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Instil Bio and ImmuneOnco to Host Investor and Analyst Breakfast to Discuss the Evolving PD-(L)1xVEGF Bispecific Antibody Landscape and Clinical Trial Updates During the 2025 ASCO Annual Meeting in Chicago

On May 23, 2025 Instil Bio, Inc. (Nasdaq: TIL, "Instil") and ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (HKEX Code: 1541.HK, "ImmuneOnco"), reported that they will jointly host an investor and research analyst breakfast in Chicago, Illinois on Saturday, May 31, 2025 at 8:00 to 9:30 am CT adjacent to the McCormick Convention Center (Press release, Instil Bio, MAY 23, 2025, View Source [SID1234653358]).

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!

Instil and ImmuneOnco management, along with a key opinion leader in the field of immuno-oncology, will discuss the evolving PD-(L)1xVEGF bispecific antibody landscape and recent clinical trial updates from Instil and ImmuneOnco.

Investors and analysts interested in attending should register by emailing their contact information to reserve seating to [email protected].

IMUNON Announces 2025 ASCO Annual Meeting Oral Presentation Highlighting Unprecedented Survival Data from Phase 2 Trial of IMNN-001 in Treatment of Newly Diagnosed Advanced Ovarian Cancer

On May 23, 2025 IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in Phase 3 development of its DNA-mediated immunotherapy, reported new positive data from the Company’s Phase 2 OVATION 2 Study of IMNN-001, an investigational therapy for the treatment of advanced ovarian cancer. Results are being highlighted in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held May 30 – June 3, 2025, in Chicago, Illinois and virtually, and are also being published simultaneously in the peer-reviewed journal Gynecologic Oncology (Press release, IMUNON, MAY 23, 2025, View Source [SID1234653357]).

Based on the highly encouraging Phase 2 OVATION 2 Study results and following alignment with the U.S. Food and Drug Administration (FDA), IMUNON recently initiated the first two sites for its pivotal Phase 3 OVATION 3 Study of IMNN-001 in newly diagnosed advanced ovarian cancer.

"We are very encouraged by these remarkable results and the fact that they are being presented in two of the most prestigious platforms in oncology research – the ASCO (Free ASCO Whitepaper) Annual Meeting and Gynecologic Oncology," said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. "As we continue to evaluate findings from our Phase 2 OVATION 2 Study, the data show consistently strong improvement in overall and progression-free survival, suggesting that IMNN-001 may drive positive outcomes that can truly make a difference in the lives of women with ovarian cancer, even for those with advanced and very difficult to treat stages of disease."

"The results from this Phase 2 trial are powerful and highly encouraging. Typically, an increase in survival of six months is considered clinically meaningful. The data being presented at ASCO (Free ASCO Whitepaper) indicate that IMNN-001 could extend the lives of women with newly diagnosed with advanced ovarian cancer by one year or longer, representing a potentially historic advance in standard of care," said Premal H. Thaker, M.D., Interim Chief of Gynecologic Oncology, David & Lynn Mutch Distinguished Professor of Obstetrics & Gynecology, Director of Gynecologic Oncology Clinical Research at Washington University School of Medicine, OVATION 2 Study Chair and Study Chair of Phase 3 OVATION 3 trial. "This is the first immunotherapy with a favorable safety profile to demonstrate survival benefits when used in conjunction with standard of care chemotherapy in a frontline setting. The fact that IMNN-001 has the potential to be used in conjunction with PARP inhibitors and in women with HRD and BRCA mutations is also particularly exciting. I look forward to helping enroll the Phase 3 trial in the months ahead."

