Rigel Highlights New GAVRETO® (pralsetinib) Data Across RET Fusion-Positive Cancers in Oral and Poster Presentations at ESMO Congress 2026

On October 19, 2026 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, reported analysis of the pooled efficacy and safety data from two clinical trials of GAVRETO (pralsetinib), ARROW (NCT03037385) and TAPISTRY (NCT04589845), in patients with rearranged during transfection (RET) fusion-positive solid tumors will be presented in a rapid oral session at the European Society For Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026 on Sunday, October 25, 2026.

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In addition, the ESMO (Free ESMO Whitepaper) Congress will feature two poster presentations and an ePoster with additional clinical and health-related quality of life data from the TAPISTRY clinical trial in patients with RET fusion-positive thyroid cancer and ARROW trial in patients with RET fusion-positive non-small cell lung cancer (NSCLC). The ESMO (Free ESMO Whitepaper) Congress is being held in Madrid, Spain and virtually from October 23 to October 27, 2026.

"These analyses reinforce the breadth of evidence supporting pralsetinib across RET fusion-positive cancers and provide important new insights into its clinical activity, durability and impact on patients," said Alison L. Hannah, M.D., Rigel’s chief medical officer. "We are particularly encouraged by the findings across multiple solid tumor types, as well as the first-line clinical outcomes and quality-of-life data in RET fusion-positive NSCLC, which further our understanding of the potential role of pralsetinib for patients whose tumors are driven by RET fusions."

Key highlights from the presentations at ESMO (Free ESMO Whitepaper) include:

In a pooled analysis of 49 patients with RET fusion-positive solid tumors from the ARROW and TAPISTRY studies excluding NSCLC and thyroid tumors, pralsetinib demonstrated robust and durable activity across a range of tumor types, including pancreatic and colorectal, with an overall response rate (ORR) of 53% and median duration of response of 12.2 months. Notably, patients with previously-treated pancreatic tumors had an ORR of 88% (7/8). These data support the potential use of pralsetinib in a tumor-agnostic approach for RET fusion-positive solid tumors.
In the TAPISTRY clinical trial cohort that evaluated pralsetinib in 16 response-evaluable thyroid cancer patients with RET fusion-positive tumors, pralsetinib demonstrated robust and durable activity against RET fusion-positive thyroid cancer with an ORR of 81.3% and manageable safety, results that are consistent with the ARROW study and further highlight its utility in this population.
In patients with RET fusion–positive NSCLC enrolled in ARROW, patients treated with pralsetinib in the first-line setting had a higher investigator-assessed ORR than patients who had received standard of care first-line therapies before ARROW enrollment (75% vs. 26%). Median times to progression, treatment discontinuation, and next treatment or death were also longer with first-line pralsetinib. These findings support pralsetinib as an effective first-line therapy and are consistent with treatment guidelines recommending selective RET inhibition for patients with RET fusion-positive advanced NSCLC.
In the ARROW clinical trial, pralsetinib therapy was associated with clinically meaningful improvements in Health-Related Quality of Life (HRQoL) among patients with advanced or metastatic RET fusion-positive NSCLC, with at least 75% of evaluable patients experiencing improved or stable scores across all assessed domains at Cycle 12 Day 1.
ESMO Congress 2026 abstracts may be accessed online via the ESMO (Free ESMO Whitepaper) 2026 – Conference Calendar.

Abstract Title

Lead Author / Presenter

Presentation Type / Abstract #

Session Title

Session Date / Time

Efficacy and Safety of Pralsetinib in RET Fusion-Positive Solid Tumors: Pooled Analysis of the ARROW and TAPISTRY Trials

Jacqueline Vuky, MD

Rapid Oral #1005RO

Rapid Oral: Developmental therapeutic

October 25, 8:30 – 10:00 am CET

Pralsetinib for Advanced RET Fusion-Positive Thyroid Cancer: Results from the TAPISTRY Clinical Trial

