On June 23, 2026 Mabwell (688062.SH, 02493.HK), an innovation-driven biopharmaceutical company with a fully integrated industry chain, reported that the National Medical Products Administration (NMPA) of China has cleared the clinical trial application for its innovative LILRB4/CD3 targeting T Cell Engager (TCE) bispecific antibody (R&D code: 6MW5311), for the treatment of hematologic malignancies, including acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML), and multiple myeloma (MM).

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6MW5311 is the first LILRB4/CD3 targeting TCE drug candidate globally to receive clinical trial approval. Previously, it received FDA clearance for the clinical trial application.

6MW5311 is developed based on Mabwell’s TCE technology platform and features a "2+1" asymmetric molecular structure. It simultaneously targets LILRB4 and CD3, forming an immunological synapse by bridging tumor cells and T cells, thereby activating T cells to efficiently kill tumors. The molecule incorporates a unique steric hindrance design. This structure significantly reduces the binding activity of the CD3 antibody to T cells in the absence of tumor cells. T cells are specifically activated only when tumor cells are present, which substantially enhances safety while improving anti-tumor efficacy.

In vitro studies have demonstrated that 6MW5311 exhibits potent cytotoxic activity across multiple tumor cell lines and patient-derived samples. In vivo pharmacodynamic studies have shown that 6MW5311 achieves significant tumor inhibition in both LILRB4-high and LILRB4-low expressing AML tumor models. Notably, it achieved complete tumor clearance in high-expression models. Furthermore, 6MW5311 demonstrated a favorable safety profile in cynomolgus monkey safety evaluation models.

As a key technological approach for directly mobilizing T cells to kill tumors, TCE has shown significant clinical value in various lymphoma indications, with multiple products successfully launched. However, current treatments for AML and CMML primarily remain primarily limited to chemotherapy, hematopoietic stem cell transplantation, and targeted therapies for specific mutations; no TCE products have been approved for these indications to date.

About Acute Myeloid Leukemia (AML)

AML is a group of clonal malignant disorders originating from myeloid stem cells, characterized by high heterogeneity and mortality. Globally, approximately 172.4 thousand new cases of AML were diagnosed in 2022, with the number projected to reach 221.4 thousand by 2035, representing a compound annual growth rate (CAGR) of 1.94%. In China, approximately 30.8 thousand new AML cases were diagnosed in 2022, accounting for approximately 17.9% of the global total. The number is expected to reach 36.7 thousand by 2035, representing approximately 16.6% of the global total, with a CAGR of 1.36%.

About Chronic Myelomonocytic Leukemia (CMML)

CMML is a clonal hematopoietic stem cell disorder that shares overlapping features with both myelodysplastic syndrome (MDS) and Myeloproliferative Neoplasm (MPN). It is characterized by significant monocytosis in peripheral blood and carries an inherent risk of transformation to AML (approximately 15-20% within 3-5 years). CMML is a rare disease with an annual incidence of approximately 3-4 per 100,000, and currently lacks effective treatment options.

About Multiple Myeloma (MM)

MM is a clonal plasma cell malignancy characterized by the uncontrolled proliferation of monoclonal plasma cells in the bone marrow. This leads to the overproduction of abnormal immunoglobulins and subsequent end-organ damage, manifested as hypercalcemia, renal impairment, anemia, and bone lesions (collectively known as CRAB features). Globally, MM accounts for approximately 1%-2% of all cancers and about 10% of hematologic malignancies. The median age at diagnosis is approximately 69 years, with higher incidence rates observed in males and individuals of African descent. Over the past two decades, patient survival rates have significantly improved thanks to the application of proteasome inhibitors, immunomodulatory drugs, and monoclonal antibodies. However, MM remains largely incurable, and most patients experience multiple relapses during the course of the disease.

(Press release, Mabwell Biotech, JUN 23, 2026, View Source [SID1234668915])

On June 23, 2026 Abbisko Therapeutics Co., Ltd. ("Abbisko Therapeutics" hereafter, HKEX code: 02256.HK) reported that it has entered into a strategic research collaboration and license agreement with Eli Lilly and Company ("Lilly"), a leading global pharmaceutical company. Under the agreement, the two companies will collaborate on the discovery and development of innovative medicines across multiple targets, advancing novel drug candidates with global potential.

