Immutep Secures Fourth United States Patent for Eftilagimod Alfa in Combination with a PD-1 Pathway Inhibitor

On July 14, 2026 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapies, reported the grant of a new patent (number 12,673,088) entitled "Combined Preparations for the Treatment of Cancer or Infection" by the United States Patent and Trademark Office (USPTO).

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This patent is the fourth in the series and follows the grant of the United States parent patent, first divisional patent, and second divisional patent announced in December 2020, March 2021 and June 2023, respectively.

The claims of the new patent build on the protection provided by the three previously granted patents and are directed to methods for the treatment of cancer by administering eftilagimod alfa in combination with an anti-PD-1 antibody or an anti-PD-L1 antibody, or fragments thereof. The expiry date of the patent is 20 January 2036.

This grant further expands Immutep’s intellectual property protection for eftilagimod alfa in combination with PD-1 pathway inhibitors, a key class of immunotherapies used in modern cancer treatment.

Marc Voigt, CEO of Immutep, said: "We are very pleased to add this fourth United States patent to our expanding patent portfolio covering eftilagimod alfa in combination with PD-1 pathway inhibitors. This represents a meaningful addition to our intellectual property estate. As we consider next steps for efti, this expanded IP estate supports future development pathways and business development opportunities."

About Eftilagimod Alfa (Efti)
Efti is a novel immunotherapy that directly activates antigen-presenting cells or APCs (e.g. dendritic cells, monocytes) via the MHC Class II pathway to fight cancer. As an MHC Class II agonist, its activation of APCs engages the adaptive and innate immune system to initiate a broad anti-cancer immune response. This includes priming and activating cytotoxic T cells as well as generating important co-stimulatory signals and cytokines that further boost the immune system’s ability to combat cancer.

Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), soft tissue sarcoma, and breast cancer. Its favourable safety profile enables various combinations including with anti-PD-[L]1 immunotherapy, radiotherapy, and/or chemotherapy. Efti has received Fast Track designation in 1st line HNSCC and in 1st line NSCLC from the United States Food and Drug Administration (FDA).

(Press release, Immutep, JUL 14, 2026, View Source [SID1234669172])

CancerVax Develops Novel Smart mRNA to Harness Pre-Existing Immunity in 99% of World Population

On July 14, 2026 CancerVax, Inc., the developer of a breakthrough universal cancer treatment platform that "tricks" the body’s immune system into fighting cancer, reported that it has successfully developed a single Polyepitope Smart mRNA that can disguise cancer cells as multiple viral infections.

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The CancerVax platform is designed to harness the body’s existing immunity to detect, mark, and kill cancer cells with precision. At the core of the platform is a Smart mRNA that activates selectively in cancer cells. When activated, this Smart mRNA instructs cancer cells to produce proteins associated with viruses that are highly prevalent in the human population. This effectively disguises cancer cells as familiar viral infections and "tricks" the immune system into recognizing and killing them.

"Our earlier work focused on individual viral epitopes, such as measles," explained Dr. George Katibah, Chief Scientific Officer. "With our Polyepitope Smart mRNA design, we have expanded that concept by encoding multiple viral epitopes with broad population immunity, including measles, influenza, CMV and others, into a single mRNA construct. This approach is designed to increase the probability that a patient’s existing T-cell immunity will recognize at least one of these viral signals and direct an immune response against the cancer cell. Our recent in vitro results provide encouraging validation of this strategy and represent an important step toward a broadly applicable cancer immunotherapy platform."

Dr. Adam Grant, Principal Scientist, added, "Using large-scale immune epitope datasets and AI-assisted analysis, we identified and combined the most viable viral epitopes for our design to maximize the broadest population coverage. With every epitope we add, we increase the likelihood of activating existing T-cells. However, given the physical size constraints of practical mRNA design, we had to be selective. Using computational analysis, we designed a Version 1 Polyepitope Smart mRNA that provided a global population coverage of 96.26%. Since then, we’ve expanded our dataset and generated Version 2, which has a population coverage of 99.50%! This is truly a one of a kind mRNA design and we believe this broad and universal approach will be the winner we take to the clinic."

