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])

U.S. FDA Approves PADCEV® plus Keytruda® as Neoadjuvant and Adjuvant Treatment for Muscle-Invasive Bladder Cancer Regardless of Cisplatin Eligibility

On July 13, 2026 Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") reported that the U.S. Food and Drug Administration (FDA) has approved PADCEV (enfortumab vedotin-ejfv), a Nectin-4 directed antibody-drug conjugate, plus the PD-1 inhibitor, Keytruda (pembrolizumab) or Keytruda QLEX (pembrolizumab and berahyaluronidase alfa-pmph) as neoadjuvant and adjuvant (before and after surgery) treatment for adult patients with muscle-invasive bladder cancer regardless of cisplatin eligibilityi. This now marks the first platinum-free regimen approved for adult patients with MIBC, regardless of cisplatin eligibility.

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The approval was based on results from the pivotal Phase 3 EV-304 clinical trial (also known as KEYNOTE-B15), which were presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO GU). This expanded indication builds on the November 2025 U.S. FDA approval of the combination for use as neoadjuvant and adjuvant treatment in cisplatin-ineligible adult patients with MIBC, based on results from the EV-303 Phase 3 clinical trial (also known as KEYNOTE-905) that were published in the New England Journal of Medicine.

Christopher Hoimes, DO, Director of the Bladder Cancer Program and Center for Cancer Immunotherapy at Duke Cancer Institute, and an EV-304 Principal Investigator
"For muscle-invasive bladder cancer, a comprehensive treatment approach is important; the neoadjuvant phase can help shrink the tumor and target undetectable cancer cells early before surgery, while the adjuvant phase can be critical in eliminating residual, undetectable cancer cells following surgery. These data from EV-304 and this approval show that by delivering this regimen across both the neoadjuvant and adjuvant phases, without platinum-based chemotherapy, we can significantly reduce the risk of recurrence and improve overall survival — offering a potential new standard of care for adult patients with muscle-invasive bladder cancer."

Aamir Malik, Executive Vice President, Chief U.S. Commercial Officer, Pfizer
"Today’s approval marks a historic turning point for the treatment of muscle-invasive bladder cancer, providing adult patients with the first approved platinum-free combination regimen shown to significantly improve survival over the current standard of care – regardless of cisplatin-eligibility. PADCEV plus pembrolizumab has established itself as the standard of care for first line therapy of advanced stages of bladder cancer, and we’re thrilled to be able to provide this community a much-needed new treatment option in an earlier, potentially curative-intent setting."

Moitreyee Chatterjee-Kishore, PhD, MBA, Head of Oncology Development, Astellas
"The approval of neoadjuvant and adjuvant PADCEV plus pembrolizumab expands the established impact of this combination and represents a critical leap forward in how muscle-invasive bladder cancer can be treated. By delivering a clinically meaningful survival benefit, with profound event-free survival and pathological complete response rates, this regimen is the first platinum-free treatment option in nearly 25 years to outperform standard of care chemotherapy, offering new hope to patients living with this disease."

In the EV-304 clinical trial, patients were randomized to receive surgery with neoadjuvant and adjuvant PADCEV plus pembrolizumab or surgery with neoadjuvant chemotherapy. PADCEV plus pembrolizumab was administered as a planned total of 9 cycles of PADCEV and 17 cycles of pembrolizumab split before and after surgery.ii PADCEV plus pembrolizumab demonstrated:

A 47% reduction in the risk of tumor recurrence, progression or death compared to patients treated with standard of care neoadjuvant gemcitabine and cisplatin (Hazard Ratio (HR) of 0.53; 95% Confidence Interval (CI), 0.41–0.70; 1-sided p<0.0001).ii
An estimated 79.4% of patients were event-free at two years, compared with 66.2% treated with standard of care.ii
A 35% reduction in the risk of death compared to neoadjuvant chemotherapy (HR of 0.65; 95% CI, 0.48-0.89; 1-sided p=0.0029).ii
A pathological complete response (pCR) rate of 55.8% compared with 32.5% with chemotherapy at the time of surgery (estimated difference 23.4%; 95% CI 16.7-29.8; 1-sided p<0.0001).ii
A safety profile consistent with prior experience with this combination, and no new identifiable safety signals. Grade ≥3 adverse events (AEs) due to any cause occurred in 75.7% of patients treated with neoadjuvant and adjuvant PADCEV plus pembrolizumab compared to 67.2% of patients treated with neoadjuvant chemotherapy.ii
About the EV-304/KEYNOTE-B15 Trial
The EV-304 trial is an ongoing, open-label, randomized, controlled, Phase 3 study evaluating neoadjuvant and adjuvant enfortumab vedotin in combination with pembrolizumab versus neoadjuvant chemotherapy (gemcitabine and cisplatin) in patients with MIBC who are eligible for cisplatin-based chemotherapy. Patients were randomized to receive either neoadjuvant and adjuvant (before and after surgery) enfortumab vedotin in combination with pembrolizumab (arm A) or neoadjuvant gemcitabine-cisplatin chemotherapy (arm B). Curative-intent surgery (cystectomy) was performed in both arms. Enfortumab vedotin in combination with pembrolizumab was administered as a planned total of 9 cycles of enfortumab vedotin and 17 cycles of pembrolizumab split before and after surgery.ii

The primary endpoint of this trial is EFS, defined as the time from randomization to the first occurrence of any of the following events: progression of disease that precludes radical cystectomy (RC) or failure to undergo RC in participants with residual disease, gross residual disease left behind at the time of surgery, local or distant recurrence based on blinded independent central review (BICR) or death due to any cause. Key secondary endpoints include OS and pCR rate.iii

For more information on the global EV-304 trial, go to clinicaltrials.gov.

About Muscle-Invasive Bladder Cancer
Bladder cancer is the ninth most common cancer worldwide, diagnosed in more than 614,000 people each year globally, including an estimated 85,000 people in the U.S.iii,iv MIBC represents approximately 30% of all bladder cancer cases.v The standard treatment for patients with MIBC is neoadjuvant cisplatin-based chemotherapy followed by surgery.vi Even after undergoing surgery to have their bladder removed, approximately half of patients with MIBC experience disease recurrence.vii

About PADCEV (enfortumab vedotin-ejfv)
PADCEV (enfortumab vedotin-ejfv) is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.viii Nonclinical data suggest the anticancer activity of PADCEV is due to its binding to Nectin-4-expressing cells, followed by the internalization and release of the anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis).i

PADCEV plus pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph is approved for the treatment of adult patients with MIBC in the United States and for cisplatin-ineligible patients with MIBC in the European Union.

PADCEV plus pembrolizumab is also approved for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC) in the United States, the European Union, Japan and a number of other countries around the world. PADCEV is also approved as a single agent for the treatment of adult patients with la/mUC who have previously received a PD-1/PD-L1 inhibitor and platinum-containing chemotherapy or are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy.

(Press release, Astellas, JUL 13, 2026, View Source [SID1234670182])

VERAXA Biotech to Launch AI-enabled Drug Discovery Collaboration with Ardigen to Support Growing BiTAC® Pipeline

On July 13, 2026 VERAXA Biotech AG (NASDAQ: VRXA; "VERAXA"), an emerging leader in designing novel cancer therapies, reported a collaboration with Ardigen S.A., an AI-driven computational partner for modern R&D recognized for pioneering the use of artificial intelligence (AI) and bioinformatics for precision medicine, to support VERAXA’s growing BiTAC pipeline of t cell engagers (TCEs) and antibody drug conjugates (ADCs). The collaboration is another milestone in VEREXA’s mission to integrate AI into its research and development, with the long-term goal to achieve success rates in drug development that exceed industry benchmarks.