Participants with newly diagnosed advanced epithelial ovarian cancer in the Phase 2 OVATION 2 Study (n=112) were randomized 1:1 to evaluate the safety and efficacy of IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus neoadjuvant and adjuvant chemotherapy (N/ACT) compared to standard of care (SoC) N/ACT alone, with a median follow-up of 31 months. Among the findings being presented at the ASCO (Free ASCO Whitepaper) Annual Meeting:

Patients in the intent-to-treat (ITT) population administered IMNN-001 plus SoC N/ACT achieved a median increase in overall survival (OS) of 13 months compared to SoC N/ACT alone (46 vs. 33 months), with a hazard ratio of 0.69.
Increased therapeutic activity was observed among patients treated with poly ADP-ribose polymerase (PARP) inhibitors as part of standard maintenance therapy, with the median OS not yet reached in the IMNN-001 treatment arm after more than five years (vs. 37 months in the control arm), with a hazard ratio of 0.38.
Increased therapeutic activity was also observed in women positive for homologous recombination deficiency (HRD+), including BRCA1 or BRCA2 mutations, with a hazard ratio of 0.42.
For the ITT population, patients treated with IMNN-001 plus SoC N/ACT achieved a median 3-month increase in progression-free survival (PFS) compared to SoC N/ACT alone (14.9 vs. 11.9 months), with a hazard ratio of 0.79.
Patients also receiving PARP inhibitors achieved a median 11.7-month increase in PFS when treated with IMNN-001 and SoC N/ACT compared to SoC N/ACT alone (33.8 vs. 22.1 months), with a hazard ratio of 0.8.
IMNN-001 was well tolerated, with the most common adverse events (AEs) primarily including abdominal pain, nausea and vomiting. There were no reports of cytokine release syndrome, systemic toxicity or serious immune-related AEs.
The details of the ASCO (Free ASCO Whitepaper) oral presentation are as follows:

Abstract Title: A phase I/II study of the safety and efficacy of intraperitoneal IMNN-001 in combination with neoadjuvant chemotherapy (NACT) of paclitaxel and carboplatin in patients newly diagnosed with advanced epithelial ovarian cancer (EOC): Updated survival analysis from OVATION-2 trial.
Presenting Author: Premal H. Thaker, M.D., Washington University School of Medicine, OVATION 2 Study Chair
Date: Tuesday, June 3, 2025
Session Time: 8:00-9:30 a.m. CT
Session Title: Gynecologic Cancer
Abstract Number: 5516
"These data also further validate our TheraPlas technology platform on which IMNN-001 is based and its potential to harness the powerful immunological properties of IL-12 to target the tumor micro-environment and treat ovarian cancer effectively, while alleviating side effects often seen with other immunotherapies. We look forward to advancing our Phase 3 pivotal trial of IMNN-001 as quickly as possible in efforts to bring this novel therapy to the many women in desperate need of new treatment options," added Dr. Lindborg.

In the pivotal Phase 3 OVATION 3 Study of IMNN-001, study participants will be randomized 1:1 and include women with newly diagnosed advanced ovarian cancer (stage IIIC or IV) who are eligible for N/ACT (the ITT population), with a sub-group of HRD+ women including those with BRCA1 or BRCA2 mutations. The primary endpoint of the study is OS, and secondary endpoints are surgical response score, chemotherapy response score, clinical response and time to second-line treatment. The study will also assess several exploratory endpoints.

About the Phase 2 OVATION 2 Study

OVATION 2 evaluated the dosing, safety, efficacy and biological activity of intraperitoneal administration of IMNN-001 in combination with neoadjuvant and adjuvant chemotherapy (NACT) of paclitaxel and carboplatin in patients newly diagnosed with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. Treatment in the neoadjuvant period is designed to shrink the tumors as much as possible for optimal surgical removal after three cycles of chemotherapy. Following NACT, patients undergo interval debulking surgery, followed by three additional cycles of adjuvant chemotherapy to treat any residual tumor. This open-label study enrolled 112 patients who were randomized 1:1 and evaluated for safety and efficacy to compare NACT plus IMNN-001 versus standard-of-care NACT. In accordance with the study protocol, patients randomized to the IMNN-001 treatment arm could receive up to 17 weekly doses of 100 mg/m2 in addition to NACT. As a Phase 2 study, OVATION 2 was not powered for statistical significance. Additional endpoints included objective response rate, chemotherapy response score and surgical response.

