Enliven Therapeutics Announces Updated Positive Phase 1 Clinical Data and Alignment with FDA on Key Phase 3 Trial Design Components

On June 11, 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 updated positive data from the Phase 1 ENABLE clinical trial evaluating ELVN-001 in patients with previously treated chronic myeloid leukemia (CML). An oral presentation will be delivered later today at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress, taking place June 11-15 in Stockholm, Sweden, and virtually. The Company also provided an update on recent regulatory interactions with the Food and Drug Administration (FDA). Enliven will host a webcast and conference call today, June 11, at 8:30 a.m. ET / 2:30 p.m. CEST.

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"Despite recent advances in CML treatment, there remains a need for highly effective therapies with excellent safety and tolerability profiles optimized for long-term treatment and capable of deep and durable molecular responses," said Dennis Kim, M.D., Professor of Medicine in the Department of Medical Oncology and Hematology at the Princess Margaret Cancer Centre, Canada. "The updated data from the ENABLE trial are very promising and encouraging. The trial demonstrated meaningful responses across lines of therapy in heavily pretreated patients, including responses in patients who had shown a lack of efficacy to the most effective approved therapies. Further, ELVN-001 demonstrated a favorable safety and tolerability profile, reflecting its high selectivity. I look forward to the initiation of the planned Phase 3 ENABLE-2 trial, which could establish ELVN-001 as an important new treatment option for patients with previously treated CML."

"These promising results continue to showcase the consistency of ELVN-001’s overall profile and reinforce its potential to be a best-in-class ATP-competitive inhibitor with differentiated activity relative to allosteric inhibitors," said Helen Collins, M.D., Chief Medical Officer of Enliven. "In these data, we observed higher response rates in patients treated in earlier lines of therapy, and comparable response rates regardless of prior asciminib exposure. We are also thrilled by the outcome of our recent End-of-Phase 1 meeting with the FDA, where we reached alignment on the 80 mg once daily dose and the inclusion of patients who have received at least one prior TKI in the planned ENABLE-2 Phase 3 trial. This is an important milestone as we advance towards initiating ENABLE-2 later this year."

ELVN-001 is a potent, highly selective, potentially best-in-class small molecule kinase inhibitor designed to specifically target the BCR::ABL1 gene fusion, the oncogenic driver for patients living with CML. Data presented at EHA (Free EHA Whitepaper) are from the ongoing ENABLE Phase 1 clinical trial, which enrolled patients with CML that is relapsed, refractory or intolerant to available tyrosine kinase inhibitors (TKIs) (NCT05304377).

ELVN-001 Updated Data Highlights

ENABLE Has Enrolled a Heavily Pretreated Patient Population

As of the cutoff date of March 10, 2026, 161 patients were enrolled in the ongoing Phase 1 trial across dose levels ranging from 10-240 mg daily.
Most patients (76%) remain on study with a median treatment duration of 35 weeks.
Patients enrolled were heavily pretreated, with 70% having received three or more prior unique TKIs and 23% having received five or more unique TKIs.
62% of patients received prior asciminib, and these patients were more heavily pretreated than the overall trial population: 93% received three or more prior unique TKIs, and 34% received five or more unique TKIs.
8% of patients enrolled with mutations associated with resistance to allosteric inhibitors, increasing from 4% in Phase 1a to 11% in Phase 1b.
Encouraging ELVN-001 Efficacy Data by 24 Weeks

Of the 90 patients enrolled in the Phase 1b, 78 had typical BCR::ABL1 transcripts and had at least one post-baseline transcript; 69 patients were evaluable for major molecular response (MMR) by 24 weeks.
Additionally, of the 49 patients enrolled in the 80 mg once daily (QD) Phase 1b cohort, 37 had typical BCR::ABL1 transcripts and had at least one post-baseline transcript; 28 patients were evaluable for MMR by 24 weeks.
Cohort (n = evaluable for MMR)

Phase 1b

Phase 1b 80 mg QD
Cohort

Overall MMR

54% (n=69)

61% (n=28)

Achieved MMR

40% (n=53)

48% (n=21)

Maintained MMR

100% (n=16)

100% (n=7)

Deep Molecular Response (DMR) achievement rates were also encouraging.
By 24 weeks, DMR was achieved in 22% of patients in the overall Phase 1b and 30% of patients in the 80 mg QD Phase 1b cohort.
Response rates were higher in less heavily pretreated patients, and prior asciminib exposure did not meaningfully impact response rates.
Achieved Response Rates by 24-weeks (n = evaluable for MMR)

