T-MAXIMUM B7-H3-Targeted Allogeneic CAR-T Therapy MT027 Receives FDA Fast Track Designation, Accelerating Global Development for Intracranial Solid Tumors

On August 31, 2026 T-MAXIMUM PHARMACEUTICAL Inc. ("T-MAXIMUM") reported that its investigational allogeneic CAR-T cell therapy MT027 has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of recurrent glioblastoma.

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MT027 had previously received FDA Orphan Drug Designation (ODD) for the treatment of recurrent high-grade glioma, and clearance from the FDA to conduct a Phase II clinical study in recurrent glioblastoma. Together, the Orphan Drug Designation, the Phase II clearance and the newly granted Fast Track Designation add further momentum to the global development of MT027.

A Competitive B7-H3 Field: Allogeneic CAR-T Charts a Differentiated Course

B7-H3 has emerged in recent years as a target of significant interest in solid tumor drug development, with antibody-drug conjugates (ADCs), antibody therapeutics and cell therapies all being actively pursued. In July 2026, Hansoh Pharmaceutical announced that its B7-H3 ADC, HS-20093, met the primary endpoint of progression-free survival (PFS) as assessed by an independent review committee (IRC) in patients with relapsed or progressive osteosarcoma in the pivotal Phase III ARTEMIS-011 study. Developments across the field indicate that the clinical value of B7-H3 continues to be validated along multiple technology routes.

Against this backdrop, MT027 is differentiated by the combination of three elements: B7-H3 targeting, an allogeneic "off-the-shelf" product format, and a locoregional intracavitary route of administration — directed at recurrent glioblastoma and brain metastases, settings of high unmet medical need.

From a Single Asset to a Method: Building a Verifiable, Repeatable Translational Approach for Intracranial Solid Tumors

For T-MAXIMUM, the significance of MT027 extends beyond the advancement of one pipeline asset. Recurrent glioblastoma is among the most demanding settings in which to test the capabilities of cell therapy in solid tumors. It requires solving the delivery of cells to compartments associated with the central nervous system, while at the same time addressing the in vivo persistence of allogeneic cells, safety monitoring following local administration, and the clinical execution of repeat dosing and long-term follow-up.

What MT027 is exploring is a development methodology built around intracranial solid tumors — B7-H3 as the target, allogeneic universal CAR-T as the product format, and local intracavitary delivery as the route of administration — refined through clinical research across patient selection, dosing, monitoring and the accumulation of evidence.

If this approach continues to generate high-quality evidence in recurrent glioblastoma, its value may not be limited to a single indication. The company is also exploring the potential of MT027 in brain metastases and in other solid tumor settings suited to local delivery. Based on the company’s prior disclosure, preliminary first-in-human data in brain metastases are planned for formal presentation during the World Conference on Lung Cancer (WCLC) in September 2026.

Fast Track Designation: Added Speed for Global Development

Fast Track is an FDA process designed to facilitate the development of drugs that treat serious conditions and address unmet medical needs. A sponsor whose program receives the designation has the opportunity for more frequent interactions with the FDA over the course of drug development, and, where the relevant criteria are met, the program may also be eligible for Rolling Review of a marketing application, as well as for Accelerated Approval and Priority Review. These mechanisms are intended to support a more efficient path for the clinical development and potential registration of MT027 in the United States and, if development is successful, earlier treatment access for patients with recurrent glioblastoma worldwide.

MT027’s existing Orphan Drug Designation confers benefits including FDA guidance on clinical development, tax credits for qualified clinical trials, exemption from certain application fees, and seven years of market exclusivity in the designated indication upon approval. With the addition of Fast Track Designation, MT027 now holds dual designations under the FDA regulatory framework, further consolidating its position as one of the leading global allogeneic CAR-T programs in solid tumors.

Company Comment

"Receiving Fast Track Designation from the FDA is an important milestone in the global development of MT027, but it is not the destination," said Xiaoyun Shang, CEO of T-MAXIMUM PHARMACEUTICAL. "What matters more to us is the continued validation — in the demanding setting of recurrent glioblastoma — of how target selection, an allogeneic off-the-shelf product, local delivery and clinical execution work together. Every piece of solid clinical evidence helps us refine the ongoing development of MT027 and provides translational experience that can inform our next-generation products and other intracranial solid tumor settings suited to local delivery. Going forward, T-MAXIMUM will continue to be guided by patient needs, and to advance allogeneic CAR-T in solid tumors on a foundation of safety, rigor and verifiable evidence."

