On July 27, 2026 Eikon Therapeutics, Inc. (Nasdaq: EIKN) (Eikon), a late-stage clinical biopharmaceutical company dedicated to developing innovative medicines to address serious unmet medical needs, reported that the first patient has been dosed in TeLuRide-008, a Phase 2/3 registrational study evaluating EIK1001 in combination with pembrolizumab and histology-appropriate chemotherapy as first-line therapy for treatment-naïve patients with stage 4 Non-Small Cell Lung Cancer (NSCLC).

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"Treating the first patient in TeLuRide-008 is a significant milestone for Eikon as we continue to advance EIK1001 in multiple indications, with the ultimate goal of delivering improved outcomes to patients with significant unmet need," said Roy Baynes, M.D., Ph.D. Chief Medical Officer of Eikon. "Despite advancements in NSCLC, the current standard of care was established over a decade ago and does not deliver durable benefit for many patients. EIK1001 is designed to drive an enhanced immune response by stimulating both innate and adaptive immunity, improving antigen presentation in secondary lymphoid tissues and recruiting a broader répertoire of T-cells. We are grateful to the patients and investigators participating in this study who are vital partners as we work to develop therapies that may deliver more meaningful and sustained responses for people living with cancer."

About TeLuRide-008
TeLuRide-008 (NCT07365319) is a global, multicenter, double-blind, placebo-controlled, randomized adaptive Phase 2/3 study to evaluate the clinical activity and safety of EIK1001 administered intravenously in combination with pembrolizumab and histology-appropriate chemotherapy to systemic therapy-naïve participants with Stage 4 non-squamous or squamous NSCLC. The specific chemotherapy for non-squamous histology is pemetrexed plus either carboplatin or cisplatin, while for squamous histology it is carboplatin plus paclitaxel or nab-paclitaxel. The study is being conducted in two phases (Phase 2 and Phase 3) and will be analyzed in three parts (dose optimization, dose expansion and confirmatory hypothesis testing). TeLuRide-008 is the second registrational phase 2/3 trial for EIK1001. TeLuRide-006 (NCT06697301), which is enrolling patients with advanced malignant melanoma, was initiated in May of 2025.

About NSCLC
Lung cancer is one of the most common cancers globally, with NSCLC making up 80 to 85 percent of all lung cancer cases. NSCLC is often diagnosed at advanced stages when treatment options are more limited and there remains significant unmet medical need in this patient population. The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. The current standard of care for Stage 4 NSCLC combining immune checkpoint inhibitors (ICIs) (e.g., pembrolizumab) plus histology-appropriate chemotherapy confers significant clinical benefit over chemotherapy alone, yet many patients progress nonetheless, highlighting the large unmet medical need in the management of this disease.

About EIK1001
EIK1001 is an investigational, systemically administered dual-agonist of Toll-like receptors 7 and 8 designed to stimulate both innate and adaptive immune responses. In Phase 1 trials of EIK1001, single-agent activity was observed in patients with advanced malignancy. This mechanism may complement the antitumor immune response engendered by PD-(L)1 blockade. EIK1001 has been studied in over 500 patients and observed to be well-tolerated to date, both as a monotherapy, and in combination with PD-(L)1-specific antibody-based therapy.

(Press release, Eikon Therapeutics, JUL 27, 2026, View Source [SID1234669447])

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.

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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.

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

"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])

On July 27, 2026 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, reported Lumara Bio as a dedicated oncology therapeutics division that combines ITM’s existing pipeline and the internal teams supporting its development and commercialization.

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Lumara Bio will operate as a defined division within ITM to focus key resources toward commercial readiness for its most advanced drug candidate, 177Lu-edotreotide (ITM-11), which is currently under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) goal date of August 28, 2026, alongside its broader early- and late-stage drug development activities.

"As we approach ITM-11’s PDUFA date, creating the Lumara Bio division enables us to focus our internal efforts and create a structure around the teams responsible for a potential commercial launch," said Dr. Andrew Cavey, chief executive officer of ITM. "In addition, Lumara Bio reflects the evolution of the two pillars of ITM’s business and builds on our deep expertise in isotope manufacturing and supply as well as our proven track record in radiopharmaceutical development. Lumara Bio is uniquely positioned to address the growing need for radiopharmaceutical innovation by accelerating progress across our targeted radiopharmaceutical pipeline and expanding our portfolio."

Beyond 177Lu-edotreotide, Lumara Bio will advance ITM’s diverse pipeline of targeted radiopharmaceutical candidates spanning multiple cancer types, treatment approaches, and proprietary isotope platforms, with the goal of bringing innovative radiopharmaceutical therapies to more patients. The division builds on ITM’s scientific foundation and isotope expertise, as well as its radiopharmaceutical development and strategic scientific collaborations. Lumara Bio will leverage ITM’s isotope manufacturing and supply services to support its pipeline and potential commercial launch activities.

177Lu-edotreotide is currently under regulatory review by the U.S. Food and Drug Administration and is not approved by any regulatory authority for any use.

(Press release, ITM Isotopen Technologien Munchen, JUL 27, 2026, View Source [SID1234669448])

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.

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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])

On July 27, 2026 Calidi Biotherapeutics, Inc. (NYSE American: CLDI) ("Calidi" or the "Company"), a clinical-stage biotechnology company pioneering the development of systemically delivered, targeted genetic medicines, reported on July 23, 2026, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Drug Discovery and Development (AACR D3) Conference in Boston, MA. The Company presented new data on its CLD-401 program that it expects to enter the clinic in the first quarter of 2027 and its in situ T-cell engager (TCE) program.

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"The data presented last week at the conference shows the advances we have made in both our CLD-401 program that we expect will be entering the clinic soon and our in situ TCE program including a new TCE targeting the EpCam receptor," said Calidi Chief Executive Officer Eric Poma, PhD. "The data highlights the unique ability of the RedTail platform to deliver genetic medicines to distal tumor sites to drive efficacy."

(Press release, Calidi Biotherapeutics, JUL 27, 2026, View Source [SID1234669449])