Enliven Therapeutics Announces Oral and Poster Presentations at the Society of Hematologic Oncology (SOHO) 2026 Annual Meeting

On August 31, 2026 Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics, reported that the Company will present data from the ENABLE Phase 1 clinical trial of ELVN-001 in an oral and a poster presentation at the Society of Hematologic Oncology (SOHO) Annual Meeting, taking place September 9-12, 2026, at the George R. Brown Convention Center in Houston, Texas. This is an encore presentation of data that were previously presented at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress.

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Details of the presentation are as follows:
Title: ENABLE: A Phase 1 Study of ELVN-001, a Novel, Selective ATP-Competitive Inhibitor of BCR::ABL1, in Patients with Previously Treated CP-CML
Presenter: Fadi Haddad, M.D.
Poster Session: Wednesday, September 9, 6:55-7:55 p.m. CDT
Poster Location: Hall B3, Level 3
Poster Number: CML-652
Oral Session Title: Session V: Chronic Myeloid Leukemia
Oral Session Date/Time: Thursday, September 10, 11:47 – 11:57 a.m. CDT

Following the presentation, a copy will be available on the "Program Presentations & Publications" section of the Company’s website at www.enliventherapeutics.com.

About the ENABLE Trial
The ENABLE study (NCT05304377) is a Phase 1 study of ELVN-001 in patients with previously treated CML. ENABLE is a dose escalation and expansion trial designed to evaluate safety and tolerability and to determine the recommended dose for further clinical evaluation of ELVN-001 in patients with CML with and without T315I mutations that is relapsed, refractory or intolerant to tyrosine kinase inhibitors (TKIs). Secondary endpoints include pharmacokinetics, major molecular response (MMR) by central quantitative reverse transcriptase polymerase chain reaction, duration of MMR, BCR::ABL1 transcript levels and complete hematologic response.

About ELVN-001
ELVN-001 is a potent, highly selective, potentially best-in-class small molecule kinase inhibitor designed to specifically target the BCR::ABL gene fusion, the oncogenic driver for patients with chronic myeloid leukemia. As a highly selective active-site TKI, ELVN-001 has a mechanism of action that is complementary to allosteric BCR::ABL1 inhibitors, which may play an increasingly important role in the standard of care. ELVN-001 was also designed to have activity against the T315I mutation, the most common BCR::ABL1 mutation, which confers resistance to nearly all approved TKIs, as well as activity against mutations known to confer resistance to allosteric BCR::ABL1 inhibitors.

(Press release, Enliven Therapeutics, AUG 31, 2026, View Source [SID1234670458])

ORYZON announces Notice of Allowance for U.S. patent application covering iadademstat combination with gilteritinib

On August 31, 2026 Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company and a global leader in epigenetics, reported that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. patent application No. US 18/554,241, entitled "Combinations of LSD1 inhibitors for treating myeloid cancers". The allowed claims cover combinations of iadademstat, or certain other LSD1 inhibitors, with gilteritinib and their use for the treatment of myeloid cancers, including acute myeloid leukemia (AML).

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Once granted, the U.S. patent is expected to expire in 2042, excluding any potential patent term adjustment or patent term extension. A corresponding patent has recently also been granted in Taiwan, with additional patent applications pending in other jurisdictions.

"This U.S. Notice of Allowance further strengthensthe intellectual property protection around iadademstat and its use in combination with gilteritinib in AML," said Neus Virgili, Oryzon’s Chief IP Officer. "Together with our broader portfolio of patents covering iadademstat combinations with other AML therapies, this allowance reinforces the long-term protection of our iadademstat franchise."

Iadademstat is currently being evaluated in seven ongoing oncology clinical trials, including the Phase Ib FRIDA study in combination with gilteritinib in FLT3-mutated relapsed/refractory AML and the Phase Ib ALICE-2 study in combination with venetoclax and azacitidine in first-line AML. Updated positive clinical data from both studies were presented at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Annual Congress in June

In FRIDA, iadademstat in combination with gilteritinib achieved a composite complete remission (CRc) rate of 67% at the dose level selected for expansion in a heavily pretreated population with relapsed/refractory FLT3-mutated AML, together with a favorable safety profile. These results are particularly encouraging when compared with contemporary real-world data for gilteritinib monotherapy in a broadly comparable population, which reported a CR/CRi rate of 28% and a median overall survival of 7.1 months.

