BlossomHill Therapeutics to Present Initial Clinical Dose Escalation Data from the Phase 1/1b Trial of BH-30236 in Patients with R/R AML or HR-MDS at EHA2026

On May 12, 2026 BlossomHill Therapeutics, Inc., a privately-held, clinical-stage biopharmaceutical company applying an intentional, chemistry-based approach to develop innovative small molecule medicines for the treatment of cancer, reported that initial dose escalation data from its Phase 1/1b trial of BH-30236, a macrocyclic CDC-link kinase (CLK) inhibitor, in relapsed or refractory acute myeloid leukemia (R/R AML) and higher-risk myelodysplastic syndrome (HR-MDS) will be presented during a poster session on June 12, 2026, at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress in Stockholm, Sweden. Additionally, BH-30236 has been granted orphan drug designation by the U.S. Food and Drug Administration for the treatment of AML.

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"We are highly encouraged by the initial safety data and early signs of anti-leukemic activity observed with BH-30236, both as a monotherapy and in combination with venetoclax," said Jean Cui, Ph.D., Founder and Chief Executive Officer of BlossomHill Therapeutics. "By modulating aberrant alternative mRNA splicing, our potential first-in-class CLK inhibitor, BH-30236, represents a novel approach for patients with relapsed or refractory AML and higher-risk MDS, who face a significant unmet medical need. We look forward to presenting additional data from more patients with longer follow-up at the meeting and to advancing BH-30236 in both monotherapy and combination settings."

BH-30236 was designed to target the CLK kinase family, leading to the modulation of aberrant alternative mRNA splicing, a defining feature implicated in cancer progression and therapeutic resistance across both hematologic malignancies and solid tumors. Our Phase 1/1b trial evaluating BH-30236 was initiated following encouraging preclinical data, including evidence of synergistic activity between BH-30236 and venetoclax, a BCL-2 inhibitor and an established standard of care therapy for patients with AML. The trial is currently enrolling patients in dose escalation, evaluating BH-30236 as both a monotherapy and in combination with venetoclax.

As of the January 23, 2026 cutoff date for the EHA (Free EHA Whitepaper) abstract submission, 28 patients received BH-30236 monotherapy at 5-120 mg on a continuous daily administration schedule (QD) and 11 patients received BH-30236 at 20-60mg QD in combination with venetoclax. Initial findings demonstrated:

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, as well as one grade 3 DLT (diarrhea)
Dose escalation showed predictable pharmacokinetics without drug accumulation or reduction, and no significant drug-drug interactions were observed with venetoclax
Early signs of clinical activity were observed:
In the monotherapy cohort, 29% (n=5) 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 duration of treatment 7.6 months.
In the combination cohort, 55% (n=5) 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.
"In March of this year, the U.S. Food and Drug Administration granted Orphan Drug Designation to BH-30236 for the treatment of acute myeloid leukemia, underscoring the need for new therapies in this rare malignancy," said Dr. Geoff Oxnard, Chief Medical Officer of BlossomHill Therapeutics. "This designation is an important milestone that reflects the potential of BH-30236 to address a significant unmet need and provides benefits that may support our ongoing clinical development, as well as potential market exclusivity upon approval."

Poster Session Details

Title: A First-in-Human Study of the Oral CLK Inhibitor BH-30236 in Adults with Relapsed/Refractory Acute Myeloid Leukemia or Higer-Rish Myelodysplastic Syndrome: Monotherapy and Venetoclax Combination
Presenting Author: Eytan M. Stein, MD, Chief of the Leukemia Service, Associate Attending Physician, Clinical Investigator and Director of the Program for Drug Development in Leukemia on the Leukemia Service at Memorial Sloan Kettering Cancer Center
Date & Time: Friday, June 12 from 12:45 to 1:45 ET / 18:45 – 19:45 CEST
Abstract Code: PF494
About BH-30236
BH-30236 is an investigational orally bioavailable, macrocyclic inhibitor of the CDC-like kinase (CLK) family. BH-30236 is designed to modulate aberrant alternative splicing in cancerous tissue, targeting the same aberrant splicing machinery that drives 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 currently in clinical development for the treatment of relapsed or refractory AML (R/R AML) and HR-MDS.

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 has granted orphan drug designation to BH-30236 for the treatment of AML.

(Press release, BlossomHill Therapeutics, MAY 12, 2026, View Source [SID1234665580])

Ascentage Pharma to Participate in Three Upcoming Investor Conferences

On May 12, 2026 Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855) ("Ascentage Pharma" or the "Company"), a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer, reported that the Company’s management is scheduled to participate in three upcoming investor conferences.