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By leveraging their respective strengths in drug discovery, research and development, and global drug development, Abbisko and Lilly aim to accelerate the advancement of innovative therapeutic programs and bring new treatment options to patients worldwide.

Under the terms of this agreement, Abbisko will utilize its early-stage drug discovery platform, innovative R&D ecosystem, and extensive development expertise to conduct discovery and early development activities for novel drug programs directed against disease targets selected by Lilly. Abbisko will receive an upfront payment and is eligible to receive development, regulatory and commercial milestone payments totaling up to approximately US$1.9 billion. In addition, Abbisko will be eligible to receive tiered royalties based on annual net sales of products arising from this collaboration.

In 2022, Abbisko and Lilly entered into a global collaboration and exclusive license agreement to collaborate on the discovery, development, and potential commercialization of a novel small-molecule therapeutic.

Supported by its continually evolving drug discovery platform, extensive R&D experience and proven execution capabilities, Abbisko has continued to expand its global partnership network and accelerate the translation of scientific innovation into therapeutic advances. This collaboration with Lilly is expected to advance multiple innovative programs and further strengthen Abbisko’s global innovation strategy and long-term value creation potential.

(Press release, Abbisko Therapeutics, JUN 23, 2026, View Source [SID1234668914])

On June 23, 2026 Orion Corporation (Orion Pharma) reported that its investigational drug ODM-212 has received Orphan Designation from the European Commission, based on the recommendation from the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP), for the treatment of malignant mesothelioma, which is a rare and difficult to treat cancer. The US Food and Drug Administration (FDA) has previously granted Orphan Drug Designation to ODM-212 for the treatment of mesothelioma.

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ODM-212 is an oral small-molecule pan-TEAD (Transcriptional Enhanced Associate Domain) inhibitor being tested in a Phase 2 clinical study (TEADES) for the treatment of malignant pleural mesothelioma (MPM), epithelioid hemangioendothelioma (EHE) and other solid tumors with dysfunction in Hippo pathway. The trial includes patients who have progressed after receiving standard treatments and have no further treatment options. This is a global trial conducted at leading oncology centers in the US and Europe. For more information on the TEADES Phase 2 clinical study, please visit ClinicalTrials.gov and reference identifier NCT06725758.

"The Orphan Designation for ODM-212 is an important milestone for Orion Pharma. It highlights the need for new treatments in mesothelioma and reinforces our commitment to developing innovative therapies for patients with rare cancers," said Praveen Aanur, MD, MPH, MBA, Chief Medical Officer, Oncology Therapy Area, Orion Pharma.

About Orphan Designation in the EU
The EMA grants Orphan Designation to medicines intended for the treatment, prevention or diagnosis of life-threatening or chronically debilitating rare diseases, defined as having a prevalence of no more than 5 in 10,000 in the EU. Additionally, for a medicine to be granted Orphan Designation there should be no satisfactory method of diagnosis, prevention or treatment of the condition concerned, or, if such a method exists, the medicine must be of significant benefit to those affected by the condition.

With this designation for ODM-212, Orion Pharma, the sponsor, is now qualified for incentives including protocol assistance, fee reductions for certain regulatory activities, and eligibility for a 10-year period of market exclusivity following approval. Orphan Designation neither shortens the development time or regulatory review time of a drug nor gives the drug any advantage in the regulatory review or approval process.

About ODM-212
ODM-212 is an oral small-molecule pan-TEAD (Transcriptional Enhanced Associate Domain) inhibitor developed by Orion Pharma. It targets the Hippo signaling pathway, which regulates cell growth and organ size. Dysregulation of this pathway—particularly through YAP/TAZ activation—can lead to uncontrolled tumor growth and resistance to cancer therapies. ODM-212 works by blocking TEAD transcription factors, disrupting YAP-TEAD protein-protein interactions, and inhibiting TEAD auto-palmitoylation, which is essential for TEAD activity.

