On June 15, 2026 Daiichi Sankyo reported Vanflyta (quizartinib) has been approved in China for use in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive as detected by an adequate validated test. Vanflyta is a FLT3 inhibitor being developed and commercialized by Daiichi Sankyo (TSE: 4568).

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Approximately 82,000 new cases of leukemia were diagnosed in China in 2022.1 AML is a common and aggressive subtype, accounting for approximately 50% of leukemia cases in China.2 Up to 37% of newly diagnosed patients with AML have a FLT3 gene mutation and approximately 80% of these are FLT3-ITD mutations, which drive cancer growth and contribute to increased risk of relapse and shorter overall survival.3,4 The five-year survival rate for patients with FLT3-ITD positive AML has been reported at approximately 20%.

The approval of Vanflyta by China’s National Medical Products Administration (NMPA) is based on results from the QuANTUM-First phase 3 trial published in The Lancet. In QuANTUM-First, Vanflyta combined with standard cytarabine and anthracycline induction and standard cytarabine consolidation, and continued as maintenance monotherapy following consolidation, demonstrated a 22% reduction in the risk of death compared to standard chemotherapy alone (HR = 0.78 [95% CI: 0.62-0.98; p=0.032]) in patients with newly diagnosed FLT3-ITD positive AML. Median overall survival (OS) was 31.9 months for patients receiving Vanflyta (n=268; 95% CI: 21.0-NE) compared to 15.1 months for patients in the control arm (n=271; 95% CI: 13.2-26.2) at a median follow-up of 39.2 months.

"Newly diagnosed FLT3-ITD positive AML has long been associated with poor outcomes, even with intensive chemotherapy," said Professor Wang Jianxiang, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences and leading primary investigator in China of the QuANTUM-First trial. "In the QuANTUM-First study, Vanflyta in combination with standard chemotherapy, followed by monotherapy maintenance treatment, significantly extended survival of patients. The approval of Vanflyta in China now brings a new treatment option for eligible patients with this aggressive and difficult-to-treat form of leukemia."

"The approval of Vanflyta as the first FLT3 inhibitor available for use in the newly diagnosed setting in China marks an important milestone for patients. FLT3-ITD positive AML is a subtype of AML associated with rapid disease progression and historically limited treatment options," said Michio Hayashi, China President, Daiichi Sankyo. "As the third oncology medicine from our pipeline approved in China, Vanflyta reflects our commitment to delivering innovation for patients."

The safety profile of Vanflyta was evaluated in 268 patients with newly diagnosed FLT3-ITD positive AML. The most common grade 3 or 4 adverse reactions (occurring in ≥10% of patients) were decreased platelet count (40%), decreased hemoglobin (35.5%), decreased neutrophil count (21.5%) and increased alanine aminotransferase (12.1%). QTcF > 500 ms occurred in 2.3% of patients receiving Vanflyta and 0.8% of patients discontinued Vanflyta due to QT prolongation. Ventricular arrhythmia events with Vanflyta were uncommon. Two (0.8%) patients receiving Vanflyta experienced cardiac arrest with recorded ventricular fibrillation on ECG (one with fatal outcome), both in the setting of severe hypokalemia.

About QuANTUM-First

QuANTUM-First is a randomized, double-blind, placebo-controlled, global phase 3 study evaluating Vanflyta in combination with standard induction and consolidation therapy, including hematopoietic stem cell transplant, and as maintenance monotherapy, in adult patients aged 18-75 with newly diagnosed FLT3-ITD positive AML. Patients were randomized 1:1 to receive Vanflyta or placebo combined with cytarabine and anthracycline induction and cytarabine consolidation chemotherapy followed by up to three years of treatment with single-agent maintenance. There was no re-randomization at the start of post-consolidation therapy

The primary study endpoint was OS. Secondary endpoints included event-free survival, post-induction rates of complete remission (CR) and composite complete remission (CRc) and the percentage of patients who achieve CR or CRc with FLT3-ITD measurable residual disease negativity. Safety and pharmacokinetics, along with exploratory efficacy and biomarker endpoints including duration of CR, also were evaluated.

QuANTUM-First enrolled 539 patients in Asia, Europe, North America, Oceania and South America. For more
information, visit ClinicalTrials.gov

About FLT3-ITD Positive Acute Myeloid Leukemia

More than 487,000 new cases of leukemia were reported globally in 2022, with more than 305,000 deaths.6 AML
accounts for 23.1% of total leukemia cases worldwide and is most common in adults.7,8 In China, nearly 82,000
people were diagnosed with leukemia in 2022 and more than 50,000 people died from the disease, making it the
tenth deadliest cancer.1 AML is a common and aggressive subtype, accounting for approximately 50% of leukemia
cases in China

A number of gene mutations have been identified in AML and FLT3 (FMS-like tyrosine kinase 3) mutations are the
most common.4 Approximately 80% of FLT3 mutations are FLT3-ITD mutations, which drive cancer growth and
contribute to particularly unfavorable prognosis, including increased risk of relapse and shorter overall survival.3,4
FLT3-ITD mutations occur in about 25% of all AML cases, with frequency reported as high as 30%.