Prior number of unique TKIs:

Phase 1b (n=69)

Phase 1b post-asciminib (n=43)

1-2

55% (n=27)

60% (n=6)

3-4

32% (n=26)

28% (n=22)

5+

29% (n=16)

29% (n=15)

ELVN-001’s Safety Profile Consistent with High Selectivity for ABL1

ELVN-001 was generally well-tolerated, consistent with its high selectivity.
6% of patients discontinued due to adverse events.
The majority of treatment-emergent adverse events (TEAEs) were Grade 1 or 2.
Grade ≥3 TEAEs were reported in 53/158 (34%) patients overall; with thrombocytopenia (6%), neutropenia (6%) and lipase elevation (6%) as the most common.
At the biologically optimal dose of 80 mg QD (n=62), Grade ≥3 TEAEs were reported in 15/62 (24%) patients, with thrombocytopenia (6%) being the only Grade ≥3 TEAE reported in >5% of patients.
Key Outcomes from the End-of-Phase 1 Meeting with the FDA

80 mg QD selected as the recommended dose for Phase 3 ENABLE-2 trial.
ENABLE-2 is expected to enroll patients with CML previously treated with one or more TKIs, and to be randomized to receive either ELVN-001 or physician’s choice of an ATP-competitive TKI.
Additional details of the Phase 3 trial design are expected to be finalized following further discussions with the FDA, including at a planned End-of-Phase 2 meeting anticipated in the third quarter of 2026.
The oral presentation titled: "ENABLE: Updated Efficacy and Safety Results of ELVN-001, a Novel Selective ATP-Competitive Inhibitor of BCR::ABL1, in Patients with Previously Treated CP-CML" will be presented today at 5:45 p.m. CEST during the European Hematology Association (EHA) (Free EHA Whitepaper) Congress in Stockholm, Sweden, by Dennis Kim, M.D., Professor of Medicine, Department of Medical Oncology and Hematology at the Princess Margaret Cancer Centre, Canada. A copy of the presentation will be available on the "Program Presentations & Publications" section of the Company’s website at www.enliventherapeutics.com.

Webcast and Conference Call Information
Enliven will host a live webcast and conference call today at 8:30 a.m. ET / 2:30 p.m. CEST. To participate in the live event, please register using this link. Following registration, participants will have access to dial in numbers and a unique passcode should they prefer to participate by phone. The event and accompanying slides can also be accessed by visiting the investor relations section of the Company’s website at View Source An archived webcast will be available on the Company’s website following the event.

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 TKIs. Secondary endpoints include pharmacokinetics, 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. ELVN-001, a highly selective active-site TKI, 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 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, JUN 11, 2026, View Source [SID1234666582])

FDA grants Priority Review for Roche’s Tecentriq for a certain type of stage III colon cancer

On June 11, 2026 Roche (SIX: RO, ROP; OTCQX: RHHBY) reported that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) filing for adjuvant Tecentriq (atezolizumab) and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) in combination with chemotherapy in stage III deficient DNA mismatch repair (dMMR) or microsatellite instability-high (MSI-H) colon cancer, a type of tumour characterised by high mutation rates. The FDA has granted Priority Review and is expected to make a decision on the approval by 9 October 2026.

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"This filing acceptance brings us closer to establishing adjuvant Tecentriq plus chemotherapy as a new standard of care for certain types of early colon cancer," said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. "The ATOMIC results demonstrate that Tecentriq plus chemotherapy can substantially reduce the risk of disease recurrence or death, helping more patients remain cancer-free following surgery."

"One in three patients with stage III colon cancer will relapse within five years, underscoring the need for new adjuvant treatment options," said Michael Sapienza, CEO, Colorectal Cancer Alliance. "This milestone represents a critical step toward a reality where treatment is tailored to a patient’s specific tumor biology from the very beginning, giving them a better chance of preventing a recurrence."