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· B. Riley Commercial/Late-Stage Oncology Best Ideas Summit: One-on-one meetings on May 18th

· Stifel 2026 Virtual Targeted Oncology Forum: One-on-one meetings and fireside chat at 10:30 am EDT on May 19th

· Jefferies Global Healthcare Conference in New York: One-on-one meetings and presentation at 8:10 am EDT on June 3rd

The webcasts for the fireside chat and presentation can be accessed by visiting the Events page in the Investor Relations section of Ascentage Pharma’s website.

(Press release, Ascentage Pharma, MAY 12, 2026, View Source [SID1234665524])

Immunome Reports First Quarter 2026 Financial Results and Provides Business Update

On May 12, 2026 Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, reported financial results for the quarter ended March 31, 2026, and provided a business update.

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"This quarter reflects the progress we are making in building Immunome into a multi-program targeted oncology company," said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Immunome. "The NDA submission for varegacestat is an important milestone that reflects our commitment to improving the lives of patients with desmoid tumors, for whom new treatment options are still needed. We are also pleased that detailed Phase 3 RINGSIDE data were selected for oral presentation at ASCO (Free ASCO Whitepaper). In parallel, we continue to advance our ADC pipeline, with IM-1021 progressing in Phase 1 and IM-1617 recently receiving IND clearance."

Pipeline Highlights

Varegacestat:


In April 2026, Immunome submitted an NDA to the U.S. FDA for varegacestat for the treatment of adults with desmoid tumors.

Immunome plans to submit a Marketing Authorization Application to the European Medicines Agency for varegacestat by the end of 2026.

Data from RINGSIDE, the global, Phase 3, randomized, placebo-controlled trial of varegacestat in patients with progressing desmoid tumors, have been selected for presentation in an oral abstract session at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting.

In December 2025, Immunome announced positive topline results from RINGSIDE:
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The registrational trial met its primary endpoint of improving progression-free survival vs. placebo, with a statistically significant and clinically meaningful 84% reduction in the risk of disease progression or death (hazard ratio = 0.16, p<0.0001).
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The trial also met all key secondary endpoints, including achieving an objective response rate of 56% vs. 9% with placebo (p<0.0001), as assessed by blinded independent central review.
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In an exploratory analysis, varegacestat demonstrated a median best change in tumor volume of -83% vs. +11% with placebo, as assessed by blinded independent central review.
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Varegacestat was generally well tolerated with a manageable safety profile, consistent with the gamma secretase inhibitor class.

IM-1021: The Phase 1 clinical trial of IM-1021 is ongoing, with objective responses observed in participants with B-cell lymphoma at multiple dose levels. Immunome expects to present initial lymphoma data for IM-1021 in 2026.

IM-3050: In March 2026, Immunome initiated the first clinical trial site for a Phase 1 trial of IM-3050 in patients with FAP-expressing solid tumors.

IM-1617: In April 2026, Immunome received IND clearance for IM-1617 and plans to initiate a Phase 1 trial in the second quarter of 2026. IM-1617 is a potential first-in-class ADC directed at an undisclosed solid tumor target and incorporates HC74, Immunome’s proprietary TOP1 inhibitor payload.

Preclinical ADC Pipeline: Immunome expects to submit INDs for IM-1340 and IM-1335 in mid- and late 2026, respectively. The programs are each directed at undisclosed solid tumor targets and incorporate HC74. Additional undisclosed ADCs are in discovery and lead optimization to support INDs in 2027 and beyond.

First Quarter 2026 Financial Results


As of March 31, 2026, cash and cash equivalents totaled $582.7 million. Immunome expects its current cash position to fund operations into 2028.

Research and development expenses for the quarter ended March 31, 2026, were $46.4 million, including stock-based compensation costs of $3.7 million.

General and administrative expenses for the quarter ended March 31, 2026, were $13.0 million, including stock-based compensation expense of $4.2 million.

Immunome reported a net loss of $53.8 million for the quarter ended March 31, 2026.

(Press release, Immunome, MAY 12, 2026, View Source [SID1234665539])

Molecular Partners Reports Financial Results and Highlights for Q1 2026, with Clinical Studies Initiated on MP0712 and MP0317

On May 12, 2026 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a novel class of custom-built protein drugs known as DARPin therapeutics ("Molecular Partners" or the "Company"), reported corporate highlights and unaudited financial results for the first quarter of 2026.

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"Molecular Partners had a strong start to 2026, with two clinical studies initiated. Our lead Radio-DARPin program, MP0712 targeting DLL3, is advancing in a Phase 1/2a trial, with clinical sites open and initial data anticipated this year. In addition, our new data highlight the ability to interchange isotopes on Radio-DARPins, including Lead-212 and Actinium-225, enabling our isotope-agnostic strategy in Radio. It is an exciting time for our company, and we have a strong financial position supporting the development of our growing pipeline of candidates," said Patrick Amstutz, Ph.D., CEO of Molecular Partners.

