On August 4, 2025 Alphamab Oncology (stock code: 9966.HK) reported that the Investigational New Drug (IND) application for JSKN022, an independently developed innovative bispecific antibody-drug conjugate (ADC) targeting PD-L1 and integrin αvβ6, has been officially accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The Company plans to initiate a clinical study of JSKN022 for the treatment of advanced malignant solid tumors.

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JSKN022 is an innovative bispecific ADC developed in-house with Alphamab’s proprietary glycan-specific conjugation platform. The molecule simultaneously targets and binds to both PD-L1 and integrin αvβ6 on the surface of tumor cells. After binding to either target, JSKN022 enters the lysosome through target-mediated endocytosis. The cleavable linker is specifically hydrolyzed by proteolytic enzymes such as cathepsin B, releasing cytotoxic topoisomerase I inhibitor (T01), which then induces apoptosis of PD-L1 and/or integrin αvβ6 positive tumor cells. In addition, the inhibitor can penetrate the cell membrane and enter the antigen-negative tumor cells to exert bystander effects. These combined effects can effectively inhibit the growth of tumor cells.

At present, no ADC targeting integrin αvβ6 or PD-L1 has been approved for marketing worldwide, with all related investigational candidates remaining in clinical development stages. Preclinical data demonstrate that JSKN022 exhibits potent antitumor activity in both in vitro and in vivo models against tumor cells expressing integrin αvβ6 and/or PD-L1. JSKN022 will potentially bring in novelty in the therapeutic approach for cancers that are refractory or resistant to PD-1/PD-L1 inhibitors, including non-small cell lung cancer, head and neck squamous cell carcinoma, and colorectal cancer.

This Phase I clinical study will evaluate the safety, tolerability, pharmacokinetics (PK)/pharmacodynamics (PD), and antitumor activity of JSKN022 in patients with advanced malignant solid tumors who have failed standard therapies, and determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D).

About JSKN022

JSKN022 is a first-in-class ADC targeting both PD-L1 and integrin αvβ6. Based on independently developed Envafolimab, Alphamab integrates immuno-oncology (IO) mechanisms with ADC approaches. This novel drug molecule utilizes glycan-specific conjugation technology to enhance both stability and homogeneity. The topoisomerase I inhibitor T01 is site-specifically conjugated to antibodies via a cleavable linker, enhancing therapeutic efficacy. JSKN022 is expected to provide a novel therapeutic option for cancers that are refractory or resistant to PD-1/PD-L1 inhibitors. The IND application for the clinical study of JSKN022 for the treatment of advanced malignant solid tumors has been accepted by CDE.

(Press release, Alphamab, AUG 4, 2025, View Source [SID1234656999])

On August 4, 2025 Tikva Allocell (Tikva), a biotechnology company developing off-the-shelf CAR-T cell therapies for solid tumors, reported that its Founder and CEO, Dr. Ivan Horak will join a keynote panel at the Asian Pharma and Biotech Project, Program and Portfolio Management Conference, being held in Singapore, August 5-6, 2025 (Press release, Tikva Allocell, AUG 4, 2025, https://www.prnewswire.com/news-releases/tikva-allocell-to-participate-in-keynote-panel-discussion-at-asian-pharma-and-biotech-project-program-and-portfolio-management-conference-302519921.html [SID1234654741]).

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"I look forward to exploring how innovation, investment, and strategic thinking are shaping the region’s future in drug development, including advancing next generation therapies for cancer," said Dr. Horak. "Headquartered in Singapore, Tikva is led by a seasoned cell therapy development team with extensive experience in designing and developing ‘off-the-shelf’ T cell therapies utilizing Allogeneic Epstein-Barr Virus (EBV)-Specific T cells (ALLO EBVST). We look forward to discussing how Tikva is leading this next generation of CAR-T technology, and the role Singapore will play in the future of this key sector."