The Immune Epitope Database ("IEDB") population coverage algorithm was used to generate the following analysis of V1 and V2 Polyepitope Smart mRNA designs. IEDB, funded by the National Institute of Allergy and Infectious Diseases (NIAID), is the gold standard repository for experimentally validated immune epitope data.

(Press release, CancerVax, JUL 14, 2026, View Source [SID1234669221])

European Commission Approves Erbitux® (cetuximab) in Combination with Encorafenib and FOLFOX for First-Line Treatment of Metastatic Colorectal Cancer with BRAF V600E Mutation

On July 14, 2026 Merck, a leading global science and technology company, reported that the European Commission (EC) approved an update to the Erbitux (cetuximab) EU label on June 26, 2026. Erbitux is now indicated in combination with encorafenib for patients with BRAF V600E-mutant metastatic colorectal cancer (mCRC) — both in first-line treatment in combination with FOLFOX (BREAKWATER regimen) and for patients who have received prior systemic therapy (BEACON regimen).

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The first-line approval is based on results from the Phase 3 BREAKWATER trial, which showed that the cetuximab–encorafenib–FOLFOX combination delivered statistically significant and clinically meaningful improvements in the dual primary endpoints of objective response rate (ORR) and PFS, as well as a significant overall survival benefit — reducing the risk of death by 51% versus chemotherapy with or without bevacizumab.

"The approval of Erbitux in combination with encorafenib and FOLFOX marks an important milestone for patients with BRAF V600E-mutant mCRC who can now benefit from a first targeted treatment option in the first-line setting," said Matthias Wernicke, Head of Global Therapeutic Area Specialty Care, in the healthcare business sector of Merck. "BRAF V600E-mutant mCRC is associated with a historically poor prognosis and limited effective options. This approval reinforces Erbitux as the backbone of anti-EGFR therapy in colorectal cancer — and reflects our ongoing commitment to addressing unmet needs for patients across the full treatment continuum."

BREAKWATER (NCT04607421) is a Phase 3, randomized, active-controlled, open-label, multicenter trial evaluating encorafenib in combination with cetuximab and FOLFOX in participants with previously untreated BRAF V600E-mutant mCRC. The trial was conducted by Pfizer, in collaboration with Merck, and Ono Pharmaceutical. The combination of cetuximab, encorafenib and FOLFOX received accelerated FDA approval in December 2024 for treatment-naïve patients based on ORR data, and full FDA approval in February 2026 based on PFS and OS data — with the indication expanded to include fluorouracil-based chemotherapy (FOLFOX or FOLFIRI).

The BREAKWATER regimen demonstrated statistically significant and clinically meaningful improvements across all key endpoints versus standard-of-care chemotherapy (FOLFOX/FOLFOXIRI/CAPOX with or without bevacizumab).[1],[2] Median PFS was 12.8 months versus 7.1 months (HR 0.53; 95% CI: 0.41–0.68; P<0.001), representing a 47% reduction in the risk of progression or death. Overall survival was likewise significantly improved, with a median OS of 30.3 months versus 15.1 months (HR 0.49; 95% CI: 0.38–0.63; P<0.001) — a 51% reduction in the risk of death, more than doubling median overall survival compared to standard care. Confirmed ORR was 65.7% (95% CI: 59.4–71.4) in the BREAKWATER arm versus 37.4% (95% CI: 31.6–43.7) in the control arm. Safety profiles were consistent with those previously established for each individual agent; serious adverse events occurred in 46.1% versus 38.9% in the standard-care arm.

