On August 20, 2026 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported it will present new clinical data from its diversified development program in lung cancer treatment at the IASLC 2026 World Conference on Lung Cancer ("WCLC") in Seoul, Republic of Korea, from September 12-15, 2026.

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The breadth of data highlights the latest progress across key strategic assets, pumitamig (BNT327/BMS986545) and gotistobart (BNT316/ONC-392), as well as BioNTech’s mRNA-based immunotherapy approaches, highlighting the strength of BioNTech’s lung cancer treatment pipeline. Additionally, a late breaking oral presentation will detail data from the novel-novel combination trial of pumitamig with the investigational B7H3-targeted antibody-drug conjugate ("ADC") elfetabart drozuntecan (elfe-D or BNT324/DB-1311), representing the first combination data for any PD-(L)1xVEGF bispecific immunomodulator and an ADC in lung cancer.

"Progress in lung cancer care means both improving treatment outcomes for patients and, importantly, finding better options for more patients who still do not sufficiently benefit from current standard therapies," said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. "The data we are presenting at this year’s WCLC provide further clinical evidence for our late-stage assets, gotistobart and pumitamig, and help to define the role of next-generation immunomodulators in addressing unmet medical needs in lung cancer. We are also presenting the first clinical evidence from a novel-novel treatment combination in lung cancer as part of our evaluation of pumitamig as a potential backbone for combination strategies of complementary mechanisms. Taken together, these data will inform the next steps in our clinical development programs and our broader efforts to expand treatment options for patients."

Highlights from BioNTech’s presentations at WCLC 2026:

Novel-novel combination trial of pumitamig, developed in collaboration with Bristol Myers Squibb Company ("BMS"), and elfetabart drozuntecan, developed in collaboration with Duality Biologics (Suzhou) Co. Ltd. ("DualityBio"):
•Advanced/metastatic SCLC and NSCLC: First data from the global Phase 1/2 trial (NCT06892548) evaluating pumitamig in combination with the B7H3-targeting ADC elfetabart drozuntecan in patients with advanced or metastatic small cell lung cancer ("SCLC") and NSCLC will be presented for this novel-novel treatment combination approach, underlining BioNTech’s leadership in novel-novel combination treatment strategies.

Gotistobart – a tumor microenvironment-selective regulatory T cell depletion candidate targeting CTLA-4, developed in collaboration with OncoC4, Inc. ("OncoC4"):

•2L+ squamous NSCLC: Updated overall survival data from stage 1 of the PRESERVE-003 Phase 3 clinical trial (NCT05671510) of gotistobart in patients with squamous non-small cell lung cancer ("NSCLC") who progressed on prior PD-(L)1 inhibitor treatment will be presented. The results further contribute to the growing body of evidence for this chemotherapy-free treatment approach. The pivotal stage 2 part of the trial is ongoing.

All abstracts are available through the WCLC website. Further information on BioNTech’s lung cancer pipeline can be accessed here.

Full presentation details:

Candidate
Abstract Title
Abstract Number/Presentation Details
Pumitamig + elfetabart drozuntecan
Pumitamig (PD-L1 x VEGF-A bsAb) + Elfetabart Drozuntecan (Elfe-D, B7H3 ADC) in Patients with Advanced/Metastatic Lung Cancer (NSCLC or SCLC)
Abstract # OA14.01
Oral Presentation
The Breakthrough Immunotherapy for Advanced NSCLC
Sep 15, 2026: 12:30 – 01:45pm KST
Pumitamig
First-line Pumitamig (PD-L1 × VEGF-A bsAb) Plus Chemotherapy in Unresectable Malignant Mesothelioma: Long-term PFS and OS
Abstract #MO04.09
Mini Oral
Novel Therapeutics and Molecular Insights in Thymic Malignancies and Pleural Mesothelioma
Sep 13, 2026: 4:45 – 6:00pm KST
ROSETTA Lung‑201: A Phase 3 Trial of Pumitamig Monotherapy vs Durvalumab in Unresectable Stage III NSCLC Post-Chemoradiation
Abstract #P2.330
Poster
Clinical Trials in Progress
Sep 14, 2026: 10:30am – 12:00pm KST
ROSETTA Lung-202: A Phase 3 trial of first-line pumitamig monotherapy vs pembrolizumab in locally advanced/metastatic NSCLC
Abstract #P2.355
Poster
Clinical Trials in Progress
Sep 14, 2026: 10:30am – 12:00pm KST
Gotistobart
Gotistobart vs Docetaxel in Metastatic Squamous NSCLC After PD-(L)1 Progression: Updated Overall Survival of the stage 1 of PRESERVE-003
Abstract #MO07.04
Mini Oral
Novel Immunotherapeutic Strategies in mNSCLC
Sep 14, 2026: 5:00 – 6:15pm KST
BNT116
Neoadjuvant BNT116 + Cemiplimab + Carboplatin + Paclitaxel in Resectable NSCLC: Preliminary Results From a Phase I Trial
Abstract #MO06.03
Mini Oral
Emerging Precision Approaches in Perioperative Therapy for Resectable NSCLC Integrating Targeted Therapy, Immunotherapy, Biomarkers, and Multimodal Strategies
Sep 14, 2026: 3:30 – 4:45pm KST