The panel is titled "The Evolving Pharma and Biotech Landscape in Asia, Accelerating Drug Development Through Innovation, Investment, and Strategic Growth." Panelists will discuss the state of drug development projects in Asia including key opportunities and challenges in clinical trials, R&D, and commercialization, as well as the role of incubators, government agencies, and venture funding are playing to supporting early-stage innovation and accelerate drug development. The dialogue will also elaborate on key regulatory shifts, AI, and emerging technologies and how these factors are transforming clinical development and portfolio management in Asia.

Details of the presentation are as follows:

Event:

Asian Pharma and Biotech Project, Program and Portfolio Management Conference

Date and Time:

August 5, 2025 at 9:00 AM SGT

Location:

One Farrer Hotel, Singapore

Participant:

Dr. Ivan Horak, Founder and CEO, Tikva Allocell

During the conference, Dr. Horak will conduct one-on-one meetings with registered investors and potential partners, showcasing the company’s business and clinical development strategy, recent achievements, and anticipated milestones.

On August 4, 2025 US WorldMeds (USWM) reported the successful closing of the previously announced acquisition of Adaptimmune Therapeutics plc’s (Adaptimmune) cell–therapy assets—including TECELRA (afamitresgene autoleucel), lete–cel, afami–cel, and uza–cel (Press release, US WorldMeds, AUG 4, 2025, View Source [SID1234654740]). The acquisition was first announced on July 28, 2025 and has now been finalized.

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Under the terms of the Asset Purchase Agreement, USWM paid $55 million in cash at closing and will fund up to an additional $30 million in performance-based milestone payments tied to commercial and regulatory outcomes. Adaptimmune has retained rights to its pre–clinical programs, including PRAME– and CD70–directed T–cell therapies, and its allogeneic pipeline.

Key Highlights:

Patient care continuity: TECELRA will remain available to patients without interruption, now under USWM’s stewardship.

Future development: USWM plans to bring lete–cel to the U.S. market, with potential regulatory approval anticipated in 2026, and will continue development of uza–cel in collaboration with Galapagos.

Employee transition: Approximately half of Adaptimmune’s U.S.-based workforce is being offered roles at USWM to support commercialization, production, and ongoing development of the acquired assets.

Transition support: Adaptimmune is providing transition services through June 2026 to ensure operational continuity.
Breck Jones, Chief Executive Officer of US WorldMeds, commented: "With the transaction now complete, we are excited to officially welcome Adaptimmune’s programs and people into our organization. We are committed to building on the strong foundation Adaptimmune has established and advancing these therapies to bring lasting impact to patients with high unmet needs."

TD Cowen acted as financial advisor, and Ropes & Gray LLP provided legal counsel, to Adaptimmune.

Gibson, Dunn & Crutcher LLP provided legal counsel to US WorldMeds.

The transaction was financed by debt financing led by funds managed by Oaktree Capital Management, L.P. ("Oaktree"), with participation from funds managed by Athyrium Capital Management, LP ("Athyrium").

Indication

TECELRA is a medicine, called a genetically modified autologous T cell immunotherapy, that is used to treat synovial sarcoma. It is used when other kinds of treatment do not work. TECELRA is different from other cancer medicines because it is made from your own white blood cells that are made to recognize and attack your cancer cells. Your healthcare provider will perform tests to see if TECELRA is right for you. TECELRA is approved based on patient response data. Additional data are needed to confirm the clinical benefit of TECELRA. It is not known if TECELRA is safe and effective in children.

Important Safety Information

Important Warning: You will likely be in a hospital before and after getting TECELRA. TECELRA may cause side effects that can be severe or life-threatening. Call your healthcare provider or get emergency help right away if you get any of the following: fever (100.4°F/38°C or higher); chills/shivering; difficulty breathing; fast or irregular heartbeat; low blood pressure; fatigue; severe nausea, vomiting, or diarrhea; severe headache; or new skin rash. Tell all your healthcare providers that you were treated with TECELRA.

After getting TECELRA, you will be monitored daily at the healthcare facility for at least 7 days after the infusion. You should plan to stay close to a healthcare facility for at least 4 weeks. Do not drive, operate heavy machinery, or do other activities that could be dangerous for at least 4 weeks after you get TECELRA. Your healthcare provider will do blood tests to follow your progress. It is important that you have your blood tested. If you miss a scheduled appointment for your collection of blood, call your healthcare provider as soon as possible to reschedule.