The cetuximab–encorafenib–FOLFOX regimen has been endorsed as first-line standard of care by the April 2026 ESMO (Free ESMO Whitepaper) Clinical Practice Guidelines (Recommendation Grade I, A) for patients with metastatic colorectal cancer harboring the BRAF V600E mutation.[3]

While the BREAKWATER regimen redefines first-line therapy, the Phase 3 BEACON CRC trial confirmed Erbitux as a standard of care in second-line and beyond. The combination of Erbitux and encorafenib — also approved by the EC on June 26, 2026 for patients with BRAF V600E-mutant mCRC who have received prior systemic therapy — significantly improved OS versus the irinotecan-based control (median 9.3 vs. 5.9 months; HR 0.61; 95% CI: 0.48–0.77; p<0.0001), reducing the risk of death by 39%.[4],[5] This regimen maintains quality of life with no increase in Grade ≥3 adverse events versus standard chemotherapy.

Erbitux is the first and only anti-EGFR therapy approved for both RAS wild-type and BRAF V600E-mutant mCRC patients — supporting patients throughout their treatment journey and across multiple lines of therapy.

Colorectal cancer remains a major global health challenge. It is the third most commonly diagnosed cancer worldwide and the second leading cause of cancer-related deaths, with 1.92 million new cases and approximately 900,000 deaths recorded in 2022 alone.[6] Projections indicate cases will increase by more than 85% and mortality will double in coming decades. Of patients presenting with metastatic disease — approximately 20% at diagnosis — 5-year survival remains at only 16.2%.

BRAF V600E mutations occur in approximately 8–12% of patients with mCRC and are associated with a particularly poor prognosis, with mortality risk more than double that of patients without the mutation. Extending the indication of Erbitux to this patient population represents a meaningful step toward more personalized and effective treatment — addressing a significant and clinically important unmet need.

With this dual approval — first-line (BREAKWATER) and second-line (BEACON) — Erbitux is now established as the pioneering anti-EGFR backbone across the mCRC treatment continuum. This milestone underscores Merck’s commitment to driving innovation in oncology and improving outcomes for patients with difficult-to-treat cancers.

(Press release, Merck & Co, JUL 14, 2026, View Source [SID1234669207])

Ernexa Therapeutics CEO Corner Highlights Differentiated ERNA-101 Platform as Company Advances Toward Planned First-in-Human Phase 1 Study in 2026

On July 14, 2026 Ernexa Therapeutics (Nasdaq: ERNA), an industry innovator developing novel cell therapies for the treatment of advanced cancer and autoimmune disease, reported a new installment of its CEO Corner series featuring President and Chief Executive Officer Sanjeev Luther discussing the significant unmet need in ovarian cancer, the Company’s differentiated approach with ERNA-101 and Ernexa’s progress toward advancing its lead cell therapy candidate into the clinic in the fourth quarter of 2026.

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Ovarian cancer remains one of the deadliest cancers affecting women worldwide. While treatment options have improved over time, many patients eventually experience disease recurrence and progression, leaving limited options for women with platinum-resistant ovarian cancer. In the discussion, Mr. Luther explains how the ability of many ovarian tumors to evade immune detection represents one of the greatest scientific challenges in the disease and why ERNA-101 is designed to help overcome this barrier.

"Every ovarian cancer diagnosis impacts far more than a single patient. It affects families, loved ones and futures, which is why we believe there remains an urgent need for new therapeutic approaches," said Sanjeev Luther, President and Chief Executive Officer of Ernexa Therapeutics. "At Ernexa, we believe ERNA-101 has the potential to address one of the greatest scientific challenges in ovarian cancer by helping transform immunologically ‘cold’ tumors into tumors the immune system can recognize. This CEO Corner provides additional insight into the science behind our approach, the encouraging preclinical data supporting ERNA-101 and the progress we are making as we advance toward our planned first-in-human Phase 1 study in the fourth quarter of this year."

The discussion also highlights ERNA-101, Ernexa’s lead cell therapy candidate, which is designed to deliver a proprietary immune-activating cytokine directly within the tumor microenvironment with the goal of transforming immunologically "cold" tumors into tumors the immune system can recognize. Mr. Luther also discusses the Company’s proprietary off-the-shelf induced mesenchymal stem cell (iMSC) platform, which the Company believes has the potential to improve manufacturing consistency, increase scalability and ultimately make advanced cell therapies more broadly accessible to patients.

