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Insilico Medicine Announces Oral Presentation at ESMO 2026 for Phase 1 Clinical Study of ISM6331 in Mesothelioma and Advanced Solid Tumors

On July 27, 2026 Insilico Medicine ("Insilico", HKEX:3696), a clinical-stage, generative AI-driven drug discovery company, reported that first-in-human Phase 1 trial data for ISM6331, its novel AI-designed pan-TEAD inhibitor, has been accepted for a Rapid Oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026, taking place October 23–27, 2026, in Madrid, Spain.

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"TEAD has long been recognized as an attractive target in hard-to-treat solid tumors, but small-molecule inhibition has historically posed significant design challenges, said Feng Ren, Ph.D., Co-CEO and Chief Scientific Officer of Insilico Medicine. "The selection of ISM6331 for a Rapid Oral presentation at ESMO (Free ESMO Whitepaper) 2026 highlights the potential of our AI-generated platform to target complex oncogenic drivers like the Hippo pathway and represents a promising pan-TEAD approach that we are eager to share with the community."

Details of the Rapid Oral Presentation

Title: First-in-human Multicenter Phase 1 Study of ISM6331, an AI-Designed Pan-TEAD Inhibitor, in Patients with Mesothelioma or Other Advanced Solid Tumors
Abstract Number: #997
Session Name: Rapid Oral Presentation: Developmental Therapeutic
Location: Cordoba Auditorium – Hall 4
Date/Time: Sunday 25.10.2026 08:30 – 10:00
"Presenting our first-in-human Phase 1 study at ESMO (Free ESMO Whitepaper) marks an important clinical milestone for ISM6331," said Halle Zhang, Ph.D., Vice President, Clinical Development – Oncology at Insilico Medicine. "Patients with advanced mesothelioma and other Hippo-driven solid tumors face limited therapeutic options. These preliminary clinical findings provide early encouragement as we evaluate ISM6331’s safety, pharmacokinetics, and initial antitumor activity to inform our ongoing clinical development strategies."

About ISM6331

ISM6331 is a novel, potent, small-molecule pan-TEAD inhibitor discovered and designed using Insilico Medicine’s proprietary generative AI-powered drug discovery platform, Chemistry42. The molecule targets TEAD transcription factors, the principal downstream effectors of the Hippo signaling pathway, a critical regulator of cell proliferation, survival, tissue homeostasis, and therapeutic resistance across a broad range of solid tumors. Although the Hippo pathway has long been recognized as a promising therapeutic target in oncology, developing effective small-molecule TEAD inhibitors has remained a significant medicinal chemistry challenge. ISM6331 was designed to selectively inhibit pan-TEAD activity and is being evaluated in a global, multicenter Phase 1 clinical trial in patients with malignant mesothelioma and other advanced solid tumors. The study is assessing ISM6331 safety, tolerability, pharmacokinetics, and preliminary antitumor activity to inform its continued clinical development.

(Press release, Insilico Medicine, JUL 27, 2026, View Source [SID1234669437])

Akeso IO2.0 + ADC2.0 Strategy Makes Another Advancement: First Patient Dosed in Phase Ib/II Study of HER3 ADC (AK138D1) Combined with Ivonescimab in Lung Cancer

On July 27, 2026 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that the first patient has been dosed in a Phase Ib/II clinical study (AK138D1-201) evaluating its internally developed next-generation differentiated HER3 ADC, AK138D1, as monotherapy or in combination with ivonescimab (PD-1/VEGF bispecific antibody) for advanced non-small cell lung cancer (NSCLC).

The study aims to evaluate the potential of Akeso’s IO2.0 + ADC2.0 regimen across multiple settings in advanced NSCLC, including: first-line treatment, treatment after EGFR-TKI resistance, and treatment after immuno-chemotherapy resistance.