In ALICE-2, iadademstat in combination with venetoclax and azacitidine achieved a 100% overall response rate, an 89% CRc rate and a 78% complete remission rate. These findings compare favorably with historical outcomes for venetoclax plus azacitidine, where approximately 36% of patients failed to achieve a clinical response. Additional, more mature data from both studies are expected to be presented by year-end.

In addition to this patent family covering combinations with gilteritinib, Oryzon has patent protection covering combinations of iadademstat with venetoclax, azacitidine and other AML therapies, including granted patents in the United States and other major markets.

(Press release, Oryzon, AUG 31, 2026, View Source;utm_medium=email&utm_campaign=NdP.21+2026-08-31+Grant+iada+gilte+ENG844 [SID1234670457])

Torqur Receives European Commission Orphan Drug Designation for Bimiralisib in Thymic Epithelial Tumours

On August 31, 2026 Torqur AG, a Swiss Rockets company advancing innovative clinical-stage treatments for oncology and dermatology, reported that the European Commission has granted orphan drug designation (ODD) for bimiralisib for the treatment of thymic epithelial tumours, following a positive opinion from the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP). This marks bimiralisib’s third orphan drug designation, and its first in a solid tumour indication, building on the company’s broader oral bimiralisib oncology pipeline.

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An EU Orphan drug designation reflects the intention to diagnose, prevent or treat a life-threatening or chronically debilitating condition affecting not more than five in 10 thousand people in the Community when the application is made. Thymic epithelial tumours are severe and life-threatening cancers with significant unmet medical need and a lack of effective treatment options and are chronically debilitating due to their association with severe autoimmune comorbidities, such as myasthenia gravis, and their potential progression to refractory disease. The ODD recognizes the potential of bimiralisib to address the needs of patients affected by this devastating disease. Orphan designation in the EU provides access to protocol assistance and reduced regulatory fees during development and, upon marketing authorisation, up to ten years of market exclusivity in the designated indication.

The COMP’s positive opinion was based on the nonclinical and clinical data package submitted for bimiralisib in this indication. The ODD in thymic epithelial tumours adds to Torqur’s broader oral bimiralisib oncology development program. The company continues to evaluate bimiralisib’s potential across additional solid tumour types linked to this pathway, alongside its topical bimiralisib program in actinic keratosis (AK), which is advancing towards Phase 3.

Dr. Vladimir Cmiljanović, Founder, Chairman and CEO of Swiss Rockets AG, commented: "This orphan drug designation is an important milestone for bimiralisib’s development — the first time our dual PI3K/mTOR platform has earned this recognition in a solid tumour. It reflects our continued commitment to bringing bimiralisib to patients with thymic epithelial tumours, who currently have very few treatment options. It also strengthens our conviction in bimiralisib’s potential across the broader oncology pipeline we are building."

Dr. Fabio Conforti, Chief of the medical oncology breast unit at Humanitas Gavazzeni, Bergamo: "Thymic epithelial tumours are rare and biologically diverse cancers, and treatment options for patients have historically been limited. Research into therapies that target relevant molecular pathways is an important step forward, and I am glad to see bimiralisib being evaluated for its potential to address this significant unmet need."

About Bimiralisib

Bimiralisib is Torqur’s dual pan-PI3K/mTOR inhibitor developed for oral administration in the treatment of malignant diseases with altered PI3K/AKT/mTOR pathway signalling, one of the most frequently dysregulated signalling cascades in cancer. By potently and selectively blocking the PI3K/AKT/mTOR pathway at two nodes rather than one, bimiralisib is designed to promote cancer-cell death while suppressing or reversing the drug-resistance mechanisms that can limit single-node inhibitors. In dermatology, bimiralisib is being developed as a topical formulation for actinic keratosis (AK), the world’s most common precancerous skin condition, with pivotal Phase 3 trials expected to begin in 2027.

