On June 16, 2026 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to zocilurtatug pelitecan (zoci, formerly ZL-1310), the Company’s potential first-in-class Delta-like ligand 3 (DLL3)-targeting antibody-drug conjugate (ADC), for the treatment of pulmonary neuroendocrine carcinomas (NECs).

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The designation follows a positive opinion from the EMA’s Committee for Orphan Medicinal Products (COMP), recognizing both the seriousness of neuroendocrine carcinomas and the need for new treatment options. Small cell lung cancer (SCLC) is the most significant pulmonary NEC, accounting for around 15% of the approximately 2.5 million patients diagnosed with lung cancer worldwide each year (an estimated 375,000 new cases annually), and is one of the most aggressive and lethal solid tumors. 1,2

In granting the designation, the COMP noted that preliminary clinical data in patients with relapsed or refractory extensive-stage SCLC suggest zoci may offer a more favorable effect than currently authorized therapies, including durable responses, a finding the Committee characterized as a clinically relevant advantage.

The U.S. FDA previously granted Fast Track designation (FTD) and ODD to zoci for SCLC. The FDA also recently granted FTD to zoci for extrapulmonary NECs (epNECs).

"This important designation from the EMA supports zoci’s potential to become a first-in-class therapy for pulmonary neuroendocrine carcinomas," said Rafael G. Amado, M.D., President, Head of Global Research and Development at Zai Lab. "This milestone is another demonstration of Zai Lab’s commitment to address critical unmet needs for patients with limited treatment options."

The EMA’s ODD provides important regulatory and development incentives, including potential market exclusivity following approval, reduced development fees, and enhanced development efficiency, which may help streamline clinical development.

About Zocilurtatug Pelitecan (Zoci, ZL-1310)

Zoci targets Delta-like ligand 3 (DLL3), a validated therapeutic target that is overexpressed in many neuroendocrine carcinomas, such as small cell lung cancer (SCLC) and extrapulmonary neuroendocrine carcinomas (epNECs), and is generally associated with poor clinical outcomes. Zoci is on track to potentially become Zai Lab’s first global oncology launch, with plans for three registration-enabling studies across second- and third-line SCLC, first-line SCLC, and epNECs by the end of 2026. Its potential best-in-class safety profile, coupled with compelling systemic and intracranial efficacy, supports its potential role as a new standard of care in previously treated extensive stage SCLC, as well as a backbone DLL3-targeting antibody-drug conjugate (ADC) in first line combination regimens, including those that reduce the burdens of chemotherapy, such as check point inhibitors and T-cell engagers.

(Press release, Zai Laboratory, JUN 16, 2026, View Source [SID1234668766])

On June 16, 2026 Silexion Therapeutics Corp. ("Silexion" or the "Company"), a clinical-stage biotechnology company pioneering RNA interference (RNAi) therapies for KRAS-driven cancers, reported that Company management, including the Company’s Chief Executive Officer, Ilan Hadar, and the Company’s Chief Financial Officer, Mirit Horenshtein-Hadar, will attend the 2026 BIO International Convention, taking place on June 22-25 in San Diego, CA.  

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Silexion’s management will host one-on-one meetings during the BIO Convention. Interested parties should contact Silexion company representative to arrange a meeting.

(Press release, Silexion Therapeutics, JUN 16, 2026, View Source [SID1234668767])

On June 16, 2026 NeOnc Technologies Holdings, Inc. (Nasdaq: NTHI) ("NeOnc" or the "Company"), a clinical-stage biopharmaceutical company developing novel therapies for central nervous system (CNS) cancers, reported that the Department of Health – Abu Dhabi (DOH) has granted Investigational New Drug (IND) status for NEO212, the Company’s orally administered perillyl alcohol-temozolomide carbamate conjugate being developed for patients with aggressive brain tumors. The authorization marks the first international regulatory clearance for NEO212 following completion of Phase 1 clinical evaluation and represents a significant step toward expanding the program into multiple global markets.

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NEO212 recently completed the Phase 1 dose-escalation portion of its Phase 1/2 study, which established 610 mg as the recommended Phase 2 dose. In that study, the Company reported encouraging early signs of clinical activity, including potential durable disease stabilization, in heavily pretreated patients with recurrent glioblastoma (GBM) and brain metastases. NeOnc expects this authorization to support the advancement of NEO212 into Phase 2 clinical development while continuing discussions with the U.S. Food and Drug Administration regarding the design of a potential registrational pathway. The Company believes parallel regulatory and clinical activities across multiple jurisdictions may accelerate the overall development strategy for NEO212.

Under the terms of the DOH authorization, NeOnc must satisfy a number of conditions before patient enrollment in the UAE, including separate approval from the DOH Institutional Review Board (IRB) and amendments to the study protocol, investigator’s brochure, and product labeling. The DOH clearance applies to the conduct of clinical research and does not constitute marketing authorization.

The Company has also submitted applications to the Department of Health – Abu Dhabi for its NEO100 clinical programs, including NEO100-01, NEO100-02, and NEO100-03, and is currently awaiting regulatory decisions. If approved, these programs would further expand NeOnc’s clinical development footprint in the UAE and support the Company’s strategy of advancing multiple brain cancer and neurological therapeutic programs in parallel across key international markets.