(Press release, T-MAXIMUM Pharmaceutical, AUG 31, 2026, View Source [SID1234670463])

IDEAYA Biosciences Announces Successful FDA Type C Meeting for IDE849, DLL3 TOP1 ADC, on Phase 3 Registrational Trial Design for Potential Accelerated and Full Approval in Extensive Stage Small Cell Lung Cancer

On August 31, 2026 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported a successful FDA Type C meeting to determine the Phase 3 registrational trial design for IDE849, a potential best-in-class delta-like ligand 3 (DLL3)-targeting Topo-I-payload antibody drug conjugate (ADC), in extensive stage small cell lung cancer (ES-SCLC). IDEAYA is targeting to initiate the Phase 3 registrational study in ES-SCLC by year-end 2026.

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"Based on the FDA Type C meeting, we are targeting to initiate a randomized Phase 3 registrational study for IDE849 monotherapy in extensive stage small cell lung cancer to enable a potential accelerated approval and full approval in one seamless study design," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences. "We also look forward to the clinical data updates at ESMO (Free ESMO Whitepaper) 2026 and later this year from our company sponsored clinical trial in ES-SCLC and NEC to support a potential best-in-class profile."

The anticipated enrollment target for the IDEAYA-sponsored global Phase 3 registrational study is approximately 400 ES-SCLC patients with prior tarlatamab treatment. The study will be randomized 1:1 between the treatment and an investigator’s choice control arm that will include topotecan and ambrucin. The primary endpoint for accelerated approval will be overall response rate (ORR) by blinded independent central review (BICR) and the primary endpoint for full approval will be median overall survival. The secondary endpoints will include median duration of response by BICR, progression free survival, safety, among others.

IDEAYA has an ongoing multi-site global Phase 1 clinical trial for IDE849 in DLL3 upregulated solid tumor indications, including SCLC, and neuroendocrine carcinomas (NEC) (NCT07174583). The study is enrolling patients globally, including in North America, Europe, Australia, South America, and Asia. In this ongoing Phase 1 dose escalation study, IDE849 is currently evaluating the expansion doses of 2.4 mg/kg and 3.5 mg/kg IV once every 3-weeks (Q3W) to determine the recommended Phase 3 dose (RP3D).

In addition, IDE849 is being evaluated in clinical combination study with AstraZeneca’s PDL1 inhibitor Imfinzi, and IDEAYA’s potential first-in-class Phase 1 PARG inhibitor, IDE161, to determine a potential first-line (1L) SCLC Phase 3 registrational trial design. IDE161 prevents the removal of poly(ADP-ribose) chains generated by PARP during the DNA damage response, leading to persistent PARylation and impaired resolution of DNA repair complexes. Together with TOP1-payload ADCs, this unique mechanism-of-action results in sustained TOP1 cleavage complexes and the accumulation of DNA damage that delivers enhanced anti-tumor activity. We believe this potential first-in-class combination has the potential to enhance durability of IDEAYA’s TOP1-payload based ADC pipeline, including IDE849 and IDE034 (Phase 1 B7H3/PTK7 Bispecific TOP1 ADC).

DLL3 has been reported to be upregulated in multiple solid tumor types, including in SCLC, NEC and melanoma, among others. IDEAYA estimates the annual incidence of SCLC and NEC in the United States is approximately 34,000 and 19,000 patients, respectively. DLL3 has limited extracellular expression in normal tissues, making it a promising potential therapeutic target in these solid tumors, for which there remains significant unmet medical need.

(Press release, Ideaya Biosciences, AUG 31, 2026, View Source [SID1234670462])

TransCode Therapeutics Announces Publication Demonstrating Survival Benefit of TTX-MC138 in Preclinical Model of Breast Cancer Bone Metastasis

On August 31, 2026 TransCode Therapeutics, Inc. (NASDAQ: RNAZ), a clinical stage company pioneering immuno-oncology and RNA-based therapeutics for the treatment of high risk and advanced cancers, reported the publication of a peer-reviewed article in Cancers titled, "Targeting miR-10b in Breast Cancer Bone Colonization Model Using Image-Guided Nucleic Acid-Based Therapeutics." The study reports that TransCode’s lead therapeutic candidate, TTX-MC138, produced significant survival benefits in a preclinical model of breast cancer bone metastasis while demonstrating favorable tolerability and no observed systemic toxicity.

