On June 10, 2025 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") reported that its TROP2-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT) in combination with the PD-L1 monoclonal antibody tagitanlimab was granted Breakthrough Therapy Designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China for the first-line treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) without actionable genomic alterations (Press release, Kelun, JUN 10, 2025, View Source [SID1234653797]). Breakthrough Therapy Designation is granted for treatment options that demonstrate significant clinical advantages over currently available treatments and is aimed at expediting the research, development and marketing of innovative treatment options that address clinically urgent medical needs. This designation is based on the efficacy and safety data from the non-squamous cohort of the Phase II OptiTROP-Lung01 study.

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This marks the fifth Breakthrough Therapy Designation granted to sac-TMT by the NMPA. Sac-TMT has previously received this designation for:

Locally advanced or metastatic triple-negative breast cancer (TNBC) in July 2022;
EGFR-mutant, locally advanced or metastatic NSCLC after progression on EGFR-TKI therapy in January 2023;
Locally advanced or metastatic hormone-receptor positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer (BC) in patients who have previously received at least two lines of systemic chemotherapy in June 2023；
First-line treatment of unresectable locally advanced, recurrent or metastatic PD-L1 negative TNBC in March 2024.
Results from a Phase 2 OptiTROP-Lung01 study of sac-TMT in combination with tagitanlimab in first-line advanced or metastatic non-squamous NSCLC patients were presented in a poster session at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting[1].

Dr. Michael Ge, CEO of Kelun-Biotech said, "This designation by the NMPA highlights the importance of developing novel therapeutic options for diverse NSCLC subtypes. Sac-TMT in combination with tagitanlimab demonstrated clinically meaningful outcomes in key endpoints for patients with non-squamous NSCLC without actionable genomic alterations as a first-line treatment. We are excited about the therapeutic potential of TROP2 ADC- immunotherapy combinations, and we look forward to working with regulatory authorities in China to bring this combination therapy to patients in need as soon as possible."

About sac-TMT
Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as NSCLC, BC, gastric cancer (GC), gynecological tumors, among others. Sac-TMT is developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells.

In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc., Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (includes Mainland China, Hong Kong, Macao, and Taiwan).

To date, two indications for sac-TMT have been approved and marketed in China for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting) and EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy. Sac-TMT became the first domestic ADC with global intellectual property rights to be fully approved for marketing. It is also the world’s first TROP2 ADC to be approved for marketing in a lung cancer indication. In addition, two new indication applications for sac-TMT for the treatment of adult patients with EGFR-mutant locally advanced or metastatic NSCLC who progressed after treatment with EGFR-TKI therapy and with unresectable locally advanced, metastatic HR+/HER2- BC who have received prior endocrine therapy and other systemic treatments in the advanced or metastatic setting were accepted by the CDE, and were included in the priority review and approval process. As of today, the Company has initiated 8 registrational clinical studies in China. MSD has initiated 14 ongoing Phase 3 global clinical studies of sac-TMT as a monotherapy or with pembrolizumab2 or other agents for several types of cancer. These studies are sponsored and led by MSD.

About Tagitanlimab
Tagitanlimab is the first PD-L1 mAb globally to receive authorization for the first-line treatment of NPC. Previously, the NMPA has approved the marketing in China of tagitanlimab used in combination with cisplatin and gemcitabine for the first-line treatment of patients with R/M NPC and monotherapy for the treatment of patients with recurrent or metastatic NPC who have failed after prior 2L+ chemotherapy, respectively.

On June 10, 2025 XL-protein GmbH, a pioneer in the area of biopolymers for pharmacokinetic optimization, reported that it has entered into a worldwide License, Development and Commercialization Agreement with Grifols, a global healthcare company and leading manufacturer of plasma-derived medicines, for a novel, long-acting biopharmaceutical product (Press release, XL-protein, JUN 10, 2025, View Source [SID1234653796]).

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Under this collaboration, XL-protein will leverage its proprietary, clinical-stage PASylation technology to extend the circulation of Grifols therapeutics, paving the way for a more effective and long-lasting treatment. XL-protein will actively support preclinical development activities while Grifols will be entitled to further developing as well as, manufacturing and marketing the PASylated-enhanced biologic.

