On June 11, 2026 Cellectis (the "Company") (Euronext Growth: ALCLS – NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene editing platform to develop life-saving cell and gene therapies, reported final Phase 1 data from the BALLI-01 clinical trial evaluating lasme-cel, a CD22 directed allogeneic CAR-T therapy, in patients with relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL), and preliminary data from the NATHALI-01 study evaluating eti-cel, a dual CD20 and CD22 directed CAR-T in relapsed/refractory B-cell non Hodgkin lymphoma (r/r B-NHL), at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Annual Congress.

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BALLI-01 clinical trial evaluating lasme-cel in r/r B-ALL – Oral Presentation

The BALLI-01 final Phase 1 data will be presented as an oral presentation by Nitin Jain, M.D., Professor of Medicine, Department of Leukemia at the University of Texas MD Anderson Cancer Center in Houston, TX.

45 patients in third line and beyond (3L+) were treated in the BALLI-01 study. 15 patients were treated at the recommended Phase 2 dose and 7 in the target Phase 2 population. Patients were heavily pretreated with those in the target Phase 2 population receiving a median of 5 prior lines of therapy (Range 2-11). Almost all patients were previously treated with blinatumumab (82%) and were also heavily exposed to CD19 CAR-T (53%), CD22-directed antibody-drug conjugate (ADC) (56%) and many had a prior hematopoietic stem cell transplantation (HSCT) (47%).

Final Phase 1 data

In the target Phase 2 population

An overall response rate (ORR) of 100% (7/7) was achieved with a complete remission/complete remission with incomplete count recovery (CR/CRi) rate of 57% (4/7). Of these, 75% achieved minimal residual disease negative (MRD-ve) status.

All patients subsequently proceeded to HSCT.

Lasme-cel demonstrated a manageable safety profile

Cytokine release syndrome (CRS) ≥ grade 3 occurred in 4% of patients.
Immune effector cell-associated neurotoxicity syndrome (ICANS) ≥ grade 3 occurred in 4% of patients.
Immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS) ≥ grade 3 occurred in 2% of patients.
All CRS, ICANS, and IEC-HS resolved.

"These final Phase 1 results are particularly meaningful for a patient population that has very limited treatment options" said Nitin Jain, M.D., Professor of Medicine, Department of Leukemia at UT MD Anderson. "Being able to achieve deep remissions in these patients and allowing them to subsequently receive an HSCT is promising. We look forward to accelerating accrual into the ongoing Pivotal Phase 2 study and bringing this treatment to patients."

The Pivotal Phase 2 BALLI-01 trial is open for recruitment. Eligible patients and treating physicians are encouraged to visit BALLI-01 (NCT04150497) or contact Cellectis at [email protected] for information and participating sites. The first interim analysis is expected in Q4 2026.

Oral Presentation: Safety and efficacy of UCART22 in heavily pretreated patients with relapsed or refractory CD22+ B-cell acute lymphoblastic leukemia (B-ALL): results of the Phase 1 BALLI-01 trial

Date/Time: Saturday, June 13 at 5:15 – 6:30pm, local time
Session Title: Advances in the treatment of lymphoblastic leukemia
Session Room: K1
Abstract Number: 4689

Note: presentation slides will be uploaded to Cellectis’ website concurrently with the live presentation.

NATHALI-01 clinical trial evaluating eti-cel in r/r B-NHL – Poster Presentation

The NATHALI-01 preliminary data on the role of alemtuzumab in optimizing responses will be presented as a poster by Professor Emmanuel Bachy, M.D., Ph.D., Department of Hematology, Hospices Civils de Lyon, France.

Eti-cel is a highly differentiated product being the first allogeneic dual CAR-T targeting both CD20 and CD22, for patients with r/r B-NHL.

As of the February 2026 data cutoff, 14 patients with r/r B-NHL had been treated across three dose levels, in a heavily pre-treated population with a median of 3 prior lines of therapy, 93% of whom had received prior CD19-directed CAR-T therapy, and all of whom presented with stage IV disease at baseline.

In the optimal dose cohort, ORR and complete response (CR) were 88% and 63%, respectively. The analysis identified a positive correlation between alemtuzumab exposure and clinical outcomes: higher alemtuzumab exposure created a favorable lower inflammatory homeostatic milieu prior to eti-cel infusion and was associated with enhanced eti-cel expansion and higher response rates. Additionally, responders maintained sustained low-level interleukin 2 (IL-2) secretion when compared to non-responders.