(Press release, Orion, JUN 23, 2026, View Source [SID1234668913])

On June 23, 2026 GENFIT (Euronext: GNFT), a biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, reported positive Phase 1b results for GNS561 in combination therapy in patients with heavily pretreated cholangiocarcinoma, demonstrating a favorable safety and tolerability profile and early signs of antitumor activity.

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Clinical trial context and objective
CCA is a rare and aggressive bile duct cancer, often diagnosed at an advanced stage. It is associated with a high unmet medical need, driven by limited treatment options and poor prognosis. GNS561 is an investigational small molecule targeting PPT1, leading to autophagy inhibition and lysosomal dysfunction, thereby disrupting cancer cell survival mechanisms. By blocking autophagy, GNS561 aims to promote cancer cell death and may enhance sensitivity to other treatments. Its combination with a MEK inhibitor is intended to unlock synergistic potential by simultaneously targeting autophagy and MAPK signaling pathways. In the Phase 1b study, patients with advanced KRAS mutated CCA, who have previously failed one or two lines of prior standard of care therapies, were enrolled to evaluate the safety and tolerability of GNS561 when given in combination with trametinib, a MEKi.

Clinical results and next steps
The initial part of the Phase 1b study has been completed as planned, with 19 patients enrolled across four cohorts evaluating increasing doses of GNS561. A favorable safety and tolerability profile was observed, with no dose-limiting toxicities (DLT) reported, supporting continued clinical development. Continued signals of antitumor activity were also noted in this heavily pretreated population, with approximately half of patients achieving Stable Disease (SD) at Week 6, including one patient maintaining this status up to Week 30. While based on a limited dataset, these findings contribute to shaping the emerging clinical profile of the combination. On this basis, GENFIT has decided to expand the Phase 1b study with additional cohorts at higher dose levels. This expansion, intended to further strengthen the clinical dataset, does not alter the planned transition to Phase 2, which remains on track for initiation in the second half of 2026. The recommended Phase 2 dose and study design are expected to be finalized over the summer.

Dr. Mark Yarchoan, Associate Professor of Oncology at Johns Hopkins Medicine (Baltimore, MD, USA), principal investigator of the program, commented: "Advanced KRAS-mutated cholangiocarcinoma remains an area of high unmet medical need, particularly in patients who have progressed after prior therapies. What is notable in these data is the consistency of the signal as additional patients have been treated, which helps reinforce the initial findings. Combined with a favorable safety and tolerability profile and signs of activity, these results support continued clinical investigation of this combination strategy targeting autophagy and MAPK signaling pathways."

Details available on ClinicalTrials.gov (NCT05874414) cover both the Phase 1b and planned Phase 2 components of this open-label, multicenter study, and will be updated upon initiation of Phase 2.

END

ABOUT CHOLANGIOCARCINOMA

Biliary tract cancer (BTC) is the second most common primary liver malignancy diagnosed globally. Cholangiocarcinoma (CCA) is a type of BTC and represents approximately 15% of all primary liver tumors and 3% of gastrointestinal cancers. Based on its anatomical origin, CCA is best classified anatomically as intrahepatic (iCCA) or extrahepatic (eCCA), which is comprised of perihilar (pCCA) and distal (dCCA) CCA. Early diagnosis is a major challenge as most patients with early-stage disease do not have symptoms due to limited biliary obstruction. Rather, patients characteristically manifest symptoms related to their underlying cirrhosis, a condition present in some patients with CCA. Taken together, the majority of patients with CCA are diagnosed with advanced disease, often precluding potentially curative therapies. There are limited therapeutic options for this aggressive disease. The 5-year survival rates drop to 5-15% in the advanced and unresectable settings. The only potentially curative treatment remains surgical resection. Unfortunately, at the time of first diagnosis, only about 25% of the patients are eligible for surgery. Moreover, even after curative intent surgery, the clinical outcomes are disappointing, with 5-year survival rates of 7% to 20%.