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Current high-potency modalities, including TCEs and ADCs, are frequently limited by severe on-target, off-tumor toxicities, restricting therapeutic efficacy and leading to high failure rates in development. VERAXA’s BiTAC-TCEs and future BiTAC-ADCs utilize a Boolean "AND-gate" logic, requiring the co-expression of two distinct targets on the same cancer cell for activation. This innovative approach has the potential to significantly widen the therapeutic window by sparing healthy tissues and even systemic toxicity.

With the BiTAC platform, VERAXA believes that it can leverage the extensive body of existing preclinical and clinical data generated across the industry, particularly from programs that failed due to toxicity despite demonstrating promising efficacy. AI could enable the integration and analysis of such large datasets to identify improved dual-target combinations, refine therapeutic design, and potentially rescue previously challenging or "undruggable" targets. The partnership with Ardigen will initially focus on developing AI-enabled tools and models to guide the selection process of synergistic cancer target pairs for VERAXA’s growing BiTAC portfolio.

"We see enormous potential in the application of AI processes to help guide the development strategy of our proprietary BiTAC programs," commented Christoph Antz, Ph.D., CEO and Co-Founder of VERAXA. "Because of the nature of BiTACs, smart cancer target selection and thorough validation from the outset can have a transformative impact on future success rates and product profiles. This collaboration represents a strategic step forward in harnessing the power of AI to bring precision oncology therapies to patients faster."

(Press release, Veraxa Biotech, JUL 13, 2026, View Source [SID1234669184])

Artelo Biosciences Announces Positive Results with ART27.13 in a Nonclinical Model of Paclitaxel-Induced Peripheral Neuropathy

On July 13, 2026 Artelo Biosciences, Inc. (Nasdaq: ARTL) ("Artelo" or the "Company), a clinical-stage pharmaceutical company focused on modulating lipid-signalling pathways to develop treatments for people living with cancer, pain, dermatologic, or neurological conditions, reported promising results from nonclinical studies in neuropathic pain with ART27.13, the Company’s proprietary peripherally restricted cannabinoid receptor agonist, currently in Phase 2 clinical development evaluating patients experiencing cancer-related anorexia cachexia syndrome (CACS).

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To determine whether ART27.13 has the potential to address neuropathic pain in cancer patients, researchers at Artelo investigated its proprietary dual cannabinoid agonist in a nonclinical model of paclitaxel-induced peripheral neuropathy, a debilitating side effect that affects approximately 60%-80% of patients receiving paclitaxel1.

Results demonstrated that repeated dosing with ART27.13 reduced neuropathic pain-associated behaviors (mechanical allodynia and thermal hyperalgesia) in both male and female paclitaxel-treated animals, supporting further exploration of the compound in oncology supportive care settings.

"Chemotherapy-induced peripheral neuropathy can significantly affect patient quality of life and may limit cancer treatment adherence," said George Warren, Ph.D., lead scientist at Artelo Biosciences and presenter of the pain study results at the International Cannabinoid Research Society (ICRS) 2026 Annual Symposium recently held in Dijon, France. "The results observed in this model suggest that ART27.13 may have broader applications in cancer supportive care beyond CACS. We have incorporated several pain endpoints into the Cancer Appetite Recovery Study (CAReS) trial and, we look forward to reviewing these upon study completion to determine if the analgesic potential of ART27.13 in a cancer setting translates into the clinic."

CACS affects up to 80% of patients with advanced malignancies2 and is associated with reduced treatment tolerance, diminished physical functioning and poorer clinical outcomes. There are currently no FDA-approved treatment options available for CACS. ART27.13 is being evaluated in the CAReS and interim results also presented at ICRS demonstrated encouraging trends across several clinically meaningful endpoints, including improvements in body weight and lean body mass, increased activity levels, and favorable safety profile at doses up to 1300 µg/day.