HER3 expression is strongly linked to the development, progression, and treatment resistance in patients with NSCLC. Traditional HER3 ADCs have faced limitations in clinical use due to toxicity concerns, and none have been approved to date. Akeso designed the next-generation HER3 ADC, AK138D1, with an unique and innovative approach that minimizes uptake in normal tissues to reduce off-target toxicity and broaden the therapeutic window. This approach also prevents surface aggregation on tumor cells to improve deep and uniform tumor penetration, effectively overcoming the binding site barrier. Early clinical studies conducted in China and Australia have demonstrated that AK138D1 monotherapy delivers potent anti-tumor activity in patients with lung cancer, along with a favorable safety profile featuring low hematologic toxicity and no reported cases of interstitial lung disease (ILD).

Ivonescimab, a first-in-class PD-1/VEGF bispecific antibody, has shown strong clinical results compared to PD-1 inhibitor-based therapies across multiple Phase III studies. The combination of AK138D1 with ivonescimab is expected to further amplify ivonescimab’s immune-activating effects. This combination enables ivonescimab to exert synergistic anti-tumor activity with the next-generation HER3 ADC, potentially delivering superior clinical efficacy across various NSCLC subtypes while maintaining a favorable safety profile.

Leveraging its technological leadership in bispecific and multi-specific antibodies, Akeso is systematically building a comprehensive global IO2.0 + ADC2.0 therapeutic matrix.

In the immuno-oncology field, Akeso has two approved bispecific antibodies for cancer treatment. The Company is actively evaluating ivonescimab and cadonilimab in combination with the Company’s proprietary next-generation ADC candidates. Increasingly, global partners recognize both ivonescimab and cadonilimab as preferred agents for combination regimens and breakthrough therapy explorations across a wide spectrum of tumor types.

In the ADC space, Akeso has built a differentiated pipeline of next-generation candidates, including AK146D1 and AK138D1, both of which have entered into Phase II clinical studies, and AK157D1 and AK158D1 (a bispecific ADC), both of which will soon enter clinical studies.

Currently, multiple Phase II clinical studies are underway evaluating ivonescimab and cadonilimab in combination with AK138D1, AK146D1, and other assets. These combination studies from Akeso’s own approved therapies and pipelines continue to drive global treatment paradigms upgrades for major malignancies, including lung cancer and breast cancer.

About AK138D1
Injectable AK138D1 is a HER3-targeted antibody-drug conjugate (ADC), with a fully humanized anti-HER3 IgG1 antibody, patritumab. It is conjugated to the topoisomerase I inhibitor DXd through a cleavable linker, MC-AAA (maleimide-alanine-alanine-alanine). After binding to HER3 on tumor cells, the ADC is internalized into the tumor cells, where the linker is cleaved, releasing the membrane-permeable DXd. This leads to DNA damage and subsequent cell apoptosis. Early study results have shown that AK138D1 possesses potent biological activity and a favorable safety profile. A phase II clinical trial is currently ongoing to investigate AK138D1 combined with cadonilimab and ivonescimab in patients with solid tumors. This regimen is a critical part of Akeso’s IO2.0 + ADC 2.0 combination approach.

(Press release, Akeso Biopharma, JUL 27, 2026, View Source;adc2-0-strategy-makes-another-advancement-first-patient-dosed-in-phase-ibii-study-of-her3-adc-ak138d1-combined-with-ivonescimab-in-lung-cancer-302835843.html [SID1234669436])

ORYZON reports financial results and corporate update for half year ended June 30th, 2026

On July 27, 2026 Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company and a global leader in epigenetics, reported financial results for the three months ended June 30, 2026, and provided a corporate update on recent developments.