These findings provide a scientific rationale for the implementation of a weight-based alemtuzumab dosing regimen, currently under investigation to optimize lymphodepletion. Additionally, subcutaneous low-dose IL-2 is being investigated to further enhance eti-cel expansion and treatment response.

"These encouraging data demonstrate that not only can eti-cel drive responses in a very difficult-to-treat population, but that by optimizing exposure to alemtuzumab we may be able to create a favorable environment for CAR-T expansion and persistence." said Professor Emmanuel Bachy, M.D., Ph.D., Department of Hematology, Hospices Civils de Lyon, France.

The NATHALI-01 study is open for recruitment with the full Phase 1 clinical data expected in Q4 2026.

Poster Presentation: Alemtuzumab exposure and sustained IL-2 drive UCART20x22 expansion and clinical response in adults with relapsed or refractory B-cell non-Hodgkin lymphoma: NATHALI-01 study

Date/Time: Saturday, June 13 at 6:45 – 7:45pm, local time
Session: Poster Session 2
Poster Number: 4758

(Press release, Cellectis, JUN 11, 2026, View Source [SID1234666597])

On June 11, 2026 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation (TPD) science, reported it will present further analysis from its fully enrolled Phase 1 trial of cemsidomide, a next-generation oral IKZF1/3 degrader, in combination with dexamethasone for the treatment of relapsed/refractory multiple myeloma (RRMM) in a poster presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress on Friday, June 12, 2026 at 6:45 pm CEST / 12:45 pm ET.

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The analysis is consistent with previous data disclosed from the Phase 1 clinical trial and highlights cemsidomide’s anti-myeloma activity and differentiated safety profile, further supporting its development as a potential best-in-class IKF1/3 degrader. The poster will be presented by Sagar Lonial, M.D., FACP, FASCO, chief medical officer at the Winship Cancer Institute at Emory University, and an investigator in the cemsidomide clinical trials.

"Despite advances in multiple myeloma therapies, IKZF1/3 degradation remains a foundational treatment strategy across lines of therapy because it is the only approach that addresses the underlying biology of the disease and has the built-in ability to stimulate the immune function, becoming a natural partner for immune therapies. Next-generation IKZF1/3 degraders are expected to help advance treatment regimens for this persistent disease, given data demonstrating their efficacy and tolerability," said Dr. Lonial. "The clinical activity and safety profile of cemsidomide are highly encouraging for patients with relapsed/refractory multiple myeloma as they continue to seek disease-altering treatment options. The data from the ongoing Phase 1 study support the continued development of cemsidomide for patients with relapsed/refractory multiple myeloma who may benefit from IKZF1/3 degradation."

"The totality of cemsidomide data, particularly data showing that patients have experienced a deepening response over time, continue to demonstrate its potential to deliver a tolerable therapy that can provide sustained benefit for patients who have progressed through other treatment options," said Len Reyno, M.D., chief medical officer of C4 Therapeutics. "We remain focused on advancing our clinical development strategy to capitalize upon cemsidomide’s differentiated profile in hopes patients at various stages of their treatment journey may be able to benefit from this important investigational therapeutic regimen."

The poster presentation includes data on 73 patients with a data cutoff of February 27, 2026. Patients were heavily pretreated, receiving a median of seven prior lines of therapy. Fifty-five patients (75%) received prior BCMA therapy, and 55 patients (75%) received prior CAR-T or T-cell engager therapy (TCE).

At the RP2D and maximum tolerated dose (100 µg,) cemsidomide achieved a 53% overall response rate (ORR). At the 75 µg dose level, cemsidomide achieved a 40% ORR. Across all doses evaluated, cemsidomide achieved a 36% ORR.