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The publication builds on a growing body of evidence supporting microRNA-10b (miR-10b) as an important driver of cancer metastasis and further validates TransCode’s therapeutic approach of inhibiting miR-10b using proprietary oligonucleotide nanotechnology.

The study was led by Dr. Anna Moore, Professor in the Radiology and Physiology Departments, Director of the Precision Health Program and Associate Dean for Research Development at the College of Human Medicine at Michigan State University. Dr. Moore is a co-founder of TransCode Therapeutics and Chair of the Scientific Advisory Board, and a globally recognized expert in molecular imaging and RNA-targeted cancer therapeutics.

"Metastatic disease remains responsible for the overwhelming majority of cancer deaths, and effective therapies specifically designed to target metastasis remain limited," said Zdravka Medarova, Ph.D., Chief Scientific Officer of TransCode Therapeutics and co-author of the publication. "These findings demonstrate that miR-10b inhibition can significantly impact survival in a challenging model of metastatic cancer and further support the potential applicability of our platform across multiple metastatic tumor types."

Key Findings

Among the study’s findings:

TTX-MC138 successfully accumulated in metastatic bone lesions in a mouse model of bone cancer bone metastasis following systemic administration.
Treatment significantly reduced expression of miR-10b, a microRNA implicated in metastatic progression, and increased expression of HOXD10, a downstream tumor-suppressor target.
Animals treated with anti-miR-10b therapeutics demonstrated significant survival benefits compared with controls.
Repeated dosing was well tolerated, with no evidence of systemic toxicity observed during the study.
The results support the use of image-guided anti-miR-10b nanotherapeutics as a potentially translatable strategy for treating metastatic cancer.
Bone is the most common site of metastatic spread in breast cancer and represents a major unmet medical need, with patients experiencing substantial morbidity and poor long-term outcomes. The authors concluded that targeting miR-10b using an image-guided anti-miR-10b nanotherapeutic represents a promising and translatable strategy for treating breast cancer bone metastases.

Relevance to TransCode’s Clinical Program

While TransCode’s current clinical development efforts are focused on metastatic cancers and its ongoing TTX-MC138 program in molecular residual disease-positive colorectal cancer, the newly published findings suggest potential future applicability of miR-10b inhibition across additional metastatic disease settings where tumor spread drives poor outcomes.

The article was published online on August 23, 2026, in Cancers, a peer-reviewed oncology journal.

About TTX-MC138

TTX-MC138 is a first-in-class therapeutic candidate designed to inhibit microRNA-10b, or miR-10b, a microRNA widely believed to be critical to the emergence and progression of many metastatic cancers. TransCode’s Phase 1a first-in-human clinical trial achieved its primary safety endpoint and established a recommended Phase 2 dose, as announced at ESMO (Free ESMO Whitepaper) 2025.

(Press release, TransCode Therapeutics, AUG 31, 2026, View Source [SID1234670461])

CStone 2026 Interim Results: Accelerating Pipeline 2.0 Execution and Sustained Global Commercial Momentum

On August 31, 2026 CStone reported 2026 Interim Results: Accelerating Pipeline 2.0 Execution and Sustained Global Commercial Momentum.

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CS2009 Achieved Key Clinical Validations for Efficacy and Safety

As of August 2026, updated data further confirmed the favorable safety profile of CS2009 and demonstrated strengthened efficacy across multiple key cohorts compared with the data presented at ASCO (Free ASCO Whitepaper) in May 2026. With expanded patient enrollment and longer follow-up, improvements were observed in both the objective response rate (ORR) and duration of response (DOR):

Compelling monotherapy efficacy in first-line non-small cell lung cancer (NSCLC)

At the 30 mg/kg dose level, CS2009 achieved an ORR of 100% and a disease control rate (DCR) of 100% in patients with PD-L1 TPS ≥50%. In the broader PD‑L1 TPS ≥1% population, the ORR was 70.8% and DCR was 91.7%.
Monotherapy efficacy in Immunotherapy (IO)-pretreated NSCLC and IO-nonresponsive "cold tumors" further validates CTLA-4 activity and efficacy.

In second-line NSCLC patients (all previously treated with IO plus chemotherapy), CS2009 monotherapy (30 mg/kg dose level) yielded an ORR of 38.5% and a DCR of 84.6%;
In patients with heavily pretreated metastatic colorectal cancer (mCRC), CS2009 monotherapy (30 mg/kg dose level) achieved an ORR of 20% and a DCR of 93.3%;
In patients with heavily pretreated soft tissue sarcoma (STS) and non-clear cell renal cell carcinoma (nccRCC), CS2009 monotherapy delivered ORR of 38.5% and 42.9%, respectively.
CStone will present additional more mature Phase I/II clinical data for CS2009 in patients with advanced NSCLC and mCRC via two rapid oral presentations at ESMO (Free ESMO Whitepaper) 2026 in October. The Company also expects to reach consensus with global regulatory authorities including the U.S. Food and Drug Administration (FDA) and the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA), on the global Phase III registrational trial protocol in the fourth quarter of 2026.