"During the second quarter of 2026, Oryzon reported important clinical progress while strengthening our financial position," said Dr. Carlos Buesa, Oryzon’s Chief Executive Officer. "At the European Hematology Association (EHA) (Free EHA Whitepaper) conference, we presented updated results from the ALICE-2 and FRIDA trials that further support the potential of iadademstat in AML. In first-line AML, the triplet combination of iadademstat with azacitidine and venetoclax continues to demonstrate a highly competitive efficacy profile, including encouraging activity in patients with adverse genetic backgrounds, while maintaining a favorable and manageable safety profile. We are also encouraged by the proportion of patients who have been able to proceed to allogeneic hematopoietic cell transplantation, a potentially curative treatment option that may contribute to improved long-term outcomes. We believe the ALICE-2 results compare favorably with those reported for other emerging triplet regimens and further reinforce the differentiated positioning of iadademstat in this setting."

"We expect to present final data from ALICE-2 and FRIDA by year-end," Dr. Buesa continued. "Subject to confirmation of the current efficacy and safety findings in the final ALICE-2 dataset, we remain on track to engage with the FDA on the design of a potentially registrational study in first-line AML, with the objective of initiating the trial in 2027. We also see iadademstat as an increasingly diversified asset across oncology and hematology, having enrolled the first patient in the IDEAL Phase II trial in essential thrombocythemia."

"We continue to advance vafidemstat toward a Phase III trial in aggression in borderline personality disorder (BPD), as well as a new Phase II trial in aggression in autism spectrum disorder (ASD), while enrollment progresses in the ongoing Phase IIb trial in schizophrenia", Dr. Buesa added. "The recent grant of a U.S. patent significantly extends our IP protection for vafidemstat in BPD and strengthens our longterm development plans for the asset."

"To support our pipeline through the clinical catalysts expected this year and beyond, we raised €12 million through a recent capital increase and entered into a financing agreement with the Social Impact Fund managed by COFIDES," Dr. Buesa concluded. "Under the agreement, the Fund has committed to invest €25 million in future capital increases to support Oryzon’s mental health programs, subject to certain conditions. These additional resources provide us with greater financial flexibility as we work to translate our innovative epigenetic therapies into clinical benefit for patients and long-term value for our stakeholders."

Second Quarter and Recent Highlights

Iadademstat:

Oryzon shared updated positive data from the ongoing ALICE-2 (NCT06357182) Phase Ib clinical trial of iadademstat in combination with azacitidine and venetoclax in patients with newly diagnosed AML at the EHA (Free EHA Whitepaper) 2026 Congress. As reported, the iadademstat-azacitidine-venetoclax triplet combination demonstrated high levels of clinical activity and continued to exhibit a favorable safety profile. Among evaluable patients (n=18), a 100% (18/18) overall response rate (ORR), an 89% (16/18) composite complete remission (CRc) rate and a 78% (14/18) complete response (CR) rate were observed. CRs occurred early, most of them in cycle 1. Efficacy was observed across different genomic risk groups, including TP53 and RAS pathway mutations and patients with complex karyotypes, all considered adverse risk: patients with TP53-mutated disease (2/2) attained CR and showed a reduction in TP53 variant allele frequency (14% to undetected and 22% to 1%, respectively), and patients with RAS pathway mutations (3/3) achieved CR. After a median followup of 8 months, median overall survival (OS) and event-free survival (EFS) were not reached; estimated 12-month OS and EFS were 79% and 71%, respectively. Additionally, 9 patients successfully transitioned to allogeneic HCT, with an estimated 12-month OS of 88%. This investigator-initiated study (IIS) is led by the Oregon Health & Science University (OHSU) Knight Cancer Institute and continues to actively enroll patients. The trial aims to enroll 21 evaluable patients; the 18 evaluable patients reported at EHA (Free EHA Whitepaper) represent around 85% of the target enrollment.

Updated positive data from the fully enrolled Phase Ib FRIDA (NCT05546580) clinical trial of iadademstat in combination with gilteritinib in patients with relapsed or refractory (R/R) FLT3-mutated AML were also presented at EHA (Free EHA Whitepaper) 2026. Updated data from the expansion cohort at the selected pharmacological active dose (PAD, 75 μg iadademstat) included 18 patients evaluable for response. The iadademstat+gilteritinib combination showed a favorable safety profile and a CRc rate of 67% (12/18) in a heavily pre-treated patient population. These results compare favorably with gilteritinib monotherapy responses in contemporary real‑world cohorts enriched for heavily pre‑treated patients, which are reported to be 28% CR+CRi.