About Vanflyta

Vanflyta (quizartinib) is an oral, highly potent type II FLT3 inhibitor that targets FLT3-ITD mutations.

Vanflyta is approved in more than 35 countries/regions in combination with standard cytarabine and anthracycline
induction and cytarabine consolidation, and as maintenance monotherapy following consolidation therapy, for the
treatment of adult patients with newly diagnosed FLT3-ITD positive AML based on the results from the QuANTUMFirst trial.

Vanflyta also is approved in Japan as a monotherapy for the treatment of patients with relapsed/refractory AML
that is FLT3-ITD mutation positive, as detected by an approved test, based on results from the QuANTUM-R trial.

About the Vanflyta Clinical Development Program

The Vanflyta clinical development program includes the QuANTUM-Wild phase 3 trial in adult patients with newly
diagnosed FLT3-ITD negative AML, a phase 1/2 trial in pediatric and young adult patients with relapsed/refractory
FLT3-ITD positive AML in Asia, Europe and North America and several phase 1/2 combination studies as part of a
strategic collaboration with The University of Texas MD Anderson Cancer Center.

(Press release, Daiichi Sankyo, JUN 15, 2026, View Source [SID1234668731])

On June 15, 2026 enGene Therapeutics Inc. (Nasdaq: ENGN, "enGene" or the "Company"), a clinical-stage, non-viral genetic medicines company reported its financial results for the second quarter ended April 30, 2026, and provided clinical and corporate updates.

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"Feedback from the urology community on the emerging detalimogene without surfactant profile, presented at the AUA meeting in May, supports our plan to await mature durability data in the second half of 2026 and meet with the FDA about initiating a BLA submission for detalimogene before year end," said Ron Cooper, President and Chief Executive Officer, enGene.

Mr. Cooper continued, "We are also encouraged by the interest in the detalimogene surfactant bladder rinse study from the medical community. With patients already enrolled, we are optimistic about the potential to further enhance efficacy while maintaining the ease of use and tolerability profile that has resonated with urologists."

"To preserve shareholder capital as we await additional durability data and meetings with the FDA, we made the very difficult decision to downsize the organization to streamline operations. We are sincerely grateful to the enGeneers who have created a high-performance culture and helped advance detalimogene and our mission to provide people living with NMIBC a new treatment option," added Mr. Cooper.

Recent Clinical Updates

LEGEND Pivotal Cohort 1: During a plenary presentation at the recent American Urological Association (AUA) meeting, interim data were shared from LEGEND’s pivotal Cohort 1 studying detalimogene without surfactant in high-risk (HR), Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in-situ (CIS).

Efficacy overview:

54% (95% CI: 45%, 63%) complete response (CR) at any time (67/124)
Low rate of progression to muscle invasive or more advanced disease (3.2%)
Safety overview:

Low percentage of patients experienced treatment-related adverse events (TRAEs) leading to treatment interruption (2.4%) and treatment discontinuation (2.4%)
Twenty-one patients were pending disease assessments at either six-, nine-, or 12-months as of the data cutoff date of April 21, 2026. enGene is awaiting 12-month CR data from Cohort 1, as well as the majority of 12-month durability data, and expects to engage with the FDA in 2H 2026 to discuss a BLA filing.

Detalimogene plus Surfactant Cohort: In tandem with its pivotal update in May, the Company announced the initiation of an additional LEGEND cohort, which incorporates a short surfactant bladder rinse using diluted polidocanol solution. Polidocanol is an FDA-approved product used for the treatment of spider and reticular veins. Surfactants have been shown to boost efficacy with other gene therapies in preclinical models and were subsequently incorporated into clinical development of those gene therapies. In murine models tested by the Company, pretreatment with polidocanol demonstrated a 10-fold increase in mean IL-12 expression and was able to boost efficacy of a subtherapeutic dose of detalimogene. Findings were validated in a large mammal model tested by the Company where a surfactant rinse increased the distribution of detalimogene nanoparticles throughout the bladder by approximately 50% and IL-12 expression by nine-fold. The first patients have been enrolled in the surfactant cohort, and the Company may enroll up to 80 patients in this global cohort. The Company believes this approach has the potential to further enhance efficacy and durability while preserving the simplicity, tolerability, and office-based administration profile that may make detalimogene a preferred option for community urology practices, where approximately 80% of NMIBC patients receive treatment.

