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])

On June 11, 2026 RenovoRx, Inc. ("RenovoRx" or "the Company") (Nasdaq: RNXT), a life-sciences company developing innovative targeted oncology therapies and commercializing RenovoCath, a patented, FDA-cleared drug-delivery device, reported the publication of a peer-reviewed case study from researchers at Moffitt Cancer Center was recently published in Radiology Case Reports.

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The case study highlights potential optimization of the TAMP procedure with RenovoCath to deliver intra-arterial gemcitabine (a commonly used chemotherapy) directly near a tumor (rather than traditional systemic IV administration) in a patient with locally advanced pancreatic cancer (LAPC). Importantly, PET-CT imaging, rather than CT alone, showed a meaningful reduction in tumor metabolic activity after treatment, suggesting that PET may improve monitoring of therapeutic response following treatment delivered via TAMP.

The case study, titled "Trans-arterial gemcitabine micro perfusion of locally advanced pancreatic cancer enabled by coil plus glue embolization of a pancreaticoduodenal branch," was authored by Bela Kis, MD, PhD, and his colleagues at Moffitt Cancer Center and published in Radiology Case Reports. This is the first reported case in which physicians successfully embolized, or sealed off, a small branching artery using tiny coils and surgical glue to better optimize isolation of flow with TAMP-mediated gemcitabine delivered with RenovoCath during the same procedure.

The case study describes treatment of an 82-year-old patient with unresectable LAPC who underwent targeted intra-arterial gemcitabine treatment using TAMP following stereotactic body radiation therapy. During the procedure, physicians identified a pancreaticoduodenal artery (PDA) side branch that prevented optimal vessel isolation required for TAMP’s approach to pressure-mediated drug-delivery. Investigators subsequently performed coil plus glue embolization of the side branch, successfully enabling localized gemcitabine delivery via TAMP in the same procedural setting. The patient tolerated all 8 TAMP procedures (twice per month) without complications. Post eighth treatment at the 4-month follow-up, CT scans revealed stable disease (no change in tumor size) relative to scans performed prior to the first TAMP treatment, whereas PET-CT revealed a 52% reduction in tumor metabolic activity at the site of treatment.

"LAPC is already difficult-to-treat, and a pancreaticoduodenal artery (PDA) side branch adds another challenge to targeted therapy," said Bela Kis, MD, PhD, Moffitt Cancer Center and the first author of the case study. "TAMP uses RenovoCath, an innovative dual-balloon occlusion catheter designed to deliver therapy directly near tumors while reducing systemic exposure. The technology creates localized intra-arterial pressure that drives therapeutic agents across the vessel wall near the tumor."

Dr. Kis added, "We were encouraged by this case because the patient completed all eight RenovoCath-enabled TAMP treatments without complications. At the four-month follow-up, PET-CT imaging showed stable disease, while metabolic imaging indicated a positive treatment response, including a 52% reduction in fluorodeoxyglucose (FDG) activity at the treatment site."

"These findings further strengthen the growing body of peer-reviewed evidence supporting the procedural flexibility and targeted delivery capabilities of our TAMP therapy platform enabled by RenovoCath," said Ramtin Agah, MD, RenovoRx’s Chief Medical Officer, Executive Chairman, and Founder. "They also show how physicians may be able to address anatomical challenges to optimize targeted intra-arterial therapy, potentially increasing the therapeutic benefit of localized treatment options for patients with difficult-to-treat cancers."

Publication Details

Title: Trans-arterial gemcitabine micro perfusion of locally advanced pancreatic cancer enabled by coil plus glue embolization of a pancreaticoduodenal branch
Journal: Radiology Case Reports
DOI: View Source
Lead Author: Dr. Bela Kis, MD, PhD
Institution: Moffitt Cancer Center, Tampa, FL

About RenovoCath
Based on its FDA clearance, RenovoCath is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system. RenovoCath is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. For further information regarding our RenovoCath Instructions for Use ("IFU"), please see: IFU-10004-Rev.-G-Universal-IFU.pdf.

(Press release, Renovorx, JUN 11, 2026, View Source [SID1234666592])

On June 11, 2026 Imviva Biotech, a clinical-stage biotechnology company developing next-generation allogeneic CAR-T cell therapies, reported new research findings at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress (EHA2026), June 11-14, in Stockholm, Sweden. Shared in two poster presentations, the data demonstrated encouraging safety and efficacy results in both adult and pediatric patients with relapsed or refractory T-cell acute lymphoblastic leukemia/lymphoblastic lymphoma (R/R T-ALL/LBL), a disease with limited treatment options and poor prognosis.

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Patients with R/R T-ALL/LBL face substantial treatment challenges due to paucity and limited efficacy of available therapies. Findings presented at EHA (Free EHA Whitepaper)2026 highlight the value of CTD402 as an "off-the-shelf", point-of-care-ready CAR-T cell therapy for heavily pretreated pediatric and adult patients.