Enrollment has continued across additional ongoing iadademstat clinical studies, conducted under the Cooperative Research and Development Agreement (CRADA) with the U.S. National Cancer Institute (NCI) in first-line AML, myeloproliferative neoplasms and extensive-disease small cell lung cancer (ED-SCLC), as well as investigator-initiated studies in myelodysplastic syndrome and EDSCLC.

Oryzon has initiated and enrolled the first patient in the IDEAL Phase II trial to evaluate iadademstat in adult patients with essential thrombocythemia (ET) who are resistant/intolerant to hydroxyurea. The study is designed to evaluate the safety, tolerability and clinical activity of iadademstat, including its efficacy in reducing the percentage of adult ET patients with abnormal platelet counts. Iadademstat will be administered for up to 24 weeks, with an additional 24-week extension period available for those benefiting from treatment.

Oryzon continues to advance the RESTORE Phase Ib trial of iadademstat in adult patients with sickle cell disease (SCD). The study will evaluate the safety and tolerability of iadademstat, establish the Recommended Phase II dose (RP2D), and investigate iadademstat’s effect on inducing fetal hemoglobin (HbF) expression, a clinically meaningful endpoint in SCD. The trial is actively enrolling patients.

Vafidemstat:

Oryzon continues active regulatory and development activities to support the advancement of the Phase III PORTICO-2 trial with vafidemstat in aggression in BPD. Following receipt of written FDA feedback regarding study endpoints and certain non-clinical considerations, the Company is actively generating additional supporting information and protocol refinements required for resubmission. These activities include qualitative research and endpoint-validation work intended to further support the proposed clinical outcome measures.
Patient enrollment is ongoing in the EVOLUTION Phase IIb trial of vafidemstat in schizophrenia. The study is primarily assessing its effects on negative symptoms, with cognitive impairment and positive symptoms included as secondary endpoints. Initially launched in Spain, EVOLUTION is being extended to additional European countries (Bulgaria, Poland, Romania and Slovakia).
Oryzon is finalizing preparations for the HOPE-2 Phase II study of vafidemstat for the treatment of aggression in autism spectrum disorder (ASD). The trial will focus on genetically-defined ASD subpopulations, in particular individuals with Phelan-McDermid syndrome (PMS). The study will initially be conducted in Spain and forms part of the activities supported by the Med4Cure IPCEI EU initiative.
Oryzon continues to reinforce its IP portfolio for vafidemstat, as the United States Patent and Trademark Office (USPTO) recently granted U.S. Patent No. 12,673,044, entitled "Methods of treating borderline personality disorder". The granted claims cover methods of treating non-aggressive symptoms of borderline personality disorder (BPD) using LSD1 inhibitors, including vafidemstat, complementing Oryzon’s patent portfolio covering the treatment of aggression. The patent is expected to expire in March 2043, including 1,095 days of Patent Term Adjustment (PTA) awarded by the USPTO to compensate for delays during patent prosecution. This estimate does not include any potential Patent Term Extension (PTE) that may become available following regulatory review, if applicable. A corresponding patent application has also been allowed in Canada.
Earlier stage programs:

ORY-4001, Oryzon’s highly selective histone deacetylase 6 (HDAC6) inhibitor for neurological disorders, continues IND-enabling studies to enable future clinical trials. The program remains focused on potential applications in Amyotrophic Lateral Sclerosis (ALS), Charcot-Marie-Tooth disease (CMT) and other neurological disorders.
Financial Update: First half 2026 Financial Results

Research and development (R&D) expenses were $6.3 million and 11.4 million for the quarter and six months ended June 30th, 2026, compared to $3.0 and $5.8 million for the quarter and six months ended June 30th, 2025.

