On October 16, 2026 ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, reported the publication of long-term data from the Phase 2/3 QUILT-3.032 study (N=100) in the Journal of Urology. The study evaluated ANKTIVA (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin (BCG) in patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary disease.

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Highlights:

71% complete response (CR) rate in patients with BCG-unresponsive NMIBC CIS, with or without papillary disease
Median duration of CR of 26.6 months, with responses extending beyond 53 months
More than half of responding patients in the FDA-reviewed population maintained complete responses beyond 45 months
84% cystectomy-free survival at 36 months among responders
98.2% disease-specific survival at three years
No Grade 4 or Grade 5 treatment-related adverse events reported
"The QUILT-3.032 study represents one of the longest follow-up data sets in BCG-unresponsive NMIBC to date, and the results continue to support the durability of ANKTIVA’s unique mechanism of action in generating sustained immune responses," said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. "These long-term findings are encouraging, suggesting the potential for prolonged disease control and the possibility of avoiding or delaying radical cystectomy for some patients."

The publication also reported:

63.8% of responders maintained CR for at least 12 months
52.3% maintained CR for at least 24 months
44.2% maintained CR for at least 36 months
Progression-free survival remained 80.9% at three years
In BCG refractory (never responded) patients, the CR rate was 66%
4% of responders progressed to muscle-invasive disease
The treatment continued to demonstrate a favorable safety profile. Most treatment-related adverse events were Grade 1 or Grade 2 and consisted of localized bladder symptoms associated with intravesical therapy. Grade 3 treatment-related adverse events occurred in 4% of patients, with no Grade 4 or Grade 5 treatment-related adverse events reported.

"Achieving a durable response and avoiding cystectomy are important treatment goals for patients with BCG-unresponsive NMIBC," said Richard Adcock, President and CEO of ImmunityBio. "These peer-reviewed results add to the growing body of evidence supporting ANKTIVA plus BCG and highlight its potential to provide sustained disease control and meaningful cystectomy avoidance for patients with limited treatment options. We thank the patients and clinical teams who contributed to this long-term follow-up."

The publication builds upon the growing body of clinical evidence supporting ANKTIVA plus BCG, which was initially approved by the U.S. Food and Drug Administration (FDA) in 2024 for the treatment of adult patients with BCG-unresponsive NMIBC with CIS, with or without papillary tumors. In October 2026, the FDA expanded the approved indication to include patients with BCG-unresponsive NMIBC with papillary-only disease. ANKTIVA is the first FDA-approved IL-15 receptor agonist and the first approved immunotherapy in NMIBC designed to activate natural killer (NK) cells and T cells to generate durable immune responses.

About the QUILT 3.032 Study

QUILT-3.032 (NCT03022825) is a multicenter Phase 2/3 study evaluating ANKTIVA plus BCG in patients with BCG-unresponsive NMIBC. The published analysis includes 100 patients with CIS with or without papillary disease and represents one of the longest follow-up datasets reported in this disease setting, with outcomes extending beyond five years in some patients.

About ANKTIVA (nogapendekin alfa inbakicept-pmln)

The interleukin-15 (IL-15) cytokine plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. ANKTIVA is a first-in-class IL-15 receptor agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones.

IMPORTANT SAFETY INFORMATION

INDICATION AND USAGE: ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

WARNINGS AND PRECAUTIONS: Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle-invasive or metastatic bladder cancer, which can be lethal. If patients with CIS do not have a complete response to treatment after a second induction course of ANKTIVA with BCG, reconsider cystectomy.

DOSAGE AND ADMINISTRATION: For Intravesical Use Only. Do not administer by subcutaneous or intravenous routes.

Please see the complete Indication and Important Safety Information and Prescribing Information for ANKTIVA at Anktiva.com.

(Press release, ImmunityBio, OCT 16, 2026, View Source [SID1234673523])

On October 16, 2026 GSK plc (LSE/NYSE: GSK) reported it will present more than 20 abstracts from its expanding solid tumour portfolio at the 2026 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress (23-27 October) in Madrid, Spain. Presentations across lung, gynaecological and gastrointestinal cancers include new investigational data for risvutatug rezetecan (Ris-Rez), mocertatug rezetecan (Mo-Rez) and Jemperli (dostarlimab).