TENACITY-01 A Global Study of CTD402, Allogeneic Anti-CD7 CAR T-Cell, In Relapsed or Refractory (R/R) T-Cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-ALL/LBL)

In a second poster presentation delivered by Dr. Lori Muffly of Stanford Medicine, preliminary data from TENACITY-01, a global Phase 1b/2 study of CTD402, was featured. As of June 8th, 2026, seven patients with R/R T-ALL/LBL received CTD402 at the recommended phase 2 dose following standard lymphodepletion chemotherapy. The therapy demonstrated an overall response rate of 85.7% (6/7 patients) and an overall complete remission (CRc = CR + CRi) rate of 71.4% (5/7 patients), with 80% (4/5) achieving MRD-negative status.

The safety profile has been manageable, with low-grade (<=G2) cytokine release syndrome observed in 86% of patients and immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome observed in 29% of patients. Notably, no cases of immune effector cell-associated neurotoxicity syndrome or graft-versus-host disease were reported. CTD402 demonstrated robust pharmacokinetics with peak expansion at Day 10 and persistence beyond 28 days in 60% of patients. One highlighted case involved a heavily pretreated patient with 90% bone marrow blasts and extensive extramedullary disease who achieved complete remission with incomplete hematologic recovery and successfully transitioned to allogeneic hematopoietic stem cell transplant, continuing in remission thereafter.

"These results from TENACITY-01 validate our earlier CTD402 findings in a global setting," said Lori Muffly, MD, MS, of Stanford Medicine. "We’re now seeing consistent efficacy with an 85.7% overall response rate and high rates of MRD-negative remissions, reinforcing the potential of this off-the-shelf therapy for patients with very limited treatment options."

CTD402 Allogeneic Anti-CD7 CAR T-Cell Therapy is Safe and Effective in Adolescent/Pediatric Patients (pts) with Relapsed/Refractory (R/R) T ALL/LBL

In a poster presentation delivered by Dr. Xian Zhang of Hebei Yanda Ludaopei Hospital, researchers analyzed pooled safety and efficacy data from multiple Phase 1/2 studies, conducted across five academic centers in China, evaluating CTD402 in 15 adolescent and pediatric patients with a median age of 15 years (range 10-17). Despite treating a challenging patient population who had received a median of two prior lines of therapy (range 1-5), with 26.7% having primary refractory disease, 60% with extramedullary disease, and 60% with high-risk molecular features, the therapy demonstrated an impressive 80% complete remission rate (12/15 patients), with 83.3% of responders (10/12) achieving MRD-negative status.

The safety profile was favorable, with 66.7% experiencing predominantly mild Grade 1-2 CRS and notably no neurotoxicity or severe infections observed. CAR-T cells persisted for at least 28 days in 66.7% of patients, with some showing persistence up to 90-180 days, and at a median follow-up of 21.94 months, median overall survival was not reached in patients who received consolidative allogeneic transplant, compared with 4.8 months in non-transplant patients (p=0.026), highlighting the potential benefit of post-CAR-T consolidation strategies.

"These encouraging results from our pediatric cohort underscore CTD402’s potential to transform care for patients with R/R T-ALL/LBL," said Imviva Biotech Chief Medical Officer Jan Davidson-Moncada, MD, PhD. "The combination of strong efficacy—with 80% of pediatric patients achieving complete remission—and a favorable safety profile, alongside CTD402’s immediate availability as an off-the-shelf therapy, demonstrates the potential to address a critical unmet need in this patient population."

Abstracts are currently available to the public at: View Source!*menu=6*browseby=3*sortby=2*ce_id=2934.

About CTD402

CTD402 is an investigational ‘ready-at-point of care’ allogeneic anti-CD7 CAR-T cell therapy designed for T-cell mediated disease. The product candidate incorporates T-cell receptor (TCR) and HLA class II knockout, along with Imviva’s proprietary ANSWER inhibitory ligands to enhance resistance to host immune rejection. The robustness of CTD402’s manufacturing process, showing product consistency across multiple donors and production lots, promises to deliver an ‘off-the-shelf’ allogeneic platform with the critical advantage of immediate availability, eliminating manufacturing delays that can be life-threatening for patients with rapidly progressive disease.

A global Phase 1b/2 clinical trial (TENACITY-01) evaluating CTD402 for the treatment of relapsed/refractory T-ALL/LBL patients is enrolling patients (NCT07070219). The U.S. Food and Drug Administration has granted Rare Pediatric Disease Designation (RPDD), and Regenerative Medicine Advanced Therapy (RMAT) designation to CTD402 for the treatment of relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL).

(Press release, Imviva Biotech, JUN 11, 2026, View Source [SID1234666591])