General and administrative expenses were $1.3 and $2.8 million for the quarter and six months ended June 30th, 2026, compared to $1.4 and $2.7 million for the quarter and six months ended June 30th, 2025.

Net losses were $1.6 and $3.6 million for the quarter and six months ended June 30th, 2026, compared to $1.7 and $3.4 million for the quarter and six months ended June 30th, 2025. The result is as expected, given the biotechnology business model where companies in the development phase typically have a long-term maturation period for products and do not have recurrent income.

Negative net result was $1.6 million (–$0.02 per share) for the six months ended June 30th, 2026, compared to a negative net result of $1.8 million (–$0.03 per share) for the six months ended June 30th, 2025.

Cash, cash equivalents, and marketable securities totaled $16.7 million (€14.7 million) as of June 30, 2026.

After quarter-end, Oryzon raised gross proceeds of €12.0 million ($13.7 million) through a capital increase, without the issuance of warrants, as announced on July 1, 2026.

On the same date, the Company announced that it had entered into a share subscription agreement with the Social Impact Fund, managed by Compañía Española de Financiación del Desarrollo (COFIDES), an entity attached to the Spanish Ministry of Inclusion, Social Security and Migration. Under the agreement, the Social Impact Fund has committed, as an anchor investor, to subscribe for newly issued Oryzon shares in a future financing for an aggregate investment of €25 million, subject to the satisfaction of certain corporate, financial, business, and social impact-related conditions.

(Press release, Oryzon, JUL 27, 2026, View Source;utm_medium=email&utm_campaign=NdP.20+27-07-2026+Resultados+2Q26+ENG842 [SID1234669435])

Aptevo Strengthens Solid Tumor Strategy with Patent Filing for Nectin-4 x PD-L1 Dual Targeting Backbone

On July 27, 2026 Aptevo Therapeutics Inc. (NASDAQ:APVO), a clinical-stage biotechnology company developing novel multispecific immuno-oncology therapeutics, reported a new solid tumor strategy designed to fight cancer on multiple fronts. The Company has filed a patent application covering a proprietary Nectin-4 x PD-L1 dual-targeting backbone designed to strengthen Aptevo’s oncology pipeline, expand partnering opportunities and support multiple therapeutic approaches from a single platform-derived innovation.

For Aptevo, the filing helps secure the engine behind that strategy. Instead of pursuing one product built for one use, the filing will protect a backbone that may be adapted into multiple cancer-fighting approaches. That gives Aptevo more ways to advance its own pipeline, expands opportunities to work with large pharmaceutical companies and brings new thinking to the challenges of treating solid tumors.

"This filing is about building value from our science and using it to create more ways to fight solid tumors," said Jeff Lamothe, President and Chief Executive Officer of Aptevo. "Aptevo has built a reusable targeting architecture that can generate multiple assets, support multiple therapeutic approaches and create multiple paths to value. For a focused biotech company, that matters. It gives us a powerful way to expand our pipeline, engage larger pharmaceutical companies and pursue difficult solid tumors with a strategy that is bigger than any single asset."

"What excites us scientifically is the versatility of this backbone," said Mary Janatpour, Ph.D., Chief Scientific Officer of Aptevo. "We designed it to recognize two important targets in solid tumors, Nectin-4 and PD-L1, and to give us a foundation we can build on in multiple ways. That means we can think beyond a single drug candidate and use the same core approach to support radiopharmaceuticals, T-cell engagers and other immune-modulating therapies. That kind of flexibility matters because it gives us more ways to address the complexity of difficult-to-treat solid tumors."

The Company notes that radiopharmaceutical therapy is one potential application of this strategy and an area of growing focus for Aptevo. Pairing tumor-targeting constructs with radioligands supports the development of new targeted radiopharmaceutical candidates designed to deliver treatment activity directly to tumors. The Nectin-4 x PD-L1 backbone may also support T-cell engagers and other immune-based therapies, giving Aptevo multiple ways to pursue solid tumors through tumor targeting, immune activation and payload delivery.