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Key presentations include:

Ris-Rez in extensive-stage small-cell lung cancer (ES-SCLC): Results from the first global phase I/II EMBOLD PanTumor-101 trial will show positive anti-tumour activity and manageable tolerability at the dose selected for phase III. Together with positive phase III data previously reported in China, the findings support the potential of Ris-Rez to address limited treatment options and poor outcomes for patients with relapsed ES-SCLC. (Abstracts #1071P, #3841P).

Ris-Rez in osteosarcoma: GSK’s licensor Hansoh Pharma will present detailed late-breaking phase III ARTEMIS-011 data evaluating Ris-Rez in osteosarcoma. This follows positive topline results announced earlier this year and adds to the body of evidence across multiple difficult-to-treat tumour types (Abstract #LBA9).

Mo-Rez in platinum-resistant ovarian cancer (PROC): Late-breaking 13-month follow-up data from the phase I BEHOLD-1 study will demonstrate clinically meaningful, durable responses and encouraging progression-free survival data for Mo-Rez in platinum-resistant ovarian cancer, alongside tolerability data, supporting its potential as a differentiated B7-H4-targeted treatment. (Abstract #LBA41).

Jemperli in rectal cancer: Results from the registrational phase II AZUR-1 trial evaluating Jemperli (dostarlimab) in adults with MSI-H/dMMR locally advanced rectal cancer will be presented during a late-breaking oral session. The analysis includes clinically meaningful data on sustained clinical complete responses. (Abstract #LBA87).

Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: "The data we are presenting at ESMO (Free ESMO Whitepaper) reflect our progress across some of the most difficult-to-treat cancers. From lung and gynaecological cancers to gastrointestinal tumours, we are building a portfolio of differentiated medicines designed to deliver deep and durable responses, overcome resistance and reduce treatment burden."

Full list of GSK’s presentations at ESMO (Free ESMO Whitepaper):
Ris-Rez
Abstract Name

Presenter

Presentation details

EMBOLD PanTumor-101: Safety and efficacy of Risvutatug Rezetecan (Ris-Rez) monotherapy during dose escalation in a global patient population with advanced/metastatic (A/M) solid tumours (ST)

S. Goel

Abstract #: 1071P

Poster Session

Friday, 23 October, 15:15-16:00 CET

EMBOLD PanTumor-101: Risvutatug Rezetecan (Ris-Rez) dose optimisation in patients with extensive stage small cell lung cancer (ES-SCLC)

H. R. Kim

Abstract #: 3841P

Poster Session

Monday, 26 October, 12:00-12:45 CET

Pooled analysis of interstitial lung disease (ILD) cases among patients (pts) with advanced solid tumours who received risvutatug rezetecan (Ris-Rez) monotherapy

J. Zugazagoitia

Abstract #: 1068P

Poster Session

Friday, 23 October, 15:15-16:00 CET

EMBOLD-SCLC-301: A global, phase 3, randomised study assessing risvutatug rezetecan (Ris-Rez) versus standard of care in patients with relapsed small cell lung cancer (SCLC)

S. Peters

Abstract #: 3861TiP

Poster Session

Monday, 26 October, 12:00-12:45 CET

Real-world treatment patterns among European patients with extensive stage small cell lung cancer (ES-SCLC): Insights from the RESONANCE study

N. Girard

Abstract #: 3836P

Poster Session

Monday, 26 October, 12:00-12:45 CET

Mo-Rez
Abstract Name

Presenter

Presentation details

Mocertatug rezetecan (Mo-Rez) in patients with platinum-resistant ovarian cancer (PROC): Updated results with longer follow-up from the global BEHOLD-1 study

V. Salutari

Abstract #: LBA41

Rapid Oral Session

Saturday, 24 October, 8:30-10:00 CET

BEHOLD-1: Exploratory analysis of biomarkers associated with mocertatug rezetecan (Mo-Rez) response in patients with platinum-resistant ovarian cancer (PROC)

