On May 27, 2026 Ori Biotech, a leader in cell and gene therapy (CGT) manufacturing technology, and ImmuXell Biotech, a Shanghai-based clinical-stage cell therapy company, reported their strategic partnership which began in December 2025. The milestone: the first patient has been dosed in an investigator initiated trial (IIT) using ImmuXell’s TCR-T cell therapy manufactured on Ori’s IRO platform.

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The IIT is aiming to evaluate ImmuXell’s TCR-T therapy in patients with solid tumors harboring KRAS G12V mutations, including those with colorectal cancer, pancreatic cancer, and lung cancer — all among the deadliest and most treatment-resistant cancers. This is a proof point that the IRO platform can take a therapy from process development to patient dosing with the speed, quality, and consistency that GMP manufacturing demands.

From platform installation to first patient dosed in four months, the Ori and ImmuXell teams working together have rapidly adapted and optimized ImmuXell’s proprietary manufacturing process on IRO, demonstrating the platform’s flexibility without sacrificing safety, efficacy or quality. The partnership includes IRO platform deployment at ImmuXell’s Shanghai facilities, with full scientific and technical support from Ori. The two companies plan to progress the current IIT and file an IND application in China to conduct a Phase 1 clinical trial later in 2026.

Jason C. Foster, CEO, Ori Biotech, said:

"This is the milestone we’ve been building toward for the last 7 years — IRO manufacturing a therapy for a patient who desperately needs it. Our platform was designed to eliminate the tradeoffs that have held back cell therapy: speed vs. quality, scale vs. cost, R&D vs. GMP. This partnership with ImmuXell demonstrates that IRO can deliver on all of them, in one of the world’s most important emerging biopharma markets, in the most intractable cancers, quickly and efficiently. We’re proud to be the manufacturing backbone for ImmuXell’s clinical ambitions, and we see this as the first step in a long and impactful collaboration."

Dr. HongMing Hu, Founder, ImmuXell Biotech, said:

"When you’re developing therapies for cancers with no good treatment options, speed to patients is everything. IRO let us move faster than we thought possible — adapting to our unique process, hitting our CQAs, and outperforming the flask and bag based manufacturing approach we had been using for years in just a few short months. Ori is the kind of partner that makes the impossible feel achievable. We look forward to bringing our TCR-T therapy to more patients in China this year and working together with Ori on our ex-vivo cell therapy pipeline."

This partnership marks Ori’s first collaboration in Asia Pacific and underscores the company’s rapid global momentum. IRO now counts 18 partners worldwide — including the recently announced partnership with AdAlta and Cell Therapies Pty in Australia as well as longstanding US partners Charles River Laboratories, CTMC, ElevateBio, and Kincell Bio, as well as other leading CDMOs and two Tier 1 pharma companies. Since its commercial launch in December 2024, IRO has been adopted across R&D, PD and now clinical settings. Ori expects the first INDs for IRO-manufactured products to be filed in late 2026.

(Press release, ImmuXell Biotech, MAY 27, 2026, View Source [SID1234666130])

On May 27, 2026 NUCLIDIUM AG, a clinical-stage radiopharmaceutical company, reported the closing of an oversubscribed CHF 26 million (EUR 28.4 million) Series B extension, bringing the Series B total raised to CHF 105 million (approximately EUR 115 million). The financing was led by existing investors Kurma Growth Opportunities Fund, Angelini Ventures, together with EIB co-investment facility Aurea, Wellington Partners and Neva SGR (Intesa Sanpaolo Group), with participation from DeepTech & Climate Fonds (DTCF), Bayern Kapital, Vives Partners, NRW.BANK, and additional existing investors.

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„Emerging data from our Phase 1/2 diagnostics studies continue to generate strong momentum for NUCLIDIUM’S true radiotheranostics approach. We will build on our programs‘ best-in-class potential by initiating Phase 1/2a therapeutic studies for NU-101 and NU-201 later this year, demonstrating our direct conversion strategy from diagnosis to treatment. The Series B extension and support from our world-class investors further validate our strategy to advance next-generation copper-based radiotheranostics and unlock the full potential of the theranostic modality," said Leila Jaafar, PhD, CEO and Co-Founder of NUCLIDIUM .

Proceeds from the Series B extension will accelerate and expand the clinical development of NUCLIDIUM’S lead theranostic programs, NU101 in metastatic castration resistant prostate cancer (mCRPC) and NU201 in metastatic breast cancer (mBC), into advanced clinical trials. The financing will also support the continued buildout of its worldwide production and manufacturing network for diagnostics and therapeutics and expand novel target development for its preclinical programs to bring radiotheranostics to novel solid tumor indications.

