On July 13, 2026 Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" or the "Company," Stock Code: 9887.HK) reported that six of its latest research studies have been accepted for presentation at the 2026 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress. Among these, two have been selected as Proffered Papers—the congress’s highest-profile oral presentation format, while four will be presented as posters, covering multiple tumor types such as extrapulmonary neuroendocrine carcinoma (EP‑NEC), biliary tract cancer (BTC), and relapsed/refractory multiple myeloma (RRMM). In addition, the Company has been granted a Late‑Breaking Abstract (LBA) status and plans to submit the full LBA abstract in September.

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The ESMO (Free ESMO Whitepaper) Annual Congress is one of the most influential scientific conferences in oncology. The 2026 congress will take place in Madrid, Spain, from October 23 to 27, 2026. Proffered Papers are reserved for studies considered to have the greatest clinical significance and scientific innovation, while LBA features the latest clinical findings with breakthrough potential and the ability to change clinical practice. The selection of multiple Leads Biolabs’ studies underscores the international academic community’s strong recognition of the Company’s clinical data and the value of its pipeline, further demonstrating its sustained innovation capabilities and expanding leadership in cancer immunotherapy. The full data from the selected studies will be released through the ESMO (Free ESMO Whitepaper) online abstract publication and during the congress.

Separately, the Company previously announced that Opamtistomig for first‑line non‑small cell lung cancer (1L NSCLC) has been selected for an oral presentation at the 2026 World Conference on Lung Cancer (WCLC), to be held in September 2026. The full abstract is scheduled to be published on the WCLC website on August 19.

Executive Commentary

Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, stated: "The acceptance of multiple studies at ESMO (Free ESMO Whitepaper) represents strong international recognition of Leads Biolabs’ innovative capabilities and clinical development achievements, and marks another important step in our journey toward becoming a leading global innovator in drug development. Opamtistomig continues to demonstrate encouraging depth of responses, favorable survival trends, and a well-tolerated safety profile across multiple tumor types, further reinforcing its strategic positioning as an IO 2.0 pan‑tumor backbone therapy. Meanwhile, LBL‑034 further validates the global competitiveness of our proprietary LeadsBody platform in the TCE field. Looking ahead, we remain committed to advancing global registrational clinical development and commercialization of our core assets, with the goal of bringing breakthrough therapies to more patients worldwide as quickly as possible."

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. Developed using Leads Biolabs’ proprietary X-Body bispecific platform, Opamtistomig is designed to simultaneously block PD-1/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. To date, Opamtistomig has demonstrated first- or best-in-class potential in Phase II or registrational clinical trials across four indications: non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), biliary tract cancer (BTC), and extrapulmonary neuroendocrine carcinoma (EP-NEC).

As the first 4-1BB–targeting bispecific antibody globally to advance to a single-arm pivotal trial as monotherapy, Opamtistomig has been evaluated in 13 solid tumor indications in China, including 1 pivotal registration trial and 8 proof-of-concept studies. These cover EP-NEC, NSCLC, SCLC, BTC, ovarian cancer (OC), esophageal squamous cell carcinoma (ESCC), hepatocellular carcinoma (HCC), gastric cancer (GC), triple-negative breast cancer (TNBC), malignant melanoma, and other areas with high unmet medical needs.

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. Recognizing its clinical potential, Opamtistomig received Breakthrough Therapy Designation (BTD) 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) for the treatment of neuroendocrine carcinoma in November 2024. Additionally, in January 2026, Opamtistomig was granted Fast Track Designation (FTD) by the FDA and ODD by the European Commission for the treatment of EP-NEC, further underscoring its potential to address unmet medical needs in this patient population.

About LBL-034

LBL-034 is a bispecific T-cell engager (TCE) that targets both GPRC5D and CD3, developed using the Company’s proprietary LeadsBody platform. Designed with a 2:1 binding format—two sites for GPRC5D and one for CD3—LBL-034 can selectively target GPRC5D+ cancer cells, conditionally activate T cells, reduce the risk of cytokine release, minimize the risk of systemic toxicity, and lower the risk of T cell exhaustion, thereby exerting anti-tumor effects in an efficient, low-toxic, and long-term stable manner.