The CEO Corner also reviews encouraging preclinical findings demonstrating complete tumor clearance and 100% long-term survival in preclinical ovarian cancer models when ERNA-101 was combined with PD-1 blockade. Mr. Luther also discusses findings demonstrating remodeling of the tumor microenvironment and increased immune cell infiltration, which further support the scientific rationale behind ERNA-101. He concludes by reviewing the Company’s ongoing manufacturing, regulatory and clinical development activities as Ernexa advances toward its planned IND submission expected in Q3 2026 and anticipated first-in-human clinical study anticipated to start in Q4 2026.

The Ernexa CEO Corner is now accessible on the Company’s website and social media channels. Access it here.

(Press release, Ernexa Therapeutics, JUL 14, 2026, View Source [SID1234669222])

Kura Oncology to Present First Long-Term Follow-Up Data Further Supporting Darlifarnib’s Potential to Enhance VEGFR-Targeted Therapy in Renal Cell Carcinoma at KCRS 2026

On July 14, 2026 Kura Oncology, Inc. (Nasdaq: KURA), a biopharmaceutical company focused on precision medicines for the treatment of cancer, reported that updated Phase 1a results from the ongoing FIT-001 Phase 1a/1b clinical trial (NCT06026410) evaluating darlifarnib in combination with cabozantinib in advanced renal cell carcinoma (RCC) will be featured in an oral presentation at the 2026 Kidney Cancer Research Summit (KCRS) in Boston.

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The presentation will highlight long-term follow-up results in heavily pretreated cabozantinib-naïve patients with refractory RCC, providing further evidence of darlifarnib’s potential as a combination agent with VEGFR-targeted therapies, a widely used treatment approach in this patient population. RCC is the most common form of kidney cancer, and clear cell RCC (ccRCC) is the most common histology in RCC, accounting for more than 61,000 new cases in the U.S. each year.1

"Despite meaningful advances in the treatment of renal cell carcinoma, there remains a significant need for combination strategies capable of delivering deeper and more durable responses," said Mollie Leoni, M.D., Chief Medical Officer of Kura Oncology. "The updated FIT-001 data will further inform the potential of darlifarnib plus cabozantinib as a precision combination strategy in advanced ccRCC. More broadly, Kura’s KCRS presentation builds on the growing body of clinical evidence supporting darlifarnib’s mechanism of action across VEGF-TKI, KRAS and PI3Ka inhibitor combinations, supporting darlifarnib’s potential to enhance clinical activity of these targeted-therapy backbones."

The KCRS presentation adds to the FIT-001 RCC results presented at ESMO (Free ESMO Whitepaper) 2025 and additional findings in cabozantinib-exposed ccRCC patients presented at 2026 IKCS: Europe.

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, advanced ccRCC. The randomized 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 registrational study planned for 2028.

The KCRS presentation represents another step in Kura’s broader strategy to establish darlifarnib as a precision combination agent capable of enhancing multiple targeted therapy classes through inhibition of adaptive mTORC1 signaling. The first planned expansion is expected to evaluate darlifarnib in combination with daraxonrasib in previously treated RAS-mutated pancreatic ductal adenocarcinoma.

2026 KCRS Presentation Details

Title: Farnesyl transferase inhibitor (FTI) darlifarnib combined with cabozantinib in renal cell carcinoma (RCC): Updated phase 1a results from FIT-001
Date: July 24, 2026
Time: 3:05 p.m. – 3:45 p.m. ET

Virtual Investor Event
Kura will host a webcast and conference call on 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 Director of Genitourinary Medical Oncology Research, 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.

About darlifarnib
Darlifarnib is a next-generation farnesyl transferase inhibitor (FTI) designed to inhibit farnesylation of RHEB and suppress mTORC1 signaling, a pathway implicated in adaptive signaling across multiple targeted therapy settings. By suppressing adaptive mTORC1 signaling, darlifarnib is designed to counter a key mechanism of resistance to targeted therapies, with the goal of enhancing the depth and durability of response across multiple targeted therapy classes.

(Press release, Kura Oncology, JUL 14, 2026, View Source [SID1234669208])