The application is based on the landmark ATOMIC study, recently published in The New England Journal of Medicine. ATOMIC demonstrated that adding Tecentriq to standard FOLFOX6 chemotherapy reduced the risk of disease recurrence or death by 50%, compared to chemotherapy alone for people with stage III dMMR colon cancer, determined by an immunohistochemistry test, such as the VENTANA MMR RxDx Panel. The 36-month disease-free survival was 86% for Tecentriq combined with FOLFOX6 compared with 76% in the FOLFOX6 alone group. The safety profile was consistent with previous studies of Tecentriq and FOLFOX6.1

Colon cancer remains one of the world’s most common and deadliest tumours.4 Over one million people are diagnosed globally each year, and despite surgery and chemotherapy, approximately 30% of stage III patients relapse within five years.2-4 Approximately 15% of colon cancer patients present with dMMR/MSI-H tumours, which indicate a higher mutation rate and thus have the potential to respond to immunotherapy.5

Roche is pursuing further regulatory filings for Tecentriq, including with the European Medicines Agency, to bring this first immunotherapy-based adjuvant option to patients with dMMR/MSI-H colon cancer worldwide.

The ATOMIC study was sponsored by the National Cancer Institute (NCI) and conducted by the Alliance for Clinical Trials in Oncology in partnership with Roche and the Arbeitsgemeinschaft Internistische Onkologie (AIO) group in Germany. It highlights Roche’s commitment to working alongside leading academic groups to tackle some of the most challenging cancers.

About the ATOMIC study
ATOMIC (A021502, NCT02912559) is a phase III, randomised, open-label, multicentre study investigating the addition of Tecentriq (atezolizumab) to FOLFOX6 chemotherapy (a combination of folinic acid, fluorouracil, and oxaliplatin) in patients with stage III colon cancer who have a deficiency in DNA mismatch repair (dMMR). The trial enrolled 712 patients. Participants were randomised 1:1 to receive either FOLFOX6 plus Tecentriq for 12 cycles (six months) followed by Tecentriq monotherapy for 13 cycles (an additional six months), or FOLFOX6 alone for 12 cycles. The primary endpoint is disease-free survival (DFS).

About Tecentriq (atezolizumab)
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1, which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.

Tecentriq has been approved for some of the most aggressive and difficult-to-treat forms of cancer, and is the first PD-(L)1 cancer immunotherapy available in both subcutaneous and intravenous formulations.

(Press release, Hoffmann-La Roche, JUN 11, 2026, View Source [SID1234666598])

Nurix Therapeutics to Report Updated Phase 1a/b Results for BTK Degrader Bexobrutideg, Highlighting Durable Responses in Relapsed/Refractory CLL/SLL and Promising Activity in Earlier Lines of Therapy

On June 11, 2026 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines, reported updated clinical data from the Company’s ongoing NX-5948-301 Phase 1a/b clinical trial evaluating bexobrutideg (NX-5948), an investigational oral CNS-penetrant BTK degrader, in patients with chronic lymphocytic leukemia (CLL). The data will be presented during an oral presentation at the 2026 EHA (Free EHA Whitepaper) Congress taking place June 11–14, 2026, in Stockholm, Sweden.

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"These updated data continue to demonstrate the differentiated profile of bexobrutideg, including durable responses in heavily pretreated patients and encouraging activity in patients earlier in their treatment journey," said Talha Munir, M.B. Ch.B., Ph.D., consultant hematologist at Leeds Teaching Hospitals NHS Trust and deputy chair of the United Kingdom National Cancer Research Institute CLL Study Group. "Importantly, responses were observed across patients with difficult-to-treat disease characteristics, including BTK inhibitor resistance mutations, high-risk molecular features and CNS involvement, while maintaining a favorable tolerability profile."

"With longer follow-up in relapsed/refractory CLL and expansion into earlier-line treatment settings, we continue to see a consistent efficacy and safety profile for bexobrutideg," said Paula O’Connor, M.D., chief medical officer of Nurix. "The durability of responses observed in heavily pretreated patients together with the promising activity seen in BCL2i-naïve and BTKi-naïve patients further support the broad potential of BTK degradation across all lines of therapy in CLL."

"These latest findings continue to reinforce our belief that bexobrutideg has the potential to redefine BTK-directed therapy and emerge as a potentially best-in-class treatment for CLL," said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix Therapeutics. "The updated data to be presented at EHA (Free EHA Whitepaper) across Phase 1 cohorts continue to support the launch of a broad Phase 3 monotherapy program and strengthen the rationale for exploring the use of combination regimens in first- and second-line patients. We look forward to advancing these programs through our recently announced collaboration with Roche."

Growing Safety Cohort Continues to Support Differentiated Profile
Across all Phase 1a/b CLL patients (n=142), bexobrutideg was well tolerated, consistent with prior disclosures, with safety findings generally comparable between patients treated at the 600 mg RP2D and the broader study population.