S. Lheureux

Abstract #: 1248RO

Rapid Oral Session

Saturday, 24 October, 8:30-10:00 CET

BEHOLD-Ovarian01: A Phase 3 randomised trial to evaluate mocertatug rezetecan (Mo-Rez) versus standard of care (SoC) in patients (pts) with platinum-resistant ovarian cancer (PROC)

F. Backes

Abstract #: 1341TiP

Poster Session

Monday, 26 October, 12:00-12:45 CET

BEHOLD-Endometrial01: A randomised Phase 3 study evaluating the efficacy and safety of mocertatug rezetecan (Mo-Rez) versus chemotherapy in patients with advanced or recurrent endometrial cancer after platinum-based therapy and immunotherapy

A. Oaknin

Abstract #: 1340TiP

Poster Session

Monday, 26 October, 12:00-12:45 CET

Jemperli (dostarlimab)
Abstract Name

Presenter

Presentation details

Real-world data from the French early access programme of dostarlimab plus chemotherapy in primary advanced or recurrent dMMR/MSI-H endometrial cancer

I. Ray-Coquard

Abstract #: 1285P

Poster Session

Monday, 26 October, 12:00-12:45 CET

Real-world outcomes of dostarlimab plus chemotherapy in US patients with stage III primary advanced endometrial cancer

L. Randall

Abstract #: 1287P

Poster Session

Monday, 26 October, 12:00-12:45 CET

Real-world outcomes of dostarlimab plus chemotherapy in US patients with MMRp/MSS primary advanced or recurrent endometrial cancer (pA/R EC): Subgroup analyses by histology and age

L. Randall

Abstract #: 1286P

Poster Session

Monday, 26 October, 12:00-12:45 CET

Clinical complete response with dostarlimab monotherapy in dMMR/MSI-H locally advanced rectal cancer (LARC): First results from the global registrational AZUR-1 trial

A. Cercek

Abstract #: LBA87

Proffered Paper Session

Sunday, 25 October, 10:15-11:45 CET

A natural history (NH) study of patients (pts) with previously untreated dMMR/MSI-H stage II/III locally advanced rectal cancer (LARC) in Europe

R. V. Garcia

Abstract #: 3115eP

ePoster

Productivity loss, disability and indirect costs associated with locally advanced rectal cancer in the US

T. Bekaii-Saab

Abstract #: 3558eP

ePoster

Velzatinib (IDRX-42)
Abstract Name

Presenter

Presentation details

Molecular Response (MR) in KIT circulating tumour DNA (ctDNA) from StrateGIST 1: A Phase 1/1b study of Velzatinib (IDRX-42) in patients (pts) with advanced gastrointestinal stromal tumours (GIST)

S. Bauer

Abstract #: 3718RO

Rapid Oral Session

Monday, 26 October, 8:35-10:00 CET

Velzatinib exhibits broad c-KIT mutation coverage in a novel panel of Ba/F3 mutant cell models representing the majority of secondary resistance mutations observed clinically in gastrointestinal stromal tumors (GIST)

V. Quereda

Abstract #: 3730P

Poster Session

Monday, 26 October, 12:00-12:45 CET

Zejula (niraparib)
Abstract Name

Presenter

Presentation details

Evaluation of bevacizumab (bev) contribution to efficacy outcome in first-line advanced ovarian cancer phase 3 trial FIRST/ENGOT-OV44

Anne-Claire Hardy-Bessard

Abstract #: 1272P

Presentation

Monday, 26 October, 12:00 – 12:45 CET

GSK5471713
Abstract Name

Presenter

Presentation details

First-time-in-human Phase 1/2 study of GSK5471713, an androgen receptor (AR) degrader, in patients with metastatic castration-resistant prostate cancer (mCRPC)

R. Saleh

Abstract #: 2302TiP

Poster Session

Friday, 23 October, 15:15-16:00 CET

GSK5533524
Abstract Name

Presenter

Presentation details

A phase 1, open-label, multicenter study to investigate the safety and preliminary activity of GSK5533524 alone or in combination in adult patients with advanced solid tumors

V. Samnotra

Abstract #: 1139eTiP

ePoster

CD226
Abstract Name

Presenter

Presentation details

Deep-Learning serial CT imaging predictions of survival compared with RECIST 1.1 objective response rate in immunotherapy-treated NSCLC

