma," said Dr. Constance Hoefer, CEO of Vaximm AG. "We are encouraged by these early results and the potential to improve outcomes for patients with this aggressive cancer. We remain committed to advancing VXM01 as a key therapeutic candidate for the treatment of glioblastoma, other cancers and other diseases where VXM01 may have positive impact on treatment outcomes"

About VXM01:

VXM01 is an oral T-cell immunotherapy that is designed to activate T-cells to attack the tumor vasculature and, in several tumor types, attack cancer cells directly. It is based on a live attenuated, safe, orally available bacterial vaccine strain, which is modified to carry vascular endothelial growth factor receptor-2 (VEGFR2) as the target gene. VXM01 stimulates the patient’s immune system to activate VEGFR2-specific, cytotoxic T-cells (so-called killer cells). These immune killer cells then actively destroy cells in the tumor vasculature, leading to an increased infiltration of various immune cells into the tumor. In several tumor types, including brain cancer, VEGFR2 is highly over-expressed on the cancer cells themselves. In preclinical studies, a murine analog VXM01 vaccine showed broad anti-tumor activity in different tumor types. This activity was linked to a VEGFR2-specific T-cell response and was accompanied by the destruction of the tumor vasculature and increased immune cell infiltration. In a Phase I double-blind, randomized, placebo-controlled study in 71 patients with advanced pancreatic cancer, VXM01 appeared to be safe and well tolerated and led to the activation of VEGFR2-specific cytotoxic T-cells, which was associated with significantly improved patient survival. Clinical activity in terms of objective responses and survival has been observed in recurrent glioblastoma.

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 Lutris Pharma, a clinical stage biopharmaceutical company focused on improving anti-cancer therapies by reducing cutaneous dose limiting toxicity, reported the upcoming presentation of the results of its double-blind, placebo-controlled phase 2 randomized clinical trial of lead compound, LUT014 gel (Press release, Lutris Pharma, MAR 26, 2025, View Source [SID1234651486]). The topically-applied novel B-Raf inhibitor is optimized for paradoxical MAPK activation, for patients treated with epidermal growth factor receptor (EGFR) inhibitor therapy who develop dose-limiting acneiform rash. The new clinical data will be released in an oral presentation at the Clinical Trials Plenary Session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025, being held April 25-30 in Chicago, IL.

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Presentation Details:

Presentation Title: A double-blind placebo-controlled randomized phase 2 clinical trial to assess the efficacy of a topical BRAF inhibitor for acneiform rash toxicities from anti-EGFR therapies
Presenting Author: Anisha B. Patel, MD, Associate Professor, Department of Dermatology, University of Texas MD Anderson Cancer Center, Houston, TX
Abstract Number: CT018
Session Title: New Frontiers in Precision Oncology
Session Date: Sunday, April 27, 2025
Session Time: 3:30 pm – 5:30 pm CT
About EGFR Inhibitor-Induced Rash
EGFR is a receptor on the surface of cells which is expressed in many normal epithelial tissues, including skin. The EGFR signaling pathway is one of the key pathways that regulate growth, survival, proliferation, and differentiation of cells. B-Raf is a protein encoded by the BRAF gene and is a downstream effector component of the EGFR signaling pathway. EGFR has been shown to be over-activated in various human cancers, including colorectal, lung, head and neck, urinary bladder, pancreatic and breast cancers, eliciting downstream phosphorylation and activation of the MAP Kinase pathway.

EGFR inhibitors can block the EGFR signal responsible for cell growth. Among the various types of pharmacological therapies for cancer, EGFR inhibitors are increasingly being used both as primary therapy as well as in patients who have progressed on prior chemotherapy treatments. Although effective as anti-cancer therapy leading to tumor shrinkage, EGFR inhibitors have many adverse reactions associated with their use. The majority of patients treated with EGFR inhibitors will experience adverse dermatological side effects typically manifested as a papulopustular skin rash, also known as acneiform lesions, which can impact quality of life and affect adherence to therapy.

About LUT014
LUT014 is a novel B-Raf inhibitor which is applied topically to the skin. When the B-Raf protein is mutated, as is the case in some human cancers such as melanoma, blocking this pathway leads to apoptosis of the cells and tumor shrinkage. However, when the same pathway is blocked in normal, non-mutated cells, the opposite happens: the MAPK pathway is activated, and cells start growing. This phenomenon is recognized as the paradoxical effect of B-Raf Inhibitors. LUT014 harnesses the paradoxical effect of B-Raf Inhibitors in order to enhance cell proliferation and balance cell destruction, typical to radiation dermatitis.