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

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

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

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

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

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

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

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

Key Findings from AMPLIFY-7P

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

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

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

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

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

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

About ELI-002

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

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

About the AMP Platform

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

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

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

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

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

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

Poster Presentation:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

EHA 2026 Presentation Details

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

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

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

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

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

On June 15, 2026 Alvotech (NASDAQ: ALVO; ALVO-SDB) ("Alvotech" or the "Company"), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, reported the pricing of its previously announced underwritten public offering (the "Offering") of 22,666,667 of its ordinary shares at an offering price of $3.75 per share. All ordinary shares to be sold in the Offering will be offered by Alvotech. The Offering is expected to close on or about June 17, 2026, subject to satisfaction of customary closing conditions. The Company has also granted the underwriters a 30-day option to purchase up to an additional 3,400,000 ordinary shares at the public offering price, less underwriting discounts and commissions. Before deducting the underwriting discounts and commissions and offering expenses, the Company expects to receive total gross proceeds of approximately $85 million from the Offering, or approximately $98 million if the underwriters exercise in full their option to purchase additional shares.

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Concurrent with the Offering, Alvotech has entered into Subscription Agreement(s) with certain investors that are professional clients or eligible counterparties in the European Economic Area falling within article 1(4) of Regulation (EU) 2017/1129, pursuant to which Alvotech will issue and sell 17,826,666 ordinary shares to such investors at a price of $3.75 per ordinary share, which represents the per share public offering price, in a private placement exempt from the registration requirements of the Securities Act of 1933, as amended. The gross proceeds from the concurrent private placement, before deducting any transaction-related expenses, are expected to be approximately $67 million. The concurrent private placement is expected to close on or about June 25, 2026, subject to the consummation of the Offering and other customary conditions. However, the consummation of the Offering is not contingent on the consummation of the concurrent private placement.

The total gross proceeds from the Offering and the concurrent private placement are expected to be approximately $152 million, or approximately $165 million if the underwriters exercise in full their option to purchase additional shares, in each case before deducting underwriting discounts and commissions and estimated offering expenses payable.

Alvotech intends to use the net proceeds from this Offering and the concurrent private placement to fund the continued development of its biosimilar assets, as well as working capital and general corporate purposes, which may include, among others, intellectual property protection and enforcement, commercial expenditures, capital expenditures, acquisitions or collaborations, pre-clinical and clinical development of its product candidates, research and development and product development, pre-commercialization activities and repayment or refinancing of indebtedness or other corporate borrowings.

BofA Securities, Jefferies and Evercore ISI are acting as joint book-running managers for the Offering.

The Offering is being made pursuant to a registration statement on Form F-3, including a base prospectus, that was previously filed with the U.S. Securities and Exchange Commission ("SEC") on October 20, 2023, and declared effective on October 30, 2023. The ordinary shares referred to in this press release are being offered in the United States only by means of a prospectus supplement and the accompanying prospectus that forms a part of the registration statement. Copies of the final prospectus supplement and the accompanying prospectus related to this Offering may be obtained, when available, from: BofA Securities, Attention: Prospectus Department, 201 North Tryon Street, Charlotte, NC 28255-0001, or by email at [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, by telephone at (888) 474-0200, or by email at [email protected]. Investors may also obtain these documents at no cost by visiting the SEC’s website at View Source

(Press release, Alvotech, JUN 15, 2026, View Source [SID1234668750])

On June 15, 2026 Aptose Biosciences Inc. ("Aptose" or the "Company") (TSX: APS; OTC: APTOF), a clinical-stage precision oncology company, reported that data from its Phase 1/2 TUSCANY trial in newly diagnosed AML patients treated with tuspetinib (TUS) in combination with standard of care dosing venetoclax and azacitidine (TUS+VEN+AZA triplet) was presented yesterday in an oral presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress (EHA 2026) in Stockholm, Sweden.

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The TUS+VEN+AZA triplet is being developed as a mutation agnostic frontline therapy to treat large, mutationally unrestricted and diverse populations of newly diagnosed AML patients who are ineligible to receive induction chemotherapy. Nikolai Podoltsev, MD, PhD, Associate Professor Medical Oncology & Hematology, Clinical Director, Malignant Hematology, Yale School of Medicine, and an investigator in the TUSCANY study, reported updated safety and efficacy data from the 80 mg and 120 mg dose cohorts, as well as new data from the 160 mg dose of TUS in the TUS+VEN+AZA triplet.