About IMNN-001 Immunotherapy

Designed using IMUNON’s proprietary TheraPlas platform technology, IMNN-001 is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system that enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anticancer immunity acting through the induction of T-lymphocyte and natural killer cell proliferation. IMUNON previously reported positive safety and encouraging Phase 1 results with IMNN-001 administered as monotherapy or as combination therapy in patients with advanced peritoneally metastasized primary or recurrent ovarian cancer and completed a Phase 1b dose-escalation trial (the OVATION 1 Study) of IMNN-001 in combination with carboplatin and paclitaxel in patients with newly diagnosed ovarian cancer. IMUNON previously reported positive results from the recently completed Phase 2 OVATION 2 Study, which assessed IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus neoadjuvant and adjuvant chemotherapy (NACT) of paclitaxel and carboplatin compared to standard-of-care NACT alone in 112 patients with newly diagnosed advanced ovarian cancer.

About Epithelial Ovarian Cancer

Epithelial ovarian cancer is the sixth deadliest malignancy among women in the U.S. There are approximately 20,000 new cases of ovarian cancer every year and approximately 70% are diagnosed in advanced Stage III/IV. Epithelial ovarian cancer is characterized by dissemination of tumors in the peritoneal cavity with a high risk of recurrence (75%, Stage III/IV) after surgery and chemotherapy. Since the five-year survival rates of patients with Stage III/IV disease at diagnosis are poor (41% and 20%, respectively), there remains a need for a therapy that not only reduces the recurrence rate, but also improves overall survival. The peritoneal cavity of advanced ovarian cancer patients contains the primary tumor environment and is an attractive target for a regional approach to immune modulation.

HUTCHMED Highlights Clinical Data to be Presented at the 2025 ASCO Annual Meeting

On May 23, 2025 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) reported that new data from several studies of compounds discovered by HUTCHMED including savolitinib, ranosidenib, fruquintinib and surufatinib, will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting taking place on May 30 – June 3, 2025 in Chicago, USA (Press release, Hutchison China MediTech, MAY 23, 2025, View Source [SID1234653356]).

Results from the SACHI China Phase III study of savolitinib in combination with osimertinib in patients with locally advanced or metastatic epidermal growth factor receptor ("EGFR") mutation-positive non-small cell lung cancer ("NSCLC") with MET amplification after disease progression on EGFR inhibitor therapy will be presented at a late breaking oral presentation. SACHI had met the pre-defined primary endpoint of progression-free survival (PFS) in a planned interim analysis. SACHI data supports the New Drug Application (NDA) for this oral-only treatment, which has been accepted and granted priority review in China.

Further data with additional analysis stratified by brain metastasis status from a high MET overexpression and/or amplification treatment subset of the SAVANNAH Phase II study of the savolitinib and osimertinib combination in NSCLC patients harboring EGFR mutation and MET amplification or overexpression after progressing on osimertinib were reported. The savolitinib and osimertinib combination demonstrated better efficacy outcomes compared to savolitinib plus placebo. The combination showed promising central nervous system ("CNS") activity, with reduced CNS progression and fewer new CNS lesions.

Results will be presented from the dose-escalation stage of the Phase I study of ranosidenib (HMPL-306), a novel, small-molecule, highly selective oral dual-inhibitor of both Isocitrate dehydrogenase ("IDH") 1 and IDH2 enzymes, being studied in patients with locally advanced or metastatic solid tumors with IDH mutations. Results show that the compound was well tolerated, showing target inhibition and durable responses in patients. Efficacy signals were observed especially in the efficacy evaluated group of lower-grade glioma patients (N=14), with an objective response rate ("ORR") of 7.1% and a disease control rate ("DCR") of 100%.

