On November 5, 2026 NORROY BIOSCIENCE (NORROY), a late-stage clinical biotechnology company focused on innovative targeted radiopharmaceuticals, reported that its proprietary pipelines were featured in eight Top Rated Oral Presentations (TROP) and three e-posters at the 39th Annual Congress of the European Association of Nuclear Medicine (EANM’26), held from October 17 to 21 in Vienna, Austria, with the corresponding data presented during the congress.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The presentations further highlighted NORROY’s early- and late-stage radiopharmaceutical pipelines, including the first China-originated innovative radiopharmaceutical having received both Breakthrough Therapy Designation (BTD) and Fast Track Designation (FTD), as well as the first China-originated terbium-161-based radiopharmaceutical for prostate cancer. The presentations and e-Posters featured well-established radionuclides used in diagnostic imaging and targeted radioligand therapy, including 18F, 68Ga, and 177Lu, as well as the next-generation therapeutic radionuclide, 161Tb. It also explored targets including ACP3 and GPC3, with indications spanning from prostate cancer, renal cell carcinoma to hepatocellular carcinoma, neuroendocrine tumors, small cell lung cancer and primary aldosteronism.

During the congress, NORROY hosted its themed ecosystem forum, the KUNLUN SALON, which was chaired by Thomas Tulip, Ph.D., Chief Business Officer (CBO) of NORROY, and reached preliminary cooperation intentions with Esente Healthcare and other international partners. The collaborations will focus mainly on the development of radiopharmaceutical automation equipment, further expanding NORROY’s network of global industry partners.

Oliver Sartor, M.D., Chairman of NORROY’s Scientific Advisory Board and an internationally recognized prostate cancer expert, delivered in the congress an oral presentation titled "Initial Safety and Efficacy of 177Lu-NYM032 in Progressive mCRPC: A Phase I–II Study" and also participated in the KUNLUN SALON.

NORROY presented multiple molecular imaging studies targeting carbonic anhydrase IX (CAIX) in clear cell renal cell carcinoma (ccRCC). Research results involving 68Ga-NYM096 were explored with respect to lesion detection in ccRCC, one-stop-shop imaging for von Hippel–Lindau (VHL) syndrome, and the characterization of cystic renal masses. Separately, another radiotracer, 18F-NYM124, was evaluated in a prospective head-to-head comparison with 18F-FDG PET/CT, further investigating the potential application of CAIX-targeted molecular imaging in renal cancer diagnosis.

In prostate cancer, NORROY presented research on PSMA-targeted radiopharmaceutical candidates. 161Tb-labeled NYM032 was evaluated in a preliminary first-in-human, low-dose study in patients with metastatic castration-resistant prostate cancer (mCRPC). In addition, research on the ACP3-targeted candidate, 68Ga/177Lu-NY129, revealed its potential applications in molecular imaging for prostate cancer.

Other studies presented included preclinical evaluation of 68Ga/177Lu-NY123, a GPC3-targeted radiotheranostic candidate for hepatocellular carcinoma (HCC); 68Ga-NYM184, a CXCR4-targeted radiotracer for PET imaging; and 177Lu-NYM158, an SSTR2-targeted radiopharmaceutical candidate being investigated for treating aggressive neuroendocrine neoplasms and small cell lung cancer.

During EANM’26, NORROY showcased its integrated "Radiopharmaceuticals + Equipment" strategy at booth 267, highlighting developments in AI-enabled drug discovery, automated radiopharmaceutical manufacturing and unmanned production support systems.

The exhibition featured the Mortenon M1 multifunctional synthesis module, the Mortenon P1 automated production line, the Mortenon S3/S4 radionuclide dispensing modules, and the Mortenon D2 radiopharmaceutical transport containers, demonstrating NORROY’s equipment portfolio for radiopharmaceutical production and handling/transporting.

Through continued R&D and investment in radiopharmaceutical innovation, clinical development and automation technologies, NORROY aims to advance its pipelines and strengthen collaboration with global partners to support the development of nuclear medicine and radiotheranostics.

