On May 20, 2025 Vir Biotechnology, Inc. (Nasdaq: VIR), reported that Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer, and Mika Kakefuda Derynck, M.D., Executive Vice President, Therapeutic Area Head, Oncology, will participate in a virtual fireside chat at the TD Cowen 6th Annual Oncology Innovation Summit on Tuesday, May 27 at 1:30 p.m. PT / 4:30 p.m. ET (Press release, Vir Biotechnology, MAY 20, 2025, View Source [SID1234653261]).

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A live webcast of the fireside chat will be made available under Events & Presentations in the Investors section of the Vir Biotechnology website and will be archived for 30 days.

On May 20, 2025 CCM Biosciences, a diversified pharmaceutical discovery and development company, reported the upcoming presentation of its next-generation FLT3 inhibitor drug program for acute myeloid leukemia (AML) at the 2025 Annual Conference of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), taking place May 30 to June 3 in Chicago (Press release, CCM Biosciences, MAY 20, 2025, View Source [SID1234653260]).

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Acute Myeloid Leukemia (AML) is the most severe form of leukemia with few treatment options, and a malignancy frequently driven by mutations in the FMS-like tyrosine kinase 3 (FLT3) gene. The FLT3 internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations, particularly D835 and F691, appear in approximately 30% of AML patients, often leading to poor prognosis and resistance to existing therapies. Gilteritinib (Xospata; Astellas Pharma, peak annual sales projection: $1.5 billion) and Quizartinib (Vanflyta; Daiichi Sankyo) are two FDA-approved FLT3 inhibitors, with the former approved only for relapsed/refractory AML and the latter approved only for newly diagnosed AML. Quizartinib does not target TKD resistance mutations, whereas Gilteritinib’s efficacy on FLT3-ITD-D835 mutations is limited and it is not effective against the FLT3-ITD-F691 gatekeeper mutation, both of which are very common. Crenolanib (AROG/Pfizer) is an FLT3 inhibitor whose NDA submitted to the FDA does not address the indications above, whose NDA was previously rejected by the FDA, and which binds to FLT3 mutants less tightly than Gilteritinib. Consequently, there is a critical need for next-generation FLT3 inhibitors that can address all of these mutations.

At ASCO (Free ASCO Whitepaper) 2025, CCM Biosciences’ presentation "Novel, Potent and Selective Inhibitors Targeting FLT3 for AML Therapy" in the Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant session (Abstract #: 6542, View Source) will report novel FLT3 inhibitors have been identified that can both target FLT3-ITD and potentially overcome mutational resistance to FDA-approved FLT3 inhibitors. These agents are significantly more effective than Gilteritinib and have significant potential clinical applications.

CCM Biosciences’ novel, orally bioavailable FLT3 inhibitors (CCM-405 and CCM-445) are the first drug candidates to overcome both FLT3-ITD juxtamembrane domain and tyrosine kinase domain (TKD) mutational drug resistance (including D835Y, F691L), significantly outperforming the aforementioned current-generation inhibitors both in the absence and presence of resistance mutations. Other reported investigational drug candidates capable of addressing FLT3-ITD resistance mutations either have poor pharmacokinetics, significant off-target binding, or both.

CCM Biosciences is advancing clinical candidates from its FLT3 inhibitor program to investigational new drug (IND) filing this year for entry into clinical trials for both newly diagnosed FLT3-positive AML and relapsed/refractory FLT3-positive AML. Multiple failures in AML clinical trials from competitors in 2024 present an attractive landscape for clinical trials of these drug candidates.

The company is actively partnering with biotechnology and pharmaceutical companies for co-development rights in selected countries. CCM Biosciences, a sister company of the global chemical and pharmaceutical services company PMC Group, Inc., is also a Featured Exhibitor at ASCO (Free ASCO Whitepaper) 2025 — View Source — and will be showcasing both its drug programs and the state-of-the-art platforms used to discover and develop them.