Pralsetinib Delivers Strong Sales Growth

Following its effective inclusion in the National Reimbursement Drug List (NRDL) on January 1, 2026, pralsetinib’s in-market sales volume increased by almost 500% year-over-year in the seven‑month period ending July 2026.

Solid Cash Position

As of June 30, 2026, cash and cash equivalents and time deposits totaled RMB1,560.2 million.

SUZHOU, China, Aug. 31, 2026 /PRNewswire/ — CStone Pharmaceuticals ("CStone," HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of therapies for oncology, immunology, inflammation, and other key disease areas, reported its 2026 interim results and recent business highlights.

Dr. Jason Yang, CEO, President of R&D, and Executive Director at CStone, commented, "In the first half of 2026, CStone entered a pivotal stage of transition from innovation-driven accumulation to global value realization.

Our lead asset, CS2009, continues to advance rapidly through global clinical development. To date, we have accumulated clinical data from more than 300 patients, consistently demonstrating three key clinical validations: first, proof of safety; second, multidimensional confirmation of CTLA‑4 target activity and efficacy, evidenced by pharmacodynamic biomarkers and clinical activity in "cold tumors" and IO‑pretreated NSCLC; and third, broad‑spectrum and highly competitive antitumor efficacy across multiple tumor types. The most recent data show that CS2009’s antitumor activity continues to deepen and strengthen with longer follow-up, exhibiting particularly competitive efficacy and a well-tolerated safety profile in key patient populations, including NSCLC and mCRC. These robust data provide strong support for the upcoming global Phase III registrational trials. We look forward to presenting additional more mature clinical data on CS2009 in oral presentations at the ESMO (Free ESMO Whitepaper) Congress this October.

Beyond CS2009, other Pipeline 2.0 candidates are also progressing steadily toward clinical stage. CS5007, built on our proprietary ADC platform, has initiated a global Phase I clinical trial in both China and Australia. In addition, more than ten early-stage programs spanning next-generation ADCs, immunology & inflammation and other areas are advancing smoothly. The successive entry of these differentiated innovative assets into clinical development will serve as a critical driver for the Company’s sustained growth and global expansion.

On the commercial front, our three key products, sugemalimab, pralsetinib, and avapritinib, continued to achieve breakthroughs across domestic and international markets, contributing significant momentum to revenue growth. Notably, following pralsetinib’s first-time inclusion in the NRDL earlier this year, its in-market sales volume increased by almost 500% year-over-year during the first seven months of 2026, making it the primary driver of the Company’s revenue growth in the first half of 2026.

Looking ahead, CStone will focus on advancing the clinical value of its Pipeline 2.0 assets and actively pursue global partnerships to accelerate their development. Concurrently, the Company will continue to maximize the commercial potential of its marketed products through strategic partnerships and resource integration. Our goal is to foster a sustainable growth model where R&D and commercialization reinforce each other, creating a virtuous cycle between innovation and business operations."

Clinical Stage Core Asset

CS2009, PD-1/VEGF/CTLA-4 trispecific antibody

– Accelerating global clinical development toward Phase III registrational trials by year end

The ongoing global Phase I/II trial has enrolled more than 300 patients across China and Australia, with U.S. Investigational New Drug (IND) clearance obtained in February 2026.

CStone plans to initiate the first wave of global Phase III multi-regional clinical trials (MRCTs) for CS2009 by the end of 2026. Planned registrational studies include first-line non-small cell lung cancer (NSCLC) in combination with chemotherapy (versus pembrolizumab plus chemotherapy), and first-line mCRC in combination with chemotherapy (versus bevacizumab plus chemotherapy), with additional registrational studies planned for 2027 and following years.