Key new data include:

Responses deepened over time across the cemsidomide 75 µg and 100 µg dose levels:
At 75 µg, one patient whose best response was previously a partial response (PR) deepened to a very good partial response (VGPR).
At 100 µg, several patients achieved a deeper response:
One patient whose best response was previously a PR deepened to a stringent complete response (sCR)
One patient whose best response was previously a PR deepened to a VGPR
Minimal residual disease (MRD) negativity was achieved in two patients who achieved a sCR and complete response (CR) at 100 µg.
ORR was consistent across key subgroups:

ORR % (95% confidence interval (CI))
All Doses
Prior CAR-T or TCE 37% (24, 51)
Prior BCMA 33% (21, 48)
Prior Lines of Therapy > 5 Lines 33% (20, 48)
100 µg (RP2D)
Prior CAR-T or TCE 53% (28, 77)
Prior BCMA 47% (21, 73)
Prior Lines of Therapy > 5 Lines 47% (21, 73)

Durable responses were observed across all dose levels:
Patients experienced a median duration of response of 7.9 months (95% CI, 3.0 – non-evaluable).
Seven patients remain on treatment currently.

Cemsidomide in combination with dexamethasone was generally well tolerated. Incidences of on-target neutropenia remained manageable; 42 patients (58%) experienced Grade 3/4 neutropenia. All treatment emergent adverse events were manageable with no discontinuations deemed related to cemsidomide and minimal dose reductions (five patients; 7%).

UPCOMING INVESTOR EVENTS

June 18, 2026 at 9 am ET: C4T will host an educational webinar with Nisha Joseph, M.D., associate professor at the Winship Cancer Institute at Emory University and investigator in the cemsidomide clinical trials to discuss the evolving multiple myeloma landscape, the role of IKZF1/3 degradation in treating multiple myeloma, and cemsidomide’s profile.

About Cemsidomide
Cemsidomide is an investigational, next-generation orally bioavailable MonoDAC degrader (molecular glue) of IKZF1/3, transcription factors foundational to multiple myeloma biology. Data from the fully enrolled Phase 1 trial show cemsidomide’s differentiated safety and tolerability profile and potentially class-leading anti-myeloma activity that support the potential for durable outcomes.

About Multiple Myeloma
Multiple myeloma is a blood cancer that affects plasma cells in the bone marrow. It is the second most common blood cancer, with approximately 36,000 people in the United States diagnosed each year. Multiple myeloma is characterized by cycles of remission and relapse, which leads to patients needing multiple lines of therapy to manage this persistent disease. More than 175,000 patients in the United States are estimated to be living with or in remission from myeloma. However, despite treatment advances, approximately 40% of patients do not survive beyond five years.

About IKZF1/3 Degradation
Targeted degradation of IKZF1 (Ikaros) and IKF3 (Aiolos) is a foundational therapeutic strategy to treat multiple myeloma, a blood cancer affecting plasma cells. IKZF1/3 degradation leads to downregulation of IRF4, which promotes myeloma cell death. IKZF1/3 degradation also activates T-cells, which contributes to broader anti-myeloma response. For decades, IKZF1/3 degradation has been used in approved therapies for multiple myeloma. Next-generation IKZF1/3 degraders are being developed to leverage advances in targeted protein degradation research while continuing to address the biology foundational to multiple myeloma.

About the MOMENTUM Trial
MOMENTUM (Multi-center trial Of cemsidoMidE iN relapsed/refracTory mUltiple Myeloma) is a Phase 2, open-label, single-arm study to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of cemsidomide in combination with dexamethasone in patients with relapsed/refractory multiple myeloma. Data from the Phase 1 trial identified 100 µg as the recommended Phase 2 dose. The primary endpoint is overall response rate per International Myeloma Working Group response criteria, as assessed by an independent review committee. Approximately 100 patients who have received at least three prior anti-myeloma regimens that must have included an IKZF1/3 degrader, a proteasome inhibitor, an anti-CD38 antibody, and a T-cell engager or CAR-T therapy will be enrolled in the trial. More information is available at clinicaltrials.gov (NCT07284758).

About Cemsidomide in Combination With Elranatamab (ELREXFIO)
The Phase 1b trial is designed to evaluate the safety, tolerability and preliminary efficacy of cemsidomide and dexamethasone in combination with elranatamab, an FDA-approved B-cell maturation antigen CD3 targeted bispecific antibody. Data generated from the cemsidomide Phase 1 trial in relapsed/refractory multiple myeloma demonstrate robust T-cell activation and cytokine expression across multiple doses. By activating immune T-cells, cemsidomide, when combined with a BCMAxCD3 bispecific such as elranatamab, may amplify the anti-myeloma immune response and lead to deeper and more durable responses. The study will evaluate different cemsidomide dose levels (beginning with 75 µg, with the opportunity to simultaneously explore 50 µg and 100 µg) in patients who have received one to four prior lines of therapy, which must have consisted of at least one IKZF1/3 degrader. Exclusion criteria for patients include those who have received prior treatment with a BCMA-directed T-cell engager or BCMA-directed CAR-T therapy. More information is available at clinicaltrials.gov (NCT07280013).