Under the terms of the agreement, XL-protein will receive an upfront payment as well as payments for achievement of preclinical, clinical, regulatory and commercial milestones. Furthermore, XL-protein will receive tiered royalties on sales from marketed therapeutics resulting from the collaboration. Grifols will have worldwide exclusive marketing rights under the agreement. Further financial terms have not been disclosed.

"Grifols continues to innovate across its therapeutic portfolio to develop new treatments and enhancing existing ones for patients", said Dr. Jörg Schüttrumpf, Grifols Chief Scientific Innovation Officer. "We look forward to collaborating with XL-protein and combining our advanced scientific efforts in this leading initiative".

"We are excited to work with Grifols to enhance the pharmacological properties of their therapeutics", said Dr. Michaela Gebauer, Managing Director of XL-protein. "This partnership leverages the potential of our PASylation technology, together with other PASylated drugs currently under development, and creates added value for Grifols", commented Uli Binder, Managing Director of XL-protein.

On June 10, 2025 Quest Diagnostics (NYSE: DGX), a leading provider of diagnostic information services, reported a collaboration with The University of Texas MD Anderson Cancer Center (MD Anderson) designed to improve the assessment of elevated risk of cancer in individuals who would benefit from medically appropriate cancer screenings (Press release, Quest Diagnostics, JUN 10, 2025, View Source [SID1234653795]).

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Under terms of the agreement, Quest will develop and validate a laboratory-developed blood test based on circulating protein biomarkers associated with high risk for one or more cancers, including colorectal, lung, breast, pancreatic, ovarian, liver, prostate, esophageal and stomach. Quest will base the test on a developmental license to technology and intellectual property associated with the Multi-Cancer Stratification Test (MCaST), a cohesive risk model developed by the laboratory of Samir Hanash, M.D., Ph.D., at MD Anderson. Dr. Hanash and his team identified a set of biomarkers that inform the model through extensive clinical research conducted on screening study cohorts involving tens of thousands of individuals. Quest plans to refine and further develop and validate the MCaST technology for its own lab-developed test.

Assuming successful test validation, the parties may agree for Quest to exercise rights to commercialize the test, with the goal to make it available to providers in North America in 2026.

Quest expects the future test will supplement, not replace, conventional screening methods, by providing insights to help providers identify patients that would benefit from medically appropriate screening or other forms of evaluation. Conventional screening methods target a limited number of cancers and only one at a time, often with invasive or costly procedures that patients resist. While multi-cancer early detection (MCED) liquid biopsy tests that detect cancer DNA in circulating blood are convenient, they are comparatively expensive, not intended to personalize risk, and may lack well-established protocols for clinical follow-up.

Only 51% of U.S. adults say they have had a routine medical appointment or routine cancer screening in the last year.

"One of the biggest problems in cancer care today is patients skipping preventive screenings because the methods are too invasive, inconvenient or unaffordable," said Mark Gardner, senior vice president, Oncology, Genomics and R&D, Quest Diagnostics. "Another huge problem is a lack of tests for infrequent, but often deadly cancers, like pancreatic cancer. Building on proteomics discoveries from Dr. Hanash and his team, Quest intends to create a simple blood test anyone can conveniently access and reasonably afford to identify risk of a range of cancers. A patient identified with elevated risk may be more inclined to pursue preventive cancer screening or other medical assessments that could identify cancer in early, more treatable stages of disease."

On June 10, 2025 Philochem AG ("Philochem"), a wholly-owned subsidiary of the Philogen Group (MIL:PHIL), and RayzeBio, Inc. ("RayzeBio"), a wholly-owned subsidiary of Bristol-Myers Squibb company (NYSE: BMY), reported a definitive agreement under which Philochem will license the exclusive worldwide rights to develop, manufacture, and commercialise OncoACP3, a clinical stage therapeutic and diagnostic agent targeting prostate cancer, to RayzeBio (Press release, Philogen, JUN 10, 2025, View Source [SID1234653794]).

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OncoACP3 is a small molecule ligand with high affinity and specificity for Acid Phosphatase 3 (ACP3), a novel target in prostate cancer. The compound is currently under evaluation in a company-sponsored Phase I trial (NCT06840535). Initial data from the first cohort of patients evaluated with the OncoACP3 diagnostic has been promising, displaying selective tumour uptake and long residence time with minimal healthy tissue uptake. IND-enabling activities to support the application for a Phase I therapeutic study with 225Ac-OncoACP3 are ongoing.

