On April 9, 2026 Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" or the "Company," Stock Code: 9887.HK) reported that its proprietary PD-L1/4-1BB bispecific antibody, Opamtistomig (LBL-024), has successfully completed the safety run-in stage of a Phase II clinical trial in the first-line treatment of advanced biliary tract cancer (BTC). Based on favorable safety and encouraging preliminary efficacy data, the study has progressed into the expansion phase, with the first patient already enrolled.

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The study is led by Dr. Jian Zhou from Zhongshan Hospital, Fudan University, and is being conducted across multiple clinical sites in China. A total of 20 patients were included in the safety run-in cohort and completed preliminary evaluation. Results demonstrated that Opamtistomig in combination with chemotherapy was generally well tolerated, with a favorable safety profile and no new safety signals observed. Preliminary efficacy assessments indicated encouraging tumor reduction trends. Based on these results, the study has advanced to the expansion phase with accelerated enrollment underway.

Opamtistomig is a uniquely engineered bispecific antibody designed to simultaneously block PD-1/L1-mediated immune suppression and selectively activate the 4-1BB co-stimulatory pathway. By restoring T-cell functionality and expanding effector T-cell populations within the tumor microenvironment, Opamtistomig has the potential to deliver more potent and durable anti-tumor activity than PD-1/PD-L1 blockade alone, particularly in difficult-to-treat and immunotherapy-resistant tumors. To date, Opamtistomig has demonstrated first- or best-in-class potential in Phase II or registrational clinical trials across three indications: non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and extrapulmonary neuroendocrine carcinoma (EP-NEC).

Executive Commentary
Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, commented: "Based on favorable safety and encouraging efficacy signals from the safety run-in cohort, Opamtistomig has advanced into the expansion phase of the Phase II BTC study, with strong support from investigators unanimously. This represents an important milestone for the program and reinforces our confidence in its clinical potential. As additional efficacy data mature, we plan to initiate a confirmatory study, leveraging our extensive clinical network to accelerate development and bring a differentiated immunotherapy option to patients with advanced biliary tract cancer as early as possible."

About Biliary Tract Cancer
Biliary tract malignancies primarily include gallbladder cancer and intrahepatic/extrahepatic cholangiocarcinoma, with approximately 419,100 new cases globally in 2024. These malignancies are predominantly ‌adenocarcinomas‌ with high invasiveness, and most cases are diagnosed at advanced stages, leading to ‌poor prognosis‌ (5-year survival rate <5%)‌. Currently, global incidence of biliary tract malignancies is rising, with the highest prevalence observed in Asian countries.

Although ‌PD-1/L1 inhibitors combined with chemotherapy‌ have been approved as first-line treatment for advanced biliary tract malignancies, clinical benefits remain limited: ‌Modest improvement in median overall survival (OS)‌ (from ~11.5 to 12.8 months)‌ and ‌Low objective response rate (ORR)‌ (<30%)‌. These gaps highlight ‌unmet medical needs‌ for more effective therapies‌.

About Opamtistomig (LBL-024)
Opamtistomig (LBL-024) is a potential first-in-class bispecific antibody that simultaneously targets PD-L1 and the co-stimulatory receptor 4-1BB. It is the first 4-1BB–targeting bispecific antibody globally to advance to a single-arm pivotal trial as monotherapy, and it holds promise to become the first approved therapy specifically for extrapulmonary neuroendocrine carcinoma (EP-NEC)—a rare malignancy with substantial unmet clinical need.

Developed using Leads Biolabs’ proprietary X-Body bispecific platform, Opamtistomig features a 2:2 molecular format, incorporating two binding domains each for PD-L1 and 4-1BB with an optimized affinity ratio. This unique design enables dual functionality: reversing PD-L1–mediated immune suppression while selectively enhancing T-cell activation, resulting in a potent and synergistic anti-tumor immune response.

In two ongoing clinical studies in China, Opamtistomig has demonstrated promising efficacy and a favorable safety profile in patients with advanced EP-NEC, both as monotherapy and in combination with chemotherapy. Given the absence of a globally accepted standard of care for EP-NEC, these results support the advancement of a single-arm pivotal study toward potential accelerated approval.

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.

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. Beyond EP-NEC, Opamtistomig has received clinical trial approvals across multiple tumor types with high unmet medical needs, including small cell lung cancer (SCLC), biliary tract cancer (BTC), ovarian cancer (OC), non-small cell lung cancer (NSCLC), esophageal squamous cell carcinoma (ESCC), hepatocellular carcinoma (HCC), gastric cancer (GC), triple-negative breast cancer (TNBC), and malignant melanoma. Encouraging clinical activity has already been observed in NSCLC, SCLC, BTC, OC, and other indications, underscoring Opamtistomig’s potential as a broad-spectrum immuno-oncology therapy.

(Press release, Nanjing Leads Biolabs, APR 9, 2026, View Source [SID1234664288])

On April 9, 2026 Kainova Therapeutics ("the Company"), a key player for breakthrough treatments in immuno-oncology and inflammation, reported dosing of the first patient in the European expansion of its DOMISOL Phase I/II clinical trial evaluating DT‑7012, a proprietary Treg‑depleting anti‑CCR8 monoclonal antibody, in patients with advanced solid tumors.