On May 20, 2025 PeproMene Bio, Inc. (PMB) a clinical-stage biotech company developing novel therapies to treat cancers and immune disorders, reported that the first r/r FL patient treated in its phase 1 PMB-102 study, r/r B-cell non-Hodgkin’s Lymphoma (r/r B-NHL) trial of PMB-CT01 (BAFFR-CAR T Cells), has achieved complete remission at one month post treatment (Press release, PeproMene Bio, MAY 20, 2025, View Source [SID1234653259]).

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"We are excited to report that a patient with r/r FL has achieved complete remission after treatment with PMB-CT01, bringing the total to seven patients-all achieving a 100% CR rate with durable responses and a manageable safety profile. Notably, this patient had previously undergone 7 prior lines of therapy including chemoimmunotherapies, CD19 CAR T cells, an investigational trispecific antibody, and an antibody-drug conjugate (ADC). Remarkably, the patient experienced no CRS or ICANS," said Elizabeth Budde M.D., Ph.D., the trial’s lead principal investigator and associate professor of hematology at City of Hope, one of the largest and most advanced cancer research and treatment organizations in the U.S.

Follicular lymphoma (FL) is the most common indolent (slow-growing) form of B-cell non-Hodgkin Lymphoma (NHL), accounting for 20% of NHL in the US.1 FL is considered incurable with current standard of care therapies.2 Patients often relapse and with each relapse, the remission and time to next treatment is shorter.3 Patients with r/r FL are in need of additional medical options. "IFLI is dedicated to accelerating the development of innovative treatment options for patients with r/r FL" stated Dr. Michel Azoulay, M.D., CMO of the Institute for Follicular Lymphoma Innovation. "I am very excited that PMB-CT01 has shown promising efficacy and safety in this first FL patient."

"Most of the PMB-102 trial participants relapsed after CD19 CAR T therapy and/or presented with CD19 negative tumors. PMB-CT01 could present a viable alternative option for patients facing this challenging scenario," said Hazel Cheng PhD., COO of PMB. "We are deeply committed to the development of this first-in-class BAFFR CAR T therapy and are excited to advance our study into a multi-site expansion phase that will include r/r MCL, DLBCL and FL patients."

About PMB-CT01

PMB-CT01 is a first-in-class, BAFF-R targeted, autologous CAR T cell therapy. BAFF-R (B-Cell Activating Factor Receptor), a member of the tumor necrosis factor (TNF) receptor superfamily, is the main receptor for BAFF and is expressed almost exclusively on B cells. Since BAFF-R signaling promotes normal B-cell proliferation and appears to be required for B-cell survival, tumor cells are unlikely to escape therapy via loss of the BAFF-R antigen. This unique characteristic makes BAFF-R CAR T therapy a highly promising option for treating B-cell malignancies PMB-CT01 (BAFFR-CAR T cells) is currently being investigated to treat relapsed and refractory B-cell non-Hodgkin’s lymphoma (B-NHL; NCT05370430), B-cell, acute lymphoblastic leukemia (B-ALL; NCT04690595) in phase 1 clinical trials. Early results from PMB-101 and PMB-102 have demonstrated PMB-CT01 to be highly active and tolerable in heavily pre-treated r/r ALL and r/r NHL patient populations. PeproMene Bio has licensed intellectual property relating to PMB-CT01 from City of Hope.

On May 20, 2025 Minghui Pharmaceutical, a late-stage biopharmaceutical company dedicated to developing transformative therapies in immunology and oncology, reported that the first patient has been successfully dosed in a Phase Ⅱ clinical trial evaluating the safety and efficacy of an investigational combination therapy with MHB039A, a PD-1xVEGF bispecific antibody, and MHB036C, a TROP-2-directed antibody-drug conjugate, in patients with advanced non-small cell lung cancer (NSCLC) (Press release, Minghui Pharmaceutical, MAY 20, 2025, View Source;combination-study-of-pd-1xvegf-bispecific-and-trop-2-adc-in-advanced-nsclc-302460254.html [SID1234653258]).