ABOUT GNS561

GNS561 is a first-in-class investigational lysosomotropic agent with a novel mechanism of action. When combined with Mitogen-Activated Protein Kinase Kinase (MEK) inhibitors, GNS561 targets complementary pathways critical for cancer cell survival and proliferation, resulting in potent antitumor activity. The combination is being developed as a potential breakthrough therapy for patients with advanced solid tumors. In December 2021, we licensed the exclusive rights from Genoscience Pharma to develop and commercialize the investigational treatment GNS561 in CCA in the United States, Canada and Europe, including the United Kingdom and Switzerland. In early 2025, GENFIT completed the acquisition of the full intellectual property rights for GNS561 from Genoscience Pharma, expanding upon the limited rights initially obtained through the 2021 license.

(Press release, Genfit, JUN 23, 2026, https://ir.genfit.com/news-releases/news-release-details/genfit-positive-phase-1b-data-gns561-combination-therapy-heavily [SID1234668912])

On June 23, 2026 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, reported positive preliminary data from the ongoing TARGET-D 101 Phase 1/2 clinical trial evaluating VS-7375, an investigational oral KRAS G12D (ON/OFF) inhibitor, with best-in-class potential, in patients with advanced KRAS G12D-mutated solid tumors. The data demonstrate encouraging clinical activity along with a favorable safety and tolerability profile across multiple dose levels and tumor types, including metastatic pancreatic ductal carcinoma (mPDAC), metastatic colorectal cancer (mCRC), and advanced non-small cell lung cancer (NSCLC).

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"VS-7375 has demonstrated anti-tumor activity across multiple dose levels and tumor types, encouraging signals from rational combination strategies, and a favorable safety profile that improves meaningfully beyond the first treatment cycle, underscoring its potential to be not only the best-in-class oral KRAS G12D inhibitor, but also the preferred treatment option for patients with KRAS-G12D-mutated cancers," said Michael Kauffman, M.D., Ph.D., president of development at Verastem Oncology. "Importantly, VS-7375 has demonstrated compatibility with both anti-EGFR therapy and standard-of-care chemotherapy, supporting the broad development strategy we are pursuing across pancreatic, non-small cell lung, and colorectal cancers. As patient follow-up matures in the TARGET-D 101 study, we are enrolling patients in our three Phase 2 registration-directed studies. We look forward to sharing additional data on VS-7375 in patients with KRAS G12D-mutated cancers later this year."

Highlights of TARGET-D 101 Phase 1/2 Dose Escalation & Dose Expansion Trial
In the TARGET-D 101 trial, dose-escalation is ongoing at 1200 mg once daily (QD). In updated pharmacokinetic (PK) data, the 900 mg QD dose continues to achieve target plasma levels of VS-7375 and provides clear separation from the 600 mg QD dose. VS-7375 demonstrated anti-tumor activity at multiple dose levels, including 400 mg QD, 600 mg QD and 900 mg QD both as monotherapy and in combination with anti-EGFR therapy, across multiple KRAS G12D-driven tumors, including mPDAC, mCRC and advanced NSCLC. In addition, patient follow-up continues to mature across both monotherapy and combination cohorts.

Metastatic PDAC

Promising clinical activity observed at 900 mg QD monotherapy in previously treated mPDAC, with evidence of dose-dependent anti-tumor activity between 600 mg QD and 900 mg QD
93% (13/14) of heavily pretreated (2L-4L) patients with mPDAC receiving 900 mg QD monotherapy achieved greater than 50% reduction in the tumor marker CA19-9. All 14 evaluable patients had elevated baseline CA19-9 levels (>37 U/mL) and at least one scheduled on-treatment CA19-9 assessment. All patients remain on treatment.
Preliminary data suggest the combination with the anti-EGFR antibody cetuximab is associated with deeper and more rapid tumor reductions, even at a subtherapeutic VS-7375 dose of 400 mg QD.
Combination cohorts in previously treated mPDAC demonstrate good combinability with standard-of-care chemotherapy, gemcitabine plus Nab-paclitaxel (Gem/NabP). VS-7375 600 mg QD in combination with full-dose Gem/NabP has been DLT-cleared, and enrollment is ongoing with 900 mg QD plus full-dose Gem/NabP.
Among patients with mPDAC who had received at least one prior therapy (2L+), 7 of 20+ patients enrolled at the 600 mg QD dose level and 1 of 20+ patients enrolled at the 900 mg QD dose level had completed at least six months of follow-up.
Metastatic CRC