Do-Youn Oh, MD, PhD

Poster Presentation #4215P

Poster Display Session: Thyroid Cancer

October 26, 12:00 – 12:45 pm CET

Clinical Outcomes With First-Line Pralsetinib vs Other Accepted Therapies in ARROW Patients with RET Fusion-Positive NSCLC

Vivek Subbiah, MD

Poster Presentation #2718P

Poster Display Session: NSCLC, metastatic

October 26, 12:00 – 12:45 pm CET

Health-Related Quality of Life (HRQoL) Among Patients With Advanced or Metastatic RET-Fusion-Positive NSCLC Treated With Pralsetinib in ARROW

Giuseppe Curigliano, MD, PhD

ePoster Presentation #2808eP

N/A

N/A

About NSCLC
It is estimated that over 229,000 adults in the U.S. will be diagnosed with lung cancer in 2026. Lung cancer is the leading cause of cancer death in the U.S., with non-small cell lung cancer (NSCLC) being the most common type accounting for 77% of all lung cancer diagnoses.1 RET fusions are implicated in approximately 1-2% of patients with NSCLC.2

About GAVRETO (pralsetinib)

INDICATIONS

GAVRETO (pralsetinib) is indicated for the treatment of:

Adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test
Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate)*
*This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

IMPORTANT SAFETY INFORMATION

WARNING: SERIOUS INFECTIONS, INCLUDING OPPORTUNISTIC INFECTIONS

GAVRETO may increase the risk for serious infections, including bacterial, fungal, viral and opportunistic infections, which can lead to hospitalization or death. Withhold, reduce the dose or permanently discontinue GAVRETO based on severity.

WARNINGS AND PRECAUTIONS

Serious Infections, Including Opportunistic Infections: GAVRETO may increase the risk for serious infections, including fatal and opportunistic infections. In the AcceleRET-Lung trial, infections occurred in 72% of patients who received GAVRETO, including 18% with Grade 3 and 3.7% with Grade 4 and 7% with fatal outcomes. Among the patients who received chemotherapy/immunotherapy, infections occurred in 52%, including 10% with Grade 3. Infections in the GAVRETO arm included pneumonia, urinary tract infection, opportunistic infections (such as pneumocystis jirovecii pneumonia and fungal infections) and others. Monitor patients for signs and symptoms of infection and treat appropriately. Withhold, reduce the dose, or permanently discontinue GAVRETO based on severity.
Interstitial Lung Disease (ILD)/Pneumonitis: Severe, life-threatening, and fatal ILD/pneumonitis can occur in patients treated with GAVRETO. Pneumonitis occurred in 12% of patients who received GAVRETO, including 3.3% with Grade 3-4, and 0.2% with fatal reactions. Monitor for pulmonary symptoms indicative of ILD/pneumonitis. Withhold GAVRETO and promptly investigate for ILD in any patient who presents with acute or worsening of respiratory symptoms (e.g., dyspnea, cough, and fever). Withhold, reduce dose or permanently discontinue GAVRETO based on severity of confirmed ILD.
Hypertension: Occurred in 35% of patients, including Grade 3 hypertension in 18% of patients. Overall, 8% had their dose interrupted and 4.8% had their dose reduced for hypertension. Treatment-emergent hypertension was most commonly managed with anti-hypertension medications. Do not initiate GAVRETO in patients with uncontrolled hypertension. Optimize blood pressure prior to initiating GAVRETO. Monitor blood pressure after 1 week, at least monthly thereafter and as clinically indicated. Initiate or adjust anti-hypertensive therapy as appropriate. Withhold, reduce dose, or permanently discontinue GAVRETO based on the severity.
Hepatotoxicity: Serious hepatic adverse reactions occurred in 1.5% of patients treated with GAVRETO. Increased aspartate aminotransferase (AST) occurred in 49% of patients, including Grade 3 or 4 in 7% and increased alanine aminotransferase (ALT) occurred in 37% of patients, including Grade 3 or 4 in 4.8%. The median time to first onset for increased AST was 15 days (range: 5 days to 2.5 years) and increased ALT was 24 days (range: 7 days to 3.7 years). Monitor AST and ALT prior to initiating GAVRETO, every 2 weeks during the first 3 months, then monthly thereafter and as clinically indicated. Withhold, reduce dose or permanently discontinue GAVRETO based on severity.
Hemorrhagic Events: Serious, including fatal, hemorrhagic events can occur with GAVRETO. Grade ≥3 events occurred in 4.1% of patients treated with GAVRETO including one patient with a fatal hemorrhagic event. Permanently discontinue GAVRETO in patients with severe or life-threatening hemorrhage.
Tumor Lysis Syndrome (TLS): Cases of TLS have been reported in patients with medullary thyroid carcinoma receiving GAVRETO. Patients may be at risk of TLS if they have rapidly growing tumors, a high tumor burden, renal dysfunction, or dehydration. Closely monitor patients at risk, consider appropriate prophylaxis including hydration, and treat as clinically indicated.
Risk of Impaired Wound Healing: Impaired wound healing can occur in patients who receive drugs that inhibit the vascular endothelial growth factor (VEGF) signaling pathway. Therefore, GAVRETO has the potential to adversely affect wound healing. Withhold GAVRETO for at least 5 days prior to elective surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing. The safety of resumption of GAVRETO after resolution of wound healing complications has not been established.
Embryo-Fetal Toxicity: Based on findings from animal studies and its mechanism of action, GAVRETO can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with GAVRETO and for 2 weeks after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with GAVRETO and for 1 week after the last dose.
ADVERSE REACTIONS