D. R. Spigel

Abstract #: 169eP

ePoster

Full list of Alliance studies at ESMO (Free ESMO Whitepaper):
Abstract Name

Presenter

Presentation details

Risvutatug rezetecan (Ris-Rez) versus gemcitabine and docetaxel (GD) in heavily pretreated patients (pts) with relapsed or refractory (R/R) osteosarcoma: Primary results from the phase 3 ARTEMIS-011 study

L. Xie

Abstract #: LBA9

Presidential Symposium

Monday, 26 October, 16:30-18:15 CET

Watch-and-wait (W&W) strategy for dostarlimab in localized deficient dMMR/MSI-H gastroesophageal adenocarcinoma (GEA): Results from the first interim analysis of the GERCOR-GONO DEWI phase II study

T. André

Abstract #: 2877RO

Rapid Oral Session

Friday, 23 October, 16:15-17:45 CET

PRODIGE 90 (PREDIR-NEOREC). Neoadjuvant dostarlimab with short course radiotherapy in a watch-and-wait strategy for microsatellite unstable or mismatch repair-deficient locally advanced rectal cancer patients: a randomized phase II trial

M. Karoui

Abstract #: 3548TiP

Poster Session

Sunday, 25 October, 12:00-12:45 CET

RODEO: pReOperative dostarlimab and novel therapies in endometrial cancer

S. Nicum

Abstract #: 1345TiP

Poster Session

Monday, 26 October, 12:00-12:45 CET

Niraparib and dostarlimab plus radiotherapy (RT) in locally advanced head and neck squamous cell carcinoma (LA-HNSCC) patients (TTCC-2022-01 RADIAN)

M. Oliva

Abstract #: LBA46

Rapid Oral Session

Sunday, 25 October, 14:45-16:15 CET

Genotype-Restricted activity of niraparib plus dostarlimab in HRD-positive solid tumours: A translational phase II study

G. A. Vidal

Abstract #: 4361P

Poster Session

Friday, 23 October, 15:15-16:00 CET

About lung cancer
Lung cancer is the most commonly diagnosed cancer and the leading cause of cancer death worldwide, with approximately 2.5 million new cases and 1.88 million deaths annually.1 Non-small cell lung cancer (NSCLC) accounts for approximately 85% of all lung cancer cases, while small cell lung cancer (SCLC) is less common but typically more aggressive.1 Despite advances in treatment, lung cancer is often diagnosed at an advanced stage, when prognosis is poor and risk of disease progression or recurrence is high.1 Extensive-stage SCLC (ES-SCLC) represents the majority of SCLC diagnoses, with most patients presenting after the disease has spread beyond the lungs.2

About ovarian cancer and endometrial cancer
Endometrial cancer affects 1.6 million people globally, with 417,000 new cases each year and 15% to 20% of patients presenting in later stages of the disease. 3,4 Ovarian cancer affects 843,000 people with 240,000 new cases annually.5 70% of these patients present with advanced disease.6 Recurrence is common in advanced cases of disease, up to 67% in endometrial cancer and 70% in ovarian cancer, and survival usually declines after recurrence. 7,8

About stage II/III dMMR/MSI-H locally advanced rectal cancer
Around 5–10% of rectal cancers are mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H).9 These tumours have a specific genetic characteristic where they are unable to properly repair DNA damage, leading to an accumulation of mutations. This unique biological feature often makes them responsive to immunotherapies.10, 11 These biomarkers are most commonly found in colorectal, endometrial and other gastrointestinal cancers, but can also be present in other solid tumours.12

About GIST
Gastrointestinal stromal tumours (GIST) are the most common subtype of soft tissue sarcoma, with about 80,000 to 120,000 patients diagnosed with GIST per year worldwide.13 GIST typically presents in the gastrointestinal tract with 80% of cases driven by mutations in the KIT gene that lead to the growth, proliferation and survival of tumour cells (primary or activating mutations in exons 9 and 11).14 Additionally, about 90% of patients treated in the first-line develop new KIT mutations (secondary or resistance mutations in exons 13 and 17) that typically lead to relapse with limited therapeutic options.15 There are currently no approved tyrosine kinase inhibitors (TKIs) that inhibit the full spectrum of clinically relevant primary and secondary mutations in KIT.

