On December 19, 2024 PharmaMar (MSE: PHM) reported that the Phase III LAGOON clinical trial, which evaluates Zepzelca (lurbinectedin) for the treatment of patients with relapsed small cell lung cancer (SCLC), has achieved its recruitment target of 705 patients (Press release, PharmaMar, DEC 19, 2024, View Source [SID1234649219]).

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LAGOON is a randomized (1:1:1), multicenter, open-label Phase III clinical trial with three arms: in the first arm, patients receive lurbinectedin as monotherapy; in the second arm, lurbinectedin is administered in combination with irinotecan; and in the third arm, patients are treated with physician’s choice of topotecan or irinotecan. The study enrolled patients with SCLC whose disease has progressed after one prior line of platinum-based chemotherapy, with or without anti-PD-1 or anti-PD-L1 agents.

The primary objective of the trial is to evaluate overall survival (OS) and progression-free survival (PFS) is one of the secondary endpoints. Top-line results from the study are anticipated in the first quarter of 2026.

Lurbinectedin received accelerated approval from the FDA in June 2020 for the treatment of adult patients with metastatic SCLC whose disease has progressed during or after platinum-based chemotherapy. Since then, it has been approved in 17 territories, including recently in China, although in Europe it has only received approval in Switzerland.

Lurbinectedin is also being investigated in the Phase 3 IMforte clinical trial in combination with atezolizumab compared to atezolizumab alone when administered as a maintenance treatment for adults with extensive-stage small cell lung cancer (ES-SCLC) following induction therapy with carboplatin, etoposide and atezolizumab. As previously announced in October 2024 by Jazz Pharmaceuticals and PharmaMar, the preliminary results from the IMforte trial demonstrated a statistically significant improvement in the primary endpoints of OS and PFS, as assessed by an independent review facility (IRF), for the combination compared to treatment with atezolizumab alone.

SCLC accounts for 15% of all lung cancer diagnoses and is among the most aggressive cancer types. It is characterized by its rapid growth, invasive nature, and early metastasis. Approximately 70% of cases are diagnosed at advanced stages. While the disease often initially responds well to treatment, it tends to recur frequently.

On December 19, 2024 CStone Pharmaceuticals (stock code: 2616.HK), an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer drugs, reported that the first patient has been successfully enrolled in the global multi-center Phase 1b clinical trial of CS5001 (ROR1 ADC), a key product in its 2.0 pipeline (Press release, CStone Pharmaceauticals, DEC 19, 2024, View Source [SID1234656224]).

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To date, CS5001 has demonstrated a favorable safety profile and significant anti-tumor activity across 10 dose cohorts in a Phase 1a dose-escalation trial. CS5001 has been well-tolerated in patients with multiply pretreated advanced B-cell lymphoma and solid tumors, with no dose-limiting toxicities (DLTs) observed across all 10 dose cohorts. At the initially selected Phase II recommended dose (RP2D) of 125 μg/kg, CS5001 achieved ORRs of 70% and 100% in advanced B-cell non-Hodgkin’s lymphoma and Hodgkin’s lymphoma, respectively . Furthermore, significant efficacy signals have been observed in advanced solid tumors such as non-small cell lung cancer and pancreatic cancer.

Dr. Jianxin Yang, CEO, President of R&D, and Executive Director of CStone Pharmaceuticals, said, "This year, the clinical results of CS5001 have been presented at numerous international conferences and have garnered widespread attention within the industry. The latest clinical data demonstrate that CS5001 monotherapy achieves a higher ORR than competing agents in both aggressive and indolent advanced lymphomas, and the efficacy data have stabilized with increasing patient enrollment. Therefore, we believe CS5001 has the potential for accelerated registration and marketing, as well as the potential to impact the frontline combination therapy landscape . We are very pleased to see the initiation of a Phase 1b dose optimization and expansion trial of CS5001, which is expected to be further expanded into a Phase 2, single-arm, registration-enabling trial in relapsed or refractory diffuse large B-cell lymphoma (DLBCL) . Concurrently, we will continue to explore the safety and efficacy of CS5001 in Phase 1b, either as a monotherapy or in combination with frontline standard therapies, across a variety of hematologic malignancies and solid tumors, with the goal of bringing innovative therapies with even greater survival benefits to cancer patients worldwide."

About the CS5001 (ROR1 ADC)

CS5001 is an antibody-drug conjugate (ADC) targeting receptor tyrosine kinase-like orphan receptor 1 (ROR1). CS5001 features a unique design, utilizing a tumor-specifically activated pyrrolobenzodiazepine (PBD) protoxin payload and a linker. CS5001 is delivered only after tumor cell internalization. Within the lysosome, the linker is cleaved by a specific enzyme highly expressed in tumor cells, releasing the PBD protoxin, which is then activated and killed within the tumor cell. This "dual-control" mechanism of linker plus protoxin effectively mitigates the toxicity issues associated with traditional PBD payloads, resulting in a wider safety window. CS5001 has demonstrated complete tumor inhibition in several preclinical cancer models and exhibits favorable serum half-life and pharmacokinetic properties. All of this indicates that CS5001 has significant clinical development potential and broad application prospects in a variety of solid tumors and hematological malignancies. Furthermore, CS5001 utilizes directed conjugation technology to achieve a precise drug-antibody ratio (DAR), facilitating homogeneous production and large-scale production.