"Interim CAReS results, and the new data in neuropathic pain, suggests peripheral cannabinoid receptor modulation may influence multiple pathways associated with appetite regulation, metabolism, body composition and symptom management, particularly chemotherapy-induced neuropathic pain, in patients with cancer," said Professor Saoirse E. O’Sullivan, Vice President of Translational Science at Artelo Biosciences and presenter of the interim results from CAReS. "Importantly, the supportive care opportunity for ART27.13 may extend beyond appetite stimulation and weight maintenance, as demonstrated by additional research presented at ICRS."

"Despite its significant impact on patient outcomes and quality of life, CACS remains an area of substantial unmet medical need with limited therapeutic options available to patients and physicians," continued Professor O’Sullivan. "The trends observed in body composition and activity measures from CAReS are particularly encouraging given the profound impact these factors can have on patients living with CACS."

https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2026.1762734/full?utm_source
View Source
About ART27.13
ART27.13 is a novel cannabinoid receptor agonist being developed as supportive care for people with cancer experiencing anorexia and cachexia. Administered orally once daily, the treatment goals with ART27.13 are to improve appetite, body weight, and activity levels while preserving muscle and elevating quality of life. Initially developed by AstraZeneca plc, ART27.13 selectively targets peripheral cannabinoid (CB1 and CB2) receptors to avoid the CNS side effects typically associated with some cannabinoids. While exhibiting a favorable safety profile at all doses in the CAReS trial, interim analysis from the blinded and randomized Phase 2 study demonstrated a mean weight gain of over 6% for participants that received the top dose of ART27.13 compared to a 5% loss in the placebo group. A weight loss of more than 5% can predict a poor outcome for cancer patients and a lower response to therapy. Currently, there areno FDA approved treatments for cancer anorexia cachexia syndrome.

About CAReS
The Cancer Appetite Recovery Study (CAReS) is a Phase 1/2 randomized, placebo-controlled trial of the Company’s lead clinical program, ART27.13, in people with cancer experiencing anorexia and weight loss. Cancer-related anorexia, or the lack or loss of appetite in the person with cancer, may result from the cancer and/or its treatment with radiation or chemotherapy. It is common for people with cancer to lose weight. Anorexia and the resulting weight loss can affect a patient’s health, often weakening their immune system and causing discomfort and dehydration. Interim data from the Phase 2 portion of CAReS showed improvements in lean body mass, weight gain, and activity among patients treated with all doses of ART27.13, particularly at the highest dose, compared to the participants administered placebo. (ISRCTN registry: View Source)

(Press release, Artelo Biosciences, JUL 13, 2026, View Source [SID1234669183])

Erasca Announces Updated Preliminary Phase 1 Data and Registration-Enabling Plans for Potentially Best-in-Class Pan-RAS Molecular Glue ERAS-0015 in KRAS-Mutant Solid Tumors

On July 13, 2026 Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, reported updated preliminary Phase 1 data for its potentially best-in-class, pan-RAS molecular glue ERAS-0015 in patients with RAS-mutant solid tumors. The Company also announced clinical development plans for the ERAS-0015 program, including potentially registration-enabling trials in lung and pancreatic cancers.

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Updated preliminary data from Erasca’s ongoing AURORAS-1 Phase 1 trial in the U.S. builds on the Company’s April 2026 announcement, with additional patients and longer follow-up.

"We believe the continued notable responses in patients with pancreatic cancer in the U.S., together with the encouraging data in lung cancer and early signal in combination with panitumumab in metastatic colorectal cancer that we have seen in Phase 1, underscore the broad potential of ERAS-0015 to become a foundational therapy for multiple RAS-mutant solid tumors," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. "We look forward to additional preliminary monotherapy and combination data expected in the first half of 2027. We believe that we are well positioned to execute our robust clinical development plan and transition into Phase 3 development."