„Radiopharmaceuticals are one of the most compelling growth opportunities in oncology today. NUCLIDIUM has established clear differentiation with its copper-based radiotheranostic approach, demonstrating clinical superiority to competing radioligands and ease-of-use that supports seamless integration into hospital workflow. We are proud to support NUCLIDIUM through this new phase of growth as it advances its pipeline toward additional clinical proof-of-concept data," said Regina Hodits, PhD, Managing Director at Angelini Ventures , Daniel Parera, MD, Partner at Kurma Partners and Mario Costantini, CEO and General Manager at Neva SGR (Intesa Sanpaolo Group) for all participating investors.

The Series B financing transaction was advised by VISCHER AG as legal counsel.

(Press release, NUCLIDIUM, MAY 27, 2026, View Source [SID1234666099])

On May 27, 2026 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biotech company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for autoimmune diseases, solid tumors and hematological malignancies indications, reported that following review by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA), the company has received CDE endorsement to conduct the pivotal Phase III CLINCH-3 study of ATG-022, a Claudin 18.2 (CLDN18.2) antibody-drug conjugate (ADC), for the treatment of CLDN18.2+ advanced gastric or gastroesophageal junction adenocarcinoma. The study is expected to be initiated in China first and is planned as a multi-regional clinical trial (MRCT).

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"Receiving CDE endorsement to conduct the pivotal Phase III CLINCH-3 study represents a defining milestone for Antengene." said Dr. Jay Mei, Founder, Chairman and Chief Executive Officer of Antengene. "This achievement underscores Antengene’s fully integrated R&D capabilities, from the design and discovery of novel molecules to clinical translation and registrational development. The Breakthrough Therapy Designation previously granted by CDE provided an important basis for our regulatory discussions on this pivotal study and enabled efficient feedback from CDE. We are highly encouraged by the potential of ATG-022 to address the significant unmet medical needs of patients with CLDN18.2+ advanced gastric or gastroesophageal junction adenocarcinoma, and we look forward to working closely with investigators to advance this important study."

The CLINCH-3 study will be led by Prof. Lin Shen from Peking University Cancer Hospital as the principal investigator. This is a randomized, controlled, open-label, multicenter Phase III clinical study designed to evaluate the efficacy and safety of ATG-022 versus treatment of investigator’s choice in patients with CLDN18.2+ advanced gastric or gastroesophageal junction adenocarcinoma. As a pivotal registrational study, CLINCH-3 is intended to support a future marketing approval application for ATG-022 as monotherapy for the treatment of CLDN18.2+ advanced gastric or gastroesophageal junction adenocarcinoma. The primary endpoints of the study are progression-free survival as assessed by independent review committee (PFS by IRC) and overall survival (OS). Secondary endpoints include objective response rate (ORR), duration of response (DOR), disease control rate (DCR), safety, and other measures. The initiation of this pivotal study is supported by encouraging results from the Phase I/II CLINCH study, which showed that ATG-022, as monotherapy, demonstrated a differentiated efficacy and safety profile in patients with advanced gastric or gastroesophageal junction adenocarcinoma. As of December 25, 2025, among patients whose tumors had CLDN18.2 expression of IHC 2+ >20%, ATG-022 achieved ORRs of 46.7% and 40.0% at 1.8 mg/kg and 2.4 mg/kg, respectively, with corresponding DCRs of 86.7% and 90.0%. Median PFS (mPFS) was 6.97 months and 5.09 months, respectively, while median OS (mOS) was not yet reached in the 1.8 mg/kg cohort and was 14.72 months in the 2.4 mg/kg cohort. In the 1.8 mg/kg cohort, the incidence of Grade 3 or higher treatment-related adverse events (TRAEs) was 19.4%, highlighting a highly differentiated safety profile for an ADC. Together with its robust antitumor activity, encouraging survival outcomes and favorable tolerability, these data position ATG-022 as a potential best-in-disease therapy for gastric cancer or gastroesophageal junction adenocarcinoma.

"Advanced gastric and gastroesophageal junction adenocarcinoma remains one of the most difficult solid tumors to treat, and the challenge is particularly acute in the 3L setting, where current options, including chemotherapy, anti-angiogenic agents and immunotherapy, provide limited efficacy, low objective response rates and insufficient survival benefit," said Professor Lin Shen of Peking University Cancer Hospital, principal investigator of the CLINCH-3 study. "ATG-022 has shown a compelling clinical profile as monotherapy at 1.8 mg/kg, with strong anti-tumor activity, meaningful survival benefit and a favorable safety profile. The CDE endorsement to conduct this pivotal Phase III study represents an important step toward potentially transforming the treatment landscape for patients with CLDN18.2+ advanced gastric or gastroesophageal junction adenocarcinoma. I am pleased to lead CLINCH-3 and look forward to working with Antengene to bring this promising therapy to more patients."