– CS2009 validates its potential as a next-generation I/O backbone

At the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, CStone presented comprehensive Phase I/II data from the ongoing global multicenter trial. As of the data cutoff date of August 2026, updated monotherapy efficacy data from the ongoing global Phase I/II trial of CS2009, reflecting a longer follow-up and larger sample size than the ASCO (Free ASCO Whitepaper) 2026 presentation continued to demonstrate robust and deepening antitumor activity across multiple tumor types. Three important key clinical validations are achieved from over 300 patient data:

Proof of safety
Across all dose levels, no dose-limiting toxicities (DLTs) were observed, and the maximum tolerated dose (MTD) was not reached. In the ASCO (Free ASCO Whitepaper) 2026, the incidence of Grade ­3 treatment-related adverse events (TRAEs) and immune-related adverse events (irAEs) were 24.6% and 12.7%, respectively. Notably, the incidence of Grade ­3 VEGF-related TRAEs was only 5.1%. No excessive toxicities typically associated with CTLA-4/PD-(L)1 combinations were observed. As of August 2026, the safety profile of CS2009 remained consistent with that presented at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting, with no new safety signals identified.

Proof of CTLA-4 activities and efficacy
Dose-dependent upregulation of ICOS on CD4+ T cells was observed as a pharmacodynamic biomarker of CTLA-4 blockade. Activity was also seen in "cold tumor" not sensitive to PD-(L)1 mAb:

Later-line monotherapy for mCRC (30 mg/kg): the objective response rate (ORR) was 20.0% (3/15) and the disease control rate (DCR) was 93.3% (14/15).
Later-line monotherapy for soft-tissue sarcoma (STS): the ORR was 38.5% (5/13) and the DCR was 69.2% (9/13). Later-line monotherapy for non-clear cell renal cell carcinoma (nccRCC): the ORR was 42.9% (3/7) and the DCR was 100.0% (7/7).
Promising anti-tumor activity in later-line post immuno-oncology (IO) NSCLC monotherapy: ORR was 23.8% (5/21), DCR was 61.9% (13/21). Among patients who had previously received immunotherapy plus platinum-based chemotherapy (n=13), ORR was 38.5% (5/13) and DCR was 84.6% (11/13).
Proof of broad efficacy
Monotherapy and chemo-combination activity in first-line and later-line NSCLC:

First-line NSCLC monotherapy (PD-L1 tumor proportion score [TPS]­ ≥1%; enrollment completed): ORR of 61.7% (29/47) and DCR of 93.6% (44/47), including ORR of 70.8% (17/24), DCR 91.7% (22/24) in patients treated at 30 mg/kg; in the PD-L1 TPS ≥­50% group (n=24), ORR was 83.3% (20/24) and DCR was 95.8% (23/24) (versus ORR of 81.3% [13/16] at the 2026 ASCO (Free ASCO Whitepaper) cutoff), including ORR of 100.0% (11/11) and DCR of 100.0% (11/11) in patients treated at 30 mg/kg. After median follow up of 6 months, median progression-free survival (PFS) and DOR have not been reached.
Second-line or later NSCLC monotherapy (30 mg/kg): ORR of 28.0% (7/25) and DCR of 60.0% (15/25), with a 6-month DOR rate of 83.3% (versus ORR of 24.0% and a 6-month DOR rate of 80.0% at the 2026 ASCO (Free ASCO Whitepaper) cutoff). Across all evaluated dose levels (n=54), ORR was 16.7% (9/54) and DCR was 68.5% (37/54), with a 6-month DOR rate of 87.5% (versus 85.7% at the 2026 ASCO (Free ASCO Whitepaper) cutoff).
Later-line NSCLC (second/third-line combination therapy, n=6): ORR of 66.7% (4/6), DCR of 100.0% (6/6). Data are as of the 2026 ASCO (Free ASCO Whitepaper) data cutoff and will be updated at ESMO (Free ESMO Whitepaper) 2026.
First-line squamous NSCLC combination therapy (PD-L1-low/negative, TPS ≤5%, n=8): ORR of 75.0% (6/8), DCR of 100.0% (8/8); notably, the ORR reached 100.0% (4/4) in the PD-L1-negative subgroup. Data are as of the ASCO (Free ASCO Whitepaper) 2026 data cutoff and will be updated at ESMO (Free ESMO Whitepaper) 2026.
Robust Chemo-combo efficacy in the first-line mCRC, mostly proficient mismatch repair or microsatellite stable (pMMR/MSS):

First-line mCRC (with XELOX, n=6): ORR of 66.7% (4/6), DCR of 100.0% (6/6). Data as of 2026 ASCO (Free ASCO Whitepaper) cutoff, will be updated at ESMO (Free ESMO Whitepaper) 2026.
Promising monotherapy activity observed in metastatic castration-resistant prostate cancer (mCRPC), ovarian cancer, triple-negative breast cancer, gastric cancer, esophageal cancer, as well as STS and nccRCC.