The approach is designed to help therapies find tumors more precisely and simultaneously enhance anti-tumor immunity. Nectin-4 is found on several solid tumors, and PD-L1 can be found both on tumor cells and immune-suppressing cells within the tumor. By targeting both, Aptevo aims to direct treatment activity more selectively where it is needed most, better avoiding normal tissues than single-targeted agents. In addition to enhanced tumor localization, targeting PD-L1 immune-suppressing cells will enhance anti-tumor immunity. From here, Aptevo can deepen anti-tumor efficacy by adding additional functional components.

The backbone also demonstrates how Aptevo’s ADAPTIR and ADAPTIR-FLEX platforms are used to build smarter, more flexible cancer therapies. Aptevo can adjust how each construct is designed and add different therapeutic components depending on the goal. In simple terms, the same targeting concept may be used to create different kinds of therapies for hard-to-treat solid tumors.

The filing strengthens Aptevo’s intellectual property portfolio and supports a focused, platform-driven strategy: use proprietary science to create multiple shots on goal, retain strategic control and open the door to collaborations that could accelerate development.

(Press release, Aptevo Therapeutics, JUL 27, 2026, View Source [SID1234669434])

Kura Oncology Reports Durable Clinical Activity of Darlifarnib Plus Cabozantinib in Cabozantinib-Naïve Clear Cell Renal Cell Carcinoma Patients at KCRS 2026

On July 27, 2026 Kura Oncology, Inc. (Nasdaq: KURA), a biopharmaceutical company focused on precision medicines for the treatment of cancer, reported updated Phase 1a results from the ongoing FIT-001 clinical trial (NCT06026410) demonstrating encouraging and durable clinical activity of darlifarnib plus cabozantinib in cabozantinib-naïve patients with advanced clear cell renal cell carcinoma (ccRCC). The results were presented at the 2026 Kidney Cancer Research Summit (KCRS) in Boston and support continued development of the combination, including dose selection for the randomized Phase 1b portion of the study.

The long-term data compare favorably with benchmarks for advanced RCC, showing robust antitumor activity with darlifarnib plus cabozantinib, as well as evidence of durable benefit. The combination had a manageable safety profile across all dose levels, including when administered with full-dose cabozantinib.

Clinical Activity in Cabozantinib-naïve ccRCC Patients (N=34):

Objective response rate ranged from 33% to 50% across evaluated darlifarnib dose levels
Median progression free survival was 13 months across pooled dose levels
Median duration of response was not estimable at most dose levels assessed because multiple responses remain ongoing
Durable clinical benefit was observed across all evaluated combination dose levels, with more than half of patients remaining on treatment at data cut-off

Safety and Tolerability in RCC Patients (N=72):

The safety and tolerability profile was manageable and generally consistent with reported safety profiles of the individual agents
Supportive care, including for neutropenia, was not allowed during the dose-limiting toxicity study period
Neutropenia was successfully managed with dose interruption/reduction and supportive care (as allowed after the initial dose-limiting toxicity period)

"The response rates and progression-free survival observed with darlifarnib plus cabozantinib are encouraging in this refractory, pretreated, cabozantinib-naïve population, particularly given the limited treatment options after prior immunotherapy, immune check point inhibitors, and VEGFR-targeted therapy," said Adanma Ayanambakkam, M.D., M.S., Assistant Professor of Hematology Oncology, Assistant Medical Director Clinical Trials Office, Stephenson Cancer Center, University of Oklahoma Health Sciences Center. "Continued follow-up will further define the durability of benefit."

Duration of Treatment and Clinical Outcomes

Clinical benefit observed across combination dose levels, with multiple patients remaining on treatment.