(Press release, Norroy Bioscience, NOV 5, 2026, View Source [SID1234674354])

On November 5, 2026 HERVolution Therapeutics ApS, a biotechnology company pioneering human endogenous retrovirus (HERV)-targeting immunotherapies for oncology, metabolic diseases, cellular senescence and longevity, reported the publication of peer-reviewed data supporting human endogenous retrovirus K (HERV-K) as a tumor antigen in non-small cell lung cancer (NSCLC) — the indication selected for the Company’s planned first-in-human study of HTX-IPT001.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The study, titled "Endogenous Retrovirus-Targeted Immunotherapy for Non-Small Cell Lung Cancer Supported by Cellular HERV-K Expression, Dependency and Efficacy of ERV Therapy in a Murine Model," appears open access in the International Journal of Molecular Sciences and is available at View Source

Where the Company’s recent platform publication described how the HERV-K envelope can be engineered to break immune tolerance, this study addresses the indication question: whether HERV-K is present, targetable and difficult for tumors to discard in advanced NSCLC specifically.

HERV-K antigen sequences are expressed across advanced NSCLC

Using total RNA sequencing of 207 biopsies from patients with advanced, predominantly pretreated NSCLC, the authors detected expression of HERV-K Gag and envelope (Env) antigen-coding sequences across the cohort. Every tumor analyzed expressed at least one such sequence, and expression was typically distributed across multiple loci rather than confined to a single one. This redundancy is relevant to a vaccine strategy, because it reduces the likelihood that a tumor can escape a HERV-K-directed immune response by silencing any one sequence.

Genetic redundancy of dark genome loci enables an off-the-shelf cancer vaccine

This redundancy also sets HERV-K apart from the personalized approaches that dominate current cancer vaccine development. Personalized mRNA vaccines must be custom-designed around each patient’s private tumor mutations — a set of targets unique to that patient, and one a tumor can edit away under immune pressure. HERV-K, by contrast, is encoded in the human genome itself, with more than 90 full-length loci shared by every patient. A single off-the-shelf product can therefore address the antigen in any HERV-K-expressing tumor, and because expression is spread across many loci, there is no single sequence whose loss would allow the tumor to escape.

NSCLC cell lines show dependency on HERV-K

Knockdown of HERV-K in five NSCLC cell lines impaired proliferation and survival in each line tested. The authors present these as initial dependency experiments, each conducted as a single independent experiment, and further work will be required to establish the mechanism and generality of the effect. If confirmed, the observation would indicate that HERV-K expression is not an incidental feature of these tumors but one the cells retain under selective pressure.

Antigen expression is retained under cytokine and chemotherapy pressure

HERV-K protein was detected in all five cell lines. Exposure to inflammatory cytokines and to cisplatin altered HERV-K protein levels, but antigen expression was retained and in some conditions increased. The same exposures consistently raised PD-L1 expression. Separately, a single envelope locus, HERV-K102, was associated with interferon signaling and antigen-presentation programs, suggesting it may mark an interferon-active tumor state. These are observational associations in tumor transcriptomes and in vitro systems, and have not been tested prospectively.

Preclinical proof-of-concept for ERV-targeted immunotherapy

In a murine tumor model, immunization against an endogenous retrovirus antigen conferred significant protection against tumor challenge. Late therapeutic immunization combined with anti-PD-L1 treatment produced complete tumor regression in a subset of animals. Importantly, these experiments used a murine endogenous retrovirus surrogate antigen rather than HERV-K itself, because HERV-K is not present in the mouse genome. The authors therefore describe the result as proof-of-concept for ERV-targeted immunotherapy in a murine surrogate system, not as direct evidence of HERV-K-targeted efficacy. The study was not powered a priori, and these findings are preclinical.

"Our platform publication established that HERV-K can be rationally engineered to break tolerance. This study answers the question that follows from it — why lung cancer, and why now. It also underlines a structural advantage of the target: because HERV-K is written into every human genome at more than 90 loci, it is an off-the-shelf antigen — one product for every patient, rather than a vaccine redesigned around each patient’s tumor, and one a tumor cannot discard by silencing a single sequence. It places the target rationale for our planned first-in-human study in the open literature, where investigators, partners and the wider field can assess it on its merits."
— J. Robert Coleman, PhD, MBA, Chief Executive Officer, HERVolution Therapeutics

The study was conducted by HERVolution Therapeutics in collaboration with the University of Copenhagen and Copenhagen University Hospital – Rigshospitalet. It was supported by the European Innovation Council Accelerator (grant 190120397) and the EUREKA Eurostars Programme (grant 3150-00110B). Human samples were collected under ethics approval H-16046103 with written informed consent from all patients; animal work was approved by the Danish Animal Experimentation Inspectorate (2024-15-0201-01692).