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This dosing follows the initiation of the DOMISOL Phase I/II study in Australia, announced in October 2025, marking a significant milestone in the global clinical development of DT-7012, Kainova Therapeutics’ lead immuno-oncology program. The European expansion (NCT06819735) includes leading oncology centers in France, led by renowned early-phase clinical investigators, including Dr Lauriane Eberst at Hôpitaux Universitaires de Strasbourg, Professor Antoine Italiano at Institut Gustave Roussy in Paris, and Dr Maxime Brunet at Institut Bergonié Bordeaux.

Professor Antoine Italiano, MD PhD, Head of Precision Medicine at Institut Gustave Roussy and member of Kainova Therapeutics’ Scientific Advisory Board, said: "This study brings together strong clinical expertise and advanced translational capabilities, creating an important opportunity to explore how targeted Treg depletion may translate into meaningful benefit for patients with advanced solid tumors. DT‑7012 offers a novel, differentiated approach to precisely address CCR8 biology and reshape the tumor microenvironment."

Dr Jean‑Marie Cuillerot, Chief Medical Officer of Kainova Therapeutics, commented: "Dosing of the first patient in Europe marks an important step in the clinical maturation of our flagship program, DT‑7012. The DOMISOL study has been designed to generate a comprehensive clinical and biological profile for DT‑7012 across both monotherapy and combination settings, including paired biopsies to directly assess the intra tumoral Treg depletion. These data will be essential to inform dose selection and support the next phases of development."

The Phase I/II multicenter, open‑label DOMISOL clinical study is evaluating DT‑7012 as monotherapy in a Phase I dose-escalation, in combination with the immune checkpoint inhibitor pembrolizumab in a Phase Ib dose-escalation in patients with advanced solid tumors, and in selected tumor types in a Phase II component focused on clinical efficacy. The primary objectives include determining the maximum tolerated dose (MTD) or maximum administered dose (MAD) of DT‑7012 as monotherapy and assessing the safety and tolerability of DT‑7012 in combination with pembrolizumab.

The study also includes a translational research program with paired tumor biopsies to evaluate intratumoral Treg depletion induced by DT‑7012, providing a direct demonstration of DT-7012’s mechanism of action to turn the immunosuppressive tumor microenvironment into an immunocompetent one.

Sean A. MacDonald, Chief Executive Officer of Kainova Therapeutics, added: "As our flagship program, DT‑7012 is central to Kainova Therapeutics’ strategy and reflects our commitment to advancing breakthrough GPCR‑modulating therapies in immuno‑oncology and inflammation. With multiple high‑value milestones ahead, 2026 is a pivotal year for Kainova Therapeutics. We are excited to expand the DOMISOL trial into Europe and we look forward to sharing compelling data in the coming quarters."

(Press release, Kainova Therapeutics, APR 9, 2026, View Source [SID1234664287])

On April 9, 2026 Kymera Therapeutics, Inc. (NASDAQ: KYMR) reported that Gilead Sciences, Inc. has exercised its option to exclusively license KT-200, a first-in-class, oral CDK2 molecular glue degrader development candidate discovered and characterized by Kymera, under their strategic collaboration agreement. As a result, Kymera will realize a $45 million milestone payment. Gilead will progress the program into IND-enabling studies to support an IND filing in 2027.

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"We are excited to have reached this key milestone in our strategic collaboration with Gilead, underscoring our commitment to advancing a new generation of medicines for patients through our innovative discovery engine," said Nello Mainolfi, PhD, Founder, President and CEO, Kymera Therapeutics. "KT-200 is expected to be the first molecular glue discovered by Kymera to enter the clinic, reflecting the company’s ability to apply our discovery capabilities to some of the most challenging disease-causing targets. KT-200’s compelling preclinical profile demonstrates its potential to transform the therapeutic landscape for patients with cancers that remain difficult to treat."

CDK2-directed molecular glue degraders represent a novel therapeutic approach designed to selectively remove CDK2, a key driver of tumor growth, rather than just inhibiting its function whilst sparing other CDK family proteins. CDK2 acts as a cyclin E binding partner and drives disease in CCNE1 amplified and over expressed cancers. Traditional CDK2 inhibitors can lack specificity and interfere with closely related proteins, leading to undesired side effects. Degraders have the potential to provide more precise, safe, effective, oral treatments for cancers that rely on CDK2 activity, with the potential to meaningfully improve outcomes for patients, including those with advanced breast cancer where treatment options remain limited.

In preclinical testing, KT-200 demonstrated low-nanomolar degradation of CDK2, robust activity in CCNE1 amplified, overexpressed cell lines and in vivo tumor models, brain penetrant potential, and a favorable safety profile.

Under the terms of the agreement, Kymera is eligible to receive up to $750 million in total payments. To date, Kymera has realized $85 million in upfront and option exercise payments. In addition, Kymera may also receive tiered royalties ranging from high single-digit to mid-teens on net product sales under the collaboration. Gilead has global rights to develop, manufacture and commercialize all products resulting from the collaboration.