Results will also be presented from the sub-group analyses of the FRUSICA-1 open-label, single-arm, pivotal Phase II study to evaluate the efficacy and safety of fruquintinib plus sintilimab in previously treated advanced endometrial cancer (EMC) patients with pMMR (proficient mismatch repair) status. Efficacy findings for patients with serous carcinoma (N=27) were clinically meaningful and characterized by responses similar to those observed in full trial population (N=98), with an Independent Review Committee ("IRC")-assessed ORR of 37.0% and a DCR of 88.9%. The analysis of whether the response was affected by prior neoadjuvant/adjuvant chemotherapy ("NACT/ACT") showed durable and clinically meaningful responses regardless of whether the patient had received NACT/ACT. Results were comparable for patients with and without prior NACT/ACT, with an IRC-assessed ORR of 34.0% versus 31.4% and DCR of 85.1% versus 82.4%, respectively.

Results from two subgroup analyses of a Phase IV study of fruquintinib involving 2,798 colorectal cancer patients in China will be presented. In the subgroup analysis evaluating the safety of fruquintinib as monotherapy and in combination therapy, fruquintinib demonstrated a manageable safety profile in both groups. Treatment-emergent adverse events (TEAE) of Grade 3 or above occurred in 23.94% in the fruquintinib monotherapy group and 26.06% in the combination therapy group with other anti-cancer treatments. The most common treatment related adverse events (TRAE) of any grade in both groups were palmar-plantar erythrodysesthesia (PPES) and hypertension. The combination therapy group exhibited a longer treatment duration, potentially indicating improved patient outcomes. In the subgroup analysis by age, the safety of fruquintinib was assessed in younger (age <50) and late-elderly (age ≥75) patients. The safety profile was comparable across both age groups, with younger patients receiving more intensive treatment. Combination therapy with fruquintinib also showed a longer duration than monotherapy in both age subgroups, which may suggest improved survival potential.

Details of the presentations, including links to available abstracts, are as follows:

Abstract title

Presenter / Lead author

Presentation details

Blenrep (belantamab mafodotin) combinations receive positive CHMP opinion in relapsed/refractory multiple myeloma

On May 23, 2025 GSK plc (LSE/NYSE: GSK) reported the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of Blenrep for the treatment of adults with relapsed or refractory multiple myeloma in combination with bortezomib plus dexamethasone (BVd) in patients who have received at least one prior therapy, and in combination with pomalidomide plus dexamethasone (BPd) in patients who have received at least one prior therapy including lenalidomide (Press release, GlaxoSmithKline, MAY 23, 2025, View Source [SID1234653355]). An approval decision by the European Commission is expected in the third quarter of 2025.

The CHMP opinion follows the approval of Blenrep combinations by the UK Medicines and Healthcare products Regulatory Agency (MHRA) in April and Japan’s Ministry of Health, Labour and Welfare earlier this month.

Superior efficacy results shown by Blenrep combinations in the pivotal DREAMM-7 and DREAMM-8 phase III trials in relapsed or refractory multiple myeloma support the CHMP opinion. These include statistically significant and clinically meaningful progression-free survival (PFS) results for Blenrep combinations versus standards of care in both trials and overall survival (OS) versus a daratumumab-based triplet in DREAMM-7.2,3,4 The safety and tolerability profiles of the Blenrep combinations were broadly consistent with the known profiles of the individual agents.2,3

Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: "Today’s positive CHMP opinion is an important milestone toward bringing the benefits of Blenrep combinations to patients with multiple myeloma in Europe. Blenrep is well positioned to address the unmet needs of these patients while also providing the benefit of in-office administration in both academic and community treatment settings without complex pre-administration regimens or hospitalisation."