As of the January 1, 2026, data cutoff:
•No dose-limiting toxicities were observed
•No treatment-related Grade 5 adverse events were reported
•Treatment discontinuations due to adverse events occurred in only 5.6% of patients
•The most common treatment-emergent adverse events included purpura/contusion, neutropenia, petechiae, diarrhea, and fatigue.

Updated Phase 1a Data in Relapsed/Refractory CLL Continue to Support Durable Responses
The Phase 1a dose escalation study enrolled 48 patients with relapsed/refractory CLL/SLL treated with bexobrutideg at doses ranging from 50 mg to 600 mg once daily. Patients were heavily pretreated, having received a median of four prior lines of therapy (range 2–12), including prior BTK inhibitors (97.9%), prior BCL2 inhibitors (83.3%), and prior non-covalent BTK inhibitors (27.1%). Baseline high-risk features included BTK inhibitor resistance mutations (38.3%), TP53 mutations (44.7%), PLCG2 mutations (14.9%), and central nervous system (CNS) involvement (10.4%).

As of the January 1, 2026, data cutoff:
•Median follow-up was 22.4 months
•Median progression-free survival (PFS) was 22.1 months (95% CI: 14.0–NR)
•Objective response rate (ORR) was 83.0% (95% CI: 69.2–92.4)
•Responses included two complete responses, one nodal partial response, and 36 partial responses.
•Responses were observed across patients with BTK inhibitor resistance mutations, high-risk molecular features, and CNS involvement

Phase 1b Data Supports High ORR in Earlier-Line Cohorts
Nurix also presented new data from two of the Phase 1b cohorts evaluating bexobrutideg in earlier lines of treatment, including patients who had received prior BTKi treatment but were BCL2i-naïve (Cohort 5) and patients who were BTKi-naïve, including treatment-naïve patients (Cohort 15).

In Cohort 5 (n=19), patients had received prior BTK inhibitor therapy but no prior BCL2 inhibitor:
•ORR was 92.9% (95% CI: 66.1–99.8) among evaluable patients (n=14)
•18 of 19 patients remained on treatment at data cutoff
•Median follow-up was 5.2 months
•Five patients have not yet reached their first scan but remain on treatment

In Cohort 15 (n=20), which included BTKi-naïve and treatment-naïve patients:
•ORR was 84.2% (95% CI: 60.4–96.6) among evaluable patients (n=19)
•19 of 20 patients remained on treatment at data cutoff
•Median follow-up was 4.9 months
•Three patients with stable disease remain on treatment

About Bexobrutideg
Bexobrutideg (NX-5948) is an investigational, orally bioavailable, brain-penetrant, highly selective small-molecule degrader of Bruton’s tyrosine kinase (BTK) being developed by Nurix and Roche as a potential best-in-class therapy across oncology, immunology and neurology.

Bexobrutideg is currently being evaluated in the DAYBreak CLL-201 clinical trial (NCT07221500), a pivotal single-arm Phase 2 study in patients with relapsed or refractory chronic lymphocytic leukemia (CLL), and in the NX-5948-301 Phase 1a/1b clinical trial (NCT05131022) in patients with relapsed or refractory B-cell malignancies. A new tablet formulation of bexobrutideg is also being evaluated in a first-in-human single-ascending-dose and multiple-ascending-dose study in healthy volunteers (NCT06717269) to support future development in immunology and neurology indications. Additional information about ongoing clinical trials can be found at clinicaltrials.gov.

(Press release, Nurix Therapeutics, JUN 11, 2026, View Source [SID1234666567])

Compugen to Present Phase 1 MAIA-Ovarian Trial-in-Progress Poster at ESMO Gynaecological Cancers Congress 2026

On Jiune 11, 2026 Compugen Ltd. (NASDAQ: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in predictive computational drug target discovery powered by AI/ML, reported that it will present a trial-in-progress poster on the MAIA-ovarian Phase 1 study of COM701, a potential first-in-class anti-PVRIG antibody, at the ESMO (Free ESMO Whitepaper) Gynaecological Cancers Congress 2026, taking place from June 17 to June 19, 2026, in Copenhagen, Denmark.

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Poster details:

Title: MAIA-ovarian (NCT06888921) Adaptive Platform Clinical Trial to Evaluate Safety and Efficacy of COM701 Maintenance Treatment in Relapsed Platinum Sensitive Ovarian Cancer (PSOC)

Speaker: Dr. Oladapo Yeku, Massachusetts General Hospital, Boston, MA, U.S.