In the mCRC cohort, promising preliminary efficacy was observed with full dose cetuximab at both the 600 mg QD and 900 mg QD dose levels of VS-7375.
VS-7375 900 mg QD in combination with full dose cetuximab was DLT-cleared in May 2026, with no overlapping toxicities observed to date. Additional patients will be enrolled at this dose level in the TARGET-D 203 Phase 2 registration-directed mCRC trial.
Follow-up remains early in the mCRC cohort, with no patients out of 20+ at 600 mg QD in combination with full dose cetuximab having more than six months of follow-up.
Advanced NSCLC

In the advanced NSCLC cohort, promising preliminary efficacy was observed at 600 mg QD monotherapy.
Follow-up remains early in the NSCLC cohort, with only one out of 20+ patients at 600 mg QD having more than six months of follow-up.
The 900 mg QD dose level in advanced NSCLC will be studied in the registration-directed TARGET-D 202 Phase 2 study.
Updated Safety & Tolerability from Phase 1/2 TARGET-D 101
Across monotherapy and combination cohorts in TARGET-D 101, VS-7375 continued to demonstrate a favorable and manageable safety profile, consistent with prior observations and supported by increasing patient exposure and longer follow-up. As of the June 12, 2026 data cutoff, VS-7375 monotherapy has demonstrated a favorable and manageable safety profile at both the 600 mg QD (n=57) and 900 mg QD (n=25) dose levels.

Treatment-related adverse events (TRAEs) were primarily low-grade nausea, vomiting and diarrhea, which generally diminished over time, with substantially reduced incidence after cycle 1 dosing. The vast majority of the gastrointestinal (GI) side effects were effectively managed with standard supportive care measures, with only 1 reported Grade 3 case of nausea at the 900 mg QD dose that resolved in 4 days after optimization of anti-emetic agents. A very low frequency of rash was observed in either the 600 mg QD or 900 mg QD dose level and no rash above Grade 1.
TRAEs occurring in more than one patient were largely confined to the first treatment cycle and attenuated substantially thereafter among patients with at least 29 days of follow-up receiving VS-7375 at both the 600 mg QD (n=51) and 900 mg QD (n=22) dose levels.
No unexpected adverse events (AEs) were observed, and rates of Grade 3 AEs remained low.
Importantly, no clinically meaningful cytopenias or liver function abnormalities were reported at either the 600 mg QD or 900 mg QD dose level.
The limited dose-response relationship observed for gastrointestinal AEs is consistent with a localized irritant effect rather than systemic toxicity.
Emerging longer-term follow-up data are encouraging, with no clinically significant cumulative toxicities observed to date.
VS-7375 Development Collaboration
Verastem and Erasca, Inc., announced today their intent to enter into an agreement to evaluate VS-7375, Verastem’s potential best-in-class oral KRAS G12D (ON/OFF) inhibitor, in combination with ERAS-0015, Erasca’s potential best-in-class oral pan-RAS molecular glue, across KRAS G12D mutant solid tumor models. Subject to the execution of a definitive agreement and the outcome of the preclinical evaluation, the Companies intend to explore a future clinical trial collaboration to evaluate the combination in patients with advanced solid tumors. Additional details regarding the potential collaboration will be announced at a later date.

"In the first half of this year we have made tremendous progress in advancing the development of VS-7375 in order to bring this truly differentiated KRAS G12D inhibitor with promising emerging clinical efficacy and a favorable safety and tolerability profile both as monotherapy and in combination regimens as quickly as possible to patients," said Dan Paterson, president and chief executive officer of Verastem Oncology. "The momentum behind the VS-7375 program continues to accelerate with the initiation of three Phase 2 registration-directed trials in only three months. We are now expanding the development strategy through a collaboration designed to explore a complementary mechanism and address areas of significant unmet need within KRAS G12D-mutated cancers. Overall, the development strategy for VS-7375 is aimed at maximizing the therapeutic potential of this program across multiple tumor types and treatment settings and supporting multiple potential registration pathways."