Common adverse reactions (≥25%) were musculoskeletal pain, constipation, hypertension, diarrhea, fatigue, edema, pyrexia, and cough. Common Grade 3/4 laboratory abnormalities (≥2%) were decreased lymphocytes, decreased neutrophils, decreased hemoglobin, decreased phosphate, decreased leukocytes, decreased sodium, increased aspartate aminotransferase (AST), increased alanine aminotransferase (ALT), decreased calcium (corrected), decreased platelets, increased alkaline phosphatase, increased potassium, decreased potassium, and increased bilirubin.
DRUG INTERACTIONS

Avoid coadministration of GAVRETO with strong or moderate CYP3A inhibitors, P-gp inhibitors, or combined P-gp and strong or moderate CYP3A inhibitors. If coadministration cannot be avoided, reduce the GAVRETO dose. Avoid coadministration of GAVRETO with strong or moderate CYP3A inducers. If coadministration cannot be avoided, increase the GAVRETO dose.
Lactation: Advise women not to breastfeed during treatment with GAVRETO and for 1 week after the last dose.

Pediatric Use: Monitor open growth plates in adolescent patients. Consider interrupting or discontinuing GAVRETO if abnormalities occur.

Click here for Important Safety Information and Full Prescribing Information, including Boxed WARNING.

To report side effects of prescription drugs to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088).

GAVRETO is a registered trademark of Rigel Pharmaceuticals, Inc.

(Press release, Rigel, OCT 19, 2026, View Source [SID1234673564])

$2.9 Million NCI Grant Awarded for Clinical Development of RedHill’s Opaganib and CAR T-Cell Combination in Ultra-High-Risk Multiple Myeloma

On October 19, 2026 RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, reported that its partner, the University of Oklahoma (OU), has received $2.9 million in funding from the National Cancer Institute (NCI) to study, in clinical trials, whether RedHill’s opaganib1, given after CAR (chimeric antigen receptor) T-cell therapy, may help immune cells fight cancer more effectively.

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The five-year, $2.9 million grant from the NCI is planned to fund two phases of clinical trials. A Phase 1b trial plans to enroll up to 18 patients to evaluate the safety of the treatment combination of CAR T-cell therapy and opaganib and determine the appropriate dosage of opaganib. A subsequent Phase 2 trial plans to enroll up to 21 additional patients to seek preliminary evidence of effectiveness.