About BioNTech in Lung Cancer Treatment
Lung cancer is one of BioNTech’s key focus areas. Through a diversified portfolio of investigational next-generation immunomodulators, ADCs and mRNA-based cancer immunotherapies, the Company is pursuing multiple approaches designed to address significant unmet needs for patients across lung cancer subtypes, histologies and treatment settings. BioNTech’s clinical pipeline encompasses both monotherapies and combinations with standard of care treatments, as well as novel-novel combination regimens aimed at delivering differentiated therapeutic profiles for the treatment of patients with lung cancer. With 16 ongoing lung cancer trials, including five pivotal Phase 3 and two novel-novel combination trials, BioNTech is advancing a comprehensive development strategy with the aim of improving outcomes for patients across the continuum of lung cancer.

(Press release, BioNTech, AUG 20, 2026, View Source [SID1234670248])

On August 20, 2026 Artelo Biosciences, Inc. (Nasdaq: ARTL) ("Artelo" or the "Company"), a clinical-stage pharmaceutical company focused on modulating lipid-signalling pathways to develop treatments for people living with cancer, pain, dermatologic, or neurological conditions, reported that the Japanese Patent Office has issued a notification of allowance with a Decision to Grant for the Company’s patent application covering the intended commercial formulation of ART27.13, Artelo’s peripherally selective dual cannabinoid agonist currently being evaluated in two Phase 2 clinical trials.

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The allowed claims in Japan protect compositions of ART27.13 dispersed in polyethylene glycol. These claims are consistent with those previously allowed in the United States and Europe, and all jurisdictions are expected to provide patent protection through 2041. This brings Artelo’s intellectual property estate for ART27.13 to issued or allowance status in three major pharmaceutical markets, the United States, Japan, and Europe, and further strengthens the program’s global IP position while supporting its long-term commercial potential.

"Receiving this allowance decision in Japan represents another important advancement in our global intellectual property and clinical development strategy for ART27.13," said Gregory D. Gorgas, President and Chief Executive Officer of Artelo Biosciences. "The innovator of our investigational drug, AstraZeneca, previously conducted a Phase 1 safety study with ART27.13 in Japan, with no major safety or tolerability concerns, and had concluded the plasma exposure and adverse event profiles were comparable between Japanese and Caucasian participants." ART27.13 was fully licensed to Artelo in 2019.

Currently being evaluated in the Phase 2 portion of CAReS targeting cancer-related anorexia, ART27.13 was well-tolerated in the Phase 1 stage and showed early signs of stabilizing or reversing weight loss in more than 60% of participants. Interim results from the CAReS Phase 2 demonstrated the ability of the drug to reverse cancer-related anorexia in all patients taking the highest dose of 1300 µg whereas the all the participants on placebo continued to lose weight throughout the study.

ART27.13 is also being evaluated in the DREAM study, a pilot Phase 2 in people with glaucoma or ocular hypertension. Funded by Glaucoma UK and the HSC R&D Division in the UK, the investigator-led study is evaluating ART27.13’s potential at a 600 µg orally administered daily dose to reduce intraocular pressure, alongside additional assessments of visual acuity, body weight, mood, safety and tolerability. Initial results are anticipated in the fourth quarter of this year.

"With allowances now secured in the United States, Europe and Japan for claims covering our intended commercial formulation, we believe we have established a strong foundation for ART27.13 across three of the world’s major pharmaceutical markets. This growing patent estate further enhances the strategic and commercial value of the program as ART27.13 advances in multiple potential indications," concluded Mr. Gorgas.