About risvutatug rezetecan
Ris-Rez is a novel investigational B7-H3-targeted ADC composed of a fully human anti-B7-H3 monoclonal antibody covalently linked to a topoisomerase inhibitor payload. GSK acquired exclusive worldwide rights (excluding China’s mainland, Hong Kong, Macau and Taiwan) from Hansoh Pharma to progress clinical development and commercialisation of Ris-Rez.

Regulatory designations received for Ris-Rez to date include orphan drug designations from the US Food and Drug Administration (FDA) and Japan’s Ministry of Health, Labour and Welfare in SCLC and the European Medicines Agency (EMA) in a category of cancer that includes SCLC, called pulmonary neuroendocrine carcinoma; Priority Medicines (PRIME) Designation from the EMA for relapsed or refractory ES-SCLC; and Breakthrough Therapy Designations for relapsed or refractory ES-SCLC and relapsed or refractory osteosarcoma from the US FDA. 16, 17, 18, 19, 20, 21 , 22

About mocertatug rezetecan
Mo-Rez is a novel investigational B7-H4-targeted antibody-drug conjugate designed to optimise efficacy and tolerability. It is composed of a fully human anti-B7-H4 monoclonal antibody covalently linked to a topoisomerase inhibitor payload and has a drug-to-antibody ratio (DAR) of 6. GSK acquired exclusive worldwide rights (excluding China’s mainland, Hong Kong, Macau and Taiwan) from Hansoh Pharma to progress clinical development and commercialisation of Mo-Rez globally.

About dostarlimab
Jemperli, a programmed death receptor-1 (PD-1)-blocking antibody, plays an important role in GSK’s immune-oncology research and development programme. A clinical trial programme includes studies of Jemperli alone and in combination with other therapies in gynaecologic, colorectal, and head and neck cancers.

Jemperli was discovered by AnaptysBio, Inc. and licensed to TESARO, Inc., under a collaboration and exclusive license agreement signed in March 2014. Under this agreement, GSK is responsible for the ongoing research, development, commercialisation and manufacturing of Jemperli. 

More information about the product and its currently approved indications is available at EU product information and US product information.

About velzatinib
Velzatinib is a highly selective, investigational small molecule tyrosine kinase inhibitor (TKI) designed to target all key KIT mutations in GIST. The US Food and Drug Administration (FDA) has granted velzatinib Fast Track designation for the treatment of patients with GIST after disease progression on or intolerance to imatinib, and Orphan Drug designations for the treatment of GIST.

(Press release, GlaxoSmithKline, OCT 16, 2026, View Source [SID1234673522])

On October 16, 2026 Curis, Inc. (Nasdaq: CRIS) ("Curis" or the "Company"), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 and FLT3 inhibitor, reported that it has entered into securities purchase agreements with certain existing healthcare focused institutional investors for the purchase and sale of 16,666,680 shares of common stock (or pre-funded warrants to purchase shares of common stock in lieu thereof) and common warrants to purchase up to 16,666,680 shares of common stock at an effective combined price of $0.51 per share (or pre-funded warrant) and accompanying common warrant (the "Offering"). The common warrants have an exercise price of $0.60 per share, will be exercisable six months following their issuance and will expire five and a half years from the issuance date. The pre-funded warrants have an exercise price of $0.01 per share and will be exercisable immediately until exercised in full.

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The Company also has agreed that certain existing January 2026 warrants to purchase up to 1,126,676 shares of common stock at an exercise price of $15.00 per share and all of the August 2026 warrants to purchase up to 3,733,334 shares of common stock at an exercise price of $1.75 per share will be amended such that the existing January 2026 and August 2026 warrants will have a reduced exercise price of $0.60 per share.

The gross proceeds from the Offering are expected to be approximately $8.5 million, before deducting placement agents fees and other Offering expenses. The Company intends to use the net proceeds of this Offering to fund its research and development activities and for working capital and general corporate purposes. Proceeds from the Offering are expected to be sufficient to fund operations through the Company’s initial Chronic Lymphocytic Leukemia (CLL) data in 5-10 patients in December 2026. The Offering is expected to close on or about October 19, 2026, subject to market conditions and the satisfaction of customary closing conditions.