About HTX-IPT001 and the planned first-in-human study

HTX-IPT001 is an adenovirus-based advanced therapy medicinal product (ATMP) encoding an engineered HERV-K antigen. HERVolution is preparing a first-in-human study of HTX-IPT001 in patients with NSCLC as well as in metabolic disease, with both planned to begin in 2027. The studies has not yet begun and remains subject to regulatory and ethics approval. HTX-IPT001 is an investigational candidate and is not approved for use in any indication.

(Press release, Hervolution Therapeutics, NOV 5, 2026, View Source [SID1234674353])

On November 5, 2026 ImmunoGenesis, a clinical-stage biotech company developing innovative, science-driven immunotherapies, reported two publications providing new nonclinical evidence and scientific insights into the ability of its novel stimulator of interferon genes (STING) agonist, IMGS-203, to remodel the tumor microenvironment and enhance antitumor activity in combination with the Company’s novel cytotoxic dual-specific PD-L1/PD-L2 antibody.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

IMGS-203 is a novel STING agonist being developed by ImmunoGenesis as a cancer immunotherapy designed to stimulate antitumor immune responses. The Company plans to advance IMGS-203 into clinical development initially for recurrent glioblastoma (GBM), an aggressive brain cancer with limited therapeutic options and significant unmet medical need.

Dr. Federica Pericle, Chief Scientific Officer, ImmunoGenesis, commented: "These findings reinforce the scientific rationale for developing IMGS-203 in GBM, where local STING activation has the potential to overcome the immunosuppressive tumor microenvironment. We are completing IND-enabling studies to advance IMGS-203 into clinical development while exploring its potential in combination with our cytotoxic dual-specific PD-L1/PD-L2 antibody."

The data from these publications are directly relevant to GBM, a highly immunosuppressive, myeloid-rich tumor in which monotherapy with conventional immune checkpoint inhibitors have shown limited efficacy. Nonclinical studies demonstrate that local administration of IMGS-203 remodels the tumor microenvironment (TME), reduces immunosuppressive myeloid cell populations, enhances T-cell activation, and improves survival in tumor models. STING activation also induces PD-L1 and PD-L2 expression, creating an opportunity to enhance antitumor activity through combination with ImmunoGenesis’ cytotoxic dual-specific PD-L1/PD-L2 antibody.

"Together, these publications reinforce our commitment to translating STING biology into innovative cancer therapies," said James Barlow, President and Chief Executive Officer, ImmunoGenesis. "We are focused on advancing IMGS-203 into clinical development for patients with GBM, a devastating disease with limited treatment options and significant unmet clinical need."

Publication Details:
Salameh, et al., (2026), Tumor Microenvironment Remodeling by STING Agonism Sensitizes Endothelial Cells to Cytotoxic anti-PD-L1/L2 Antibody in Journal of Experimental and Clinical Cancer Research highlights promising results showing activation of the STING pathway can overcome immune exclusion by promoting Tumor Microenvironment (TME) remodeling and immune cell recruitment.

Boda et al., (2026) "STING-Mediated Tumor Microenvironment Remodeling: Turning Adaptive Resistance into Therapeutic Vulnerability." Frontiers in Immunology reviews data showing how STING activation can reconfigure the TME to yield potent anti-tumor effects.

(Press release, ImmunoGenesis, NOV 5, 2026, View Source [SID1234674352])

On November 5, 2026 Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics, reported financial results for the third quarter ended September 30, 2026, and provided a business update.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"This quarter marked an important milestone for Enliven as we reached alignment with the FDA on the final design of ENABLE-2, providing a clear path to initiate our first pivotal trial," said Rick Fair, Chief Executive Officer of Enliven. "The compelling ENABLE data presented at EHA (Free EHA Whitepaper) in June generated strong engagement across the medical community, and we are encouraged by the enthusiasm from physicians and investigators as we prepare to initiate ENABLE-2. As we approach year-end, we remain confident in relcobatinib’s potential to become a best-in-class therapy for patients with CML and are focused on executing our Phase 3 development program."