About ART27.13
ART27.13 is a dual cannabinoid agonist and novel benzimidazole derivative. Initially developed by AstraZeneca plc, ART27.13 has been in over seven clinical studies with nearly 300 participants. It is primarily being developed as a once-daily, orally administered agent selectively targeting peripheral CB1 and CB2 receptors, with the potential to reduce muscle degeneration while improving body weight, appetite, and quality of life in cancer patients. Importantly, the drug enables systemic metabolic effects while minimizing central nervous system-mediated toxicity. Artelo is conducting a Phase 2 named the Cancer Appetite Recovery Study (CAReS) evaluating ART27.13 as a supportive care therapy for cancer patients suffering from anorexia and weight loss. Interim Phase 2 data revealed patients who had lost at least 5% of body weight to be included in CAReS and titrated to the highest ART27.13 dose (1300 µg) achieved an average +6% weight gain over 12 weeks, while patients on placebo lost an additional ~5%. Currently, there is no FDA approved treatment for cancer anorexia cachexia syndrome. In addition to CAReS, ART27.13 is also being evaluated in a Phase 2 study in people with glaucoma, called the DREAM study. In DREAM, ART27.13 is administered orally at a daily dose of 600 µg.

(Press release, Artelo Biosciences, AUG 20, 2026, View Source [SID1234670265])

On August 19, 2026 Hengrui Pharma ("Hengrui" or "the Company") reported its financial results for the first half of 2026. During the reporting period, innovative drugs remained the Company’s key growth driver, while globalization initiatives continued to validate the global value of Hengrui’s innovation portfolio.

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Financial Highlights

In the first half of 2026, Hengrui reported revenue of RMB15.46 billion. Drug sales revenue was RMB13.95 billion, representing a year-over-year increase of 1.87%. Innovative drug sales increased by 16.38% year-over-year and accounted for 63.16% of total drug sales, with non-oncology innovative drug sales increasing by 73.97% year-over-year and emerging as an increasingly important growth driver.

Net profit attributable to shareholders of the listed company was RMB4.47 billion, up 0.34%. R&D investment totaled RMB4.61 billion, representing 29.8% of revenue.

Pipeline and Regulatory Highlights

Hengrui continued to advance its pipeline in China during the reporting period, obtaining seven innovation-related approvals, including two Class 1 innovative medicines, one Class 2 innovative medicine and four additional indications. At the end of the reporting period, nine marketing applications had been accepted for review by China’s National Medical Products Administration, while 17 clinical programs had advanced to Phase III, 22 to Phase II, and 10 innovative assets had entered Phase I clinical development.

Hengrui also reported progress across its metabolic pipeline. Two Phase III studies of ribupatide injection, a GLP-1/GIP dual receptor agonist, in China for type 2 diabetes reported positive topline results, supporting a planned NDA submission. HRS-7535, an oral small molecule GLP-1 receptor agonist, met all primary and key secondary endpoints at Week 44 in a China Phase III obesity study, with continued weight loss through Week 50 and mean body-weight reduction of up to 11.1%. An NDA submission is planned.

Global Partnerships and Business Development

Hengrui continued to advance its globalization strategy through diversified collaboration models. Since 2023, the Company has completed 13 overseas business development transactions, including out-licensing, NewCo and strategic alliances, with a total potential transaction value of approximately US$42 billion. These collaborations include leading global pharmaceutical companies such as BMS, GSK and others.

Among the diversified collaboration models Hengrui has explored, NewCo has also seen important progress in 2026. Kailera Therapeutics completed its Nasdaq IPO in April 2026, becoming one of the largest biotech IPOs at the time. Braveheart Bio also successfully listed on the Nasdaq Global Market on August 6, 2026.

Scientific Recognition

During the reporting period, 204 research findings related to Hengrui products were published in academic journals and received international recognition. Hengrui participated in the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting for the 16th consecutive year, with 91 studies accepted, including 11 oral presentations—a new high for the Company. Research in non-oncology areas was also presented at major international congresses, including the American Diabetes Association, International Stroke Conference, World Congress of Nephrology‌, American College of Cardiology, American Academy of Dermatology, and European Alliance of Associations for Rheumatology.

Outlook

Looking ahead, Hengrui will continue to advance its innovation and globalization strategy, while further pursuing its dual-growth strategy across oncology and chronic diseases. The Company will strengthen its global R&D capabilities, pursue diversified international collaboration models, and continue to focus on delivering sustainable long-term value and bringing more high-quality innovative therapies to patients worldwide.

(Press release, Hengrui Pharmaceuticals, AUG 19, 2026, View Source [SID1234670232])

On August 19, 2026 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported it has entered into a clinical collaboration with Genentech, a member of the Roche Group, to evaluate the efficacy and safety of IDE892, its investigational, potential best-in-class MTA-cooperative PRMT5 inhibitor, in combination with GDC-7035 (RG6620), Genentech’s KRAS G12D inhibitor, in patients with pancreatic ductal adenocarcinoma (PDAC) harboring both an MTAP-deletion and a KRAS G12D mutation. Genentech will sponsor the clinical combination study, and IDEAYA will supply IDE892.