A.G.P./Alliance Global Partners is acting as the lead placement agent and Laidlaw & Company (UK) Ltd. is acting as co-placement agent in connection with the Offering.

The offer and sale of the foregoing securities is being made in reliance on an exemption from the registration requirement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act") and applicable state securities laws, and the securities have not been and will not initially be registered under the Securities Act, or applicable state securities laws. Accordingly, the securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and applicable state securities laws. Pursuant to the terms of the registration rights agreement entered into with the investors, the Company has agreed to file a registration statement with the U.S. Securities and Exchange Commission (the "SEC") covering the resale of the shares of common stock and the shares of common stock underlying the pre-funded warrants and common warrants sold in the Offering.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

(Press release, Curis, OCT 16, 2026, View Source,-Inc-Announces-Pricing-of-8-5-Million-Private-Placement-Priced-At-the-Market-Under-Nasdaq-Rules-with-Existing-Healthcare-Focused-Institutional-Investors [SID1234673520])

On October 16, 2026 Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" or the "Company," Stock Code: 9887.HK) reported that the first patient has been dosed in an open-label, multicenter Phase Ib/II clinical trial evaluating opamtistomig (LBL-024), a PD-L1/4-1BB bispecific antibody, in combination therapy for metastatic colorectal cancer (mCRC). This milestone marks a further expansion of the Company’s strategy to address immunologically cold tumors, building on the clinical development of opamtistomig in extrapulmonary neuroendocrine carcinoma (EP-NEC), biliary tract cancer (BTC), hepatocellular carcinoma (HCC), and platinum-resistant ovarian cancer (PROC).

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In mCRC, patients with microsatellite stable (MSS) and proficient mismatch repair (pMMR) status account for approximately 95% of cases. Due to insufficient T-cell infiltration in the tumor microenvironment, this patient population responds poorly to conventional immune checkpoint inhibitors, and standard treatment remains centered on chemotherapy combined with targeted therapy, leaving a significant need for new treatment strategies. Opamtistomig conditionally activates 4-1BB, reactivating and substantially expanding T cells while relieving PD-1/PD-L1 immunosuppression. This dual mechanism is expected to help address the immunotherapy gap for this patient population and has the potential to deliver durable, long-tail survival benefit.

The Phase Ib/II clinical trial is led by Academician Xu Ruihua of Sun Yat-sen University Cancer Center and will be conducted concurrently across multiple hospitals nationwide, with the aim of evaluating the efficacy and safety of opamtistomig in combination therapy in patients with mCRC. A translational medicine study of opamtistomig in MSS colorectal cancer has been selected for poster presentation at the 2026 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress. Opamtistomig has also shown a trend of markedly prolonged survival benefits compared with historical data across several representative immunologically cold tumor types, including EP-NEC, BTC, HCC, and PROC, supporting further development of opamtistomig in mCRC.

Executive Commentary
Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, stated: "Colorectal cancer, particularly MSS/pMMR disease, remains a major challenge for immunotherapy. Opamtistomig combines PD-L1 blockade with conditional 4-1BB activation, a differentiated approach designed to enhance antitumor immunity in immunologically cold tumors. We are encouraged by our translational research in MSS colorectal cancer and the clinical findings emerging across multiple cold tumor types. The enrollment of the first patient in this trial represents an important step in extending our strategy to mCRC. We look forward to further evaluating opamtistomig’s potential to address the unmet medical needs of these patients."

About Colorectal Cancer
Colorectal cancer is among the most common gastrointestinal malignancies worldwide. According to the International Agency for Research on Cancer (IARC), there were approximately 1.93 million new cases and 904,000 deaths globally in 2022, making CRC the third most commonly diagnosed cancer and the second leading cause of cancer-related death worldwide. Data from the National Cancer Center of China show approximately 517,000 new cases and 240,000 deaths in China in 2022, ranking CRC second for incidence and fourth for mortality among all malignancies.