– Upcoming two oral presentations of CS2009 at ESMO (Free ESMO Whitepaper) 2026

The clinical research results of CS2009 have been accepted for two Rapid Oral presentations at the 2026 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress. The presentations will feature Phase I/II clinical data of CS2009 in patients with advanced NSCLC and mCRC.

Other Clinical Stage Asset

CS5007, EGFR/HER3 ADC

– Global Phase I trial initiated in China and Australia

The Company initiated the Phase I first-in-human study in June 2026. This trial consists of dose-escalation and dose-expansion cohorts evaluating CS5007 as a monotherapy in patients with advanced solid tumors, and will be conducted concurrently in Australia and China. CStone presented preclinical data for CS5007 at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, further supporting its broad-spectrum anti-tumor potential.

Preclinical/IND-enabling Stage Programs

A balanced, differentiated early-stage portfolio spanning oncology and immunology/inflammation

CStone’s preclinical Pipeline 2.0 comprises innovative candidates across multispecific

antibodies, ADCs and other next-generation modalities, with potential first FIC or BIC opportunities spanning oncology, immunology, inflammation and other high-value therapeutic areas.

The Company’s proprietary ADC platform incorporates optimized linker technologies designed to enable tumor-selective payload release and supports multiple Pipeline 2.0 ADC candidates, including CS5007 (EGFR and HER3 bispecific ADC), CS5006 (ITGB4 ADC), CS5008 (DLL3 and SSTR2 bispecific ADC), etc. The Company is also exploring next-generation ADC technologies, including dual-payload ADCs (e.g., CS5009, a B7H3/PD-L1 bispecific dual-payload ADC, and CS5010, a HER2-targeting dual-payload ADC) and novel-payload ADCs (e.g., CS5012, a HER2-targeting novel-payload ADC). In April 2026, CStone presented preclinical data for CS5007, CS5006 and CS5008 at the 2026 AACR (Free AACR Whitepaper) Annual Meeting, highlighting the breadth and differentiation of its next-generation ADC pipeline.

Beyond oncology, CStone has expanded Pipeline 2.0 into immunology and inflammation by leveraging its proprietary multispecific antibody platform. The Company has developed CS2015 (OX40L/TSLP bispecific antibody) targeting Type 2 inflammatory diseases, CS2013 (BAFF/APRIL bispecific antibody) targeting B cell-mediated autoimmune diseases, CS2016 (TL1A/α4β7 bispecific antibody), and CS1016 (PD-1 agonist antibody).

Future and Outlook

Our mission is to deliver transformative therapies through scientific excellence and technological innovation, making high-quality treatments accessible worldwide to benefit patients and their families.

We reaffirm our commitment to advancing a robust and differentiated pipeline by prioritizing internal discovery capabilities and sustained R&D investments, while executing strategic partnerships to unlock the global value of our in-market products. Key catalysts for the second half of 2026 include:

Clinical milestones

Accelerate global development of CS2009 by advancing interactions with global regulatory authorities, including the U.S. FDA and the CDE of NMPA, on Phase III registrational trial design, with the first wave of global Phase III MRCTs planned to be initiated by the end of 2026, while continuing to pursue global partnerships.
Advance clinical development of CS5007 (EGFR/HER3 bispecific ADC), CS5006 (ITGB4 ADC), CS5008 (SSTR2/DLL3 ADC) and other early-stage candidates.
Innovation and technology

Further strengthen proprietary technology platforms, including multi-specific antibody and next-generation ADC technologies, to support sustained expansion of the preclinical pipeline.
Present key clinical data, including updated CS2009 data, at major international scientific conferences, including two Rapid Oral presentations of CS2009 Phase I/II data at the 2026 ESMO (Free ESMO Whitepaper) Congress.

(Press release, CStone Pharmaceauticals, AUG 31, 2026, View Source [SID1234670460])

GRAIL to Present at Morgan Stanley’s 24th Annual Global Healthcare Conference

On August 31, 2026 GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, reported that company management will present at the Morgan Stanley 24th Annual Global Healthcare Conference in New York on Monday, Sep. 14 at 11:30 a.m. ET.

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A live and replay webcast may be accessed in the investor relations section of GRAIL’s website at investors.grail.com. The webcast will be archived and available for reply for at least 30 days after the event.

(Press release, Grail, AUG 31, 2026, View Source [SID1234670459])