On May 12, 2026 Kura Oncology, Inc. (Nasdaq: KURA) and Kyowa Kirin Co., Ltd. (TSE: 4151, "Kyowa Kirin") reported that updated results from the frontline arm of the Phase 1 KOMET-007 (NCT05735184) clinical trial evaluating ziftomenib in combination with cytarabine plus daunorubicin (7+3) in patients with newly diagnosed NPM1-mutant (NPM1-m) or KMT2A-rearranged (KMT2A-r) acute myeloid leukemia (AML) have been accepted for an oral presentation on Sunday, June 14, 2026, at the upcoming 2026 European Hematology Association (EHA) (Free EHA Whitepaper) Congress in Stockholm, Sweden.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The oral presentation will highlight updated results in 99 patients with newly diagnosed NPM1-m or KMT2A-r AML treated with ziftomenib 600 mg once daily in combination with 7+3. These results represent one of the largest datasets reported to date for the evaluation of a menin inhibitor in combination with intensive chemotherapy in frontline AML.

As of the abstract data cut-off on January 16, 2026:

High response rates across both molecular subtypes
Composite complete response (CRc) rates of 96% (47/49) for NPM1-m and 90% (45/50) for KMT2A-r AML
Deep molecular responses
Measurable residual disease (MRD)-negativity rates among CRc responders of 83% (39/47) for NPM1-m and 82% (32/39) for KMT2A-r AML
Encouraging durability with extended follow-up
Median follow-up of 14.9 months (NPM1-m) and 9.3 months (KMT2A-r)
Median duration of CRc not reached (NPM1-m) and 11.2 months (KMT2A-r)
Consistent and manageable safety profile
Safety profile consistent across the NPM1-m and KMT2A-r groups with no new safety signals observed with long-term treatment
Updated analyses with longer median follow-up, central MRD assessment, durability outcomes, and deeper characterization of safety and hematologic recovery will be included at the time of the oral presentation

"With nearly 100 patients treated as well as extended follow-up, ziftomenib in combination with 7+3 continues to demonstrate consistently high response rates, deep MRD negativity, and encouraging durability across genetically defined AML subsets," said Mollie Leoni, M.D., Chief Medical Officer of Kura Oncology. "These data support our belief ziftomenib has potential to serve as a foundational backbone for frontline AML therapy, and we are advancing this regimen in our ongoing Phase 3 registrational program."

In addition to the oral presentation, abstracts for the KOMET-007 and KOMET-017 trials have been accepted for a poster presentation and online publication, respectively. Details are provided below and are available on the EHA (Free EHA Whitepaper)web.org website.

EHA 2026 Presentation Details

Title: Ziftomenib combined with intensive induction (7+3) for newly diagnosed NPM1-m or KMT2A-r acute myeloid leukemia (AML): Long-term results from the KOMET-007 trial
Session: s446 Novel treatments in AML
Date and Time: Sunday, June 14; 11:00-12:15 CEST
Location: Nobel Hall
Publication Number: S130

Title: Exposure-response analysis of ziftomenib combined with venetoclax/azacitidine or cytarabine/daunorubicin in newly diagnosed and relapsed/refractory NPM1-m or KMT2A-r acute myeloid leukemia
Session: Poster Session 1
Date and Time: Friday, June 12; 18:45-19:45 CEST
Location: Poster Hall
Publication Number: PF537

Title: Registrational Phase 3 studies of ziftomenib in combination with nonintensive or intensive chemotherapy for newly diagnosed NPM1-m or KMT2A-r acute myeloid leukemia (AML): The KOMET-017 trial
Location: Online Publication
Date and Time: Tuesday, May 12; 9:30 AM ET/15:30 CEST
Publication Number: PB2766

Copies of the presentations will be available on Kura’s website at www.kuraoncology.com/pipeline/publications following presentation at the meeting.