"This clearance represents an important international milestone for NeOnc and for the NEO212 program," said Amir Heshmatpour, Chief Executive Officer, Executive Chairman and President of NeOnc. "Brain cancers such as glioblastoma remain among the most difficult diseases in oncology, and patients urgently need new treatment options. We are grateful to the Department of Health – Abu Dhabi for its rigorous and collaborative review, and we look forward to working with investigators and healthcare institutions in the UAE as we advance NEO212 toward Phase 2 development."

Glioblastoma remains one of the deadliest forms of cancer, with limited treatment options and poor long-term survival outcomes. NEO212 is designed to combine the chemotherapeutic temozolomide with perillyl alcohol in a single orally administered conjugate intended to improve delivery across the blood-brain barrier. The Company expects to work with healthcare institutions, investigators, and regulatory authorities in the UAE as clinical development activities advance.

(Press release, Neonc, JUN 16, 2026, View Source [SID1234668768])

On June 16, 2026 Syncromune, Inc., a privately held clinical-stage biopharmaceutical company developing SYNC-T, an investigational in situ multi-target immunotherapy platform for solid tumors, reported that Executive Chairman and Chief Innovation Officer Charles Link, M.D., presented and served as a panelist at the inaugural Intratumoral Immunotherapy Symposium 2026. The event was hosted by Gustave Roussy in partnership with MD Anderson Cancer Center on June 11–12, 2026, in Villejuif, Paris, France.

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Dr. Link’s presentation highlighted the growing need for a multi-modal, immune-aware framework to better assess efficacy in intratumoral immunotherapy. He addressed a key challenge in the field: while these therapies are delivered locally, they are designed to elicit systemic anti-tumor responses. Importantly, this often manifests as an abscopal effect observed both with ipsilateral and contra-lateral cancer regression distally. Conventional response criteria alone often fail to fully capture their activity due to delayed or non-linear response patterns and inflammatory changes that can mimic disease progression. His talk emphasized the value of integrating complementary readouts from imaging and other clinical measures to provide a more comprehensive evaluation of treatment effects over time.

"It was an honor to be invited to present at the inaugural Gustave Roussy Intratumoral Immunotherapy Symposium, which brought together many of the world leaders helping define this emerging field," said Charles Link, M.D., Executive Chairman and Chief Innovation Officer of Syncromune, and Adjunct Professor at the Lankenau Institute for Medical Research. "Intratumoral immunotherapies hold significant promise, as they are designed to generate potent systemic anti-tumor activity while potentially limiting systemic drug exposure and toxicity. The local delivery approach with systemic therapeutic intent also requires a more dynamic, immune-aware paradigm for assessing efficacy. We believe the framework presented at the symposium will help support the clinical development and broader adoption of intratumoral immunotherapy for patients who need it most."

Dr. Link also participated in the panel discussion on "Cross-Sector Collaboration," which brought together leaders from academia, biotechnology, interventional oncology, and regulatory science to explore how strategic partnerships can accelerate the development, clinical translation, and adoption of intratumoral immunotherapies.

The two-day international symposium was the first event fully dedicated to intratumoral immunotherapy. The program featured discussions on next-generation agents, image-guided and minimally invasive delivery technologies, patient and lesion selection based on tumor biology and imaging, response monitoring using CT, MRI, bone scans, PSMA PET, and other biomarkers, lessons from late-stage trials, regulatory considerations, and best practices in trial design. A central focus was fostering cross-sector dialogue to advance the field.

"Our experience in metastatic prostate cancer has underscored the importance of evaluating intratumoral immunotherapies in a way that reflects the unique biology and response kinetics of this therapeutic approach," said Stephen Dale, M.D., Chief Medical Officer of Syncromune. "The insights generated from our Phase 1 study are already helping inform assessment strategies in our ongoing LEGION-100 trial, and we believe this type of translational learning will be critical to advancing the field."

(Press release, Syncromune, JUN 16, 2026, View Source [SID1234668769])

On June 16, 2026 Calidi Biotherapeutics, Inc. (NYSE American: CLDI) ("Calidi" or "the Company"), a biotechnology company pioneering the development of targeted genetic medicines, reported that it has received pre-IND regulatory feedback from the U.S. Food and Drug Administration (FDA) providing alignment and clarity on Calidi’s IND-enabling preclinical plans and clinical strategy for CLD-401 prior to advancing the drug candidate into Phase 1 clinical studies.

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"We thank the FDA for its regulatory feedback, and we believe we are in agreement with the agency on our overall IND strategy for CLD-401," said Calidi Biotherapeutics Chief Executive Officer Eric Poma, Ph.D. "We look forward to our regulatory submission for CLD-401, a potentially ground-breaking oncolytic virus with in situ delivery of an IL-15 superagonist, which we are targeting by year-end. This positions us to initiate our first-in-human clinical trial in early 2027."

In the pre-IND meeting, the FDA and Calidi agreed on key aspects of the CMC and non-clinical programs as well as feedback on the overall design for the proposed first-in-human clinical study. This pre-IND (Type B) interaction builds on the engagement and alignment achieved through early scientific advice as part of a Type D interaction with the FDA.

Calidi is committed to rapidly advancing CLD-401 into the clinic, believing that early Phase I data for CLD-401 will validate the Company’s proprietary RedTail platform. The Company continues to expand the functionality of the RedTail platform while actively pursuing strategic partnerships to accelerate clinical development and broaden its impact.

(Press release, Calidi Biotherapeutics, JUN 16, 2026, View Source [SID1234668770])