Research & Development Highlights

MP0712 & Radio-DARPin Pipeline

The US multicenter Phase 1/2a study of MP0712 has started (ClinicalTrials.gov: NCT07278479) and is recruiting. Four clinical sites are now open, with a total of nine expected by the end of 2026. Molecular Partners will present trial-in-progress posters on the Phase 1/2a study at the 2026 Annual Meeting of the Society of Nuclear Medicine and Molecular Imaging (SNMMI) and 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and expects to share initial clinical data from this study in 2026.

MP0712 is the Company’s lead Radio-DARPin Therapy (RDT) targeting the tumor-associated protein delta-like ligand 3 (DLL3) and carrying the therapeutic payload 212Pb. MP0712 is being co-developed with Molecular Partners’ strategic partner Orano Med, a pioneer in targeted alpha therapy, for the treatment of patients with small cell lung cancer (SCLC) and other neuroendocrine cancers. The Phase 1/2a study objectives are to assess safety and determine a recommended Phase 2 dose for MP0712. The study contains a pre-treatment imaging and dosimetry step with 203Pb-labeled MP0712.

Molecular Partners and the NuMeRI team of Dr. Mike Sathekge presented first patient imaging and dosimetry data on MP0712 at the 8th Theranostics World Congress (TWC) in January 2026. The data from five evaluable patients with various DLL3-expressing cancers, including SCLC, urothelial, and other neuroendocrine cancers, were generated with MP0712 carrying the diagnostic isotope 203Pb as part of a Named Patient Access Program under the legal framework for compassionate care in South Africa. The dosimetry data and the images, which showed specific uptake as well as robust accumulation of MP0712 in tumor lesions and limited uptake in healthy tissues, as intended, are supportive of the clinical development plans of MP0712 carrying the therapeutic isotope 212Pb.

The Company’s second RDT program MP0726 targets mesothelin (MSLN), a tumor target overexpressed across several cancers with high unmet need, such as ovarian cancer.
Molecular Partners has developed Radio-DARPins able to selectively bind to membrane-bound MSLN without being impacted by shed MSLN – a mechanism which has hampered the development of other MSLN-targeting therapeutics. Molecular Partners intends to advance MP0726 towards first-in-human imaging within the second half of 2026.

Molecular Partners is evaluating tumor targets in an isotope-agnostic manner for its Radio-DARPin pipeline and expects to nominate a new target in the second half of the year.

Molecular Partners presented pre-clinical data at the 3rd Global Radiopharmaceuticals Development Summit (RDS) in March 2026, outlining the suitability of Radio-DARPins to different isotopes. The data showed that the Company’s Radio-DARPin vector design allows interchangeability of alpha isotopes, including 212Pb and 225Ac, enabling an isotope-agnostic strategy to tailor therapeutic candidates to a specific target and disease biology.

In February 2026, the Company announced it entered into a non-exclusive development agreement with Eckert & Ziegler, a global leader in radiopharmaceutical manufacturing. This will expand the potential of Radio-DARPins as vectors for precise delivery of therapeutic alpha-emitting isotopes to tumors, now including 225Ac, in addition to 212Pb through the strategic partnership with Orano Med.

MP0317 (tumor-localized CD40 agonist)

An investigator-initiated, proof-of-concept Phase 2 study of MP0317 combined with standard-of-care (SoC) for the treatment of patients with advanced cholangiocarcinoma has started, with eight sites activated (NCT07036380) and patient treatment ongoing. The study is a randomized, multicenter study in France and aims to recruit 75 patients (with a 2-to-1 design, including 50 patients in the experimental arm and 25 in the control arm). The objective of the study is to assess the clinical benefit of MP0317 combined with SoC comprising the immunotherapy durvalumab, an anti-PD-L1 checkpoint inhibitor, plus gemcitabine-cisplatin-based chemotherapy, compared to SoC alone. MP0317, a FAP-localized CD40 agonist designed to lead to immune-mediated reshaping of the tumor microenvironment (TME), is hypothesized to improve the 12-month progression-free survival rate of patients compared to those treated with SoC only. The TME is known to play a crucial role in the development of cholangiocarcinoma, and of other solid tumor indications, and in treatment resistance.