In October 2020, CStone Pharmaceuticals and LigaChem Biosciences, Inc. (LCB) entered into a licensing agreement for the development and commercialization of CS5001. CS5001 was originally synthesized by LCB and ABL bio, two leading Korean biotech companies. Under the terms of the agreement, CStone Pharmaceuticals obtained exclusive development and commercialization rights for CS5001 worldwide, excluding Korea.

Data from the first-in-human study of CS5001 in patients with advanced solid tumors and lymphomas were presented as a poster at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Furthermore, updated clinical data on CS5001 as a monotherapy for advanced lymphomas were recently presented at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.

On December 18, 2024 Inceptor Bio, a leading innovator in cell therapy, and GRIT Bio, a clinical-stage immunotherapy developer, reported a strategic partnership to advance IB-T101, a potentially best-in-class CAR-T therapy targeting solid tumors (Press release, Inceptor Bio, DEC 18, 2024, View Source [SID1234649204]).

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IB-T101, Inceptor Bio’s autologous CD70 CAR-T program, utilizes the proprietary OUTLAST platform to reprogram T cells for superior stemness, durability, and effector function in the hostile tumor microenvironment. The program targets clear cell Renal Cell Carcinoma (ccRCC), a cancer with significant unmet medical need and over 300,000 new cases annually worldwide.

"We are excited to partner with GRIT Bio to bring IB-T101 into the clinic and address the urgent need for effective solid tumor therapies," said Dr. Matthias Schroff, CEO of Inceptor Bio. "This collaboration highlights the potential of our proprietary OUTLAST platform, and the data generated will play a critical role in advancing the program as we strive to deliver best-in-class therapies for patients."

Dr. Mengyang Chong, Chief Business Officer of GRIT Bio, shared, "Partnering with Inceptor Bio allows us to bring a highly differentiated CAR-T program to patients. IB-T101 has the potential to transform the treatment landscape for solid tumors, and we are eager to contribute our expertise in clinical development and manufacturing to accelerate its progress."

Under the terms of the agreement, Inceptor Bio will grant GRIT Bio an exclusive license for IB-T101 in China. GRIT Bio will oversee development, manufacturing, and commercialization. Inceptor Bio is eligible to receive milestone payments and royalties upon IB-T101 achieving certain response criteria and plans to leverage clinical data from this collaboration to support regulatory submissions and development in other regions.

This partnership represents a critical step in Inceptor Bio’s mission to validate the OUTLAST platform as a best-in-class approach for engineered T cell therapies and bring transformative treatments to patients worldwide.

On December 18, 2024 Xcovery Holdings, Inc., an oncology focused pharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has approved ensartinib (Ensacove, Xcovery Holdings, Inc.) for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) (Press release, Xcovery, DEC 18, 2024, View Source [SID1234649205]). This approval marks an important advancement in providing a new first line option for patients with ALK-positive NSCLC.

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Ensartinib is an ALK tyrosine kinase inhibitor (TKI) designed to improve outcomes for patients with ALK-positive NSCLC. The FDA approval is based on data from the pivotal global Phase III eXalt3 clinical trial, in which ensartinib demonstrated statistically significant improvements in progression-free survival (PFS) over crizotinib.

"The approval of Ensartinib by FDA brings another new medicine to patients battling ALK-positive NSCLC, expanding the options to optimize treatment in the first-line setting. This result could not have been achieved without the dedication of our team members and the support of patients, physicians, and all stakeholders involved in the clinical development of Ensartinib," said Giovanni Selvaggi, Chief Medical Officer of Xcovery.

"FDA approval of Ensartinib represents a significant milestone in Xcovery’s mission to advance precision medicine for patients with cancer," said Kevin Sang, CEO of Xcovery. "In addition to Ensartinib, we are continuing our efforts in developing more pipeline targeted drugs for patients worldwide."

About Ensartinib

Ensartinib is a next generation ALK inhibitor jointly developed by Xcovery and Betta Pharmaceuticals. It is indicated for the treatment of adult patients with ALK-positive locally advanced or metastatic NSCLC.

On December 18, 2024 Iambic Therapeutics, a clinical-stage biotechnology company developing novel therapeutics using its unique AI-driven discovery platform, reported that Tom Miller, Ph.D., Iambic’s Chief Executive Officer and Co-Founder, will present at the 43rd Annual JP Morgan Healthcare Conference (Press release, Iambic Therapeutics, DEC 18, 2024, View Source [SID1234649206]). The presentation will take place on Tuesday, January 14th, at 5 p.m. PT at the Westin St. Francis Hotel in San Francisco.

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Dr. Miller will detail progress and anticipated milestones for Iambic’s emerging pipeline of development candidates, as well as advances to its AI drug discovery platform. The Company’s pipeline currently includes IAM1363, a highly selective, brain penetrant small molecule inhibitor of both wild-type and oncogenic HER2 mutants currently in a Phase 1/1b study, as well as a potential first-in-class selective dual CDK2/4 inhibitor for multiple cancer indications, an allosteric inhibitor for KIF18A, and additional new programs.