CAR T-cell therapy takes a patient’s immune cells, genetically modifies them so they can recognize and attack cancer cells, and then returns them to the patient. In a first for Oklahoma, the CAR T cells will be manufactured on the OU campus rather than being sent to a commercial manufacturer, potentially saving both time and money.

"We need to find a novel, more effective treatment option for patients with ultra-high-risk multiple myeloma as they continue to have poor outcomes despite current treatments," said grant awardee, Yubin Kang, M.D., OU Health hematologist-oncologist, division chief of Hematology, Bone Marrow Transplant and Cellular Therapy at OU Health Stephenson Cancer Center, and a professor at the OU College of Medicine. "With 10 years of preclinical studies on CAR T-cell therapy and opaganib, we believe the findings suggest that opaganib may help the modified immune cells remain active and continue attacking myeloma for longer. Opaganib works by blocking a protein called sphingosine kinase-2 (SPHK2), which appears to act as a kind of brake on the immune system’s cancer-fighting T cells. When SPHK2 was absent or blocked in mice, T cells multiplied more effectively and became better at killing myeloma cells. When combining opaganib with CAR T-cell therapy in vivo in mice, the results were encouraging, with tumor growth controlled for a longer period of time2. I am excited to see whether combining CAR T-cell therapy with opaganib can produce longer-lasting responses and improve outcomes for these high-risk patients."

Dr. Mark Levitt, RedHill’s Chief Scientific Officer said: "Opaganib has shown promise in preclinical studies as a potential combination therapy in a number of oncology and other indications. Prior preclinical and clinical work has shown that through a reduction of cancer cell survival proteins like c-Myc and Mcl-13, opaganib can potentially play a role in the treatment of multiple myeloma. We congratulate Dr. Kang and OU on this grant, which has the potential to be an important step to determine through clinical trials, whether these preclinical findings can turn into reality."

For patients with ultra-high-risk multiple myeloma, cancer often returns despite treatment, including bone marrow transplantation. CAR T-cell therapy is already an option for some patients whose cancer has returned.

The clinical trials will be conducted in partnership with RedHill, which is expected to provide opaganib, and Lentigen Technology, Inc., a Miltenyi Biotec, which developed the CAR construct. Miltenyi Biotec is enabling clinical translation by producing GMP-grade lentiviral vector for CAR T manufacturing on the CliniMACs Prodigy.

About the project

Research reported in this press release is supported by the National Cancer Institute of the National Institutes of Health under award No. R01CA293516-01A1.

About Opaganib (ABC294640)

Opaganib is a proprietary first-in-class investigational, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor drug. Potentially broad-acting, it is in development for multiple oncology, viral, inflammatory, metabolic (diabetes and obesity) and additional indications.

Opaganib’s suggested mechanism of action, published in the journal Drug Design, Development and Therapy, is host-directed and potentially broad-acting and is expected to maintain its effect against emerging viral variants. Opaganib is thought to work through the inhibition of multiple pathways, the induction of autophagy and apoptosis, and disruption of viral replication, through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells (SPHK2, DES1 and GCS).

Opaganib has received Orphan Drug designation from the FDA for the treatment of neuroblastoma and cholangiocarcinoma. A Bayer-supported placebo-controlled randomized Phase 2 study is ongoing to evaluate the efficacy of opaganib in combination with Bayer’s darolutamide in men with metastatic castrate-resistant prostate cancer (mCRPC), testing the potentially enhancing effect of opaganib in patients with a poor prognosis4. Opaganib also has a Phase 1 chemoradiotherapy study protocol ready for FDA-IND submission.

Opaganib has demonstrated its safety and tolerability profile in more than 470 participants in multiple clinical studies and expanded access use, including a large global Phase 2/3 study in hospitalized patients with moderate to severe COVID-19, published in Microorganisms.