The Company recently published in Nature Cancer (Steeghs et al. 2026 (e-pub 1 May); DOI: 10.1038/s43018-026-01150-1) the results from the completed Phase 1 dose-escalation study of MP0317 in patients with advanced solid tumors (NCT05098405; 46 patients treated across 9 dose levels). Comprehensive biomarker analyses from this trial confirmed tumor-localized CD40 activation and remodeling of the TME by MP0317, with a favorable safety profile. In addition, MP0317’s pharmacokinetic profile is suited for combination treatment settings, including checkpoint inhibitors. CD40 is an attractive target for cancer immunotherapy due to its strong immune-stimulatory activity. Molecular Partners believes that MP0317’s tumor-localized approach has the potential to deliver superior efficacy with fewer side effects compared to systemic CD40 agonists.

MP0533 (multispecific T cell engager)

MP0533 is being evaluated in a Phase 1/2a clinical trial for relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndrome/AML (NCT05673057), with the dose escalation part fully recruited (10 cohorts). Last patients are on treatment, including two patients in remission for over one year who reached minimal residual disease (MRD) negativity.

Data presented at the 2025 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting showed an acceptable safety profile for MP0533 monotherapy across all 9 reported treatment cohorts. The pooled data from these 9 cohorts, comprising relapsed/refractory patients, indicate preliminary clinical activity for MP0533 independent of genetic risk profile, in particular in patients with low bone marrow blast count at baseline across different treatment cohorts.

Initial data from cohort 10 are in line with cohorts 1-9 findings and will contribute to defining a recommended dose range for MP0533. The results of this study support the exploration of MP0533 in combination with other AML therapies, and Molecular Partners has been approached by several consortia expressing interest in conducting such studies.

MP0533 is a novel tetra-specific T cell-engaging DARPin designed for selective and broad killing of AML cells in a mutation-agnostic manner. MP0533’s mode of action enables T cell-mediated killing of AML cells – which commonly co-express at least two of the three targeted antigens (CD33, CD123, CD70) – while preserving a therapeutic window that minimizes damage to healthy cells, which normally express one or none of the targets.

MP0632 and Switch-DARPin Platform (logic-gated immune cell engagers)

Molecular Partners presented new pre-clinical data on its Switch-DARPin T cell engager, with MP0632 announced as lead, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2026. These data support proof-of-concept of the Switch-DARPin design, showing that MP0632 leads to regression of established tumors expressing both EpCAM and MSLN, with minimal impact on tumors expressing only one of the antigens, thereby indicating a favorable therapeutic window. In addition, MP0632 allowed for safe use of potent CD2 co-stimulation for efficient tumor cell killing with low cytokine release profile. The data support MP0632’s potential as clinical lead candidate for the treatment of solid cancers expressing MSLN and EpCAM, including ovarian, endometrial, pancreatic, and other cancers.

MP0632 is a logic-gated Switch-DARPin T-cell engager (TCE), designed to achieve conditional tumor-localized immune activation targeting MSLN and EpCAM, which are highly co-expressed in ovarian cancer and other solid tumors. The CD3-engaging DARPin is unmasked ("Switched" on) and activates T cells only upon binding to both MSLN and EpCAM. MP0632 is half-life extended through a Fc domain, which broadens the Company’s capabilities in half-life engineering modalities.

Corporate Governance Highlights

All motions proposed by the Board of Directors at the Annual General Meeting, held in April, were approved by the shareholders of the Company by a wide majority.

This included the election of Clare Fisher by shareholders to the Board of Directors. Clare Fisher has more than two decades of healthcare experience in leadership roles, including corporate and business development, mergers and acquisitions, and strategy. She is currently the SVP for Global Business Development and M&A at BeOne Medicines, a global oncology company committed to discovering and developing innovative treatments for cancer patients worldwide.

Financial and Business Outlook

The Company’s cash and cash equivalents and short-term time deposits were CHF 79 million (approximately USD 100 million) as of March 31, 2026, which, based on current operating assumptions, will be sufficient to fund its operations and capital requirements into late 2027 (previously early 2028) with increased R&D investment in an expanding pipeline.

Financial Calendar

August 25, 2026
Half-year results 2026
October 29, 2026
Interim Management Statement Q3 2026 (unaudited)

The latest timing of the above events can be viewed on the investor section of the website.

(Press release, Molecular Partners, MAY 12, 2026, View Source [SID1234665549])

Verastem Oncology to Present at Upcoming Investor Conferences

On May 12, 2026 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, reported that its management team is scheduled to participate and present at the following investor conferences in New York City:

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HCW 4th Annual BioConnect Investor Conference: Tuesday, May 19, 2026, 4:00-4:30 pm ET
RBC Global Healthcare Conference: Wednesday, May 20, 2026, 9:30-9:55 am ET

A live webcast of the fireside chat can be accessed under "Events & Presentations" on the Company’s website at www.verastem.com. A replay of the webcasts will be archived on the website for approximately 90 days following the presentation.

(Press release, Verastem, MAY 12, 2026, View Source [SID1234665565])