(Press release, Kymera Therapeutics, APR 9, 2026, View Source [SID1234664286])

On April 9, 2026 Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") reported that the United States (U.S.) Food and Drug Administration (FDA) has accepted the Company’s resubmitted New Drug Application (NDA) for TLX101-Px1, (Pixclara2, Floretyrosine F 18 or 18F-FET), an investigational PET3 agent for the imaging of glioma (brain cancer), and has assigned a PDUFA4 goal date of September 11, 2026.

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The approval of TLX101-Px will fulfil a significant unmet medical need for the characterization of recurrent or progressive glioma from treatment related changes in both adult and pediatric patients5. Neuroimaging of glioma with 18F-FET is already broadly recommended in international clinical practice guidelines – including NCCN Guidelines6 – and TLX101-Px has been granted Orphan Drug7 and Fast Track8 designations by the FDA.

"There remains a critical unmet need in improving our ability to image residual glioma after treatment," said Thomas Hope, MD, Vice Chair, Department of Radiology and Biomedical Imaging, University of California, San Francisco (UCSF). "We have worked with Telix for the last three years to help leverage our clinical data to help make FET-PET9 available to patients in the United States."

Patrick Wen, MD, E. Antonio Chiocca, MD, PhD, Family Endowed Chair in Neuro-Oncology at Mass General Brigham Cancer Institute, added, "Distinguishing tumor progression from treatment-related change remains one of the most challenging aspects of glioma care. PET imaging with 18F-FET is an important tool in clinical practice worldwide, and the FDA’s acceptance of this application is a meaningful step toward broader access for patients and clinicians in the United States."

Kevin Richardson, CEO, Telix Precision Medicine, added, "The FDA’s acceptance of our NDA resubmission is an important milestone for Telix. We appreciate the FDA’s constructive engagement and look forward to working closely with the Agency to urgently obtain approval and then bring this product to market for the benefit of patients."

Telix’s FY 2026 financial guidance does not include any revenue contribution from TLX101-Px.

About TLX101-Px

TLX101-Px is a PET imaging candidate, which has been granted Fast Track and Orphan Drug designations by the FDA for the characterization of recurrent or progressive glioma from treatment related changes. TLX101-Px targets membrane transport proteins known as L-type amino acid transporters 1 and 2 (LAT1 and LAT2). This enables TLX101-Px to be potentially utilized as a patient selection and response assessment tool for Telix’s LAT1-targeting therapy candidate TLX101-Tx (iodofalan 131I), currently under investigation in the pivotal IPAX-BrIGHT trial in patients with recurrent glioblastoma10. TLX101-Px and TLX101-Tx have not received marketing authorizations in any jurisdiction.

About gliomas

Gliomas are diffusely infiltrative tumors that affect the surrounding brain tissue. They are the most common form of central nervous system (CNS) cancer that originates from glial cells, accounting for approximately 30% of all brain and CNS tumors and 80% of all malignant brain tumors11. In the U.S., there are approximately 24,000 new glioma cases diagnosed annually12. Glioblastoma (GBM) is a high-grade glioma and the most common and aggressive form of primary brain cancer. The mainstay of treatment for GBM comprises surgical resection, followed by combined radiotherapy and chemotherapy. Despite such treatment, recurrence occurs in almost all patients13, with an expected survival duration of 12-15 months from diagnosis.

(Press release, Telix Pharmaceuticals, APR 9, 2026, View Source [SID1234664285])

On April 9, 2026 Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine, reported an expanded, multi-year collaboration with Gilead Sciences, Inc. (Nasdaq: GILD) aimed at building and advancing Gilead’s oncology pipeline.

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To date, Gilead has leveraged Tempus’ extensive repository of de-identified multimodal data to inform a range of oncology R&D initiatives, including trial design, indication selection, biomarker strategy, health outcomes analysis and clinical real world evidence. The expanded agreement provides Gilead with enterprise-wide access to Tempus’ AI-driven Lens platform, unlocking access to broader datasets across multiple indications and integrating dedicated Tempus analytical services.

"We are excited to announce this expanded partnership with Tempus that reflects our shared priority of putting patients at the heart of innovation," said Patrick Loerch, SVP of Clinical Data Science at Gilead Sciences. "By combining Gilead’s scientific expertise with Tempus’ real world data insights in oncology, we aim to maximize generation of key insights to help inform clinical decision making and ultimately improve care for cancer patients."

"By providing access to the Tempus multimodal data library, we are empowering the Gilead team to further fuel its R&D engine with AI-driven insights," said Ryan Fukushima, CEO of Tempus Data & Apps. "We are thrilled to expand this collaboration, offering the multimodal depth necessary to uncover critical biological insights. This approach helps navigate billions of data points to find the ‘signal in the noise,’ ultimately increasing the probability of success for life-altering medicines."

(Press release, Tempus, APR 9, 2026, View Source [SID1234664284])