(Press release, RedHill Biopharma, OCT 19, 2026, View Source [SID1234673563])

PharmaMar presents latest data on PM54 and will hold a Satellite Symposium on Small Cell Lung Cancer at ESMO 2026 in Madrid

On October 19, 2026 PharmaMar (MSE: PHM), leader in the research, development, and commercialization of marine-derived oncology therapies reported it will participate in the European Society Medical Oncology (ESMO) (Free ESMO Whitepaper), taking place in Madrid from October 23rd to 27th.

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The Company will present two posters on PM54, one on the preliminary results of this molecule in advanced solid tumors and the other on CombiVista, an AI tool that identifies and prioritizes oncology drug combinations across multiple workstreams for further development.

PharmaMar will also host a Satellite Symposium on Saturday, October 24th between 18:30 – 20:00h focused on the latest advances in the treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC). The symposium, chaired by Professor Silvia Novello from Oncology Department AOU San Luigi, University of Turin, Italy and with the participation of Professor Martin Reck, Head of the Department of Thoracic Oncology at the Lung Clinic Grosshansdorf, Germany, Professor Raffaele Califano, Consultant in Medical Oncology at The Christie and University Hospital of South Manchester, United Kingdom and Dr. Luis Paz-Ares, Head of Medical Oncology Department at Hospital Universitario 12 de Octubre, Madrid, Spain.

Luye, PharmaMar’s partner in China, will present the results of an exploratory study of flat-dose lurbinectedin plus serplulimab as first-line maintenance therapy in Chinese Patients with ES-SCLC.

The Association for Research on Lung Cancer in Women (ICAPEM), In collaboration with PharmaMar, will present two posters on the CLARISSE study, the first project in Spain to analyze the evolution of SCLC over the past six years, in more than 4,400 patients across the country. The posters will cover both the trends in sex-based differences and sex and clinical trial participation in SCLC.

Highlighted studies at ESMO (Free ESMO Whitepaper) 2026

PRODUCT TITLE AUTHOR ABSTRACT
PM54 CombiVista: An Evidence-Driven Decision Support Tool for Prioritizing Oncology Drug Combinations Across Multiple Workstreams I. Carmi-Levy TYPE: e-Poster SESSION: AI for Clinical research and drug development ABSTRACT: 164eP
Safety and Preliminary Activity of PM54 in Two Phase I Clinical Studies with Different Treatment Schedules M. de Miguel SESSION: Developmental therapeutics ABSTRACT: 1054P DATE: Fri, 23.10.2026 Time 15:15 – 16:00
Zepzelca (lurbinectedin) Flat-Dose Lurbinectedin Plus Serplulimab as First-Line Maintenance Therapy in Chinese Patients with Extensive-Stage Small-Cell Lung Cancer: An Exploratory Study L. Chong TYPE: Poster SESSION: SCLC ABSTRACT: 3818P DATE: Mon, 26.10.2026 Time 12:00 – 12:45
SCLC Time Trends in Sex-Based Differences in SCLC: CLARISSE Study J. Chamorro-Pérez TYPE: e-Poster SESSION: SCLC ABSTRACT: 3863Ep
Sex and Clinical Trial Participation in Small Cell Lung Cancer: the CLARISSE study Y. Lague TYPE: Poster SESSION: SCLC ABSTRACT: 3830P DATE: Mon, 26.10.2026 Time 12:00 – 12:45
Trabectedin Quantitative PARP1 H-score as a predictive biomarker for trabectedin plus olaparib combination in advanced soft tissue sarcoma: exploratory analysis of the TOMAS2 study L. D’Ambrosio TYPE: rapid oral session SESSION: Sarcoma DATE: Mon, 26.10.2026 08:30 – 10:00 Malaga Auditorium – Hall 3

(Press release, PharmaMar, OCT 19, 2026, View Source [SID1234673562])

NUCLIDIUM and NorthStar Enter Long-term Strategic Partnership to Advance NUCLIDIUM’s Copper-67 Radiotheranostic Oncology Pipeline

On October 19, 2026 NUCLIDIUM AG, a clinical-stageradiopharmaceutical company, and NorthStar Medical Technologies, LLC (NorthStar), a global radiopharmaceutical supply-chain partner, reported a long-term partnership through which NorthStar will produce Copper-67 (Cu-67) and provide comprehensive announced radiopharmaceutical manufacturing services to support NUCLIDIUM’s therapeutic programs from clinical development through commercialization. Copper-67 is the therapeutic isotope component of NUCLIDIUM’s radiotheranostic programs to treat cancers with high unmet medical need.