Virtual Investor Event
Kura will host a webcast and conference call on June 12, 2026, at 8:00 am ET / 5:00 am PT, featuring management and a clinical investigator from the KOMET-007 study. The live webcast and replay will be available on the Company’s website at www.kuraoncology.com under the Investors tab in the Events and Presentations section.

(Press release, Kura Oncology, MAY 12, 2026, View Source [SID1234665543])

On May 12, 2026 ModeX Therapeutics Inc., an OPKO Health company (NASDAQ: OPK), reported preclinical data demonstrating the in vivo generation of CAR-T cells and deep systemic B-cell depletion achieved with its MDX3001 candidate in animal models. The data, generated using ModeX’s CD3xCD28 antibody-conjugated lipid nanoparticle (LNP)/mRNA platform, will be presented at the ASGCT (Free ASGCT Whitepaper) 2026 Annual Meeting, being held May 11-15 in Boston.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The abstract, titled "Bispecific CD3xCD28 Antibody-LNPs Drive In Vivo CAR-T Cell Generation with Deep B-Cell Depletion," highlights preclinical studies showing B-cell depletion in blood and lymphoid tissues, including spleen, bone marrow, and lymph nodes. Activity was confirmed in both humanized mouse and non-human primate models.

By combining CD3 with CD28 costimulatory engagement, the technology enables efficient T-cell transfection, activation, and functional CAR-T cell generation directly in vivo. The antibody-conjugated LNP directs cell-specific gene delivery, and the mRNA nature of the platform, obviates the need for pre-conditioning chemotherapy while allowing for repeat dosing, leading to expansion and persistence of functional memory T-cell populations.

"These data demonstrate the strength of our in vivo targeting technology," said John Mascola, M.D., Chief Scientific Officer of ModeX Therapeutics. "Our antibody-conjugated LNP platform offers a simple and versatile approach to gene delivery for immune cells in vivo, and has the potential to simplify treatment access by eliminating the burden of ex vivo manufacturing."

"Our targeted gene delivery platform uses proprietary ModeX technology to generate CAR-T cells directly in patients," said Gary Nabel, M.D., Ph.D., President and Chief Executive Officer of ModeX Therapeutics. "It offers a promising clinical modality for diverse diseases, including autoimmunity and oncology."

Oral Presentation Details

Title: Bispecific CD3xCD28 Antibody-LNPs Drive In Vivo CAR-T Cell Generation with Deep B Cell Depletion
Abstract Number: 338
Meeting: ASGCT (Free ASGCT Whitepaper) 2026 Annual Meeting
Date/Time: May 14, 2026 at 10:15 a.m. Eastern time
Location: Thomas M. Menino Convention Center, Boston

(Press release, Opko Health, MAY 12, 2026, View Source [SID1234665554])

On May 12, 2026 Servier reported that the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to Emi-Le, an investigational ADC directed against B7-H4, a well-characterized target in certain cancers. One of those cancers, ACC, is a challenging rare cancer usually arising within the salivary gland with no currently approved treatments for advanced or metastatic disease. The breakthrough therapy designation has been granted for treatment of patients with locally advanced, recurrent or metastatic ACC with solid histology or high-grade transformation.

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"At Servier, we are committed to pursuing first‑in‑class medicines for rare diseases in oncology. This Breakthrough Therapy designation for Emi‑Le will help accelerate development and may provide an important new treatment option for patients with few effective choices today," said Peter Adamson, Global Head, Oncology Clinical Development, Servier. "Following the acquisition of Day One Biopharmaceuticals, this designation reinforces our confidence in Day One’s portfolio and our commitment to advancing innovative treatments for patients facing difficult‑to‑treat cancers."

Emi-Le is being evaluated in a multicenter Phase 1 trial to investigate the safety, tolerability and anti-tumor activity of the treatment in patients with solid tumors, including aggressive ACC, breast, endometrial and ovarian cancers. In the initial data reported from Phase 1, Emi-Le had manageable side effects, and confirmed objective responses were observed across multiple tumor types.