There are approximately 50,000 new cases of multiple myeloma diagnosed each year in Europe, and nearly all patients will experience relapse from initial treatment.1,5 Blenrep is the only anti-BCMA (B-cell maturation antigen) antibody-drug conjugate (ADC) agent in multiple myeloma, providing patients at or after first relapse with a differentiated mechanism of action. Blenrep combinations can be administered to a range of patient types in any oncology treatment setting.

DREAMM-7 and DREAMM-8 showed that any eye-related side effects associated with Blenrep can be managed and reversed with appropriate dose modifications and follow-up, allowing patients to maintain benefit and resulting in low rates of discontinuation (≤9%) in both trials.2,3 The most commonly reported non-ocular adverse events (>30% of participants) in the Blenrep combination arm were thrombocytopenia (87%) and diarrhoea (32%) in DREAMM-7, and neutropenia (63%), thrombocytopenia (55%) and COVID-19 (37%) in the Blenrep combination arm of DREAMM-8.

Blenrep combinations are currently under review in all major markets globally, including in the US6 with a Prescription Drug User Fee Act (PDUFA) date of 23 July 2025, China7 (based on the results of DREAMM-7, with Breakthrough Therapy Designation for the combination and priority review for the application), Canada, and Switzerland (with priority review for DREAMM-8).

About multiple myeloma
Multiple myeloma is the third most common blood cancer globally and is generally considered treatable but not curable.8,9 There are approximately more than 180,000 new cases of multiple myeloma diagnosed globally each year.10 Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.1 Many patients with multiple myeloma are treated in a community cancer setting, leaving an urgent need for new, effective therapies with manageable side effects that can be administered outside of an academic centre.11,12

About Blenrep
Blenrep is an ADC comprising a humanised BCMA monoclonal antibody conjugated to the cytotoxic agent auristatin F via a non-cleavable linker. The drug linker technology is licensed from Seagen Inc.; the monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa Inc., a member of the Kyowa Kirin Group.

Indication
In the UK, Blenrep is indicated in adults for the treatment of multiple myeloma:
• in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and
• in combination with pomalidomide and dexamethasone in patients who have received at least one prior therapy including lenalidomide.

IMPORTANT SAFETY INFORMATION FOR BLENREP
More information can be found in the Blenrep Summary of Product Characteristics and Patient Information leaflets available on the MHRA Products website.13

About DREAMM-7
DREAMM-7 is a multicentre, open-label, randomised phase III clinical trial evaluating the efficacy and safety of belantamab mafodotin combined with bortezomib plus dexamethasone (BVd) compared to daratumumab combined with bortezomib plus dexamethasone (DVd) in patients with relapsed or refractory multiple myeloma who previously were treated with at least one prior line of multiple myeloma therapy, with documented disease progression during or after their most recent therapy. The trial enrolled 494 participants who were randomised 1:1 to receive either BVd or DVd. Belantamab mafodotin was administered at a dose of 2.5mg/kg intravenously every three weeks. The primary endpoint was PFS as per an independent review committee, with secondary endpoints including OS, duration of response (DOR), and minimal residual disease (MRD) negativity rate as assessed by next-generation sequencing. Other secondary endpoints include overall response rate (ORR), safety, and patient reported and quality of life outcomes.

In DREAMM-7, BVd nearly tripled median PFS versus DVd (36.6 months versus 13.4 months, respectively (hazard ratio [HR]: 0.41 [95% confidence interval (CI): 0.31-0.53], p-value<0.00001). DREAMM-7 also met the key secondary endpoint of OS, showing a statistically significant and clinically meaningful 42% reduction in the risk of death at a median follow-up of 39.4 months favouring BVd (n=243) versus DVd (n=251) (HR 0.58; 95% CI: 0.43-0.79; p=0.00023). The three-year OS rate was 74% in the BVd arm and 60% in the DVd arm.