(Press release, C4 Therapeutics, JUN 11, 2026, View Source [SID1234666596])

On June 11, 2026 BlossomHill Therapeutics, Inc., a privately-held, clinical-stage biopharmaceutical company applying an intentional, chemistry-based approach to design and develop innovative small molecule medicines for the treatment of cancer, reported initial clinical data from its ongoing first-in-human Phase 1/1b trial of BH-30236 in relapsed or refractory acute myeloid leukemia (R/R AML) and higher-risk myelodysplastic syndrome (HR-MDS) at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress in Stockholm, Sweden. BH-30236 is an intentionally designed novel, orally bioavailable, macrocyclic CDC-like kinase (CLK) inhibitor that modulates aberrant alternative mRNA splicing, a defining feature implicated in cancer progression and therapeutic resistance across both hematologic malignancies and solid tumors.

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"The preliminary anti-leukemic activity observed with BH-30236 in R/R AML and HR-MDS, both as a monotherapy and in combination with venetoclax, is very encouraging," said Geoff Oxnard, M.D., Chief Medical Officer of BlossomHill Therapeutics. "In addition to the reassuring tolerability profile, we have seen provocative responses in patients after progression on prior venetoclax-based therapy, a population with few treatment options. In the ongoing study of BH-30236, we will further characterize the effect of this novel mechanism in myeloid malignancies, both as a monotherapy and in synergy with venetoclax to maximize the potential of this promising program."

"We intentionally designed BH-30236 to target CLK, which is upstream of multiple resistance pathways, not by addressing one resistance mechanism after it develops, but by suppressing the splicing machinery that enables resistance to begin," said Jean Cui, Ph.D., Founder and Chief Executive Officer of BlossomHill Therapeutics. "We believe these data further validate our approach of leveraging a deep understanding of disease and protein dynamics and applying our structure-based rational drug design expertise to identify specific structural liabilities that limit existing therapies or approaches and design novel chemical scaffolds to directly address these limitations."

Presentation Highlights:

As of the data cutoff date of April 10, 2026, 30 patients received BH-30236 monotherapy at doses ranging from 5 to 120 mg on a continuous daily administration schedule (QD), and 18 patients received BH-30236 at doses ranging from 20 to 90 mg QD in combination with venetoclax
BH-30236 was generally well tolerated as both a monotherapy and in combination with venetoclax, with most treatment-related adverse events being low-grade and manageable, with one dose limiting toxicity of Grade 3 diarrhea at the 120 mg QD monotherapy dose level
Dose escalation showed predictable pharmacokinetics without drug accumulation, and no significant drug-drug interactions were observed with venetoclax
With efficacy follow-up through May 20, 2026, preliminary anti-leukemic activity was observed in patients with R/R AML and HR-MDS when treated with BH-30236 as a monotherapy or in combination with venetoclax, including in patients previously relapsed or refractory to venetoclax-based therapy:
In the monotherapy cohort, 28.6% (n=6) of evaluable patients achieved at least a 50% reduction in bone marrow blast counts, including one HR-MDS patient treated at 60 mg with ongoing blast count reduction with treatment ongoing for more than a year
In the combination cohort, 87% (n=13) of patients had prior venetoclax exposure and 53% (n=8) of evaluable patients experienced at least a 50% blast reduction, including one patient refractory to all prior therapy including venetoclax, who achieved a minimal residual disease (MRD)-negative complete remission

About R/R AML and HR-MDS
AML is the most common acute leukemia in adults, with approximately 21,000 new diagnoses annually in the United States, with as many as 75% of those being patients resistant to or relapsing on first-line venetoclax therapy. Approximately 14,000 patients are diagnosed with HR-MDS annually in the United States. There is no currently approved targeted therapy for the venetoclax-resistant and refractory segment of AML patients without targetable genetic alterations. Patients with HR-MDS closely mirror AML in clinical course, frontline treatment, and unmet need in the relapsed and refractory setting.