Approximately 15% to 30% of patients with CRC have metastatic disease at initial diagnosis, and 20% to 50% of patients initially diagnosed with localized disease eventually develop mCRC. Despite advances in treatment, mCRC remains associated with poor prognosis, with a five-year survival rate of only approximately 15%. Currently, immunotherapies are primarily approved for patients with microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) CRC. However, these patients account for only approximately 5% of mCRC cases, whereas approximately 95% of patients have microsatellite-stable (MSS) or mismatch repair-proficient (pMMR) disease, which generally exhibits limited responsiveness to conventional immunotherapy, highlighting a significant unmet medical need.

About Opamtistomig
Opamtistomig (LBL-024) is emerging as a next-generation pan-cancer backbone therapy with potential overall survival (OS) benefit that simultaneously targets PD-L1 and the co-stimulatory receptor 4-1BB. Currently, opamtistomig is being evaluated in 14 indications, including one pivotal single-arm registrational study, one confirmatory Phase III study, and nine proof-of-concept studies, covering major indications such as NSCLC and multiple cold tumors. To date, opamtistomig has demonstrated robust antitumor activity across seven tumor types—extrapulmonary neuroendocrine carcinoma (EP-NEC), non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), biliary tract cancer (BTC), hepatocellular carcinoma (HCC), esophageal squamous cell carcinoma (ESCC), and ovarian cancer (OC)—highlighting its clinical value and broad therapeutic promise.

Developed using Leads Biolabs’ proprietary X-body bispecific platform, opamtistomig is designed to simultaneously block PD-1/PD-L1 immune suppression and conditionally activate 4-1BB, an agonist pathway, resulting in a potent and synergistic anti-tumor immune response. It has a safety profile comparable to PD-1/PD-L1 inhibitors and demonstrates broader-spectrum anti-cancer potential. Mechanistically, 4-1BB agonism can reactivate exhausted T cells and promote robust T-cell proliferation, offering significant promise for PD-1/PD-L1–resistant or immunologically "cold" tumors and potentially offering durable survival benefits.

Recognizing its clinical potential, opamtistomig received Breakthrough Therapy Designation from China’s National Medical Products Administration (NMPA) in October 2024, and Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) in November 2024. Additionally, in January 2026, opamtistomig was granted Fast Track Designation by the FDA and ODD by the European Commission, and in September 2026, ODD from Japan’s Ministry of Health, Labour and Welfare (MHLW), further underscoring its potential to address unmet medical needs in this patient population. In July 2026, its New Drug Application (NDA) was granted priority review designation by the NMPA, followed by NDA acceptance in August 2026, positioning opamtistomig as a potential world’s first approved 4-1BB-targeting antibody, the first approved agonist antibody, and the first approved treatment for EP-NEC.

(Press release, Nanjing Leads Biolabs, OCT 16, 2026, View Source [SID1234673513])

On October 15, 2026 Adriana Baker, a MD PhD candidate in the laboratory of EtiraRx founder Dr. Ratna Vadlamudi at UT Health San Antonio, reported exciting new findings at the 2026 San Antonio Liver Cancer Symposium, held October 8–9.

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Her presentation, "ERX-315 Creates Metabolic Stress Vulnerability to DNA Damaging Therapy in HCC," demonstrated that ERX-315 creates metabolic stress in hepatocellular carcinoma (HCC), the most common form of liver cancer, and acts synergistically with PARP inhibitors to enhance cancer cell killing.

PARP inhibitors are cancer therapies that interfere with DNA repair, but their effectiveness is limited in tumors with intact DNA repair mechanisms. These new preclinical findings suggest that ERX-315 may create vulnerabilities that make liver cancers more sensitive to these treatments.

The findings extend Etira’s growing body of research showing that LIPA-targeting compounds can disrupt cancer cell survival and DNA repair pathways, supporting the development of ERX-315 in combination with PARP inhibitors across multiple tumor types.

ERX-315 is currently being evaluated in a Phase 1 clinical trial in patients with advanced solid tumors (NCT06533332).

Congratulations to Adriana and Dr. Vadlamudi’s team on advancing this promising research!

⁠Learn more about the San Antonio Liver Cancer Symposium.

These findings are preclinical. ERX-315 is investigational, and its safety and efficacy in combination with PARP inhibitors have not been established.

(Press release, EtiraRx, OCT 15, 2026, View Source [SID1234673521])