Relcobatinib Updates

The United States Adopted Names (USAN) Council adopted relcobatinib as the nonproprietary name for ELVN-001.
The Company announced that it reached alignment with the U.S. Food and Drug Administration (FDA) on the final design of the ENABLE-2 pivotal trial of relcobatinib in patients with previously treated chronic myeloid leukemia (CML).
Clinical data for relcobatinib from the Phase 1 ENABLE trial were featured in encore oral presentations at the meetings of the Society of Hematologic Oncology (SOHO), the International CML Foundation (ESH-iCMLf), the Japanese Society of Hematology (JSH) and the German Society for Hematology and Medical Oncology (DGHO), reflecting continued enthusiasm for its clinical profile.
Preclinical data published in the peer-reviewed journal Leukemia demonstrated relcobatinib’s unique binding mode, high selectivity for BCR::ABL1 and activity against a broad range of clinically relevant tyrosine kinase inhibitor (TKI)-resistant mutations, supporting its potential as a best-in-class TKI for CML.
The Company remains on track to initiate ENABLE-2 before year-end 2026.
Additional Company Updates

Enliven appointed Kristine Ball, an accomplished biopharmaceutical executive, to its Board of Directors.
Management will participate at the following investor conferences:
Guggenheim Healthcare Innovation Conference, November 9-11, Boston, MA (Fireside Chat and 1×1 Meetings)
Stifel Healthcare Conference, November 10-12, New York, NY (1×1 Meetings)
Jefferies Global Healthcare Conference, November 16-19, London, UK (Fireside Chat and 1×1 Meetings)
The fireside chat will be webcast live and can be accessed by visiting the investor relations section of the Company’s website at View Source The webcast will be archived for a period of 90 days following the conclusion of the live event.
Third Quarter 2026 Financial Results

Cash position: As of September 30, 2026, the Company had cash, cash equivalents and marketable securities totaling $884.4 million, which is expected to provide cash runway into 2030.
Research and development (R&D) expenses: R&D expenses were $28.0 million for the third quarter of 2026, compared to $18.2 million for the third quarter of 2025.
General and administrative (G&A) expenses: G&A expenses were $8.0 million for the third quarter of 2026, compared to $6.9 million for the third quarter of 2025.
Net loss: Enliven reported a net loss of $27.7 million for the third quarter of 2026, compared to a net loss of $20.1 million for the third quarter of 2025.
About Relcobatinib (ELVN-001)
Relcobatinib (ELVN-001) is a potent, highly selective, potentially best-in-class small molecule kinase inhibitor designed to specifically target the BCR::ABL1 gene fusion, the oncogenic driver for patients living with CML. As a highly selective active-site TKI, relcobatinib has a mechanism of action that is complementary to allosteric BCR::ABL1 inhibitors, which may play an increasingly important role in the standard of care. Relcobatinib was also designed to have activity against the T315I mutation, the most common BCR::ABL1 mutation, which confers resistance to nearly all approved TKIs, as well as activity against mutations known to confer resistance to allosteric BCR::ABL1 inhibitors.

About the ENABLE-2 Trial
ENABLE-2 is a planned randomized Phase 3 trial of relcobatinib in adults with CML previously treated with one or more TKIs. The trial is expected to enroll approximately 450 patients, who will be randomized 1:1 to receive relcobatinib 80 mg once daily or an investigator-selected second-generation TKI (dasatinib, nilotinib, or bosutinib). The primary endpoint is major molecular response (MMR) at Week 24, which could support accelerated approval, with MMR at Week 96 serving as the key secondary endpoint that could support full approval.