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The partnership underscores NUCLIDIUM and NorthStar’s mutual commitment to expanding global patient access to precision radiopharmaceutical therapies. NUCLIDIUM’s pipeline includes lead programs NU101 addressing metastatic castration resistant prostate cancer (mCRPC) and NU201 for metastatic breast cancer (mBC) as well as earlier stage programs in other solid tumor indications with a focus on women’s oncology.

The work will be led through NorthStar’s vertically integrated US-based radiopharmaceutical campus, where the company has pioneered advanced isotope production technologies, made significant investments in cGMP manufacturing, and maintains commercial-scale infrastructure to support growing global demand for targeted radiopharmaceutical therapies. NorthStar’s comprehensive approach enables a seamless transition from clinical development to commercialization, while reducing supply-chain complexity and accelerating program execution.

"Our collaboration with NorthStar strengthens our copper isotope supply chain at a critical moment, ensuring we are well prepared to execute on our near-term clinical development objectives and meet the long-term demand for our radiotheranostics," said Leila Jaafar, PhD, CEO and Co-Founder of NUCLIDIUM . "NUCLIDIUM remains on track to initiate multiple therapeutic studies utilizing Copper-67 for mCRPC and mBC in the coming months, while expanding our radiotheranostic portfolio into the clinic, including specifically women’s oncology indications."

"As demand for copper-based radiotheranostics continues to grow, reliable isotope supply and scalable manufacturing infrastructure will be essential for successful commercialization," said Dr. Frank Scholz, President & CEO of NorthStar . "NorthStar’s integrated platform is designed to provide both, allowing NUCLIDIUM to advance its programs efficiently from clinical development through future commercial launch."

Copper-67 is a short-range radioisotope that emits beta radiation to induce cell death in targeted tumor cells. The short half-life and lower radiation burden of Copper-67 limit the impact on surrounding healthy tissue. NUCLIDIUM’s radiopharmaceutical programs link Copper-67 to tumor-specific ligands to enable precision delivery and have the potential to achieve a best- or first-in-class clinical profile. The use of copper isotopes offers several distinct advantages over competing radioligands, including streamlined manufacturing, seamless integration into hospital workflows, reduced waste burden, and the potential for a wider therapeutic window.

(Press release, NUCLIDIUM, OCT 19, 2026, View Source [SID1234673561])

Nouscom Raises €120 Million ($135 Million) in Oversubscribed Series D Financing and will Present Long-Term Cancer Interception Clinical Data in Lynch Syndrome Carriers at ESMO

On October 19, 2026 Nouscom, a clinical-stage, cancer interception focused biotech developing next-generation immunotherapies, reported the closing of an oversubscribed €120 million ($135 million) Series D financing. The round was co-led by M Ventures and Revelation Partners alongside new investors Angelini Industries (through Angelini Investments), the European Investment Bank (through Aurea, its co-investment facility with Angelini Ventures), and Neva SGR (Intesa Sanpaolo Group). Nouscom’s other existing international life sciences investors, 5AM Ventures, Andera Partners, Angelini Ventures, Bpifrance (through its InnoBio2 fund), CDP Venture Capital (through its Large Ventures Fund), EQT Life Sciences, Indaco Venture Partners, Panakes Partners, Versant Ventures and XGEN Ventures, all participated in the round. The strong demand for the round reflects investor conviction in Nouscom’s pipeline and recently published clinical data.

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Proceeds from the Series D round will fund the advancement of NOUS-209, an investigational off-the-shelf neoantigen-based cancer immunotherapy, through a single, global, registration-enabling clinical trial for cancer interception in Lynch Syndrome (LS) carriers, for which FDA has granted Fast Track designation.