LBL-034 has demonstrated promising efficacy signals in both preclinical and clinical studies. It is currently being evaluated in a Phase I/II clinical trial for RRMM and other malignant plasma cell neoplasms in China. Notably, breakthrough clinical data from LBL-034 monotherapy in RRMM were presented as the first oral presentation on the opening day of the ASH (Free ASH Whitepaper) 2025 Annual Meeting, highlighting its emerging clinical profile.

In October 2024, LBL-034 received Orphan Drug Designation from the U.S. FDA for the treatment of multiple myeloma. In January 2026, LBL-034 received Fast Track Designation from the U.S. FDA for the treatment of RRMM.

(Press release, Nanjing Leads Biolabs, JUL 13, 2026, View Source [SID1234669174])

On July 13, 2026 Zelluna ASA (OSE: ZLNA), a company pioneering allogeneic "off-the-shelf" T Cell Receptor-based Natural Killer (TCR-NK) cell therapies for the treatment of solid cancers, reported that the first patient has been given the first dose in ZIMA-101, the Company’s first-in-human Phase 1 clinical trial evaluating ZI-MA4-1, Zelluna’s lead TCR-NK product candidate.

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The first patient was treated at The Christie NHS Foundation Trust in the United Kingdom, the largest single site cancer centre in Europe and the lead clinical site for the study where Professor Fiona Thistlethwaite serves as Chief Investigator for the study.

ZIMA-101 is evaluating ZI-MA4-1, the world’s first MAGE-A4-targeting TCR-NK cell therapy to enter clinical development, in patients with advanced MAGE-A4-positive solid tumours. MAGE-A4 is present in several common cancer types, including ovarian cancer, squamous non-small cell lung cancer, synovial sarcoma and head and neck cancer, making it an attractive target for precision cell therapy.

ZIMA-101 also represents the first clinical evaluation of Zelluna’s proprietary TCR-NK platform and builds on years of scientific innovation, preclinical research and manufacturing development. The study is now active at two clinical sites in the United Kingdom: The Christie and The Royal Marsden NHS Foundation Trusts.

"This is a defining milestone for Zelluna and marks the beginning of the clinical evaluation of our proprietary TCR-NK platform," said Namir Hassan, Chief Executive Officer of Zelluna. "Dosing the first patient in ZIMA-101 is the culmination of years of scientific innovation, preclinical research and manufacturing development, and represents the transition from laboratory science to treating patients for the first time with our novel TCR-NK therapy. We are deeply grateful to the investigators and the clinical teams for making this milestone possible. We now look forward to advancing the study, generating the first clinical data from our proprietary TCR-NK platform and, ultimately, improving outcomes for patients with advanced solid tumours."

Professor Fiona Thistlethwaite, Consultant Medical Oncologist at The Christie and honorary professor at The University of Manchester and Chief Investigator for the study said: "Dosing the first patient represents an exciting moment for everyone who has worked collaboratively to bring this brand-new class of cellular therapy to the clinic. In the coming weeks and months, we will be monitoring the patient’s progress closely and gathering important data from this very innovative first-in-human early-phase trial, which will inform the next stages of patient recruitment. We are extremely grateful to the patient for agreeing to participate in this important research."

Patient identification, pre-screening and screening activities continue across all four tumour indications included in the ZIMA-101 study. Zelluna expects initial clinical data from the ZIMA-101 study to emerge from mid-2026.

About ZIMA-101

ZIMA-101 is a first-in-human, multicentre Phase 1 dose-escalation study evaluating the safety, tolerability and preliminary anti-tumour activity of ZI-MA4-1 in patients with advanced MAGE-A4-positive solid tumours. The study is being conducted at The Christie and The Royal Marsden NHS Foundation Trusts in the United Kingdom.

The study follows a dose escalation design (3+3) with three predefined dose levels and three patients per dose level. Each patient will receive three doses on Days 1, 4 and 8 of a treatment cycle. For the first patient at each dose level, an Independent Data Monitoring Committee will review the patient’s data following completion of the initial safety observation period before providing recommendations on enrolment of the remaining two patients at that dose level.

