CARsgen Therapeutics Introduced Zhuhai SB Xinchuang to Accelerate Allogeneic CAR-T Cell Products Development in Mainland China

On February 25, 2025 CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK, "CARsgen Therapeutics"), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, reported reaching agreements with an investment fund managed by Zhuhai Hengqin SB Xinchuang Equity Investment Management Enterprise (Limited Partnership) ("Zhuhai SB Xinchuang") to jointly invest in UCARsgen Biotech Limited ("UCARsgen"), a China-based new drug discovery biotechnology company focused on allogeneic CAR-T cell therapies for the treatment of hematologic malignancies (Press release, Carsgen Therapeutics, FEB 25, 2025, View Source [SID1234650563]).

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Under the agreements, UCARsgen has secured the exclusive rights in mainland China for the research, development, manufacture, and commercialization of the following allogeneic CAR-T products from CARsgen Therapeutics: the BCMA-targeted allogeneic CAR-T cell therapy for the treatment of multiple myeloma and plasma cell leukemia and the CD19/CD20 dual-targeted allogeneic CAR-T cell therapy for the treatment of B-cell malignancies. An investment fund managed by Zhuhai SB Xinchuang (currently undergoing registration and filing procedures) subscribed to the newly increased registered capital of UCARsgen for a consideration of RMB 80,000,000, thus retaining an 8% equity stake in the registered capital of UCARsgen upon completion of the transaction, equity stake of CARsgen Therapeutics in UCARsgen will be diluted from 100% to 92%.

AKTIS ONCOLOGY TO PARTICIPATE IN THE 45th ANNUAL TD COWEN HEALTH CARE CONFERENCE

On February 25, 2025 Aktis Oncology, an oncology company focused on unlocking the breakthrough potential of targeted radiopharmaceuticals for large patient populations not addressed by existing platform technologies, reported that Matthew Roden, Ph.D., President and Chief Executive Officer of Aktis Oncology, will participate in investor meetings at the 45th Annual TD Cowen Health Care Conference in Boston, Mass. on Tuesday, March 4, 2025 (Press release, Aktis Oncology, FEB 25, 2025, View Source [SID1234650562]).

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Kangpu Biopharmaceuticals Received IND Approval from NMPA for KPG-818 to Treat Relapsed/Refractory Multiple Myeloma

On February 25, 2025 Kangpu Biopharmaceuticals, Ltd. ("Kangpu") reported that the Company has received IND approval from the CDE (Center for Drug Evaluation) of China National Medical Products Administration (NMPA) for KPG-818 for the treatment of relapsed/refractory multiple myeloma (RRMM) (Press release, Kangpu Biopharmaceuticals, FEB 25, 2025, View Source [SID1234650561]).

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KPG-818 is a novel oral molecular glue modulator of the E3 ubiquitin ligase complex CRL4-CRBN. It demonstrated high cereblon (CRBN) binding affinity and potent degradation of Aiolos (IKZF3) and Ikaros (IKZF1), two members of the Ikaros family of zinc-finger transcription factors associated with B-cell development. KPG-818 possesses immunomodulatory, anti-angiogenic, and anti-tumor effects.

The Phase I clinical trial of KPG-818 in the United States for the treatment of various hematological tumors has been completed. Preliminary results indicate that in RRMM patients who have previously received two immunomodulatory drugs (lenalidomide and pomalidomide), at least one proteasome inhibitor (bortezomib, ixazomib, or carfilzomib), and a CD38 monoclonal antibody (daratumumab or isatuximab), KPG-818 demonstrated good safety, tolerability, pharmacokinetic characteristics, and encouraging therapeutic effects.

WuXi XDC and LigaChem Biosciences Strengthen Partnership with Expanded MOU to Accelerate ADC Development

On February 25, 2025 WuXi XDC Cayman Inc. ("WuXi XDC", or the "Company", stock code: 2268.HK), a leading global CRDMO (Contract Research, Development, and Manufacturing Organization) specializing in antibody-drug conjugates (ADCs) and other bioconjugates, reported the signing of an expanded Memorandum of Understanding (MOU) with LigaChem Biosciences, Inc., a leader in the development of innovative ADC therapies targeting cancer and other serious diseases (Press release, LigaChem Biosciences, FEB 25, 2025, View Source [SID1234650560]). This new agreement broadens the scope of the ongoing collaboration, further accelerating the development of next generation innovative ADC therapies.