About Emi-Le
Emi-Le is a B7-H4-directed Dolasynthen ADC with a precise, target-optimized drug-to-antibody ratio (DAR 6) and a proprietary auristatin-F HPA payload with controlled bystander effect. This candidate is under evaluation in an ongoing Phase 1 clinical trial (previously with Mersana Therapeutics). The U.S. Food and Drug Administration has granted Fast Track designations to Emi-Le for the treatment of 1) adult patients with advanced or metastatic triple-negative breast cancer, and 2) advanced or metastatic HER2 low / HER2 negative breast cancer post-topo-1 ADC (including TNBC and certain HR+ breast cancers). It has also received Breakthrough Designation from the FDA for the treatment of patients with locally advanced, recurrent or metastatic adenoid cystic carcinoma with solid histology or high-grade transformation. For more information about the trial, visit clinicaltrials.gov (NCT05377996).

About Adenoid Cystic Carcinoma
Adenoid cystic carcinoma (ACC) occurs in the secretory glands, typically in the head and neck, but also in other areas of the body. Globally, more than 200,000 people have ACC. It is diagnosed in roughly four per one million people annually, and does not discriminate by ethnicity or lifestyle factors. Today there are no approved or preferred systemic therapies to treat advanced or metastatic ACC; most people are treated with surgery or radiation, but the disease recurs in 50 percent of cases, often becoming more aggressive with metastases in distant areas of the body.

(Press release, Servier, MAY 12, 2026, View Source [SID1234665570])

On May 12, 2026 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported two presentations from the company’s Advanced Systemic Mastocytosis (AdvSM) program, including an oral presentation highlighting the results of the APEX trial, as well as a poster presentation from its emerging JAK2 V617F program at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress being held in Stockholm, Sweden, June 11-14, 2026.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Details of the presentations are as follows:

Bezuclastinib

Oral Presentation

Abstract Title: Efficacy and Safety of Bezuclastinib in Patients With Advanced Systemic Mastocytosis: Primary Results From the Apex Study
Presenter: Daniel DeAngelo, M.D., Ph.D., Chief of the Division of Leukemia at the Dana-Farber Cancer Institute and Professor of Medicine, Harvard Medical School
Session Date and Time: June 13, 2026 – 17:15 – 18:30 CEST (11:15 AM ET – 12:30 PM ET)
Oral Session: S438 Myeloproliferative Neoplasms – Clinical
Session Room: A2-3 Hall

Poster Presentation

Abstract Title: The Effect of Bezuclastinib on the Pathobiology of Advanced Systemic Mastocytosis: Results from the Pivotal Apex Trial
Poster #: PF885
Presenter: Tracy George, M.D., President and Chief Scientific Officer at ARUP Laboratories, Professor of Pathology at the University of Utah School of Medicine
Session Date and Time: June 12, 2026 – 18:45-19:45 CEST (12:45pm – 1:45pm ET)

JAK2 V617F

Poster Presentation

Abstract Title: Preclinical characterization of CGT1145 a novel, wild-type-sparing, JAK2 V617F mutant-selective inhibitor
Poster #: PF853
Presenter: Mark J Chicarelli, Senior Director Medicinal Chemistry, Cogent Biosciences
Session Date and Time: June 12, 2026 – 18:45-19:45 CEST (12:45pm – 1:45pm ET)

(Press release, Cogent Biosciences, MAY 12, 2026, View Source [SID1234665530])