About ZI-MA4-1

ZI-MA4-1 is Zelluna’s lead allogeneic (off the shelf) TCR-NK product candidate and the world’s first MAGE-A4-targeting TCR-NK cell therapy in clinical development. The product combines the innate tumour-killing properties of NK cells with precision tumour targeting enabled by affinity engineered T cell receptors (TCRs), with the goal of addressing key limitations of existing cell therapies in solid tumours, including scalability, tumour targeting and access.

(Press release, Zelluna Immunotherapy, JUL 13, 2026, View Source [SID1234669173])

On July 13, 2026 Oncolytics Biotech Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage company developing pelareorep, an investigational, systemically active immunotherapy that promotes potentially protective immune responses, including the upregulation of key inflammatory cytokines resulting in the formation of tertiary lymphoid structures and the expansion of tumor-infiltrating lymphocytes, reported a clinical and regulatory update on REO 033, the Company’s randomized controlled study evaluating pelareorep in combination with folinic acid, fluorouracil and irinotecan ("FOLFIRI") and bevacizumab for the second-line treatment of patients with Rat Sarcoma ("RAS")-mutant, microsatellite stable ("MSS") metastatic colorectal cancer.

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REO 033 builds upon the previously reported REO 022 study, which more than doubled historical standard-of-care benchmarks across progression-free survival, overall survival, duration of response, and objective response rate.1-4 Based on these data, pelareorep has received Fast Track designation from the U.S. Food and Drug Administration ("FDA") for this indication. The multi-part randomized REO 033 study is designed to prospectively validate these encouraging findings against a contemporary control arm while advancing pelareorep toward a potential registration pathway. The Company continues to make rapid operational progress in Part A of REO 033 (n=60 patients), with approximately half of the planned clinical sites activated by the end of July, and more than 20 patients have been pre-identified across participating centers. The remaining sites are expected to be activated by the end of August, positioning the study for accelerated enrollment during the second half of 2026. Most recently, global lead principal investigator Dr. Sanjay Goel and his team opened enrollment at Rutgers Cancer Institute of New Jersey.

"The magnitude and durability of the efficacy observed in REO 022 warrant earnest evaluation in a randomized setting," said Dr. Sanjay Goel, Global Lead Principal Investigator for REO 033 and Professor of Medicine and Director of the Phase I Program at Rutgers Cancer Institute of New Jersey. "It is encouraging to see REO 033 expanding rapidly across leading academic centers, and I believe this study has the potential to further define the role of pelareorep in RAS-mutant MSS metastatic colorectal cancer."

The Company also announced that it will hold a Type D meeting with the FDA in the first half of August 2026 to discuss the registrational design for REO 033 through the addition of Part B of the study. Building on the currently enrolling Part A of the study, this new registration-directed Part B would preserve the core design elements of REO 033 while increasing enrollment and incorporating blinded independent central review to support both a potential accelerated approval and a traditional full approval within the same study. The Company intends to align with the FDA on a registrational pathway that preserves the operational efficiencies already established through REO 033 while maintaining continuity with the existing clinical program under a prospectively agreed regulatory framework.

"Launching a global randomized study with multiple high-quality sites in a short period of time reflects the operational capabilities of our clinical organization and our investigators," said Jared Kelly, Chief Executive Officer of Oncolytics. "Just as importantly, our ongoing interactions with the FDA have enabled us to focus on efficiently transitioning REO 033 into a registration-directed program built upon the existing trial infrastructure. We believe this strategy has the potential to significantly reduce development timelines while maintaining scientific rigor as we work to bring a much-needed immunotherapeutic option to patients in a treatment landscape that desperately needs innovation."

The Company believes this approach provides the opportunity to generate early randomized efficacy data from Part A while simultaneously positioning Part B as a potential registrational study without the need to initiate a separate registrational trial. It also expects to report an initial tumor response update from patients enrolled in Part A by year-end 2026 and, subject to FDA feedback, initiate enrollment in Part B of the study during the first quarter of 2027.

About REO 033
REO 033 is a multi-part randomized controlled clinical trial evaluating pelareorep in combination with FOLFIRI and bevacizumab versus FOLFIRI and bevacizumab alone in patients with second-line RAS-mutant, microsatellite stable metastatic colorectal cancer (link to study on ClinicalTrials.gov). The study is designed to confirm the encouraging efficacy signals observed in REO 022 while generating the controlled clinical data necessary to support future regulatory interactions and potential registration.