Antengene will continue to advance a comprehensive clinical development strategy for ATG-022 across multiple settings, including its pivotal monotherapy study in advanced gastric or gastroesophageal junction adenocarcinoma, ongoing combination studies with anti-PD-1 therapy and chemotherapy in the 1L gastric cancer setting, and further exploration in other CLDN18.2+ solid tumors, including tumor types beyond the digestive system where encouraging efficacy signals with confirmed tumor responses, have been observed. Through this strategy, the company aims to maximize the clinical potential of ATG-022 and bring innovative, impactful therapies to patients in China and around the world.

(Press release, Antengene, MAY 27, 2026, View Source [SID1234666115])

On May 27, 2026 Palleon Pharmaceuticals, the first company to translate glycan editing science into clinical-stage therapeutics for immune modulation, reported the first patient has been dosed in a Phase 1 clinical trial of E-688/HLX316, a first-in-class B7-H3-targeted sialidase. The study is being conducted in China by strategic collaborator Shanghai Henlius Biotech in patients with tumors prone to B7-H3 overexpression and hypersialylation, with an initial focus on platinum-resistant ovarian cancer.

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This milestone marks the clinical translation of a fundamentally new mechanism — glycan editing for immune modulation — grounded in the pioneering glycobiology research of Nobel laureate Carolyn Bertozzi. Tumor hypersialylation, the upregulation of sialic acid-containing glycans on the surface of cancer cells, can suppress anti-tumor immunity by activating sialic acid-dependent immune regulatory pathways. This axis of immune evasion is present across many solid tumors and correlates with poor clinical outcomes in dozens of published studies.

"E-688/HLX316 is designed to enzymatically remove sialic acid from tumor cell surfaces at the site of B7-H3 overexpression, unmasking tumors to the immune system in a durable, mechanistically distinct way. This first-in-human trial is a critical step toward validating glycan editing for immune modulation as a new therapeutic paradigm across hypersialylated solid tumors," said Jim Broderick, M.D., Chief Executive Officer and Founder of Palleon. "The protocol includes a planned expansion into platinum-resistant ovarian cancer, where high B7-H3 expression and hypersialylation provide a compelling biological rationale for this approach."

About E-688/HLX316

E-688/HLX316 is generated from Palleon’s EAGLE (Enzyme-Antibody Glycan-Editing) platform and combines a human sialidase enzyme with a targeting arm directed at B7-H3, a tumor antigen broadly overexpressed across solid tumors and associated with aggressive disease biology and poor prognosis. By enzymatically removing sialic acid from tumor cell surfaces, E-688/HLX316 restores immune recognition through glycan-binding receptor pathways, disrupts the immunosuppressive tumor microenvironment, and is designed to generate durable anti-tumor immune responses — activating both innate and adaptive immunity through a mechanism distinct from existing checkpoint therapies.

In preclinical studies, E-688/HLX316 demonstrated tumor surface desialylation lasting more than seven days in vivo and showed improved anti-tumor activity relative to anti-PD-1 monotherapy in humanized tumor models.

Phase 1 Trial Design

The Phase 1 first-in-human trial will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics, and preliminary anti-tumor activity of E-688/HLX316 monotherapy, comprising a Phase 1a dose escalation in B7-H3+ advanced solid tumors and Phase 1b dose expansion in platinum-resistant ovarian cancer. Palleon and Henlius intend to expand the program into additional solid tumor indications characterized by high B7-H3 expression and hypersialylation.

(Press release, Palleon Pharmaceuticals, MAY 27, 2026, View Source [SID1234666131])

On May 27, 2026 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported that management will be participating in the following investor conferences in June:

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Jefferies Global Healthcare Conference – Participating in a fireside chat on Wednesday, June 3, 2026, at 11:40 a.m. ET. Management will also be participating in one-on-one meetings.
Goldman Sachs 47th Annual Global Healthcare Conference – Participating in a fireside chat on Tuesday, June 9, 2026, at 8:00 a.m. ET. Management will also be participating in one-on-one meetings.

Webcasts of the fireside chat discussions will be available through the investor section of the company’s website at www.oricpharma.com. Replays of the webcasts will be available for 90 days following the event.

(Press release, ORIC Pharmaceuticals, MAY 27, 2026, View Source [SID1234666100])