Prof. Dr. Dario Neri, CEO and CSO of Philogen, commented: "We are delighted to enter into this new collaboration with RayzeBio, a leader in the field of radiopharmaceutical medicines. This partnership will focus on the development and commercialization of OncoACP3 for both diagnostic and therapeutic applications in prostate cancer. OncoACP3 is a best-in-class targeting agent with the potential to become a breakthrough treatment in this field. This collaboration reflects our shared commitment to translating scientific innovation into meaningful clinical solutions, making OncoACP3 therapies widely available to patients in need."

Ben Hickey, President, RayzeBio commented: "This collaboration with Philochem enhances our leadership in the rapidly advancing radiopharmaceuticals space, consistent with our strategy to bring forward best-in-class RPT candidates. OncoACP3, with its initial encouraging safety profile, provides a differentiated entry for Bristol Myers Squibb and RayzeBio into the prostate cancer arena, building on our leadership in actinium-based RPT development. This agreement is a significant milestone for RayzeBio and our goal to deliver radiopharmaceuticals to patients."

Under the terms of the agreement, Philochem will receive an up-front payment of $350m and up to $1.0bn in development, regulatory and commercial milestones. The company will also receive mid-single to low double-digit royalties payable on Global Net Sales of both Therapeutic and Diagnostic agents of OncoACP3.

The closing of the transaction is subject to regulatory approvals and other customary closing conditions. The parties expect that the agreement will close in the third quarter of 2025.

For Philochem, Centerview Partners UK LLP is acting as exclusive financial advisor and Cooley LLP is acting as exclusive legal counsel.

On June 10, 2025 PharmaMar (MSE:PHM) reported that the U.S Food and Drug Administration (FDA) has granted Priority Review for the supplemental New Drug Application (sNDA) for Zepzelca (lurbinectedin) in combination with atezolizumab (Tecentriq) as a first-line maintenance treatment for people with extensive-stage small cell lung cancer (ES-SCLC), following induction therapy with carboplatin, etoposide and atezolizumab (Press release, PharmaMar, JUN 10, 2025, View Sourcefda-grants-priority-review-for-zepzelca-lurbinectedin-and-atezolizumab-tecentriq-combination-in-extensive-stage-small-cell-lung-cancer/" target="_blank" title="View Sourcefda-grants-priority-review-for-zepzelca-lurbinectedin-and-atezolizumab-tecentriq-combination-in-extensive-stage-small-cell-lung-cancer/" rel="nofollow">View Source [SID1234653793]).

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The FDA’s Priority Review designation is assigned to applications for drugs that would offer a significant improvement in the safety or effectiveness of the treatment of a serious condition and means FDA’s goal is to take action on the NDA within six months (compared to ten months under standard review). The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of October 7, 2025.

Jazz Pharmaceuticals plc (Nasdaq: JAZZ), PharmaMar’s partner in the U.S., submitted the sNDA to the FDA in April based on data from the Phase 3 IMforte trial, which evaluated lurbinectedin plus atezolizumab as a first-line maintenance therapy in patients with ES-SCLC. 483 patients were randomized after completion of 4 cycles of induction therapy with atezolizumab plus carboplatin and etoposide. From the point of randomization, the median OS for the lurbinectedin plus atezolizumab regimen was 13.2 months versus 10.6 months for atezolizumab alone. From the point of randomization, the median PFS by independent assessment was 5.4 months versus 2.1 months, respectively.

Data from the trial served as the basis, also, for the recent submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) by PharmaMar.

PharmaMar informs that Slingshot will host a Key Opinion Leader webcast on June 12th at 17:00h CEST / 11:00 EDT to review the Phase 3 IMforte data for lurbinectedin + atezolizumab in extensive-stage small cell lung cancer, which were presented at ASCO (Free ASCO Whitepaper), as well as the treatment landscape. The webcast will include a discussion panel of Dr. Martin Wermke from TU Dresden and Dr. Nicolas Girard from Institut Curie. The webcast may be accessed from the Investors section at View Source