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Under the terms of the expanded MOU, WuXi XDC’s fully integrated ADC discovery service platform will significantly boost the speed and efficiency of LigaChem’s ADC development programs. With WuXi XDC’s cutting-edge technologies and extensive expertise, LigaChem will be well-positioned to seamlessly advance its ADC candidates from discovery through to development stages, ensuring a more streamlined and efficient process at every stage.

Furthermore, LigaChem will utilize WuXi XDC’s fully integrated ADC development and manufacturing platform to support multiple ADC projects. This strategic expansion of the partnership strengthens both companies’ shared mission to develop and deliver innovative ADC therapies that address critical unmet patients needs.

"We are excited to expand our partnership with WuXi XDC," stated Dr. Yong-Zu Kim, CEO and President of LCB, " WuXi XDC’s expertise and comprehensive service offerings are crucial to the success of our ADC programs. This expanded partnership enables us to leverage their end-to-end capabilities, accelerating the development of next-generation ADC therapies to address the needs of patients."

Dr.Jimmy Li, CEO of WuXi XDC commented: "Today’s expanded collaboration with LigaChem underscores the strength of our long-standing partnership. By leveraging our integrated service platforms across discovery, development, and manufacturing, LigaChem will be able to accelerate the development of their promising ADC candidates and streamline the development and manufacturing of their ADC projects. This collaboration reaffirms our ongoing commitment to helping our clients bring innovative therapies to market faster and more efficiently."

This expanded MOU builds on the initial collaboration between WuXi XDC and LigaChem, which began in 2021. Since then, both companies have made significant strides in advancing the innovation of ADCs and bioconjugates. This new agreement further solidifies the shared vision of advancing the next wave of innovation in the ADC field, poised to deliver meaningful benefits to patients worldwide.

Inceptor Bio Announces First Patient Dosed in Clinical Trial of IB-T101 for Clear Cell Renal Cell Carcinoma (ccRCC) and $21M Series A2 Financing

On February 25, 2025 Inceptor Bio, a clinical-stage biotechnology company pioneering next-generation cell therapies, reported that the first patient has been dosed in the clinical trial of IB-T101, the company’s lead program (Press release, Inceptor Bio, FEB 25, 2025, View Source [SID1234650559]). The trial marks a significant milestone for Inceptor Bio’s efforts to address the unmet medical needs of patients with clear cell Renal Cell Carcinoma (ccRCC)

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IB-T101 is an autologous CD70 CAR-T therapy powered by OUTLAST, Inceptor Bio’s novel platform that metabolically reprograms T cells to thrive in the hostile tumor microenvironment (TME) by conditioning for the fittest, most persistent cells through controlled TME-like stress.

This Investigator-Initiated Trial (IIT) aims to evaluate the safety, tolerability, and preliminary efficacy of IB-T101 in patients with ccRCC who have relapsed on prior VEGF-targeting therapies alone or in combination with an immune checkpoint inhibitor. The trial will enroll patients across a dose-escalation phase to determine the optimal dose of IB-T101. The primary endpoints include safety and tolerability, while secondary endpoints will evaluate anti-tumor activity and pharmacokinetics.

In conjunction with this milestone, Inceptor Bio has successfully closed a $21 million Series A2 financing, which will support the ongoing clinical development of IB-T101 and the expansion of its next-generation cell therapy pipeline. The round was led by a syndicate of insiders including Kineticos Life Sciences.

"This is a major milestone for Inceptor Bio as we advance IB-T101 into the clinic," said Dr. Matthias Schroff, Chief Executive Officer of Inceptor Bio. "Similar to elite athletes training at high elevation, T cells conditioned in challenging environments develop the attributes needed to outperform in solid tumors. With the support and confidence of our investors, we are focused on advancing our lead program with the goal of delivering a best-in-class therapy that has the potential to change the treatment paradigm for patients facing these challenging cancers."

"Dosing the first patient in a clinical trial is a significant milestone for any biotech company, and we are proud to support Inceptor Bio as they advance IB-T101 into the clinic," said Shailesh Maingi, Managing Partner of Kineticos Life Sciences. "The OUTLAST platform represents a compelling approach to addressing key challenges in CAR-T therapy, and we believe this program has the potential to make a real difference for patients with solid tumors."

About IB-T101 and ccRCC
IB-T101 is an autologous CAR-T therapy targeting CD70, a validated tumor-associated antigen overexpressed in ccRCC and other cancers. Clear cell Renal Cell Carcinoma represents the most common type of kidney cancer, with over 300,000 new cases annually worldwide and significant unmet medical need due to limited treatment options.