About BH-30236
BH-30236 is an investigational orally bioavailable, macrocyclic inhibitor of the CDC-like kinase (CLK) family. BH-30236 is was intentionally designed to potently inhibit CLK, leading to modulation of aberrant alternative splicing in cancerous tissue, targeting the same aberrant splicing machinery that drives relapsed or refractory (R/R) acute myeloid leukemia (AML) and higher-risk myelodysplastic syndrome (HR-MDS) disease biology and that cancer cells exploit to develop resistance to venetoclax, FLT3 inhibitors and cytarabine.

BH-30236 is being evaluated in a Phase 1/1b multicenter, open-label, first-in-human dose escalation and expansion trial in adults with R/R AML and HR-MDS. The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to BH-30236 for the treatment of AML.

(Press release, BlossomHill Therapeutics, JUN 11, 2026, View Source [SID1234666595])

On June 11, 2026 Immuneering Corporation (Nasdaq: IMRX), a late-stage clinical oncology company focused on keeping cancer patients alive and helping them thrive, reported that the first patient has been dosed in MAPKeeper 301, a global, randomized, open-label pivotal Phase 3 clinical trial evaluating atebimetinib plus modified gemcitabine/nab-paclitaxel (mGnP) in first-line metastatic pancreatic cancer patients. Atebimetinib is a novel MEK inhibitor with a pulsatile mechanism designed to target RAS, RAF, and other MAPK pathway-driven cancers with greater durability and tolerability than traditional chronic inhibitors.

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"Pancreatic cancer remains a challenging malignancy to treat," said Eileen M. O’Reilly, MD, FASCO, Winthrop Rockefeller Endowed Chair in Medical Oncology at Memorial Sloan Kettering Cancer Center, and the lead principal investigator of the MAPKeeper 301 study. "There is an urgent need for new first-line treatment options that can improve treatment outcomes by augmenting survival and improving quality of life. The MAPKeeper 301 trial evaluating atebimetinib with standard of care therapy represents an exciting step toward addressing that need."

The global MAPKeeper 301 trial (NCT07562152) is evaluating the safety and efficacy of atebimetinib + mGnP in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) who have received no prior systemic anti-cancer therapy. Patients are being randomized to receive either atebimetinib + mGnP, or standard GnP treatment alone. The primary endpoint is overall survival (OS) of patients in the atebimetinib + mGnP arm versus patients in the GnP arm. Key secondary endpoints include progression free survival (PFS), overall response rate (ORR), disease control rate (DCR), safety and tolerability, and quality of life.

"The dosing of the first patient in our pivotal Phase 3 trial is a significant milestone for Immuneering and, more importantly, patients with pancreatic cancer and their families," said Ben Zeskind, PhD, CEO of Immuneering. "Global interest in MAPKeeper-301 has been overwhelming, largely driven by our highly encouraging survival and tolerability data presented earlier this year. We look forward to initiating more sites and dosing more patients as expeditiously as possible with topline data from the pivotal trial expected in mid-2028."

More information about the MAPKeeper 301 trial can be found at www.clinicaltrials.gov, identifier NCT07562152 or the MAPKeeper 301 clinical trial microsite at View Source

About Pancreatic Ductal Adenocarcinoma (PDAC)
According to the National Health Institute, PDAC is the most common and highly lethal form of pancreatic cancer with nearly 68,000 new cases estimated for 2026 in the U.S. alone. Often diagnosed too late, PDAC currently carries a poor prognosis with a five-year survival rate of approximately 13%. Atebimetinib targets MEK in the MAPK pathway, from which 90% of PDAC cases grow and thrive, and is designed to shrink tumors durably with less resistance, optimize tolerability and counteract cachexia, enabling patients to live longer, stay strong and thrive.

(Press release, Immuneering, JUN 11, 2026, View Source [SID1234666594])

On June 11, 2026 Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company and a global leader in epigenetics, reported updated positive clinical data from two clinical trials of its selective LSD1 inhibitor iadademstat in acute myeloid leukemia (AML) at the 2026 European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress.