LEGEND Cohorts 2a, 2b and 3: As part of cash conservation efforts, the Company has stopped enrollment in these additional cohorts and plans to reevaluate its strategy for them following discussion with the FDA in 2H 2026.

Recent Corporate Updates

Reduction in Force and Executive Departures: In June 2026, enGene implemented a plan to reduce its workforce by approximately 50% to streamline operations and preserve cash. The Company has retained personnel and resources required to meet its key strategic goals and milestones, including completion of LEGEND Cohort 1; enrolling the detalimogene plus surfactant cohort; meeting with the FDA and planning for BLA initiation in 2H 2026; and completing necessary pre-commercial activities required to support the planned commercial launch of detalimogene in 2027.

In conjunction with its reduction in force, the following executive officers will depart from the Company, effective July 15, 2026: Ryan Daws, Chief Financial Officer, Lee Giguere, Chief Legal Officer and Alex Nichols, Chief Strategy and Operations Officer.

Anthony Cheung, Chief Scientific Officer, will continue in his role through September 30, 2026, after which, he will transition into a consulting arrangement.

Hussein Sweiti, M.D., Chief Medical Officer, stepped down from his position to pursue a new professional opportunity, effective June 14, 2026. Effective immediately, William Grossman, M.D., Ph.D., a member of enGene’s Board of Directors, will act as interim Chief Medical Officer. He is the former Senior Vice President and Therapeutic Area Head of Oncology Clinical Development at Gilead Sciences Inc. where he oversaw the oncology portfolio (early and late-stage clinical development) and collaboration programs. Prior to that, he held several Chief Medical Officer roles including at Arcus Biosciences and Bellicum Pharmaceuticals. He has held additional leadership roles at Genentech/Roche, Merck, AbbVie, and Biothera. Dr. Grossman received his M.D. and Ph.D. in Immunology from Washington University School of Medicine’s Medical Scientist Training Program and completed his medical and post-doctoral training in both the Divisions of Pediatrics and Medicine at Washington University School of Medicine. He also currently serves on several advisory boards and will continue to serve on enGene’s Board of Directors as a non-independent Director during his interim CMO role.

Constantine Chinoporos, who joined the Company in May as a business development consultant, is expected to act as enGene’s interim Chief Business Officer. Mr. Chinoporos brings deep experience across business development, licensing, and M&A in the biopharma sector. He is a member of the Board of Directors at Geron Corporation, and most recently served as Chief Operating Officer and Chief Business Officer of Applied Therapeutics. Prior to his role at Applied Therapeutics, Mr. Chinoporos served as Chief Business Officer at Albireo Pharmaceuticals, Inc. from 2021 until its acquisition by Ipsen S.A. in 2023. From 2015 to 2021, he served as Chief Business Officer at Boston Pharmaceuticals, Inc. Previously, he held senior positions in worldwide licensing, business development, corporate development, corporate finance and alliance management at Sanofi S.A., Genzyme Corporation, and Eli Lilly and Company. Mr. Chinoporos holds an M.B.A. from the Johnson Graduate School of Management at Cornell University and a B.A. in History from Cornell University.

Anticipated Milestones

12-month complete response data for all of Cohort 1 and pre-BLA meeting in 2H 2026
Initiation of BLA filing for detalimogene in 2H 2026
Potential detalimogene FDA approval decision and platform designation in 2027
Second Quarter 2026 Financial Results

As of April 30, 2026, cash, cash equivalents and marketable securities were $285.2 million providing significant operational flexibility.

Total operating expenses were $32.0 million for the three months ended April 30, 2026, compared to $27.1 million for the three months ended April 30, 2025. Research and development expenses increased by $2.0 million, primarily driven by increased personnel and clinical costs related to our LEGEND trial, completion of PPQ batch manufacturing and preparation to initiate the submission of a planned Biologics License Application with the FDA in the second half of 2026. General and administrative expenses increased by $2.9 million, primarily driven by annualization of personnel-related costs and increased facility costs.

For the three months ended April 30, 2026, net loss attributable to common shareholders was approximately $30.2 million, or $0.43 per share, compared to approximately $25.8 million, or $0.51 per share, for the three months ended April 30, 2025. The increase in net loss is mainly attributed to the increase in operating expenses, partially offset by net interest income earned during the period.

About Non-Muscle Invasive Bladder Cancer (NMIBC)

Non-muscle invasive bladder cancer (NMIBC) is a disease that poses a significant burden on both patients and clinics and has a massive economic impact on the healthcare system. NMIBC occurs when cancer cells grow in the tissues that line the interior of the bladder, but the cancer has not yet penetrated the muscle of the bladder wall. NMIBC can present as papillary outgrowths from the bladder wall, which are typically resected, or as carcinoma in situ (CIS), which consists of flat, multifocal lesions that cannot be resected. The two forms can also co-occur. About 75%-80% of new bladder cancer diagnoses are NMIBC. Patients suffering from high-risk NMIBC who are unresponsive to the standard of care, Bacillus Calmette-Guérin (BCG), face high rates of disease recurrence (50%-70%) and are potentially subject to full removal of the bladder (cystectomy) as a curative but life-altering next step.