"While there have been recent successes with targeted therapy in AML treatment, our multi-targeted approach with tuspetinib in combination is showing significant efficacy across mutations that have been historically difficult to treat, including TP53 mutations, where we thus far have achieved CRs in all of the four subjects at the highest dose cohort," said Rafael Bejar, MD, PhD, Chief Medical Officer, Aptose. "As a safe and effective inhibitor of multiple growth factor signaling pathways, the TUS+VEN+AZA triplet is a first line combination therapy with the potential to improve outcomes in nearly all AML populations."

The oral presentation at EHA (Free EHA Whitepaper) included updated safety, complete remission, minimal residual disease (MRD) assessments, and longer duration of follow-up:

Presentation title: TUSCANY Study of Safety and Efficacy of Tuspetinib Plus Standard of Care Venetoclax and Azacitidine in Study Participants with Newly Diagnosed AML Ineligible for Induction Chemotherapy

Presenter: Nikolai Podoltsev, MD, PhD, Associate Professor (Medical Oncology & Hematology), Department of Internal Medicine; Clinical Director, Malignant Hematology, Associate Program Director, Hematology / Medical Oncology Fellowship Program, Yale School of Medicine

Key findings:

32 (29 response evaluable), newly diagnosed AML patients have received the TUS+VEN+AZA combination:
4 received the 40 mg dose of TUS, 12 received the 80 mg dose of TUS, 3 received the 120 mg dose of TUS, and 13 received the 160 mg dose

The overall CRc rate across dose levels in response evaluable (29) patients was 86.2%.
The MRD negative rate among all patients dosed was 62.5%; MRD negative rate in CR/CRh patients was 86.2%.

At the 160 mg TUS dose level (n=13):
The overall CRc rate was 76.9% (10 of 13 patients), including 8 of 11 (72.7%) with unmutated (or wildtype) FLT3
100 % composite complete remission in all 4 patients with TP53-mutation with complex karyotype (TP53-mut/CK)

Regardless of mutation status, TUS is active in newly diagnosed AML patients
MRD-negative responses achieved across diverse genetic populations, including adverse TP53 mutations and CK
Responses continue to evolve with 19 subjects remaining on treatment, including 6 that moved on to stem cell transplantation

TUS can be administered safely with standard-of-care dosing of VEN/AZA
TUS PK properties were not significantly altered by VEN, AZA, antifungals or food
No treatment-related deaths
No treatment-related adverse events of QTc prolongation, CPK elevations or differentiation syndrome
Abstracts are available on the EHA (Free EHA Whitepaper)2026 website here. The presentation is available on the Aptose website here.

TUSCANY: TUS+VEN+AZA Triplet Phase 1/2 Study

The tuspetinib-based TUS+VEN+AZA triplet therapy is being advanced in the TUSCANY Phase 1/2 clinical study with the goal of creating an improved frontline therapy for newly diagnosed AML patients that is active across diverse AML populations, durable, and well tolerated. Earlier APTIVATE trials of TUS as a single agent and in combination as TUS+VEN demonstrated favorable safety and broad activity in diverse relapsed or refractory (R/R) AML populations that went beyond the more prognostically favorable NPM1 and IDH mutant subgroups. Indeed, responses were also in R/R AML patients with highly adverse TP53 and RAS mutations, and those with mutated or unmutated (wildtype) FLT3 genes.

The TUSCANY Phase 1/2 study, being conducted at 10 leading U.S. clinical sites by elite clinical investigators, is designed to test various doses and schedules of TUS in combination with standard dosing of AZA and VEN for patients with AML who are ineligible to receive induction chemotherapy. A convenient, once daily oral agent, TUS, is being administered in 28-day cycles.

More information on the TUSCANY Phase 1/2 study can be found on www.clinicaltrials.gov (here).

(Press release, Aptose Biosciences, JUN 15, 2026, View Source [SID1234668735])