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"We are encouraged by the sustained strength and consistency of the data from both the ALICE-2 and FRIDA trials," said Carlos Buesa, Chief Executive Officer of Oryzon Genomics. "With over 80% of patients now enrolled in ALICE-2, the favorable safety profile and strong efficacy signals of iadademstat in newly diagnosed, unfit AML patients reinforce our confidence in this combination approach, including within genomically defined adverse-risk populations such as TP53-mutated and RAS pathway–mutated AML. These results are consistent with prior findings in TP53-mutated patients in our ALICE trial, where the combination of iadademstat and azacitidine doubled median overall survival compared with historical rates. As enrollment continues, we anticipate reporting final data by year-end and advancing toward a potential registrational study in first-line AML by 2027, with a focus on adverse-risk populations."

Ana Limón, Senior Vice President of Clinical Development and Global Medical Affairs at Oryzon, added: "Historically, with azacitidine plus venetoclax, one third of first line AML patients do not respond, and the depth of response is variable, underscoring the need for novel triplet strategies, particularly for patients without targetable mutations. The maturing data from both trials continue to reinforce the strength of LSD1 inhibition as an add-on approach in AML. In addition to the high ORR and CR rates observed to date in the ALICE-2 trial, treatment with the iadademstat-azacitidine-venetoclax triplet has enabled a high proportion of patients to transition to allogeneic hematopoietic cell transplantation (HCT), potentially improving long-term survival. Overall, the safety and efficacy observed across both trials support further clinical development."

Data Summary

ALICE-2 Phase Ib clinical trial (NCT06357182) investigating iadademstat in combination with azacitidine and venetoclax in newly diagnosed AML

High rates of activity, with a 100% (18/18) overall response rate (ORR), 89% (16/18) composite complete remission (CRc) rate and 78% (14/18) complete response (CR) rate.
CRs occur early, most of them in cycle 1.
Efficacy was observed across different genomic risk groups, including TP53 and RAS pathway mutations and patients with complex karyotypes, all considered adverse risk.
Patients with TP53-mutated disease (2/2) attained CR and showed a reduction in TP53 variant allele frequency (14% to undetected and 22% to 1%, respectively).
All patients with RAS pathway mutations (3/3) achieved CR.
After a median follow-up of 8 months, median overall survival (OS) and event-free survival (EFS) were not reached; estimated 12-month OS and EFS were 79% and 71%, respectively.
9 patients successfully transitioned to allogeneic HCT, with an estimated 12-month OS of 88%.
The iadademstat-azacitidine-venetoclax combination continues to show a favorable safety profile.

FRIDA Phase Ib clinical trial (NCT05546580) investigating iadademstat in combination with gilteritinib in FLT3‑mutated relapsed/refractory AML

The poster reports data from the expansion cohort at the selected pharmacological active dose (PAD, 75 ug iadademstat); 23 patients have been enrolled at this dose, with 18 being evaluable for response.
High CRc rate of 67% (12/18) in a heavily pre-treated population.
Iadademstat plus standard of care (SoC) treatment gilteritinib demonstrated a manageable safety profile, without adding toxicity to the SoC.

About ALICE-2

ALICE-2 (NCT06357182) is a Phase Ib investigator-initiated study sponsored by Oregon Health & Science University (OHSU) in newly diagnosed AML. It is evaluating treatment with iadademstat in combination with azacitidine and venetoclax, the standard of care, in newly diagnosed unfit patients. The study’s primary endpoint is the incidence of dose-limiting toxicities (DLTs). Secondary endpoints include efficacy measurements such as composite complete remission (CRc: complete remission [CR] + CR with partial hematologic recovery [CRh] + CR with incomplete recovery [CRi]), and overall response rate (ORR: CRc + morphologic leukemia free state [MLFS] + partial remission [PR]). The trial plans to enrol 24 patients to achieve 21 evaluable patients.

About FRIDA

FRIDA (NCT05546580) is a Phase Ib clinical study sponsored by Oryzon. It is evaluating iadademstat in combination with gilteritinib for the treatment of FLT3-mutant relapsed/refractory AML. The primary endpoints are incidence of treatment emergent adverse events (TEAEs) and determination of the recommended Phase II dose (RP2D). Secondary endpoints include response rates (CR, CRh, CRi, MLFS, CRc), event-free survival (EFS), and overall survival (OS).

(Press release, Oryzon, JUN 11, 2026, View Source [SID1234666593])