About Detalimogene Voraplasmid

Detalimogene is a novel, investigational, non-viral gene therapy for patients with high-risk, non-muscle invasive bladder cancer (NMIBC), including Bacillus Calmette-Guérin (BCG)-unresponsive disease. It is designed to be instilled in the bladder and elicit a powerful yet localized anti-tumor immune response.

Detalimogene was developed using the Company’s Dually Derivatized Oligochitosan (DDX) platform, a technology designed to transform how gene therapies are accessed by patients and utilized by clinicians. Medicines developed with the DDX platform can potentially overcome the limitations of viral-based gene therapies, reduce complexities related to safe handling and cold storage, and streamline both manufacturing processes and administration paradigms.

Regenerative Medicine Advanced Therapy (RMAT) and Fast Track Designations

Detalimogene has received Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the U.S. Food and Drug Administration (FDA) based on its potential to address the high unmet medical need for patients with BCG-unresponsive carcinoma in situ (CIS) NMIBC with or without resected papillary tumors who are unable to undergo cystectomy. These designations are intended to expedite the development and review of drugs intended to treat serious or life-threatening conditions and fill an unmet medical need. Detalimogene has also been selected for the FDA’s Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) program, designed to facilitate CMC development for therapies with compressed clinical development timeframes based on the anticipated clinical benefits of earlier patient access to the therapy.

About the LEGEND Trial

Detalimogene is being evaluated in the ongoing, open-label, multi-cohort, Phase 2 LEGEND trial to establish its safety and efficacy in high-risk NMIBC. LEGEND’s pivotal cohort (Cohort 1) consists of 125 patients with high-risk, BCG-unresponsive NMIBC with CIS (with or without papillary disease) and is designed to serve as the basis of the Company’s planned Biologics License Application (BLA) filing. In addition to this pivotal cohort, LEGEND includes four additional cohorts, including NMIBC patients with CIS who are naïve to treatment with BCG (Cohort 2a); NMIBC patients with CIS who have been exposed to BCG but have not received adequate BCG treatment (Cohort 2b); BCG-unresponsive high-risk NMIBC patients with papillary-only disease (Cohort 3); and BCG-unresponsive high-risk NMIBC patients with CIS who receive polidocanol plus detalimogene.

(Press release, enGene Therapeutics, JUN 15, 2026, View Source [SID1234668747])

On June 15, 2026 Elicio Therapeutics, Inc. (Nasdaq: ELTX, "Elicio" or the "Company"), a clinical-stage biotechnology company developing next-generation immunotherapies for mKRAS-driven cancers, reported results from its randomized Phase 2 AMPLIFY-7P study evaluating ELI-002 7P in patients with adjuvant mKRAS-driven pancreatic ductal adenocarcinoma ("PDAC") following completion of standard locoregional therapy.

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The AMPLIFY-7P study did not meet its pre-specified primary DFS endpoint in the intent-to-treat population. However, landmark analyses during active ELI-002 7P treatment indicated early treatment benefit. Post-hoc landmark analyses showed a consistent ~14% absolute DFS benefit during active treatment at both 3 and 6 months, suggesting early clinical activity, with treatment-arm separation persisting through 9 months.

While nodal status, the prespecified stratification factor, was balanced between treatment arms, a higher proportion of patients with the adverse prognostic factor, R1 resection status, were included in the ELI-002 7P arm (19% vs. 10%). Post-hoc analyses showed significant DFS improvement (R0: HR 0.65, p=0.048, n=121) in lower residual disease patients. Importantly, this subgroup represented approximately 84% of enrolled patients. Currently, there are no approved therapies following locoregional treatment.

The study informed a refined Phase 3 development strategy focused on a defined, lower residual disease, R0 resected population with additional dosing. The study also demonstrated a strong association between mKRAS-specific immune responses and clinical outcomes (HR 0.22, p<0.0001, n=90), supporting the biological activity of ELI-002 7P.

"While AMPLIFY-7P did not meet its primary endpoint in the intent-to-treat study population, promising efficacy signals in patients with lower residual disease burden sharpen our path forward," said Robert Connelly, President and Chief Executive Officer of Elicio. "We identified the patients who benefit most, validated the biology, and demonstrated a favorable safety profile that supports extended dosing in Phase 3. In a disease where no approved options exist after surgery, we believe AMPLIFY-7P demonstrates that ELI-002 7P, an mKRAS-targeted immunotherapy, can generate robust immune responses associated with improved clinical outcomes."