On May 12, 2026 Kura Oncology, Inc. (Nasdaq: KURA) and Kyowa Kirin Co., Ltd. (TSE: 4151, "Kyowa Kirin") reported that updated results from the frontline arm of the Phase 1 KOMET-007 (NCT05735184) clinical trial evaluating ziftomenib in combination with cytarabine plus daunorubicin (7+3) in patients with newly diagnosed NPM1-mutant (NPM1-m) or KMT2A-rearranged (KMT2A-r) acute myeloid leukemia (AML) have been accepted for an oral presentation on Sunday, June 14, 2026, at the upcoming 2026 European Hematology Association (EHA) (Free EHA Whitepaper) Congress in Stockholm, Sweden.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The oral presentation will highlight updated results in 99 patients with newly diagnosed NPM1-m or KMT2A-r AML treated with ziftomenib 600 mg once daily in combination with 7+3. These results represent one of the largest datasets reported to date for the evaluation of a menin inhibitor in combination with intensive chemotherapy in frontline AML.

As of the abstract data cut-off on January 16, 2026:

High response rates across both molecular subtypes
Composite complete response (CRc) rates of 96% (47/49) for NPM1-m and 90% (45/50) for KMT2A-r AML
Deep molecular responses
Measurable residual disease (MRD)-negativity rates among CRc responders of 83% (39/47) for NPM1-m and 82% (32/39) for KMT2A-r AML
Encouraging durability with extended follow-up
Median follow-up of 14.9 months (NPM1-m) and 9.3 months (KMT2A-r)
Median duration of CRc not reached (NPM1-m) and 11.2 months (KMT2A-r)
Consistent and manageable safety profile
Safety profile consistent across the NPM1-m and KMT2A-r groups with no new safety signals observed with long-term treatment
Updated analyses with longer median follow-up, central MRD assessment, durability outcomes, and deeper characterization of safety and hematologic recovery will be included at the time of the oral presentation

"With nearly 100 patients treated as well as extended follow-up, ziftomenib in combination with 7+3 continues to demonstrate consistently high response rates, deep MRD negativity, and encouraging durability across genetically defined AML subsets," said Mollie Leoni, M.D., Chief Medical Officer of Kura Oncology. "These data support our belief ziftomenib has potential to serve as a foundational backbone for frontline AML therapy, and we are advancing this regimen in our ongoing Phase 3 registrational program."

In addition to the oral presentation, abstracts for the KOMET-007 and KOMET-017 trials have been accepted for a poster presentation and online publication, respectively. Details are provided below and are available on the EHA (Free EHA Whitepaper)web.org website.

EHA 2026 Presentation Details

Title: Ziftomenib combined with intensive induction (7+3) for newly diagnosed NPM1-m or KMT2A-r acute myeloid leukemia (AML): Long-term results from the KOMET-007 trial
Session: s446 Novel treatments in AML
Date and Time: Sunday, June 14; 11:00-12:15 CEST
Location: Nobel Hall
Publication Number: S130

Title: Exposure-response analysis of ziftomenib combined with venetoclax/azacitidine or cytarabine/daunorubicin in newly diagnosed and relapsed/refractory NPM1-m or KMT2A-r acute myeloid leukemia
Session: Poster Session 1
Date and Time: Friday, June 12; 18:45-19:45 CEST
Location: Poster Hall
Publication Number: PF537

Title: Registrational Phase 3 studies of ziftomenib in combination with nonintensive or intensive chemotherapy for newly diagnosed NPM1-m or KMT2A-r acute myeloid leukemia (AML): The KOMET-017 trial
Location: Online Publication
Date and Time: Tuesday, May 12; 9:30 AM ET/15:30 CEST
Publication Number: PB2766

Copies of the presentations will be available on Kura’s website at www.kuraoncology.com/pipeline/publications following presentation at the meeting.

Virtual Investor Event
Kura will host a webcast and conference call on June 12, 2026, at 8:00 am ET / 5:00 am PT, featuring management and a clinical investigator from the KOMET-007 study. The live webcast and replay will be available on the Company’s website at www.kuraoncology.com under the Investors tab in the Events and Presentations section.

(Press release, Kura Oncology, MAY 12, 2026, View Source [SID1234665543])