(Press release, Oncolytics Biotech, JUL 13, 2026, View Source [SID1234669170])

On July 13, 2026 GSK plc (LSE/NYSE: GSK) reported positive interim results from the registrational phase II AZUR-1 trial of Jemperli (dostarlimab) in patients with stage II/III mismatch repair deficient/microsatellite instability-high (dMMR/MSI-H) locally advanced rectal cancer. The single arm trial met its primary objective, showing a meaningful and sustained clinical complete response rate at 12 months (cCR12).

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These results support the potential for dostarlimab, if approved, to become the first immunotherapy capable of eliminating or delaying the need for chemotherapy, radiation and surgery for some patients in this population.

Rectal cancer, a type of bowel cancer, affects around 730,000 people globally each year1 and approximately 5-10% of all rectal cancers have the dMMR/MSI-H subtype2. Current standard of care typically includes chemotherapy, radiation, and surgery3. While often effective, these treatments can profoundly impact a patient’s quality of life, potentially leading to lifelong use of a colostomy bag, significant physiological dysfunction, and infertility4,5,6.

Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: "The AZUR-1 results support the potential for dostarlimab to transform treatment for dMMR/MSI-H locally advanced rectal cancer. For many patients today, rectal cancer treatment comes with the tolerability burden and lasting impacts from chemotherapy, radiation and surgery. These data demonstrate that some patients may be able to avoid those interventions while remaining free of detectable signs of cancer."

AZUR-1 results represent a substantial improvement compared to the historical standard of care7 and build on earlier research conducted in collaboration with Memorial Sloan Kettering Cancer Center, which first demonstrated the potential for dostarlimab to achieve clinical complete responses without other treatments in patients with dMMR/MSI-H locally advanced rectal cancer.

In interim data, the safety and tolerability profile of dostarlimab was consistent with its well-characterised and manageable safety profile observed across solid tumours.

Dostarlimab has received both Breakthrough Therapy and Fast Track designations from the US Food and Drug Administration (FDA) in this setting. GSK plans to share interim AZUR-1 data with global regulatory authorities to support review. Detailed results will be presented at a future scientific congress.

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)8. 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 highly responsive to immunotherapies like dostarlimab9,10. These biomarkers are most commonly found in colorectal, endometrial and other gastrointestinal cancers, but can also be present in other solid tumours11.

About AZUR-1
AZUR-1 is a global, open-label, single-arm, registrational phase II trial evaluating dostarlimab monotherapy in patients with stage II/III dMMR/MSI-H locally advanced rectal cancer. The trial was designed to assess sustained clinical complete responses for 12 months (cCR12) and determine whether dostarlimab alone could enable patients to avoid chemotherapy, radiation and/or surgery. A total of 154 participants received nine cycles of dostarlimab over six months, administered as a 500 mg intravenous infusion every three weeks.

About Jemperli (dostarlimab)
Jemperli, a programmed death receptor-1 (PD-1)-blocking antibody, is the backbone of GSK’s ongoing immuno-oncology-based research and development programme. A robust clinical trial programme includes studies of Jemperli alone and in combination with other therapies in gynaecologic, colorectal and head and neck cancers, as well as where there are opportunities for transformational outcomes.

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 Jemperli, its indications and complete important safety information is available at EU product information12 and US product information13. Jemperli is not currently approved anywhere in the world for rectal cancer.

(Press release, GlaxoSmithKline, JUL 13, 2026, View Source [SID1234669169])

On July 13, 2026 Bristol Myers Squibb (NYSE: BMY) reported that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for mezigdomide in combination with carfilzomib and dexamethasone (MeziKd) in patients with relapsed or refractory multiple myeloma (RRMM). Mezigdomide is an oral cereblon E3 ligase modulator, or CELMoD, for the treatment of multiple myeloma. The FDA has granted a Prescription Drug User Fee Act (PDUFA) date of May 13, 2027 for this indication.

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"The FDA’s acceptance of our application for mezigdomide highlights the continued momentum of our targeted protein degradation programs, as we now have two distinct agents under review in relapsed or refractory multiple myeloma, which remains a persistent disease," said Cristian Massacesi, MD, executive vice president, chief medical officer and head of development, Bristol Myers Squibb. "We’re rapidly progressing the development of our CELMoD pipeline and are committed to leveraging this platform to bring the next wave of advances for patients in both hematologic malignancies and solid tumors."