Christopher Haqq, M.D., Ph.D., Executive Vice President, Head of Research and Development and Chief Medical Officer of Elicio, added, "The AMPLIFY-7P trial generated important clinical and biological insights that have sharpened our development strategy and strengthened our conviction in ELI-002 7P. The stronger treatment effect observed in completely resected R0 patients, combined with the robust relationship between KRAS-specific T-cell responses and clinical outcomes, supports a clear Phase 3 path focused on patients most likely to benefit from treatment. We look forward to discussing these findings with regulators and believe the results provide important support for the broader application of AMP-enabled immunotherapies across multiple oncogenic drivers."

Eileen M. O’Reilly, MD, FASCO, Winthrop Rockefeller Endowed Chair in Medical Oncology Memorial Sloan Kettering Cancer Center, said, "Future progress in pancreatic cancer will increasingly depend on precision medicine approaches that identify patients most likely to benefit from targeted and immune-based therapies. These findings show the promise of immunological targeting of mKRAS in patients previously considered to be refractory to immunotherapy."

The AMPLIFY-7P study enrolled 144 patients across 24 U.S. sites and evaluated ELI-002 7P versus observation in patients with resected Stage I-III mKRAS-driven PDAC who had completed surgery and standard locoregional therapy and were radiographically free of disease at enrollment.

Key Findings from AMPLIFY-7P

Post-hoc landmark analyses demonstrated a ~14% absolute improvement in DFS rates during active treatment at both 3 months (90.3% vs. 76.6%, p=0.022) and 6 months (75.7% vs. 61.7%, p=0.056).
Randomization was stratified by nodal status; however, there was an imbalance in baseline R1 resection status, a known adverse prognostic factor, which disproportionately favored the observation arm (ELI-002 7P 19% vs. observation 10%).
Multivariable analyses identified R1 resection as an adverse prognostic factor for recurrence (HR 1.56, p=0.181).
Post-hoc analyses demonstrated stronger treatment effect in the R0 resected patient population (HR 0.65, p=0.048, n=121).
mKRAS-specific T cell responses strongly correlated with improved DFS, with patients demonstrating the strongest immune responses experiencing the most favorable outcomes (T cell fold change from baseline, >9.17x vs <9.17x: HR 0.22, p<0.0001, n=90 evaluable).
ELI-002 7P demonstrated a favorable safety profile with no treatment-related discontinuations or treatment-related deaths. ELI-002 7P treatment was associated with proportionally fewer adverse events than SOC observation.
Phase 3 Development Strategy

Insights from AMPLIFY-7P have enabled Elicio to refine its Phase 3 development strategy, focusing on patients with the greatest potential to benefit from treatment and extending treatment duration to enhance the durability of anti-tumor immunity. Subject to financing, the Company plans to initiate a Phase 3 study with the following key elements:

Enrollment of R0 resected patients following completion of standard locoregional therapy
Additional dosing beyond the initial ELI-002 7P immunization and booster regimen
A registrational study with a primary endpoint of DFS
Cash Runway

As previously guided, the Company expects its current cash and cash equivalents to support planned operations into the fourth quarter of 2026. Elicio is currently evaluating multiple strategic financing and partnership opportunities to advance its planned Phase 3 adjuvant PDAC program and broader AMP platform.

Conference Call and Webcast Details
Elicio will host a conference call and webcast beginning at 8:30 AM ET today, June 15, 2026. The live webcast may be accessed HERE. The conference call can be accessed by dialing toll-free 1-877-407-9208 or 1-201-493-6784 (international). The conference call ID is 13761190.

A replay of the webcast will be available on the "EVENTS" tab in the Investors section of the Company’s website.

About ELI-002

Elicio’s lead product candidate, ELI-002, is a structurally novel investigational AMP cancer immunotherapy that targets cancers that are driven by mutations in the KRAS-gene—a prevalent driver of many human cancers. ELI-002 is comprised of two powerful components that are built with Elicio’s proprietary AMP technology consisting of AMP-modified mutant KRAS peptide antigens and ELI-004, an AMP-modified CpG oligodeoxynucleotide adjuvant that is available as an off-the-shelf subcutaneous administration.

ELI-002 7P (7-peptide formulation) was evaluated in the randomized Phase 2 AMPLIFY-7P trial in patients with mKRAS-driven pancreatic cancer (NCT05726864). The Phase 2 AMPLIFY-7P trial included patients with mKRAS-positive pancreatic cancer who completed standard therapy but remain at high risk of relapse. Based on topline results and post-hoc analyses, Elicio has refined its Phase 3 development strategy to focus on patients with lower residual disease burden and extended treatment duration. At the time of the Phase 2 AMPLIFY-7P analysis, data for overall survival remained immature. The ELI-002 7P formulation is designed to provide immune response coverage against seven of the most common KRAS mutations present in 25% of all solid tumors, thereby increasing the potential patient population for ELI-002.