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MHB039A is a novel bispecific antibody targeting PD-1 and VEGF. It demonstrated full blocking activities against both PD-1 and VEGF with superior PD-1 activity compared to competitor antibodies. In a completed Phase Ⅰ dose-escalation study, MHB039A was well-tolerated at doses up to 30 mg/kg, with no DLTs observed and the MTD not reached. The safety profile was consistent with that of previously reported PD-1xVEGF bispecifics. Robust PD-1 receptor occupancy and VEGF biomarker responses were observed across all dose levels. Encouraging anti-tumor activity was noted in NSCLC patients who had progressed after prior PD-1 inhibitor and chemotherapy treatment.

MHB036C is a novel antibody-drug conjugate targeting TROP-2, developed using Minghui’s proprietary SuperTopoi ADC platform. In ongoing Phase 1/2 studies, MHB036C has been evaluated in 138 patients with advanced or metastatic solid tumors. The ADC has demonstrated a favorable safety profile, with no major hematologic adverse events and ILD. Promising anti-tumor activity has been observed in heavily pre-treated NSCLC and breast cancer patients.

"We are excited to initiate this Phase Ⅱ trial investigating the combination therapy with MHB039A and MHB036C in advanced NSCLC," said Guoqing Cao, Ph.D., Chief Executive Officer of Minghui Pharmaceutical. "Emerging clinical data increasingly support the potential of combining ADCs with immuno-oncology (I/O) agents to achieve more robust and durable anti-tumor responses across multiple solid tumors. We believe these combinations will play a pivotal role in reshaping the standard-of-care treatment paradigms. Our PD-1xVEGF bispecific antibody offers a promising new backbone for I/O-based combination therapies."

Dr. Cao added, "This trial underscores our strategic focus on developing ADCs and PD-1xVEGF bispecific combination therapies and establishes a strong foundation for extending this approach to other solid tumors, including breast cancer."

On May 20, 2025 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for cancer, reported it has entered into a global clinical collaboration with MSD (Merck & Co., Inc., Rahway, NJ, USA) to evaluate the combination of ATG-022, a CLDN18.2-targeting antibody-drug conjugate (ADC), and MSD’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in patients with advanced solid tumors (Press release, Antengene, MAY 20, 2025, View Source [SID1234653257]).

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At the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI 2025), Antengene presented the latest data from its Phase I/II CLINCH study. Results showed an objective response rate (ORR) of 42.9% and a disease control rate (DCR) of 95.2% in patients with moderate to high CLDN18.2 expression (IHC 2+ ≥ 20%). Additionally, the study demonstrated an ORR of 30.0% and a DCR of 50.0% in patients with low CLDN18.2 expression (IHC 2+ < 20%). ATG-022 also exhibited a favorable safety profile and extended treatment durations, with no observed cases of ophthalmological or neurological toxicities, nor interstitial lung disease.

ATG-022 is uniquely positioned in the global landscape, with data supporting meaningful efficacy across all levels of Claudin 18.2 expression in gastric cancer, including high, low, and ultra-low expressors. This broad-spectrum activity positions ATG-022 as a promising treatment for a wider patient population compared to other CLDN18.2-targeting therapies.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About ATG-022

ATG-022 is an antibody-drug conjugate (ADC) designed to target CLDN18.2, a member of the Claudin family of cell adhesion molecules. Under normal conditions, Claudins are located within tight junctions between cells, forming a barrier to regulate cell permeability. However, in cancer, Claudins are aberrantly expressed on the cell surface due to changes in cell polarity. CLDN18.2 is frequently overexpressed in a range of primary malignant tumors, including gastric, esophageal, cholangiocarcinoma, and pancreatic cancers. The U.S. Food and Drug Administration (FDA) has awarded Orphan Drug Designations to ATG-022, for gastric and pancreatic cancers.

Data from the ongoing CLINCH study demonstrated that ATG-022 delivers robust efficacy across all levels of CLDN18.2 expression in gastric cancer patients, including those with high, low, and ultra-low expression. This broad activity positions ATG-022 as a potential market leader, capable of addressing the largest patient population with CLDN18.2-positive tumors. Furthermore, the strong efficacy observed in patients with low CLDN18.2 expression suggests promise for treating other tumor types with similar expression profiles.