The financing coincides with a presentation of long-term cancer interception data from a Phase 1b/2 trial of NOUS-209 in LS carriers, to be presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress by the study’s principal investigator Eduardo Vilar-Sanchez, M.D., Ph.D., chair ad interim of Clinical Cancer Prevention at The University of Texas MD Anderson Cancer Center. ESMO (Free ESMO Whitepaper) is taking place in Madrid, Spain on 23-27 October 2026. Details of the presentation are below.

The abstract, published by ESMO (Free ESMO Whitepaper), reports that all evaluable LS carriers dosed with NOUS-209 remained free of advanced adenomas and colorectal cancer, as determined by colonoscopy, after years 1 and 2 (n=43; n=17, respectively), representing an encouraging signal of durable clinical activity consistent with a treatment effect relative to the expected incidence in LS carriers. These data were strengthened by broad, potent, and durable anti-neoantigen T-cell responses driven by NOUS-209 that were further enhanced following annual re-treatment.

"Over two million LS carriers live with up to an 80% lifetime cancer risk and nothing to offer them but surveillance and surgery", said Marina Udier, Ph.D., Chief Executive Officer of Nouscom. "We built Nouscom to change that equation. This financing, alongside the data we are presenting at ESMO (Free ESMO Whitepaper), puts us closer to a world where cancer is stopped before it starts. I am grateful to our new and existing investors for backing that conviction, and to the team behind NOUS-209."

"This significant financing reflects the confidence of our investors in Nouscom’s vision, team and the transformative potential of cancer interception," said Göran Ando, M.D., Independent Chair of the Board of Nouscom. "With this backing, we are well positioned to accelerate NOUS-209’s clinical development and our commitment to those living with Lynch Syndrome. I am delighted to welcome our new investors, whose support further strengthens Nouscom as we enter this next chapter."

Dr. Hakan Goker, Managing Director and Head of Biotechnology Investments at M Ventures, said: "What sets Nouscom apart is its unique cancer interception approach and the platform that enables it. Maturing clinical evidence and a regulatory-aligned path into a registration-enabling trial in such an unchartered space is a rare combination for a private biotech company and the commitment of the investor syndicate underpins this deep conviction."

Angelini Industries joins as a new investor, having followed Nouscom since its Series C round through Angelini Ventures, which also participated in the Series D. "Angelini Industries is becoming an increasingly innovation-driven group competing on a global scale, bringing together the search for companies set to shape the future of healthcare with the research and pharmaceutical assets of our industrial heritage." said Sergio Marullo di Condojanni, Chief Executive Officer of Angelini Industries, and VP of Angelini Investments. "We see significant potential in Nouscom’s pioneering approach to cancer prevention in Lynch Syndrome and we are proud to support its outstanding team."

Details of the Presentation:

Title: Safety and Immunogenicity of Re-vaccination with Nous-209: a neoantigen vaccine for cancer interception in Lynch syndrome carriers

Presenter: Eduardo Vilar-Sanchez, M.D., Ph.D., The University of Texas MD Anderson Cancer Center

Abstract #: 3438O

Date/Time: Sunday 25 October, 15:15hrs CEST

Location: Granada Auditorium, Hall 4

The Phase 1b/2 clinical trial of NOUS-209 in LS carriers (NCT05078866) was a collaborative effort between the National Cancer Institute’s Cancer Prevention Clinical Trials Network (CP-CTNet) and the iCAN-PREVENT consortium at UT MD Anderson. The NCI, part of the National Institutes of Health, provided primary funding through Award Number UG1-CA-242609, with additional support from the Data Management, Auditing, and Coordination Center (grant U24CA242637).

(Press release, NousCom, OCT 19, 2026, View Source;utm_medium=rss&utm_campaign=nouscom-raises-e120-million-135-million-in-oversubscribed-series-d-financing-and-will-present-long-term-cancer-interception-clinical-data-in-lynch-syndrome-carriers-at-esmo [SID1234673560])