About the AMP Platform

Elicio’s proprietary AMP platform delivers investigational immunotherapy directly to the "brain center" of the immune system – the lymph nodes. Elicio believes this site-specific delivery of disease-specific antigens, adjuvants and other immunomodulators may efficiently educate, activate and amplify critical immune cells, potentially resulting in induction and persistence of potent adaptive immunity required to treat many diseases. In pre-clinical models, Elicio observed lymph node-specific engagement driving therapeutic immune responses of increased magnitude, function and durability. Elicio believes its AMP lymph node-targeted approach will produce superior clinical benefits compared to immunotherapies that do not engage the lymph nodes based on preclinical studies.

Elicio’s AMP platform, originally developed at the Massachusetts Institute of Technology, has broad potential in the cancer space to advance a number of development initiatives through internal activities, in-licensing arrangements or development collaborations and partnerships.

The AMP platform has been shown to deliver immunotherapy directly to the lymph nodes by latching on to the protein albumin, found in the local injection site, as it travels to lymphatic tissue.

(Press release, Elicio Therapeutics, JUN 15, 2026, View Source [SID1234668748])

On June 15, 2026 InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, reported that over 40 clinical studies of the Company’s novel BTK inhibitor orelabrutinib were presented at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress. Clinical data on the efficacy and safety of orelabrutinib in treatment-naïve (TN) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients from the United States and Europe was released for the first time.

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A series of clinical studies on orelabrutinib covered multiple hematological malignancies, including CLL/SLL, marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), and primary central nervous system lymphoma (PCNSL). These findings further support the excellent efficacy and safety of orelabrutinib.

Poster Presentation:

1. Orelabrutinib for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: Safety and Efficacy Results from a Global Phase 1/2 Study. (No. PF610)

This study is to evaluate the safety and efficacy of orelabrutinib in patients with CLL/SLL from the United States and Europe. The researchers include multiple world-renowned oncology centers such as Mayo Clinic. Results are consistent with the prior report in Chinese patients, confirming the efficacy and safety of orelabrutinib for CLL/SLL in a global population.

In evaluable TN CLL/SLL patients (median follow-up 38.1 months), ORR was 100%, with 36-month PFS rate at 94.4% and 36-month OS rate at 100% respectively.

In evaluable R/R CLL/SLL patients (median follow-up 36.8 months), ORR was 86.7%, with 36-month PFS rate 77.9% and the 36-month OS rate 80.1% respectively.

Orelabrutinib demonstrates high kinase selectivity, alleviates off-target inhibition, and reduces cardiovascular, bleeding, and hematologic adverse events.

2. Long-term Follow-up of Orelabrutinib in Patients with Relapsed or Refractory Marginal Zone Lymphoma (No. PF949)

With long-term follow-up, orelabrutinib demonstrated rapid and durable responses, indicating sustained therapeutic benefit in patients with r/r MZL. Importantly, no new safety signals were observed during extended follow-up.

At a median follow-up of 36.8 months, the investigator-assessed ORR was 58.9%, median PFS was 44.4 months, and the 36-month OS rate was 84.7%.

3. Risk-Adapted Management with Obinutuzumab and Orelabrutinib with or without Lenalidomide in Untreated Marginal Zone Lymphoma: First Report of a Prospective, Phase II, Multi-Centre (MAGIC) Study (No. PS2037)

This is a prospective, phase II, multicenter study. The preliminary results demonstrated encouraging efficacy and a manageable safety profile in patients with previously untreated MZL.

Patients with an MZL-IPI score of 0–2 received obinutuzumab plus orelabrutinib (O2 regimen). Those with a score of 3–5 received obinutuzumab, orelabrutinib and lenalidomide (RO2 regimen). In patients who completed six cycles of induction therapy, the CRR was 85.7% and ORR was 95.3% in the O2 group, and the CRR was 71.4% and ORR was 85.7% in the RO2 group.

The study is ongoing, and updated efficacy and safety data will be reported in due course.

4. Polatuzumab Vedotin Combined with Orelabrutinib and Rituximab (PRO Regimen) as Frontline Therapy in Very Elderly and Frail Patients with DLBCL: Updated Results from a Phase II Study (No. PS2072)

Results support the PRO regimen, which includes orelabrutinib, as a feasible strategy for vulnerable patients.

Patients had a median age of 78 years. At the completion of combination therapy, the CR rate was 91.7%. With a median follow-up of 7.0 months, neither the median PFS nor the median OS has been reached. The estimated 9-month PFS rate was 92.8%.