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"We are excited to expand our clinical collaboration with Roche to evaluate a second KRAS combination with potential best-in-class MTA-cooperative PRMT5 inhibitor IDE892 for pancreatic cancer patients, where there remains a high unmet medical need. IDEAYA is advancing multiple rational combination strategies for the IDE892 program, including with MAT2A inhibitor IDE397, pan-RAS inhibitors, KRAS G12D inhibitors, and IDEAYA’s lead CDKN2A compound," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences.

IDE892 has potential best-in-class properties, including approximately 1,400-fold selective MTA-PRMT5 cooperative binding versus SAM-PRMT5 cooperative binding and lack of brain penetrance intended to maximize its therapeutic window, and favorable drug-like properties to enable rational combinations with IDE397, pan-RAS inhibitors, KRAS-mutant specific therapies, and IDEAYA’s CDKN2A lead molecule. IDE892 has a CYP3A4 IC50 greater than 45 micromolar and did not show time dependent inhibition of any of the 7 major cytochrome P450s (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP3A4) based on full kinetic CYP inactivation assays, positioning IDE892 as a potential best-in-class MTA-cooperative PRMT5 combination partner. IDEAYA is evaluating IDE892 in a Phase 1 dose escalation and expansion clinical trial in MTAP-deleted solid tumors and has initiated a Phase 1 combination cohort in NSCLC and other solid tumors with IDE397, IDEAYA’s proprietary MAT2A inhibitor. IDEAYA also plans to initiate a Phase 1 combination cohort with Roche’s RG6505 in MTAP-deleted, RAS-mutant PDAC in 2H 2026. The collaboration announced today adds GDC-7035 as an additional KRAS-directed combination partner for IDE892 in MTAP-deleted, KRAS G12D positive PDAC.

MTAP deletions and KRAS G12D mutations are estimated to co-occur in up to approximately 15% of PDAC patients. Combining a PRMT5 inhibitor with a KRAS G12D mutant-specific inhibitor may have the potential to drive deeper and more durable responses for those PDAC patients with co-occurring alterations, who currently have no approved targeted treatment options.

Under the clinical collaboration, IDEAYA and Genentech each retain all commercial rights to their respective compounds, including as monotherapy and as combination therapies. There will be joint governance to oversee the clinical supply collaboration.

(Press release, Ideaya Biosciences, AUG 19, 2026, View Source [SID1234670233])

On August 19, 2026 BioArctic AB (publ) (NASDAQ Stockholm: BIOA B) and Mesenkia Therapeutics reported that the companies have signed a research collaboration agreement to explore a novel antibody-based approach for glioblastoma, one of the most aggressive and treatment-resistant forms of brain cancer, where effective delivery of large molecules to the brain remains a major challenge.

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The collaboration combines BioArctic’s proprietary BrainTransporter technology with an antibody, developed with Mesenkia’s KITAIbodies platform. The antibody targets HVEM[1], a protein found on the surface of certain glioblastoma tumor cells, including tumor stem cells. By addressing these cells, which are thought to contribute to tumor recurrence and treatment resistance, the project aims to unlock new treatment possibilities for patients with a very high unmet medical need.

Under the agreement, BioArctic will be responsible for generating a novel drug candidate by combining its BrainTransporter technology with Mesenkia’s antibody. BioArctic and Mesenkia thereafter plan to perform preclinical studies to validate the concept and, based on the results of these studies, decide on next steps.

This research collaboration represents an important step in expanding BioArctic’s BrainTransporter pipeline into oncology and further validates the platform’s potential beyond neurodegenerative diseases. It also builds on BioArctic’s core expertise in development and delivery of pharmaceuticals to the brain.

"We are excited to broaden our research and take a first step into oncology through this collaboration," said Gunilla Osswald, Chief Executive Officer of BioArctic. "Glioblastoma remains one of the most challenging cancers to treat, with limited therapeutic options and poor prognosis for those affected. By combining our BrainTransporter technology with Mesenkia’s innovative antibody approach, we aim to target key disease-driving mechanisms to develop new ways to treat this devastating disease."

"This agreement marks an important step for Mesenkia and creates clear opportunities to explore a new treatment strategy for patients with glioblastoma together with BioArctic. The need for new treatments is substantial, particularly given the challenge of delivering medicines to tumor cells throughout the brain. By combining Mesenkia’s antibody expertise with BioArctic’s BrainTransporter technology, we can address one of the disease’s key barriers in a new way. We look forward to advancing the concept together with BioArctic, with the long-term goal of enabling better treatment options for patients and their loved ones," said Moa Fransson, Chief Executive Officer of Mesenkia.

(Press release, Mesenkia Therapeutics, AUG 19, 2026, View Source [SID1234670234])