PFS results were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Plenary Series in February 2024 and published in the New England Journal of Medicine. OS results were presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2024.2,4

About DREAMM-8
DREAMM-8 is a multicentre, open-label, randomised phase III clinical trial evaluating the efficacy and safety of belantamab mafodotin in combination with pomalidomide plus dexamethasone (BPd) compared to bortezomib and pomalidomide plus dexamethasone (PVd) in patients with relapsed or refractory multiple myeloma previously treated with at least one prior line of multiple myeloma therapy, including a lenalidomide-containing regimen, and who have documented disease progression during or after their most recent therapy. The trial included 302 participants who were randomised 1:1 to receive either BPd or PVd. Compared to the patient population studied in the DREAMM-7 trial, patients in DREAMM-8 were more heavily pre-treated in that all had prior exposure to lenalidomide, 78% were refractory to lenalidomide, 25% had prior daratumumab exposure and of those most were daratumumab refractory. Belantamab mafodotin was administered at a dose of 2.5mg/kg intravenously for the first cycle and 1.9mg/kg intravenously every four weeks. The primary endpoint was PFS as per an independent review committee, with key secondary endpoints including OS and MRD negativity rate as assessed by next-generation sequencing. Other secondary endpoints include ORR, DOR, safety, and patient reported and quality of life outcomes.

In DREAMM-8, a statistically significant and clinically meaningful improvement in PFS (HR: 0.52 [95% CI: 0.37-0.73], p-value<0.001) was observed with BPd (n=155) compared to PVd (n=147). At a median follow-up of 21.8 months, the median PFS was not yet reached (95% CI: 20.6-not yet reached [NR]) with BPd compared to 12.7 months (95% CI: 9.1-18.5) for PVd. At the end of one year, 71% (95% CI: 63-78) of patients in the BPd combination group compared to 51% (95% CI: 42-60) in the PVd combination group were alive and had not progressed. A benefit for BPd was observed across all pre-specified subgroups including those with poor prognostic features, such as patients who were refractory to lenalidomide and patients with high-risk cytogenetics. A positive OS trend was observed but not statistically significant (HR: 0.77 [95% CI: 0.53-1.14]) at the interim analysis. OS follow-up continues and further analyses are planned.

Results were first presented at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting and published in the New England Journal of Medicine.

Allogene Therapeutics Announces Participation in Upcoming Investor Conferences

On May 23, 2025 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, reported that it will participate in four upcoming investor conferences in May and June (Press release, Allogene, MAY 23, 2025, View Source [SID1234653354]).

TD Cowen’s 6th Annual Oncology Innovation Summit: Insights for ASCO (Free ASCO Whitepaper) & EHA (Free EHA Whitepaper)
Tuesday, May 27
9:30AM PT/12:30PM ET

Jefferies Global Healthcare Conference
Wednesday, June 4
1:55PM PT/4:55PM ET

Goldman Sachs 46th Annual Global Healthcare Conference
Tuesday, June 10
5:00AM PT/8:00AM ET

Oppenheimer Innovators in I&I Summit
Wednesday, June 25
9:45AM PT/12:45PM ET

Any available webcasts will be posted to the Company’s website at www.allogene.com under the Investors tab in the News and Events section. Following a live webcast, a replay will be available on the Company’s website for approximately 30 days.

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Instil Bio and ImmuneOnco to Host Investor and Analyst Breakfast to Discuss the Evolving PD-(L)1xVEGF Bispecific Antibody Landscape and Clinical Trial Updates During the 2025 ASCO Annual Meeting in Chicago

IMUNON Announces 2025 ASCO Annual Meeting Oral Presentation Highlighting Unprecedented Survival Data from Phase 2 Trial of IMNN-001 in Treatment of Newly Diagnosed Advanced Ovarian Cancer

HUTCHMED Highlights Clinical Data to be Presented at the 2025 ASCO Annual Meeting

Blenrep (belantamab mafodotin) combinations receive positive CHMP opinion in relapsed/refractory multiple myeloma

Allogene Therapeutics Announces Participation in Upcoming Investor Conferences