Most other hematologic and non-hematologic toxicities were confined to Grade 1-2 and were clinically manageable with supportive care.

5. The Real-World Efficacy of Bruton’s Tyrosine Kinase Inhibitors Plus High-Dose Methotrexate-Based Induction Treatment for Untreated Primary CNS Lymphoma: A Single-Center Retrospective Analysis (No. PF1035)

This analysis aims to evaluate the efficacy of BTKi like orelabrutinib plus HD-MTX-based chemotherapy regimens as induction treatment for newly diagnosed PCNSL patients in a real-world cohort. The results show that the ORR after induction treatment was 88.6% and the CR rate was 81.1%. There was no significant difference in PFS among the three BTKi, but a significant improvement in OS was observed in the orelabrutinib group (HR 0.26, P = 0.016). These results support the use of BTKi-containing treatment regimens as a first-line therapy for PCNSL in clinical practice.

More studies on orelabrutinib have been accepted for poster presentations at the 2026 EHA (Free EHA Whitepaper) Congress. Details are listed below:

Orelabrutinib Combined with Bendamustine-Rituximab or Obinutuzumab Followed by Orelabrutinib Maintenance in Untreated Marginal Zone Lymphoma (OPTIMIZE): A Multicenter, Single-Arm, Phase II Study (No. PF959)
Efficacy, Safety, and Genetic Analysis of Orelabrutinib Combined with Rituximab as First-Line Systemic Treatment for Marginal Zone Lymphoma (No. PF951)
Preliminary Analysis of Orelabrutinib Combined with Obinutuzumab for Marginal Zone Lymphoma (ORION Study) (No. PS2050)
Preliminary Results of Orelabrutinib Followed by Response-Adapted Ultra-Low-Dose 4Gy Radiotherapy as First-Line Treatment for Localized MALT Lymphoma: A Prospective, Open-Label, Phase II Study (No. PS2053)
Integrative Transcriptomic Profiling Reveals the Molecular Landscape and Regulatory Drivers of Blastoid Mantle Cell Lymphoma (No. PS1099)
Bruton Tyrosine Kinase Inhibitor Maintenance Therapy in First-Line Diffuse Large B-Cell Lymphoma: A Multicenter Real-World Study Challenging Conventional Paradigms (No. PS2127)
Orelabrutinib Plus R-CHOP for the Treatment of Newly Diagnosed Non-GCB Double-Expressor Diffuse Large B-Cell Lymphoma: A Multicenter, Single-Arm, Phase II Study (No. PS2075)
Large-Scale Real-World Clinical Characteristics and Efficacy of Diffuse Large B-Cell Lymphoma Across Distinct Molecular Subtypes: Interim Data from the BELIEVE Study (No. PF991)
Clinical Characteristics and Efficacy of MYC/BCL-2 Double-Expressing Diffuse Large B-Cell Lymphoma: Real-World Data from the BELIEVE Study (No. PS2103)
Orelabrutinib, Rituximab, and Thiotepa (ORT) With or Without High-Dose Methotrexate for Untreated Primary Central Nervous System Lymphoma (No. PS2088)
Efficacy and Safety of Orelabrutinib Combined with Sintilimab in Patients with Relapsed/Refractory Primary Central Nervous System Lymphoma (R/R PCNSL): A Prospective Multicenter Phase II Study (No. PS2130)
Orelabrutinib in Patients with Relapsed or Refractory Primary or Secondary Central Nervous System Lymphoma: A Multicenter, Open-Label, Phase II Study (No. PS2090)
Additionally, more than 20 studies on orelabrutinib were selected for online presentation.

The 2026 EHA (Free EHA Whitepaper) Congress is one of the most influential academic conferences in hematology and was held in Stockholm, Sweden.

(Press release, InnoCare Pharma, JUN 15, 2026, View Source [SID1234668749])

On June 15, 2026 Enterome SA, a clinical-stage company pioneering OncoMimics, a new class of off-the-shelf, multi-targeted immune therapies to expand specific CD8 T-cells in vivo, reported new interim data from the ongoing Phase 1/2 SIDNEY study of OncoMimics EO2463 in patients with indolent non-Hodgkin lymphoma (iNHL). The data are being presented at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress in Stockholm (Abstract PF938, Poster Session 1).

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SIDNEY is a multi-cohort study evaluating EO2463 as monotherapy in patients who are previously untreated and having low-tumor-burden disease suitable for watchful waiting (Cohort 2; N=25), in combination with rituximab in patients previously untreated with low-tumor burden disease requiring treatment (Cohort 3; N=6), and in combination with lenalidomide plus rituximab (R2) in patients with relapsed/refractory (Cohorts 1+4; N=23). EO2463 continued to be well tolerated across all settings.