(Press release, Enliven Therapeutics, NOV 5, 2026, View Source [SID1234674351])

On November 5, 2026 Akeso, Inc. (9926.HK) reported that results from a Phase II clinical study evaluating its first-in-class PD-1/VEGF bispecific antibody ivonescimab in the perioperative treatment of resectable non-small cell lung cancer (NSCLC) have been published in the journal Nature Medicine. This Phase II trial assessed the efficacy and safety of perioperative ivonescimab administered either as monotherapy or in combination with chemotherapy. Patients received neoadjuvant treatment followed by surgical resection and subsequent adjuvant ivonescimab.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The study demonstrated that neoadjuvant ivonescimab in combination with chemotherapy produced high rates of pathological response in patients with resectable NSCLC. Among patients who underwent surgery, the major pathological response (MPR) rate was 70.1% and the pathological complete response (pCR) rate was 50.7%.

Key findings:

In the ivonescimab plus chemotherapy cohort, the MPR rate reached 70.1%, the pCR rate was 50.7%, and 68.7% of patients had residual viable tumor (RVT) ≤5%.
The ivonescimab monotherapy cohort also showed meaningful pathological responses, with an MPR rate of 60.0% and a pCR rate of 30.0%.
Both cohorts achieved high objective response rates and frequent T-stage downstaging. All patients who proceeded to surgery achieved R0 resection (100%). The 12-month event-free survival (EFS) rates exceeded 80% in both arms, comparing favorably with outcomes reported in prior Phase III perioperative immunotherapy trials.
Subgroup analyses revealed particularly notable activity in clinically relevant populations: patients with squamous histology achieved an MPR rate of 81.5% and a pCR rate of 61.1%; those with Stage III disease achieved an MPR rate of 65.5% and a pCR rate of 47.3%; and PD-L1-negative patients achieved an MPR rate of 69.2%, comparable to that observed in PD-L1-positive patients.
The perioperative safety profile of ivonescimab was manageable. No grade ≥3 bleeding events occurred, and no surgeries were cancelled due to treatment-related adverse events.
Approximately one-quarter of patients with NSCLC have resectable disease at the time of diagnosis. Nevertheless, 30–70% of patients experience disease recurrence after surgery, frequently with distant metastases, contributing to poor long-term outcomes. Although neoadjuvant immuno-chemotherapy is now established in treatment guidelines, current regimens leave room for improvement, particularly in subgroups such as Stage IIIB disease, squamous histology, and PD-L1-negative tumors, where unmet clinical need remains substantial.

These Phase II results further support the potentially important role of ivonescimab as a next-generation immunotherapy option across the continuum of NSCLC treatment options.

About Ivonescimab

Ivonescimab is a first-in-class PD-1/VEGF bispecific antibody independently developed by Akeso. It is the world’s first approved bispecific antibody that combines immuno-oncology and anti-angiogenesis mechanisms in a single molecule, helping to define a new generation of bispecific immuno-oncology therapies. Ivonescimab is also the first therapy to demonstrate positive results in a Phase III head-to-head study against pembrolizumab.

Building on its strong clinical profile in the IO2.0 landscape, Akeso is advancing a comprehensive global development program for ivonescimab across multiple tumor types and treatment settings. As a cornerstone of the Company’s IO2.0 + ADC2.0 strategy, ivonescimab aims to help reshape standards of care in major cancers worldwide.

More than 17 Phase III studies of ivonescimab are underway globally, including seven international multi-regional registrational Phase III trials and seven head-to-head studies versus PD-1/PD-L1 therapies. These programs encompass eight registrational or Phase III studies in lung cancer, as well as trials in first-line MSS/pMMR colorectal cancer, first-line PD-L1-positive head and neck squamous cell carcinoma (in combination with ligufalimab versus pembrolizumab), first-line biliary tract cancer (versus pembrolizumab/ durvalumab-based regimen), first-line triple-negative breast cancer, first-line pancreatic cancer, and first-line urothelial carcinoma (versus pembrolizumab plus a Nectin-4 ADC).

Akeso has out-licensed the exclusive rights to develop and commercialize ivonescimab in the United States and Canada, South America, Europe, the Middle East, Africa, and Japan to Summit Therapeutics under an agreement with a total potential value of up to US$5 billion.

(Press release, Akeso Biopharma, NOV 5, 2026, View Source [SID1234674350])