Poster presentation number: 170

Date and time of poster presentation: June 18, 2026, 12:45 – 13:30 CEST

Following the presentation, the poster will be available in the publications section of Compugen’s website, www.cgen.com

(Press release, Compugen, JUN 11, 2026, View Source [SID1234666583])

Medicenna Strengthens U.S. Patent Estate with Newly Issued and Allowed Patents Across its IL-2, IL-4 and IL-13 Superkine Platforms

On June 11, 2026 Medicenna Therapeutics Corp. ("Medicenna" or the "Company") (TSX: MDNA, OTCQX: MDNAF), a clinical-stage immunotherapy company developing Superkines for targeting cancer and autoimmune disease, reported the issuance of two new U.S. patents and the allowance of an additional U.S. patent application covering its proprietary IL-4 and IL-13 Superkine platforms, including bizaxofusp (formerly MDNA55), the Company’s IL-4 Empowered Superkine in clinical development for recurrent glioblastoma (rGBM).

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The newly issued U.S. patents, together with parallel patents recently granted in Australia and Canada within the same patent families, further reinforce Medicenna’s intellectual property position across the cytokine biology underlying its lead clinical programs: bizaxofusp, MDNA11 (IL-2 Superkine) and MDNA113 (anti–PD-1 × IL-2 bifunctional Superkine).

"These newly issued and allowed U.S. patents underscore the depth and breadth of the Superkine science Medicenna has built and the strength of the IP estate now protecting the platforms behind bizaxofusp, MDNA11 and MDNA113," said Dr. Fahar Merchant, President and Chief Executive Officer of Medicenna. "Our cytokine engineering work spans three distinct receptor systems, including IL-2, IL-4 and IL-13 and these grants extend protection into important new applications, including cellular immunotherapy and combination treatment of CNS tumors. With more than 100 active granted patents and applications worldwide, Medicenna has assembled what we believe is one of the most comprehensive patent estates in Superkine-based immunotherapy."

U.S. Patents Recently Issued

U.S. Patent No. 12,503,496: "Interleukin-4 Receptor-Binding Fusion Proteins and Uses Thereof" (Medicenna and the U.S. National Institutes of Health, co-owners). The issued patent covers the application of Medicenna’s proprietary IL-4 Superkine fusion proteins to enhancing cellular immunotherapy. With this grant, the family now includes three issued U.S. patents, and additional granted patents in Europe and India.
U.S. Patent No. 12,590,133: "IL-13/IL-4 Superkines: Immune Cell Targeting Constructs and Methods of Use Thereof" (in-licensed by Medicenna from Stanford University). The issued patent is directed to IL-13 Superkine immune cell targeting constructs, vectors, and engineered cells. The family is now granted in the United States and China, with pending applications in Canada and Europe.
U.S. Patent Recently Allowed

U.S. Patent Application No. 18/248,601: "Combination Therapy of MDNA55 and a Vascular Endothelial Growth Factor a (VEGF-A)" (Medicenna-owned). Once issued, the patent will cover combinatorial treatment of CNS tumors with bizaxofusp, including with VEGF-A-directed agents. The family also has pending applications in Canada, China, Europe, India, Japan and Korea.
Additional Recent Patent Grants Outside the United States

In parallel with these U.S. milestones, Medicenna recently received patent grants in two additional jurisdictions that extend the geographic reach of its core Superkine families:

Australian Patent No. 2018347796, "IL-4 Fusion Formulations for Treatment of Central Nervous System (CNS) Tumors," directed to Medicenna’s proprietary bizaxofusp formulation and its application to the treatment of CNS tumors. This family is now granted in Australia, Europe and the United States, with pending applications in Canada, China and India.
Canadian Patent No. 3,067,909, "Uses and Methods for IL-2 Superagonists, Agonists, and Fusions Thereof," directed to the combination of Medicenna’s IL-2 Super Agonist and checkpoint inhibitors for the treatment of cancer. This family is now granted in Australia, Canada, Japan and the United States, with additional pending applications in China, Europe and India, as well as further applications in Australia, Japan and the United States.
Medicenna continues to develop a robust global patent portfolio across its R&D platforms and clinical programs, with over 100 active granted patents and applications.

(Press release, Medicenna Therapeutics, JUN 11, 2026, View Source [SID1234666599])