Positive immune responses were confirmed in 43 of 48 tested patients (90%). EO2463 rapidly induced expansion of EO2463-mimic and B cell target peptide-specific CD8 T cells, predominantly displaying an effector memory phenotype cross-reactive with cancerous B-cell lineage markers. Responses were durable, with specific CD8 T cells detectable up to 34 months after the last EO2463 administration.

EO2463 demonstrated clinical activity across treatment settings. As monotherapy in patients who are usually recommended watchful waiting, EO2463 produced a 41% objective response rate (ORR) (Lugano criteria). Patients receiving EO2463 plus R2 combination achieved a 74% ORR, and 61% complete response rate, with a median duration of objective response of 35.2 months.

Importantly, EO2463-induced CD8 T cell expansions were significantly associated with objective response on EO2463 monotherapy and complete responses on EO2463 in combination with R2, suggesting that the EO2463 treatment and mechanism of action is linked to the clinical outcome in both settings. The data show that, on EO2463 monotherapy, higher early expansion was statistically significantly associated with objective response. These data also support development of a predictive biomarker based on the EO2463-induced immune responses.

"The EHA (Free EHA Whitepaper) data demonstrate that EO2463 consistently induces rapid and durable expansions of CD8 T cells against the B-cell lineage markers targeted by EO2463 while having a favorable tolerability profile. The significant association between expansion of specific CD8 T cells and objective responses both for EO2463 monotherapy and EO2463 in combination with standard of care supports continued development of EO2463 as a novel immunotherapy for B cell lymphomas," said Jan Fagerberg, MD, Chief Medical Officer of Enterome.

"These data confirm EO2463’s unique profile as an off-the-shelf immunotherapy that generates rapid, durable and clinically meaningful immune responses across treatment settings. Patients in the watch-and-wait setting currently receive no active treatment despite the psychological burden of their diagnosis. We believe EO2463 could change that paradigm and are actively seeking partners and investors to advance its registrational development," said Pierre Belichard, Chief Executive Officer of Enterome.

Updated data from the ongoing SIDNEY trial will also be presented at the Pan Pacific Lymphoma Conference (PPLC) in Hawaii (July 20–24, 2026). Enterome will attend the BIO International Convention 2026 in San Diego (June 22–25).

EHA 2026 Presentation Details

Title: EO2463 an off-the-shelf multi-target peptide immunotherapy: in vivo CD8 T cell expansion kinetics correlates with efficacy in patients with follicular (FL) and marginal zone (MZL) lymphoma. Study EONHL1-20/SIDNEY (NCT04669171)
Abstract: PF938 | Poster Session 1, Friday June 12, 2026
European Hematology Association Congress 2026, Stockholm, Sweden
Poster viewing: 08:00–18:45 CEST | Presenter-attended session: 18:45–19:45 CEST

SIDNEY (NCT04669171) is an ongoing open-label Phase 1/2 study evaluating the safety, tolerability, immunogenicity and preliminary efficacy of EO2463 as monotherapy and in combination regimens patients with follicular lymphoma and marginal zone lymphoma. The trial includes a dedicated watch-and-wait monotherapy cohort, a first-line low-tumor-burden combination cohort with rituximab, and relapsed/refractory cohorts treated with EO2463+R2. Interim data continue to support further evaluation of EO2463 both as a standalone treatment and in combination with established anti-lymphoma therapies.

EO2463 is an off-the-shelf OncoMimics active immunotherapy composed of four synthetic microbial-derived peptides designed to mimic the B-cell lineage markers CD20, CD22, CD37 and CD268 (BAFF receptor), plus the helper peptide UCP2. This multi-target approach is intended to expand in vivo pre-existing memory CD8 T cells, selectively targeting malignant B cells, broaden target coverage and obviate antigen escape. In May 2026, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to EO2463 for treatment of patients with follicular lymphoma.

OncoMimics consist of bacteria-derived peptide antigens that closely mimic tumor-associated antigens (TAAs) of solid tumors, or lineage markers (e.g. as observed in B cell lymphomas). These peptides induce a fast and potent in vivo expansion of effector-memory CD8 T-cells, naturally primed by gut bacteria, and cross-reactive with TAAs/B cell markers, thereby eliciting cytotoxic responses against tumor cells. Because they are recognized as foreign entities by the immune system, OncoMimics help overcome the self-tolerance that limits the ability of many cancer immunotherapies to trigger rapid, potent, and durable endogenous immune responses. The synthetically produced OncoMimics peptides are selected and designed in silico by mining Enterome’s proprietary database of 23 million commensal bacteria genes. Each product combines multiple highly immunogenic peptides specifically designed to broaden target coverage, mitigate tumor heterogeneity and obviate the cancer’s ability to escape the therapeutic intervention.

(Press release, Enterome, JUN 15, 2026, View Source [SID1234668734])