The filing was based on positive results from the Phase 3 SUCCESSOR-2 trial (NCT05552976) showing MeziKd demonstrated a clinically meaningful and statistically significant improvement in progression-free survival (PFS) (95% CI: 18.0 months vs. 8.3 months [HR:0.48; p<0.0001]), representing a 52% reduction in the risk of disease progression or death compared with Kd in patients with relapsed or refractory multiple myeloma, including those at first relapse after prior treatment with an anti-CD38 monoclonal antibody and lenalidomide. The safety profile of MeziKd was consistent with that observed in prior studies of mezigdomide, as well as with the known safety profiles of the individual agents in the regimen. Results were recently presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting as a late-breaking oral presentation and published in The Lancet.

Bristol Myers Squibb thanks the patients and investigators involved with the Phase 3 SUCCESSOR-2 study.

About mezigdomide
Mezigdomide is an oral CELMoD specifically optimized to modulate cereblon for maximal and rapid degradation of Ikaros and Aiolos target proteins, leading to higher multiple myeloma cell killing and immune stimulation than traditional immunomodulatory agents. Pre-clinical data suggest mezigdomide enhances T cell function and prevents and reinvigorates an exhausted immune system.​ Mezigdomide is also being evaluated in the ongoing Phase 3 SUCCESSOR-1 trial vs. standard of care regimen in relapsed or refractory multiple myeloma.

About SUCCESSOR-2
There is a growing number of patients exposed and/or refractory to lenalidomide and anti-CD38 antibodies from first relapse. The SUCCESSOR-2 trial addressed this growing need. SUCCESSOR-2 (NCT05552976) is an inferential, seamless Phase 3, multicenter, randomized, open-label study evaluating the efficacy and safety of mezigdomide in combination with carfilzomib and dexamethasone (MeziKd) versus carfilzomib and dexamethasone (Kd) in patients with relapsed or refractory multiple myeloma (RRMM).

The primary endpoint of the Phase 3 study is progression-free survival. Key secondary endpoints include overall survival, overall response rate, duration of response, time to progression, time to next treatment, minimal residual disease negativity, and health-related quality of life.

Dose optimization for mezigdomide occurred in stage 1. The mezigdomide dose selected for stage 2 of the study was 1.0 mg. In total, 479 patients (288 MeziKd at 1.0 mg of mezigdomide; 191 Kd) were included in the analysis. Across both arms, median age was 68 with 25.1% of patients ≥75 years old; median number of prior therapies was 2; 92.1% of patients were triple-class-exposed, with 85.8% refractory to an anti-CD38 monoclonal antibody and 75.8% to lenalidomide; 37.2% were exposed to pomalidomide and 7.3% to anti-BCMA treatment. At data cutoff, median follow-up was 10.6 months with 52.4% (MeziKd) and 31.4% (Kd) of patients still on treatment.

About Targeted Protein Degradation and CELMoD
Targeted protein degradation (TPD) is a differentiated research platform at Bristol Myers Squibb built on more than two decades of scientific expertise, providing new avenues to degrade therapeutically relevant proteins that were previously considered difficult to address. BMS is the only company that has successfully developed and commercialized protein degrader agents for the treatment of multiple myeloma. These agents, known as immunomodulatory drugs (IMiDs), helped establish the current standard of care in the treatment of this disease, which remains without a cure. BMS is building on this foundation with several investigational protein degraders in clinical trials, leveraging three different modalities including CELMoD, ligand-directed degraders (LDDs), and degrader antibody conjugates (DACs). This three-pronged approach enables matching the right therapeutic modality to a molecular mechanism of action to modulate targets most effectively and ultimately provides more opportunities for potential breakthroughs that may offer meaningful new options for patients across a broad range of diseases, in and beyond hematology and oncology.

(Press release, Bristol-Myers Squibb, JUL 13, 2026, View Source;Food-and-Drug-Administration-Accepts-Bristol-Myers-Squibbs-New-Drug-Application-for-Mezigdomide-in-Patients-with-Relapsed-or-Refractory-Multiple-Myeloma/default.aspx [SID1234669168])