(Press release, Torqur, AUG 31, 2026, View Source [SID1234670456])

SRX Global Acquires Senior Secured Debt in CERo Therapeutics Holdings, Inc., an Innovative Cellular Immunotherapy Company with Cancer Fighting Molecule for the Treatment of Hematologic Cancers

On August 31, 2026 SRX Global Inc. (NYSE American: SRXH) (the "Company" or "SRX"), an AI-enabled platform dedicated to generating long-term shareholder value through investments in high-conviction operating companies and strategic assets, reported that it has purchased senior secured debt in CERo Therapeutics Holdings, Inc. (OTCQB: CERO) ("CERo Holdings" and, together with CERo Therapeutics, "CERo"), an innovative cellular immunotherapy company advancing next generation engineered T cell therapeutics that employ phagocytic mechanisms. The investment is expected to provide CERo with additional capital to accelerate the advancement of its clinical programs.

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SRX Global CEO Kent Cunningham stated, "This secured investment reflects our strategy of investing in high-conviction operating companies with differentiated assets and meaningful long-term value creation potential. CERo’s novel approach to engineered T cell therapeutics with multifunctional tumor clearing, and the clinical progress the team has made with CER-1236, make it a compelling addition to our platform.

"We expect this investment to provide CERo with enhanced access to capital and broader operational resources to support the continued advancement of CER-1236 and its broader R&D efforts."

To date, CERo has treated six patients in the ongoing Phase 1 CERTAIN-T trial. In the most recent cohort of three patients, CER-1236 was administered at an increased dose level, with no dose-limiting toxicities ("DLTs") observed during the DLT assessment period. As previously reported, CERo has also observed expansion of infused CER-1236 cells following administration, and the company continues to evaluate the pharmacokinetic and pharmacodynamic profile of CER-1236 as the study advances through dose escalation.

CERo has initiated the third planned cohort of the CERTAIN-T study, which is expected to evaluate the planned one billion cells/patient protocol and is currently screening patients for enrollment. The cohort is also expected to include patients with myelodysplastic syndromes ("MDS") and myelofibrosis ("MF"), reflecting CERo’s strategy to further evaluate CER-1236 in additional myeloid disease settings.

About the CERTAIN-T Trial
The first-in-human, multicenter, open-label Phase 1/1b CERTAIN-T study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of CER-1236 in patients with hematologic malignancies. The study initially enrolled patients with acute myeloid leukemia ("AML"), including relapsed/refractory AML, measurable residual disease AML, and newly diagnosed TP53-mutated AML, and has since expanded to include transfusion-dependent myelodysplastic syndromes ("TD-MDS"), high-risk myelodysplastic syndromes ("HR-MDS"), and post-JAK inhibitor myelofibrosis ("MF"). Primary endpoints include safety and tolerability. Secondary endpoints include pharmacokinetics and measures of clinical response, including overall response rate ("ORR"), complete response ("CR"), composite complete response ("cCR"), and measurable residual disease ("MRD").

(Press release, Cero Therapeutics, AUG 31, 2026, View Source;storyId=5745116834070015 [SID1234670455])

Beam Therapeutics to Participate in Upcoming September 2026 Investor Conferences

On August 31, 2026 Beam Therapeutics Inc. (Nasdaq: BEAM), a biotechnology company developing precision genetic medicines through base editing, reported that management will participate in fireside chats at the following upcoming investor conferences:

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Wells Fargo 21st Annual Healthcare Conference on Tuesday, September 8, 2026 at 1:30 p.m. ET in Boston
Citi’s Biopharma Back to School Conference on Wednesday, September 9, 2026 at 1:00 p.m. ET in New York
Cantor Fitzgerald Global Healthcare Conference 2026 on Thursday, September 10, 2026 at 8:00 a.m. ET in New York

The live webcasts will be available in the investor section of the company’s website at www.beamtx.com and will be archived for 60 days following the presentation.

(Press release, Beam Therapeutics, AUG 31, 2026, View Source [SID1234670454])