Before you receive TECELRA, tell your healthcare provider about all the medicines and supplements you take and your medical conditions, including: seizure, stroke, confusion, or memory loss; heart, liver, or kidney problems; low blood pressure; lung or breathing problems; recent or active infection; past infections that can be reactivated following treatment with TECELRA; low blood counts; pregnancy, you think you may be pregnant, or plan to become pregnant; breastfeeding; or taking a blood thinner.

The most common side effects of TECELRA include nausea, vomiting, fatigue, infection, constipation, fever (100.4°F/38°C or higher), abdominal pain, difficulty breathing, decreased appetite, diarrhea, low blood pressure, back pain, fast heart rate, chest pain, general body swelling, low white blood cells, low red blood cells, and low platelets.

You are encouraged to report side effects to the FDA at (800) FDA–1088 or www.fda.gov/medwatch.

On August 4, 2025 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that its global, multicenter, randomized Phase II registrational trial (COMPASSION-36/AK104-225) has been approved to initiate by both China’s National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA) (Press release, Akeso Biopharma, AUG 4, 2025, View Source [SID1234654739]). The trial will evaluate cadonilimab, Akeso’s first-in-class PD-1/CTLA-4 bispecific antibody, in combination with lenvatinib versus lenvatinib alone for the treatment of advanced hepatocellular carcinoma (HCC) in patients previously treated with atezolizumab (a PD-L1 inhibitor) and bevacizumab. Akeso is now moving forward with the initiation of the study.

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The COMPASSION-36/AK104-225 study is a key part of cadonilimab’s global development for hepatocellular carcinoma, continuing Akeso’s mission to advance cancer immunotherapy standards and to address the current limited survival benefits of single-target therapies. This international, multicenter Phase II trial is designed to tackle the common issue of limited treatment options following resistance to immune checkpoint inhibitors (IO) in cancer therapy.

Currently, immune checkpoint inhibitor (IO) combination therapies have become the standard first-line treatment for various advanced malignancies. However, for patients worldwide whose disease progresses after IO combination therapy, there is a lack of effective second-line treatment options. The very limited second-line treatment options for advanced malignancies drives the critical need to explore new therapeutic strategies. Cadonilimab-based combination therapies have shown substantial potential in overcoming IO resistance across multiple tumor types.

Hepatocellular carcinoma (HCC) is one of the most prevalent malignancies worldwide, with approximately 865,000 new cases of liver cancer reported globally in 2022. The combination of atezolizumab and bevacizumab (A+T regimen) is the standard first-line therapy for advanced HCC, as recommended by the NCCN guidelines. However, for patients whose disease progresses after first-line A+T treatment, there is currently no FDA-approved second-line therapy available in the U.S., and also no approved treatment options from the NMPA in China. This creates a significant unmet need in the clinical management of these patients.

Cadonilimab is the first bispecific antibody for cancer immunotherapy to be approved globally and also the first bispecific antibody to be approved in China. The potential of cadonilimab for the treatment of HCC has been validated in multiple studies：

At the 2023 European Society for Medical Oncology Asia Congress (ESMO Asia), a study was presented demonstrating that cadonilimab, combined with FOLFOX-HAIC as neoadjuvant therapy, achieved a 100% disease control rate (DCR) in patients with resectable multinodular HCC, with an acceptable safety profile.
Additionally, data presented at the 2023 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress revealed that the combination of cadonilimab and lenvatinib as first-line treatment for advanced HCC shows superior antitumor activity compared to currently approved therapies for advanced HCC.
Akeso’s exploration of combination therapies with cadonilimab in the treatment of HCC offers a broad and effective approach to disease management. These combinations address both early and advanced stages of HCC and provide promising therapeutic options for a wide range of patients:

In addition to the international multicenter Phase II registrational study COMPASSION-36, patient enrollment for the Phase III clinical trial of cadonilimab as adjuvant therapy for high-risk recurrence following curative surgery for HCC has been completed.
Furthermore, a Phase III registrational study of cadonilimab combined with lenvatinib and transarterial chemoembolization (TACE) for the treatment of intermediate to advanced unresectable HCC is currently ongoing.
Additionally, multiple Phase II studies investigating cadonilimab in combination with pulocimab (VEGFR-2), ivonescimab (PD-1/VEGF), and other therapies are currently underway for PD-1/L1 inhibitor-resistant non-small cell lung cancer (NSCLC), HCC, and other malignancies. These studies demonstrate cadonilimab’s potential in treating IO-resistant tumors.
Dr. Yu Xia, Founder, Chairwoman, President, and CEO of Akeso, remarked, "We are excited to initiate cadonilimab’s first international multicenter registrational trial, a pivotal step in addressing the global challenge of cancer immunotherapy resistance. This study represents a key milestone in Akeso’s global strategy to address the substantial clinical unmet needs in oncology. Akeso is advancing the clinical development of its innovative pipeline, including ivonescimab, cadonilimab, ligufalimab (CD47), and AK146D1 (Trop2/Nectin4 bispecific ADC) through both in-house initiatives and strategic global collaborations. Our goal is to provide accessible and impactful survival benefits to patients worldwide, and to position Akeso at the forefront of oncology innovation."

On August 4, 2025 Anbogen Therapeutics reported that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for ABT-301, enabling the initiation of a Phase 1/2 clinical trial in combination with tislelizumab and bevacizumab for patients with metastatic colorectal cancer (mCRC) (Press release, Anbogen Therapeutics, AUG 4, 2025, View Source [SID1234654738]).

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This open-label, multi-center international study plans to enroll 66 patients with proficient mismatch repair (pMMR) or non-microsatellite instability-high (non-MSI-H) mCRC to evaluate the safety and preliminary efficacy of the triplet therapy. Enrollment is planned in Taiwan and Australia. Tislelizumab, a PD-1 monoclonal antibody, used in this trial is provided by BeOne Medicines (formerly known as BeiGene). Further details on this collaboration were disclosed by Anbogen in a press release dated September 27, 2024.

ABT-301 is an oral HDAC1/2/3 inhibitor. Preclinical studies have shown that it promotes CD8+ cytotoxic T cell infiltration and activity, enhances antigen presentation, and inhibits M-MDSCs cells, effectively modulating the tumor microenvironment and converting "cold tumors" into "hot tumors" to improve the efficacy of immune checkpoint inhibitors. ABT-301 also exhibits pro-apoptotic, anti-angiogenic, and tumor metabolic regulation effects. As a single-molecule, multi-modality anti-cancer agent, ABT-301 aims to enhance tumor treatment when combined with the two antibody drugs.

Notably, in a previous Phase 1 monotherapy clinical trial involving 23 participants, ABT-301 did not exhibit neutropenia or cardiac toxicity, which are commonly observed in other HDAC inhibitors—further supporting its suitability for use in combination immunotherapy.

Approximately 95% of mCRC patients are pMMR or non-MSI-H types—commonly referred to as "cold tumors"—which respond poorly to current immunotherapies. Only around 5% of patients with deficient mismatch repair (dMMR) or microsatellite instability-high (MSI-H) "hot tumors" typically benefit from immune checkpoint inhibitors. According to GlobalData, an estimated 370,000 new pMMR/non-MSI-H patients in second-line or later settings are diagnosed annually across the U.S., China, Japan, and the top five European markets (UK, France, Germany, Spain, and Italy), representing a potential market size of USD $9 billion.

Anbogen stated that the FDA’s IND approval marks a key milestone in the development of ABT-301, demonstrating the safety profile of the triplet therapy and advancing it into clinical stages. The company emphasized that the study targets the majority of patients (over 90%) with poor responses to immunotherapy, aiming to provide a novel treatment option and address this unmet clinical need.

Looking ahead, Anbogen will continue to advance the clinical development of ABT-301 while pursuing global licensing and strategic partnerships to accelerate commercialization and market entry. The company is also launching its Series B fundraising to attract strategic partners committed to advancing innovative cancer therapies and global expansion.