Kura Oncology Reports Durable Clinical Activity of Darlifarnib Plus Cabozantinib in Cabozantinib-Naïve Clear Cell Renal Cell Carcinoma Patients at KCRS 2026
07-27-2026
PDF Version
– Response rates up to 50% across evaluated dose levels and median PFS of 13 months observed in pre-treated, cabozantinib-naïve, locally advanced or metastatic ccRCC patients –

– Activity compares favorably with historical outcomes for TKI and HIF-2α monotherapies -–

– Combination was well tolerated and safety profile consistent with reported profiles of the individual agents –

– Findings support potential for darlifarnib to enhance activity of VEGFR-targeted therapies in second- and third-line RCC settings –

– Global, randomized Phase 1b study underway to establish recommended Phase 3 dose –

– Investor call scheduled for today, July 27, 2026, at 5:00 a.m. PT / 8:00 a.m. ET –

SAN DIEGO, July 27, 2026 (GLOBE NEWSWIRE) — Kura Oncology, Inc. (Nasdaq: KURA), a biopharmaceutical company focused on precision medicines for the treatment of cancer, announced updated Phase 1a results from the ongoing FIT-001 clinical trial (NCT06026410) demonstrating encouraging and durable clinical activity of darlifarnib plus cabozantinib in cabozantinib-naïve patients with advanced clear cell renal cell carcinoma (ccRCC). The results were presented at the 2026 Kidney Cancer Research Summit (KCRS) in Boston and support continued development of the combination, including dose selection for the randomized Phase 1b portion of the study.

Clinical Activity in Cabozantinib-naïve ccRCC Patients (N=34):

Safety and Tolerability in RCC Patients (N=72):

Duration of Treatment and Clinical Outcomes

"These updated Phase 1a data continue to support the potential for darlifarnib to enhance VEGFR-targeted therapy in advanced RCC and have informed the dose combinations advancing into the randomized Phase 1b portion of FIT-001," said Mollie Leoni, M.D., Chief Medical Officer of Kura Oncology. "Cabozantinib-naïve patients represent an increasingly important treatment population as cabozantinib is often reserved for later lines of therapy following immunotherapy-based regimens. We look forward to longer follow-up from Phase 1a and randomized data from Phase 1b as we continue development toward a planned registrational study."

Kura is currently enrolling patients in the U.S. and E.U. in the randomized Phase 1b dose-optimization portion of FIT-001 in cabozantinib-naïve, refractory ccRCC. The Phase 1b portion is evaluating darlifarnib plus cabozantinib versus cabozantinib alone and is designed to inform selection of a recommended Phase 3 dose for a planned registrational study in 2028.

Virtual Investor Event
Kura will host a webcast and conference call today, July 27, 2026, at 5:00 a.m. PT / 8:00 a.m. ET featuring management and Adanma Ayanambakkam, M.D., M.S., Assistant Professor of Hematology Oncology and Assistant Medical Director, Clinical Trials Office, Stephenson Cancer Center, University of Oklahoma Health Sciences Center. The live webcast and replay will be available on the Company’s website at www.kuraoncology.com under the Investors tab in the Events and Presentations section.

Abbreviations
HIF-2α, hypoxia-inducible factor 2 alpha; PD, progressive disease; PFS, progression-free survival; PR, partial response; RCC, renal cell carcinoma; SD, stable disease; TKI, tyrosine kinase inhibitor; VEGFR, vascular endothelial growth factor receptor

About Darlifarnib
Darlifarnib is a next-generation farnesyl transferase inhibitor (FTI) under development that inhibits farnesylation of RHEB, resulting in selective mTORC1 inhibition while sparing mTORC2. This mechanism has potential to enhance the activity of multiple targeted therapies where complementary inhibition of oncogenic pathways may improve clinical outcomes, including VEGFR-targeted therapies such as cabozantinib.

(Press release, Kura Oncology, JUL 27, 2026, View Source [SID1234669433])