Expected Key Milestones:

Report an update on the TARGET-D 101 trial in 2H 2026.
Complete target enrollment in TARGET-D 101 PDAC and NSCLC monotherapy cohorts and mCRC cetuximab combination cohorts by the end of June 2026.
Announce first patient dosed in the TARGET-D 202 and TARGET-D 203 clinical trials in mid-2026.
Complete enrollment across all three TARGET-D Phase 2 trials by the end of 2026.
Meet with the U.S. Food and Drug Administration (FDA) before the end of the year to review Phase 3 pivotal trial designs in 1L mPDAC, 1L mCRC and 1L advanced NSCLC.
Enroll the first patient in each of the Phase 3 pivotal trials in the first half of 2027.
Webcast Information
On June 23rd at 4:30 p.m. ET, a live audio webcast of the call, along with accompanying slides, will be available under "Events & Presentations" in the Investor section of the Company’s website, View Source A replay of the webcast will be archived and available following the event.

About KRAS G12D
KRAS G12D represents 26% of all KRAS mutations, making it the most prevalent KRAS mutation in human cancers. When the KRAS gene is mutated, it can promote cancer development and growth. Patients with KRAS G12D-mutant tumors often have poorer outcomes, underscoring the need for therapies designed specifically to inhibit this mutation potently and for a long duration. The KRAS G12D mutation occurs most commonly in pancreatic (40%), colorectal (15%), endometrial (8%), biliary tract (7-15%), and non-small cell lung (5%) cancers. Currently, no therapies are approved by the U.S. Food and Drug Administration (FDA) specifically targeting KRAS G12D mutations in cancer.

About VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor & TARGET-D Clinical Program
VS-7375 is a potential best-in-class, potent, and selective investigational oral KRAS G12D dual ON/OFF inhibitor. It is designed to uniquely bind to both the active (ON) and inactive (OFF) states of KRAS G12D, with the potential to inhibit KRAS G12D signaling and tumor growth more completely than compounds that block KRAS G12D only in the OFF state or only in the ON state.

In June 2025, Verastem initiated TARGET-D 101, a Phase 1/2 dose escalation, dose expansion, and combination clinical trial evaluating the safety and efficacy of VS-7375 in patients with advanced KRAS G12D mutant solid tumors. Verastem has further expanded the VS-7375 clinical program with the initiation of three Phase 2 registration-directed, open-label clinical trials: TARGET-D 201 (NCT07644559) in second-line advanced or metastatic pancreatic ductal carcinoma, TARGET-D 202 (NCT07659782) in second/third-line advanced or metastatic non-small cell lung cancer, and TARGET-D 203 (NCT07659795) in metastatic colorectal cancer. On June 16, 2026, the first patient was dosed in the TARGET-D 201 trial.

In July 2025, U.S. Food and Drug Administration (FDA) granted Fast Track Designation (FTD) to VS-7375 for the first-line treatment of patients with KRAS G12D-mutated locally advanced or metastatic adenocarcinoma of the pancreas and for the treatment of patients with KRAS G12D-mutated locally advanced or metastatic pancreatic ductal carcinoma who have received at least one prior line of standard systemic therapy. In June 2026, the FDA also granted FTD to VS-7375 for the treatment of adult patients with KRAS G12D-mutated unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received platinum-based chemotherapy and an anti-PD-(L)1 antibody either concurrently or sequentially.

In December 2023, Verastem selected VS-7375 as its lead program from its collaboration with GenFleet Therapeutics, which aims to advance three oncology discovery programs related to RAS/MAPK pathway-driven cancers. The collaboration provides Verastem with an exclusive option to obtain a license for each of the three compounds in the collaboration after the successful completion of pre-determined milestones in a Phase 1 trial. In January 2025, Verastem exercised its license for VS-7375. The licenses would give Verastem development and commercialization rights outside the GenFleet markets of mainland China, Hong Kong, Macau, and Taiwan. GenFleet is developing VS-7375 as GFH375 in China.

(Press release, Verastem, JUN 23, 2026, View Source [SID1234668911])