Encouraging Monotherapy Responses Observed in Second Line or Greater (2L+) KRAS G12X Pancreatic Ductal Adenocarcinoma (PDAC)1

57% uORR8wk (N=7) at recommended dose for expansion (RDE) of 32 mg QD2
Across doses, all patients with either confirmed or unconfirmed responses remained on treatment
At RDE of 32 mg QD, 6 of 7 enrolled patients remained on treatment; at RDE of 24 mg QD, 6 of 8 enrolled patients remained on treatment

With Additional Patients and Longer Follow-up, Monotherapy Safety Data Remained Consistent with Prior Disclosure and ERAS-0015 Continued to be Generally Well-Tolerated1

Frequency and severity of treatment-related adverse events (TRAEs) remained consistent with the Company’s April 2026 announcement
Mostly low-grade TRAEs, no dose-limiting toxicities (DLTs), low rate of dose interruptions or reductions due to TRAEs, and no discontinuations due to TRAEs
Median relative dose intensity (RDI) was 100% at both 24 mg QD and 32 mg QD

Promising Combination Potential with Panitumumab in Metastatic Colorectal Cancer (CRC), including Clearance of First Dose Escalation Cohort3

No DLTs were observed for the combination in the 16 mg cohort during dose escalation in four DLT-evaluable patients
Backfill enrollment is ongoing in the 16 mg combination cohort
Dose escalation is ongoing with continued enrollment in the 24 mg combination cohort

Accelerating Potentially Registration-Enabling Development Plans in Highest Value Indications

Initiate potentially registration-enabling trial in 2L+ NSCLC in 1H27
Initiate 1L PDAC Phase 3 pivotal trial in 2027
Initiate RASm NSCLC Phase 3 pivotal trial in 2H27-1H28

____________________
1 Data cutoff (DCO) May 25, 2026
2 The uORR8wk is the overall response rate (ORR) (confirmed and unconfirmed responses) for patients who received first dose of ERAS-0015 at least 8 weeks prior to the May 25, 2026 cutoff date
3 DCO July 6, 2026

About ERAS-0015
ERAS-0015 is an investigational, oral, highly potent pan-RAS molecular glue designed to inhibit RAS signaling with a potential best-in-class profile. Erasca is evaluating ERAS-0015 in the AURORAS-1 Phase 1 trial in patients with RAS-mutant solid tumors. Early dose escalation data in AURORAS-1 demonstrated favorable safety and tolerability results, well-behaved, linear PK, and confirmed and unconfirmed partial responses in multiple patients across multiple tumor types with different RAS mutations, including confirmed partial responses at doses as low as 8 mg once daily (QD). ERAS-0015 is also designed to prevent resistance against mutant-selective inhibitors through inhibition of RAS wildtype variants. In addition, ERAS-0015 has demonstrated favorable absorption, distribution, metabolism, and excretion (ADME) and pharmacokinetic (PK) properties in multiple animal species.

About ERAS-4001
ERAS-4001 is an investigational, oral, highly potent, and selective pan-KRAS inhibitor with a potential first-in-class and best-in-class profile. Erasca is evaluating ERAS-4001 in the BOREALIS-1 Phase 1 trial in patients with KRAS-mutant solid tumors. ERAS-4001 demonstrated favorable preclinical in vitro potency against KRAS G12X mutations as well as KRAS wildtype amplifications, which may limit treatment resistance mediated through KRAS wildtype activation. No activity was observed for ERAS-4001 against HRAS or NRAS wildtype proteins in preclinical studies, which may enable a better therapeutic window compared to pan-RAS inhibitors. ERAS-4001 showed potent activity against both GTP-bound (active state) and GDP-bound (inactive state) KRAS with single digit nanomolar IC50s. In vivo, ERAS-4001 induced tumor regression in multiple KRAS-mutant models. In preclinical studies, ERAS-4001 showed encouraging ADME and PK properties.

(Press release, Erasca, JUL 13, 2026, View Source [SID1234669182])